COMPOSITION:
Each 5 ml of reconstituted suspension contains:
Artemether.........................15mg
Excipients..........................q.s.
INDICATIONS:
Antimalarial drug. For the treatment of all kinds of malaria including the chloroquine - resistant P. falciparum malaria and the first aid of critical malaria.
PHARMACOLOGY ANO TOXICOLOGY:
Animal pharmacodynamics showed that the drug is a strong schizonticlde. Parasitemia clearance occurs rapidly with stable efficiency after administration.
It is also effective against chloroquine - resistant P. falciparum malaria. Acute toxicity studies on animals showed that the LD50 of Artemether In mice of a single I.g. administration Is 895mg/kg and a single i.m. Injection is296mg/kg; in rats, the LD50 of a single i.m. injection is 597mg/kg. This proves the toxicity of Artemether is quite low.
CONTRA-INDICATIONS:
1 .Hypersensitivity to the active substances or any of the excipients.
2.Patients suffering from severe or complicated malaria.
ADVERSE REACTIONS:
Clinical dosage exhibits slight adverse reactions. Atransient low fever and reticulocytopenia may occur in individual cases. Slight rise of SGOT and SGPT may occur in individual cases. Arrhythmia may occur in rare (such as ventricular tachycardia).
CAUTIONS, DRUGS INTERACTION:
However, the use of complementary medication during the clinical trials (antipyretics, fluid and electrolyte replacement etc) showed no evidence of drug interaction.
Studies and reviews In the literature demonstrated that the active substance of Artemether had no Interactions with other drugs on decreasing therapeutic effects and increasing toxicity and side effects in human bodies.
PREGNANCY AND LACTATION:
It should be used with caution in the first trimester of pregnancy since some fetus absorption has been observed. OVERDOSE:
Although no case of over dosage has been documented, In case of accident, symptomatic treatment is recommended under the instructions of doctors.
DOSAGE & ADMINISTRATION:
Oral. 1 time daily, taken 5 or 7 days conlinuely.
Usual Adult Dose: 80mg taken 1 time daily, either as 1.6mg/kg of body weight. For the first time, taken 160mg 1 time. Children: Decrease progressively according to the age.
IN CASE OF DOUBT, CONSULT YOUR DOCTOR.
STORAGE INSTRUCTIONS:
Store below 25ºC. Protect from light.
for Export use only
Each 5 ml of reconstituted suspension contains:
Artemether.........................15mg
Excipients..........................q.s.
INDICATIONS:
Antimalarial drug. For the treatment of all kinds of malaria including the chloroquine - resistant P. falciparum malaria and the first aid of critical malaria.
PHARMACOLOGY ANO TOXICOLOGY:
Animal pharmacodynamics showed that the drug is a strong schizonticlde. Parasitemia clearance occurs rapidly with stable efficiency after administration.
It is also effective against chloroquine - resistant P. falciparum malaria. Acute toxicity studies on animals showed that the LD50 of Artemether In mice of a single I.g. administration Is 895mg/kg and a single i.m. Injection is296mg/kg; in rats, the LD50 of a single i.m. injection is 597mg/kg. This proves the toxicity of Artemether is quite low.
CONTRA-INDICATIONS:
1 .Hypersensitivity to the active substances or any of the excipients.
2.Patients suffering from severe or complicated malaria.
ADVERSE REACTIONS:
Clinical dosage exhibits slight adverse reactions. Atransient low fever and reticulocytopenia may occur in individual cases. Slight rise of SGOT and SGPT may occur in individual cases. Arrhythmia may occur in rare (such as ventricular tachycardia).
CAUTIONS, DRUGS INTERACTION:
However, the use of complementary medication during the clinical trials (antipyretics, fluid and electrolyte replacement etc) showed no evidence of drug interaction.
Studies and reviews In the literature demonstrated that the active substance of Artemether had no Interactions with other drugs on decreasing therapeutic effects and increasing toxicity and side effects in human bodies.
PREGNANCY AND LACTATION:
It should be used with caution in the first trimester of pregnancy since some fetus absorption has been observed. OVERDOSE:
Although no case of over dosage has been documented, In case of accident, symptomatic treatment is recommended under the instructions of doctors.
DOSAGE & ADMINISTRATION:
Oral. 1 time daily, taken 5 or 7 days conlinuely.
Usual Adult Dose: 80mg taken 1 time daily, either as 1.6mg/kg of body weight. For the first time, taken 160mg 1 time. Children: Decrease progressively according to the age.
IN CASE OF DOUBT, CONSULT YOUR DOCTOR.
STORAGE INSTRUCTIONS:
Store below 25ºC. Protect from light.
for Export use only