TELZIR Film-coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Telzir 700 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 700 mg of fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir). For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. Pink film coated, capsule shaped, biconvex tablets, marked with GXLL7 on one side.
Therapeutic indications
Telzir in combination with low dose ritonavir is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults, adolescents and children of 6 years and above in combination ...
Posology and method of administration
Telzir must only be given with low dose ritonavir as a pharmacokinetic enhancer of amprenavir and in combination with other antiretroviral medicinal products. The Summary of Product Characteristics of ...
Contraindications
Hypersensitivity to fosamprenavir, amprenavir, or ritonavir, or to any of the excipients listed in section 6.1. Telzir must not be administered concurrently with medicinal products with narrow therapeutic ...
Special warnings and precautions for use
While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded. Precautions to prevent transmission ...
Interaction with other medicinal products and other forms of interaction
When fosamprenavir and ritonavir are co-administered, the ritonavir metabolic drug interaction profile may predominate because ritonavir is a more potent CYP3A4 inhibitor. The full prescribing information ...
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
No studies on the effects of Telzir in combination with ritonavir on the ability to drive and use machines have been performed. The adverse reaction profile of Telzir should be borne in mind when considering ...
Undesirable effects
Summary of safety profile The adverse reaction profile was similar across all the respective adult studies: antiretroviral naïve patients (APV30002, ESS100732), protease inhibitor experienced (twice daily ...
Overdose
There is no known antidote for Telzir. It is not known whether amprenavir can be removed by peritoneal dialysis or haemodialysis. If overdose occurs, the patient should be monitored for evidence of toxicity ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antivirals for systemic use, protease inhibitor ATC Code: J05AE07 Mechanism of action The in vitro antiviral activity observed with fosamprenavir is due to the presence of trace ...
Pharmacokinetic properties
After oral administration, fosamprenavir is rapidly and almost completely hydrolysed to amprenavir and inorganic phosphate prior to reaching the systemic circulation. The conversion of fosamprenavir to ...
Preclinical safety data
Toxicity was similar to that of amprenavir and occurred at amprenavir plasma exposure levels below human exposure after treatment with fosamprenavir in combination with ritonavir at the recommended dose. ...
List of excipients
Tablet core: Microcrystalline cellulose Croscarmellose sodium Povidone K30 Magnesium stearate Colloidal anhydrous silica Tablet film-coat: Hypromellose Titanium dioxide (E171) Glycerol triacetate Iron ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
HDPE bottles with a child resistant polypropylene closure containing 60 tablets.
Special precautions for disposal and other handling
Any unused medicinal product should be disposed of in accordance with local requirements.
Marketing authorization holder
ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands
Marketing authorization number(s)
EU/1/04/282/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 12 July 2004 Date of renewal of authorisation: 15 May 2009
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