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HSA Product

OXYCODONE KALCEKS SOLUTION FOR INJECTION OR INFUSION 10 MG/ML

Product approved by Health Sciences Authority (SG)

Basic Information

OXYCODONE KALCEKS SOLUTION FOR INJECTION OR INFUSION 10 MG/ML

INJECTION, SOLUTION

Regulatory Information

SIN16635P

November 4, 2022

Prescription Only

Therapeutic

INTRAVENOUS, SUBCUTANEOUS

August 10, 2023

June 3, 2025

XN02AA05

Company Information

HBM Pharma s.r.o.

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

Active Ingredients

Oxycodone hydrochloride

Strength: 10.0mg/ml

Detailed Information

Contraindications

**4.3 Contraindications** Hypersensitivity to oxycodone or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Oxycodone must not be used in any situation where opioids are contraindicated: - known sensitivity to morphine or other opioids; - severe respiratory depression with hypoxia; - head injury; - chronic obstructive airways disease; - cor pulmonale; - severe bronchial asthma; - moderate or severe hepatic impairment; - severe renal impairment (creatinine clearance < 10 ml/min); - elevated carbon dioxide levels in the blood; - paralytic ileus; - acute abdomen; - chronic constipation; - concurrent administration of monoamine oxidase (MAO) inhibitors or within 2 weeks of discontinuation of their use; - pregnancy.

Indication Information

**4.1 Therapeutic indications** For the treatment of moderate to severe pain in patients with cancer and postoperative pain. For the treatment of severe pain requiring the use of a strong opioid. OXYCODONE KALCEKS is indicated in adults only.

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