INFLECTRA Powder for solution for infusion (2022)
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Περιεχόμενα
1. Name of the medicinal product
Inflectra 100 mg powder for concentrate for solution for infusion.
2. Qualitative and quantitative composition
One vial contains 100 mg of infliximab*. After reconstitution each mL contains 10 mg of infliximab. * Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by ...
3. Pharmaceutical form
Powder for concentrate for solution for infusion (powder for concentrate). The powder is white.
4.1. Therapeutic indications
Rheumatoid arthritis Inflectra, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease ...
4.2. Posology and method of administration
Inflectra treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic ...
4.3. Contraindications
Hypersensitivity to the active substance, to other murine proteins, or to any of the excipients listed in section 6.1. Patients with tuberculosis or other severe infections such as sepsis, abscesses, and ...
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. Infusion reactions and hypersensitivity ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. In rheumatoid arthritis, psoriatic arthritis and Crohns disease patients, there are indications that concomitant use of methotrexate and other immunomodulators ...
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 6 months after the last infliximab ...
4.7. Effects on ability to drive and use machines
Inflectra may have a minor influence on the ability to drive and use machines. Dizziness may occur following administration of infliximab (see section 4.8).
4.8. Undesirable effects
Summary of the safety profile Upper respiratory tract infection was the most common adverse drug reaction (ADR) reported in clinical trials, occurring in 25.3% of infliximab-treated patients compared with ...
4.9. Overdose
No case of overdose has been reported. Single doses up to 20 mg/kg have been administered without toxic effects.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> immunosuppressants, tumour necrosis factor alpha (TNF<sub>α</sub>) inhibitors <b>ATC code:</b> L04AB02 Mechanism of action Infliximab is a chimeric human-murine monoclonal ...
5.2. Pharmacokinetic properties
Single intravenous infusions of 1, 3, 5, 10 or 20 mg/kg of infliximab yielded dose proportional increases in the maximum serum concentration (C<sub>max</sub>) and area under the concentration-time curve ...
5.3. Preclinical safety data
Infliximab does not cross react with TNF<sub>α</sub> from species other than human and chimpanzees. Therefore, conventional preclinical safety data with infliximab are limited. In a developmental toxicity ...
6.1. List of excipients
Sucrose Polysorbate 80 Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
<u>Before reconstitution:</u> 5 years at 2°C–8°C. Inflectra may be stored at temperatures up to a maximum of 25°C for a single period of up to 6 months, but not exceeding the original expiry date. The ...
6.4. Special precautions for storage
Store in a refrigerator (2°C–8°C). For storage conditions up to 25°C before reconstitution of the medicinal product, see section 6.3. For storage conditions after reconstitution of the medicinal product, ...
6.5. Nature and contents of container
Type 1 glass vial with a (butyl) rubber stopper and an aluminium seal with a flip-off button. Pack sizes of 1, 2, 3, 4, 5 vials. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
1. The dose and the number of Inflectra vials have to be calculated. Each Inflectra vial contains 100 mg infliximab. The required total volume of reconstituted Inflectra solution has to be calculated. ...
7. Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
8. Marketing authorization number(s)
EU/1/13/854/001 EU/1/13/854/002 EU/1/13/854/003 EU/1/13/854/004 EU/1/13/854/005
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 10 September 2013 Date of latest renewal: 21 June 2018
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