A. Amikacin Sulphate Injection IP 100mg/2ml
B. Amikacin Sulphate Injection IP 250mg/2ml
C. Amikacin Sulphate Injection IP 500mg/2ml
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Amikacin Sulphate Injection IP 100mg/2ml
Each 2ml contains:
Amikacin Sulphate I.P.
Eq. to Amikacin ……………100mg
Methylparaben I.P. …….0.08%w/v
(As Preservative)
Propylparaben I.P. ……0.02%w/v
(As Preservative)
Water for Injection I.P. ……...q.s.
B. Amikacin Sulphate Injection IP 250mg/2ml
Each 2ml contains:
Amikacin Sulphate I.P.
Eq. to Amikacin ……………250mg
Methylparaben I.P. …….0.08%w/v
(As Preservative)
Propylparaben I.P. ……0.02%w/v
(As Preservative)
Water for Injection I.P. ……...q.s.
C. Amikacin Sulphate Injection IP 500mg/2ml
Each 2ml contains:
Amikacin Sulphate I.P.
Eq. to Amikacin ……………500mg
Methylparaben I.P. …….0.08%w/v
(As Preservative)
Propylparaben I.P. ……0.02%w/v
(As Preservative)
Water for Injection I.P. ……...q.s.
Each 2ml contains:
Amikacin Sulphate I.P.
Eq. to Amikacin ……………100mg
Methylparaben I.P. …….0.08%w/v
(As Preservative)
Propylparaben I.P. ……0.02%w/v
(As Preservative)
Water for Injection I.P. ……...q.s.
B. Amikacin Sulphate Injection IP 250mg/2ml
Each 2ml contains:
Amikacin Sulphate I.P.
Eq. to Amikacin ……………250mg
Methylparaben I.P. …….0.08%w/v
(As Preservative)
Propylparaben I.P. ……0.02%w/v
(As Preservative)
Water for Injection I.P. ……...q.s.
C. Amikacin Sulphate Injection IP 500mg/2ml
Each 2ml contains:
Amikacin Sulphate I.P.
Eq. to Amikacin ……………500mg
Methylparaben I.P. …….0.08%w/v
(As Preservative)
Propylparaben I.P. ……0.02%w/v
(As Preservative)
Water for Injection I.P. ……...q.s.
THERAPEUTIC INDICATIONS:
Amikacin injection is used to treat certain serious infections that are caused by bacteria such as meningitis (infection of the membranes that surround the brain and spinal cord) and infections of the blood, abdomen (stomach area), lungs, skin, bones, joints, and urinary tract.
DIRECTION OF USE:
For IV/IM use only.
See insert for detailed dosage, directions for use and precautions.
See insert for detailed dosage, directions for use and precautions.
CAUTION AND SCHEDULE:
CAUTION: Do not use if solution is not clear or having suspended matter/particles and ask for replacement.
Discard any unused product immediately after use.
SCHEDULE: SCHEDULE H DRUG: WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
Discard Unused portion.
Keep medicine out of reach of children.
Discard any unused product immediately after use.
SCHEDULE: SCHEDULE H DRUG: 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 in a cool, dry & dark place.
Do not allow to freeze.
Dosage: As directed by physician.
Do not allow to freeze.
Dosage: As directed by physician.
Amikacin Sulphate Injection IP 500mg/2mL Technical Specification:
| Product Name: | Amikacin Sulphate Injection IP (500mg/2mL) |
| Brand Name: | Amikataj |
| Strength: | (100mg/2mL), (250mg/2mL), (500mg/2mL) |
| Dosage Form: | Liquid Injection (Vial) |
| Packing: | 2mL |
| Route of Administration: | For IV/IM use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antibiotics (aminoglycoside) |
| Indication: | Amikacin injection is used to treat certain serious infections that are caused by bacteria such as meningitis (infection of the membranes that surround the brain and spinal cord) and infections of the blood, abdomen (stomach area), lungs, skin, bones, joints, and urinary tract. |
| Storage: | Store in a cool, dry & dark place. Do not allow to freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Amikacin Sulphate Injection IP (500mg/2mL)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Amikacin Sulphate Injection IP (500mg/2mL)
Each 2ml contains:
Amikacin Sulphate I.P.
Eq. to Amikacin ……………500mg
Methylparaben I.P. …….0.08%w/v
(As Preservative)
Propylparaben I.P. ……0.02%w/v
(As Preservative)
Water for Injection I.P. ………q.s.
THERAPEUTIC INDICATION:
Amikacin injection is used to treat certain serious infections that are caused by bacteria such as meningitis (infection of the membranes that surround the brain and spinal cord) and infections of the blood, abdomen (stomach area), lungs, skin, bones, joints, and urinary tract.
DIRECTION OF USE:
For IV/IM use only.
See insert for detailed dosage, directions for use and precautions.
CAUTION & schedule:
CAUTION: Do not use if solution is not clear or having suspended matter/particles and ask for replacement.
Discard any unused product immediately after use.
schedule: schedule H DRUG: 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 in a cool, dry & dark place. Do not allow to freeze.
Dosage: As directed by physician.
