国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Buprenorphine
Aspire Pharma Ltd
N02AE01
Buprenorphine
5microgram/1hour
Transdermal patch
Transdermal
Schedule 3 (CD No Register)
Valid as a prescribable product
BNF: 04070200; GTIN: 5060209731452
If you are affected (e.g. feel dizzy, drowsy or have blurred vision), you should not drive or operate machinery whilst using Sevodyne, or for 24 hours after removing the patch. This medicine can affect your ability to drive as it may make you sleepy or dizzy. • Do not drive while taking this medicine until you know how it affects you. • It is an offence to drive if this medicine affects your ability to drive. • However you would not be committing an offence if: • The medicine has been prescribed to treat a medical or dental problem; and • You have taken it according to the instructions given by the prescriber or in the information provided with the medicine. • It was not affecting your ability to drive safely. Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine. 3. How to use Sevodyne Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Different strengths of Sevodyne are available. Your doctor will decide which strength of Sevodyne will suit you best. When people first start using Sevodyne, they often experience some nausea and vomiting (see section 4). This usually passes after the first week of treatment. It’s a good idea to book a follow-up appointment with your doctor a week or two after you first start using Sevodyne patches to ensure that you are taking the correct dose and to manage any side effects. During treatment, your doctor may change the patch you use to a smaller or larger one if necessary or tell you to use a combination of up to two patches. Do not cut or divide the patch or use a higher dose than recommended. YOU SHOULD NOT APPLY MORE THAN TWO PATCHES AT THE SAME TIME UP TO A MAXIMUM TOTAL DOSE OF 40 MICROGRAMS/HOUR. If you feel that the effect of the Sevodyne is too weak or too strong, talk to your doctor or pharmacist. Adults and elderly patients Unless your doctor has told you differently, attach one Sevodyne patch (as described in de 完全なドキュメントを読む
OBJECT 1 SEVODYNE 5 MICROGRAM/HOUR TRANSDERMAL PATCH Summary of Product Characteristics Updated 20-Feb-2018 | Aspire Pharma Ltd 1. Name of the medicinal product Sevodyne 5 microgram/hour transdermal patch 2. Qualitative and quantitative composition Each transdermal patch contains 5 mg of buprenorphine in a 6.25 cm 2 area releasing a nominal 5 micrograms of buprenorphine per hour over a period of 7 days. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Transdermal patch Rectangular patch beige coloured with rounded edges and imprinted with “Buprenorphin” and “5 μg/h” in blue colour. 4. Clinical particulars 4.1 Therapeutic indications Treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia. Sevodyne is not suitable for the treatment of acute pain. Sevodyne is indicated in adults. 4.2 Posology and method of administration Posology _Patients aged 18 years and over:_ The lowest Sevodyne dose (Sevodyne 5 microgram/hour transdermal patch) should be used as the initial dose. Consideration should be given to the previous opioid history of the patient (see section 4.5) as well as to the current general condition and medical status of the patient. _Titration_ During initiation of treatment with Sevodyne, short-acting supplemental analgesics may be required (see section 4.5) as needed until analgesic efficacy with Sevodyne is attained. The dose of Sevodyne may be titrated upwards as indicated after 3 days, when the maximum effect of a given dose is established. Subsequent dose increases may then be titrated based on the need for supplemental pain relief and the patient's analgesic response to the patch. To increase the dose, a larger patch should replace the patch that is currently being worn, or a combination of patches should be applied in different places to achieve the desired dose. It is recommended that no more than two patches are applied at the same time, up to a maximum total dose of 40 microgram/hour buprenorphine. A new pat 完全なドキュメントを読む