NEVIRAPINE TEVA Tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Nevirapine Teva 200 mg tablets.
Qualitative and quantitative composition
Each tablet contains 200 mg of nevirapine (as anhydrous). Excipient with known effect: Each tablet contains 168 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1
Pharmaceutical form
Tablet. White, oval, biconvex tablets. One side is debossed with N, a scoreline and 200. The opposite side is debossed with a scoreline. The score line is only to facilitate breaking for ease of swallowing ...
Therapeutic indications
Nevirapine Teva is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age (see section 4.2). Most of the ...
Posology and method of administration
Nevirapine Teva should be administered by physicians who are experienced in the treatment of HIV infection. Posology Patients 16 years and older The recommended dose of Nevirapine Teva is one 200 mg tablet ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Readministration to patients who have required permanent discontinuation for severe rash, rash accompanied by ...
Special warnings and precautions for use
Nevirapine Teva should only be used with at least two other antiretroviral agents (see section 5.1). Nevirapine Teva should not be used as the sole active antiretroviral, as monotherapy with any antiretroviral ...
Interaction with other medicinal products and other forms of interaction
Nevirapine is an inducer of CYP3A and potentially CYP2B6, with maximal induction occurring within 2-4 weeks of initiating multiple-dose therapy. Compounds using this metabolic pathway may have decreased ...
Fertility, pregnancy and lactation
Women of childbearing potential / Contraception in males and females Women of childbearing potential should not use oral contraceptives as the sole method for birth control, since nevirapine might lower ...
Effects on ability to drive and use machines
There are no specific studies about the ability to drive vehicles and use machinery. However, patients should be advised that they may experience adverse reactions such as fatigue during treatment with ...
Undesirable effects
Summary of the safety profile The most frequently reported adverse reactions related to nevirapine therapy, across all clinical studies, were rash, allergic reactions, hepatitis, abnormal liver function ...
Overdose
There is no known antidote for nevirapine overdose. Cases of nevirapine overdose at doses ranging from 800 to 6,000 mg per day for up to 15 days have been reported. Patients have experienced oedema, erythema ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antivirals for systemic use, non-nucleoside reverse transcriptase inhibitors ATC code: J05AG01 Mechanism of action Nevirapine is a NNRTI of HIV-1. Nevirapine is a non-competitive ...
Pharmacokinetic properties
Absorption Nevirapine is readily absorbed (>90%) after oral administration in healthy volunteers and in adults with HIV-1 infection. Absolute bioavailability in 12 healthy adults following single-dose ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans other than those observed in clinical studies based on conventional studies of safety, pharmacology, repeated dose toxicity, and genotoxicity. In carcinogenicity ...
List of excipients
Microcrystalline cellulose Lactose (as monohydrate) Povidone K25 Sodium starch glycolate (Type A) Colloidal silicon dioxide Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Treatment initiation pack: White opaque PVC/PE/PVdC – Aluminium blisters or OPA/Alu/PVC – Aluminium blisters. Cartons containing 14 tablets (Calendar Pack). Maintenance packs: White opaque PVC/PE/PVdC ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
Marketing authorization number(s)
EU/1/09/598/001-006
Date of first authorization / renewal of the authorization
Date of first authorisation: 30 November 2009 Date of latest renewal: 26 August 2014
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