ABSTRAL Sublingual tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Abstral 100 microgram, 200 microgram, 300 microgram, 400 microgram, 600 microgram, 800 microgram sublingual tablets.
Qualitative and quantitative composition
<u>Each sublingual tablet contains:</u> 100 micrograms fentanyl (as citrate). 200 micrograms fentanyl (as citrate). 300 micrograms fentanyl (as citrate). 400 micrograms fentanyl (as citrate). 600 micrograms ...
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. ...
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.
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 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients without maintenance opioid therapy as there is an increased risk of respiratory depression. Severe respiratory ...
Special warnings and precautions for use
Patients and their carers must be instructed that Abstral contains an active substance in an amount that can be fatal to a child, and therefore to keep all tablets out of the reach and sight of children. ...
Interaction with other medicinal products and other forms of interaction
Fentanyl is metabolised by CYP3A4. Active substances that inhibit CYP3A4 activity such as macrolide antibiotics (e.g. erythromycin), azole antifungal agents (e.g. ketoconazole, itraconazole) or certain ...
Pregnancy and lactation
The safety of fentanyl in pregnancy has not been established. Studies in animals have shown reproductive toxicity, with impaired fertility in rats (see section 5.3). The potential risk for humans is unknown. ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed with Abstral. However, opioid analgesics are known to impair the mental or physical ability to perform potentially ...
Undesirable effects
Undesirable effects typical of opioids are to be expected with Abstral; they tend to decrease in intensity with continued use. The most serious potential adverse reactions associated with opioid use are ...
Overdose
The symptoms of fentanyl overdose are an extension of its pharmacological actions, the most serious effect being respiratory depression, which may lead to respiratory arrest. Coma is also known to occur. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Analgesics; Opioids; Phenylpiperidine derivatives ATC code: N02AB03 Fentanyl is a potent µ-opioid analgesic with rapid onset of analgesia and short duration of action. Fentanyl ...
Pharmacokinetic properties
Fentanyl is a highly lipophilic drug absorbed very rapidly through the oral mucosa and more slowly through the gastrointestinal tract. Orally administered fentanyl undergoes pronounced hepatic and intestinal ...
Preclinical safety data
Safety pharmacology and repeated dose toxicity data reveal no special hazard for humans that is not already covered by other sections of this SPC. Animal studies have shown reduced fertility and increased ...
List of excipients
Mannitol (E421) Silicified microcrystalline cellulose Croscarmellose sodium Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
Do not store above 25°C. Store in the original blister package in order to protect from moisture.
Nature and contents of container
Abstral sublingual tablets are packaged in child resistant blisters of OPA/Aluminium/PVC pockets with paper/polyester/Aluminium lidding contained in a cardboard outer carton. The packaging is colour-coded ...
Special precautions for disposal and other handling
Waste material should be disposed of safely. Patients/carers should be encouraged to return any unused product to the Pharmacy, where it should be disposed of in accordance with national and local requirements. ...
Marketing authorization holder
Kyowa Kirin Ltd, Galabank Business Park, Galashiels, TD1 1QH, UK
Marketing authorization number(s)
Abstral 100 microgram sublingual tablets: PL 16508/0030 Abstral 200 microgram sublingual tablets: PL 16508/0031 Abstral 300 microgram sublingual tablets: PL 16508/0032 Abstral 400 microgram sublingual ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 2008-02-29 Date of latest renewal: 2013-02-28
Date of revision of the text
March 2019
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