ILUMETRI Solution for injection (2021)
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Περιεχόμενα
Name of the medicinal product
Ilumetri 100 mg solution for injection in pre-filled syringe.
Qualitative and quantitative composition
Each pre-filled syringe contains 100 mg of tildrakizumab in 1 mL. Tildrakizumab is a humanised IgG1/k monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For ...
Pharmaceutical form
Solution for injection (injection). The solution is clear to slightly opalescent and colourless to slightly yellow. The solution pH is in the range of 5.7-6.3 and the osmolality is between 258 and 311 ...
Therapeutic indications
Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Posology and method of administration
Ilumetri is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis. Posology The recommended dose of Ilumetri is 100 mg by subcutaneous ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Clinically important active infection, e.g. active tuberculosis (see section 4.4).
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. Infections Ilumetri has the potential ...
Interaction with other medicinal products and other forms of interaction
Vaccines No data are available on the response to live or inactivated vaccines. Live vaccines should not be given concurrently with Ilumetri (see section 4.4). Interactions with cytochrome p450 Concomitant ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should use an effective method of contraception during treatment and for at least 17 weeks after treatment. Pregnancy There are no or limited ...
Effects on ability to drive and use machines
Ilumetri has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most common adverse reactions are upper respiratory tract infections, headache, gastroenteritis, nausea, diarrhoea, injection site pain and back pain. Tabulated list of ...
Overdose
Doses up to 10 mg/kg intravenously have been safely administered in clinical trials. In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors ATC code: L04AC17 Mechanism of action Tildrakizumab is a humanized IgG1/k monoclonal antibody that specifically binds to the p19 protein ...
Pharmacokinetic properties
Absorption The subcutaneous formulation of tildrakizumab showed an absolute bioavailability ranging from 73% (90% CI: 46%-115%, 200 mg SC vs. 3 mg/kg IV) to 80% (90% CI: 62%-103%, 50 mg SC vs. 0.5 mg/kg ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, and repeated dose toxicity. Animal carcinogenicity studies have not been conducted with tildrakizumab. ...
List of excipients
L-Histidine L-Histidine hydrochloride monohydrate Polysorbate 80 Sucrose 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.
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Unopened pre-filled syringe of Ilumetri may be removed from the refrigeration and stored up to 25°C for a single period of up to 30 days. Once removed ...
Nature and contents of container
1 mL solution in a type I glass pre-filled syringe with stainless steel 29G x 1⁄2" needle, covered with a needle shield and rigid needle shield of polypropylene with a fluropolymer lamination, plunger ...
Special precautions for disposal and other handling
Ilumetri is a sterile solution for injection in pre-filled syringe. The pre-filled syringes are for single use only. Do not shake or freeze the pre-filled syringe. The pre-filled syringe should be taken ...
Marketing authorization holder
Almirall, S.A., Ronda General Mitre, 151, 08022, Barcelona, Spain
Marketing authorization number(s)
EU/1/18/1323/001 EU/1/18/1323/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 17 september 2018
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