Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
FENTANYL CITRATE
AS KALCEKS Krustpils iela 71E, Riga, LV-1057,, Latvia
N01AH01
FENTANYL CITRATE 0.05 mg/ml
SOLUTION FOR INJECTION
FENTANYL CITRATE 0.05 mg/ml
POM
ANESTHETICS
Authorised
2017-08-30
_Package leaflet: Information for the user _ FENTANYL KALCEKS 0.05 MG/ML SOLUTION FOR INJECTION Fentanyl READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Fentanyl Kalceks is and what it is used for 2. What you need to know before you receive Fentanyl Kalceks 3. How Fentanyl Kalceks is given to you 4. Possible side effects 5. How to store Fentanyl Kalceks 6. Contents of the pack and other information 1. WHAT FENTANYL KALCEKS IS AND WHAT IT IS USED FOR Fentanyl Kalceks solution for injection contains the active substance fentanyl (as citrate). It belongs to a group of medicines known as opioid analgesics. These medicines prevent and relieve pain. Fentanyl Kalceks is used: - as a narcotic analgesic supplement in general or regional anaesthesia; - in combination with a neuroleptic (e.g. droperidol) in the technique of neuroleptanalgesia; - for the induction of anaesthesia, and as an adjuvant in the maintenance of general and regional anaesthesia; - as an anaesthetic agent with oxygen in high-risk patients undergoing surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE FENTANYL KALCEKS DO NOT USE FENTANYL KALCEKS: - if you are allergic to fentanyl or any of the ingredients of this medicine (listed in section 6), - if you are allergic to medicines called morphinomimetics. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before using Fentanyl Kalceks: - if you or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”). - if you are a smoker. - if you have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other ment Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fentanyl Kalceks 0.05 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 0.0785 mg of fentanyl citrate corresponding to 0.05 mg of fentanyl. One ampoule (2 ml) contains 0.157 mg of fentanyl citrate corresponding to 0.1 mg of fentanyl. One ampoule (10 ml) contains 0.785 mg of fentanyl citrate corresponding to 0.5 mg of fentanyl. Excipient with known effect Each ampoule of 2 ml contains 7.08 mg (0.31 mmol) sodium. Each ampoule of 10 ml contains 35.41 mg (1.54 mmol) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear colourless liquid. pH of solution 4.0 - 7.5. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fentanyl citrate is used: - as a narcotic analgesic supplement in general or regional anaesthesia; - in combination with a neuroleptic (e.g. droperidol) in the technique of neuroleptanalgesia; - for the induction of anaesthesia, and as an adjuvant in the maintenance of general and regional anaesthesia; - as an anaesthetic agent with oxygen in high-risk patients undergoing surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicine should be given only in an environment where the airway can be controlled and by personnel who can control the airway (see section 4.4). Posology The dose of medicine should be individualised according to age, body weight, physical condition, underlying pathological condition, concomitant use of other drugs, and type of surgery and anaesthesia. _Adults _ _ _ - As an analgesic supplement in general anaesthesia In low doses for minor surgical procedures: 2 mcg/kg of fentanyl. Moderate dose: 2-20 mcg/kg of fentanyl. In high doses during major surgery: 20-50 mcg/kg of fentanyl. The duration of the effect depends on the dose. During major surgery the administration of 20-50 mcg/kg of fentanyl with nitrous oxide/oxygen has been shown to have an attenuating effect. Page 2 of 10 When these doses were used during s Baca dokumen lengkapnya