OXYNORM® STERILE SOLUTION FOR INJECTION OR INFUSION 10MG/ML

RAFA LABORATORIES LTD (ISRAEL)🇸🇬 Health Sciences Authority

Approval Date: Nov 18, 2009
Approval ID: 3119b462aa4935f2
Company: RAFA LABORATORIES LTD (ISRAEL)
Type: Therapeutic

Approval Details

Approval Id: 3119b462aa4935f2
Drug Name: OXYNORM® STERILE SOLUTION FOR INJECTION OR INFUSION 10MG/ML
Product Name: OXYNORM® STERILE SOLUTION FOR INJECTION OR INFUSION 10MG/ML
Approval Number: SIN13733P
Approval Date: 2009-11-18
Registrant: DKSH SINGAPORE PTE. LTD.
Licence Holder: DKSH SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION, SOLUTION
Dosage: Posology and method of administration Route of administration: Subcutaneous injection or infusion Intravenous injection or infusion. 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. i.v. (Bolus): Dilute to 1 mg/ml in 0.9% saline, 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. i.v. (Infusion): Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections. A starting dose of 2 mg/hour is recommended. i.v. (PCA): Dilute to 1 mg/ml in 0.9% saline, 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. s.c. (Bolus): Use as 10 mg/ml concentration. A starting dose of 5 mg is recommended, repeated at 4-hourly intervals as required. s.c. (Infusion): Dilute in 0.9% saline, 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. Elderly: 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. Children under 18 years: There are no data on the use of OxyNorm® 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. Treatment goals and discontinuation Before initiating treatment with OxyNorm injection, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines. During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered (see Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Route Of Administration: INTRAVENOUS
Indication Info: Therapeutic indications For the treatment of moderate to severe pain in patients with cancer and post-operative pain. For the treatment of severe pain requiring the use of a strong opioid.
Contraindications: Contraindications OxyNorm® injection is contraindicated in patients with known hypersensitivity to oxycodone or any of the other constituents, or in any situation where opioids are contraindicated; respiratory depression; head injury; paralytic ileus; acute abdomen; chronic obstructive airways disease; cor pulmonale; chronic bronchial asthma; hypercarbia; moderate to severe hepatic impairment; severe renal impairment (creatinine clearance <10 ml/min); chronic constipation; concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use; pregnancy.
Atc Code: N02AA05
Atc Item Name: oxycodone
Pharma Manufacturer Name: MUNDIPHARMA PHARMACEUTICALS PTE. LTD.

Active Ingredients

Oxycodone hydrochloride 10mg/ml eqv to Oxycodone base

9 mg/ml

Oxycodone hydrochloride 10mg/ml eqv to Oxycodone base

9 mg/ml

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Nov 18, 2009

Approval ID

3119b462aa4935f2

Type

Therapeutic

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