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.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Alpha Beta Arteether Injection 75mg/ml
B. Alpha Beta Arteether Injection 150mg/2ml
C. Alpha Beta Arteether Injection 225mg/3ml

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.

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.

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.

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.