KOVATRAX Film-coated tablet (2018)
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Περιεχόμενα
1. Name of the medicinal product
Kovatrax Tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains: Dolutegravir sodium equivalent to dolutegravir 50 mg, Lamivudine 300 mg and Tenofovir disoproxil fumarate 300 mg. Contains sugar (120,0 mg mannitol).
3. Pharmaceutical form
Film-coated tablets. White to off white, capsule shaped, film coated tablets, debossed with F67 on one side and plain on the other side.
4.1. Therapeutic indications
KOVATRAX TABLETS is indicated for the treatment of HIV-1 infection in adults aged 18 years and older.
4.2. Posology and method of administration
Therapy should be initiated by a medical practitioner experienced in the management of HIV infection. Adults The dose of KOVATRAX TABLETS is one tablet taken orally, once daily, without regard to food. ...
4.3. Contraindications
KOVATRAX TABLETS are contra-indicated in patients with known hypersensitivity to lamivudine, tenofovir or dolutegravir or to any of the components of the tablets. Impaired renal failure. Pregnancy and ...
4.4. Special warnings and precautions for use
WARNING LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION WITH OTHER ANTIRETROVIRALS (SEE WARNINGS ...
4.5. Interaction with other medicinal products and other forms of interaction
The likelihood of interactions is low due to the limited metabolism as plasma protein binding and almost complete renal clearance. Zidovudine plasma levels are not significantly altered when co-administered ...
4.6. Pregnancy and lactation
Pregnancy KOVATRAX TABLETS is contraindicated in pregnancy and lactation. Neural tube defects have been noted in an observational study in humans, where dolutegravir based regimens were used at the time ...
4.7. Effects on ability to drive and use machines
KOVATRAX TABLETS may affect the ability to drive and use machines. Patients should ensure that they do not engage in driving or using machines until they know how KOVATRAX TABLETS affects them.
4.8. Undesirable effects
KOVATRAX TABLETS can have side effects. Lamivudine The following side-effects have been reported during therapy for HIV disease with KOVATRAX TABLETS alone and in combination with other antiretrovirals. ...
4.9. Overdose
Tenofovir disoproxil fumarate If overdose occurs the patient must be monitored for evidence of toxicity and palliative supportive treatment be applied as necessary. Tenofovir can be removed by haemodialysis; ...
5.1. Pharmacodynamic properties
Category A: 20.2.8 Antimicrobial (Chemotherapeutic) Medicines. Antiviral Medicines. Lamivudine Lamivudine, a nucleoside reverse transcriptase inhibitor (NRTI), is a selective inhibitor of HIV-1 and HIV-2 ...
5.2. Pharmacokinetic properties
Lamivudine Pharmacokinetics in adults: Absorption Lamivudine is well absorbed from the gastrointestinal tract, and the bioavailability of oral lamivudine in adults is normally between 80% and 85%. Following ...
6.1. List of excipients
Microcrystalline cellulose, sodium starch glycolate, povidone, sodium stearyl fumarate, ferric oxide yellow, pregelatinized starch, croscarmellose sodium, isopropyl alcohol, magnesium stearate and coating ...
6.4. Special precautions for storage
Store at or below 25°C. Protect from light and moisture. Keep the containers tightly closed. KEEP OUT OF REACH AND SIGHT OF CHILDREN.
6.5. Nature and contents of container
HDPE container pack of 28 or 30 tablets: Tablets are packed in a 120 ml, round white HDPE bottle with 38-400 neck finish closed with 38 mm white, continuous thread polypropylene closure with pulp and heat ...
7. Marketing authorization holder
Macleods Pharmaceuticals SA (Pty) Ltd, Office block 1, Bassonia Estate Office Park (East), 1 Cussonia Drive, Bassonia Rock, Ext.12, Alberton, South Africa
8. Marketing authorization number(s)
52/20.2.8/0772.770
10. Date of revision of the text
10 October 2018
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