SUBLIMAZE Solution for injection (2021)
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Περιεχόμενα
1. Name of the medicinal product
Sublimaze.
2. Qualitative and quantitative composition
Each 1ml of solution contains 78.5 micrograms fentanyl citrate equivalent to 50 micrograms per ml fentanyl base. <u>Excipient(s) with known effect:</u> Sodium 3.5 mg/ml. For Sublimaze 2 and 5 ml ampoules: ...
3. Pharmaceutical form
Solution for injection.
4.1. Therapeutic indications
Sublimaze is an opioid analgesic used: In low doses to provide analgesia during short surgical procedures. In high doses as an analgesic/respiratory depressant in patients requiring assisted ventilation. ...
4.2. Posology and method of administration
Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with fentanyl citrate in order to minimise the risk of addiction and ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or other opioids. Respiratory depression, obstructive airways disease. Concurrent administration with monoamine ...
4.4. Special warnings and precautions for use
Warnings Drug dependence, tolerance and potential for abuse For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. The risks are increased in ...
4.5. Interaction with other medicinal products and other forms of interaction
Effect of other drugs on fentanyl Central Nervous System (CNS) depressants The use of opioid premedication, barbiturates, benzodiazepines or related drugs, neuroleptics, general anaesthetics and other ...
4.6. Pregnancy and lactation
Pregnancy Fentanyl can cross the placenta in early pregnancy. Studies in animals have shown some reproductive toxicity (see Section 5.3, Preclinical safety data). Administration during childbirth (including ...
4.7. Effects on ability to drive and use machines
Where early discharge is envisaged, patients should be advised not to drive or operate machinery for at least 24 hours following administration. This medicine can impair cognitive function and can affect ...
4.8. Undesirable effects
The safety of fentanyl IV was evaluated in 376 subjects who participated in 20 clinical trials evaluating fentanyl IV as an anaesthetic. These subjects took at least 1 dose of fentanyl IV and provided ...
4.9. Overdose
Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur. Symptoms and signs ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Anaesthetic general, opioid anaesthetic <b>ATC code:</b> N01AH01 Fentanyl is a synthetic opiate with a clinical potency of 50 to 100 times that of morphine. Its onset ...
5.2. Pharmacokinetic properties
<u>Some pharmacokinetic parameters for fentanyl are as follows:</u> Urinary excretion = 8% Bound in plasma = 80% Clearance (ml/min/kg) = 13 ± 2 Volume of distribution (litres/kg) = 4.0 ± 0.4 Estimates ...
5.3. Preclinical safety data
<em>In vitro</em> 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 ...
6.1. List of excipients
Sodium chloride Water for injections
6.2. Incompatibilities
The product is chemically incompatible with the induction agents thiopentone and methohexitone because of the wide differences in pH.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Protect from light. Do not store above 30°C. Keep container in the outer carton.
6.5. Nature and contents of container
Colourless glass ampoules (PhEur, USP Type I). Pack size: packs of 10 and 50* of 2 ml and 5 ml* ampoules; packs of 5 and 10* of 10 ml ampoules. * not marketed
6.6. Special precautions for disposal and other handling
Wear gloves while opening ampoule. Accidental dermal exposure should be treated by rinsing the affected area with water. Avoid usage of soap, alcohol, and other cleaning materials that may cause chemical ...
7. Marketing authorization holder
Piramal Critical Care Limited, Suite 4, Ground Floor, Heathrow Boulevard East Wing, 280 Bath Road, West Drayton, UB7 0DQ, United Kingdom
8. Marketing authorization number(s)
PL 37071/0004
9. Date of first authorization / renewal of the authorization
26 February 1980 / 25 March 2002
10. Date of revision of the text
19/11/2021
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