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
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.
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.
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.
Dosage: As directed by an Oncologist.
