RETROVIR Concentrate for solution for infusion (2022)
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Περιεχόμενα
Name of the medicinal product
Retrovir 10 mg/ml IV Concentrate for Solution for Infusion.
Qualitative and quantitative composition
Vials containing zidovudine 200 mg in 20ml solution (10 mg zidovudine/ml). For a full list of excipients, see section 6.1.
Pharmaceutical form
Concentrate for solution for infusion (Sterile concentrate). Retrovir IV for Infusion is a clear, nearly colourless, sterile aqueous solution with a pH of approximately 5.5.
Therapeutic indications
Retrovir IV for Infusion is indicated for the short-term management of serious manifestations of Human Immunodeficiency Virus (HIV) infection in patients with Acquired Immune Deficiency Syndrome (AIDS) ...
Posology and method of administration
Retrovir should be prescribed by physicians who are experienced in the treatment of HIV infection. The required dose of Retrovir IV for Infusion must be administered by slow intravenous infusion of the ...
Contraindications
Retrovir IV for Infusion is contra-indicated in patients known to be hypersensitive to zidovudine, or to any of the excipients listed in section 6.1. Retrovir IV for infusion should not be given to patients ...
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
Retrovir IV for Infusion is generally used in an in-patient hospital population and information on ability to drive and use machinery is not usually relevant. There have been no studies to investigate ...
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 oral overdose with zidovudine apart from those listed as undesirable effects. Treatment Patients should be observed ...
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 Dose-independent kinetics were observed in patients receiving one-hour infusions of 1 to 5 mg/kg 3 to 6 times daily. Mean steady state peak (C<sub>ssmax</sub>) and trough (C<sub>ssmin ...
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
Hydrochloric acid (pH for adjustment) Sodium hydroxide (pH for adjustment) Water for injection
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
3 years. (Refer to Section 6.6 for shelf life after opening)
Special precautions for storage
Do not store above 30°C. Keep the vial in the outer carton.
Nature and contents of container
Type I glass vial (amber, neutral glass) with chlorobutyl rubber stopper containing 20ml sterile concentrate, available in pack sizes of 5.
Special precautions for disposal and other handling
Retrovir I.V. for Infusion must be diluted prior to administration. Since no antimicrobial preservative is included, dilution must be carried out under full aseptic conditions, preferably immediately prior ...
Marketing authorization holder
ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS
Marketing authorization number(s)
PL 35728/0005
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 April 1993 Date of last renewal: 19 July 2011
Date of revision of the text
30 August 2022
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