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SPC, UK: Cimzia 200 mg solution for injection (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
UCB Pharma Limited
Διεύθυνση :
208 Bath Road, Slough, Berkshire, SL1 3WE
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Name of the medicinal product

Cimzia 200 mg solution for injection.

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 in pre-filled syringe. Clear to opalescent, colourless to yellow solution. The pH of the solution is approximately 4.7.

Therapeutic indications

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 antirheumatic ...

Posology and method of administration

Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis. Patients should be given the special alert card. Posology The recommended ...

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 Cimzia may take up to ...

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 Women of childbearing potential should use adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Cimzia administration. ...

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

Cimzia was studied in 2,367 patients with rheumatoid arthritis in controlled and open label trials for up to 57 months. The data in Table 1 are based primarily on the pivotal controlled Studies involving ...

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: 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 constant (KD) of ...

Pharmacokinetic properties

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

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

18 months.

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.

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. None of the components of the syringe contain latex. Pack size of 2 syringes ...

Special precautions for disposal and other handling

This medicinal product is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements. Comprehensive instructions for the preparation and administration ...

Marketing authorization holder

UCB Pharma SA Allée de la Recherche 60 B-1070 Bruxelles Belgium

Marketing authorization number(s)

EU/1/09/544/001-002

Date of first authorization / renewal of the authorization

Date of first authorisation: 01 October 2009

Date of revision of the text

06/2012