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COMBIVIR Film-coated tablet (2022)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Combivir 150 mg/300 mg film-coated tablets.

2. Qualitative and quantitative composition

Each film-coated tablet contains 150 mg lamivudine and 300 mg zidovudine. <u>Excipient(s) with known effect:</u> Each 150/300 mg tablet contains 0.945 mg sodium. For the full list of excipients see section ...

3. Pharmaceutical form

Film-coated tablet. White to off-white, capsule-shaped film-coated scored tablets engraved with GXFC3 on both sides.

4.1. Therapeutic indications

Combivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection (see section 4.2).

4.2. Posology and method of administration

Therapy should be initiated by a physician experienced in the management of HIV infection. Combivir may be administered with or without food. To ensure administration of the entire dose, the tablet(s) ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Zidovudine is contraindicated in patients with abnormally low neutrophil counts (<0.75 10<sup>9</sup>/l), or ...

4.4. Special warnings and precautions for use

The special warnings and precautions relevant to both lamivudine and zidovudine are included in this section. There are no additional precautions and warnings relevant to the combination Combivir. It is ...

4.5. Interaction with other medicinal products and other forms of interaction

Combivir contains lamivudine and zidovudine, therefore any interactions identified for these individually are relevant to Combivir. Clinical studies have shown that there are no clinically significant ...

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 the ability to drive and use machines have been performed.

4.8. Undesirable effects

Adverse reactions have been reported during therapy for HIV disease with lamivudine and zidovudine separately or in combination. For many of these events, it is unclear whether they are related to lamivudine, ...

4.9. Overdose

There is limited experience of overdosage with Combivir. No specific symptoms or signs have been identified following acute overdose with zidovudine or lamivudine apart from those listed as undesirable ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antivirals for treatment of HIV infections, combinations ATC Code: J05AR01 Lamivudine and zidovudine are nucleoside analogues which have activity against HIV. Additionally, lamivudine ...

5.2. Pharmacokinetic properties

Absorption Lamivudine and zidovudine are well absorbed from the gastrointestinal tract. The bioavailability of oral lamivudine in adults is normally between 80–85% and for zidovudine 60–70%. A bioequivalence ...

5.3. Preclinical safety data

The clinically relevant effects of lamivudine and zidovudine in combination are anaemia, neutropenia and leucopenia. Mutagenicity and carcinogenicity Neither lamivudine nor zidovudine are mutagenic in ...

6.1. List of excipients

<u>Tablet core:</u> Microcrystalline cellulose (E460) Sodium starch glycollate Colloidal silicon dioxide Magnesium stearate <u>Tablet film coat:</u> Hypromellose (E464) Titanium dioxide (E171) Macrogol ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Do not store above 30°C.

6.5. Nature and contents of container

Cartons containing opaque polyvinyl chloride/foil blister packs. Cartons containing white high density polyethylene (HDPE) bottle with a child-resistant closure. Each pack type contains 60 film-coated ...

6.6. Special precautions for disposal and other handling

No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands

8. Marketing authorization number(s)

EU/1/98/058/001 EU/1/98/058/002

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 18 March 1998 Date of renewal authorisation: 13 February 2008

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