Levact 100mg powder for concentrate for solution for infusion vials

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Bendamustine hydrochloride

Dostopno od:

Napp Pharmaceuticals Ltd

Koda artikla:

L01AA09

INN (mednarodno ime):

Bendamustine hydrochloride

Odmerek:

100mg

Farmacevtska oblika:

Powder for solution for infusion

Pot uporabe:

Intravenous

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 08010100; GTIN: 5012854080638

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
_LEVACT_
® 2.5 MG/ML POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Bendamustine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE, IT CONTAINS IMPORTANT INFORMATION
FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
WHAT IS IN THIS LEAFLET:
1. What _LEVACT_ is and what it is used for
2. What you need to know before you use _LEVACT_
3. How to use _LEVACT_
4. Possible side effects
5. How to store _LEVACT_
6. Contents of the pack and other information
1. WHAT _LEVACT_ IS AND WHAT IT IS USED FOR
_LEVACT_ is a medicine which is used for the treatment of certain
types of cancer (cytotoxic medicine).
_LEVACT_ is used alone (monotherapy) or in combination with other
medicines for the treatment of the
following forms of cancer:
- chronic lymphocytic leukaemia in cases where fludarabine combination
chemotherapy is not
appropriate for you,
- non-Hodgkin lymphomas, which had not, or only shortly, responded to
prior rituximab treatment,
- multiple myeloma in cases where thalidomide or bortezomib containing
therapy is not appropriate
for you.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE _LEVACT_
DO NOT USE _LEVACT_
- if you are allergic to bendamustine hydrochloride or any of the
other ingredients of_ _this medicine
(listed in section 6);
- while breast-feeding, if treatment with _LEVACT _is necessary during
lactation you must discontinue
breast-feeding (see section warnings and precautions on
breastfeeding);
- if you have severe liver dysfunction (damage to the functional cells
of the liver);
- if you have yellowing of the skin or whites of the eyes caused by
liver or blood problems
(jaund

Lastnosti izdelka

OBJECT 1
LEVACT 2.5 MG/ML POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 07-Mar-2018 | Napp
Pharmaceuticals Limited
1. Name of the medicinal product
Levact 2.5 mg/ml powder for concentrate for solution for infusion
2. Qualitative and quantitative composition
One vial contains 25 mg bendamustine hydrochloride.
One vial 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.
Front line treatment of multiple myeloma (Durie-Salmon stage II with
progress or stage III) in
combination with prednisone for patients older than 65 years who are
not eligible for autologous stem cell
transplantation and who have clinical neuropathy at time of diagnosis
precluding the use of thalidomide
or bortezomib containing treatment.
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.
Multiple myeloma
120 - 150 mg/m² body surface area bendamustine hydrochloride on days
1 and 2, 60 mg/m² body surface
area prednisone i.v. or per os on days 1 to 4; every 4 weeks for at
least 3 times.
Hepatic impairment
On the basis of pharmacokinetic data, no dose adj