GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Phytonadione Injectable Emulsion USP 10mg/1ml
B. Phytonadione Injectable Emulsion USP 1mg/0.5ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Phytonadione Injectable Emulsion USP 10mg/1ml
Each ml contains:
Phytonadione USP...………..10mg
Excipients………………………..q.s
Water for Injection USP…..q.s

B. Phytonadione Injectable Emulsion USP 1mg/0.5ml
Each 0.5ml contains:
Phytonadione USP….…..1mg
Excipients……………….......q.s
Water for Injection USP……..q.s


THERAPEUTIC INDICATIONS:

Phytonadione injection is used to treat bleeding or blood clotting problems caused by vitamin K deficiency, certain medicines (eg, warfarin), or medical conditions (obstructive jaundice, ulcerative colitis).

DIRECTION OF USE:

For Intramuscular or Subcutaneous and Intravenous (with caution) use.
See insert for full prescribing information.

CAUTION & WARNING:

CAUTION:
Do not use the solution if any foreign particulate matter is visible in the content.
Do not use if separation or oil droplets occurs.
Keep ampules in tray until time of use.
Use Intravenously with caution.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage:
Store at the controlled room temperature 15°C to 30°C (59°F to 86°F).
Protect from light.
Do not freeze.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Phytonadione Injectable Emulsion USP1mg/0.5ml  Technical Specification:

Product Name:Phytonadione Injectable Emulsion USP
Brand Name:Generic
Strength:10mg/1ml, 1mg/0.5ml (Neonatal Concentration)
Dosage Form:Liquid Injection (emulsion)
Packing:Single Dose Ampoules
Route of Administration:For I.M./S.C./I.V. (with caution) use
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Vitamins, Anti-Hypoprothrombin
Indication: Phytonadione injection is used to treat bleeding or blood clotting problems caused by vitamin K deficiency, certain medicines (eg, warfarin), or medical conditions (obstructive jaundice, ulcerative colitis).
Storage:Store at the controlled room temperature 15°C to 30°C (59°F to 86°F). Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Phytonadione Injectable Emulsion USP 1mg/0.5ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Phytonadione Injectable Emulsion USP 1mg/0.5ml
    Each 0.5ml contains:
    Phytonadione USP…………………1mg
    Excipients……………………………..q.s
    Water for Injection USP………….q.s

THERAPEUTIC INDICATIONS:

Phytonadione injection is used to treat bleeding or blood clotting problems caused by vitamin K deficiency, certain medicines (eg, warfarin), or medical conditions (obstructive jaundice, ulcerative colitis).

DIRECTION OF USE:

For Intramuscular or Subcutaneous and Intravenous (with caution) use.
See insert for full prescribing information.

CAUTION & Warning:

CAUTION: Do not use the solution if any foreign particulate matter is visible in the content.
Do not use if separation or oil droplets occurs.
Keep ampules in tray until time of use.
Use Intravenously with caution.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at the controlled room temperature 15°C to 30°C (59°F to 86°F).
Protect from light.
Do not freeze.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.