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Ondansetron Injection USP 4mg/2ml
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Ondansetron Injection USP 4mg/2ml Technical Specification:

Product Name:Ondansetron Injection USP
Brand Name:(GENERICS)
Strength:(4 mg/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 4mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ondansetron Injection USP 4mg/2ml
    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.

GENERIC NAME OF MEDICINAL PRODUCT:

A. Ondansetron Injection USP 4mg/2mL (2mg/ml)
B. Ondansetron Injection USP 8mg/4mL (2mg/ml)
C. Ondansetron Injection USP 40mg/20mL (2mg/ml)

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

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.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° to 77°). See USP controlled room temperature.
Dosage: As directed by Physician.