Abstral 300 mikrogram Resoriblett, sublingual

Pays: Suède

Langue: suédois

Source: Läkemedelsverket (Medical Products Agency)

Ingrédients actifs:

fentanylcitrat

Disponible depuis:

2care4 ApS

Code ATC:

N02AB03

DCI (Dénomination commune internationale):

fentanyl citrate

Dosage:

300 mikrogram

forme pharmaceutique:

Resoriblett, sublingual

Composition:

fentanylcitrat 471,3 mikrog Aktiv substans; mannitol Hjälpämne

Type d'ordonnance:

Receptbelagt

Statut de autorisation:

Avregistrerad

Date de l'autorisation:

2016-01-27

Résumé des caractéristiques du produit

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