Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
OXYCODONE HYDROCHLORIDE
RAFA LABORATORIES LTD
N02AA05
SYRUP
OXYCODONE HYDROCHLORIDE 10 MG / 5 ML
PER OS
Required
RAFA LABORATORIES LTD, JERUSALEM
OXYCODONE
OXYCODONE
For use in the relief of moderate to severe pain.
2022-09-30
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is sold with a doctor's prescription only OXYCOD 2 MG/ML SYRUP ACTIVE INGREDIENT: Contains: Oxycodone hydrochloride 2 mg/ml. For the list of the additional ingredients, see section 6. See also ‘Important information about some of the medicine’s ingredients’ in section 2. CAREFULLY READ THE ENTIRE LEAFLET BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or pharmacist. This medicine has been prescribed to treat your condition. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. Medicines of the opioids group may cause addiction, especially with prolonged use and they have a potential for misuse and overdose. A reaction to an overdose may be manifested by slow breathing and may even cause death. Make sure you know the name of the medicine, the dosage that you take, how often you take it, the duration of treatment, potential side effects and risks. Additional information regarding the risk of dependence and addiction can be found at the following link: https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/risk/DocLib/opioids_en.pdf Taking this medicine along with medicines from the benzodiazepines group, other medicines which depress the central nervous system (including drugs) or alcohol may cause a feeling of profound drowsiness, breathing difficulties (respiratory depression), coma and death. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for the relief of moderate to severe pain. THERAPEUTIC GROUP: Opioid analgesics. This medicine has been prescribed for you only and should not be given to anyone else. Opioids may cause addiction and you may experience withdrawal symptoms if you stop taking them suddenly. Make sure you received an explanation from the doctor on the duration of treatment with the medicine, when it is appropriate to Đọc toàn bộ tài liệu
1 Oxycod Syrup 2mg/ml -DL-Nov 2022- 06 DOCTOR LEAFLET 1 NAME OF THE MEDICINAL PRODUCT OXYCOD 2 MG/ML SYRUP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml Oxycod Syrup contains oxycodone HCl 2 mg. For the full list of excipients see section 6.1 Excipients with known effect: See section 4.4._ _ 3 PHARMACEUTICAL FORM Syrup for oral use. Clear, pink solution. 4 CLINICAL PARTICULARS WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death _[_see sections _4.4, 4.5]_. • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation. 4.1 THERAPEUTIC INDICATIONS For the relief of moderate to severe pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _METHOD of administration: _ Oxycod Syrup is for oral use. _ _ _Post-operative pain: _ In common with other strong opioids, the need for continued treatment should be assessed at regular intervals. _Elderly and adults over 18 years: _ Oxycod Syrup should be taken at 4-6 hourly intervals. The dosage is dependent on the severity of the pain, and the patient’s previous history of analgesic requirements. Generally, the lowest effective dose for analgesia should be selected. 2 Increasing severity of pain will require an increased dosage of Oxycod Syrup. The correct dosage for any individual patient is that which controls the pain and is well tolerated throughout the dosing period. Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this. The usual starting dose for opioid naive patients or patients presenting with severe pain uncontrolled by weaker opioids is 5 mg, 4-6 hourly. The dose should then be carefully titrated, as Đọc toàn bộ tài liệu