APTIVUS Soft capsules (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Aptivus 250 mg soft capsules.
Qualitative and quantitative composition
Each soft capsule contains 250 mg tipranavir. Excipients with known effect: Each soft capsule contains: 100.0 mg ethanol, 455.0 mg macrogolglycerol ricinoleate and 12.6 mg sorbitol For the full list of ...
Pharmaceutical form
Soft capsule. Pink, oblong soft gelatin capsules imprinted with TPV 250 in black.
Therapeutic indications
Aptivus, co-administered with low dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adults and adolescents 12 years of age or older with virus ...
Posology and method of administration
Aptivus must always be given with low dose ritonavir as a pharmacokinetic enhancer, and in combination with other antiretroviral medicinal products. The Summary of Product Characteristics of ritonavir ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with moderate or severe (Child-Pugh B or C) hepatic impairment. Combination of rifampicin with Aptivus ...
Special warnings and precautions for use
Aptivus must be administered with low dose ritonavir to ensure its therapeutic effect (see section 4.2). Failure to correctly co-administer tipranavir with ritonavir will result in reduced plasma levels ...
Interaction with other medicinal products and other forms of interaction
The interaction profile of Aptivus, co-administered with low dose ritonavir, is complex and requires special attention in particular in combination with other antiretroviral agents. Interaction studies ...
Pregnancy and lactation
Contraception in males and females Tipranavir adversely interacts with oral contraceptives. Therefore, an alternative, effective, safe method of contraception should be used during treatment (see section ...
Effects on ability to drive and use machines
Dizziness, somnolence, and fatigue have been reported in some patients; therefore, caution should be recommended when driving a car or operating machinery. If patients experience fatigue, dizziness, or ...
Undesirable effects
Summary of the safety profile Amongst the most common adverse reactions reported for Aptivus were gastrointestinal complaints such as diarrhoea and nausea as well as hyperlipidaemia. The most serious adverse ...
Overdose
Human experience with tipranavir overdose is very limited. No specific signs and symptoms of overdose are known. Generally, an increased frequency and higher severity of adverse reactions may result from ...
Pharmacodynamic properties
Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors ATC code: J05AE09 Mechanism of action The human immunodeficiency virus (HIV-1) encodes an aspartyl protease that is essential ...
Pharmacokinetic properties
In order to achieve effective tipranavir plasma concentrations and a twice daily dosing regimen, coadministration of tipranavir with low dose ritonavir twice daily is essential (see section 4.2). Ritonavir ...
Preclinical safety data
Animal toxicology studies have been conducted with tipranavir alone, in mice, rats and dogs, and coadministered with ritonavir (3.75:1 w/w ratio) in rats and dogs. Studies with co-administration of tipranavir ...
List of excipients
Capsule contents: Macrogolglycerol ricinoleate Ethanol Mono/diglycerides of caprylic/capric acid Propylene glycol Purified water Trometamol Propyl gallate Capsule shell: Gelatin Red iron oxide (E172) ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years. In use storage: 60 days (below 25°C), after first opening of the bottle. It is advisable that the patient writes the date of opening the bottle on the label and/or carton.
Special precautions for storage
Store in a refrigerator (2°C-8°C).
Nature and contents of container
High density polyethylene (HDPE) bottle with two-piece child-resistant closure (outer and inner shell polypropylene, with a pulpboard/aluminium liner). Each bottle contains 120 soft capsules.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany
Marketing authorization number(s)
EU/1/05/315/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 25 October 2005 Date of latest renewal: 19 June 2015
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