A. Artesunate Injection IP (60mg/vial) (Zentrom)
B. Artesunate Injection IP (120mg/vial) (Zentrom)
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Artesunate Injection IP (60mg/vial)
Composition:
Each vial contains:
Artesunate (Sterile) IP ………………………………………………60mg
This pack also contains:
1ml Ampoule of Sodium Bicarbonate Injection IP………5%w/v
5ml Ampoule of Sodium Chloride Injection IP……………0.9%w/v
B. Artesunate Injection IP (120mg/vial)
Composition:
Each vial contains:
Artesunate (Sterile) IP ………………………………………………120mg
This pack also contains:
2ml Ampoule of Sodium Bicarbonate Injection IP………5%w/v
10ml Ampoule of Sodium Chloride Injection IP……………0.9%w/v
Composition:
Each vial contains:
Artesunate (Sterile) IP ………………………………………………60mg
This pack also contains:
1ml Ampoule of Sodium Bicarbonate Injection IP………5%w/v
5ml Ampoule of Sodium Chloride Injection IP……………0.9%w/v
B. Artesunate Injection IP (120mg/vial)
Composition:
Each vial contains:
Artesunate (Sterile) IP ………………………………………………120mg
This pack also contains:
2ml Ampoule of Sodium Bicarbonate Injection IP………5%w/v
10ml Ampoule of Sodium Chloride Injection IP……………0.9%w/v
THERAPEUTIC INDICATIONS:
Artesunate for Injection is indicated for the initial treatment of severe malaria in adult and pediatric patients.
DIRECTION OF USE:
For I.V./I.M. use only.
For IV use:
Add 10ml 5% dextrose or Sodium Chloride Injection 0.9% w/v to the 120mg/vial.
Add 5ml 5% dextrose or Sodium Chloride Injection 0.9% w/v to the 60mg/vial.
Mix again.
Inject by slow IV route over 2-3 minutes.
Do not put the solution in an IV drip.
For IM use:
Add 4ml of 5% dextrose or Sodium Chloride Injection 0.9% w/v to the 120mg/vial.
Add 2ml of 5% dextrose or Sodium Chloride Injection 0.9% w/v to the 60mg/vial.
Mix again.
Inject by IM route.
For IV use:
Add 10ml 5% dextrose or Sodium Chloride Injection 0.9% w/v to the 120mg/vial.
Add 5ml 5% dextrose or Sodium Chloride Injection 0.9% w/v to the 60mg/vial.
Mix again.
Inject by slow IV route over 2-3 minutes.
Do not put the solution in an IV drip.
For IM use:
Add 4ml of 5% dextrose or Sodium Chloride Injection 0.9% w/v to the 120mg/vial.
Add 2ml of 5% dextrose or Sodium Chloride Injection 0.9% w/v to the 60mg/vial.
Mix again.
Inject by IM route.
CAUTION AND SCHEDULE:
CAUTION: If any foreign particle is visible in the vial after dissolving the content, please do not use the solution & return for replacement.
The drug should not be promoted or used as a first line treatment of malaria.
Prepared solution should be used immediately.
FOR HOSPITAL USE ONLY
SCHEDULE: SCHEDULE ‘H’ DRUG: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
The drug should not be promoted or used as a first line treatment of malaria.
Prepared solution should be used immediately.
FOR HOSPITAL USE ONLY
SCHEDULE: SCHEDULE ‘H’ DRUG: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store in a cool & dry place. Protect from moisture & direct sunlight. Do not freeze it.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Artesunate Injection IP (60mg/vial) Technical Specification:
| Product Name: | Artesunate Injection IP 60mg |
| Brand Name: | Zentrom |
| Strength: | 60mg/vial, 120mg/vial |
| Dosage Form: | Lyophilized Powder for Injection (Sterile) |
| Packing: | Combi-pack (Vial + Ampoule + FFS ampoule) |
| Route of Administration: | For I.V./I.M. use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Product Permission, Stability Studies, GMP |
| Therapeutic use: | Antimalarial |
| Indication: | Artesunate for Injection is indicated for the initial treatment of severe malaria in adult and pediatric patients. |
| Storage: | Store in a cool & dry place. Protect from moisture & direct sunlight. Do not freeze it. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Artesunate Injection IP (60mg/vial)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Artesunate Injection IP (60mg/vial)
Composition:
Each vial contains:
Artesunate (Sterile) IP ………………………………………………60mg
This pack also contains:
1ml Ampoule of Sodium Bicarbonate Injection IP………5%w/v
5ml Ampoule of Sodium Chloride Injection IP……………0.9%w/v
THERAPEUTIC INDICATIONS:
Artesunate for Injection is indicated for the initial treatment of severe malaria in adult and pediatric patients.
DIRECTION OF USE:
For I.V./I.M. use only.
- For IV use:
Add 5ml 5% dextrose or Sodium Chloride Injection 0.9% w/v to the 60mg/vial.
Mix again.
Inject by slow IV route over 2-3 minutes.
Do not put the solution in an IV drip. - For IM use:
Add 2ml of 5% dextrose or Sodium Chloride Injection 0.9% w/v to the 60mg/vial.
Mix again.
Inject by IM route.
CAUTION & SCHEDULE:
CAUTION: If any foreign particle is visible in the vial after dissolving the content, please do not use the solution & return for replacement.
The drug should not be promoted or used as a first line treatment of malaria.
Prepared solution should be used immediately.
FOR HOSPITAL USE ONLY
SCHEDULE: SCHEDULE ‘H’ DRUG: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store in a cool & dry place. Protect from moisture & direct sunlight. Do not freeze it.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
