| Product Name: | Phytomenadione Injection BP |
| Brand Name: | Generic |
| Strength: | 1mg/0.5ml, 10mg/1ml |
| Dosage Form: | Liquid Injection (emulsion) |
| Packing: | Single Dose Ampoules |
| Route of Administration: | For I.M./ S.C./Slow I.V. use only |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Product Permission, Stability Studies, GMP |
| 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 a temperature not exceeding 25°C in a dark place. Do not freeze. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Phytomenadione Injection BP 1mg/0.5ml
- Phytomenadione Injection BP 10mg/1ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Phytomenadione Injection BP 1mg/0.5ml
Each 0.5ml contains:
Phytomenadione BP……….1mg
Water for Injections IP…….q.s
*No preservatives - Phytomenadione Injection BP 10mg/1ml
Each 0.5ml contains:
Phytomenadione BP……….10mg
Water for Injections IP…….q.s
*No preservatives
THERAPEUTIC 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).
DIRECTION OF USE:
For Intramuscular, Slow Intravenous or Subcutaneous use only.
See insert for full prescribing information.
CAUTION AND SCHEDULE:
CAUTION: Do not use if separation or oil droplets occurs.
Do not use the solution if any foreign particulate matter is visible in the content.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
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 25°C. Protect from light. Do not freeze.
DOSAGE: As directed by the Physician.