Carmustine 50 mg powder and solvent for concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Carmustine

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

L01AD01

INN (International Name):

Carmustine

Pharmaceutical form:

Powder and solvent for concentrate for solution for infusion

Therapeutic area:

carmustine

Authorization status:

Not marketed

Authorization date:

2023-03-31

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
CARMUSTINE 50 MG POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
CARMUSTINE 300 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 is and what it is used for
2.
What you need to know before Carmustine is given to you
3.
How to use Carmustine
4.
Possible side effects
5.
How to store Carmustine
6.
Contents of the pack and other information
1.
WHAT CARMUSTINE IS AND WHAT IT IS USED FOR
Carmustine 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 effective 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
DO NOT USE CARMUSTINE:
-
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 plate

Summary of Product characteristics

Health Products Regulatory Authority
22 May 2023
CRN00D3W5
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carmustine 50 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
50 mg carmustine.
After reconstitution and dilution (see section 6.6), one ml of
solution contains 3.3 mg carmustine.
Excipient with known effect
Each vial of solvent contains 3 ml ethanol anhydrous (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: Pale yellow dry flakes or dry powder.
Solvent: Clear, colourless solution.
The pH and osmolality of diluted ready-to-use solutions for infusion
are
pH: 3.2 to 7.0 diluted in sodium chloride 9 mg/ml (0.9%) or 5% glucose
solution for injection.
Osmolality: 340 to 400 mOsmol/l (diluted in glucose 50 mg/ml [5%]
solution for injection or sodium chloride 9 mg/ml [0.9%]
solution for injection).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Carmustine is effective 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) and 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 drugs

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 must be administered only by specialists experienced in the
field of chemotherapy and under appropriate medical
supervision.
Posology
_Initial doses_
The recommended dose of Carmustine