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

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Ontruzant 150 mg powder for concentrate for solution for infusion. Ontruzant 420 mg powder for concentrate for solution for infusion.

Qualitative and quantitative composition

Ontruzant 150 mg powder for concentrate for solution for infusion: One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension ...

Pharmaceutical form

Powder for concentrate for solution for infusion. White to pale yellow lyophilised powder.

Therapeutic indications

Breast cancer Metastatic breast cancer Ontruzant is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): as monotherapy for the treatment of those patients who ...

Posology and method of administration

HER2 testing is mandatory prior to initiation of therapy (see sections 4.4 and 5.1). Ontruzant treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy ...

Contraindications

Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients listed in section 6.1. Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen ...

Special warnings and precautions for use

Traceability In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded. HER2 testing must be performed ...

Interaction with other medicinal products and other forms of interaction

No formal drug interaction studies have been performed. Clinically significant interactions between trastuzumab and the concomitant medicinal products used in clinical trials have not been observed. Effect ...

Pregnancy and lactation

Women of childbearing potential Women of childbearing potential should be advised to use effective contraception during treatment with trastuzumab and for 7 months after treatment has concluded (see section ...

Effects on ability to drive and use machines

Ontruzant may have a minor influence on the ability to drive or use machines (see section 4.8). Patients experiencing infusion-related symptoms (see section 4.4) should be advised not to drive and use ...

Undesirable effects

Summary of the safety profile Amongst the most serious and/or common adverse reactions reported in Ontruzant usage to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular ...

Overdose

There is no experience with overdose in human clinical trials. Single doses of trastuzumab alone greater than 10 mg/kg have not been administered in the clinical trials; a maintenance dose of 10 mg/kg ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC03 Ontruzant is a biosimilar medicinal product. Detailed information is available on the website of the European Medicines ...

Pharmacokinetic properties

The pharmacokinetics of trastuzumab were evaluated in a population pharmacokinetic model analysis using pooled data from 1,582 subjects, including patients with HER2-positive MBC, EBC, AGC or other tumour ...

Preclinical safety data

There was no evidence of acute or multiple dose-related toxicity in studies of up to 6 months, or reproductive toxicity in teratology, female fertility or late gestational toxicity/placental transfer studies. ...

List of excipients

L-histidine hydrochloride monohydrate L-histidine α,α-trehalose dihydrate Polysorbate 20

Incompatibilities

This medicinal product must not be mixed or diluted with other medicinal products except those mentioned under section 6.6. Do not dilute with glucose solutions since these cause aggregation of the protein. ...

Shelf life

Shelf life Unopened vials: 4 years. After reconstitution with sterile water for injection the reconstituted solution is physically and chemically stable for 48 hours at 2°C-8°C. Any remaining reconstituted ...

Special precautions for storage

Store in a refrigerator (2°C-8°C). For storage conditions of the opened medicinal product, see section 6.3 and 6.6.

Nature and contents of container

Ontruzant 150 mg powder for concentrate for solution for infusion: One 15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab Each carton ...

Special precautions for disposal and other handling

Ontruzant should be carefully handled during reconstitution. Causing excessive foaming during reconstitution or shaking the reconstituted solution may result in problems with the amount of Ontruzant that ...

Marketing authorization holder

Samsung Bioepis NL B.V., Olof Palmestraat 10, 2616 LR Delft, The Netherlands

Marketing authorization number(s)

EU/1/17/1241/001 EU/1/17/1241/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 15 November 2017

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