VIREAD Film-coated tablet (2023)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Viread 245 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 245 mg of tenofovir disoproxil (as fumarate). Excipient with known effect: Each tablet contains 156 mg lactose (as monohydrate). For the full list of excipients, see section ...
Pharmaceutical form
Film-coated tablet (tablet). Light blue, almond-shaped, film-coated tablets, of dimensions 16.8 mm x 10.3 mm, debossed on one side with GILEAD and 4331 and on the other side with 300.
Therapeutic indications
HIV-1 infection Viread 245 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults. In adults, the demonstration of the ...
Posology and method of administration
Therapy should be initiated by a physician experienced in the management of HIV infection and/or treatment of chronic hepatitis B. Posology HIV-1 and Chronic hepatitis B Adults and adolescents aged 12 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
General HIV antibody testing should be offered to all HBV infected patients before initiating tenofovir disoproxil therapy (see below Co-infection with HIV-1 and hepatitis B). Hepatitis B Patients must ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults. Based on the results of in vitro experiments and the known elimination pathway of tenofovir, the potential for CYP450-mediated interactions involving ...
Fertility, pregnancy and lactation
Pregnancy A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with tenofovir disoproxil. Animal studies do not ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, patients should be informed that dizziness has been reported during treatment with tenofovir disoproxil. ...
Undesirable effects
Summary of the safety profile HIV-1 and hepatitis B In patients receiving tenofovir disoproxil, rare events of renal impairment, renal failure and uncommon events of proximal renal tubulopathy (including ...
Overdose
Symptoms If overdose occurs the patient must be monitored for evidence of toxicity (see sections 4.8 and 5.3), and standard supportive treatment applied as necessary. Management Tenofovir can be removed ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antiviral for systemic use; nucleoside and nucleotide reverse transcriptase inhibitors <b>ATC code:</b> J05AF07 Mechanism of action and pharmacodynamic effects Tenofovir ...
Pharmacokinetic properties
Tenofovir disoproxil is a water soluble ester prodrug which is rapidly converted <em>in vivo</em> to tenofovir and formaldehyde. Tenofovir is converted intracellularly to tenofovir monophosphate and to ...
Preclinical safety data
Non-clinical safety pharmacology studies reveal no special hazard for humans. Findings in repeated dose toxicity studies in rats, dogs and monkeys at exposure levels greater than or equal to clinical exposure ...
List of excipients
Tablet core: Croscarmellose sodium Lactose monohydrate Magnesium stearate (E572) Microcrystalline cellulose (E460) Starch pregelatinised Film-coating: Glycerol triacetate (E1518) Hypromellose (E464) Indigo ...
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and a silica gel desiccant. The following pack sizes are available: outer cartons ...
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
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Marketing authorization number(s)
EU/1/01/200/001 EU/1/01/200/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 5 February 2002 Date of latest renewal: 14 December 2011
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