País: Suècia
Idioma: suec
Font: Läkemedelsverket (Medical Products Agency)
fentanylcitrat
2care4 ApS
N02AB03
fentanyl citrate
400 mikrogram
Resoriblett, sublingual
mannitol Hjälpämne; fentanylcitrat 628,4 mikrog Aktiv substans
Receptbelagt
Avregistrerad
2016-01-27
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Abstral 100 microgram sublingual tablets Abstral 200 microgram sublingual tablets Abstral 300 microgram sublingual tablets Abstral 400 microgram sublingual tablets Abstral 600 microgram sublingual tablets Abstral 800 microgram sublingual tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sublingual tablet contains: 100 micrograms fentanyl (as citrate) 200 micrograms fentanyl (as citrate) 300 micrograms fentanyl (as citrate) 400 micrograms fentanyl (as citrate) 600 micrograms fentanyl (as citrate) 800 micrograms fentanyl (as citrate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sublingual tablet 100 microgram sublingual tablet is a white round tablet 200 microgram sublingual tablet is a white oval-shaped tablet 300 microgram sublingual tablet is a white triangle-shaped tablet 400 microgram sublingual tablet is a white diamond-shaped tablet 600 microgram sublingual tablet is a white “D”-shaped tablet 800 microgram sublingual tablet is a white capsule-shaped tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain. Breakthrough pain is a transient exacerbation of otherwise controlled chronic background pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Abstral should only be administered to patients who are considered tolerant to their opioid therapy for persistent cancer pain. Patients can be considered opioid tolerant if they take at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. Method of administration: Abstral sublingual tablets should be administered directly under the tongue at the deepest part. Abstral sublingual tablets should not be swallowed, but allowed to completely dissolve in the sublingual cavity without chewing or suck Llegiu el document complet