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DARUNAVIR KRKA Film-coated tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Darunavir Krka 400 mg film-coated tablets. Darunavir Krka 800 mg film-coated tablets.

Qualitative and quantitative composition

Darunavir Krka 400 mg film-coated tablets: Each film-coated tablet contains 400 mg darunavir. Darunavir Krka 800 mg film-coated tablets: Each film-coated tablet contains 800 mg darunavir. For the full ...

Pharmaceutical form

Film-coated tablet (tablet). Darunavir Krka 400 mg film-coated tablets: Yellowish brown, oval, biconvex film-coated tablets, engraved with a mark S1 on one side. Tablet dimension: 17 8.5 mm. Darunavir ...

Therapeutic indications

Darunavir Krka, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) ...

Posology and method of administration

Therapy should be initiated by a health care provider experienced in the management of HIV infection. After therapy with darunavir has been initiated, patients should be advised not to alter the dosage, ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with severe (Child-Pugh Class C) hepatic impairment. Concomitant treatment with any of the following ...

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

The interaction profile of darunavir may differ depending on whether ritonavir or cobicistat is used as pharmacoenhancer. The recommendations given for concomitant use of darunavir and other medicinal ...

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

Darunavir in combination with cobicistat or ritonavir has no or negligible influence on the ability to drive and use machines. However, dizziness has been reported in some patients during treatment with ...

Undesirable effects

Summary of the safety profile During the clinical development program (N=2,613 treatment-experienced subjects who initiated therapy with darunavir/ritonavir 600/100 mg twice daily), 51.3% of subjects experienced ...

Overdose

Human experience of acute overdose with darunavir co-administered with cobicistat or low dose ritonavir is limited. Single doses up to 3,200 mg of darunavir as oral solution alone and up to 1,600 mg of ...

Pharmacodynamic properties

Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors ATC code: J05AE10 Mechanism of action Darunavir is an inhibitor of the dimerisation and of the catalytic activity of the HIV-1 ...

Pharmacokinetic properties

The pharmacokinetic properties of darunavir, co-administered with cobicistat or ritonavir, have been evaluated in healthy adult volunteers and in HIV-1 infected patients. Exposure to darunavir was higher ...

Preclinical safety data

Animal toxicology studies have been conducted at exposures up to clinical exposure levels with darunavir alone, in mice, rats and dogs and in combination with ritonavir in rats and dogs. In repeated-dose ...

List of excipients

Tablet core: Cellulose, microcrystalline Crospovidone Hydroxypropylcellulose Silica, colloidal anhydrous Silicified microcrystalline cellulose (Cellulose, microcrystalline; Silica, colloidal anhydrous) ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years. Shelf life after first opening: 3 months.

Special precautions for storage

Keep the bottle tightly closed in order to protect from moisture. For storage conditions after first opening of the medicinal product, see section 6.3.

Nature and contents of container

400 mg film-coated tablets: Bottle (HDPE), child resistant temper evident PP closure with a desiccant: 30 tablets: 1 bottle of 30 film-coated tablets, 60 tablets: 2 bottles of 30 film-coated tablets, ...

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Marketing authorization number(s)

400 mg film-coated tablets: 30 film-coated tablets: EU/1/17/1249/001 60 film-coated tablets: EU/1/17/1249/002 90 film-coated tablets: EU/1/17/1249/003 180 film-coated tablets: EU/1/17/1249/004 800 mg film-coated ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 26 January 2018

Πηγαίο έγγραφο

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