AIMOVIG Solution for injection (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Aimovig 70 mg solution for injection in pre-filled syringe. Aimovig 140 mg solution for injection in pre-filled syringe. Aimovig 70 mg solution for injection in pre-filled pen. Aimovig 140 mg solution ...
Qualitative and quantitative composition
Aimovig 70 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 70 mg erenumab. Aimovig 140 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains ...
Pharmaceutical form
Solution for injection (injection). The solution is clear to opalescent, colourless to light yellow.
Therapeutic indications
Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.
Posology and method of administration
Treatment should be initiated by physicians experienced in the diagnosis and treatment of migraine. Posology Treatment is intended for patients with at least 4 migraine days per month when initiating treatment ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Patients with certain major cardiovascular diseases were excluded from clinical studies (see section 5.1). No safety data are available in these patients. Hypersensitivity reactions Serious hypersensitivity ...
Interaction with other medicinal products and other forms of interaction
No effect on exposure of co-administered medicinal products is expected based on the metabolic pathways of monoclonal antibodies. No interaction with oral contraceptives (ethinyl estradiol/norgestimate) ...
Pregnancy and lactation
Pregnancy There are a limited amount of data from the use of erenumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section ...
Effects on ability to drive and use machines
Aimovig is expected to have no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile A total of over 2,500 patients (more than 2,600 patient years) have been treated with Aimovig in registration studies. Of these, more than 1,300 patients were exposed for ...
Overdose
No cases of overdose have been reported in clinical studies. Doses up to 280 mg have been administered subcutaneously in clinical studies with no evidence of dose-limiting toxicity. In the event of an ...
Pharmacodynamic properties
Pharmacotherapeutic group: Analgesics, antimigraine preparations ATC code: N02CX07 Mechanism of action Erenumab is a human monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) receptor. ...
Pharmacokinetic properties
Erenumab exhibits non-linear kinetics as a result of binding to the CGRP-R receptor. However, at therapeutically relevant doses, the pharmacokinetics of erenumab following subcutaneous dosing every 4 weeks ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, toxicity to reproduction and development. Carcinogenicity studies have ...
List of excipients
Sucrose Polysorbate 80 Sodium hydroxide (for pH adjustment) Glacial acetic acid Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Pre-filled syringe: Store in a refrigerator (2°C-8°C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light. After removal from the refrigerator, Aimovig must be ...
Nature and contents of container
Pre-filled syringe: Aimovig is supplied in a pre-filled syringe (1 ml, Type 1 glass) with a stainless steel needle and a needle cover (rubber containing latex). Aimovig is available in packs containing ...
Special precautions for disposal and other handling
Before administration, the solution should be inspected visually. The solution should not be injected if it is cloudy, distinctly yellow or contains flakes or particles. Pre-filled syringe: To avoid discomfort ...
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
EU/1/18/1293/001-006
Date of first authorization / renewal of the authorization
26 July 2018
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