| Product Name: | Amikacin Sulfate Injection USP |
| Brand Name: | (GENERICS) |
| Strength: | 50mg/ml,100mg/ml, 250mg/ml, 500mg/ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 2ml, 4ml Vial |
| Route of Administration: | For I.M. /I. V 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: | 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 at 20°C to 25°C (68° to 77°). See USP-controlled room temperature. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Amikacin Sulfate Injection USP 50mg/ml
- Amikacin Sulfate Injection USP 100mg/ml
- Amikacin Sulfate Injection USP 250mg/ml
- Amikacin Sulfate Injection USP 500mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Amikacin Sulfate Injection USP 50mg/ml
Each ml contains:
Amikacin Sulfate USP
Equivalent to Amikacin ………………………….50mg
Methyl Paraben USP……………0.04 % w/v
Propyl Paraben USP……………………………………..0.01 % w/v
Water for Injections USP………………………………….q.s. - Amikacin Sulfate Injection USP 100mg/ml
Each ml contains:
Amikacin Sulfate USP
Equivalent to Amikacin ………………………….100mg
Methyl Paraben USP……………0.04 % w/v
Propyl Paraben USP……………………………………..0.01 % w/v
Water for Injections USP………………………………….q.s. - Amikacin Sulfate Injection USP 250mg/ml
Each ml contains:
Amikacin Sulfate USP
Equivalent to Amikacin ………………………….250mg
Methyl Paraben USP……………0.04 % w/v
Propyl Paraben USP……………………………………..0.01 % w/v
Water for Injections USP………………………………….q.s. - Amikacin Sulfate Injection USP 500mg/ml
Each ml contains:
Amikacin Sulfate USP
Equivalent to Amikacin ………………………….500mg
Methyl Paraben USP……………0.04 % w/v
Propyl Paraben USP……………………………………..0.01 % w/v
Water for Injections USP………………………………….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 I.M. /I. V use only.
Refer enclosed leaflet for further information.
CAUTION & WARNING:
CAUTION:
- Do not use it if any foreign particulate matter is visible.
- DO NOT ACCEPT IF THE VIAL SEAL IS BROKEN.
- KEEP OUT OF REACH AND SIGHT OF CHILDREN.
- Do not exceed 1.5 grams daily.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature.
Dosage: 15mg/kg/day divided into 2 or 3 equal doses for IM. See Package Insert for IV & other uses.