RELETRANS Transdermal patch (2021)
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Περιεχόμενα
Name of the medicinal product
Reletrans 5 microgram/hour transdermal patch.
Qualitative and quantitative composition
Each transdermal patch contains 5 mg of buprenorphine per 6.25 cm², releasing 5 micrograms of buprenorphine per hour. For the full list of excipients, see section 6.1.
Pharmaceutical form
Transdermal patch. The product is composed of a drug containing transdermal patch integrated with an oversized pale yellowish-brown cover patch without any active substance. The shape of the transdermal ...
Therapeutic indications
Treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia. Reletrans is not suitable for the treatment of acute pain. Reletrans is indicated in ...
Posology and method of administration
Posology Reletrans should be administered every 7th day. Patients aged 18 years and over The lowest Reletrans strength (Reletrans 5 microgram/hour transdermal patch) should be used as the initial dose. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Opioid dependent patients and for narcotic withdrawal treatment Conditions in which the respiratory centre and ...
Special warnings and precautions for use
Buprenorphine transdermal patches should be used with particular caution in patients with acute alcohol intoxication, head injury, shock, a reduced level of consciousness of uncertain origin, intracranial ...
Interaction with other medicinal products and other forms of interaction
Buprenorphine transdermal patches must not be used concomitantly with MAOIs or in patients who have received MAOIs within the previous two weeks (see section 4.3). Effect of other active substances on ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amounts of data from the use of buprenorphine transdermal patches in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential ...
Effects on ability to drive and use machines
This medicine can impair cognitive function and can affect a patients ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. ...
Undesirable effects
Serious adverse reactions that may be associated with buprenorphine transdermal patches therapy in clinical use are similar to those observed with other opioid analgesics, including respiratory depression ...
Overdose
Symptoms Symptoms similar to those of other centrally acting analgesics are to be expected. These include respiratory depression, sedation, drowsiness, nausea, vomiting, cardiovascular collapse and marked ...
Pharmacodynamic properties
Pharmacotherapeutic group: Analgesics, opioids, oripavine derivatives ATC code: N02AE01 Mechanism of action Buprenorphine is a partial agonist opioid, acting at the mu opioid receptor. It also has antagonistic ...
Pharmacokinetic properties
Each transdermal patch provides a steady delivery of buprenorphine for up to seven days. Steady state is achieved during the first application. After removal of Reletrans, buprenorphine concentrations ...
Preclinical safety data
Reproductive and developmental toxicity No effect on fertility or general reproductive performance was observed in rats treated with buprenorphine. In embryofoetal developmental toxicity studies conducted ...
List of excipients
Release liner (to be removed before applying the patch): Poly (ethylene terephthalate) foil, siliconized Adhesive matrix (containing buprenorphine): Levulinic acid Oleyl oleate Povidone K90 Poly [acrylic ...
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Each transdermal patch is individually packed in a child resistant sachet made of PET/Alu/PE. Carton containing 1, 2, 3, 4, 5, 8, 10, 12 or 20 transdermal patches. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
Used transdermal patches should be folded with the adhesive surface in wards. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom
Marketing authorization number(s)
PL 04416/1406
Date of first authorization / renewal of the authorization
Date of first authorisation: 10 February 2016 Last renewal date: 10 November 2020
Date of revision of the text
05/03/2021
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