Страна: Танзания
Язык: английский
Источник: Tanzania Medicinces & Medical Devices Authority
Artesunate
Cipla Limited, INDIA
Artesunate
100 mg
Suppositories
Cipla Limited, INDIA
Physical description: White to off white coloured elongated soft gelatin capsule containing white to off white paste; Local technical representative: Phillips Distributors Limited (9823)
Registered/Compliant
2019-08-02
Page 1 of 13 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. Прочитать полный документ