Carmustine medac (previously Carmustine Obvius)

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

carmustine

Διαθέσιμο από:

medac Gesellschaft für klinische Spezialpräparate mbH

Φαρμακολογική κατηγορία (ATC):

L01AD01

INN (Διεθνής Όνομα):

carmustine

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Hodgkin Disease; Lymphoma, Non-Hodgkin

Θεραπευτικές ενδείξεις:

Carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): , Brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases, Secondary therapy in non-Hodgkin’s lymphoma and Hodgkin’s disease, as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (HPCT) in malignant haematological diseases (Hodgkin’s disease / Non-hodgkin’s lymphoma).

Περίληψη προϊόντος:

Revision: 9

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2018-07-18

Φύλλο οδηγιών χρήσης

23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
CARMUSTINE MEDAC
100 MG POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION
carmustine
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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Carmustine medac is and what it is used for
2.
What you need to know before Carmustine medac is given to you
3.
How to use Carmustine medac
4.
Possible side effects
5.
How to store Carmustine medac
6.
Contents of the pack and other information
1.
WHAT CARMUSTINE MEDAC IS AND WHAT IT IS USED FOR
Carmustine medac is a medicine which contains carmustine. Carmustine
belongs to a group of
anticancer medicines known as nitrosourea that act by slowing the
growth of cancer cells.
Carmustine is indicated in adults in the following malignant neoplasms
as a single agent or in
combination with other antineoplastic agents and/or other therapeutic
measures (radiotherapy,
surgery):
-
Brain tumours (glioblastoma, Brain-stem gliomas, medulloblastoma,
astrocytoma and
ependymoma), brain metastases
-
Secondary therapy in non-Hodgkin’s lymphoma and Hodgkin’s disease
-
Tumours of gastrointestinal tract or digestive system tract
-
Malignant melanoma (skin cancer)
-
as conditioning treatment prior to autologous haematopoietic
progenitor cell transplantation
(HPCT) in malignant haematological diseases (Hodgkin’s disease /
Non-hodgkin’s lymphoma).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CARMUSTINE MEDAC
_ _
DO NOT USE CARMUSTINE MEDAC:
-
if you are allergic to carmustine or any of the other ingredients of
this medicine (listed in section
6).
-
if you suffer from suppression of blood cell formation in the bone
marrow and the number of
your platelets, whi

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Carmustine medac 100 mg powder and solvent for concentrate for
solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder for concentrate for solution for infusion contains
100 mg carmustine.
After reconstitution and dilution (se section 6.6), one ml of solution
contains 3.3 mg carmustine.
Excipient with known effect
Each ampoule of solvent contains 3 ml ethanol anhydrous (that is
equivalent to 2.37 g).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for concentrate for solution for infusion.
Powder: white to almost white powder or lyophilisate.
Solvent: colourless clear liquid.
The pH and osmolarity of ready-to-use solutions for infusion are:
pH 4.0 to 5.0 and 385-397mOsm/l (if diluted in glucose 50 mg/ml [5%]
solution for injection), and
pH 4.0 to 6.8 and 370-378mOsm/l (if diluted in sodium chloride 9 mg/ml
[0.9%] solution for
injection).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Carmustine is indicated in adults in the following malignant neoplasms
as a single agent or in
combination with other antineoplastic agents and/or other therapeutic
measures (radiotherapy,
surgery):
-
Brain tumours (glioblastoma, Brain-stem gliomas, medulloblastoma,
astrocytoma and
ependymoma), brain metastases
_ _
_ _
-
Secondary therapy in non-Hodgkin’s lymphoma and Hodgkin’s disease
_ _
_ _
-
Tumours of the gastrointestinal tract,
_ _
_ _
-
Malignant melanoma in combination with other antineoplastic medicinal
products.
_ _
_ _
-
as conditioning treatment prior to autologous haematopoietic
progenitor cell transplantation
(HPCT) in malignant haematological diseases (Hodgkin’s disease /
Non-hodgkin’s
lymphoma).
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Carmustine medac must be administered only by specialists experienced
in the field of chemotherapy
and under appropriate medical supervision
3
Posology
_Initial doses _
The recommended dose of Carmustine medac as a si