DARUNAVIR KRKA 400 mg / 800 mg Film-coated tablet (2023)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Darunavir Krka 400 mg film-coated tablets. Darunavir Krka 800 mg film-coated tablets.
Qualitative and quantitative composition
<u>Darunavir Krka 400 mg film-coated tablets:</u> Each film-coated tablet contains 400 mg darunavir. <u>Darunavir Krka 800 mg film-coated tablets:</u> Each film-coated tablet contains 800 mg darunavir. ...
Pharmaceutical form
Film-coated tablet (tablet). <u>Darunavir Krka 400 mg film-coated tablets:</u> Yellowish brown, oval, biconvex film-coated tablets, engraved with a mark S1 on one side. Tablet dimension: 17 8.5 mm. <u> ...
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 healthcare provider experienced in the management of HIV infection. After therapy with darunavir has been initiated, patients should be advised not to alter the dose, dose ...
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
Regular assessment of virological response is advised. In the setting of lack or loss of virological response, resistance testing should be performed. Darunavir must always be given orally with cobicistat ...
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
<b>Pharmacotherapeutic group:</b> antivirals for systemic use, protease inhibitors <b>ATC code:</b> J05AE10 Mechanism of action Darunavir is an inhibitor of the dimerisation and of the catalytic activity ...
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
<u>Tablet core:</u> Cellulose, microcrystalline Crospovidone Hydroxypropylcellulose Silica, colloidal anhydrous Silicified microcrystalline cellulose (Cellulose, microcrystalline; Silica, colloidal anhydrous) ...
Incompatibilities
Not applicable.
Shelf life
3 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
<u>400 mg film-coated tablets:</u> Bottle (HDPE), child resistant tamper 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)
<u>400 mg film-coated tablets:</u> 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 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 26 January 2018 Date of latest renewal: 9 November 2022
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
