RETROVIR Capsules, hard (2022)
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Περιεχόμενα
Name of the medicinal product
Retrovir 250 mg capsules, hard.
Qualitative and quantitative composition
Each capsule contains 250 mg zidovudine. For a full list of excipients, see section 6.1.
Pharmaceutical form
Capsules, hard. Hard gelatin capsules with opaque blue cap and opaque white body coded GSJV2.
Therapeutic indications
Retrovir oral formulations are indicated in anti-retroviral combination therapy for Human Immunodeficiency Virus (HIV) infected adults and children. Retrovir chemoprophylaxis is indicated for use in HIV-positive ...
Posology and method of administration
Retrovir should be prescribed by physicians who are experienced in the treatment of HIV infection. Dosage in adults and adolecents weighing at least 30 kg The usual recommended dose of Retrovir in combination ...
Contraindications
Retrovir Oral Formulations are contra-indicated in patients known to be hypersensitive to zidovudine, or to any of the excipients listed in section 6.1. Retrovir Oral Formulations should not be given to ...
Special warnings and precautions for use
Retrovir is not a cure for HIV infection or AIDS. Patients receiving Retrovir or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection. ...
Interaction with other medicinal products and other forms of interaction
Limited data suggests that co-administration of zidovudine with rifampicin decreases the AUC (area under the plasma concentration curve) of zidovudine by 48% ± 34%. This may result in a partial loss or ...
Fertility, pregnancy and lactation
Pregnancy As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, ...
Effects on ability to drive and use machines
There have been no studies to investigate the effect of Retrovir on driving performance or the ability to operate machinery. Furthermore, a detrimental effect on such activities cannot be predicted from ...
Undesirable effects
The adverse reaction profile appears similar for adults and children. The most serious adverse reactions include anaemia (which may require transfusions), neutropenia and leucopenia. These occurred more ...
Overdose
Symptoms and signs No specific symptoms or signs have been identified following acute overdose with zidovudine apart from those listed as undesirable effects. Treatment Patients should be observed closely ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> nucleoside analogue <b>ATC code:</b> J05AF01 Mode of action Zidovudine is an antiviral agent which is highly active <em>in vitro</em> against retroviruses including the ...
Pharmacokinetic properties
Adults Absorption Zidovudine is well absorbed from the gut and, at all dose levels studied, the bioavailability was 60-70%. From a bioequivalence study, steady-state mean (CV%) C<sub>ssmax</sub>, C<sub> ...
Preclinical safety data
Mutagenicity No evidence of mutagenicity was observed in the Ames test. However, zidovudine was weakly mutagenic in a mouse lymphoma cell assay and was positive in an <em>in vitro</em> cell transformation ...
List of excipients
<u>Capsule core:</u> Maize starch Microcrystalline cellulose Sodium starch glycollate Magnesium stearate <u>Capsule coating:</u> Titanium dioxide E171 Gelatin <u>Printing ink (black inks opacode 10A1 or ...
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
Do not store above 30°C. Store in the original package.
Nature and contents of container
PVC/aluminium foil blister pack containing 40 capsules.
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS
Marketing authorization number(s)
PL 35728/0002
Date of first authorization / renewal of the authorization
Date of first authorisation: 03 March 1987 Date of last renewal: 14 July 2011
Date of revision of the text
30 August 2022
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