A. Alpha Beta Arteether Injection 75mg/ml
B. Alpha Beta Arteether Injection 150mg/2ml
C. Alpha Beta Arteether Injection 225mg/3ml
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Alpha Beta Arteether Injection 75mg/ml
Each ml contains:
α- β arteether…………75mg
Arachis oil BP…………………. q.s.
B. Alpha Beta Arteether Injection 150mg/2ml
Each 2ml contains:
α- β arteether…………150mg
Arachis oil BP…………………. q.s.
C. Alpha Beta Arteether Injection 225mg/3ml
Each 3ml contains:
α- β arteether…………225mg
Arachis oil BP…………………. q.s.
Each ml contains:
α- β arteether…………75mg
Arachis oil BP…………………. q.s.
B. Alpha Beta Arteether Injection 150mg/2ml
Each 2ml contains:
α- β arteether…………150mg
Arachis oil BP…………………. q.s.
C. Alpha Beta Arteether Injection 225mg/3ml
Each 3ml contains:
α- β arteether…………225mg
Arachis oil BP…………………. q.s.
THERAPEUTIC INDICATIONS:
Useful in severe malaria including cerebral malaria & as a second line treatment in chloroquine resistant malaria cases only.
PACKING:
75mg/ml (150mg/2ml, 225mg/3ml)
DIRECTION OF USE:
For Intramuscular use only.
See insert for detailed dosage, directions for use and precautions.
See insert for detailed dosage, directions for use and precautions.
CAUTION AND WARNING:
CAUTION: The drug should not be promoted or used as a first line treatment for malaria.
Do not use if any particle/suspended matter is visible.
Discard any unused product immediately after use.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
Discard Unused portion.
Keep medicine out of reach of children.
Do not use if any particle/suspended matter is visible.
Discard any unused product immediately after use.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
Discard Unused portion.
Keep medicine out of reach of children.
STORAGE AND DOSAGE:
Storage: Store at 20° to 25°C.
Do not allow to freeze.
Protect from light.
Dosage:
Adult: 150mg i.e., 1 ampoule of α/β arteether once daily for 3 consecutive days.
Children: 3mg/kg per day administered by intramuscular injection over a 3-day period.
Deep intramuscularly in the upper lateral quadrant of the buttock. No other drug should be mixed in the same syringe.
Do not allow to freeze.
Protect from light.
Dosage:
Adult: 150mg i.e., 1 ampoule of α/β arteether once daily for 3 consecutive days.
Children: 3mg/kg per day administered by intramuscular injection over a 3-day period.
Deep intramuscularly in the upper lateral quadrant of the buttock. No other drug should be mixed in the same syringe.
Alpha Beta Arteether Injection 150mg/2ml Technical Specification:
| Product Name: | Alpha Beta Arteether Injection 150mg/2ml (Arachis oil Injection) |
| Brand Name: | Artemotial |
| Strength: | 75mg/ml, 150mg/2ml, 225mg/3ml |
| Dosage Form: | Liquid Injection (Ampoule) |
| Packing: | 1 mL, 2 mL, 3 mL |
| Route of Administration: | For Intramuscular use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antimalarials, Antiparasitic |
| Indication: | Useful in severe malaria including cerebral malaria & as a second line treatment in chloroquine resistant malaria cases only. |
| Storage: | Store at 20° to 25°C. Do not allow to freeze. Protect from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Alpha Beta Arteether Injection 150mg/2ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Alpha Beta Arteether Injection 150mg/2ml
Each 2ml contains:
α- β arteether…………150mg
Arachis oil BP…………………. q.s.
THERAPEUTIC INDICATION:
Useful in severe malaria including cerebral malaria & as a second line treatment in chloroquine resistant malaria cases only.
PACKING:
75mg/ml (150mg/2ml, 225mg/3ml)
DIRECTION OF USE:
For Intramuscular use only.
See insert for detailed dosage, directions for use and precautions.
CAUTION & WARNING:
CAUTION: The drug should not be promoted or used as a first line treatment for malaria. Do not use if any particle/suspended matter is visible.
Discard any unused product immediately after use.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
Discard Unused portion.
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C. Do not allow to freeze. Protect from light.
Dosage:
Adult: 150mg i.e., 1 ampoule of α/β arteether once daily for 3 consecutive days.
Children: 3mg/kg per day administered by intramuscular injection over a 3-day period.
Deep intramuscularly in the upper lateral quadrant of the buttock. No other drug should be mixed in the same syringe.
