BORTEZOMIB MYLAN 3.5 Milligram Pdr for Soln for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Available from:

Generics (UK) Limited

ATC code:

L01XX32

Dosage:

3.5 Milligram

Pharmaceutical form:

Pdr for Soln for Injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other antineoplastic agents

Authorization status:

Authorised

Authorization date:

2015-11-27

Patient Information leaflet

Bortezomib Mylan 3.5 mg, powder for solution for injection 
DK/H/2426/001/DC 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

BORTEZOMIB MYLAN 3.5 MG, POWDER FOR SOLUTION FOR INJECTION 
Bortezomib 

READ  ALL  OF  THIS  LEAFLET  CAREFULLY  BEFORE  YOU  START  USING  THIS  MEDICINE  BECAUSE  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, hospital pharmacist or nurse. 
-  If  you  get  any  side  effects,  talk  to  your  doctor,  hospital  pharmacist  or  nurse.  This  includes  any 
possible side effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET 
1.  What Bortezomib Mylan is and what it is used for 
2.  What you need to know before you use Bortezomib Mylan 
3.  How to use Bortezomib Mylan 
4.  Possible side effects 
5.  How to store Bortezomib Mylan 
6.  Contents of the pack and other information 

1. WHAT BORTEZOMIB MYLAN IS AND WHAT IT IS USED FOR 

Bortezomib  Mylan  contains  the  active  substance  bortezomib,  a  so-called  ‘proteasome  inhibitor’. 
Proteasomes play an important role in controlling cell function and growth. By interfering with their 
function, bortezomib can kill cancer cells. 

Bortezomib  Mylan  is  used  for  the  treatment  of  multiple  myeloma  (a  cancer  of  the  bone  marrow)  in 
patients older than 18 years: 
-  alone  or  together  with  the  medicines  pegylated  liposomal  doxorubicin  or  dexamethasone,  for 
patients  whose  disease is worsening  (progressive)  after receiving  at  least  one  prior  treatment  and 
for whom blood stem cell transplantation was
not successful or is unsuitable. 
-  in  combination  with the 

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bortezomib Mylan 3.5mg, powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 3.5 mg bortezomib (as mannitol boronic ester).
After reconstitution with 1.4 ml of solvent, 1 ml of solution for
subcutaneous injection contains 2.5 mg bortezomib.
After reconstitution with 3.5 ml of solvent, 1 ml of solution for
intravenous injection contains 1 mg bortezomib.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection.
White to off-white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bortezomib Mylan as monotherapy or in combination with pegylated
liposomal doxorubicin or dexamethasone is
indicated for the treatment of adult patients with progressive
multiple myeloma who have received at least 1 prior
therapy and who have already undergone or are unsuitable for
haematopoietic stem cell transplantation.
Bortezomib Mylan in combination with melphalan and prednisone is
indicated for the treatment of adult patients with
previously untreated multiple myeloma who are not eligible for
high-dose chemotherapy with haematopoietic stem cell
transplantation.
Bortezomib Mylan in combination with dexamethasone, or with
dexamethasone and thalidomide, is indicated for the
induction treatment of adult patients with previously untreated
multiple myeloma who are eligible for high-dose
chemotherapy with haematopoietic stem cell transplantation.
Bortezomib Mylan in combination with rituximab, cyclophosphamide,
doxorubicin and prednisone is indicated for the
treatment of adult patients with previously untreated mantle cell
lymphoma who are unsuitable for haematopoietic stem
cell transplantation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated and administered under the supervision of
a physician qualified and experienced in the use
of chemotherapeutic agents. Bortezomib Mylan must be reconstituted by
a healthcare professional.
Posology for
treatment
of pr