Artesiane 80 Injection 80 mg/ml

País: Tanzània

Idioma: anglès

Font: Tanzania Medicinces & Medical Devices Authority

ingredients actius:

Artemether

Disponible des:

Dafra Pharma GmbH, SWITZERLAND

Designació comuna internacional (DCI):

Artemether

Dosis:

80 mg/ml

formulario farmacéutico:

Injection

Fabricat per:

Rotexmedica GmbH Arzneimittelwerk, GERMANY

Resumen del producto:

Physical description: Clear, colourless to slightly yellowish oily; Local technical representative: Harleys (T) Limited (4194)

Estat d'Autorització:

Registered/Compliant

Data d'autorització:

2020-11-19

Fitxa tècnica

ARTESIANE
®
(ARTEMETHER)
1. NAME OF THE MEDICINAL PRODUCT
ARTESIANE
®
20
ARTESIANE
®
40
ARTESIANE
®
80
ARTESIANE
®
100
ARTESIANE
®
300
ARTESIANE
®
40 mg Suppogel for Rectal Administration
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ARTESIANE
®
20:
Artemether 20 mg/ml in fractionated coconut oil.
ARTESIANE
®
40:
Artemether 40 mg/ml in fractionated coconut oil
.
ARTESIANE
®
80:
Artemether 80 mg/ml in fractionated coconut oil.
ARTESIANE
®
100:
Artemether 100 mg/ml in fractionated coconut oil
.
ARTESIANE
®
300:
Artemether 300 mg/3ml.
ARTESIANE
®
40 mg Suppogel for Rectal Administration:
Artemether 40 mg
Refined soya oil, glycerine, gelatine, water.
3. PHARMACEUTICAL FORMS
ARTESIANE
®
20:
Artemether 20 mg/ml paediatric ampoules.
Box of 10 ampoules of 1 ml containing Artemether 20 mg/ml in
fractionated coconut oil. Sterile and
colourless solution.
ARTESIANE
®
40:
Artemether 40 mg/ml paediatric ampoules.
Box of 10 ampoules of 1 ml containing Artemether 40 mg/ml in
fractionated coconut oil. Sterile and
colourless solution.
ARTESIANE
®
80:
Artemether 80 mg/ml ampoules.
Box of 5 ampoules of 1 ml containing Artemether 80 mg/ml in
fractionated coconut oil. Sterile and
colourless solution.
ARTESIANE
®
100:
Artemether 100 mg/ml ampoules.
Box of 10 ampoules of 1 ml containing Artemether 100 mg/ml in
fractionated coconut oil. Sterile and
colourless solution.
ARTESIANE
®
300:
Artemether 300 mg/3ml ampoules.
Box of 1 ampoule of 3 ml containing Artemether 300 mg in 3 ml (or 100
mg/ml), in fractionated
coconut oil. Sterile and colourless solution. Additionally sterile
syringe + needle and pre-injection
skin cleansing swab is added.
ARTESIANE
®
40 mg Suppogel for Rectal Administration:
One blister of six suppogels packed in one cardboard box with a
package insert. Each suppogel
contains 40 mg of beta-Artemether (Artemether) dissolved in soya oil.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Artemether is indicated for the treatment of malaria in children and
in adults caused by all species of
_Plasmodium_, i