Daptomycin for Injection 350mg Technical Specification:

Product Name:Daptomycin for Injection 350mg
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 350mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Daptomycin for Injection 350mg
    Composition:
    Each vial contains:
    Daptomycin …………………350mg
    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

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)

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.

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.

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.