ARTEPIL Solution for injection 60

Quốc gia: Tanzania

Ngôn ngữ: Tiếng Anh

Nguồn: Tanzania Medicinces & Medical Devices Authority

Thành phần hoạt chất:

Artesunate

Sẵn có từ:

Psychotropics India Limited, INDIA

Mã ATC:

Antimalarials

INN (Tên quốc tế):

Artesunate

Liều dùng:

60

Dạng dược phẩm:

Solution for injection

Sản xuất bởi:

Psychotropics India Limited, INDIA

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

Registered/Compliant

Ngày ủy quyền:

2022-12-05

Đặc tính sản phẩm

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