FENTANYL Solution for injection (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Fentanyl 50 micrograms/ml Solution for Injection/Infusion.
Qualitative and quantitative composition
Contains Fentanyl citrate the equivalent of 50 micrograms of Fentanyl in 1ml. Each 2ml ampoule contains 100 micrograms of Fentanyl as Fentanyl citrate. Each 10ml ampoule contains 500 micrograms of Fentanyl ...
Pharmaceutical form
Solution for injection. A clear, colourless, sterile solution.
Therapeutic indications
Fentanyl citrate is a narcotic analgesic. In low doses it is used to provide analgesia during short surgical procedures and as a premedicant. In higher doses it is employed as an analgesic/respiratory ...
Posology and method of administration
Posology Adult The usual dosage regimen is as follows: Initial micrograms Supplemental micrograms Spontaneous Respiration 50–200 50 Assisted ventilation 300-3500 100-200 Doses greater than 200 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Known intolerance to fentanyl or other morphino-mimetics. Respiratory depression. Obstructive airways disease. ...
Special warnings and precautions for use
Fentanyl should be given only in an environment where the airway can be controlled and by personnel who can control the airway. As with all potent opioids. Respiratory depression is dose related and can ...
Interaction with other medicinal products and other forms of interaction
Effect of other drugs on fentanyl Drugs such as barbiturates, benzodiazepines, neuroleptics, halogenic gases, and other non-selective CNS depressants (e.g. alcohol) may potentiate the respiratory depression ...
Pregnancy and lactation
Pregnancy There are no adequate data from the use of fentanyl in pregnant women. Fentanyl can cross the placenta in early pregnancy. Studies in animals have shown some reproductive toxicity. (See section ...
Effects on ability to drive and use machines
Fentanyl has a moderate influence on the ability to drive and use machines. Patients should only drive or operate a machine if sufficient time has elapsed after the administration of fentanyl. This medicine ...
Undesirable effects
The safety of fentanyl IV was evaluated in 376 subjects who participated in 20 clinical trials evaluating fentanyl IV as an anesthetic. These subjects took at least 1 dose of fentanyl IV and provided safety ...
Overdose
Symptoms An overdosage of fentanyl manifests itself as an extension of its pharmacologic actions. Depending on the individual sensitivity, the clinical picture is determined primarily by the degree of ...
Pharmacodynamic properties
Pharmacotherapeutic group: Opioid analgesic ATC code: N01AH01 Fentanyl is a well established chemical entity. It is an opioid analgesic with a high affinity for the μ-opioid receptor. Fentanyl can be used ...
Pharmacokinetic properties
Absorption Fentanyl is a lipid-soluble drug and its pharmacokinetics can be described in terms of a three-compartment model. Following intravenous injection, there is a short distribution phase during ...
Preclinical safety data
In vitro fentanyl showed, like other opioid analgesics, mutagenic effects in a mammalian cell culture assay, only at cytotoxic concentrations and along with metabolic activation. Fentanyl showed no evidence ...
List of excipients
Sodium chloride Sodium hydroxide Water for injections
Incompatibilities
Fentanyl citrate is incompatible with alkaline solutions (due to reduced solubility) and some drugs. Published data show that Fentanyl 50 micrograms/ml Solution for Injection/Infusion is incompatible with ...
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 25°C. Keep container in the outer carton.
Nature and contents of container
2ml/10ml clear One point cut (OPC) glass ampoules, glass type I Ph. Eur. borosilicate glass, packed in cardboard cartons to contain 10 2ml/10ml ampoules. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
The injection is for single patient use and should be used immediately after opening. The injection should not be used if particles are present. Any unused portion should be discarded. Fentanyl for infusion ...
Marketing authorization holder
Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL, UK
Marketing authorization number(s)
PL 12762/0575
Date of first authorization / renewal of the authorization
18/10/1999
Date of revision of the text
30/05/2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
