DEMUSTIN 25 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BENDAMUSTINE HYDROCHLORIDE

Available from:

RAFA LABORATORIES LTD

ATC code:

L01AA09

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

BENDAMUSTINE HYDROCHLORIDE 25 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

INTAS PHARMACEUTICALS LTD, INDIA

Therapeutic area:

BENDAMUSTINE

Therapeutic indications:

First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate.Indolent non-Hodgkin’s lymphomas as monotherapy in patients, who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen.Follicular non-Hodgkin’s lymphoma as first line treatment in combination with rituximab.

Authorization date:

2017-11-28

Patient Information leaflet

ינוי
2019
,ה/דבכנ ת/חקור ,ה/אפור
, DEMUSTIN 100 MG,
DEMUSTIN 25 MG
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
רישכתה לש אפורל ןולעה ןכדוע יכ
םכתעידיל איבהל תשקבמ אפר תודבעמ
.
ה ביכרמ
ה
ליעפ
Demustin 25 mg contains 25 mg bendamustine hydrochloride/vial.
Demustin 100 mg contains 100 mg bendamustine hydrochloride/vial.
יוותה
ה
:
First-line treatment of chronic lymphocytic leukaemia (Binet stage B
or C) in patients for whom
fludarabine combination chemotherapy is not appropriate.
Indolent non-Hodgkin's lymphomas as monotherapy in patients, who have
progressed during or within 6
months following treatment with rituximab or a rituximab containing
regimen.
Follicular non-Hodgkin’s lymphoma as first line treatment in
combination with rituximab.
:ןולעב םייתועמשמה םייונישה

ףיעסב
POSOLOGY
)ןותחת וק םע בוהצב ןמוסמ( לק יוניש השענ
_Monotherapy for chronic lymphocytic leukaemia_
_ _
100 mg/m
2
body surface area bendamustine hydrochloride on days 1 and 2; every 4
weeks
up to 6 times. _ _
_Monotherapy for indolent non-Hodgkin's lymphomas refractory to
rituximab_
_ _
120 mg/m
2
body surface area bendamustine hydrochloride on days 1 and 2; every 3
weeks for at least 6 times.
 :יכ ןייוצ םימוהיזל תועגונה תורהזאב
In case of low CD4-positive T-cell counts (< 200/μl) Pneumocystis
jirovecii pneumonia (PJP)
prophylaxis should be considered
.
 :תוירוע תובוגת יבגל תורהזאב
ףסוה
DRESS (Drug reaction with eosinophilia and systemic symptoms
:ןכו
Patients should be advised of the signs and symptoms of these
reactions by their prescribers and
should be told to seek medical attention immediately if they develop
these symptoms.

:יאוול תועפות
:ופסוה
Pneumonitis
,
Pulmonary alveolar haemorrhage
,
Urticaria
,
DRESS.
ולעל רושיק ב"צמ
ן
כדועמה
ן
ב
ו
.םייתועמשמה םייונישה םי�

Summary of Product characteristics

The content of this leaflet was approved by the Ministry of Health in
November 2017, and updated according to the guidelines of
the Ministry of Health in May 2019.
Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
DEMUSTIN 25 MG
DEMUSTIN 100 MG
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of Demustin 25 mg contains 25 mg bendamustine hydrochloride.
One vial of Demustin 100 mg contains 100 mg bendamustine
hydrochloride.
1 ml of the concentrate contains 2.5 mg bendamustine hydrochloride
when reconstituted according to section 6.6.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion
White, microcrystalline powder
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
First-line treatment of chronic lymphocytic leukaemia (Binet stage B
or C) in patients for whom fludarabine
combination chemotherapy is not appropriate.
Indolent non-Hodgkin's lymphomas as monotherapy in patients, who have
progressed during or within 6 months
following treatment with rituximab or a rituximab containing regimen.
Follicular non-Hodgkin’s lymphoma as first line treatment in
combination with rituximab.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Monotherapy for chronic lymphocytic leukaemia_
_ _
100 mg/m
2
body surface area bendamustine hydrochloride on days 1 and 2; every 4
weeks
up to 6 times. _ _
_Monotherapy for indolent non-Hodgkin's lymphomas refractory to
rituximab_
_ _
120 mg/m
2
body surface area bendamustine hydrochloride on days 1 and 2; every 3
weeks for at least 6 times.
_Follicular non-Hodgkin’s lymphoma: Combination with rituximab: _
The dose is 90 mg/m² body surface area Demustin I.V. on days 1 and 2
plus 375 mg/m² rituximab on day 1; repetition
every 4 weeks.
_Hepatic impairment_
_ _
On the basis of pharmacokinetic data, no dose adjustment is necessary
in patients with mild hepatic impairment
(serum bilirubin < 1.2mg/dl). A 30% dose reduction is recommended in
patients with moderate hepatic impairment
(serum bilirubin