ZIAGEN Oral solution (2023)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Ziagen 20 mg/ml oral solution.
Qualitative and quantitative composition
Each ml of oral solution contains 20 mg of abacavir (as sulfate). <u>Excipients with known effect:</u> Sorbitol (E420) 340 mg/ml Methyl parahydroxybenzoate (E218) 1.5 mg/ml Propyl parahydroxybenzoate (E216) ...
Pharmaceutical form
Oral solution. The oral solution is clear to slightly opalescent yellowish, aqueous solution which may turn into a brown colour over time.
Therapeutic indications
Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children (see sections 4.4 and 5.1). The demonstration ...
Posology and method of administration
Ziagen should be prescribed by physicians experienced in the management of HIV infection. Ziagen can be taken with or without food. Ziagen is also available as a tablet formulation. Adults, adolescents ...
Contraindications
Hypersensitivity to abacavir or to any of the excipients listed in section 6.1. See sections 4.4 and 4.8.
Special warnings and precautions for use
Hypersensitivity reactions (see also section 4.8) Abacavir is associated with a risk for hypersensitivity reactions (HSR) (see section4.8) characterised by fever and/or rash with other symptoms indicating ...
Interaction with other medicinal products and other forms of interaction
The potential for P450 mediated interactions with other medicinal products involving abacavir is low. <em>In vitro</em> studies have shown that abacavir has potential to inhibit cytochrome P450 1A1 (CYP1A1). ...
Fertility, pregnancy and lactation
Pregnancy As a general rule, when deciding to use antiretroviral agents for the treatment 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
No studies on the effects on ability to drive and use machines have been performed.
Undesirable effects
For many adverse reactions reported, it is unclear whether they are related to Ziagen, to the wide range of medicinal products used in the management of HIV infection or as a result of the disease process. ...
Overdose
Single doses up to 1200 mg and daily doses up to 1800 mg of Ziagen have been administered to patients in clinical studies. No additional adverse reactions to those reported for normal doses were reported. ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> nucleoside reverse transcriptase inhibitors <b>ATC Code:</b> J05AF06 Mechanism of action Abacavir is a NRTI. It is a potent selective inhibitor of HIV-1 and HIV-2. Abacavir ...
Pharmacokinetic properties
Absorption Abacavir is rapidly and well absorbed following oral administration. The absolute bioavailability of oral abacavir in adults is about 83%. Following oral administration, the mean time (t<sub> ...
Preclinical safety data
Abacavir was not mutagenic in bacterial tests but showed activity <em>in vitro</em> in the human lymphocyte chromosome aberration assay, the mouse lymphoma assay, and the <em>in vivo</em> micronucleus ...
List of excipients
Sorbitol 70% (E420) Saccharin sodium Sodium citrate Citric acid anhydrous Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Propylene glycol (E1520) Maltodextrin Lactic acid Glyceryl ...
Incompatibilities
Not applicable.
Shelf life
2 years. <u>After first opening the container:</u> 2 months.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Ziagen oral solution is supplied in high density polyethylene bottles with child-resistant closures, containing 240 ml of oral solution. The pack also includes a polyethylene syringe-adapter and a 10 ml ...
Special precautions for disposal and other handling
A plastic adapter and oral dosing syringe are provided for accurate measurement of the prescribed dose of oral solution. The adapter is placed in the neck of the bottle and the syringe attached to this. ...
Marketing authorization holder
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
Marketing authorization number(s)
EU/1/99/112/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 8 July 1999 Date of latest renewal: 21 March 2014
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