| Product Name: | Palonosetron Hydrochloride Injection |
| Brand Name: | Palonosetron |
| Strength: | 0.25mg/2ml, 0.25mg/5ml |
| Dosage Form: | Liquid Injection |
| Packing: | SINGLE USE VIAL |
| Route of Administration: | For I.V. use 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: | Palonosetron hydrochloride is used to prevent nausea and vomiting caused by chemotherapy and nausea and vomiting after surgery. |
| Storage: | Store at 20°C to 25°C (68° F to 77° F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Palonosetron Hydrochloride Injection 0.25mg/2ml
- Palonosetron Hydrochloride Injection 0.25mg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Palonosetron Hydrochloride Injection 0.25mg/2ml
Each ml contains
Palonosetron Hydrochloride
Equivalent to
Palonosetron………………………….0.25mg
Mannitol…………………………..……41.5mg
Edetate disodium dihydrate…..0.5mg
Sodium citrate………………….……3.7mg
Citric acid monohydrate………..1.56mg
Water for Injection………………..q.s. to 1.0ml
Hydrochloric acid or sodium hydroxide may have been added to adjust pH - Palonosetron Hydrochloride Injection 0.25mg/5ml
Each ml contains
Palonosetron Hydrochloride
Equivalent to
Palonosetron………………………….0.25mg
Mannitol…………………………..……41.5mg
Edetate disodium dihydrate…..0.5mg
Sodium citrate………………….……3.7mg
Citric acid monohydrate………..1.56mg
Water for Injection………………..q.s. to 1.0ml
Hydrochloric acid or sodium hydroxide may have been added to adjust pH
THERAPEUTIC INDICATION:
Palonosetron hydrochloride is used to prevent nausea and vomiting caused by chemotherapy and nausea and vomiting after surgery.
DIRECTION OF USE:
For I.V. use only
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 an Oncologist/ Cancer Hospital/ Institution.
Retain in carton until time of use.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° F to 77° F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light.
Dosage: As directed by the Oncologist.