Ibuprofeno Gemepe may be available in the countries listed below.
Ibuprofen lysine (a derivative of Ibuprofen) is reported as an ingredient of Ibuprofeno Gemepe in the following countries:
International Drug Name Search
Bridion
1 ml contains sugammadex sodium equivalent to 100 mg sugammadex.
2 ml contains sugammadex sodium equivalent to 200 mg sugammadex.
5 ml contains sugammadex sodium equivalent to 500 mg sugammadex.
For a full list of excipients, see section 6.1.
Excipient(s):
Each ml contains 9.7 mg sodium (see section 4.4).
Solution for injection (injection).
Clear and colourless to slightly yellow solution.
The pH is between 7 and 8 and osmolality is between 300 and 500 mOsm/kg.
Reversal of neuromuscular blockade induced by rocuronium or vecuronium.
For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents.
Sugammadex should only be administered by, or under the supervision of an anaesthetist. The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade. As is normal post-anaesthetic practice following neuromuscular blockade it is recommended to monitor the patient in the immediate post-operative period for untoward events including re-occurrence of blockade (see section 4.4). When certain medicinal products that may cause displacement interactions are administered parenterally within a period of 6 hours of sugammadex, the patient should be monitored for signs of re-occurrence of blockade (see section 4.4 and 4.5).
The recommended dose of sugammadex depends on the level of neuromuscular blockade to be reversed.
The recommended dose does not depend on the anaesthetic regimen.
Sugammadex can be used to reverse different levels of rocuronium or vecuronium induced neuromuscular blockade:
Adults
Routine reversal:
A dose of 4 mg/kg sugammadex is recommended if recovery has reached at least 14/T1 ratio to 0.9 is around 3 minutes (see section 5.1).
A dose of 2 mg/kg sugammadex is recommended, if spontaneous recovery has occurred up to at least the reappearance of T2 following rocuronium or vecuronium induced blockade. Median time to recovery of the T4/T1 ratio to 0.9 is around 2 minutes (see section 5.1).
Using the recommended doses for routine reversal will result in a slightly faster median time to recovery of the T4/T1 ratio to 0.9 of rocuronium when compared to vecuronium induced neuromuscular blockade (see section 5.1).
Immediate reversal of rocuronium-induced blockade:
If there is a clinical need for immediate reversal following administration of rocuronium a dose of 16 mg/kg sugammadex is recommended. When 16 mg/kg sugammadex is administered 3 minutes after a bolus dose of 1.2 mg/kg rocuronium bromide, a median time to recovery of the T4/T1 ratio to 0.9 of approximately 1.5 minutes can be expected (see section 5.1).
There is no data to recommend the use of sugammadex for immediate reversal following vecuronium induced blockade.
Re
In the exceptional situation of re
Re-administration of rocuronium or vecuronium after sugammadex:
A waiting time of 24 hours should be taken into account (see section 4.4).
Additional information on special population
Renal impairment:
For mild and moderate renal impairment (creatinine clearance
The use of sugammadex in patients with severe renal impairment (including patients requiring dialysis (CrCl < 30 ml/min)) is not recommended (see section 4.4).
Elderly patients:
After administration of sugammadex at reappearance of T2 following a rocuronium induced blockade, the median time to recovery of the T4/T1 ratio to 0.9 in adults (18
Obese patients:
In obese patients, the dose of sugammadex should be based on actual body weight. The same dose recommendations as for adults should be followed.
Hepatic impairment:
For mild to moderate hepatic impairment: as sugammadex is mainly excreted renally no dose adjustments are required.
Studies in patients with hepatic impairment have not been conducted and therefore patients with severe hepatic impairment should be treated with great caution (see section 4.4).
Paediatric population:
The data for the paediatric population are limited (one study only for reversal of rocuronium induced blockade at reappearance of T2).
Children and adolescents:
For routine reversal of rocuronium induced blockade at reappearance of T2 in children and adolescents (2
Immediate reversal in children and adolescents has not been investigated and is therefore not recommended until further data become available.
Bridion 100 mg/ml may be diluted to 10 mg/ml to increase the accuracy of dosing in the paediatric population (see section 6.6).
Term newborn infants and infants:
There is only limited experience with the use of sugammadex in infants (30 days to 2 years), and term newborn infants (less than 30 days) have not been studied. The use of sugammadex in term newborn infants and infants is therefore not recommended until further data become available.
Method of administration
Sugammadex should be administered intravenously as a single bolus injection. The bolus injection should be given rapidly, within 10 seconds directly into a vein or into an existing intravenous line (see section 6.6). Sugammadex has only been administered as a single bolus injection in clinical trials.
Hypersensitivity to the active substance or to any of the excipients.
Monitoring respiratory function during recovery:
Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored following reversal of neuromuscular block. Even if recovery from neuromuscular blockade is complete, other medicinal products used in the peri- and postoperative period could depress respiratory function and therefore ventilatory support might still be required.
Should neuromuscular blockade reoccur following extubation, adequate ventilation should be provided.
Re-occurrence of blockade:
In clinical trials re-occurrence of blockade was reported mainly when sub-optimal doses (in dose finding studies) were administered. In order to prevent re
Effect on hemostasis:
In a study in volunteers doses of 4 mg/kg and 16 mg/kg of sugammadex prolonged by 17
In in vitro experiments a pharmacodynamic interaction (aPTT and PT prolongation) was noted with vitamin K antagonists, unfractionated heparin, low molecular weight heparinoids, rivaroxaban and dabigatran. In patients receiving routine post-operative prophylactic anticoagulation this pharmacodynamic interaction is not clinically relevant. Caution should be exercised when considering the use of sugammadex in patients receiving therapeutic anticoagulation for a pre-existing or co-morbid condition.
An increased risk of bleeding can not be excluded in patients:
• with hereditary vitamin K dependent clotting factor deficiencies;
• with pre-existing coagulopathies;
• on coumarin derivates and at an INR above 3.5;
• using anticoagulants who receive a dose of 16 mg/kg sugammadex.
If there is a medical need to give sugammadex to these patients the anaesthesiologist needs to decide if the benefits outweigh the possible risk of bleeding complications taking into consideration the patients history of bleeding episodes and type of surgery scheduled. If sugammadex is administered to these patients monitoring of hemostasis and coagulation parameters is recommended.
Waiting times for re
If re
If neuromuscular blockade is required before the recommended waiting time has passed, a nonsteroidal neuromuscular blocking agent should be used.
Renal impairment:
In patients with severe renal failure (creatinine clearance < 30 ml/min) the excretion of sugammadex or the sugammadex-rocuronium complex was delayed, however in these patients there were no signs of re
Interactions due to the lasting effect of rocuronium or vecuronium:
When medicinal products which potentiate neuromuscular blockade are used in the post-operative period special attention should be paid to the possibility of re-occurrence of blockade. Please refer to the package leaflet of rocuronium or vecuronium for a list of the specific medicinal products which potentiate neuromuscular blockade. In case re
Potential interactions:
• Capturing interactions:
Due to the administration of sugammadex, certain medicinal products could become less effective due to a lowering of the (free) plasma concentrations (see section 4.5, hormonal contraceptives).
If such a situation is observed, the clinician is advised to consider the re-administration of the medicinal product, the administration of a therapeutically equivalent medicinal product (preferably from a different chemical class) and/or non-pharmacological interventions as appropriate.
• Displacement interactions:
Due to the administration of certain medicinal products after sugammadex, theoretically rocuronium or vecuronium could be displaced from sugammadex. As a result re-occurrence of blockade might be observed. In this situation the patient must be ventilated. Administration of the medicinal product which caused displacement should be stopped in case of an infusion. In situations when potential displacement interactions can be anticipated, patients should be carefully monitored for signs of re-occurrence of blockade (approximately up to 15 minutes) after parenteral administration of another medicinal product occurring within a period of 6 hours after sugammadex administration. Displacement interactions are at present only expected for a few drugs substances (toremifene and fusidic acid, see section 4.5).
Light anaesthesia:
When neuromuscular blockade was reversed intentionally in the middle of anaesthesia in clinical trials, signs of light anaesthesia were noted occasionally (movement, coughing, grimacing and suckling of the tracheal tube).
If neuromuscular blockade is reversed, while anaesthesia is continued, additional doses of anaesthetic and/or opioid should be given as clinically indicated.
Hepatic impairment:
Sugammadex is not metabolised nor excreted by the liver; therefore dedicated studies in patients with hepatic impairment have not been conducted. Patients with severe hepatic impairment should be treated with great caution.
Use in Intensive Care Unit (ICU):
Sugammadex has not been investigated in patients receiving rocuronium or vecuronium in the ICU setting.
Use for reversal of neuromuscular blocking agents other than rocuronium or vecuronium:
Sugammadex should not be used to reverse block induced by nonsteroidal neuromuscular blocking agents such as succinylcholine or benzylisoquinolinium compounds.
Sugammadex should not be used for reversal of neuromuscular blockade induced by steroidal neuromuscular blocking agents other than rocuronium or vecuronium, since there are no efficacy and safety data for these situations. Limited data are available for reversal of pancuronium induced blockade, but it is advised not to use sugammadex in this situation.
Delayed recovery:
Conditions associated with prolonged circulation time such as cardiovascular disease, old age (see section 4.2 for the time to recovery in elderly), or oedematous state may be associated with longer recovery times.
Allergic reactions:
Clinicians should be prepared for the possibility of allergic reactions and take the necessary precautions (see section 4.8).
Patients on a controlled sodium diet:
Each ml solution contains 9.7 mg sodium. A dose of 23 mg sodium is considered essentially 'sodium-free'. If more than 2.4 ml solution needs to be administered, this should be taken into consideration by patients on a controlled sodium diet.
QTc-interval prolongation:
Two thorough QTc trials (N=146), both in conscious volunteers, demonstrated that sugammadex alone or in combination with rocuronium or vecuronium is not associated with QTc interval prolongation. The one-sided 95% upper confidence limits for the QTc difference to placebo were well below the 10 ms margin for each of the 12
In the clinical program, a few cases of QTc prolongation were reported (QTc> 500 msec or QTc increases> 60 msec) in clinical trials in which patients received sugammadex in combination with sevoflurane or propofol. During anaesthesia several medicinal products with the potential to prolong QTc (e.g. sevoflurane) are administered. The routine precautions for treating arrhythmia should be taken into consideration.
The information in this section is based on binding affinity between sugammadex and other medicinal products, non-clinical experiments, clinical studies and simulations using a model taking into account the pharmacodynamic effect of neuromuscular blocking agents and the pharmacokinetic interaction between neuromuscular blocking agents and sugammadex. Based on these data, no clinically significant pharmacodynamic interaction with other medicinal products is expected, with exception of the following:
For toremifene and fusidic acid displacement interactions could not be excluded (no clinically relevant capturing interactions are expected).
For hormonal contraceptives a clinically relevant capturing interaction could not be excluded (no displacement interactions are expected).
Interactions potentially affecting the efficacy of sugammadex (see also section 4.4):
Toremifene:
For toremifene, which has a relatively high affinity constant and relatively high plasma concentrations, some displacement of vecuronium or rocuronium from the complex with sugammadex could occur. The recovery of the T4/T1 ratio to 0.9 could therefore be delayed in patients who have received toremifene on the same day of the operation.
Intravenous administration of fusidic acid:
The use of fusidic acid in the pre-operative phase may give some delay in the recovery of the T4/T1 ratio to 0.9. No re-occurrence of neuromuscular blockade is expected in the post-operative phase, since the infusion rate of fucidic acid is over a period of several hours and the blood levels are cumulative over 2-3 days. For re
Interactions potentially affecting the efficacy of other medicinal products (see also section 4.4):
Hormonal contraceptives:
The interaction between 4 mg/kg sugammadex and a progestogen was predicted to lead to a decrease in progestogen exposure (34% of AUC) similar to the decrease seen when a missed daily dose of an oral contraceptive is taken 12 hours too late, which might lead to a reduction in effectiveness. For estrogens, the effect is expected to be lower. Therefore the administration of a bolus dose of sugammadex is considered to be equivalent to one missed daily dose of oral contraceptive steroids (either combined or progestogen only). If sugammadex is administered at the same day as an oral contraceptive is taken reference is made to missed dose advice in the package leaflet of the oral contraceptive. In the case of non-oral hormonal contraceptives, the patient must use an additional non hormonal contraceptive method for the next 7 days and refer to the advice in the package leaflet of the product.
Interference with laboratory tests:
In general sugammadex does not interfere with laboratory tests, with the possible exception of the serum progesterone assay. Interference with this test is observed at sugammadex plasma concentrations of 100 μg/ml (peak plasma level following 8 mg/kg bolus injection).
In a study in volunteers doses of 4 mg/kg and 16 mg/kg of sugammadex prolonged by 17
In in vitro experiments a pharmacodynamic interaction (aPTT and PT prolongation) was noted with vitamin K antagonists, unfractionated heparin, low molecular weight heparinoids, rivaroxaban and dabigatran (see section 4.4).
Paediatric population
No formal interaction studies have been performed. The above mentioned interactions for adults and the warnings in section 4.4 should also be taken into account for the paediatric population.
For sugammadex no clinical data on exposed pregnancies are available.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.
Caution should be exercised when administering sugammadex to pregnant women.
It is unknown whether sugammadex is excreted in human breast milk. Animal studies have shown excretion of sugammadex in breast milk. Oral absorption of cyclodextrins in general is low and no effects on the suckling child is anticipated following a single dose to the breast-feeding woman.
Sugammadex can be used during breast-feeding.
No studies on the effects on the ability to drive and use machines have been performed.
The safety of sugammadex has been evaluated based on an integrated safety database of approximately 1700 patients and 120 volunteers. The most commonly reported adverse reaction dysgeusia (metal or bitter taste) was mainly seen after doses of 32 mg/kg sugammadex or higher. In a few individuals allergic-like reactions (i.e. flushing, erythematous rash) following sugammadex were reported of which one was a confirmed mild allergic reaction.
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Anaesthetic complication:
Anaesthetic complications, indicative of the restoration of neuromuscular function, include movement of a limb or the body or coughing during the anaesthetic procedure or during surgery, grimacing, or suckling on the endotracheal tube. See section 4.4 light anaesthesia.
Awareness:
In sugammadex treated subjects a few cases of awareness were reported. The relation to sugammadex is uncertain.
Re-occurrence of blockade:
In the data-base of pooled phase I
Additional information on special populations
Pulmonary patients:
In one clinical trial in patients with a history of pulmonary complications bronchospasm was reported as a possibly related adverse event in two patients and a causal relationship could not be fully excluded. As with all patients with a history of pulmonary complications the physician should be aware of the possible occurrence of bronchospasm.
Paediatric population
A limited database suggests that the safety profile of sugammadex (up to 4 mg/kg) in paediatric patients was similar to that in adults.
In clinical studies, 1 case of an accidental overdose with 40 mg/kg was reported without any significant undesirable effects. In a human tolerance study sugammadex was administered in doses up to 96 mg/kg. No dose related adverse events nor serious adverse events were reported.
Pharmacotherapeutic group: all other therapeutic products, ATC code: V03AB35
Mechanism of action:
Sugammadex is a modified gamma cyclodextrin which is a Selective Relaxant Binding Agent. It forms a complex with the neuromuscular blocking agents rocuronium or vecuronium in plasma and thereby reduces the amount of neuromuscular blocking agent available to bind to nicotinic receptors in the neuromuscular junction. This results in the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
Pharmacodynamic effects:
Sugammadex has been administered in doses ranging from 0.5 mg/kg to 16 mg/kg in dose response studies of rocuronium induced blockade (0.6, 0.9, 1.0 and 1.2 mg/kg rocuronium bromide with and without maintenance doses) and vecuronium induced blockade (0.1 mg/kg vecuronium bromide with or without maintenance doses) at different time points/depths of blockade. In these studies a clear dose-response relationship was observed.
Clinical efficacy and safety:
Sugammadex can be administered at several time points after administration of rocuronium or vecuronium bromide:
Routine reversal – deep neuromuscular blockade:
In a pivotal study patients were randomly assigned to the rocuronium or vecuronium group. After the last dose of rocuronium or vecuronium, at 14/T1 ratio to 0.9 was:
Time (minutes) from administration of sugammadex or neostigmine at deep neuromuscular blockade (14/T1 ratio to 0.9
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Routine reversal – moderate neuromuscular blockade:
In another pivotal study patients were randomly assigned to the rocuronium or vecuronium group. After the last dose of rocuronium or vecuronium, at the reappearance of T2, 2 mg/kg sugammadex or 50 mcg/kg neostigmine was administered in a randomised order. The time from start of administration of sugammadex or neostigmine to recovery of the T4/T1 ratio to 0.9 was:
Time (minutes) from administration of sugammadex or neostigmine at reappearance of T2 after rocuronium or vecuronium to recovery of the T4/T1 ratio to 0.9
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Reversal by sugammadex of the neuromuscular blockade induced by rocuronium was compared to the reversal by neostigmine of the neuromuscular blockade induced by cis-atracurium. At the reappearance of T2 a dose of 2 mg/kg sugammadex or 50 mcg/kg neostigmine was administered. Sugammadex provided faster reversal of neuromuscular blockade induced by rocuronium compared to neostigmine reversal of neuromuscular blockade induced by cis-atracurium:
Time (minutes) from administration of sugammadex or neostigmine at reappearance of T2 after rocuronium or cis-atracurium to recovery of the T4/T1 ratio to 0.9
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For immediate reversal:
The time to recovery from succinylcholine-induced neuromuscular blockade (1 mg/kg) was compared with sugammadex (16 mg/kg, 3 minutes later) – induced recovery from rocuronium-induced neuromuscular blockade (1.2 mg/kg).
Time (minutes) from administration of rocuronium and sugammadex or succinylcholine to recovery of the T1 10%
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In a pooled analysis the following recovery times for 16 mg/kg sugammadex after 1.2 mg/kg rocuronium bromide were reported:
Time (minutes) from administration of sugammadex at 3 minutes after rocuronium to recovery of the T4/T1 ratio to 0.9, 0.8 or 0.7
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The sugammadex pharmacokinetic parameters were calculated from the total sum of non-complex-bound and complex-bound concentrations of sugammadex. Pharmacokinetic parameters as clearance and volume of distribution are assumed to be the same for non-complex-bound and complex-bound sugammadex in anaesthetised subjects.
Distribution:
The steady-state volume of distribution of sugammadex is approximately 11 to 14 litres. Neither sugammadex nor the complex of sugammadex and rocuronium bind to plasma proteins or erythrocytes, as was shown in vitro using male human plasma and whole blood. Sugammadex exhibits linear kinetics in the dosage range of 1 to 16 mg/kg when administered as an IV bolus dose.
Metabolism:
In preclinical and clinical studies no metabolites of sugammadex have been observed and only renal excretion of the unchanged product was observed as the route of elimination.
Elimination:
The elimination half-life (t½) of sugammadex in adults is 1.8 hours and plasma clearance is estimated to be 88 ml/min. A mass balance study demonstrated that> 90% of the dose was excreted within 24 hours. 96% of the dose was excreted in urine, of which at least 95% could be attributed to unchanged sugammadex. Excretion via faeces or expired air was less than 0.02% of the dose. Administration of sugammadex to healthy volunteers resulted in increased renal elimination of rocuronium in complex.
Special populations:
Elderly and renal impairment:
The pharmacokinetic parameters based on pharmacokinetic modelling in typical elderly and/or renally impaired patients are presented below:
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Mean and CV (%) are presented.
Paediatrics:
Pharmacokinetics in paediatric patients (n=51) with ages ranging from 0 to 17 years were evaluated using population pharmacokinetic (PK) analysis. In patients under age 18, volume of distribution and clearance increase with increasing age. Variability of plasma concentrations of sugammadex in paediatric patients is comparable to the variability in adult patients. The pharmacokinetic (PK) parameters of two typical paediatric patients are summarised below:
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Gender:
No gender differences were observed.
Race:
In a study in healthy Japanese and Caucasian subjects no clinically relevant differences in pharmacokinetic parameters were observed. Limited data does not indicate differences in pharmacokinetic parameters in Black or African Americans.
Body weight:
Population pharmacokinetic analysis of adult and elderly patients showed no clinically relevant relationship of clearance and volume of distribution with body weight.
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity potential, and toxicity to reproduction, local tolerance or compatibility with blood.
Sugammadex is rapidly cleared from most organs; however some retention of compound occurs in bone and teeth in the rat. The most likely component involved in the reversible binding is hydroxy apatite, the inorganic matrix in these tissues. Preclinical studies in young adult and mature rats have shown that this retention does not adversely affect tooth colour or bone quality, structure, turnover and development. In juvenile rats whitish discoloration was observed in the incisors and disturbance of enamel formation was observed upon repeated dosing, however at exposure levels of 48
Hydrochloric acid 3.7% and or sodium hydroxide (to adjust pH)
Water for injections
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Physical incompatibility has been reported with verapamil, ondansetron and ranitidine.
3 years
After first opening and dilution chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 25°C. From a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Store below 30°C. Do not freeze. Keep the vial in the outer carton in order to protect from light.
For storage conditions of the diluted medicinal product, see section 6.3.
Single use type I glass vial closed with grey chlorobutyl rubber stoppers with aluminium crimp-cap and flip
The rubber stopper of the vial does not contain latex.
Pack sizes: 10 vials of 2 ml or 10 vials of 5 ml.
Not all pack-sizes may be marketed.
If Bridion is administered via the same infusion line that is also used for other medicinal products, it is important that the infusion line is adequately flushed (e.g. with sodium chloride 9 mg/ml (0.9% solution)) between administration of Bridion and medicinal products for which incompatibility with Bridion has been demonstrated or for which compatibility with Bridion has not been established.
Sugammadex can be injected into the intravenous line of a running infusion with the following intravenous solutions: sodium chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%), sodium chloride 4.5 mg/ml (0.45%) and glucose 25 mg/ml (2.5%), Ringers lactate solution, Ringers solution, glucose 50 mg/ml (5%) in sodium chloride 9 mg/ml (0.9%).
Sugiran may be available in the countries listed below.
Alprostadil alfadex (a derivative of Alprostadil) is reported as an ingredient of Sugiran in the following countries:
International Drug Name Search
Misoprostol stada may be available in the countries listed below.
Misoprostol is reported as an ingredient of Misoprostol stada in the following countries:
International Drug Name Search
Metrijet may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Benzylpenicillin procaine (a derivative of Benzylpenicillin) is reported as an ingredient of Metrijet in the following countries:
Dihydrostreptomycin sulfate (a derivative of Dihydrostreptomycin) is reported as an ingredient of Metrijet in the following countries:
Oxytetracycline hydrochloride (a derivative of Oxytetracycline) is reported as an ingredient of Metrijet in the following countries:
International Drug Name Search
Adrenalin-Braun may be available in the countries listed below.
Epinephrine hydrochloride (a derivative of Epinephrine) is reported as an ingredient of Adrenalin-Braun in the following countries:
International Drug Name Search
Pro Dine 5000C™ is a concentrated iodine teat dip that,when diluted as directed, will produce a highly effective iodine teat dip. The product produced from Pro Dine 5000C™ is formulated to be safe and effective for use in pre- and post-dip or spray applications.Do not use Pro Dine 5000C™ in un-diluted form.
Dilution: 1 part Pro Dine 5000C™ to 4 parts of water. This will produce a 1% iodine teat dip with 10% skin conditioners. 1 part Pro Dine 5000C™ to 8 parts of water. This will produce a 0.5% iodine teat dip with 5% skin conditioners.For best dilution, keep concentrate stored at 70°F.
Directions: Pre-dipping: Before milking, dip or spray each teat with diluted Pro Dine 5000C™. Wait 15-30 seconds and then dry each teat with a single service towel. Post-dipping: Immediately after milking, dip or spray each teat with diluted Pro Dine 5000C™. Allow the teats to air dry. Do not wipe.
Caution: Harmful if swallowed. Eye irritant.
Use only as directed. In case of contact with eyes, flush immediately with tepid water for at least 15 minutes.
Avoid contamination of food.
Avoid freezing. if frozen, shake well before using.
Keep container away from heat and out of sunlight. Rinse empty container thoroughly before discarding.
| Pro Dine 5000C iodine solution | ||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 07/27/2010 | ||
| Labeler - ProChemicals LLC (089577290) |
| Registrant - ProChemicals LLC (089577290) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| ProChemicals LLC | 089577290 | manufacture | |
Dietary management of osteopenia and osteoporosis (weak bones).
Fosteum is a medical food. It works by slowing down bone breakdown activity and speeding up bone building activity.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Fosteum. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Fosteum. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Fosteum may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Fosteum as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Fosteum.
All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Fosteum side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include increased thirst; increased urination; lethargy; loss of appetite; severe or persistent nausea or vomiting; weakness.
Store Fosteum at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fosteum out of the reach of children and away from pets.
This information is summary only. It does not contain all information about Fosteum. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Farsifen may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Farsifen in the following countries:
International Drug Name Search
Generic Name: clotrimazole topical (kloe TRIM a zole)
Brand Names: Desenex AF Prescription Strength, Fungoid Solution, Lotrimin, Lotrimin Jock Itch Powder, Mycelex, Mycelex OTC
Clotrimazole topical is an antifungal medication. Clotrimazole topical prevents fungus from growing on your skin.
Clotrimazole topical is used to treat skin infections such as athlete's foot, jock itch, ringworm, and yeast infections.
Clotrimazole topical may also be used for purposes other than those listed in this medication guide.
Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).
Do not use clotrimazole topical if you have had an allergic reaction to it in the past.
Use clotrimazole topical exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Wash your hands before and after using this medication, unless you are using it to treat a hand infection.
Clean and dry the affected area. Apply a small amount of the cream (usually twice daily) for 2 to 4 weeks.
Do not take this medication by mouth.
If the infection does not clear up in 4 weeks, or if it appears to get worse, see your doctor.
Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.
Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of clotrimazole topical. Do not use a double dose unless otherwise directed by your doctor.
An overdose of clotrimazole topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used, or that clotrimazole topical has been ingested, contact an emergency room or a poison control center.
Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear clothing made of loose cotton and other natural fibers until the infection is healed.
Serious side effects of clotrimazole topical use are not expected. Stop using clotrimazole topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, swelling, or irritation of the skin.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Avoid using other topicals at the same time unless your doctor approves. Other skin medications may affect the absorption or effectiveness of clotrimazole topical.
Drugs other than those listed here may also interact with clotrimazole topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines.
Generic Name: acetaminophen, chlorpheniramine, and pseudoephedrine (a seet a MIN oh fen, klor fen IR a meen, soo doe e FED rin)
Brand Names: Alka-Seltzer Plus Cold Liquigel, Allerest Headache Strength, Allerest Sinus, Cold Medicine Plus, Comtrex Allergy Sinus, Comtrex Allergy Sinus Maximum Strength, Comtrex Allergy Sinus Night and Day, Kolephrin, Sinarest, Sinutab Ex-Strength, Theraflu Cold & Sore Throat (pseudoephedrine), Theraflu Flu & Sore Throat (pseudoephedrine), Theraflu Maximum Strength
Acetaminophen is a pain reliever and fever reducer.
Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of acetaminophen, chlorpheniramine, and pseudoephedrine is used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.
Acetaminophen, chlorpheniramine, and pseudoephedrine may also be used for purposes not listed in this medication guide.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
liver disease, cirrhosis, or a history of alcoholism;
a blockage in your digestive tract (stomach or intestines);
diabetes;
kidney disease;
epilepsy or other seizure disorder;
cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
enlarged prostate or urination problems;
low blood pressure;
pheochromocytoma (an adrenal gland tumor); or
if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.
Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.
Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.
Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.
chest pain, rapid pulse, fast or uneven heart rate;
confusion, hallucinations, severe nervousness;
tremor, seizure (convulsions);
easy bruising or bleeding, unusual weakness;
urinating less than usual or not at all;
nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
dizziness, drowsiness;
mild headache;
dry mouth, nose, or throat;
constipation;
blurred vision;
feeling nervous; or
sleep problems (insomnia);
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all other medicines you use, especially:
leflunomide (Arava);
topiramate (Topamax);
zonisamide (Zonegran);
an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;
an antidepressant;
birth control pills or hormone replacement therapy;
bladder or urinary medications;
blood pressure medication;
a bronchodilator;
cancer medicine;
cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;
gout or arthritis medications (including gold injections);
HIV/AIDS medication;
medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;
medicines to treat psychiatric disorders;
an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or
seizure medication.
This list is not complete and other drugs may interact with acetaminophen, chlorpheniramine, and pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Loratadina Stada may be available in the countries listed below.
Loratadine is reported as an ingredient of Loratadina Stada in the following countries:
International Drug Name Search
Generic Name: Lanthanum Carbonate
Class: Phosphate-removing Agents
VA Class: GU900
Chemical Name: Lanthanum Carbonate
Molecular Formula: La2(CO3)3 xH2O
Phosphate binder used to reduce the intestinal absorption of phosphates.1 2 3
Reduction of serum phosphorus in patients with end-stage renal disease (ESRD).1 2 3 Reductions in serum phosphorus concentrations are similar to those achieved with alternative phosphate binders (e.g., calcium salts, sevelamer).1 2 8 10
Risk of hypercalcemia apparently is less than with calcium (e.g., calcium carbonate) salts.1 5 8 9 10 11
Administer orally in divided doses with or immediately after meals (in order to bind dietary phosphates efficiently).1 2
Chew tablets completely before swallowing; do not swallow intact tablets.1
Available as lanthanum carbonate; dosage expressed in terms of lanthanum.1 2
Initially, 750 mg–1.5 g daily.1
Adjust dosage at 2- to 3-week intervals until serum phosphorus concentration is acceptable; generally titrated in increments of 750 mg daily in clinical studies.1 2
Dosage of 1.5–3 g daily usually is required to reduce serum phosphorus concentrations to <6 mg/dL;1 2 dosages up to 3.75 g daily have been studied.1
Monitor serum phosphorus concentrations as needed during titration and regularly thereafter.1
No known contraindications.1
Safety and efficacy not established in active peptic ulcer disease, ulcerative colitis, Crohn’s disease, or bowel obstruction; use with caution in patients with these disorders.1
Abdominal radiographs performed in patients taking lanthanum may have the typical radiopaque appearance of a radiograph performed using an imaging agent.1
No differences in fracture or mortality rates were observed between patients receiving lanthanum and those receiving alternative therapy for up to 3 years in clinical studies; however, data are insufficient to conclude lanthanum has no effect on fracture or mortality rates beyond 3 years of use.1
Category C.1
Not known whether lanthanum is distributed into milk.1 Caution if used in nursing women.1
Safety and efficacy not established in children <18 years of age.1 12
Deposited in developing bone (including the growth plate) of animals in long-term studies;1 although growth abnormalities in animals were not observed, the consequences of deposition in developing bone of pediatric patients are unknown.1
No substantial differences in safety and efficacy relative to younger adults.1
Nausea,1 2 3 4 vomiting,1 2 3 4 dialysis graft occlusion,1 2 abdominal pain.1 3 5
Not a substrate for CYP isoenzymes.1 5 Does not inhibit CYP isoenzymes 1A2, 2C9/10, 2C19, 2D6, or 3A4/5.1
Pharmacokinetic interaction unlikely.1 5
Possible formation of insoluble complexes; do not administer such drugs within 2 hours of lanthanum dose.1 5
Drug | Interaction |
|---|---|
Citrate salts | Lanthanum absorption not altered1 5 |
Digoxin | No formation of insoluble complexes in vitro; digoxin absorption not altered1 2 5 |
Enalapril | No formation of insoluble complexes in vitro1 5 |
Furosemide | No formation of insoluble complexes in vitro1 5 |
Metoprolol | No formation of insoluble complexes in vitro; metoprolol absorption not altered1 2 5 |
Phenytoin | No formation of insoluble complexes in vitro1 5 |
Warfarin | No formation of insoluble complexes in vitro; warfarin absorption not altered1 2 5 |
Information regarding the mass balance of lanthanum in humans after oral administration is not available.1
Minimally absorbed from the GI tract; bioavailability <0.002%.1 2 3 4 5
Minimal effect on systemic lanthanum concentrations.1
Mean plasma concentrations of the drug remain low (≤1.1 ng/mL) for up to 2 years of use.1 2 3 Plasma concentrations increase minimally with increasing dosages in the recommended range.1
Distributed into bone; bone lanthanum concentrations increase over time (e.g., 4.5 years of administration).1
Does not appear to cross the blood-brain barrier in animals.1 2 5
>99%.1
Not metabolized.1
In animals, excreted principally in the feces (94–99%), mainly as unabsorbed drug; systemically absorbed lanthanum is eliminated in the feces, principally via biliary excretion.1 2 5
Minimally excreted in urine in healthy individuals (renal clearance of IV lanthanum chloride [not commercially available in the US] is <2% of total plasma clearance).1 5
Plasma: 53 hours.1
Bone: 2–3.6 years.1
In lanthanum-treated patients with ESRD, no quantifiable amounts were present in the dialysate.1
25°C (may be exposed to 15–30°C).1 Protect from moisture.1
Dissociates in the acidic environment of the upper GI tract to release trivalent lanthanum ions, which bind dietary phosphate released during digestion, thereby forming highly insoluble lanthanum phosphate complexes that are excreted fecally.1 2 5
Lanthanum ions have a high affinity for phosphate; the drug binds about 97% of available phosphates in vitro at pH 3–5 (corresponding to that of gastric fluid) when in twofold molar excess to phosphates.1 2
Reduces phosphate absorption, serum phosphorus concentrations, and serum calcium times phosphorus product (Ca × P).1 2 3
Importance of adhering to instructions about diet.1
Importance of taking lanthanum with or immediately after meals.1 12
Importance of chewing tablets completely before swallowing, and not swallowing intact tablets.1
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1
Importance of informing patients of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets, chewable | 250 mg (of lanthanum) | Fosrenol | Shire |
500 mg (of lanthanum) | Fosrenol | Shire | ||
750 mg (of lanthanum) | Fosrenol | Shire | ||
1 g (of lanthanum) | Fosrenol | Shire |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Fosrenol 1000MG Chewable Tablets (SHIRE US INC.): 30/$217.27 or 90/$622.87
Fosrenol 500MG Chewable Tablets (SHIRE US INC.): 45/$318.69 or 135/$927.13
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions May 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Shire US Inc. Fosrenol (lanthanum carbonate) chewable tablets prescribing information. Wayne, PA; 2005 Nov.
2. Harrison TS, Scott LJ. Lanthanum carbonate. Drugs. 2004; 69:985-96.
3. Joy MS, Finn WF, for the LAM-302 Study Group. Randomized, double-blind, placeo-controlled, dose-titration, phase III study assessing the efficacy and tolerability of lanthanum carbonate: a new phosphate binder for the treatment of hyperphosphatemia. Am J Kidney Dis. 2003; 42:96-107. [IDIS 501884] [PubMed 12830461]
4. Finn WS, Joy MS, Hladik G and the Lanthanum Study Group. Efficacy and safety of lanthanum carbonate for reduction of serum phosphorus in patients with chronic renal failure receiving hemodialysis. Clin Nephrol. 2004; 62:193-201. [IDIS 523632] [PubMed 15481851]
5. Albaaj F, Hutchison AJ. Lanthanum carbonate for the treatment of hyperphosphatemia in renal failure and dialysis patients. Expert Opin Pharmacother. 2005; 6:319-28. [PubMed 15757427]
6. National Institutes of Health Consensus Development Conference Panel. Morbidity and mortality of renal dialysis: an NIH consensus conference statement. Ann Intern Med. 1994; 121:62-70. [PubMed 8198352]
7. Braintree Laboratories. PhosLo (calcium acetate) tablets prescribing information (dated May 1992). In: Physicians’ desk reference. 52nd ed. Montvale, NJ; 1998:733-4.
8. D’Haese PC, Spasovski GB, Sikole A et al. A multicenter study on the effects of lanthanum carbonate (Fosrenol) and calcium carbonate on renal bone disease in dialysis patients. Kidney Int. 2003; 85(Suppl 1):S73-8.
9. Loghman-Adham M. Safety of new phosphate binders for chronic renal failure. Drug Saf. 2003; 26:1093-115. [PubMed 14640773]
10. DeBroe ME, D’Haese PC for the Lanthanum Study Group. Improving outcomes in hyperphosphataemia. Nephrol Dial Transplant. 2004; 19(Suppl 1):i14-8.
11. Torres A, DeBroe ME, D’Haese PC et al. SU-PO1041. One-year, randomized, open-label study comparing the safety and efficacy of lanthanum carbonate (Fosrenol) and calcium carbonate in dialysis patients. J Am Soc Nephrol. 2003; 85:764A.
12. Shire, Wayne, PA: Personal communication.
