Artesunate Suppositories

Country: Tanżanija

Lingwa: Ingliż

Sors: Tanzania Medicinces & Medical Devices Authority

Ingredjent attiv:

Artesunate

Disponibbli minn:

Cipla Limited, INDIA

INN (Isem Internazzjonali):

Artesunate

Dożaġġ:

100 mg

Għamla farmaċewtika:

Suppositories

Manifatturat minn:

Cipla Limited, INDIA

Sommarju tal-prodott:

Physical description: White to off white coloured elongated soft gelatin capsule containing white to off white paste; Local technical representative: Phillips Distributors Limited (9823)

L-istatus ta 'awtorizzazzjoni:

Registered/Compliant

Data ta 'l-awtorizzazzjoni:

2019-08-02

Karatteristiċi tal-prodott

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
ARTESUNATE 100 mg Suppositories
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each rectal suppository contains artesunate 100 mg. Approved colours used in capsule shell.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suppositories.
White to off white coloured, elongated, soft gelatin capsules containing white to off white paste.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
[ARTESUNATE] is to be used as pre-referral treatment for suspected or proven severe
malaria in children under 6 years of age, who are unable to take oral medication or obtain
injectable antimalarial treatment. The patient should be immediately referred to a facility
where accurate diagnosis and comprehensive treatment with effective antimalarials can be
instituted.
Consideration should be given to official treatment guidelines for malaria (e.g. by WHO).
4.2 Posology and method of administration
Limitations of use:
• [ARTESUNATE] should not be used for patients aged 7 years and over
• [ARTESUNATE] should not be used to prevent malaria
• [ARTESUNATE] is for severe malaria only, and should not be used for the
treatment of uncomplicated malaria
Paediatric population up to 6years
This medicine is recommended for antimalarial treatment as a single dose of 10mg/kg
bodyweight. It should be given rectally as soon as a presumptive diagnosis of severe malaria has
been made; while the patient is being transferred to the nearest health clinic or hospital.
The table below indicates the number of suppositories determined by body weight.
Body Weight Number of 100 mg suppositories
Up to 10 kg 1 suppository of 100 mg artesunate
Up to 20 kg 2 suppositories of 100 mg artesunate
For community health workers and in places with limited diagnostic capacity for severe malaria,
the WHO algorithm for giving rectal artesunate for pre-referral treatment of severe febrile illness
in children under 6 years described below should be followed.