Vindesine Sulfate for Injection BP 1mg (Cilretta) Technical Specification:

Product Name:Vindesine Sulfate for Injection BP 1mg
Brand Name:Cilretta
Strength:1mg, 5mg
Dosage Form:Lyophilized
Dry Powder for Injection
Packing:SINGLE USE VIAL
Route of Administration:For I.V. infusion 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-Cancer
Indication: Vindesine Sulfate is used to treat patients who have a cancer such as leukaemia, malignant melanoma (a type of skin cancer) or breast cancer.
Storage:Store between 2°C to 8°C in a refrigerator. Do not freeze. Protect rom light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Vindesine Sulfate for Injection BP 1mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Vindesine Sulfate for Injection BP 1mg
    Each ml contains:
    Vindesine Sulfate BP…………….….….1mg
    Sodium Chloride USP……………………9mg
    Benzyl Alcohol USP………………………0.9% v/v
    Water for Injection USP…….…………q.s.

THERAPEUTIC INDICATION:

Vindesine Sulfate is used to treat patients who have a cancer such as leukaemia, malignant melanoma (a type of skin cancer) or breast cancer.

DIRECTION OF USE:

For Intravenous infusion only.

Add sterile water for injection USP. Shake to dissolve, if product does not dissolve immediately allow to stand at room temperature until solution is obtained.

See the package insert for details.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution. Fatal if given Intrathecally, for Intravenous use only.

CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.

WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.

CAUTION: Cytotoxic agent – Special Handling

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard Unused portion.

Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store between 2°C to 8°C in a refrigerator. Do not freeze. Protect rom light.

Dosage: As directed by an Oncologist.

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Vindesine Sulfate for Injection BP 1mg
b) Vindesine Sulfate for Injection BP 5 mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Vindesine Sulfate for Injection BP 1mg
Each ml contains:
Vindesine Sulfate BP…………….….….1mg
Sodium Chloride USP……………………9mg
Benzyl Alcohol USP………………………0.9% v/v
Water for Injection USP…….…………q.s.


b) Vindesine Sulfate for Injection BP 5mg
Each ml contains:
Vindesine Sulfate BP…………….….….5mg
Sodium Chloride USP……………………9mg
Benzyl Alcohol USP………………………0.9% v/v
Water for Injection USP…….…………q.s.

THERAPEUTIC INDICATIONS:

Vindesine Sulfate is used to treat patients who have a cancer such as leukaemia, malignant melanoma (a type of skin cancer) or breast cancer.

DIRECTION OF USE:

For Intravenous infusion only.
Add sterile water for injection USP. Shake to dissolve, if product does not dissolve immediately allow to stand at room temperature until solution is obtained.
See the package insert for details.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution. Fatal if given Intrathecally, for Intravenous use only.
CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
CAUTION: Cytotoxic agent – Special Handling
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store between 2°C to 8°C in a refrigerator.
Do not freeze.
Protect rom light.
Dosage: As directed by an Oncologist.