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SPC: STOCRIN Film-coated tablets (2020)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Bristol-Myers Squibb Pharmaceutical Limited
Διεύθυνση :
Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH , UK
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Περιεχόμενα

Name of the medicinal product

STOCRIN 600 mg film-coated tablets. STOCRIN 50 mg film-coated tablets. STOCRIN 200 mg film-coated tablets.

Qualitative and quantitative composition

STOCRIN 600 mg film-coated tablets: Each film-coated tablet contains 600 mg of efavirenz. Excipient with known effect: Each film-coated tablet contains 249.6 mg of lactose (as monohydrate). STOCRIN 50 ...

Pharmaceutical form

Film-coated tablet. STOCRIN 600 mg film-coated tablets: Dark yellow, capsule-shaped, debossed with 225 on one side. STOCRIN 50 mg film-coated tablets: Yellow, round, debossed with 113 on one side. STOCRIN ...

Therapeutic indications

STOCRIN is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older. STOCRIN has not been adequately studied ...

Posology and method of administration

Therapy should be initiated by a physician experienced in the management of HIV infection. Posology Efavirenz must be given in combination with other antiretroviral medicines (see section 4.5). In order ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with severe hepatic impairment (Child Pugh Class C) (see section 5.2). Co-administration with terfenadine, ...

Special warnings and precautions for use

Efavirenz must not be used as a single agent to treat HIV or added on as a sole agent to a failing regimen. Resistant virus emerges rapidly when efavirenz is administered as monotherapy. The choice of ...

Interaction with other medicinal products and other forms of interaction

Efavirenz is an in vivo inducer of CYP3A4, CYP2B6 and UGT1A1. Compounds that are substrates of these enzymes may have decreased plasma concentrations when co-administered with efavirenz. In vitro efavirenz ...

Fertility, pregnancy and breast-feeding

Contraception in males and females Barrier contraception should always be used in combination with other methods of contraception (for example, oral or other hormonal contraceptives, see section 4.5). ...

Effects on ability to drive and use machines

Efavirenz may cause dizziness, impaired concentration, and/or somnolence. Patients should be instructed that if they experience these symptoms they should avoid potentially hazardous tasks such as driving ...

Undesirable effects

Summary of the safety profile Efavirenz has been studied in over 9,000 patients. In a subset of 1,008 adult patients who received 600 mg efavirenz daily in combination with PIs and/or NRTIs in controlled ...

Overdose

Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms. One patient experienced involuntary muscle contractions. Treatment of overdose with efavirenz should ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antivirals for systemic use. Non-nucleoside reverse transcriptase inhibitors ATC code: J05A G03 Mechanism of action Efavirenz is a NNRTI of HIV-1. Efavirenz is a non-competitive ...

Pharmacokinetic properties

Absorption Peak efavirenz plasma concentrations of 1.6-9.1 μM were attained by 5 hours following single oral doses of 100 mg to 1,600 mg administered to uninfected volunteers. Dose related increases in ...

Preclinical safety data

Efavirenz was not mutagenic or clastogenic in conventional genotoxicity assays. Efavirenz induced foetal resorptions in rats. Malformations were observed in 3 of 20 foetuses/newborns from efavirenz-treated ...

List of excipients

STOCRIN 600 mg film-coated tablets Tablet core: Croscarmellose sodium, Microcrystalline cellulose, Sodium laurilsulfate, Hydroxypropylcellulose, Lactose monohydrate, Magnesium stearate Film coating: Hypromellose ...

Incompatibilities

Not applicable.

Shelf life

For bottles: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

STOCRIN 600 mg film-coated tablets: HDPE bottles with a child-resistant polypropylene closure. Each carton contains 1 bottle of 30 film-coated tablets. STOCRIN 50 mg film-coated tablets: HDPE bottles with ...

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization number(s)

EU/1/99/111/008 EU/1/99/111/010 EU/1/99/111/011

Date of first authorization / renewal of the authorization

Date of first authorisation: 28 May 1999 Date of latest renewal: 23 April 2014

Πηγαίο έγγραφο

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