Wimpat - instructions for use, dose, side effects, contraindications

Active substanceLacosamideLacosamide

Similar drugsTo uncover

Wimpat®

syrup inwards

YUSB Farma S.A. Belgium

Wimpat®

pills inwards

YUSB Farma S.A. Belgium

Wimpat®

solution d / infusion

YUSB Farma S.A. Belgium

Dosage form: & nbspfilm coated tablets

Composition:

1 film coated tablet contains:

active substance: lacosamide 50 mg, 100 mg, 150 mg or 200 mg.

Excipients: cellulose microcrystalline 14.0 mg / 28.0 mg / 42.0 mg / 56.0 mg, low-substituted giprolose 12.5 mg / 25.0 mg / 37.5 mg / 50.0 mg, HD 90 [microcrystalline cellulose and silicon dioxide colloidal anhydrous] 31.3 mg / 62.6 mg / 93.9 mg / 125.2 mg, crospovidone 10.0 mg / 20.0 mg / 30.0 mg / 40.0 mg , magnesium stearate 1.2 mg / 2.4 mg / 3.6 mg / 4.8 mg, giprolose 1.0 mg / 2.0 mg / 3.0 mg / 4.0 mg.

Shell: opadray II (color) 4.8 mg / 9.6 mg / 14.4 mg / 19.2 mg.

Composition dropping II (color):

Components	85F20249	85F38040	85F27043	85F30675
Otpadray II (color)	Purple	Yellow	Golden	Blue
Dosage Tablets	50 mg	100 mg	150 mg	200 mg
Polyvinyl alcohol	40%	40%	40 %	40%
Talc	14.8%	14,8%	14,8 %	14,8%
Macrogol	20,2 %	20,2 %	20,2 %	20,2 %
Titanium dioxide, E 171	24,07 %	19,17 %	23,09 %	20,00 %
Iron coloring agent yellow, E 172	-	5,83 %	1,39%	-
Iron colorant red oxide, E 172	0,22 %	-	0,42 %	-
Iron Oxide Dye Oxide	0,02 %	-	0,10%	-
Indigo carmine stain FD&C blue 2	0,69 %	-	-	5,00 %

Description:

Tablets 50 mg: oval, biconvex tablets, covered with a film coat of pinkish color. On one side of the tablet the "50" marking is stamped out, and on the other "SP".

Tablets 100 mg: oval, biconvex tablets, covered with a film coating of dark yellow color.On one side of the tablet the "100" marking is stamped out, and on the other side "SP".

Tablets of 150 mg: oval, biconvex tablets, covered with a film shell of pale orange color. On one side of the tablet, the label "150" is stamped out, and on the other side "SP".

Tablets 200 mg: oval, biconvex tablets, covered with a film shell of blue color. On one side of the tablet, the label "200" is stamped out, and on the other side "SP".

Pharmacotherapeutic group:Antiepileptic remedy

ATX: & nbsp

N.03.A.X Other antiepileptic drugs

N.03.A.X.18 Lacosamide

Pharmacodynamics:

Active substance - lacosamide (R-2-acetamido-N-benzyl-3-methoxypropionamide) is a functionalized amino acid.

The exact mechanism of the progivoepileptic effect of lacosamide is not established. In electrophysiological studies in vitro lacosamide selectively enhances the slow inactivation of the potential-dependent sodium channels, which leads to the stabilization of hyperexcitable neuronal membranes.

Pharmacodynamics

Lacosamid prevented the development of seizures on a large number of animal models of partial and primarily generalized epilepsy, and also delayed the development of increased convulsive readiness. In preclinical studies lacosamide in combination with levetiracegam, carbamazepine, phenytoin, valproate, lamotrigine, topiramate or Gabapeptip demonstrated a sypergic or additive anticonvulsant effect.

Clinical efficacy and safety

The efficacy of Wimpat® as an adjunctive therapy at recommended doses (200 mg / day, 400 mg / day) was demonstrated in 3 multicenter, randomized, placebo-controlled clinical trials with a 12-week maintenance period. The efficacy of Wimpat® at a dose of 600 mg / day was also shown during controlled additional therapeutic studies, although the efficacy was comparable to the dose of 400 mg / day, the tolerability of this dose (600 mg / day) was worse due to side effects from the central nervous system and gastrointestinal tract. Therefore, the use of a dose of 600 mg / day is not recommended. The maximum recommended dose is 400 mg / day. These studies, involving 1,308 patients with a history of partial seizures over an average period of 23 years, were designed to assess the efficacy and safety of lacoside inconcomitant administration of 1-3 antiepileptic drugs in patients with uncontrolled partial seizures with or without secondary generalization. The total proportion of patients with a 50% reduction in seizure frequency in the placebo groups, lacosamide 200 mg / day, and lacosamide 400 mg / day was 23%, 34% and 40%, respectively.

Currently, there is insufficient data on the possible withdrawal of concomitant antiepileptic drugs for the use of monotherapy with lacosamide.

The pharmacokinetics and safety of a single saturating dose of an infusion lacosamid were determined in a multicenter open safety study and the tolerability of rapid initiation of lacosamide therapy using a single intravenous saturating dose (200 mg) followed by oral administration of the drug 2 times daily (at a dosage equivalent to an intravenous dose) as additional therapy in adult patients from 16 to 60 years with partial seizures.

Pharmacokinetics:

Suction

Lacosamid is quickly and completely absorbed after ingestion. BiodestugThe lacoside content of tablets is approximately 100%.After oral administration, the concentration of lacosamide in the plasma rapidly increases, the maximum concentration (C_m_Oh) is achieved after 0.5-4 hours. Food intake does not affect the speed and degree of absorption.

Distribution

The volume of distribution is approximately 0.6 l / kg, the degree of binding to plasma proteins

- less than 15%.

Metabolism

95% of lacosamides are excreted through the kidneys unchanged (about 40%) and in the form of O-desmethylmetabolite (less than 30%). The polar fraction (presumably serine derivatives) is about 20% in urine and only in small amounts (0 - 2%) is found in the blood plasma. Other metabolites are determined in urine in an amount of 0.5-2%.

Data in vitro show that the formation of O-desmethyl metabolite occurs mainly under the action of cytochrome isoenzymes CYP2C19, 2C9 and 3A4. When comparing the pharmacokinetics of lacoside in extensive metabolizers (with a functional isoenzyme of cytochrome CYP2C19) and slow metabolizers (with a deficiency of the functional isoenzyme of cytochrome CYP2C19) there was no clinically significant difference in lacosamide release. In addition, studies on the interaction with omeprazole (inhibitor of isoenzyme CYP2C19) showed no clinically significant changes in the concentration of lacosamide in plasma, which indicates a low significance of this pathway.

The concentration of O-desmethylacosamide in plasma is approximately 15% of the concentration of lacosamide. This metabolite has no pharmacological activity.

Excretion

Lacosamide is excreted by renal excretion and biotransformation. After oral administration and intravenous administration of lacosamide labeled with a radioactive isotope, about 95% of the radioactivity was noted in the urine and less than 0.5% in the feces. The half-life of the unaltered lacosamide is approximately 13 hours. Pharmacokinetic parameters are proportional to the dose, constant in time and characterized by low individual variability. When applied twice a day, the equilibrium concentration in the plasma is reached within 3 days. Cumulation is accompanied by an increase in the concentration in the plasma by about 2 times. The plasma concentration increases with an accumulation factor of about 2.

The equilibrium concentration when applying a single saturating dose of 200 mg is comparable to that for oral administration of 100 mg twice a day.

Pharmacokinetics in special patient groups

Floor

Clinical studies show that sex does not have a significant effect on the concentration of lacosamide in blood plasma.

Race

Clinically significant differences in the pharmacokinetics of lacoside in Asian, Negroid and Caucasoid races are absent.

In patients with renal insufficiency

The value of the "area under the concentration-time ratio curve" (AUC) increases to approximately 30% with mild to moderate renal failure and up to 60% in the severe and terminal stage of renal failure requiring hemodialysis, compared to healthy patients, while FROM_ma_x does not change. Lacosamide is removed from the plasma during hemodialysis. Within 4 hours of hemodialysis, the area under the concentration-time curve decreases by approximately 50%. Therefore, after the procedure of hemodialysis, an additional dose is recommended. Have patients with moderate and severe renal insufficiency, O-desmethyl metabolite release increased several fold. Have patients with terminal stage of renal failure in the absence of hemodialysis levels were increased and continuously increased during a 24-hour observation.To the end, it is not known whether increased metabolite excretion in patients with end-stage renal failure can lead to an increase in the number of side effects, but it has been confirmed that O-desmethylmetabolite has no pharmacological activity.

In patients with hepatic insufficiency

Have patients with moderate hepatic insufficiency observed increased concentrations of lacoside in the blood plasma (approximately 50% more AUC_standards). One of the reasons for the increased exposure was a decrease in renal function in patients who participated in the studies. Reduction of the non-obese clearance in patients from the study was estimated as an increase AUC lacosamide by 20%. Have patients with severe hepatic insufficiency pharmacokinetics not studied.

Have elderly patients

Four elderly patients over the age of 75 took part in the studies. AUC was increased by about 30% in men and 50% in women compared with young patients. Partly this is due to reduced body weight, 26% in men and 23% in women from normal body weight. There was also an increased isolation of lacosamide.In studies in elderly patients, the renal clearance of lacosamide was reduced only slightly.

Indications:As an additional therapy for partial seizures, accompanied or not accompanied by secondary generalization, in patients with epilepsy aged 16 years and over.

Contraindications:

Hypersensitivity to the active substance or to any of the components of the drug.

Atrioventricular block of II or III degree.

Age to 16 years.

Carefully:In patients with severe renal failure (creatinine clearance ≤ 30 ml / min). In patients with a history of conduction disorder or severe heart disease, such as heart failure and myocardial infarction in history. Elderly patients with an increased risk of heart disease. In combination with drugs that cause prolongation of the PR interval.

Pregnancy and lactation:

Pregnancy

The general risk associated with epilepsy and antiepileptic medicines

For all antiepileptic drugs, it was shown that the frequency of congenital malformations in children of women with epilepsy receiving such therapy is 2-3 times higher than in the general population (in the latter case, this figure is 3%).In patients receiving treatment, there was an increase in the incidence of congenital malformations in children at the foyer of polytherapy, but the extent of the effect of treatment and / or disease on the increase in this risk is unknown to date.

In addition, effective antiepileptic treatment should not be discontinued, since the deterioration of the course of the disease has a negative effect on the mother and on the fetus.

The risk associated with the use of lacosamide

There are no clinical data on the use of lacosamide in pregnant women. In animal studies, there were no teratogenic effects, but with the use of doses toxic to the mother's organism, embryotoxicity was noted in rabbits and rats. The potential risk to humans is unknown.

Lacosamide should not be used during pregnancy, except when the benefit to the mother clearly outweighs the possible risk to the fetus. If a woman is planning a pregnancy, it is necessary to carefully weigh the feasibility of using this drug. To monitor the effects of the use of Vimpat® in pregnant women, it is recommended that doctors register patients' data in the European andInternational Registry for Antiepileptic Drugs and Pregnancy (EURAP).

Lactation period

Data on the excretion of lacoside with human breast milk are absent. In studies on animals, excretion of lacosamide with milk was noted. During lacosamide treatment, breastfeeding should be discontinued.

Fertility

No adverse reactions have been observed on the part of fertility or reductivity in rats of both sexes in doses that create a concentration in the plasma (AUC) approximately 2 times higher AUC in human plasma with the application of the maximum recommended dose for humans.

Dosing and Administration:

Inside. The daily dose is divided into 2 doses in the morning and in the evening, regardless of the time of meal.

The recommended starting dose is 50 mg 2 times a day. After 1 week, the dose is increased to 100 mg 2 times a day.

Lacosimide treatment can also be started with a single saturating dose of 200 mg, followed by administration of 100 mg twice daily (200 mg / day) of the maintenance regimen after approximately 12 hours after the application of a saturating dose. The saturation dose can be used in patients in situations where the doctor determines that rapid achievement of equilibrium concentration in the plasma and the therapeutic effect is guaranteed.This should be applied iodine by medical control, given the possible increase in the number of unwanted reactions from the central nervous system. The appointment of a saturating dose has not been studied in acute conditions, such as epileptic status.

Given the efficacy and tolerability, the maintenance dose can be increased to 150 mg twice daily on the third week of admission to a maximum daily dose of 400 mg / day (200 mg twice daily) from the fourth week.

To abolish Wimpat® is recommended gradually, reducing the dose by 200 mg per week.

Use in patients with renal insufficiency

Patients with mild to moderate renal impairment (creatinine clearance> 30 mL / min) do not need dose adjustment. Patients with mild and moderate renal dysfunction may consider the appointment of a saturating dose of 200 mg, further titration of the dose (> 200 mg / day) should be conducted with caution. In patients with severe renal insufficiency (creatinine clearance ≤30 ml / min) and patients with terminal stage of renal failure the maximum dose is 250 mg / day. In these patients, dose titration should be performed with caution.If the purpose of the saturating dose is indicated, the initial dose is 100 mg, followed by 50 mg twice daily for the first week. Patients on hemodialysis may receive an additional 50% of a single dose immediately after the end of the procedure. Treatment of patients with terminal stage of renal failure should be carried out with caution, because the clinical experience of the drug in these patients is small, and possibly the accumulation of a metabolite that does not have a known pharmacological activity. Use in patients with impaired liver function

Patients with mild to moderate liver dysfunction do not need dose adjustment.

Titrate the dose to such patients with caution, given that the violation of liver function is often accompanied by a violation of kidney function. It is possible to administer a saturating dose of 200 mg, but further titration of the dose (> 200 mg / day) is recommended with caution.

The pharmacokinetics of lacoside in patients with severe hepatic insufficiency has not been studied.

The use of old people

Elderly, a dose reduction is not required.The experience with lacosamide in elderly patients with epilepsy is limited. In elderly people, it is necessary to take into account the possibility of an age-related decrease in renal clearance and, as a consequence, an increase in the concentration of lacosamide in blood plasma.

Use in children

Lacosamides are not recommended for children and adolescents under the age of 16 because the safety and efficacy of the drug in these age groups have not been studied.

Side effects:

Based on the analysis of pooled placebo-controlled clinical trials, dyskinesia, headache, nausea and diplopia were the most frequent adverse reactions in the treatment of lacosamides. As a rule, they were mild or moderate. The severity of some adverse reactions depended on the dose and decreased after its reduction. The frequency and severity of adverse reactions from the central nervous system (CNS) and gastrointestinal tract usually decreased with time. The most frequent undesirable reaction leading to the abolition of lacosamide therapy was dizziness. The percentage of adverse reactions from the central nervous system, such as dizziness, may be higher after applying a saturating dose.

Adverse reactions are classified according to frequency according to the following categories: very often (≥1/10); often (from ≥1/100 to <1/10); infrequently ≥1 / 1000 to <1/100), the frequency is unknown. The frequency of the following adverse reactions is indicated in accordance with the data obtained during clinical trials and in post-marketing practice.

On the part of the blood and lymphatic system

The frequency is unknown: agranulocytosis.

From the immune system

Infrequent: hypersensitivity reactions.

The frequency is unknown: hypersensitivity reactions with damage to various organs and systems (including drug response with eosinophilia and systemic manifestations, DRESS).

Disorders of the psyche:

Often: depression, confusion, insomnia.

Infrequently: aggression, excitement, euphoria, mental disorders, suicidal attempts, suicidal thoughts, hallucinations.

From the central nervous system

Very often: dizziness, headache.

Often: imbalance, impaired coordination of movements, memory impairment, cognitive impairment, drowsiness, tremor, nystagmus, hypesthesia, dysarthria, attention disorder, paresthesia.

From the side of the organ of vision

Very often: diplopia.

Often: blurred vision.

From the side of the hearing and vestibular organs

Often: vertigo, noise in the ears.

From the heart

Infrequently: atrioventricular block, bradycardia, atrial fibrillation and flutter.

From the gastrointestinal tract

Very often: nausea.

Often: vomiting, constipation, flatulence, indigestion, dry mouth, diarrhea.

From the liver and biliary tract

Infrequent: changes in hepatic samples.

From the skin and subcutaneous fat

Often: itching, rash.

Infrequently: angioedema, hives.

The frequency is unknown: toxic epidermal necrolysis, Stevens-Johnson syndrome.

From the musculoskeletal and connective tissue

Often: muscle spasms.

General disorders and disorders at the site of administration

Often: a violation of gait, asthenia, fatigue, irritability, a sense of intoxication.

Trauma, intoxication and complications of manipulation

Often: falls, skin lesions / increased risk of injury (due to impaired coordination of movements and dizziness), bruises.

Description of Selected Adverse Reactions

The use of lacosamide is associated with dose-dependent lengthening of the interval PR. There may be side effects associated with lengthening the interval PR (for example, atrioventricular blockade, syncope, bradycardia).

In clinical studies in patients with epilepsy, the percentage of episodes of grade I atrioventricular blockade was low (0.7%, 0%, 0.5%, and 0% with lacosamide at 200 mg, 400 mg, 600 mg and placebo, respectively. Atrioventricular blockade of II degree and higher in these studies was not observed. Nevertheless, in postmarketing practice, cases of the emergence of atrioventricular blockade of II and III degree in the treatment with lacosamide were reported. In clinical studies, syncope was infrequent and the incidence of episodes did not differ in epileptic patients who received lacosamide (0.1%) and those receiving placebo (0.3%).

Atrial fibrillation and flutter was not observed in short-term clinical studies; however, both phenomena were noted in open epilepsy studies, as well as in post-marketing practice.

Deviations of laboratory indicators

In controlled trials, there was a change in hepatic samples in adult patients with partial convulsive attacks with 1 to 3 antiepileptic drugs at a time.A 3-fold increase in ALT was observed in 0.7% (7/935) patients taking Wimpat ® and 0% (0/356) taking placebo.

Hypersensitivity reactions with damage to various organs and systems

Hypersensitivity reactions were noted with damage to various organs and

systems (including drug response with eosinophilia and systemic manifestations, DRESS) in patients who received some antiepileptic drugs. These reactions are different in manifestation, but are most often manifested in the form of heat and rash and may affect other systems. If there is a suspicion of a hypersensitivity reaction with the damage of various organs and systems, then the use of lacosamide should be discontinued.

Overdose:

Clinical Trials Data

The profile of adverse reactions in patients taking supertherapeutic doses did not differ from the profile of adverse reactions in patients taking the recommended doses.

After taking the drug at a dose of 1200 mg / day, clinical symptoms from the central nervous system and the gastrointestinal tract (dizziness and nausea), which disappeared after a dose reduction, were observed.

The highest declared overdose of lacosamide in the program of clinical development was 12000 mg, taken together with toxic doses of other antiepileptic drugs. Initially, there was an agrioventricular blockade, the patient fell into a coma, and then completely recovered without irreversible consequences.

Post-marketing application data

As a result of acute overdose after taking the drug in doses from 1000 mg to 12000 mg, convulsions (generalized tonic-clonic convulsions, epileptic status) and conduction disorders of the heart were noted.

Fatal cardiac arrest was observed in acute overdose after taking 7000 mg lacosamide in a patient with cardiovascular risk factors.

Treatment

The antidote of lacosamide does not exist. Treatment of an overdose is symptomatic. If necessary, hemodialysis is possible.

Interaction:

Lacosamide should be used with caution in combination with drugs that cause prolongation of the PR interval (for example, carbamazepine, lamotrigine, pregabalin) and class I antiarrhythmics. However, in the subgroup analysis of clinical trials no additional lengtheningPR interval in patients who simultaneously took lacosamide in combination with carbamazepine or lamotrigine.

In vitro data

The results of studies indicate a low probability of interaction of lacosamide with other drugs.

Metabolic Studies in vitro show that lacosamide does not induce isoenzymes CYP1A2, 2B6 and 2C9. In concentrations that were observed in the blood during clinical trials, lacosamide did not inhibit isoenzymes CYP1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2D6 and 2E1. Research in vitro evidence that lacosamide are not transported by P-glycoprotein in the intestine. Data in vitro show that isoenzymes CYP2C9, CYP2C19 and CYP3A4 can catalyze the formation of 0-desmethyl metabolite.

Data in vivo

Clinical evidence suggests that lacosamide Does not inhibit or induce isoenzymes CYP2C19 and ZA4 to a clinically significant level.

Lacosamide does not affect the area under the curve (AUC) Midazolam (metabolized via isoenzyme CYP3A4, with a dosage of lacosamide 200 mg twice daily), but C_max Midazolam was slightly increased (30%). Lacosamide does not affect the pharmacokinetics of omeprazole (metabolized via isoenzymes CYP2C19 and ZA4, with the dosage of lacosamide 300 mg twice daily).

Omeprazole is an isoenzyme inhibitor CYP2C19 (40 mg 4 times a day) did not increase the clinically significant exposure of lacosamide. Thus, it is unlikely that moderate isoenzyme inhibitors CYP2C19 can affect the systemic exposure of lacoside to a clinically significant value.

Caution should be exercised when using simultaneously with potent inhibitors of isoenzyme CYP2C19 (eg, fluconazole) and isoenzyme CYP3A4 (eg, itraconazole, ketocobalase, ritonavir, clarithromycin), which can lead to an increase in the systemic exposure of lacoside. These interactions are not proved in vivo, but are possible on the basis of data in vitro.

Powerful inducers of microsomal liver enzymes, such as rifampicin or St. John's wort (Hypericum perforatum), can cause a moderate decrease in the systemic concentration of lacoside. In this regard, when prescribing or canceling such drugs should be careful.

Antiepileptic drugs

In the studies on interaction lacosamide had no significant effect on the concentration of carbamazepine and valproic acid in blood plasma. Carbamazepine and valproic acid did not affect the concentration of lacosamide in plasma.

Pharmacokinetic analysis of the population has shown that concomitant therapy with antiepileptic drugs that induce microsomal liver enzymes (carbamazepine, phenytoin, phenobarbital in various doses) reduced the overall system exposure of lacosamide by 25%.

Oral contraceptives

There were no signs of significant interaction between lacosamide and oral contraceptives: ethinyl estradiol and levonorgestrel. Lacosamide does not affect the concentration of progesterone.

Other interactions

Lacosamide does not affect the pharmacokinetics of digoxin. Clinically significant interactions between lacosamide and metformin have not been identified. There is no data on the interaction of lacoside with alcohol.

The degree of binding of lacosamide to plasma proteins is less than 15%. In this regard, clinically significant interaction with other drugs that bind to plasma proteins is unlikely.

When used simultaneously with warfarin lacosamide has no clinically significant effect on the pharmacodynamics and pharmacokinetics of warfarin.

Special instructions:

Dizziness

Treatment with lacosamide may be accompanied by dizziness, potentially leading to an increased incidence of injuries and falls. In this regard, patients should be careful until they experience the potential effects of the drug.

Heart rhythm and conduction

In clinical trials of lacoside, an increase in the interval PR. In postmarketing practice, atrioventricular blockade of the second or higher degree was observed. In placebo-controlled studies of lacoside, patients with epilepsy had no fibrillation or atrial flutter, but both were noted in open epilepsy studies, as well as in post-marketing practice.

It is necessary to inform the patient of the symptoms of atrioventricular blockade of the second degree and higher (a rare or irregular pulse, a feeling of light dizziness and loss of consciousness), as well as symptoms of atrial fibrillation and flutter (palpitation, frequent or irregular pulse, shortness of breath). In case of their occurrence it is necessary to consult a doctor.

Suicidal thoughts and behavior

In patients who received antiepileptic drugs for several indications, suicidal thoughts and behavior were noted. Meta-analysis of randomized placebo-controlled clinical trials of antiepileptic drugs indicates a slight increase in the risk of suicidal thoughts and suicidal behavior. The mechanism of increasing risk is not clear, existing data do not allow to deny the existence of such a risk when taking lacosamide. Therefore, patients should be monitored for signs of suicidal thoughts and behavior, and consider appropriate treatment. Patients and persons caring for patients should be warned about the existing risk and the need for consultation with a specialist in case of suicidal behavior.

Effect on the ability to drive transp. cf. and fur:Lacosamide can affect the ability to drive a car or use sophisticated technology. Treatment with lacosamide may be accompanied by the development of dizziness or blurred vision. Accordingly, patients are not advised to drive a car or operate complex equipment.

Form release / dosage:Film coated tablets 50 mg, 100 mg, 150 mg or 200 mg.

Packaging:For 14 tablets in a blister of PVC / PVDH-aluminum foil. For 1 or 4 blisters in a cardboard pack together with instructions for use.

Storage conditions:Store at a temperature not exceeding 30 ° C. Keep out of the reach of children.

Shelf life:

5 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-009187/09

Date of registration:16.11.2009 / 14.12.2016

Expiration Date:Unlimited

The owner of the registration certificate: YUSB Farma S.A. YUSB Farma S.A. Belgium

Manufacturer: & nbsp

AESICA Pharmaceuticals, GmbH Germany

Representation: & nbspYUSB FARMA LLC YUSB FARMA LLC Russia

Information update date: & nbsp15.02.2017

Illustrated instructions

Instructions

Wimpat® (Vimpat®)