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SPC: ZESSLY Powder for concentrate for solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Zessly 100 mg powder for concentrate for solution for infusion.

Qualitative and quantitative composition

Each vial contains 100 mg of infliximab. Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. After reconstitution ...

Pharmaceutical form

Powder for concentrate for solution for infusion (powder for concentrate). The powder is a freeze-dried white pellet.

Therapeutic indications

Rheumatoid arthritis Zessly, 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 ...

Posology and method of administration

Zessly 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 ...

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 ...

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. Infusion reactions and hypersensitivity ...

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 ...

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 Zessly treatment. ...

Effects on ability to drive and use machines

Zessly may have a minor influence on the ability to drive and use machines. Dizziness may occur following administration of infliximab (see section 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 ...

Overdose

No case of overdose has been reported. Single doses up to 20 mg/kg have been administered without toxic effects.

Pharmacodynamic properties

Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors ATC code: L04AB02 Zessly is a biosimilar medicinal product. Mechanism of action Infliximab is a chimeric human-murine ...

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 ...

Preclinical safety data

Infliximab does not cross react with TNFα from species other than human and chimpanzee. Therefore, conventional preclinical safety data with infliximab are limited. In a developmental toxicity study conducted ...

List of excipients

Disodium succinate hexahydrate Succinic acid Sucrose Polysorbate 80

Incompatibilities

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

Shelf life

Shelf life Before reconstitution: 4 years at 2°C–8°C. Zessly may be stored at temperatures up to a maximum of 30°C for a single period of up to 6 months, but not exceeding the original expiry date. The ...

Special precautions for storage

Store in a refrigerator (2°C–8°C). For storage conditions up to 30°C before reconstitution of the medicinal product, see section 6.3. For storage conditions after reconstitution of the medicinal product, ...

Nature and contents of container

Type 1 glass vial with rubber stopper and aluminium crimp protected by a plastic cap. Zessly is available in packs containing 1, 2, 3, 4 or 5 vials. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Calculate the dose and the number of Zessly vials needed. Each Zessly vial contains 100 mg infliximab. Calculate the total volume of reconstituted Zessly solution required. Under aseptic conditions, reconstitute ...

Marketing authorization holder

Sandoz GmbH, Biochemiestr. 10, 6250 Kundl, Austria

Marketing authorization number(s)

EU/1/18/1280/001 EU/1/18/1280/002 EU/1/18/1280/003 EU/1/18/1280/004 EU/1/18/1280/005

Date of first authorization / renewal of the authorization

Date of first authorisation: 18 May 2018

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