EMGALITY Solution for injection (2020)
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Περιεχόμενα
Name of the medicinal product
Emgality 120 mg solution for injection in pre-filled pen.
Qualitative and quantitative composition
Each pre-filled pen contains 120 mg of galcanezumab in 1 mL. Galcanezumab is a recombinant humanised monoclonal antibody produced in Chinese Hamster Ovary cells. For the full list of excipients, see section ...
Pharmaceutical form
Solution for injection (injection). The solution is clear and colourless to slightly yellow.
Therapeutic indications
Emgality is indicated for the 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 The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 ...
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. Cardiovascular risk Patients with ...
Interaction with other medicinal products and other forms of interaction
No drug interaction studies were conducted. No pharmacokinetic drug interactions are expected based on the characteristics of galcanezumab.
Fertility, pregnancy and lactation
Pregnancy There are limited data from the use of galcanezumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). ...
Effects on ability to drive and use machines
Galcanezumab may have a minor influence on the ability to drive and use machines. Vertigo may occur following the administration of galcanezumab (see section 4.8).
Undesirable effects
Summary of the safety profile Over 2500 patients were exposed to galcanezumab in clinical studies in migraine prophylaxis. Over 1400 patients were exposed to galcanezumab during the double-blind treatment ...
Overdose
Doses up to 600 mg have been administered subcutaneously to humans without dose-limiting toxicity. In case of an overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse ...
Pharmacodynamic properties
Pharmacotherapeutic group: analgesics, calcitonin gene-related peptide (CGRP) antagonists ATC code: N02CD02 Mechanism of action Galcanezumab is a humanised IgG4 monoclonal antibody that binds calcitonin ...
Pharmacokinetic properties
Absorption Based on a population pharmacokinetic (PK) analysis, following a loading dose of 240 mg the maximum serum concentration (C<sub>max</sub>) of galcanezumab was approximately 30 μg/mL (27% coefficient ...
Preclinical safety data
Non-clinical data revealed no special hazards for humans based on repeat-dose toxicity studies conducted in rats and cynomolgus monkeys and safety pharmacology evaluations conducted in cynomolgus monkeys ...
List of excipients
L-histidine L-histidine hydrochloride monohydrate Polysorbate 80 Sodium chloride Water for injections
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Store in the original package in order to protect from light. Emgality may be stored unrefrigerated for up to 7 days when stored at temperatures up to ...
Nature and contents of container
1 mL of solution in a type I clear glass syringe. The syringe is encased in a disposable, single-dose pen. Packs of 1, 2 or 3 pre-filled pens. Not all pack sizes may be marketed. The needle included in ...
Special precautions for disposal and other handling
Instructions for use The instructions for using the pen included with the Package Leaflet, must be followed carefully. The pre-filled pen is for total use only. The pre-filled pen should be inspected visually ...
Marketing authorization holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, The Netherlands
Marketing authorization number(s)
EU/1/18/1330/001 EU/1/18/1330/002 EU/1/18/1330/005
Date of first authorization / renewal of the authorization
Date of first authorisation: 14 November 2018
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