GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Clindamycin Injection USP 300mg/2ml
B. Clindamycin Injection USP 600mg/4ml
C. Clindamycin Injection USP 900mg/6ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Clindamycin Injection USP 300mg/2ml
Each ml contains:
Clindamycin phosphate USP
Equivalent to
Clindamycin……………………………..……150mg
Disodium edetate USP……………………0.5mg
Benzyl Alcohol USP (preservative)….9.45mg
Water for Injection USP………………….q.s

B. Clindamycin Injection USP 600mg/4ml
Each ml contains:
Clindamycin phosphate USP
Equivalent to
Clindamycin………………………………..…150mg
Disodium edetate USP ………………..…0.5mg
Benzyl Alcohol USP (preservative)….9.45mg
Water for Injection USP…………………q.s

C. Clindamycin Injection USP 900mg/6ml
Each ml contains:
Clindamycin phosphate USP
Equivalent to
Clindamycin……………………………..……150mg
Disodium edetate USP ……………….…0.5mg
Benzyl Alcohol USP (preservative)….9.45mg
Water for Injection USP…………………q.s


THERAPEUTIC INDICATIONS:

Clindamycin injection is used to treat certain types of bacterial infections, including infections of the lungs, skin, blood, bones, joints, female reproductive organs, and internal organs. Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria.

DIRECTION OF USE:

For Intramuscular or Intravenous use.
If given intravenously, must be diluted before use.
Injected by a healthcare professional. Do not self-administer.
Refer Pack Insert for dosage, directions for use and administration.

CAUTION & WARNING:

CAUTION:
• The injection should not be used if it contains visible particulate matter.
• Not to be used in newly born babies & premature infantas.
• If given intravenously, must be diluted before use.
• Dispense aliquots from the vial via a suitable dispensing device into infusion fluids under a laminar flow hood using aseptic technique.
• Discard vial within 24 hours after initial entry.
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°F to 77°F). [See USP Controlled room temperature.]
Do not refrigerate.
Do not freeze.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Clindamycin Injection USP 900mg/6ml Technical Specification:

Product Name:Clindamycin Injection USP
Brand Name:Generic
Strength:300mg/2ml 600mg/4ml, 900mg/6ml
Dosage Form:Liquid Injection (Sterile and Non pyrogenic)
Packing:150mg/ml – 2ml Single Dose Ampoule/Vial
150mg/ml – 4ml Single Dose Ampoule/Vial
150mg/ml – 6ml Single Dose Ampoule/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:Antibacterials, Anti-Infectives, Antibiotic (lincomycin)
Indication: Clindamycin injection is used to treat certain types of bacterial infections, including infections of the lungs, skin, blood, bones, joints, female reproductive organs, and internal organs. Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria.
Storage:Store at 20°C to 25°C (68°F to 77°F).Do not refrigerate.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Clindamycin Injection USP 900mg/6ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Clindamycin Injection USP 900mg/6ml
    Each ml contains:
    Clindamycin phosphate USP
    Equivalent to
    Clindamycin………………………..………150mg
    Disodium edetate USP……………….…0.5mg
    Benzyl Alcohol USP (preservative)….9.45mg
    Water for Injection USP…………………q.s

THERAPEUTIC INDICATIONS:

Clindamycin injection is used to treat certain types of bacterial infections, including infections of the lungs, skin, blood, bones, joints, female reproductive organs, and internal organs. Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria.

DIRECTION OF USE:

For Intramuscular or Intravenous use.
If given intravenously, must be diluted before use.
Injected by a healthcare professional. Do not self-administer.
Refer Pack Insert for dosage, directions for use and administration.

CAUTION & WARNING:

CAUTION:

  • The injection should not be used if it contains visible particulate matter.
  • Not to be used in newly born babies & premature infants.
  • If given intravenously, must be diluted before use.
  • Dispense aliquots from the vial via a suitable dispensing device into infusion fluids under a laminar flow hood using aseptic technique.
  • Discard vial within 24 hours after initial entry.

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°F to 77°F). [See USP Controlled room temperature.]
Do not refrigerate.
Do not freeze.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.