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GAZYVARO Concentrate for solution for infusion (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Gazyvaro 1,000 mg concentrate for solution for infusion.

Qualitative and quantitative composition

One vial of 40 mL concentrate contains 1,000 mg obinutuzumab, corresponding to a concentration before dilution of 25 mg/mL. Obinutuzumab is a Type II humanised anti-CD20 monoclonal antibody of the IgG1 ...

Pharmaceutical form

Concentrate for solution for infusion. Clear, colourless to slightly brownish liquid.

Therapeutic indications

Chronic lymphocytic leukaemia (CLL) Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated CLL and with comorbidities making them unsuitable ...

Posology and method of administration

Gazyvaro should be administered under the close supervision of an experienced physician and in an environment where full resuscitation facilities are immediately available. Posology Prophylaxis and premedication ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered product should be clearly recorded (or stated) in the patient file. Based on a ...

Interaction with other medicinal products and other forms of interaction

No formal drug-drug interaction studies have been performed, although limited drug-drug interaction sub-studies have been undertaken for Gazyvaro with bendamustine, CHOP, fludarabine and cyclophosphamide ...

Fertility, pregnancy and lactation

Women of childbearing potential Women of childbearing potential must use effective contraception during and for 18 months after treatment with Gazyvaro. Pregnancy A reproduction study in cynomolgus monkeys ...

Effects on ability to drive and use machines

Gazyvaro has no or negligible influence on the ability to drive and use machines. IRRs are very common during the first infusion of Gazyvaro, and patients experiencing infusion related symptoms should ...

Undesirable effects

Summary of the safety profile The adverse drug reactions (ADRs) described in this section were identified during induction, maintenance and follow up for indolent Non-Hodgkin lymphoma (iNHL) including ...

Overdose

No experience with overdose is available from human clinical studies. In clinical studies with Gazyvaro, doses ranging from 50 mg up to and including 2,000 mg per infusion have been administered. The incidence ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC15 Mechanism of action Obinutuzumab is a recombinant monoclonal humanised and glycoengineered Type II anti-CD20 antibody ...

Pharmacokinetic properties

A population pharmacokinetic (PK) model was developed to analyse the PK data in 469 iNHL, 342 CLL and 130 diffuse large B-cell lymphoma (DLBCL) patients from Phase I, Phase II and Phase III studies who ...

Preclinical safety data

No studies have been performed to establish the carcinogenic potential of obinutuzumab. No specific studies in animals have been performed to evaluate the effect of obinutuzumab on fertility. In repeat-dose ...

List of excipients

Histidine Histidine hydrochloride monohydrate Trehalose dihydrate Poloxamer 188 Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Shelf life

<u>Unopened vial:</u> 3 years. <u>After dilution:</u> After dilution, chemical and physical stability have been demonstrated in sodium chloride 9 mg/mL (0.9%) solution for injection at concentrations of ...

Special precautions for storage

Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3.

Nature and contents of container

40 mL concentrate in a 50 mL vial (clear Type I glass) with stopper (butyl rubber). Pack size of 1 vial.

Special precautions for disposal and other handling

Instructions for dilution Gazyvaro should be prepared by a healthcare professional using aseptic technique. Do not shake the vial. For CLL cycles 2–6 and all FL cycles Withdraw 40 mL of concentrate from ...

Marketing authorization holder

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

Marketing authorization number(s)

EU/1/14/937/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 23 July 2014 Date of latest renewal: 02 April 2019

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