(A) Ondansetron Injection USP 4mg/2mL (2mg/ml)
(B) Ondansetron Injection USP 8mg/4mL (2mg/ml)
(C) Ondansetron Injection USP 40mg/20mL (2mg/ml)
GENERIC NAME OF MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
(A) Ondansetron Injection USP 4mg/2mL (2mg/ml)
Each ml contains:
Ondansetron Hydrochloride USP
Equivalent to Ondansetron ……….2mg
Sodium chloride USP…………………8.3mg
Citric Acid Monohydrate USP
Equivalent to Anhydrous Citric Acid ……….5.0mg
Trisodium Citrate Dihydrate USP (as buffer) …………………0.25mg
Methyl paraben NF (preservative)……………………………….1.2mg
Propyl paraben NF (preservative)………………………………..0.15mg
Water for injections USP……………………. q. s
(B) Ondansetron Injection USP 8mg/4mL (2mg/ml)
Each ml contains:
Ondansetron Hydrochloride USP
Equivalent to Ondansetron ……….2mg
Sodium chloride USP…………………8.3mg
Citric Acid Monohydrate USP
Equivalent to Anhydrous Citric Acid ……….5.0mg
Trisodium Citrate Dihydrate USP (as buffer) …………………0.25mg
Methyl paraben NF (preservative)……………………………….1.2mg
Propyl paraben NF (preservative)………………………………..0.15mg
Water for injections USP……………………. q. s
(C) Ondansetron Injection USP 40mg/20mL (2mg/ml)
Each ml contains:
Ondansetron Hydrochloride USP
Equivalent to Ondansetron ……….2mg
Sodium chloride USP…………………8.3mg
Citric Acid Monohydrate USP
Equivalent to Anhydrous Citric Acid ……….5.0mg
Trisodium Citrate Dihydrate USP (as buffer) …………………0.25mg
Methyl paraben NF (preservative)……………………………….1.2mg
Propyl paraben NF (preservative)………………………………..0.15mg
Water for injections USP……………………. q. s
Each ml contains:
Ondansetron Hydrochloride USP
Equivalent to Ondansetron ……….2mg
Sodium chloride USP…………………8.3mg
Citric Acid Monohydrate USP
Equivalent to Anhydrous Citric Acid ……….5.0mg
Trisodium Citrate Dihydrate USP (as buffer) …………………0.25mg
Methyl paraben NF (preservative)……………………………….1.2mg
Propyl paraben NF (preservative)………………………………..0.15mg
Water for injections USP……………………. q. s
(B) Ondansetron Injection USP 8mg/4mL (2mg/ml)
Each ml contains:
Ondansetron Hydrochloride USP
Equivalent to Ondansetron ……….2mg
Sodium chloride USP…………………8.3mg
Citric Acid Monohydrate USP
Equivalent to Anhydrous Citric Acid ……….5.0mg
Trisodium Citrate Dihydrate USP (as buffer) …………………0.25mg
Methyl paraben NF (preservative)……………………………….1.2mg
Propyl paraben NF (preservative)………………………………..0.15mg
Water for injections USP……………………. q. s
(C) Ondansetron Injection USP 40mg/20mL (2mg/ml)
Each ml contains:
Ondansetron Hydrochloride USP
Equivalent to Ondansetron ……….2mg
Sodium chloride USP…………………8.3mg
Citric Acid Monohydrate USP
Equivalent to Anhydrous Citric Acid ……….5.0mg
Trisodium Citrate Dihydrate USP (as buffer) …………………0.25mg
Methyl paraben NF (preservative)……………………………….1.2mg
Propyl paraben NF (preservative)………………………………..0.15mg
Water for injections USP……………………. q. s
THERAPEUTIC INDICATION:
Ondansetron injection is used to prevent nausea and vomiting caused by cancer medicines (chemotherapy or radiation), including high-dose cisplatin. This medicine is also used to prevent and treat nausea and vomiting that may happen after surgery.
CAUTION & WARNING:
CAUTION: If any foreign particle is visible, please do not use the solution & return for replacement.
KEEP OUT OF REACH OF CHILDREN.
Discard any unused portion.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
KEEP OUT OF REACH OF CHILDREN.
Discard any unused portion.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77°). See USP controlled room temperature.
Dosage: As directed by Physician.
Dosage: As directed by Physician.
Ondansetron Injection USP 8mg/4mL (2mg/ml) Technical Specification:
| Product Name: | Ondansetron Injection USP |
| Brand Name: | (GENERICS) |
| Strength: | (4mg/2mL), (8mg/4mL), (40mg/20mL) |
| Dosage Form: | Liquid Injection (Sterile) *Non-pyrogenic |
| Packing: | 2ml, 4ml Ampoule, 2 mL, 20 mL vial |
| Route of Administration: | For I.M./I.V. 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: | Nausea & Vomiting, Anti-emetic, Gastroenterology |
| Indication: | Ondansetron injection is used to prevent nausea and vomiting caused by cancer medicines (chemotherapy or radiation), including high-dose cisplatin. This medicine is also used to prevent and treat nausea and vomiting that may happen after surgery. |
| Storage: | Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Ondansetron Injection USP 8mg/4mL (2mg/ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ondansetron Injection USP 8mg/4mL (2mg/ml)
Each ml contains:
Ondansetron Hydrochloride USP
Equivalent to Ondansetron ……….2mg
Sodium chloride USP…………………8.3mg
Citric Acid Monohydrate USP
Equivalent to Anhydrous Citric Acid ……….5.0mg
Trisodium Citrate Dihydrate USP (as buffer) …………………0.25mg
Methylparaben NF (preservative)……………………………….1.2mg
Propylparaben NF (preservative)………………………………..0.15mg
Water for injections USP……………………. q. s
THERAPEUTIC INDICATION:
Ondansetron injection is used to prevent nausea and vomiting caused by cancer medicines (chemotherapy or radiation), including high-dose cisplatin. This medicine is also used to prevent and treat nausea and vomiting that may happen after surgery.
CAUTION & WARNING:
CAUTION: If any foreign particle is visible, please do not use the solution & return for a replacement.
KEEP OUT OF REACH OF CHILDREN.
Discard any unused portion.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature.
Dosage: As directed by the Physician.
