Posaconazole Gastro-Resistant Tablets 100mg Technical Specification:
Product Name: | Posaconazole Gastro-Resistant Tablets |
Brand Name: | Noxitaj |
Strength: | 100mg |
Dosage Form: | Tablets (Gastro-resistant) |
Route of Administration: | Via Oral Route |
Packing: | 10s, 100s |
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-fungal |
Indication: | Posaconazole is used to prevent certain fungal infections in patients who have severely weakened immune systems (such as patients who have had chemotherapy). It belongs to a class of drugs known as antifungals. It works by stopping the growth of fungi. It is approved for the prophylaxis of invasive fungal infections in patients with neutropenia or in haematopoietic stem cell transplant recipients undergoing high- dose immunosuppressive therapy for graft-versus-host disease, and for the treatment of fungal infections. |
Storage: | Store at a temperature not exceeding 25°C. Protect from light & moisture. Keep in cool, dry & dark place. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Posaconazole Gastro-Resistant Tablets 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Posaconazole Gastro-Resistant Tablets 100mg
Each Gastro Resistant tablet contains:
Posaconazole ………………100mg
Excipients…………………………. q.s.
Colours: Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
Posaconazole is used to prevent certain fungal infections in patients who have severely weakened immune systems (such as patients who have had chemotherapy).
It belongs to a class of drugs known as antifungals. It works by stopping the growth of fungi.
It is approved for the prophylaxis of invasive fungal infections in patients with neutropenia or in hematopoietic stem cell transplant recipients undergoing high- dose immunosuppressive therapy for graft-versus-host disease, and for the treatment of fungal infections.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
Preserve in tight container.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
WARNING: The most common side effects of Posaconazole injection include: anaemia, abdominal pain, diarrhoea.
Posaconazole use to treat (or prevent) serious fungal infections. Posaconazole (Noxitaj) is a broad-spectrum triazole antifungal.
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Storage: Store at a temperature not exceeding 25°C. Protect from light & moisture. Keep in cool, dry & dark place.
Dosage: As directed by the physician.
Attach dispensing label as per end country.
GENERIC NAME OF THE MEDICINAL PRODUCT:
Posaconazole Gastro-Resistant Tablets 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Posaconazole Gastro-Resistant Tablets 100mg
Each Gastro Resistant tablet contains:
Posaconazole ………………100mg
Excipients…………………………. q.s.
Colours: Titanium Dioxide USP
Each Gastro Resistant tablet contains:
Posaconazole ………………100mg
Excipients…………………………. q.s.
Colours: Titanium Dioxide USP
THERAPEUTIC INDICATIONS:
Posaconazole is used to prevent certain fungal infections in patients who have severely weakened immune systems (such as patients who have had chemotherapy).
It belongs to a class of drugs known as antifungals. It works by stopping the growth of fungi.
It is approved for the prophylaxis of invasive fungal infections in patients with neutropenia or in hematopoietic stem cell transplant recipients undergoing high- dose immunosuppressive therapy for graft-versus-host disease, and for the treatment of fungal infections.
It belongs to a class of drugs known as antifungals. It works by stopping the growth of fungi.
It is approved for the prophylaxis of invasive fungal infections in patients with neutropenia or in hematopoietic stem cell transplant recipients undergoing high- dose immunosuppressive therapy for graft-versus-host disease, and for the treatment of fungal infections.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
Preserve in tight container.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
WARNING: The most common side effects of Posaconazole injection include: anaemia, abdominal pain, diarrhoea.
Posaconazole use to treat (or prevent) serious fungal infections. Posaconazole (Noxitaj) is a broad-spectrum triazole antifungal.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Read enclosed leaflet before use.
Preserve in tight container.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
WARNING: The most common side effects of Posaconazole injection include: anaemia, abdominal pain, diarrhoea.
Posaconazole use to treat (or prevent) serious fungal infections. Posaconazole (Noxitaj) is a broad-spectrum triazole antifungal.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
STORAGE & DOSAGE:
Storage: Store at a temperature not exceeding 25°C.
Protect from light & moisture.
Keep in cool, dry & dark place.
Dosage: As directed by the physician.
Attach dispensing label as per end country.
Protect from light & moisture.
Keep in cool, dry & dark place.
Dosage: As directed by the physician.
Attach dispensing label as per end country.