GENERIC NAME OF MEDICINAL PRODUCT:

A. Propofol Injection IP 200mg/20ml
B. Propofol Injection IP 100mg/10ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Propofol Injection IP 200mg/20ml
Each ml of emulsion contains:
Propofol IP……………………...……………….10mg
Soyabean Oil IP………………………….......100mg
Glycerol IP……………………………………….22.5mg
Egg Lecithin…………………………………….13mg
Disodium Edetate IP……………………….0.05mg
Sodium Oleate B…………………………….0.4mg
Monothioglycerol IP……………………….1mg
Sodium Hydroxide IP………………………q.s
Water for Injections IP….………...…….q.s


B) Propofol Injection IP 100mg/10ml
Each ml of emulsion contains:
Propofol IP……………………...……………….10mg
Soyabean Oil IP………………………….......100mg
Glycerol IP……………………………………….22.5mg
Egg Lecithin…………………………………….13mg
Disodium Edetate IP……………………….0.05mg
Sodium Oleate B…………………………….0.4mg
Monothioglycerol IP……………………….1mg
Sodium Hydroxide IP………………………q.s
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:

For Intravenous use only.
For dosage, administration and direction for use, see package insert.

CAUTION AND SCHEDULE:

CAUTION:
• To be sold by retail on the prescription of an Anesthesiologist attached to hospitals, institutions and nursing homes only.
• Discard unused portion.
• Shake well before use.
• 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.
• FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE.
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.
Protected from light.
KEEP OUT OF REACH OF CHILDREN
DOSAGE: As directed by Physician.

Propofol Injection IP 200mg/20ml Technical Specification:

Product Name:Propofol Injection IP 
Brand Name:Diprikoda-10
Strength: 100mg/10ml, 200mg/20ml (1%w/v) (10mg/ml)
Dosage Form:Liquid Injection (Emulsion)  (Sterile and Non-Pyrogenic)
Packing:10ml, 20ml Single Dose vial
Route of Administration:For I.V 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. Protected from light.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Propofol Injection IP 200mg/20ml (Diprikoda-10)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Propofol Injection IP 200mg/20ml
    Each ml of emulsion contains:
    Propofol IP……………………………………….10mg
    Soyabean Oil IP………………………………….100mg
    Glycerol IP……………………………………….22.5mg
    Egg Lecithin…………………………………….13mg
    Disodium Edetate IP……………………………0.05mg
    Sodium Oleate B……………………………….0.4mg
    Monothioglycerol IP……………………………1mg
    Sodium Hydroxide IP………………………….q.s
    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:

For Intravenous use only.
For dosage, administration and direction for use, see package insert.

CAUTION AND SCHEDULE:

CAUTION:

  • To be sold by retail on the prescription of an Anesthesiologist attached to hospitals, institutions and nursing homes only.
  • Discard unused portion.
  • Shake well before use.
  • 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.
  • FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE.

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.
Protected from light.
KEEP 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.