Voriconazole for Injection 200mg Technical Specification:
| Product Name: | Voriconazole for Injection |
| Brand Name: | Ortrex |
| Strength: | 200mg/Vial |
| Dosage Form: | Lyophilized Powder for Injection (No preservatives) |
| Packing: | 1 Sterile Single Dose Vial +1 WFI Tray |
| Route of Administration: | For IV Infusion 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: | Anti-Fungals (Triazoles) |
| Indication: | Voriconazole injection is the class of medicines known as ‘antifungals’ used to treat a broad range of infections caused due to fungi and yeast. |
| Storage: | Store at controlled room temperature 15°C to 30°C (59°F TO 86°F). Do not freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Voriconazole for Injection 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Voriconazole for Injection 200mg
a. Each vial contains:
Voriconazole USP………200mg
Excipients………………….q.s
b This pack also contains:
One FFS ampule of Sterile Water for Injection USP…….20ml
THERAPEUTIC INDICATIONS:
Voriconazole injection is used to treat certain serious fungal or yeast infections, such as aspergillosis (fungal infection in the lungs), candidemia (fungal infection in the blood), esophageal candidiasis (candida esophagitis), or other fungal infections (including infections in the skin, stomach, kidney, bladder, and wounds). It may also be used to treat patients with serious fungal or yeast infections who cannot tolerate or do not respond to other types of medicine.
DIRECTION OF USE:
For Intravenous Infusion after dilution.
Reconstitute with 10ml of Water for Injection USP to give a clear solution containing 10mg/ml.
Reconstituted solution should be immediately used after preparation.
For administration, the required volume of the reconstitution solution is added to a recommended compatible infusion solution to provide a final solution containing 0.5-5mg/ml.
For appropriate diluents and storage recommendation and dosage information, refer prescribing information.
CAUTION & Warning:
CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.
Not for Bolus Injection.
Discard unused portion.
Must be further diluted before use.
Do not mix or administer as an infusion with other medical products.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at controlled room temperature 15°C to 30°C (59°F TO 86°F). Do not freeze.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Voriconazole for Injection 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Voriconazole for Injection 200mg
a) Each vial contains:
Voriconazole USP………200mg
Excipients………………….q.s
b) This pack also contains:
One FFS ampule of Sterile Water for Injection USP…….20ml
a) Each vial contains:
Voriconazole USP………200mg
Excipients………………….q.s
b) This pack also contains:
One FFS ampule of Sterile Water for Injection USP…….20ml
THERAPEUTIC INDICATIONS:
Voriconazole injection is used to treat certain serious fungal or yeast infections, such as aspergillosis (fungal infection in the lungs), candidemia (fungal infection in the blood), esophageal candidiasis (candida esophagitis), or other fungal infections (including infections in the skin, stomach, kidney, bladder, and wounds). It may also be used to treat patients with serious fungal or yeast infections who cannot tolerate or do not respond to other types of medicine.
DIRECTION OF USE:
For Intravenous Infusion after dilution.
Reconstitute with 10ml of Water for Injection USP to give a clear solution containing 10mg/ml.
Reconstituted solution should be immediately used after preparation.
For administration, the required volume of the reconstitution solution is added to a recommended compatible infusion solution to provide a final solution containing 0.5-5mg/ml.
For appropriate diluents and storage recommendation and dosage information, refer prescribing information.
Reconstitute with 10ml of Water for Injection USP to give a clear solution containing 10mg/ml.
Reconstituted solution should be immediately used after preparation.
For administration, the required volume of the reconstitution solution is added to a recommended compatible infusion solution to provide a final solution containing 0.5-5mg/ml.
For appropriate diluents and storage recommendation and dosage information, refer prescribing information.
CAUTION & WARNING:
CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.
Not for Bolus Injection.
Discard unused portion.
Must be further diluted before use.
Do not mix or administer as an infusion with other medical products.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENC
E Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
Not for Bolus Injection.
Discard unused portion.
Must be further diluted before use.
Do not mix or administer as an infusion with other medical products.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENC
E Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at controlled room temperature 15°C to 30°C (59°F TO 86°F). Do not freeze. Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Dosage: As directed by the Physician.
