Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FENTANYL BASE
JOHNSON & JOHNSON SDN BHD
FENTANYL BASE
5Pieces Pieces
JANSSEN PHARMACEUTICA N.V.
DUROGESIC ® TRANSDERMAL PATCH Fentanyl (12mcg/hr, 25mcg/hr, 50mcg/hr) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What DUROGESIC ® _ _ is used for 2. How DUROGESIC ® works 3. Before you use DUROGESIC ® 4. How to use DUROGESIC ® 5. While you are using it 6. Side effects 7. Storage and disposal of DUROGESIC ® 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT DUROGESIC ® _ _IS USED FOR DUROGESIC ® is a strong painkiller. It is used to relieve severe long-lasting pain, which requires strong painkillers. HOW DUROGESIC ® _ _WORKS DUROGESIC ® patches contain a medicine called fentanyl. This strong pain reliever belongs to a group of medicines known as opioid analgesics. Its primary therapeutic actions are analgesia and sedation. BEFORE YOU USE DUROGESIC ® - _When you must not use it _ • If you know you are oversensitive to it _ _ • Unless your doctor has prescribed it for your pain _ _ • For the relief of pain following surgery or short-term pain _ _ • if you have breathing difficulties, with slow or shallow breathing. _ _ _Pregnancy and lactation _ _Pregnancy _ • If you are pregnant or plan to become pregnant, you should inform your doctor, who will decide whether you may use DUROGESIC ® . DUROGESIC ® should not be used during childbirth as the medicine can slow the breathing of the newborn child. Prolonged use of DUROGESIC ® during pregnancy can cause withdrawal symptoms in your newborn baby that could be life- threatening if not recognized and treated. _Breastfeeding _ • If you are breast-feeding, you should not use DUROGESIC ® since it may be present in your milk. See your doctor. _Children _ DUROGESIC ® is not for children, unless your doctor has decided otherwise _ _ _ _ - _Before you start use it _ Opioids can be abused and misused, and you are at risk for opioid addiction, even if you take your dose as prescribed. Opioid addiction, abuse and misuse can lead to death. Keep unused and used DUROGESIC ® pat Přečtěte si celý dokument
1 PRODUCT NAME DUROGESIC ® TRANSDERMAL PATCH DOSAGE FORMS AND STRENGTHS DUROGESIC patches are for transdermal use only. Transdermal patch providing continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72 hours. DUROGESIC DUROGESIC DOSE (MCG/H) PATCH SIZE (CM 2 ) FENTANYL CONTENT IN PATCH (MG) DUROGESIC 12 1 5.25 2.1 DUROGESIC 25 10.5 4.2 DUROGESIC 50 21.0 8.4 DUROGESIC 75 31.5 12.6 DUROGESIC 100 42.0 16.8 1 The lowest dose is designated as 12 mcg/h (however, the actual dose is 12.5 mcg/h) to distinguish it from a 125 mcg/h dose that could be prescribed by using multiple patches. For excipients, see List of Excipients. CLINICAL INFORMATION INDICATIONS DUROGESIC is indicated in the management of chronic pain and intractable pain that requires continuous opioid administration for an extended period of time. DOSAGE AND ADMINISTRATION DUROGESIC doses should be individualized based upon the status of the patient and should be assessed at regular intervals after application. The lowest effective dose should be used. The patches are designed to deliver approximately 12, 25, 50, 75, and 100 mcg/hour fentanyl to the systemic circulation, which represent about 0.3, 0.6, 1.2, 1.8, and 2.4 mg per day (see _ Dosage Forms and Strengths_ ), respectively. _Initial Dosage Selection _ The appropriate initiating dose of DUROGESIC should be based on the patient’s current opioid use. It is recommended that DUROGESIC be used in patients who have demonstrated opioid tolerance. Other factors to be considered are the current general 2 condition and medical status of the patient, including body size, age, and extent of debilitation as well as degree of opioid tolerance. _Dosage-Adults _ _Opioid-tolerant Patients _ To convert opioid-tolerant patients from oral or parenteral opioids to DUROGESIC refer to _Equianalgesic Potency Conversion_ below. The dosage may subsequently be titrated upwards or downwards, if required, in increments of 12 mcg/hour to achieve the lowest appropriate dosage of DUROGESIC depending on respo Přečtěte si celý dokument