Artesiane 20 Solution for injection 20 mg/mL

Negara: Tanzania

Bahasa: Inggris

Sumber: Tanzania Medicinces & Medical Devices Authority

Bahan aktif:

Artemether

Tersedia dari:

Dafra Pharma GmbH, SWITZERLAND

Kode ATC:

Antimalarials

INN (Nama Internasional):

Artemether

Dosis:

20 mg/mL

Bentuk farmasi:

Solution for injection

Diproduksi oleh:

Anfarm Hellas S.A, GREECE

Ringkasan produk:

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

Status otorisasi:

Registered/Compliant

Tanggal Otorisasi:

2022-07-19

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT (FPP)
Artesiane®
_Artemether _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
•
Artesiane 20: each ampoule (1 ml) contains 20 mg artemether
•
Artesiane 40: each ampoule (1 ml) contains 40 mg artemether
•
Artesiane 80: each ampoule (1 ml) contains 80 mg artemether
•
Artesiane 100: each ampoule (1 ml) contains 100 mg artemether
•
Artesiane 300: each ampoule (3 ml) contains 300 mg artemether
3.
PHARMACEUTICAL FORM
Solution for injection
Sterile, clear, colourless to slightly yellow oily solution
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Artesiane is indicated for the treatment of malaria in children and in
adults caused by
all species of Plasmodium, including severe malaria caused by multiple
drug
resistant strains of Plasmodium falciparum.
Artesiane 20 and Artesiane 40 are indicated for use in children.
Artesiane
80 is indicated for use in children and adults.
Artesiane 100 and Artesiane 300 are indicated for use in adults.
4.2.
POSOLOGY AND MODE OF ADMINISTRATION
4.2.1.
POSOLOGY
The dosage depends on the severity of the case and the clinical state
of the patient.
_LOADING DOSE FOR CHILDREN AND ADULTS: _
3.2 mg/kg body weight administered as a single intramuscular injection
on the first
day.
_MAINTENANCE DOSE FOR CHILDREN AND ADULTS: _
1.6 mg/kg/day administered as intramuscular injection once a day
during the
following four days.
Maintenance treatment can also be continued by oral artemisinin-based
combination therapy (ACT), if the patient’s condition does not
require injections.
_PERIOD OF USE _
A full course therapy of five days is essential in order to avoid
recrudescence. In
case of severe malaria it may be necessary to increase the loading
dose and to
prolong treatment for seven days if parasitaemia is not cleared during
the first few
days.
4.2.2.
SPECIAL POPULATIONS
see posology 4.2.1.
Patients with acute renal failure might reach higher maximal
concentrations ; in
these patients the elimination half-life of artemether c