BENDAMUSTINE VIATRIS bendamustine hydrochloride 25 mg powder for injection vial

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

bendamustine hydrochloride, Quantity: 25 mg

제공처:

Alphapharm Pty Ltd

약제 형태:

Injection, powder for

구성:

Excipient Ingredients: mannitol

관리 경로:

Intravenous Infusion

패키지 단위:

1 vial

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

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.

제품 요약:

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

승인 상태:

Registered

승인 날짜:

2020-12-07

제품 특성 요약

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