Western Finished GMP Certifed Antimalarial Drug Artemether Injection 80mg: 1ml

• Customization: Available
• Application: Surgery
• Usage Mode: For external use
• Model NO.: 1 ml: 80mg
• Suitable for: Adult
• State: Liquid
• Shape: Intramuscular Administration
• Type: Biological Products
• Pharmaceutical Technology: Chemical Synthesis
• Dosage Form: Sterile and Colourless Solution
• Therapeutic Action: Antimalarial
• Function: Treatment of Severe Malaria
• Transport Package: as Per Customer Request
• Specification: 80mg: 1ml
• Trademark: No
• Origin: China
• HS Code: 3004909099
• Production Capacity: 100, 000, 000 Ampoules

Product Description

1. QUALITATIVE AND QUANTITATIVE COMPOSITIONArtemether 80 mg/ml .
2. PHARMACEUTICAL FORMArtemether 80 mg/ml ampoules. Box of 5 ampoules of 1 ml containing Artemether 80 mg/ml .
Sterile and colourless solution.
3. CLINICAL PARTICULARS
3.1 Therapeutic indications: Artemether 80 mg/ml is indicated for the treatment of malaria caused by allspecies of Plasmodium, including severe malaria caused by multiple drug resistant strains of Plasmodiumfalciparum.
3.2 Posology and method of administration:
The dosage depends on the severity of the case and theclinical state of the patient. Formulations for intramuscular injection of Artemether are mostly used in caseof severe malaria, such as cerebral malaria, but also in case of patients showing gastrointestinal problems.Loading dose for adults and children: 3.2 mg/kg body weight administered as a single intramuscularinjection on the first day.Maintenance dose for adults and children: 1.6 mg/kg/day administered as intramuscular injection oncea day during the following four days.Maintenance treatment can also be continued by oral Artemisinin-based combination therapies (ACT),ifthe patient's condition does not require injections.The drug is given by intramuscular injection in the gluteal muscle or the quadriceps. Combination ofother drugs in the same syringe should be avoided. Aseptic conditions must be respected when injectingArtemether.Note: a) A full course therapy of five days is essential in order to avoid recrudescence. b) In case of severemalaria it may be necessary to increase the loading dose and to prolong treatment for seven days ifparasitaemia is not cleared during the first few days.
3.3 Contraindications: There is no known contra-indication for the use of Artemether in the treatment ofmalaria.
3.4 Special warnings and precautions for use: Resistance of Plasmodium to Artemether has not beenobserved. Resistance is unlikely to occur in view of the specific mechanism of action of Artemether whichis very cytotoxic for the Plasmodia (opening of a peroxide bridge). An apparent resistance is sometimesseen but it is mainly due to multiple broods of Plasmodia developing at different times in the same patient.In controlled studies, recrudescence does not exceed 3 %. In case of recrudescence (real or apparent) acomplete new treatment of 5 days is recommended.
3.5 Interactions with other medicinal products: Specific drug interactions were not observed.Artemether potentialises the antimalarial activity of other antimalarials.
3.6 Fertility, pregnancy and lactation: The use of Artemether should be avoided during pregnancy,particularly during the first trimester. Breastfeeding: data on excretion in breastmilk are not available.
3.7 Undesirable effects: Adverse events were usually not reported with the recommended dose.Laboratory abnormalities such as increase in transaminases and decrease in reticulocyte count are rareand transient and usually without clinical manifestations. A decrease in sinus frequency without changesin the electrocardiogram has also been reported. At high doses, transient abdominal pain, tinnitus anddiarrhea have been described.
3.8 Overdose: Do not exceed the prescribed dose. A specific antidote is not known. The administration ofseveral times the therapeutic dose was not reported to cause serious adverse events. 

Dosage and duration

• Child and adult:

3.2 mg/kg by IM injection on the first day followed by 1.6 mg/kg once daily

 

Weight	80 mg ampoule
Loading dose	Maintenance dose
3-4 kg	0.2 ml	0.1 ml
5-6 kg	0.3 ml	0.15 ml
7-9 kg	0.4 ml	0.2 ml
10-14 kg	0.6 ml	0.3 ml
15-19 kg	0.8 ml	0.4 ml
20-29 kg	1.2 ml	0.6 ml
30-39 kg	1.6 ml	0.8 ml
40-49 kg	2 ml	1 ml
50-59 kg	2.5 ml	1.2 ml