Zoledronic acid Injection 4mg Technical Specification:

Product Name:Zoledronic acid Injection 4mg
Brand Name:Zoledronic
Strength:4mg
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: Zoledronic acid Injection is a medication used to treat a number of bone diseases. These include osteoporosis, high blood calcium due to cancer, bone breakdown due to cancer, Paget’s disease of bone and Duchenne muscular dystrophy.
Storage:Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Zoledronic acid Injection 4mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Zoledronic acid Injection 4mg
    Each combi pack contains
    One vial of
    Zoledronic acid Injection 4mg
    Each vial contains:
    Zoledronic Acid Monohydrate
    Equivalent to Zoledronic acid……….4 mg
    Mannitol………………………………………220 mg
    Sodium Citrate……………………………..24mg
    One ampoule of
    Sterile Water for Injection contains
    Water for Injection………………..……..5 ml

THERAPEUTIC INDICATION:

Zoledronic acid Injection is a medication used to treat a number of bone diseases. These include osteoporosis, high blood calcium due to cancer, bone breakdown due to cancer, Paget’s disease of bone and Duchenne muscular dystrophy.

DIRECTION OF USE:

For Intravenous infusion only.

Reconstitution: Reconstitute with 5 ml of Sterile Water for Injections USP provided with this pack.

Requires two dilution before administration.

The reconstituted solution should immediately be diluted in 100ml of calcium free sterile 0.9% w/v Sodium Chloride Injection or 0.5% w/v Dextrose Injection.

Reconstituted and diluted solution should be used immediately.

Please refer accompanying package inert for detailed dosage, directions for use and precautions.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.

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

Cytotoxic special handling procedures see insert

Requires two dilution before administration.

Reconstituted injection to be administered within 24 hours of preparation when stored at temperature between 2°C to 8°C.

Do not mix with Calcium containing infusion solution.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard Unused portion.

Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light.

Dosage: As directed by an Oncologist.

 

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

Zoledronic acid Injection 4mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Zoledronic acid Injection 4mg
Each combi pack contains
One vial of
Zoledronic acid Injection 4mg
Each vial contains:
Zoledronic Acid Monohydrate
Equivalent to Zoledronic acid……….4 mg
Mannitol………………………………………220 mg
Sodium Citrate……………………………..24mg
One ampoule of
Sterile Water for Injection contains
Water for Injection………………..……..5 ml

THERAPEUTIC INDICATION:

Zoledronic acid Injection is a medication used to treat a number of bone diseases. These include osteoporosis, high blood calcium due to cancer, bone breakdown due to cancer, Paget's disease of bone and Duchenne muscular dystrophy.

DIRECTION OF USE:

For Intravenous infusion only.
Reconstitution: Reconstitute with 5 ml of Sterile Water for Injections USP provided with this pack.
Requires two dilution before administration.
The reconstituted solution should immediately be diluted in 100ml of calcium free sterile 0.9% w/v Sodium Chloride Injection or 0.5% w/v Dextrose Injection.
Reconstituted and diluted solution should be used immediately.
Please refer accompanying package inert for detailed dosage, directions for use and precautions.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Cytotoxic special handling procedures see insert
Requires two dilution before administration.
Reconstituted injection to be administered within 24 hours of preparation when stored at temperature between 2°C to 8°C.
Do not mix with Calcium containing infusion solution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light.
Dosage: As directed by an Oncologist.