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Tamiflu 75 mg (10 capsules)

$69.20

29df84c55f71

Description

The instruction for medical use

of medicine

of Tamiflu

A trade name

of Tamiflu

the International unlicensed

name Oseltamivir Lekarstvennaya a form

of the Capsule of 75 mg

Structure

One capsule contains

active agent – an oseltamivir of phosphate 98.50 (it is equivalent to an oseltamivir) (75.00)

excipients: starch prezhelatinizirovanny, K30 povidone, sodium of a kroskarmelloz, talc, the sodium stearylfumarating

structure of the capsule: iron body (III) oxide black E 172, titan E 171 dioxide, gelatin, iron lid (III) oxide red E 172, gland (III) oxide yellow E 172, titan E 171 dioxide, gelatin, ink printing.

The description

Solid gelatin capsules, size No. 2, with the opaque body of gray color and an opaque lid of light yellow color, with marking of blue color of ROCHE on the body and 75 mg on a lid.

Capsule contents – powder from white till yellow-white color.

Pharmacotherapeutic group

Antiviral drugs of direct action. Neuraminidase inhibitors.

The code of automatic telephone exchange J05AH02

the Pharmacological

Pharmacokinetics Later properties of oral administration of an oseltamivir phosphate is easily soaked up in digestive tract and highly turns into an active metabolite under the influence of hepatic esterases. Concentration of an active metabolite in plasma are defined within 30 minutes, reach almost maximum level in 23 hours after reception and significantly (more, than by 20 times) exceed concentration of pro-medicine. Not less than 75% of the dose accepted inside get to a system blood stream in the form of an active metabolite, less than 5% in the form of initial drug. Plasma concentration both pro-drugs, and an active metabolite are proportional to a dose and do not depend on meal.

The average volume of distribution (Vss) of an active metabolite is about 23 liters. Linking of an active metabolite with proteins of blood plasma is insignificant (about 3%). Linking of pro-medicine with proteins of blood plasma makes 42% that it is not enough to serve as the reason of significant medicinal interactions.

Oseltamivira phosphate highly turns into an active metabolite under the influence of the esterases which are mainly in a liver and intestines. Neither an oseltamivira phosphate, nor an active metabolite are not substrates or inhibitors of isoenzymes of a system of P450 cytochrome.

Soaked up oseltamivir it is removed, mainly (& gt, 90%), by transformation into an active metabolite. The active metabolite is not exposed to further transformation and is removed with urine (& gt, 99%). At most of patients the elimination half-life of an active metabolite makes 610 hours of plasma. The active metabolite is removed completely (& gt, 99%) by renal excretion. The renal clearance (18.8 l/hour) exceeds the glomerular filtration rate (7.5 l/hour) that indicates that drug is removed also by canalicular secretion. With a stake less than 20% accepted inside are removed it is radioactive marked drug.

Pharmacokinetics in special groups

Patients with damage of kidneys

When prescribing Tamiflu on 100 mg 2 times a day within 5 days by the patient with various extent of damage of kidneys of the area under a curve of concentration of an active metabolite in plasma time (AUC) are inversely proportional to depression of function of kidneys. The pharmacokinetics of an oseltamivir at the patients with an end-stage of a renal failure (with clearance of creatinine & le, 10 ml/min.) who are not on dialysis was not studied.

Patients with damage of a liver

the Research in vitro showed that at patients with hepatic pathology the size AUC of an oseltamivir of phosphate is much not increased, and AUC of an active metabolite is not reduced.

Patients of senile age

At patients of senile age (6578 years) AUC of an active metabolite in an equilibrium state was 2535% higher, than at younger patients when assigning similar doses of Tamiflu. Elimination half-life of drug at elderly significantly did not differ from that at younger patients of adult age. Taking into account data on AUC drug and shipping, at treatment and prevention of flu it is not required to patients of senile age of dose adjustment.

Children

studied Pharmacokinetics of Tamiflu at children from 1 year to 16 years in a pharmacokinetic research with single dose of drug and in clinical trial at a small number of children at the age of 312 years. Children of younger age have a removal of pro-medicine and an active metabolite went quicker, than at adults that led to lower AUC in relation to a specific dose. Administration of drug in a dose of 2 mg/kg gives the same AUC of an oseltamivir of carboxylate what is reached at adults after single dose of the capsule from 75 mg of drug (that is equivalent to about 1 mg/kg). The pharmacokinetics of an oseltamivir at children is more senior than 12 years same, as at adults.

At children of 6-12 months the purpose of an oseltamivir in a dosage of 3 mg/kg twice a day provides the plasma level of an active metabolite similar to the level showing clinical performance at children of advanced age and adults.

Pharmacodynamics

Antiviral drug. Oseltamivira phosphate is pro-medicine, its active metabolite (an oseltamivira carboxylate) competitively and selectively the enzyme catalyzing process of release of again formed virus particles of the infected cells, their penetrations into cells of an epithelium of airways and further spread of a virus in an organism inhibits a neuraminidase of influenza viruses of type A and B.

Oseltamivira carboxylate acts out of cells. Growth of an influenza virus of in vitro oppresses and suppresses replication of a virus and its pathogenicity of in Vivo, reduces discharge of influenza viruses And yes In from an organism. Its concentration necessary for suppression of activity of enzyme on 50% (IC50) are at the lower bound of nanomolar range.

At intake of Tamiflu for the purpose of post-contact (7 days) and seasonal (42 days) prevention of flu of resistance to drug is not noted.

Frequency of tranzitorny discharge of an influenza virus with reduced sensitivity of a neuraminidase to an oseltamivir to carboxylate at adult patients with flu is 0.4%. Elimination of a resistant virus comes from an organism of the patients receiving Tamiflu without deterioration in a clinical condition of patients.

Indications

– treatment of flu at adults and children, including the full-term newborns at whom flu symptoms when the influenza virus circulates among the population are observed. The efficiency was shown at an initiation of treatment within 2 days after the first emergence of symptoms of flu.

– prevention of flu at adults and children:

– prevention of flu at adults and children is more senior than 1 year after cases of contact with persons with clinically confirmed flu when the influenza virus circulates among the population

– prevention of flu at children is younger than 1 year during a flu pandemic.

The route of administration and doses

of Tamiflu is accepted inside, at meal time or irrespective of meal. At some patients the tolerance of drug improves if it is accepted at meal time. Treatment needs to be begun in the first or second day of emergence of symptoms of flu.

In cases when adults, teenagers & ge, 12 years and children with the body weight & gt, 40 kg or & ge, 8 years have a problem with ingestion of capsules, it is necessary to open the capsule and to pour out its contents in a small amount (at most 1 teaspoon) of the suitable sweetened food product (chocolate syrup (with the normal content of sugar or without the content of sugar), the honey dissolved in water, a sweet dessert, sweetened condensed milk, apple puree or yogurt) to hide bitter taste. Mix needs to be mixed and given carefully to the patient entirely. It is necessary to swallow mix at once after preparation.

The standard mode of dosing

Adults and teenagers is more senior than 13 years (with body weight more than 40 kg):

Treatment of flu:

The recommended mode of dosing of Tamiflu on one capsule of 75 mg 2 times a day inside within 5 days or on 75 mg of suspension 2 times a day inside within 5 days.

Prevention of flu:

The recommended Tamiflu dose for prevention of flu after contact with the infected person on 75 mg of 1 times a day inside within 10 days.

Administration of drug needs to be begun no later than in the first 2 days after contact.

The recommended dose for prevention during a seasonal flu epidemic on 75 mg of 1 times a day, is shown efficiency and safety of drug at its reception within 6 weeks. Preventive action continues so much how many administration of drug lasts.

Children from 1 year to 12 years:

Treatment of flu:

Body weight

the Recommended dosage within 5 days:

10 15

kg 30 mg twice a day

15 23

kg 45 mg twice a day

23 40

kg 60 mg twice a day

& gt, 40

kg 75 mg twice a day

Prevention of flu:

Body weight

the Recommended dosage within 10 days:

10 15

kg 30 mg once a day

15 23

kg 45 mg once a day

23 40

kg 60 mg once a day

& gt, 40

kg 75 mg once a day

Efficiency of Tamiflu for prevention during a seasonal flu epidemic at children are younger than 12 years was not studied.

Children till 1 year

Treatment of flu:

The recommended dose for children aged till 1 year makes 3 mg/kg of body weight twice a day.

Body weight

the Recommended dosage within 5 days:

3

kg 9 mg twice a day

4

kg 12 mg twice a day

5

kg 15 mg twice a day

6

kg 18 mg twice a day

7

kg 21 mg twice a day

8

kg 24 mg twice a day

9

kg 27 mg twice a day

10

kg 30 mg twice a day

This mode of dosing is inapplicable to premature newborns (i.e., given rise till 36 weeks). On dosing this group of patients has an insufficient amount of data.

Prevention of flu:

The recommended Tamiflu dose for prevention of flu during a pandemic at children is younger than 1 year makes a half of a medical dose of 3 mg/kg within 10 days once a day. The efficiency of Tamiflu for prevention during a seasonal flu epidemic at children is younger than 1 year was not studied.

Dosing in special cases

Patients with damage of kidneys

Treatment of flu. More than 30 ml/min. dose adjustment is not required to patients with clearance of creatinine. At patients with clearance of creatinine from 10 to 30 ml/min. it is necessary to reduce a dose of Tamiflu to 75 mg within 5 days once a day.

To the patients who are on a chronic hemodialysis, Tamiflu can be appointed in a dose of 30 mg before dialysis session. For maintenance of concentration of an oseltamivir in Tamiflu plasma in a dose of 30 mg it has to be appointed after each session of a hemodialysis. At peritoneal dialysis of Tamiflu it is appointed in a dose of 30 mg before dialysis session, and then within 5 days on 30 mg a day. At the patients with an end-stage of chronic kidney disease (clearance of creatinine less than 10 ml/min.) who are not on a hemodialysis, the pharmacokinetics of an oseltamivir was not studied.

Prevention of flu. More than 30 ml/min. dose adjustment is not required to patients with clearance of creatinine. At patients with clearance of creatinine from 10 to 30 ml/min. it is necessary to reduce a dose of Tamiflu to 75 mg every other day or up to 30 mg every day. To the patients who are on a chronic hemodialysis, Tamiflu can be appointed in a dose of 30 mg before dialysis session. For maintenance of concentration of an oseltamivir in Tamiflu plasma in a dose of 30 mg it has to be appointed through one session of a hemodialysis, at the end of the procedure. At peritoneal dialysis of Tamiflu it is appointed in a dose of 30 mg before dialysis session, and then each 7 days on 30 mg.

Patients with damage of a liver

the Dose adjustment at treatment and prevention of flu is not required.

Patients of advanced age

Dose adjustment at treatment and prevention of flu is not required.

Ex-temporal preparation of Tamiflu

In cases when adults, teenagers and children have a problem with ingestion of capsules, and Tamiflu in a dosage form powder for preparation of suspension for intake is absent or with signs of aging of capsules, it is necessary to open the capsule and to pour out its contents in a small amount (at most 1 teaspoon) of the suitable sweetened food product to hide bitter taste. Mix needs to be mixed and given carefully to the patient entirely. It is necessary to swallow mix at once after preparation.

If patients need a dose of 75 mg, then it is necessary to follow the following iinstruktion:

1. Holding one capsule of 75 mg of Tamiflu over small capacity, to accurately open the capsule and to pour out powder in capacity.

2. To add a small amount (no more than 1 teaspoon) of the suitable sweetened food product (to hide bitter taste) and it is good to mix.

3. To carefully mix mix and to drink it at once after preparation. If in capacity there was a small amount of mix, then it is necessary to rinse capacity with a small amount of water and to drink the remained mix.

If doses of 30-60 mg are required for patients, then for the correct dosing the following iinstruktion need to follow:

1. Holding one capsule of 75 mg of Tamiflu over small capacity, to accurately open the capsule and to pour out powder in capacity.

2. To add to powder 5 ml of water by means of the syringe with the tags showing amount of the gathered liquid. To mix carefully within 2 minutes.

3. To gain in the syringe necessary amount of mix from capacity according to the table below:

Body weight

the Recommended dose

Amount of mix of Tamiflu on one reception

15

kg 30 mg 2 ml

& gt, 15-23

kg 45 mg 3 ml

& gt, 23-40

kg 60 mg 4 ml

There is no need for an intake of not dissolved white powder as it is inactive filler. Having pressed the syringe piston, to enter all its contents into the second capacity. The remained unused mix needs to be thrown out.

4. To add a small amount (no more than 1 teaspoon) of the suitable sweetened food product to the second capacity to hide bitter taste, and it is good to mix.

5. To carefully mix mix and to drink it at once after preparation. If in capacity there was a small amount of mix, then it is necessary to rinse capacity with a small amount of water and to drink the remained mix.

Side effects

Very often (& gt, 10%)

– nausea, vomiting

– a headache

Often (1-10%)

– dorsodynias

– cough, nasal bleedings, congestion of a nose, a nasopharyngitis, bronchitis, average otitis, sinusitis, a bronchospasm,

– diarrhea, pains in epigastric area

– herpes

– irritability, fatigue

Infrequently (1-0.1%)

– insomnia

– allergic reactions (dermatitis)

– conjunctivitis

– a lifmoadenopatiya

Seldom (& lt, 0.1%)

– reactions of hypersensitivity (including dermatitis, rash, eczema, a multimorfny erythema, anaphylactic reactions), Stephens-Johnson’s syndrome

– gastrointestinal bleedings

– hepatitis, increase in level of liver enzymes

– spasms, delirious states, overexcitation.

Contraindications

– hypersensitivity to an oseltamivir to phosphate or any component of drug

– chronic kidney disease (a constant hemodialysis, chronic peritoneal dialysis, clearance of creatinine & le, 10 ml/min.)

Medicinal interactions

Information obtained in pharmacological and pharmacokinetic researches of an oseltamivir of phosphate allows to consider clinically significant medicinal interactions improbable.

The medicinal interactions caused by the competition and linking with active centers of the esterases turning an oseltamivir phosphate into active agent in literature in detail are not lit. Low extent of binding of an oseltamivir and an active metabolite with proteins do not give the grounds to assume existence of the interactions connected with replacement of medicines from communication with proteins.

Neither an oseltamivira phosphate, nor an active metabolite are not preferable substrate for multifunctional oxidases of a system of P450 cytochrome or for glyukuroniltransferaz. There is no formal basis for interaction with oral contraceptives.

Cimetidinum, nonspecific inhibitor of isoenzymes of a system of P450 cytochrome, does not affect plasma concentration of an oseltamivir and its active metabolite.

Clinically significant intermedicinal interactions connected with the competition for canalicular secretion in view of safety reserve for the majority of similar drugs, ways of removal of an active metabolite of an oseltamivir (glomerular filtration and anion canalicular secretion) and also the removing ability of each of ways are improbable.

Co-administration of a probenetsid leads to increase in AUC of an active metabolite approximately twice. However, dose adjustment at simultaneous use with probenetsidy is not required.

The concomitant use with amoxicillin does not affect plasma concentration of both drugs. Pharmacokinetic interactions between oseltamiviry, its main metabolite are not revealed at a concomitant use with paracetamol, acetylsalicylic acid, Cimetidinum or antiacid means (magnesium and aluminum hydroxide, calcium a carbonate).

When prescribing Tamiflu together with often applied drugs, such as APF inhibitors (enalapril, captopril), thiazide diuretics, antibiotics (penicillin, cephalosporins, azithromycin, erythromycin and doxycycline), H2 receptors blockers to a histamine (ranitidine, Cimetidinum), beta-blockers (propranolol), xanthines (theophylline), sympathomimetics (pseudoephedrine), opiates (codeine), corticosteroids, inhalation bronchial spasmolytics and analgetics (aspirin, an ibuprofen and paracetamol), changes of character or frequency of the undesirable phenomena at the same time were not observed.

Special indications

of Data on efficiency of Tamiflu in any diseases caused by other activators except influenza viruses And yes In, no.

The children’s age

to Children is younger than 13 years with body weight less than 40 kg Tamiflu use powder for preparation of suspension for intake is recommended.

Children of 6-12 months: the efficiency of Tamiflu at children is younger than 1 year is not established. However children of 6-12 months according to which purpose of an oseltamivir in a dosage of 3 mg/kg twice a day provides the plasma level of an active metabolite similar to the level showing clinical performance at children of advanced age and adults have limited data on pharmacokinetics.

Pregnancy and the period of a lactation

of Controlled clinical trials according to safety of Tamiflu at pregnant women it was not carried out. Tamiflu should appoint during pregnancy or a lactation only if possible advantages of its use exceed potential risk for a fruit or the baby and the assessment of safety, pathogenicity of a specific influenza strain and the state of health of the pregnant woman is carried out.

Features of influence on ability to run vehicles or potentially dangerous mechanisms

the Overdose

of cases of overdose does not influence Now it is not described, however expected symptoms of acute overdose will be nausea with vomiting or without it. Single doses of Tamiflu up to 1000 mg were transferred well, except for nausea and vomiting.

The form of release and packing

On 10 capsules place in blister strip packaging from a film of a polyvinylchloride film / polyvinyldichloride and aluminum foil.

On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages put in a cardboard pack.

To Store storage conditions at

a temperature not higher than 25 S. Hranit out of children’s reach!

Not to use a period of storage of 7 years after the expiration date specified on packing.

Prescription status

According to the prescription

the Producer

of Seneksi of SAS, France

the Legal address of the producer:

52 Rue M. et J. Gaucher, 94120 Fontenay-sous-Bois, France

the Owner of the registration certificate

F. Hoffmann-la Roche of Ltd., Switzerland

the Packer F. Hoffmann-la Roche of Ltd., Switzerland

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of goods and responsible for pharmacovigilance

of Roche Kazakhstan LLP

050000, Almaty, Kunayev St., 77,

Business center Park View Office Tower, the 15th floor

Ph.: +7 (727) 321 24 24, fax: + 7 (727) 321 24 25

e-mail:

To develop kz.safety@roche.com, kz.quality@roche.com

Additional information

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