Gazyva 1000mg/40ml concentrate for solution for infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

obinutuzumab

Available from:

F. Hoffmann-La Roche Ltd. 4303 Kaiseraugst- batch releaser

ATC code:

L01XC15

INN (International Name):

obinutuzumab

Dosage:

1000mg/40ml

Pharmaceutical form:

concentrate for solution for infusion

Units in package:

(1) glass vial 40ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-09-26

Patient Information leaflet

GAZYVA
®
Obinutuzumab
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Antineoplastic agent, monoclonal antibody.
ATC code: L01XC15 obinutuzumab.
1.2
TYPE OF DOSAGE FORM
Concentrate for solution for infusion.
1.3
ROUTE OF ADMINISTRATION
Intravenous infusion.
1.4
STERILE / RADIOACTIVE STATEMENT
Sterile product.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _
obinutuzumab.
Gazyva is a clear, colorless to slightly brownish liquid supplied as
a single 1000 mg dose in a sterile, preservative-free, non-
pyrogenic 50 ml glass vial containing 40 ml of liquid concentrate
(25 mg/ml).
_Excipients:_
L-histidine/L-histidine hydrochloride, trehalose,
poloxamer 188, and water for injection.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION
CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
Gazyva in combination with chlorambucil is indicated for the
treatment of patients with previously untreated chronic
lymphocytic leukemia.
2.2
DOSAGE AND ADMINISTRATION
GENERAL
Substitution of Gazyva with any other biological medicinal
product requires the consent of the prescribing physician.
Gazyva should be administered as an intravenous infusion
through a dedicated line in an environment where full
resuscitation facilities are immediately available and under the
close supervision of an experienced physician. Gazyva infusions
should not be administered as an intravenous push or bolus.
Isotonic 0.9% sodium chloride solution should be used as the
infusion vehicle (see
_ 4.2 Special Instructions for Use, Handling _
_and Disposal_
).
_PROPHYLAXIS AND PREMEDICATION FOR TUMOR LYSIS SYNDROME _
_(TLS)_
Patients with a high tumor burden and/or a high circulating
lymphocyte count (> 25 x 10
9
/l) and/or renal impairment
(CrCl <70 ml/min) are considered at risk of TLS and should
receive prophylaxis. Prophylaxis should consist of adequate
hydration and administration of uricostatics (e.g. allopurinol) or
suitable alternative such as a urate oxidase (e.g. rasburicase) prior
to start of Gazyva infusion as per standard practice
(see
_2.4

Summary of Product characteristics

August 2015
Summary of Product Characteristics
Ro 5072759
Gazyva
August 2015
Product Information FE/English
1
GAZYVA
®
Obinutuzumab
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Antineoplastic agent, monoclonal antibody.
ATC code: L01XC15 obinutuzumab.
1.2
TYPE OF DOSAGE FORM
Concentrate for solution for infusion.
1.3
ROUTE OF ADMINISTRATION
Intravenous infusion.
1.4
STERILE / RADIOACTIVE STATEMENT
Sterile product.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _obinutuzumab.
Gazyva is a clear, colorless to slightly brownish liquid supplied as a
single 1000 mg dose
in a sterile, preservative-free, non-pyrogenic 50 ml glass vial
containing 40 ml of liquid
concentrate (25 mg/ml).
_Excipients:_ L-histidine/L-histidine hydrochloride, trehalose,
poloxamer 188, and water
for injection.
2.
CLINICAL
PARTICULARS
2.1
THERAPEUTIC INDICATION
CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
Gazyva in combination with chlorambucil is indicated for the treatment
of patients with
previously untreated chronic lymphocytic leukemia.
2.2
DOSAGE AND ADMINISTRATION
GENERAL
Substitution of Gazyva with any other biological medicinal product
requires the consent
of the prescribing physician.
Gazyva should be administered as an intravenous infusion through a
dedicated line in an
environment where full resuscitation facilities are immediately
available and under the
close
supervision
of
an
experienced
physician.
Gazyva
infusions
should
not
be
administered as an intravenous push or bolus. Isotonic 0.9% sodium
chloride solution
should be used as the infusion vehicle (see_ 4.2 Special Instructions
for Use, Handling and _
_Disposal_).
August 2015
Summary of Product Characteristics
Ro 5072759
Gazyva
August 2015
Product Information FE/English
2
_PROPHYLAXIS AND PREMEDICATION FOR TUMOR LYSIS SYNDROME (TLS) _
Patients
with
a
high
tumor
burden
and/or
a
high
circulating
lymphocyte
count
(> 25 x 10
9
/l) and/or renal impairment (CrCl <70 ml/min) are considered at risk
of TLS
and should receive prophylaxis. Prophylaxis should consi