Ondansetron Hydrochloride + Sodium Chloride Infusion (8mg/100ml)

GENERIC NAME OF THE MEDICINAL PRODUCT:

Ondansetron Hydrochloride + Sodium Chloride Infusion (8mg/100ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Ondansetron Hydrochloride + Sodium Chloride Infusion (8mg/100ml)
Composition:
Each 100 ml contains:
Ondansetron Hydrochloride USP………………8mg
Sodium Chloride USP…………………………… 0.9g
Water for Injection USP…………………………Q.S.

THERAPEUTIC INDICATIONS:

Ondansetron hydrochloride and sodium chloride infusions are indicated in the treatment of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin.

DIRECTION OF USE:

To be used with Non-pyrogenic I.V. administration set with aseptic technique.
For I.V. use only.

CAUTION & WARNING:

CAUTION: Not to be used if container is found leaking or solution is not clear.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Do not store above 30°C.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Read enclosed leaflet before use.
Dosage: As directed by the Physician.

Ondansetron Hydrochloride + Sodium Chloride Infusion (8mg/100ml) Technical Specification:

Product Name:Ondansetron Hydrochloride + Sodium Chloride Infusion
Brand Name:Generics
Strength:8mg/100ml
Dosage Form:I.V. Infusion Bottle (LVP)
Packing:100mL IV Bottle
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:Antiemetics
Indication: Ondansetron hydrochloride and sodium chloride infusions are indicated in the treatment of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin.
Storage:Do not store above 30°C.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Ondansetron Hydrochloride + Sodium Chloride Infusion (8mg/100ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ondansetron Hydrochloride + Sodium Chloride Infusion (8mg/100ml)
    Composition:
    Each 100 ml contains:
    Ondansetron Hydrochloride USP………………8mg
    Sodium Chloride USP…………………………… 0.9g
    Water for Injection USP…………………………Q.S.

THERAPEUTIC INDICATIONS:

Ondansetron hydrochloride and sodium chloride infusions are indicated in the treatment of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin.

DIRECTION OF USE:

To be used with Non-pyrogenic I.V. administration set with aseptic technique.

For I.V. use only.

CAUTION & WARNING:

CAUTION: Not to be used if container is found leaking or solution is not clear.

WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage:  Do not store above 30°C.

STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.

Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Read enclosed leaflet before use.

Dosage: As directed by the Physician.