SIMPONI 50mg Solution for injection in pre-filled syringe / pen (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Simponi 50 mg solution for injection in pre-filled pen. Simponi 50 mg solution for injection in pre-filled syringe.
Qualitative and quantitative composition
Simponi 50 mg solution for injection in pre-filled pen: One 0.5 mL pre-filled pen contains 50 mg of golimumab*. Simponi 50 mg solution for injection in pre-filled syringe: One 0.5 mL pre-filled syringe ...
Pharmaceutical form
Solution for injection in pre-filled pen (injection), SmartJect. Solution for injection in pre-filled syringe (injection). The solution is clear to slightly opalescent, colourless to light yellow.
Therapeutic indications
Rheumatoid arthritis (RA) Simponi, in combination with methotrexate (MTX), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying ...
Posology and method of administration
Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active tuberculosis (TB) or other severe infections such as sepsis, and opportunistic infections (see section ...
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 must be monitored ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Concurrent use with other biological therapeutics The combination of golimumab with other biological therapeutics used to treat the same conditions as golimumab, ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last golimumab treatment. Pregnancy ...
Effects on ability to drive and use machines
Simponi has minor influence on the ability to drive and use machines. Dizziness may however occur following administration of Simponi (see section 4.8).
Undesirable effects
Summary of the safety profile In the controlled period of the pivotal trials in RA, PsA, AS, nr-Axial SpA, and UC, upper respiratory tract infection was the most common adverse reaction (AR) reported in ...
Overdose
Single doses up to 10 mg/kg intravenously have been administered in a clinical study without dose-limiting toxicity. In case of an overdose, it is recommended that the patient be monitored for any signs ...
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNF-α) inhibitors ATC code: L04AB06 Mechanism of action Golimumab is a human monoclonal antibody that forms high affinity, stable ...
Pharmacokinetic properties
Absorption Following a single subcutaneous administration of golimumab to healthy subjects or patients with RA, the median time to reach maximum serum concentrations (T<sub>max</sub>) ranged from 2 to ...
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. No mutagenicity studies, animal ...
List of excipients
Sorbitol (E420) Histidine Histidine hydrochloride monohydrate Polysorbate 80 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: 24 months.
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Keep the pre-filled pen or pre-filled syringe in the outer carton in order to protect it from light. Simponi may be stored at temperatures up to a maximum ...
Nature and contents of container
Simponi 50 mg solution for injection in pre-filled pen: 0.5 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex) in a pre-filled ...
Special precautions for disposal and other handling
Simponi is supplied in a single use pre-filled pen called SmartJect or as a single use pre-filled syringe. Each pack is provided with instructions for use that fully describe the use of the pen or the ...
Marketing authorization holder
Janssen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands
Marketing authorization number(s)
1 pre-filled pen: EU/1/09/546/001 3 pre-filled pens: EU/1/09/546/002 1 pre-filled syringe: EU/1/09/546/003 3 pre-filled syringes: EU/1/09/546/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 1 October 2009 Date of latest renewal: 19 June 2014
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