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CIMZIA Solution for injection (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Cimzia 200 mg solution for injection in pre-filled syringe.

Qualitative and quantitative composition

Each pre-filled syringe contains 200 mg certolizumab pegol in one ml. Certolizumab pegol is a recombinant, humanised antibody Fab' fragment against tumour necrosis factor alpha (TNFα) expressed in Escherichia ...

Pharmaceutical form

Solution for injection (injection). Clear to opalescent, colourless to yellow solution. The pH of the solution is approximately 4.7.

Therapeutic indications

Rheumatoid arthritis Cimzia, in combination with methotrexate (MTX), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying ...

Posology and method of administration

Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Cimzia is indicated. Patients should be given the special reminder ...

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 or opportunistic infections (see section 4.4). ...

Special warnings and precautions for use

Infections Patients must be monitored closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia. Because the elimination of certolizumab pegol may ...

Interaction with other medicinal products and other forms of interaction

Concomitant treatment with methotrexate, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics showed no effect on the pharmacokinetics of certolizumab pegol based on a population ...

Fertility, pregnancy and lactation

Women of childbearing potential The use of adequate contraception should be considered for women of childbearing potential. For women planning pregnancy, continued contraception may be considered for 5 ...

Effects on ability to drive and use machines

Cimzia may have a minor influence on the ability to drive and use machines. Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of Cimzia (see section 4.8).

Undesirable effects

Summary of the safety profile Rheumatoid arthritis Cimzia was studied in 4,049 patients with rheumatoid arthritis in controlled and open label trials for up to 92 months. In the placebo-controlled studies, ...

Overdose

No dose-limiting toxicity was observed during clinical trials. Multiple doses of up to 800 mg subcutaneously and 20 mg/kg intravenously have been administered. In cases of overdose, it is recommended that ...

Pharmacodynamic properties

Pharmacotherapeutic group: immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors ATC code: L04AB05 Mechanism of action Cimzia has a high affinity for human TNFα and binds with a dissociation ...

Pharmacokinetic properties

Certolizumab pegol plasma concentrations were broadly dose-proportional. Pharmacokinetics observed in patients with rheumatoid arthritis and psoriasis were consistent with those seen in healthy subjects. ...

Preclinical safety data

The pivotal non-clinical safety studies were conducted in the cynomolgus monkey. In rats and monkeys, at doses higher than those given to humans, histopathology revealed cellular vacuolation, present mainly ...

List of excipients

Sodium acetate Sodium chloride 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: 2 years. See also section 6.4 for shelf-life related to storage at room temperature up to a maximum of 25°C.

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. The pre-filled syringes may be stored at room temperature (up to 25°C) ...

Nature and contents of container

One ml pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), containing 200 mg of certolizumab pegol. The needle shield is styrene butadiene rubber which contains a derivative of ...

Special precautions for disposal and other handling

Comprehensive instructions for the preparation and administration of Cimzia in a pre-filled syringe are given in the package leaflet. This medicinal product is for single use only. Any unused product or ...

Marketing authorization holder

UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium

Marketing authorization number(s)

EU/1/09/544/001 EU/1/09/544/002 EU/1/09/544/003 EU/1/09/544/004

Date of first authorization / renewal of the authorization

Date of first authorisation: 01 October 2009 Date of latest renewal: 16 May 2014

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