| Product Name: | Octreotide Acetate Injection 500mcg/ml |
| Brand Name: | Octreotide |
| Strength: | 50mcg/ml, 100mcg/ml, 200mcg/ml, 500mcg/ml , 1000mcg/5ml |
| Dosage Form: | Liquid Injection |
| Packing: | 50mcg/ml, 100mcg/ml, 500mcg/ml – SINGLE DOSE VIAL 200mcg/ml (1000mcg/5ml), 1000mcg/ml (5000mcg/5ml) – MULTIPLE DOSE VIAL |
| Route of Administration: | For subcutaneous or intravenous 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: | Anti-Cancer |
| Indication: | Octreotide is used to treat sudden reddening of the face and neck caused by certain types of tumors (such as carcinoid tumors, vasoactive intestinal peptide tumors) that are found usually in the intestines and pancreas and slows down the production of hormones. This helps to control the symptoms of carcinoid syndrome and slow down the growth of the cancer. |
| Storage: | Store refrigerated at 2°C to 8°C (36°F TO 46°F). Protect from light. After initial use, discard within 14 days. At room temperature 20°C to 30°C (70°F to 86°F). Octreotide acetate is stable for 14 days if protected from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Octreotide Acetate Injection 50mcg/ml
- Octreotide Acetate Injection 100mcg/1ml
- Octreotide Acetate Injection 200mcg/1ml
- Octreotide Acetate Injection 500mcg/1ml
- Octreotide Acetate Injection 1000mcg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Octreotide Acetate Injection 50mcg/ml
Each ml contains
Octreotide Acetate
Equivalent to Octreotide…………….50mcg
Sodium chloride ………………………….7mg
Glacial acetic acid USP…………………2mg
Sodium acetate trihydrate USP……2mg
Water for Injection USP………………q.s. - Octreotide Acetate Injection 100mcg/1ml
Each ml contains
Octreotide Acetate
Equivalent to Octreotide…………….100mcg
Sodium chloride ………………………….7mg
Glacial acetic acid USP…………………2mg
Sodium acetate trihydrate USP……2mg
Water for Injection USP………………q.s. - Octreotide Acetate Injection 200mcg/1ml
Each ml contains
Octreotide Acetate
Equivalent to Octreotide…………….200mcg
Sodium chloride ………………………….7mg
Glacial acetic acid USP…………………2mg
Sodium acetate trihydrate USP……2mg
Water for Injection USP………………q.s. - Octreotide Acetate Injection 500mcg/1ml
Each ml contains
Octreotide Acetate
Equivalent to Octreotide…………….500mcg
Sodium chloride ………………………….7mg
Glacial acetic acid USP…………………2mg
Sodium acetate trihydrate USP……2mg
Water for Injection USP………………q.s. - Octreotide Acetate Injection 1000mcg/5ml
Each ml contains
Octreotide Acetate
Equivalent to Octreotide…………….1000mcg
Sodium chloride ………………………….7mg
Glacial acetic acid USP…………………2mg
Sodium acetate trihydrate USP……2mg
Water for Injection USP………………q.s.
THERAPEUTIC INDICATION:
Octreotide is used to treat sudden reddening of the face and neck caused by certain types of tumors (such as carcinoid tumors, vasoactive intestinal peptide tumors) that are found usually in the intestines and pancreas and slows down the production of hormones. This helps to control the symptoms of carcinoid syndrome and slow down the growth of the cancer.
PACKING:
50mcg/ml, 100mcg/ml, 500mcg/ml – SINGLE DOSE VIAL
200mcg/ml (1000mcg/5ml), 1000mcg/ml (5000mcg/5ml) – MULTIPLE DOSE VIAL
DIRECTION OF USE:
For subcutaneous or intravenous use
See package insert for complete prescribing information.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter.
WARNING: Cytotoxic Agent – To be sold by retail on the prescription of a Registered Medical Practitioner.
Single-Dose Vials—should be opened just prior to administration and the unused portion discarded.
Multi-Dose Vials—should be discarded within 14 days after initial use.
The container closure is not made with natural rubber latex.
Keep out of reach of children
STORAGE & DOSAGE:
Storage: Store refrigerated at 2°C to 8°C (36°F TO 46°F). Protect from light. After initial use, discard within 14 days. At room temperature 20°C to 30°C (70°F to 86°F). Octreotide acetate is stable for 14 days if protected from light.
Dosage: As directed by the Physician.