Krajina: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Fentanyl 8.4mg;
Sandoz New Zealand Limited
Fentanyl 8.4 mg
50 mcg/h
Transdermal patch
Active: Fentanyl 8.4mg Excipient: Durotak 87-4287 Pegoterate
Class B1 Controlled Drug
Mallinckrodt Chemical Inc
The management of chronic cancer pain. The management of opioid-responsive chronic severe pain of non-malignant origin in opioid tolerant patients, after other conservative methods of analgesia have been tried. For use in accordance with NZMA guidelines on chronic pain management and where there is no psychological contraindication, drug seeking behaviour or history of drug misuse.
Package - Contents - Shelf Life: Individual wrap, Foil paper/PE/Al/PE. 1 patch per sachet. - 1 patches - 24 months from date of manufacture stored at or below 25°C - Individual wrap, Foil paper/PE/Al/PE. 1 patch per sachet. - 2 patches - 24 months from date of manufacture stored at or below 25°C - Individual wrap, Foil paper/PE/Al/PE. 1 patch per sachet. - 3 patches - 24 months from date of manufacture stored at or below 25°C - Individual wrap, Foil paper/PE/Al/PE. 1 patch per sachet. - 4 patches - 24 months from date of manufacture stored at or below 25°C - Individual wrap, Foil paper/PE/Al/PE. 1 patch per sachet. - 5 patches - 24 months from date of manufacture stored at or below 25°C - Individual wrap, Foil paper/PE/Al/PE. 1 patch per sachet. - 7 patches - 24 months from date of manufacture stored at or below 25°C - Individual wrap, Foil paper/PE/Al/PE. 1 patch per sachet. - 8 patches - 24 months from date of manufacture stored at or below 25°C - Individual wrap, Foil paper/PE/Al/PE. 1 patch per sachet. - 10 patches - 24 months from date of manufacture stored at or below 25°C
2013-06-26
190725-fentanyl-sandoz-cmi Page 1 FENTANYL SANDOZ ® _fentanyl transdermal patches _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Fentanyl Sandoz. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT FENTANYL SANDOZ IS USED FOR This medicine is used to relieve chronic or long-lasting pain, which requires strong painkillers. It contains the active ingredient fentanyl. Fentanyl belongs to a group of medicines called opioid analgesics. It works by blocking the nerves that recognise pain messages from the body. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine may be addictive. This medicine is available only with a doctor's prescription. WARNING Fentanyl Sandoz patches may be retrieved and abused by addicts. Please ensure that used patches are concealed and disposed of carefully. Return unused patches to the pharmacy (see Disposal at the end of this leaflet). Keep used and unused patches where children cannot reach them. BEFORE YOU USE FENTANYL SANDOZ _WHEN YOU MUST NOT USE IT _ DO NOT USE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • fentanyl, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product description. • any other similar medicines. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT USE THIS MEDICINE IF YOU HAVE OR HAVE HAD ANY OF TH Prečítajte si celý dokument
NEW ZEALAND DATA SHEET 230522-fentanyl-sandoz-ds Page 1 of 26 WARNINGS _LIMITATIONS OF USE_ Because of the risks associated with the use of opioids, Fentanyl Sandoz should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain (see _section _ _4.4 Special Warnings and Precautions for Use_ ). _HAZARDOUS AND HARMFUL USE_ Fentanyl Sandoz poses risks of hazardous and harmful use which can lead to overdose and death. Assess the patient's risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment (see _section 4.4. Special Warnings and Precautions for _ _Use_ ). _LIFE THREATENING RESPIRATORY DEPRESSION_ Serious, life-threatening or fatal respiratory depression may occur with the use of Fentanyl Sandoz. Be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase (see _section 4.4 Special Warnings and Precautions for Use_ ). _CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS, _ _INCLUDING ALCOHOL_ Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Limit dosages and durations to the minimum required; and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while taking Fentanyl Sandoz. 1 PRODUCT NAME FENTANYL SANDOZ, _12micrograms/hour, 25 micrograms/hour, 37micrograms/hour, 50 _ _micrograms/hour, 75 micrograms/hour, 100 micrograms/hour; Transdermal Patch _ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Fentanyl Sandoz 12 * : Each patch contains 2.1mg fentanyl in a patch size 5.25 cm 2 , releasing a Prečítajte si celý dokument