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SPC: RoACTEMRA Solution for injection in pre-filled syringe (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

RoActemra 162 mg solution for injection in pre-filled syringe.

Qualitative and quantitative composition

Each pre-filled syringe contains 162 mg of tocilizumab in 0.9 mL. Tocilizumab is a recombinant humanized, anti-human monoclonal antibody of the immunoglobulin G1 (IgG1) sub-class directed against soluble ...

Pharmaceutical form

Solution for injection (injection). A colourless to slightly yellowish solution.

Therapeutic indications

RoActemra, in combination with methotrexate (MTX), is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of ...

Posology and method of administration

Tocilizumab SC formulation is administered with a single-use PFS+NSD. Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA and /or GCA. ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active, severe infections (see section 4.4).

Special warnings and precautions for use

RoActemra subcutaneous formulation is not intended for intravenous administration. RoActemra subcutaneous formulation is not intended to be given to children with sJIA weighing less than 10 kg. Traceability ...

Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults. Concomitant administration of a single dose of 10 mg/kg RoActemra with 10-25 mg MTX once weekly had no clinically significant effect on MTX exposure. ...

Fertility, pregnancy and lactation

Women of childbearing potential Women of childbearing potential must use effective contraception during and up to 3 months after treatment. Pregnancy There are no adequate data from the use of RoActemra ...

Effects on ability to drive and use machines

RoActemra has a minor influence on the ability to drive and use machines (see section 4.8, dizziness).

Undesirable effects

Summary of the safety profile The safety profile comes from 4510 patients exposed to RoActemra in clinical trials; the majority of these patients were participating in adult RA studies (n=4009), while ...

Overdose

There are limited data available on overdose with RoActemra. One case of accidental overdose was reported in which a patient with multiple myeloma received a single dose of 40 mg/kg administered intravenously. ...

Pharmacodynamic properties

Pharmacotherapeutic group: Immunosuppressants, Interleukin inhibitors ATC code: L04AC07 Mechanism of action Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and ...

Pharmacokinetic properties

The pharmacokinetics of RoActemra is characterized by nonlinear elimination which is a combination of linear clearance and Michaelis-Menten elimination. The nonlinear part of RoActemra elimination leads ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development. Carcinogenicity ...

List of excipients

L-Histidine L-Histidine monohydrochloride monohydrate L-Arginine L-Arginine hydrochloride L-Methionine Polysorbate 80 Water for injections

Incompatibilities

In the absence of compatability studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 24 months. Once removed from the refrigerator, RoActemra must be administered within 8 hours and should not be kept above 30°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 and moisture.

Nature and contents of container

0.9 mL solution in a pre-filled syringe (type I glass) with a staked-in needle. The syringe is closed by a rigid needle shield (elastomer seal with a polypropylene shell) and a plunger stopper (butyl rubber ...

Special precautions for disposal and other handling

RoActemra is supplied in a single use pre-filled syringe fitted into a needle safety device. After removing the pre-filled syringe from the refrigerator the pre-filled syringe should be allowed to reach ...

Marketing authorization holder

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany

Marketing authorization number(s)

EU/1/08/492/007 EU/1/08/492/008

Date of first authorization / renewal of the authorization

Date of first authorisation: 16 January 2009 Date of last renewal: 25 September 2013

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