Bortezomib MSN

A medicinal product for the treatment of adult patients with multiple myeloma and previously untreated mantle cell lymphoma in the form of powder for solution for injection.

Bortezomib MSN

Medication details

In adult patients, Bortezomib MSN is indicated

in monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone for the treatment of adult patients with progressive multiple myeloma who have had at least one prior treatment and who have already undergone or are unsuitable for hematopoietic stem cell transplantation.
in combination with melphalan and prednisone for the treatment of adult patients with previously untreated multiple myeloma for whom high-dose chemotherapy with haematopoietic stem cell transplantation is not appropriate.
in combination with dexamethasone or dexamethasone and thalidomide for the induction treatment of adult patients with previously untreated multiple myeloma in whom high-dose chemotherapy with haematopoietic stem cell transplantation is appropriate.
in combination with rituximab, cyclophosphamide, doxorubicin and prednisone indicated for the treatment of adult patients with previously untreated mantle cell lymphoma for whom haematopoietic stem cell transplantation is not appropriate.

Medication strengths and packagings

Bortezomib 3.5 mg powder for solution for injection

Strength: 3,5mg
Packaging: 1x 3.5 mg powder for solution for injection

PDF with SmPC – see attachment

Reporting side effects

Any suspicion of a serious or unexpected effect and other actualities serious for the treated person's health must be reported to the State Institute for Drug Control (SÚKL).

Details on the report can be found at: www.sukl.cz/nahlasit-nezadouci-ucinek

Address for shipment is: Státní ústav pro kontrolu léčiv, oddělení farmakovigilance, Šrobárova 48, Praha 10, 100 41, e-mail: farmakovigilance@sukl.cz.

This information for Bortezomib MSN medicament may also be reported to the company Pharma-Service International s.r.o., contact:

Publicly accessible information line (PAPIS)

The obligation to establish a Publicly Accessible Professional Information Service (PAPIS) result from Act No. 378/2007 Sb., O léčivech. Information on our products can be found on the website of the State Institute for Drug Control (SÚKL) in the drug database. Summaries of Product Characteristics can be found in the pdf. file by clicking on the Product name.

The Publicly Accessible Professional Information Service (PAPIS) for Bortezomib MSN is operated by the marketing authorization holder - Pharma-Service International s.r.o., contact:

Bortezomib MSN

Medication details

Tags

Medication strengths and packagings

Bortezomib 3.5 mg powder for solution for injection

Reporting side effects

Publicly accessible information line (PAPIS)