OXYCODONE KALCEKS SOLUTION FOR INJECTION OR INFUSION 10 MG/ML

HBM PHARMA S.R.O. (SLOVAK REPUBLIC)🇸🇬 Health Sciences Authority

Approval Date: Nov 4, 2022
Approval ID: 6d2c63937e2711cc
Company: HBM PHARMA S.R.O. (SLOVAK REPUBLIC)
Type: Therapeutic

Approval Details

Approval Id: 6d2c63937e2711cc
Drug Name: OXYCODONE KALCEKS SOLUTION FOR INJECTION OR INFUSION 10 MG/ML
Product Name: OXYCODONE KALCEKS SOLUTION FOR INJECTION OR INFUSION 10 MG/ML
Approval Number: SIN16635P
Approval Date: 2022-11-04
Registrant: GOLDPLUS UNIVERSAL PTE LTD
Licence Holder: GOLDPLUS UNIVERSAL PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION, SOLUTION
Dosage: 4.2 Posology and method of administration Posology The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication. Adults over 18 years: The following starting doses are recommended. A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases. IV (Bolus): Dilute to 1 mg/ml in sodium chloride 9 mg/ml (0.9%) solution for injection, 50 mg/ml (5%) dextrose or water for injections. Administer a bolus dose of 1 to 10 mg slowly over 1–2 minutes. Doses should not be administered more frequently than every 4 hours. IV (Infusion): Dilute to 1 mg/ml in sodium chloride 9 mg/ml (0.9%) solution for injection, 50 mg/ml (5%) dextrose or water for injections. A starting dose of 2 mg/hour is recommended. IV (PCA): Dilute to 1 mg/ml in sodium chloride 9 mg/ml (0.9%) solution for injection, 50 mg/ml (5%) dextrose or water for injections. Bolus doses of 0.03 mg/kg should be administered with a minimum lock-out time of 5 minutes. SC (Bolus): Use as 10 mg/ml concentration. A starting dose of 5 mg is recommended, repeated at 4-hourly intervals as required. SC (Infusion): Dilute in sodium chloride 9 mg/ml (0.9%) solution for injection, 50 mg/ml (5%) dextrose or water for injections if required. A starting dose of 7.5 mg/day is recommended in opioid naïve patients, titrating gradually according to symptom control. Cancer patients transferring from oral oxycodone may require much higher doses (see below). Transferring patients between oral and parenteral oxycodone: The dose should be based on the following ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It must be emphasised that this is a guide to the dose required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose. The patient should be monitored closely until stable when switching opioid medications. Elderly patients: Elderly patients should be treated with caution. The lowest dose should be administered with careful titration to pain control. Patients with renal and hepatic impairment: The dose initiation should follow a conservative approach in these patients. The recommended adult starting dose should be reduced by 50% (for example a total daily dose of 10 mg orally in opioid naïve patients), and each patient should be titrated to adequate pain control according to their clinical situation (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Paediatric population: There are no data on the use of oxycodone injection in patients under 18 years of age. Use in non-malignant pain: Opioids are not first-line therapy for chronic non-malignant pain, nor are they recommended as the only treatment. Types of chronic pain which have been shown to be alleviated by strong opioids include chronic osteoarthritic pain and intervertebral disc disease. The need for continued treatment in non-malignant pain should be assessed at regular intervals. Duration of treatment: Oxycodone should not be used for longer than necessary. Discontinuation of treatment: When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. For instructions on dilution of the medicinal product before administration, see section 6.7 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Method of administration Subcutaneous injection or infusion. Intravenous injection or infusion.
Route Of Administration: INTRAVENOUS, SUBCUTANEOUS
Indication Info: 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.
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: <ul class="dash"> <li>known sensitivity to morphine or other opioids;</li> <li>severe respiratory depression with hypoxia;</li> <li>head injury;</li> <li>chronic obstructive airways disease;</li> <li>cor pulmonale;</li> <li>severe bronchial asthma;</li> <li>moderate or severe hepatic impairment;</li> <li>severe renal impairment (creatinine clearance < 10 ml/min);</li> <li>elevated carbon dioxide levels in the blood;</li> <li>paralytic ileus;</li> <li>acute abdomen;</li> <li>chronic constipation;</li> <li>concurrent administration of monoamine oxidase (MAO) inhibitors or within 2 weeks of discontinuation of their use;</li> <li>pregnancy.</li> </ul>
Atc Code: N02AA05
Atc Item Name: oxycodone
Pharma Manufacturer Name: GOLDPLUS UNIVERSAL PTE LTD
Company Detail Path: /organization/goldplus-universal-pte-ltd

Active Ingredients

Oxycodone hydrochloride

10.0mg/ml

Oxycodone hydrochloride

10.0mg/ml

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Nov 4, 2022

Approval ID

6d2c63937e2711cc

Type

Therapeutic

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