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Propofol Injectable Emulsion USP 100mg/10ml Technical Specification:

Product Name:Propofol Injectable Emulsion USP (100mg/10ml)
Brand Name:Diprikoda-10
Strength:100mg/10ml, 200mg/20ml, 500mg/50ml, 1g/100ml  (10mg/ml)
Dosage Form:Liquid Injection (Emulsion) (Sterile, Non-Pyrogenic and Preservative Free)
Packing:10ml, 20ml, 50ml, 100ml
Route of Administration:For 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:General anaesthetics, non-barbiturate sedative
Indication: Propofol injectable emulsion has been used with a variety of agents commonly used in anaesthesia such as atropine, as well as with inhalational and regional aesthetic agents.
Storage:Store at a temperature not exceeding between 25°C to 30°C. Do not freeze. Protect from light.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Propofol Injectable Emulsion USP 100mg/10ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Propofol Injectable Emulsion USP 100mg/10ml
    Each ml contains:
    Propofol USP……………………………10mg
    Soyabean Oil USP …………………….100mg
    Glycerol USP ……………………….…..22.5mg
    Egg Lecithin……………………………..12mg
    Benzyl Alcohol USP ……………………1mg
    Water for Injections USP………..……..q.s

THERAPEUTIC INDICATION:

Propofol injectable emulsion has been used with a variety of agents commonly used in anesthesia such as atropine, scopolamine, glycopyrrolate, diazepam, depolarizing and nondepolarizing muscle relaxants, and opioid analgesics, as well as with inhalational and regional anesthetic agents.

DIRECTION OF USE:

For Intravenous use only.
Propofol injectable emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure.
Use strict aseptic technique.
For dosage, administration and direction for use, see package insert.

CAUTION & WARNING:

CAUTION:

  • Not to be used if container is found leaking or there is evidence of separation of phases of the emulsion.
  • Shake well before use.
  • NOT TO BE USE IN NEWLY BORN OR PREMATURE INFANTS.
  • CONTAINS BENZYL ALCOHOL, which inhibits microbial growth up to 12 hours, discard within 12 hours of opening.
  • Diprikoda components and also in patients with allergies to eggs, egg product, soybeans or soy product.
  • FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Warning: To sold by the retail on the prescription of a registered medical practitioner only.
Use strict aseptic technique.

STORAGE & DOSAGE:

Storage: Store at a temperature not exceeding between 25°C to 30°C.
Protect from light.
Do not freeze.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

Dosage: As directed by the Physician.

NOTE:

Do not use if there is evidence of excessive creaming or aggregation.
If large droplets are visible, or if there are other forms of phase separation indicating that the stability of the product has been compromised.
After shaking, may be visible upon prolonged standing.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Propofol Injectable Emulsion USP 100mg/10ml
B. Propofol Injectable Emulsion USP 200mg/20ml
C. Propofol Injectable Emulsion USP 500mg/50ml
D. Propofol Injectable Emulsion USP 1g/100ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Propofol Injectable Emulsion USP 100mg/10ml
Each ml contains:
Propofol USP……………………………10mg
Soyabean Oil USP …………………….100mg
Glycerol USP ……………………….…..22.5mg
Egg Lecithin……………………………….12mg
Benzyl Alcohol USP ……………………1mg
Water for Injections USP………...…..q.s

B) Propofol Injectable Emulsion USP 200mg/20ml
Each ml contains:
Propofol USP……………………………10mg
Soyabean Oil USP …………………….100mg
Glycerol USP ……………………….…..22.5mg
Egg Lecithin……………………………….12mg
Benzyl Alcohol USP ……………………1mg
Water for Injections USP………...…..q.s

C) Propofol Injectable Emulsion USP 500mg/50ml
Each ml contains:
Propofol USP……………………………10mg
Soyabean Oil USP …………………….100mg
Glycerol USP ……………………….…..22.5mg
Egg Lecithin……………………………….12mg
Benzyl Alcohol USP ……………………1mg
Water for Injections USP………...…..q.s

D) Propofol Injectable Emulsion USP 1g/100ml
Each ml contains:
Propofol USP ……………………………10mg
Soyabean Oil USP………………………100mg
Glycerol USP……………………………………..22.5mg
Egg Lecithin……………………………….12mg
Benzyl Alcohol USP…………………….1mg
Water for Injections USP………...…...q.s

THERAPEUTIC INDICATIONS:

Propofol injectable emulsion has been used with a variety of agents commonly used in anesthesia such as atropine, scopolamine, glycopyrrolate, diazepam, depolarizing and nondepolarizing muscle relaxants, and opioid analgesics, as well as with inhalational and regional anesthetic agents.

DIRECTION OF USE:

For Intravenous use only.
Propofol injectable emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure.
Use strict aseptic technique.
For dosage, administration and direction for use, see package insert.

CAUTION & WARNING:

CAUTION:
• Not to be used if container is found leaking or there is evidence of separation of phases of the emulsion.
• Shake well before use.
• NOT TO BE USE IN NEWLY BORN OR PREMATURE INFANTS.
• CONTAINS BENZYL ALCOHOL, which inhibits microbial growth up to 12 hours, discard within 12 hours of opening.
• Diprikoda components and also in patients with allergies to eggs, egg product, soybeans or soy product.
• FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: To sold by the retail on the prescription of a registered medical practitioner only.
Use strict aseptic technique.

STORAGE & DOSAGE:

Storage: Store at a temperature not exceeding between 20°C to 25°C.
Do not refrigerate.
Protect from light.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Dosage: As directed by the Physician.