PECFENT Nasal spray, solution (2019)
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Περιεχόμενα
Name of the medicinal product
PecFent 100 micrograms/spray nasal spray, solution. PecFent 400 micrograms/spray nasal spray, solution.
Qualitative and quantitative composition
PecFent 100 micrograms/spray nasal spray, solution: Each ml of solution contains 1,000 micrograms fentanyl (as citrate) 1 spray (100 microlitres) contains 100 micrograms fentanyl (as citrate). Bottles ...
Pharmaceutical form
Nasal spray, solution (nasal spray). A clear to practically clear colourless aqueous solution.
Therapeutic indications
PecFent is indicated for the management of breakthrough pain (BTP) in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation ...
Posology and method of administration
Treatment should be initiated by and remain under the supervision of a physician experienced in the management of opioid therapy in cancer patients. Physicians should keep in mind the potential for abuse ...
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 PecFent contains an active substance in an amount that can be fatal to a child. In order to minimise the risks of opioid-related adverse reactions and ...
Interaction with other medicinal products and other forms of interaction
Fentanyl is metabolised mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when PecFent is given concurrently with medicinal products that affect ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of fentanyl in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. PecFent ...
Effects on ability to drive and use machines
Opioid analgesics may impair the mental and/or physical ability required for driving or operating machinery. Patients should be advised not to drive or operate machinery if they experience somnolence, ...
Undesirable effects
Summary of the safety profile Typical opioid adverse reactions are to be expected with PecFent. Frequently, these will cease or decrease in intensity with continued use of the medicinal product, as the ...
Overdose
The symptoms of fentanyl overdose via the nasal route are expected to be similar in nature to those of intravenous fentanyl and other opioids, and are an extension of its pharmacological actions, with ...
Pharmacodynamic properties
Pharmacotherapeutic group: Analgesics; opioids; phenylpiperidine derivatives ATC code: N02AB03 Mechanism of action Fentanyl is an opioid analgesic, interacting predominantly with the opioid μ-receptor. ...
Pharmacokinetic properties
General introduction Fentanyl is highly lipophilic and can be absorbed very rapidly through the nasal mucosa and more slowly by the gastrointestinal route. It is subject to first pass hepatic and intestinal ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenicity. Embryo-foetal developmental toxicity ...
List of excipients
Pectin (E440) Mannitol (E421) Phenylethyl alcohol Propylparahydroxybenzoate (E216) Sucrose Hydrochloric acid (0.36%) or sodium hydroxide (for pH adjustment) Purified water
Incompatibilities
Not applicable.
Shelf life
Shelf life 2 spray bottle: 18 months. After priming, use within 5 days. 8 spray bottle: 3 years. After first use: 60 days
Special precautions for storage
Do not store above 25°C. Do not freeze. Keep the bottle in the child resistant container in order to protect from light. Store the bottle in the child resistant container at all times, even when finished. ...
Nature and contents of container
Bottle (clear Type I glass) with an attached metering pump incorporating an audible dose counter and a protective cap (solid white cap for the 2 spray and translucent cap for the 8 spray). In each case ...
Special precautions for disposal and other handling
Partially used PecFent bottles may contain enough medicine to be harmful or life-threatening to a child. Even if there is little or no medicine left in the bottle, PecFent must be disposed of properly, ...
Marketing authorization holder
Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands
Marketing authorization number(s)
EU/1/10/644/007 EU/1/10/644/001 EU/1/10/644/002 EU/1/10/644/005 EU/1/10/644/003 EU/1/10/644/004 EU/1/10/644/006
Date of first authorization / renewal of the authorization
Date of first authorisation: 31 August 2010 Date of latest renewal: 17 July 2015
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