ARTEPIL Solution for injection 60

Land: Tansania

Sprache: Englisch

Quelle: Tanzania Medicinces & Medical Devices Authority

Wirkstoff:

Artesunate

Verfügbar ab:

Psychotropics India Limited, INDIA

ATC-Code:

Antimalarials

INN (Internationale Bezeichnung):

Artesunate

Dosierung:

60

Darreichungsform:

Solution for injection

Hergestellt von:

Psychotropics India Limited, INDIA

Produktbesonderheiten:

Physical description: White to almost white powder; Local technical representative: KAS MEDICS LIMITED (9670)

Berechtigungsstatus:

Registered/Compliant

Berechtigungsdatum:

2022-12-05

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT:
Brand Name: ARTEPIL
Generic Name: Artesunate for Injection Ph. Int. 60 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
EACH VIAL CONTAINS:
Artesunate (Sterile) Ph.Int 60 mg
In combipack with:
1ml ampoule of Sodium Bicarbonate Injection USP 5% w/v
5ml ampoule of Sodium Chloride Injection USP 0.9 %w/v
3.
PHARMACEUTICAL FORM
White to almost white powder filled in 5ml clear USP type III glass
vial with rubber bung
aluminium seal having Taxim blue flip on top.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Artesunate Injection is an Antimalarial drug. It is indicated for the
treatment of severe malaria
caused by Plasmodium falciparum, in adults and children.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
_Route of administration: _
Intravenous or Intramuscular Injection
Method of preparation
Using a syringe, withdraw 1 ml of the sodium bicarbonate solvent from
the ampoule and inject
into the vial containing the artesunate powder. Shake the vial for
several minutes to form a
solution. Following this reconstitution, the solution must be diluted
according to the route of
injection, as described below:
For intravenous (IV) injection: Using a syringe, add 5 ml of sodium
chloride 0.9% for injection to
the vial containing the reconstituted artesunate solution. This will
yield 6 ml of a solution
containing artesunate 10 mg/ml
For intramuscular (IM) injection: Using a syringe, add 2 ml of sodium
chloride 0.9% for injection
to the vial containing the reconstituted artesunate solution. This
will yield 3 ml of a solution
containing artesunate 20 mg/ml
WATER
FOR
INJECTION
IS
NOT
AN
APPROPRIATE
DILUENTS
DOSE:
Paediatrics less than 20 kg: 3 mg/kg
Patients above 20 kg: 2.4mg/kg
NUMBER OF VIALS REQUIRED TO INITIATE A PARENTERAL DOSE
4.3 CONTRAINDICATIONS
Artesunate Injection is contraindicated in patients with
hypersensitivity to Artesunate or other
artemisinin.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_N O N - F A L C I P A R U M _
_MALARIA _
Artes