Carmustine Accord carmustine 100 mg powder for injection vial with diluent

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

carmustine, Quantity: 100 mg

Fáanlegur frá:

Accord Healthcare Pty Ltd

Lyfjaform:

Diluent, not applicable

Samsetning:

Excipient Ingredients: ethanol absolute

Stjórnsýsluleið:

Intravenous

Einingar í pakka:

1 powder for injection vial and 1 diluent vial

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

CARMUSTINE ACCORD is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:,1. Malignant Glioma,2. Multiple Myeloma - in combination with prednisone.,3. Hodgkin?s Disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.,4. Non-Hodgkin?s lymphomas - as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy or who fail to respond to primary therapy.

Vörulýsing:

Visual Identification: clear, colourless liquid; Container Type: Vial; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Leyfisstaða:

Registered

Leyfisdagur:

2021-05-21

Upplýsingar fylgiseðill

Carmustine Accord - version 1
1
CARMUSTINE ACCORD
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CARMUSTINE ACCORD?
Carmustine Accord contains the active ingredient carmustine.
Carmustine Accord is used to treat malignant glioma (a type of
brain cancer) and multiple myeloma (a cancer of the blood). It may
also be used to treat other types of cancers called
Hodgkin's Disease and Non-Hodgkin's lymphomas.
For more information, see Section 1. Why am I using Carmustine Accord?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CARMUSTINE ACCORD?
Do not use if you have ever had an allergic reaction to carmustine or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Carmustine Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Carmustine Accord and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE CARMUSTINE ACCORD?
Carmustine Accord is an injection and will be given to you by your
doctor or nurse.
More instructions can be found in Section 4. How do I use Carmustine
Accord?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CARMUSTINE ACCORD?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Carmustine Accord.
•
Be sure to keep all your doctor's appointments so your progress can be
checked.
•
Keep follow up appointments with your doctor. It is important to have
your follow-up doses of
Carmustine Accord at the appropriate times to get the best effects
from your treatments.
DRIVING OR USING
MACHINES
•
Carmustine Accord may cause nausea, dizziness or tiredness in some
people. If y

Vara einkenni

Page 1 of 7
AUSTRALIAN PRODUCT INFORMATION
CARMUSTINE ACCORD (CARMUSTINE) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Carmustine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lyophilised powder vial contains 100 mg carmustine.
After reconstitution and dilution (see
SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION
), 1 mL of
solution contains 3.3 mg carmustine.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Carmustine Accord is presented in a composite pack that includes a
powder for injection amber glass
vial containing a pale yellow lyophilised powder and a clear
colourless liquid diluent of sterile absolute
ethanol.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Carmustine Accord is indicated as palliative therapy as a single agent
or in established combination
therapy with other approved chemotherapeutic agents in the following:
1. Malignant Glioma.
2. Multiple Myeloma - in combination with prednisone.
3. Hodgkin’s Disease - as secondary therapy in combination with
other approved drugs in patients who
relapse while being treated with primary therapy, or who fail to
respond to primary therapy.
4. Non-Hodgkin’s lymphomas - as secondary therapy in combination
with other approved drugs for
patients who relapse while being treated with primary therapy or who
fail to respond to primary therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Carmustine Accord is administered by slow intravenous infusion.
CARMUSTINE ACCORD SHOULD
NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION.
The recommended dose of Carmustine Accord as single agent in
previously untreated in patients is
200 mg/m
2
intravenously every 6 weeks. This may be given as a single dose or
divided into daily
injections such as 100 mg/m
2
on successive days. When Carmustine Accord is used in combination with
other myelosuppressive drugs or in patients in whom bone marrow
reserve is depleted, the doses should
be adjusted accordingly.
A repeat course of Carmustine Accord should not be given until
circulating blood elemen