Efavirenz, Lamivudine & Tenofovir Disoproxil Fumarate Tablets 600/300/300 mg

Χώρα: Τανζανία

Γλώσσα: Αγγλικά

Πηγή: Tanzania Medicinces & Medical Devices Authority

Δραστική ουσία:

Efavirenz, Lamivudine & Tenofovir Disoproxil Fumarate

Διαθέσιμο από:

Cipla Limited, INDIA

INN (Διεθνής Όνομα):

Efavirenz, Lamivudine & Tenofovir Disoproxil Fumarate

Δοσολογία:

600/300/300 mg

Φαρμακοτεχνική μορφή:

Tablets

Κατασκευάζεται από:

Cipla limited, (Goa Unit VII PD II), INDIA

Περίληψη προϊόντος:

Physical description: Yellow colored capsule shaped, biconvex, film coated tablets with ‘T’ debossed on one side and plain on the other; Local technical representative: Phillips Distributors Limited (9823)

Καθεστώς αδειοδότησης:

Registered/Compliant

Ημερομηνία της άδειας:

2019-08-02

Αρχείο Π.Χ.Π.

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Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
EFAVIRENZ, LAMIVUDINE & TENOFOVIR DISOPROXIL FUMARATE Film Coated Tablets
600/300/300 MG
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600 mg efavirenz, 300 mg lamivudine and 300 mg tenofovir disoproxil
fumarate equivalent to 245 mg of tenofovir disoproxil or 136 mg of tenofovir.
Excipients with known effect:
Each tablet contains 199.6 mg of lactose monohydrate and 43 mg of sodium. See
section 4.4. For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
Yellow- coloured, capsule-shaped, biconvex, film-coated tablets, with “T” debossed on one side
and plain on the other side.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
[EFAVIRENZ, LAMIVUDINE & TENOFOVIR DISOPROXIL FUMARATE TABLETS 600/300/300 MG ]
is a fixed dose combination of efavirenz, lamivudine and tenofovir disoproxil.
It is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in patients
weighing at least 35 kg.
Treatment regimens should follow most recent WHO treatment guidelines, supplemented by
other authoritative guidelines.
4.2 Posology and method of administration
Posology
Therapy should be prescribed by a physician experienced in the management of HIV-1 infection.
Adults and adolescents weighing at least 35 kg
The recommended dose of [EFAVIRENZ, LAMIVUDINE & TENOFOVIR DISOPROXIL FUMARATE
TABLETS 600/300/300 MG] is one tablet taken orally once daily.
Special populations
Elderly
[EFAVIRENZ, LAMIVUDINE & TENOFOVIR DISOPROXIL FUMARATE TABLETS 600/300/300 MG ]
should be administered with caution to elderly patients (see section 4.4).
Dose adjustments
Where discontinuation of therapy with one of the components of [EFAVIRENZ, LAMIVUDINE &
TENOFOVIR DISOPROXIL FUMARATE TABLETS 600/300/300 MG ] is indicated or where dose
modification is necessary, separate preparations of efavirenz, lamivudine and tenofovir disoproxil