PREZINTON SOLUTION FOR INJECTION 4 MG/2ML

PT FERRON PAR PHARMACEUTICALS (INDONESIA REP OF)🇸🇬 Health Sciences Authority

Approval Date: May 22, 2023
Approval ID: 7cba503fb92ea4c8
Company: PT FERRON PAR PHARMACEUTICALS (INDONESIA REP OF)
Type: Therapeutic

Approval Details

Approval Id: 7cba503fb92ea4c8
Drug Name: PREZINTON SOLUTION FOR INJECTION 4 MG/2ML
Product Name: PREZINTON SOLUTION FOR INJECTION 4 MG/2ML
Approval Number: SIN16791P
Approval Date: 2023-05-22
Registrant: GLORIOUS DEXA SINGAPORE PTE. LTD.
Licence Holder: GLORIOUS DEXA SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION, SOLUTION
Dosage: Recommended Dosage: Chemotherapy and radiotherapy induced nausea and vomiting (CINV and RINV) The selection of dose regimen of ondansetron can be varied according to the emetogenic potentials of cancer treatment. Adults The recommended intravenous (IV) or intramuscular (IM) dose of ondansetron is 8 mg administered immediately before treatment. For highly emetogenic chemotherapy, PREZINTON is administered in a maximum initial dose of 16 mg by intravenous infusion over 15 minutes. A single IV dose greater than 16 mg should not be given due to dose-dependent increase of QT prolongation risk (see Warnings and Precautions, Adverse Effects, and Clinical Pharmacology — QT Prolongation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The efficacy of PREZINTON 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 Instructions for Use and Handling and Disposal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). PREZINTON 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 PREZINTON 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/hour for up to 24 hours. Oral treatment is recommended to protect against delayed or prolonged emesis after the first 24 hours. Children and adolescents (aged 2 years and over) Paediatric patients with a body surface area of 0.6 to 1.2 m2 ondansetron is administered as a single intravenous dose of 5 mg/m2 immediately prior chemotherapy, followed by 4 mg orally 12 hours later. Then 4 mg orally twice daily can be continued for up to five days after a course of treatment. Elderly In patient 65 to 74 years of age The initial IV doses of PREZINTON 8 mg or 16 mg, infused over 15 minutes. The dose 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 patient 75 years of age or older The initial intravenous dose of ondansetron should not exceed 8 mg infused over 15 minutes. The initial dose of 8 mg may be followed by two additional intravenous doses of 8 mg, infused over 15 minutes and given no less than 4 hours apart (see Clinical Pharmacology – Elderly – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). All intravenous doses should be diluted in 50–100 ml of saline or other compatible infusion fluid (see Incompatibilities – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) and infused over 15 minutes. Postoperative nausea and vomiting (PONV) Adults For prevention of PONV, the recommended dose of PREZINTON injection is a single dose of 4 mg by intramuscular or slow intravenous injection administered at the induction of anaesthesia. For treatment of established PONV, a single dose of 4 mg given by IM or slow IV injection is recommended. Children and adolescents (aged 2 years and over) For prevention and treatment of PONV in paediatric patients having surgery performed under general anaesthesia, PREZINTON may be administered by slow intravenous 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 are limited data about the use of ondansetron in the prevention and treatment of PONV in children under 2 years of age. Elderly There is limited experience in the use of ondansetron in the prevention and treatment of PONV in elderly. However, ondansetron is well tolerated in patients over 65 years receiving chemotherapy. Special populations Patient with renal impairment No alteration of daily dosage or frequency of dosing, or route of administration are required. Patient with hepatic impairment Clearance of ondansetron is significantly reduced and serum half-life significantly prolonged in patients with moderate or severe impairment of hepatic function. In such patients, a total daily dose of 8 mg intravenous or oral should not exceeded. Patients with poor sparteine/debrisoquine metabolism The elimination half-life of ondansetron is not altered in patients 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: Indications: Adults PREZINTON is indicated for nausea and vomiting management induced by cytotoxic chemotherapy and radiotherapy. PREZINTON is also indicated for postoperative nausea and vomiting prevention and treatment management. Paediatric PREZINTON is indicated for nausea and vomiting management induced by cytotoxic chemotherapy in children. There is no data on the use of oral administration of ondansetron in prevention or treatment management of postoperative nausea and vomiting. The intravenous administration is recommended for this purpose.
Contraindications: Contraindications: <ul class="dash"> <li>Hypersensitivity to ondansetron or any other selective 5HT3 receptors antagonist (e.g. granisetron, dolosetron) or any of the excipients in this product (see List of Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> <li>Concomitant used of ondansetron with apomorphine hydrochloride is contraindicated since profound hypotension and loss of consciousness was reported (see Interactions with Other Medicines and Other Forms of Interaction – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> </ul>
Atc Code: A04AA01
Atc Item Name: ondansetron
Pharma Manufacturer Name: GLORIOUS DEXA SINGAPORE PTE. LTD.
Company Detail Path: /organization/glorious-dexa-singapore-pte-ltd

Active Ingredients

Ondansetron Hydrochloride dihydrate eqv ondansetron

4mg/2ml

ONDANSETRON HYDROCHLORIDE DIHYDRATE EQV ONDANSETRON

4 MG/2 ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

May 22, 2023

Approval ID

7cba503fb92ea4c8

Type

Therapeutic

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