BUVIDAL Prolonged-release solution for injection (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Buvidal 8 mg prolonged-release solution for injection. Buvidal 16 mg prolonged-release solution for injection. Buvidal 24 mg prolonged-release solution for injection. Buvidal 32 mg prolonged-release solution ...
Qualitative and quantitative composition
<u>8 mg prolonged-release solution for injection:</u> Each pre-filled syringe contains 8 mg buprenorphine <u>16 mg prolonged-release solution for injection:</u> Each pre-filled syringe contains 16 mg buprenorphine ...
Pharmaceutical form
Prolonged-release solution for injection. Yellowish to yellow clear liquid.
Therapeutic indications
Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.
Posology and method of administration
Administration of Buvidal is restricted to healthcare professionals. Appropriate precautions, such as to conduct patient follow-up visits with clinical monitoring according to the patients needs, should ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe respiratory insufficiency. Severe hepatic impairment. Acute alcoholism or delirium tremens.
Special warnings and precautions for use
Administration Care must be taken to avoid inadvertent injection of Buvidal. The dose must not be administered intravascularly (intravenously), intramuscularly or intradermally. Intravascular such as intravenous ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with Buvidal. Buprenorphine should be used cautiously when co-administered with: benzodiazepines: This combination may result in death due to respiratory depression ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited data from the use of buprenorphine in pregnant women. Animal studies do not indicate reproductive toxicity (see section 5.3). Buprenorphine should be used during pregnancy ...
Effects on ability to drive and use machines
Buprenorphine has minor to moderate influence on the ability to drive and use machines when administered to opioid-dependent patients. Buprenorphine may cause drowsiness, dizziness or impaired thinking, ...
Undesirable effects
Summary of the safety profile The adverse reactions most frequently reported for buprenorphine are headache, nausea, hyperhidrosis, insomnia, drug withdrawal syndrome and pain. Tabulated list of adverse ...
Overdose
Symptoms Respiratory depression, as a result of central nervous system depression, is the primary symptom requiring intervention in the case of buprenorphine overdose because it may lead to respiratory ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other nervous system drugs, drugs used in opioid dependence <b>ATC code:</b> N07BC01 Mechanism of action Buprenorphine is an opioid partial agonist/antagonist which binds ...
Pharmacokinetic properties
Weekly Buvidal Absorption After injection, the buprenorphine plasma concentration increases with a median time to maximum plasma concentration (t<sub>max</sub>) of about 24 hours. Buvidal has complete ...
Preclinical safety data
Acute toxicity of buprenorphine was determined in mice and rats following oral and parenteral (intravenous, intraperitoneal) administration. Undesirable effects were based on the known pharmacological ...
List of excipients
<u>Buvidal 8 mg, 16 mg, 24 mg, 32 mg:</u> Soybean phosphatidylcholine Glycerol dioleate Ethanol anhydrous
Incompatibilities
This medicinal product must not be mixed with other medicinal products.
Shelf life
3 years.
Special precautions for storage
Do not refrigerate or freeze.
Nature and contents of container
A 1 mL pre-filled syringe (glass, Type I) with plunger stopper (fluoropolymer-coated bromobutyl rubber) with needle (½-inch, 23 gauge, 12 mm) and needle shield (styrene butadiene rubber). The prefilled ...
Special precautions for disposal and other handling
<u>Important information:</u> Administration should be made into the subcutaneous tissue Intravascular, intramuscular and intradermal administration must be avoided. Must not be used if the safety syringe ...
Marketing authorization holder
Camurus AB, Ideon Science Park, SE-223 70 Lund, Sweden Phone: +800 2577 2577
Marketing authorization number(s)
Buvidal prolonged-release solution for injection (weekly) EU/1/18/1336/001 [8 mg buprenorphine/0.16 mL] EU/1/18/1336/002 [16 mg buprenorphine/0.32 mL] EU/1/18/1336/003 [24 mg buprenorphine 0.48 mL] EU/1/18/1336/004 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 November 2018
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