KIVEXA Film-coated tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
Kivexa 600 mg/300 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 600 mg of abacavir (as sulfate) and 300 mg lamivudine. <u>Excipient(s) with known effect:</u> Each 600 mg/300 mg tablet contains 1.7 mg sunset yellow FCF (E110) and 2.31 ...
3. Pharmaceutical form
Film-coated tablet (tablet). Orange, film-coated, modified capsule shaped tablets, debossed with GS FC2 on one side.
4.1. Therapeutic indications
Kivexa is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg (see sections 4.4 ...
4.2. Posology and method of administration
Therapy should be prescribed by a physician experienced in the management of HIV infection. Posology Adults, adolescents and children weighing at least 25 kg The recommended dose of Kivexa is one tablet ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. See sections 4.4 and 4.8.
4.4. Special warnings and precautions for use
The special warnings and precautions relevant to abacavir and lamivudine are included in this section. There are no additional precautions and warnings relevant to Kivexa. Hypersensitivity reactions (see ...
4.5. Interaction with other medicinal products and other forms of interaction
Kivexa contains abacavir and lamivudine, therefore any interactions identified for these individually are relevant to Kivexa. Clinical studies have shown that there are no clinically significant interactions ...
4.6. 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, ...
4.7. Effects on ability to drive and use machines
No studies on the effects on ability to drive and use machines have been performed. The clinical status of the patient and the adverse reaction profile of Kivexa should be borne in mind when considering ...
4.8. Undesirable effects
Summary of the safety profile The adverse reactions reported for Kivexa were consistent with the known safety profiles of abacavir and lamivudine when given as separate medicinal products. For many of ...
4.9. Overdose
No specific symptoms or signs have been identified following acute overdose with abacavir or lamivudine, apart from those listed as undesirable effects. If overdose occurs the patient should be monitored ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antivirals for systemic use, antivirals for treatment of HIV infections, combinations <b>ATC code:</b> J05AR02 Mechanism of action Abacavir and lamivudine are NRTIs, and ...
5.2. Pharmacokinetic properties
The fixed-dose combination tablet of abacavir/lamivudine (FDC) has been shown to be bioequivalent to lamivudine and abacavir administered separately. This was demonstrated in a single dose, 3-way crossover ...
5.3. Preclinical safety data
With the exception of a negative <em>in vivo</em> rat micronucleus test, there are no data available on the effects of the combination of abacavir and lamivudine in animals. Mutagenicity and carcinogenicity ...
6.1. List of excipients
<u>Tablet Core:</u> Magnesium stearate Microcrystalline cellulose Sodium starch glycollate <u>Tablet Coating:</u> Opadry Orange YS-1-13065-A containing: Hypromellose Titanium dioxide Macrogol 400 Polysorbate ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 30°C.
6.5. Nature and contents of container
30 tablets in opaque white (PVC/PVDCAluminium/Paper) child-resistant blister packs Multipacks containing 90 (3 packs of 30) tablets in opaque white (PVC/PVDC-Aluminium/Paper) child-resistant blister packs. ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
8. Marketing authorization number(s)
EU/1/04/298/002 EU/1/04/298/003
9. Date of first authorization / renewal of the authorization
Date of first authorization: 17 December 2004 Date of latest renewal: 17 November 2014
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