STELARA Solution for injection (2023)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

STELARA 45 mg solution for injection. STELARA 45 mg solution for injection in pre-filled syringe. STELARA 90 mg solution for injection in pre-filled syringe.

Qualitative and quantitative composition

STELARA 45 mg solution for injection: Each vial contains 45 mg ustekinumab in 0.5 mL. STELARA 45 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 45 mg ustekinumab ...

Pharmaceutical form

STELARA 45 mg solution for injection: Solution for injection. STELARA 45 mg solution for injection in pre-filled syringe: Solution for injection. STELARA 90 mg solution for injection in ...

Therapeutic indications

Plaque psoriasis STELARA is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic ...

Posology and method of administration

STELARA is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of conditions for which STELARA is indicated. Posology Plaque psoriasis The recommended ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Clinically important, active infection (e.g. active tuberculosis; see section 4.4).

Special warnings and precautions for use

Traceability In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded. Infections Ustekinumab may ...

Interaction with other medicinal products and other forms of interaction

Live vaccines should not be given concurrently with STELARA. Administration of live vaccines (such as the BCG vaccine) to infants exposed in utero to ustekinumab is not recommended for six months ...

Fertility, pregnancy and lactation

Women of childbearing potential Women of childbearing potential should use effective methods of contraception during treatment and for at least 15 weeks after treatment. Pregnancy There are no adequate ...

Effects on ability to drive and use machines

STELARA has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile The most common adverse reactions (>5%) in controlled periods of the adult psoriasis, psoriatic arthritis, Crohns disease and ulcerative colitis clinical studies with ustekinumab ...

Overdose

Single doses up to 6 mg/kg have been administered intravenously in clinical studies without dose-limiting toxicity. In case of overdose, it is recommended that the patient be monitored for any signs or ...

Pharmacodynamic properties

Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors ATC code: L04AC05 Mechanism of action Ustekinumab is a fully human IgG1κ monoclonal antibody that binds with specificity ...

Pharmacokinetic properties

Absorption The median time to reach the maximum serum concentration (tmax) was 8.5 days after a single 90 mg subcutaneous administration in healthy subjects. The median tmax values ...

Preclinical safety data

Non-clinical data reveal no special hazard (e.g. organ toxicity) for humans based on studies of repeated-dose toxicity and developmental and reproductive toxicity, including safety pharmacology evaluations. ...

List of excipients

L-histidine L-histidine monohydrochloride monohydrate Polysorbate 80 Sucrose Water for injections

Incompatibilities

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

Shelf life

STELARA 45 mg solution for injection: 2 years. STELARA 45 mg solution for injection in pre-filled syringe: 3 years. STELARA 90 mg solution for injection in pre-filled syringe: 3 years. ...

Special precautions for storage

Store in a refrigerator (2°C–8°C). Do not freeze. Keep the vial or pre-filled syringe in the outer carton in order to protect from light. If needed, individual pre-filled syringes may be stored at room ...

Nature and contents of container

STELARA 45 mg solution for injection: 0.5 mL solution in a type I glass 2 mL vial closed with a coated butyl rubber stopper. STELARA 45 mg solution for injection in pre-filled syringe: 0.5 ...

Special precautions for disposal and other handling

The solution in the STELARA vial or pre-filled syringe should not be shaken. The solution should be visually inspected for particulate matter or discolouration prior to subcutaneous administration. The ...

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium

Marketing authorization number(s)

STELARA 45 mg solution for injection: EU/1/08/494/001 STELARA 45 mg solution for injection in pre-filled syringe: EU/1/08/494/003 STELARA 90 mg solution for injection in pre-filled syringe: EU/1/08/494/004 ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 16 January 2009 Date of latest renewal: 19 September 2013

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