GENERIC NAME OF MEDICINAL PRODUCT:

A. Propofol Injectable Emulsion USP 10mg/ml (Diprikoda-10)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Propofol Injectable Emulsion USP 10mg/ml
Each ml contains:
Propofol USP………………..…………10mg
Water for Injections IP….………...…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:

Shake well before use.

CAUTION AND SCHADULE:

CAUTION: Not to be used if container is found leaking or there is evidence of separation of phases of the emulsion.
NOT TO BE USE IN NEWLY BORN OR PREMATURE INFANTS.
Diprikoda components and also in patients with allergies to eggs, egg product, soybeans or soy product.
SCHEDULE: SCHEDULE 'H' PRESCRIPTION DRUG; WARNING: To be sold by retail on the prescription of Registered Medical Practitioner only.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C. Do not freeze.
KEEP OUT OF REACH OF CHILDREN
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENC
For dosage, administration and direction for use, see package insert.
DOSAGE: As directed by Physician

Propofol Injectable Emulsion USP 10mg/ml Technical Specification

Product Name:Propofol Injectable Emulsion USP 10mg/ml
Brand Name:Diprikoda-10
Strength:10mg/ml (200mg/20ml) 1%w/v
Dosage Form:Liquid Injection (Emulsion)
Packing:1 Vial
Route of Administration:For I.M./I.V./ or Subcutaneous use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
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 25°C. Do not refrigerate.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Propofol Injectable Emulsion USP 10mg/ml (Diprikoda-10)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Propofol Injectable Emulsion USP 10mg/ml
    Each ml contains:
    Propofol USP………………..…………10mg
    Water for Injections IP….……………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:

Shake well before use.

CAUTION AND SCHADULE:

CAUTION: Not to be used if container is found leaking or there is evidence of separation of phases of the emulsion.
NOT TO BE USE IN NEWLY BORN OR PREMATURE INFANTS.
Diprikoda components and also in patients with allergies to eggs, egg product, soybeans or soy product.
SCHEDULE: SCHEDULE ‘H’ PRESCRIPTION DRUG; WARNING: To be sold by retail on the prescription of Registered Medical Practitioner only.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C. Do not freeze.
KEEP OUT OF REACH OF CHILDREN
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENC
For dosage, administration and direction for use, see package insert.
DOSAGE: As directed by Physician