Daptomycin for Injection 500mg Technical Specification:
| Product Name: | Daptomycin for Injection 500mg |
| Brand Name: | Generics |
| Strength: | 350mg, 500mg |
| Dosage Form: | Lyophilized Dry Powder for Solution for Injection/Infusion |
| Packing: | 1 Vial |
| Route of Administration: | For I.V. use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antibiotic |
| Indication: | Daptomycin injection is used to treat certain blood infections or serious skin infections caused by bacteria in adults and children 1 year of age and older. |
| Storage: | Store at 2°C-8°C. (in a refrigerator) Store in original package. Avoid excessive heat. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Daptomycin for Injection 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Daptomycin for Injection 500mg
Composition:
Each vial contains:
Daptomycin …………………500mg
Sodium Hydroxide………………q.s.
(to adjust pH)
THERAPEUTIC INDICATION:
Daptomycin injection is used to treat certain blood infections or serious skin infections caused by bacteria in adults and children 1 year of age and older.
DIRECTION OF USE:
For I.V. use only.
Read the package leaflet before use for direction on reconstitution.
CAUTION AND WARNING:
CAUTION: Not to be used if the reconstituted solution contains any visible particles.
The reconstituted solution should be used immediately after preparation.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE AND DOSAGE:
STORAGE: Store at 2°C-8°C. (in a refrigerator) Store in original package. Avoid excessive heat.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
Read the leaflet for the shelf life of the reconstituted product.
DOSAGE: As directed by Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Daptomycin for Injection 350mg
B. Daptomycin for Injection 500mg
B. Daptomycin for Injection 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Daptomycin for Injection 350mg
Composition:
Each vial contains:
Daptomycin …………………350mg
Sodium Hydroxide………………q.s.
(to adjust pH)
B. Daptomycin for Injection 500mg
Composition:
Each vial contains:
Daptomycin …………………500mg
Sodium Hydroxide………………q.s.
(to adjust pH)
Composition:
Each vial contains:
Daptomycin …………………350mg
Sodium Hydroxide………………q.s.
(to adjust pH)
B. Daptomycin for Injection 500mg
Composition:
Each vial contains:
Daptomycin …………………500mg
Sodium Hydroxide………………q.s.
(to adjust pH)
THERAPEUTIC INDICATIONS:
Daptomycin injection is used to treat certain blood infections or serious skin infections caused by bacteria in adults and children 1 year of age and older.
DIRECTION OF USE:
For I.V. use only.
Read the package leaflet before use for direction on reconstitution.
Read the package leaflet before use for direction on reconstitution.
CAUTION & WARNING:
CAUTION: Not to be used if the reconstituted solution contains any visible particles.
The reconstituted solution should be used immediately after preparation.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
The reconstituted solution should be used immediately after preparation.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
STORAGE: Store at 2°C-8°C. (in a refrigerator) Store in original package. Avoid excessive heat.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
Read the leaflet for the shelf life of the reconstituted product.
DOSAGE: As directed by Physician.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
KEEP OUT OF REACH OF CHILDREN
Read the leaflet for the shelf life of the reconstituted product.
DOSAGE: As directed by Physician.
