HUKYNDRA 80mg Solution for injection (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Hukyndra 80 mg solution for injection in pre-filled syringe
2. Qualitative and quantitative composition
One 0.8 ml single dose pre-filled syringe contains 80 mg adalimumab. Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells. For the full list of excipients, see ...
3. Pharmaceutical form
Solution for injection. Clear and colourless solution for injection.
4.1. Therapeutic indications
Rheumatoid arthritis Hukyndra in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying ...
4.2. Posology and method of administration
Hukyndra treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Hukyndra is indicated. Ophthalmologists are advised to ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section 4.4). ...
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 Patients taking TNF-antagonists ...
4.5. Interaction with other medicinal products and other forms of interaction
Adalimumab has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking adalimumab as monotherapy and those taking concomitant methotrexate. ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Hukyndra ...
4.7. Effects on ability to drive and use machines
Hukyndra may have a minor influence on the ability to drive and use machines. Vertigo and visual impairment may occur following administration of Hukyndra (see section 4.8).
4.8. Undesirable effects
Summary of the safety profile Adalimumab was studied in 9,506 patients in pivotal controlled and open-label trials for up to 60 months or more. These trials included rheumatoid arthritis patients with ...
4.9. Overdose
No dose-limiting toxicity was observed during clinical trials. The highest dose level evaluated has been multiple intravenous doses of 10 mg/kg, which is approximately 15 times the recommended dose.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Immunosuppressants, Tumour necrosis factor alpha (TNF-α) inhibitors <b>ATC code:</b> L04AB04 Mechanism of action Adalimumab binds specifically to TNF and neutralises the ...
5.2. Pharmacokinetic properties
Absorption and distribution After subcutaneous administration of a single 40 mg dose, absorption and distribution of adalimumab was slow, with peak serum concentrations being reached about 5 days after ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity. An embryo-foetal developmental toxicity/perinatal developmental ...
6.1. List of excipients
Sodium chloride Sucrose Polysorbate 80 Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
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. A single pre-filled syringe may be stored at temperatures up to a maximum ...
6.5. Nature and contents of container
0.8 ml preservative-free solution for injection in a pre-filled type I glass syringe with a fixed 29-gauge needle, extended finger flanges and needle guard, and a plunger stopper (bromobutyl rubber, latexfree). ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
STADA Arzneimittel AG, Stadastrasse 2–18, 61118 Bad Vilbel, Germany
8. Marketing authorization number(s)
EU/1/21/1589/007
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