RIBOMUSTIN 100 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BENDAMUSTINE HYDROCHLORIDE

Available from:

DOR PHARMACEUTICAL SERVICES LTD., ISRAEL

ATC code:

L01AA09

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

BENDAMUSTINE HYDROCHLORIDE 100 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

ZR PHARMA & GMBH

Therapeutic area:

BENDAMUSTINE

Therapeutic indications:

First-line of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotheraphy is not appropiate. Indolent non-Hodgkin’s lymphomas as monotheraphy 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:

2019-06-30

Patient Information leaflet

,ה/דבכנ ת/חקור ה/אפור
לש אפורל ןולעב ןוכדע לע ךעידוהל
וננוצרב
RIBOMUSTIN 25MG/100MG
:ליעפ רמוח
25mg /100mg Bendamustine hydrochloride אפורל ןולעב םינוכדע ןלהל
(
הרמחה ותועמשמ בוהצב ןמוסמ טסקט
,
ותומשמ קוריב ןמוסמ טסקט
ןוכדע
,
טסקט
הקיחמ ותועמשמ וק םע םודאב
)
:
[…]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of Ribomustin 25 mg contains 25 mg bendamustine
hydrochloride.
One vial of Ribomustin 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 a the full list of excipients, see section 6.1.
[…]
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Monotherapy for chronic lymphocytic leukaemia
100 mg/m² 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/m² body surface area bendamustine hydrochloride on days 1 and
2; every 3 weeks for
at least 6 times.
[…]
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
[…]
Infections
Serious and fatal infections have occurred with bendamustine
hydrochloride, including
bacterial (sepsis, pneumonia) and opportunistic infections such as
Pneumocystis jirovecii
pneumonia (PJP), varicella zoster virus (VZV) and cytomegalovirus
(CMV). Treatment with
bendamustine hydrochloride may cause prolonged lymphocytopenia (<
600/μl) and low CD4-
positive T-cell (T-helper cell) counts (< 200/μl) for at least 7–9
months after the completion
of treatment. Lymphocytopenia and CD4-positive T-cell depletion are
more pronounced
when bendamustine is combined with rituximab Patients with lymphopenia
and low CD4-
positive T-cell count following treatment with bendamustine
hydrochloride are more
susceptible to (opportunistic) infections.. In case of low
CD4-positive T-cell counts (<
200/μl) Pneumocystis jirov

Summary of Product characteristics

1 of 14
1.
NAME OF THE MEDICINAL PRODUCT
Ribomustin 25 mg
Ribomustin 100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of Ribomustin 25 mg contains 25 mg bendamustine
hydrochloride.
One vial of Ribomustin 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/m² 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
2 of 14
120 mg/m² 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 Ribomustin 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 1.2 - 3.0 mg/dl).
No data is available in patients with severe hepatic impairment (serum
bilirubin values of > 3.0 mg/dl)
(see section 4.3).
Renal impairment
On the basis of pharmacokinetic data,