ONDANSETRON HEXAL 2MG/ML INJECTION

SOLUPHARM PHARMAZEUTISCHE ERZEUGNISSE GMBH (GERMANY)🇸🇬 Health Sciences Authority

Approval Date: Oct 2, 2007
Approval ID: d70f8492259f4e5d
Company: SOLUPHARM PHARMAZEUTISCHE ERZEUGNISSE GMBH (GERMANY)
Type: Therapeutic

Approval Details

Approval Id: d70f8492259f4e5d
Drug Name: ONDANSETRON HEXAL 2MG/ML INJECTION
Product Name: ONDANSETRON HEXAL 2MG/ML INJECTION
Approval Number: SIN13361P
Approval Date: 2007-10-02
Registrant: SANDOZ SINGAPORE PTE. LTD.
Licence Holder: SANDOZ SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION, SOLUTION
Dosage: 4.2 Posology and method of administration Chemotherapy and Radiotherapy Induced Nausea and Vomiting (CINV and RINV) The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The selection of dose regimen should be determined by the severity of the emetogenic challenge. CINV and RINV in Adults The recommended intravenous (IV) or intramuscular (IM) dose of Ondansetron Hexal lnjection is 8 mg administered immediately before treatment. For highly emetogenic chemotherapy, a maximum initial ondansetron dose of 16 mg IV infused over 15 minutes may be used. A single IV dose greater than 16 mg should not be given due to dose-dependent increase of QT prolongation risk (see sections 4.4, 4.8 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The efficacy of ondansetron in highly emetogenic chemotherapy may be enhanced by the addition of a single IV dose of dexamethasone sodium phosphate 20 mg, administered prior to chemotherapy. IV doses greater than 8 mg and up to a maximum of 16 mg must be diluted in 50 mL to 100 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection before administration and infused over not less than 15 minutes (see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Ondansetron doses of 8 mg or less, do not need to be diluted and may be administered as a slow IM or IV injection in not less than 30 seconds. The initial dose of ondansetron may be followed by 2 additional IV or IM doses of 8 mg by 2 to 4 hours apart, or by a constant infusion of 1 mg/h for up to 24 hours. Oral treatment of ondansetron is recommended to protect against delayed or prolonged emesis after the first 24 hours. CINV in Children and Adolescents (aged 2 years and over) In children with a body surface area of 0.6 to 1.2 m2, ondansetron is administered as a single intravenous (IV) dose of 5 mg/m2 immediately before chemotherapy, followed by 4 mg orally twelve hours later. 4 mg orally twice daily can be continued for up to 5 days after a course of treatment. CINV and RINV in Elderly In patients 65 to 74 years of age, the initial IV dose of ondansetron 8 mg or 16 mg, infused over 15 minutes, may be followed by 2 doses of 8 mg infused over 15 minutes and given no less than 4 hours apart. All IV doses should be diluted in 50–100 mL of saline or other compatible infusion fluid and infused over 15 minutes. In patients 75 years of age or older, the initial IV dose of ondansetron should not exceed 8 mg infused over 15 minutes. The initial dose of 8 mg may be followed by 2 doses of 8 mg, infused over 15 minutes and given no less than 4 hours apart (see section 5.2 – Special Patient Populations, Elderly – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). All IV doses should be diluted in 50–100 mL of saline or other compatible infusion fluid and infused over 15 minutes. Post-Operative Nausea and Vomiting (PONV) PONV in Adults For prevention of post-operative nausea and vomiting, the recommended dose of ondansetron injection is a single dose of 4 mg by intramuscular (IM) or slow intravenous (IV) injection administered at the induction of anaesthesia. For treatment of established post-operative nausea and vomiting a single dose of 4 mg given by IM or slow IV injection is recommended. PONV in Children and Adolescents (aged 2 years and over) For prevention and treatment of PONV in paediatric patients having surgery performed under general anaesthesia, ondansetron may be administered by slow IV injection (not less than 30 seconds) at a dose of 0.1 mg/kg up to a maximum of 4 mg either prior to, at or after induction of anaesthesia, or after surgery. There is limited data on the use of ondansetron in the prevention and treatment of PONV in children under 2 years of age. PONV in Elderly There is limited experience in the use of ondansetron in the prevention and treatment of post-operative nausea and vomiting in the elderly, however ondansetron is well tolerated in patients over 65 years receiving chemotherapy. Special populations Renal Impairment No alteration of daily dose or frequency of dosing, or route of administration are required. Hepatic Impairment Clearance of ondansetron is significantly reduced and serum half-life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients, a total daily dose of 8 mg IV or oral should not be exceeded. Patients with Poor Sparteine/Debrisoquine Metabolism The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine. Consequently, in such patients, repeat dosing will give drug exposure levels no different from those of the general population. No alteration of daily dose or frequency of dosing are required.
Route Of Administration: INTRAVENOUS
Indication Info: 4.1 Therapeutic indications Adults Injection Ondansetron Hexal is indicated in the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Ondansetron Hexal is also indicated for the prevention and treatment of post-operative nausea and vomiting. Paediatric Population Injection and oral formulations Ondansetron is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy. No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting; IV injection is recommended for this purpose.
Contraindications: 4.3 Contraindications Based on reports of profound hypotension and loss of consciousness when ondansetron was administered with apomorphine hydrochloride, concomitant use with apomorphine is contraindicated (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hypersensitivity to any component of the preparation (see sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Atc Code: A04AA01
Atc Item Name: ondansetron
Pharma Manufacturer Name: NOVARTIS (SINGAPORE) PTE LTD

Active Ingredients

ONDANSETRON HYDROCHLORIDE DIHYDRATE 2.495 mg/ml EQV ONDANSETRON

2 mg/ml

ONDANSETRON HYDROCHLORIDE DIHYDRATE 2.495 mg/ml EQV ONDANSETRON

2 mg/ml

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Oct 2, 2007

Approval ID

d70f8492259f4e5d

Type

Therapeutic

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