BENDAMUSTINE VIATRIS bendamustine hydrochloride 100 mg powder for injection vial

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

bendamustine hydrochloride, Quantity: 100 mg

Saadav alates:

Alphapharm Pty Ltd

Ravimvorm:

Injection, powder for

Koostis:

Excipient Ingredients: mannitol

Manustamisviis:

Intravenous Infusion

Ühikuid pakis:

1 vial

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C). Efficacy relative to first-line therapies other than chlorambucil has not been established.,Previously untreated indolent CD20-positive, stage III-IV Non-Hodgkin?s lymphoma, in combination with rituximab.,Previously untreated CD20-positive, stage III-IV Mantle Cell Lymphoma in combination with rituximab, in patients ineligible for autologous stem cell transplantation.,Relapsed/Refractory indolent Non-Hodgkin?s lymphoma.

Toote kokkuvõte:

Visual Identification: White to off-white lyophilised powder; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Volitamisolek:

Registered

Loa andmise kuupäev:

2020-12-07

Toote omadused

AUSTRALIAN PRODUCT INFORMATION
BENDAMUSTINE VIATRIS
_Bendamustine hydrochloride powder for injection _
1
NAME OF THE MEDICINE
Bendamustine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 25 mg vial contains 25 mg of bendamustine hydrochloride (as the
monohydrate).
Each 100 mg vial contains 100 mg of bendamustine hydrochloride (as the
monohydrate).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Injection, powder for intravenous infusion.
BENDAMUSTINE VIATRIS is a white to off-white lyophilised powder .
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
First-line treatment of chronic lymphocytic leukaemia (Binet stage B
or C). Efficacy relative to first-line
therapies other than chlorambucil has not been established.
Previously untreated indolent CD20-positive, stage III-IV
Non-Hodgkin’s lymphoma, in combination with
rituximab.
Previously untreated CD20-positive, stage III-IV Mantle Cell Lymphoma
in combination with rituximab, in
patients ineligible for autologous stem cell transplantation.
Relapsed/Refractory indolent Non-Hodgkin’s lymphoma.
4.2
DOSE AND METHOD OF ADMINISTRATION
For
intravenous
infusion
over
30-60
minutes
(see
section
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION - Special Precautions for Disposal and Handling).
Infusion must be administered under the supervision of a physician
qualified and experienced in the use of
chemotherapeutic agents.
Poor bone marrow function is related to increased chemotherapy-induced
haematological toxicity. Treatment
should not be started if leukocyte and/or platelet values drop to
<3x10
9
/L or <75x10
9
/L, respectively (see
section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE –
Myelosuppression).
_MONOTHERAPY FOR CHRONIC LYMPHOCYTIC LEUKAEMIA _
100 mg/m² body surface area bendamustine hydrochloride on days 1 and
2; every 4 weeks, for up to 6 cycles.
_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 week