ONDANSETRON FRESENIUS INJECTION 2MG/ML

PT. Ethica Industri Farmasi (PT. Ethica) (INDONESIA REP OF)🇸🇬 Health Sciences Authority

Approval Date: Sep 25, 2020
Approval ID: 540b0c38305da50a
Company: PT. Ethica Industri Farmasi (PT. Ethica) (INDONESIA REP OF)
Type: Therapeutic

Approval Details

Approval Id: 540b0c38305da50a
Drug Name: ONDANSETRON FRESENIUS INJECTION 2MG/ML
Product Name: ONDANSETRON FRESENIUS INJECTION 2MG/ML
Approval Number: SIN16020P
Approval Date: 2020-09-25
Registrant: FRESENIUS KABI (SINGAPORE) PTE LTD
Licence Holder: FRESENIUS KABI (SINGAPORE) PTE LTD
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION, SOLUTION
Dosage: DOSAGE AND ADMINISTERING PROCEDURE Dosing Regimen 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 Fresenius 2 mg/mL Injection 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 WARNING AND PRECAUTION, UNDESIRABLE EFFECTS, PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The efficacy of Ondansetron Fresenius 2 mg/mL Injection 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. Ondansetron Fresenius 2 mg/mL Injection 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 Fresenius 2 mg/mL Injection 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. 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 IV dose of 5 mg/m2 immediately before chemotherapy, followed by 4 mg orally 12 hours later. 4 mg orally twice daily can be continued for up to five 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 Fresenius 2 mg/mL Injection 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 Fresenius 2 mg/mL Injection 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 PHARMACOLOGY – 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 in Adults For prevention of post-operative nausea and vomiting, the recommended dose of Ondansetron Fresenius 2 mg/mL Injection is a single dose of 4 mg by IM or slow 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 Fresenius 2 mg/mL Injection 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 Fresenius 2 mg/mL Injection 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 Fresenius 2 mg/mL Injection in the prevention and treatment of post-operative nausea and vomiting in the elderly, however Ondansetron Fresenius 2 mg/mL Injection is well tolerated in patients over 65 years receiving chemotherapy. Special populations Renal Impairment No alteration of daily dosage 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 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 dosage or frequency of dosing is required.
Route Of Administration: INTRAVENOUS, INTRAMUSCULAR
Indication Info: INDICATION Adults Ondansetron Fresenius 2 mg/mL Injection is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Ondansetron Fresenius 2 mg/mL Injection is also indicated for the prevention and treatment of post-operative nausea and vomiting. Paediatric Population Ondansetron Fresenius 2 mg/mL Injection is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy.
Contraindications: CONTRAINDICATION 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 INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hypersensitivity to any components of the preparation (see sections WARNING AND PRECAUTION and UNDESIRABLE EFFECTS – 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: FRESENIUS KABI (SINGAPORE) PTE LTD

Active Ingredients

ONDANSETRON HYDROCHLORIDE DIHYDRATE EQV ONDANSETRON

2MG/ML

ONDANSETRON HYDROCHLORIDE DIHYDRATE EQV ONDANSETRON

2 MG/ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Sep 25, 2020

Approval ID

540b0c38305da50a

Type

Therapeutic

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