BYETTA Solution for injection (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Byetta 5 micrograms solution for injection in pre-filled pen. Byetta 10 micrograms solution for injection in pre-filled pen.
Qualitative and quantitative composition
Each dose contains 5 micrograms (mcg) of exenatide in 20 microlitres (mcl), (0.25 mg exenatide per ml). Each dose contains 10 micrograms (mcg) of exenatide in 40 microlitres (mcl), (0.25 mg exenatide per ...
Pharmaceutical form
Solution for injection (injection). Clear, colourless solution.
Therapeutic indications
Byetta is indicated for treatment of type 2 diabetes mellitus in combination with: metformin sulphonylureas thiazolidinediones metformin and a sulphonylurea metformin and a thiazolidinedione in adults ...
Posology and method of administration
Posology Immediate-release exenatide (Byetta) therapy should be initiated at 5 mcg exenatide per dose administered twice daily (BID) for at least one month in order to improve tolerability. The dose of ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Exenatide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Exenatide is not a substitute for insulin. Diabetic ketoacidosis has been reported ...
Interaction with other medicinal products and other forms of interaction
The effect of immediate-release exenatide to slow gastric emptying may reduce the extent and rate of absorption of orally administered medicinal products. Patients receiving medicinal products of either ...
Fertility, pregnancy and lactation
Women of childbearing potential If a patient wishes to become pregnant, or pregnancy occurs, treatment with exenatide should be discontinued. Pregnancy There are no adequate data from the use of exenatide ...
Effects on ability to drive and use machines
Exenatide has minor influence on the ability to drive and use machines. When exenatide is used in combination with a sulphonylurea or a basal insulin, patients should be advised to take precautions to ...
Undesirable effects
Summary of the safety profile The most frequent adverse reactions were mainly gastrointestinal related (nausea, vomiting and diarrhoea). The most frequently reported single adverse reaction was nausea ...
Overdose
Signs and symptoms of overdose may include severe nausea, severe vomiting and rapidly declining blood glucose concentrations. In the event of overdose, appropriate supportive treatment (possibly given ...
Pharmacodynamic properties
Pharmacotherapeutic group: Glucagon-like peptide-1 (GLP-1) analogues ATC code: A10BJ01 Mechanism of action Exenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist that exhibits several antihyperglycaemic ...
Pharmacokinetic properties
Absorption Following subcutaneous administration to patients with type 2 diabetes, exenatide reaches median peak plasma concentrations in 2 h. Mean peak exenatide concentration (C<sub>max</sub>) was 211 ...
Preclinical safety data
Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, or genotoxicity. In female rats given exenatide for 2 years, an increased ...
List of excipients
Metacresol Mannitol Glacial acetic acid Sodium acetate trihydrate Water for injections
Incompatibilities
In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products.
Shelf life
3 years. In use pen: 30 days.
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. <u>In use pen:</u> Store below 25°C. The pen must not be stored with the needle attached. Replace cap on pen in order to protect from light.
Nature and contents of container
Type I glass cartridge with a (bromobutyl) rubber plunger, rubber disc, and aluminium seal. Each cartridge is assembled into a disposable pen-injector (pen). 5 mcg: Each pre-filled pen contains 60 doses ...
Special precautions for disposal and other handling
The patient should be instructed to discard the needle after each injection. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Instructions for ...
Marketing authorization holder
AstraZeneca AB, SE-151 85 Sodertalje, Sweden
Marketing authorization number(s)
EU/1/06/362/001-4
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 November 2006 Date of latest renewal: 22 July 2016
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