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Λογότυπο Γαληνού

SPC, UK: Ziagen 20 mg/ml oral solution (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
ViiV Healthcare UK Ltd
Διεύθυνση :
Stockley Park West, Uxbridge, Middlesex,, UB11 1BT, UK
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Name of the medicinal product

Ziagen 20 mg/ml oral solution.

Ποιοτική και ποσοτική σύνθεση

Each ml of oral solution contains 20 mg of abacavir (as sulfate). Excipients: Sorbitol (E420) 340 mg/ml Methyl parahydroxybenzoate (E218) 1.5 mg/ml Propyl parahydroxybenzoate (E216) 0.18 mg/ml For a full ...

Pharmaceutical form

Oral solution. The oral solution is clear to slightly opalescent yellowish, aqueous solution.

Therapeutic indications

Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection. The demonstration of the benefit of Ziagen is mainly based on results of studies ...

Posology and method of administration

Ziagen should be prescribed by physicians experienced in the management of HIV infection. Adults and adolescents: the recommended dose of Ziagen is 600 mg daily (30 ml). This may be administered as either ...

Contraindications

Severe hepatic impairment. Hypersensitivity to the active substance or to any of the excipients.

Special warnings and precautions for use

Hypersensitivity reaction In a clinical study, 3.4 % of subjects with a negative HLA-B*5701 status receiving abacavir developed a hypersensitivity reaction. Studies have shown that carriage of the HLA-B*5701 ...

Interaction with other medicinal products and other forms of interaction

Based on the results of in vitro experiments and the known major metabolic pathways of abacavir, the potential for P450 mediated interactions with other medicinal products involving abacavir is low. P450 ...

Pregnancy and lactation

Ziagen is not recommended during pregnancy. The safe use of abacavir in human pregnancy has not been established. Placental transfer of abacavir and/or its related metabolites has been shown to occur in ...

Ικανότητα οδήγησης και χειρισμός μηχανημάτων

No studies on the effects on ability to drive and use machines have been performed.

Undesirable effects

Hypersensitivity. In a clinical study, 3.4 % of submects with a negative HLA-B*5701 status receiving abacavir developed a hypersensitivity reaction. In clinical studies with abacavir 600 mg once daily ...

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

Pharmacotherapeutic group: nucleoside reverse transcriptase inhibitors ATC Code: J05AF06 Mechanism of action: Abacavir is a NRTI. It is a potent selective inhibitor of HIV-1 and HIV-2. Abacavir is metabolised ...

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 (tmax) ...

Preclinical safety data

Abacavir was not mutagenic in bacterial tests but showed activity in vitro in the human lymphocyte chromosome aberration assay, the mouse lymphoma assay, and the in vivo micronucleus test. This is consistent ...

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.

Ημερομηνία λήξης

Shelf life: 2 years. After first opening the container: 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 ...

Marketing authorization holder

ViiV Healthcare UK Limited 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom

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: 8 July 2004

Date of revision of the text

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu 24 Oct 2011 Ziagen is a registered trademark of the ViiV Healthcare ...
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