Clindamycin Injection USP 600mg/4ml

Product Name:	Clindamycin Injection IP
Brand Name:	Generic
Strength:	300mg/2ml, 600mg/4ml, 900mg/6ml
Dosage Form:	Liquid Injection
Packing:	150mg/1ml (2ml, 4ml Ampoules)
Route of Administration:	For I.M./I.V. use only
Pack Insert/Leaflet:	PIL (Patient Information Leaflet)
Documents:	COA, MOA, Product Permission, Stability Studies, GMP
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 a temperature not exceeding 30°C. The Injection should not be refrigerated and it should not be allowed to freeze

GENERIC NAME OF MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Clindamycin Injection IP 300mg/2ml
Each ml contains:
Clindamycin Phosphate I.P.
Equivalent to Clindamycin………………………….150mg
Benzyl Alcohol I.P (preservative)………………9.45mg
Water for Injection I.P…………………………..…..q.s
Clindamycin Injection IP 600mg/4ml
Each ml contains:
Clindamycin Phosphate I.P.
Equivalent to Clindamycin………………………….150mg
Benzyl Alcohol I.P (preservative)………………9.45mg
Water for Injection I.P…………………………..…..q.s
Clindamycin Injection IP 900mg/6ml
Each ml contains:
Clindamycin Phosphate I.P.
Equivalent to Clindamycin………………………….150mg
Benzyl Alcohol I.P (preservative)………………9.45mg
Water for Injection I.P…………………………..…..q.s

THERAPEUTIC 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.

DIRECTION OF USE:

For Intramuscular or Intravenous use.
Injected by a healthcare professional. Do not self-administer.
Refer Pack Insert for dosage, directions for use and administration.

CAUTION AND SCHEDULE:

CAUTION:

The injection should not be used if it contains visible particulate matter.
Not to be used in newly born babies & premature infants.
Not for Prophylaxis of Injection in the neck and head surgery
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 the vial within 24 hours after initial entry.

SCHEDULE: SCHEDULE ‘H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store at a temperature not exceeding 30°C. The Injection should not be refrigerated and it should not be allowed to freeze
KEEP OUT OF REACH AND SIGHT OF CHILDREN.

DOSAGE: As directed by the Physician.