AJOVY Solution for injection (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
AJOVY 225 mg solution for injection in pre-filled syringe. AJOVY 225 mg solution for injection in pre-filled pen.
Qualitative and quantitative composition
One pre-filled syringe contains 225 mg fremanezumab. One pre-filled pen contains 225 mg fremanezumab. Fremanezumab is a humanised monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant ...
Pharmaceutical form
Solution for injection (injection). Clear to opalescent, colourless to slightly yellow solution with a pH of 5.5 and an osmolality of 300-450 mOsm/kg.
Therapeutic indications
AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.
Posology and method of administration
The treatment should be initiated by a physician experienced in the diagnosis and treatment of migraine. Posology Treatment is intended for patients with at least 4 migraine days per month when initiating ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypersensitivity Hypersensitivity ...
Interaction with other medicinal products and other forms of interaction
No formal clinical drug interaction studies have been performed with AJOVY. No pharmacokinetic drug interactions are expected based on the characteristics of fremanezumab. Furthermore, concomitant use ...
Pregnancy and lactation
Pregnancy There is a limited amount of data from the use of AJOVY 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
AJOVY has 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 1,900 patient years) have been treated with AJOVY in registration studies. More than 1,400 patients were treated for at least 12 ...
Overdose
Doses up to 2,000 mg have been administered intravenously in clinical trials without dose-limiting toxicity. In case of overdose, it is recommended that the patient be monitored for any signs or symptoms ...
Pharmacodynamic properties
Pharmacotherapeutic group: Not yet assigned ATC code: Not yet assigned Mechanism of action Fremanezumab is a humanised IgG2Δa/kappa monoclonal antibody derived from a murine precursor. Fremanezumab selectively ...
Pharmacokinetic properties
Absorption After single subcutaneous administrations of 225 mg and 675 mg fremanezumab, median time to maximum concentrations (tmax) in healthy subjects was 5 to 7 days. The absolute bioavailability of ...
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. As fremanezumab is a monoclonal ...
List of excipients
L-histidine L-histidine hydrochloride monohydrate Sucrose Disodium ethylenediaminetetraacetic acid (EDTA) dihydrate Polysorbate 80 (E433) 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
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the pre-filled syringe(s) or pre-filled pen(s) in the outer carton in order to protect from light. AJOVY may be stored unrefrigerated for up to 24 ...
Nature and contents of container
Pre-filled syringe: 1.5 mL solution in a 2.25 mL Type I glass syringe with plunger stopper (bromobutyl rubber) and needle. Pack sizes of 1 or 3 pre-filled syringes. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
Instructions for use The detailed instructions for use provided at the end of the package leaflet must be followed step-bystep carefully. The pre-filled syringe and the pre-filled pen are for single use ...
Marketing authorization holder
TEVA GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany
Marketing authorization number(s)
Pre-filled syringe: EU/1/19/1358/001 1 pre-filled syringe EU/1/19/1358/002 3 pre-filled syringes Pre-filled pen: EU/1/19/1358/003 1 pre-filled pen EU/1/19/1358/004 3 pre-filled pens
Date of first authorization / renewal of the authorization
Date of first authorisation: 28 March 2019
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