Bicnu 100mg powder for injection vial with diluent vial

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

carmustine, Quantity: 100 mg

Saatavilla:

Emcure Pharmaceuticals Pty Ltd

Lääkemuoto:

Injection, powder for

Koostumus:

Excipient Ingredients:

Antoreitti:

Intravenous

Kpl paketissa:

1 vial of diluent - 3mL each, 10 vials of powders - 100mg each, 10 vials of diluent - 3mL each, 1 vial of powder - 100mg each

luokka:

Medicine Registered

Prescription tyyppi:

Not scheduled. Not considered by committee, (S4) Prescription Only Medicine

Käyttöaiheet:

INDICATIONS AS AT 16 DECEMBER 1985: Carmustine 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-Hodgkins 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.

Tuoteyhteenveto:

Visual Identification: Pale yellow powder; Container Type: Multiple containers; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

1991-09-30

Pakkausseloste

BICNU
®
1
BICNU
®
_Carmustine (kar-MUS-teen) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BiCNU
®
. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking BiCNU
against the benefits that are expected.
This leaflet does not contain
everything about BiCNU. Your
doctor has been provided with full
information and can answer any
questions you may have. Follow
your doctor's advice even if it differs
from what is in this leaflet.
Please read this leaflet carefully and
keep it in a safe place so you may
refer to it later.
WHAT BICNU IS USED
FOR
BiCNU 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.
BiCNU belongs to a group of
medicines called cytotoxic
medicines. You may also hear of
these being called chemotherapy
medicines. BiCNU may be used in
combination with other medicines to
treat your cancer.
Your doctor may have prescribed
BiCNU for another use. Ask your
doctor if you have any questions
about why BiCNU was prescribed
for you. This medicine is available
only with a doctor's prescription.
HOW BICNU WORKS
BiCNU works by killing cancer cells.
The use of BiCNU to treat your
condition can lead to side-effects,
which are discussed below.
BEFORE YOU ARE GIVEN
BICNU
_WHEN YOU MUST NOT BE GIVEN _
_IT _
You must not have BiCNU if you
have a history of severe allergic
reactions to BiCNU or to any of the
ingredients listed at the end of this
leaflet.
Do not have BiCNU if you have, or
have had, any of the following
medical conditions, unless you have
discussed it with your doctor:
•
liver problems
•
kidney problems
•
lung disease
•
blood disorder with a reduced
number of white blood cells
•
blood disorder with a low blood
platelet count
•
blood disorder with a decreased
number of red blood cells

Valmisteyhteenveto

fragments of the parent compound.
Common
≥
1/100 and <1/10
Uncommon
≥
1/1000 and <1/100
Because of the high lipid solubility and the relative
lack of ionization at a physiological pH, carmustine
Rare
≥
1/10000 and <1/1000
crosses
the
blood
brain
barrier
quite
effectively.
Very Rare <1/10000
Levels of radioactivity in the CSF are 50% or greater
HAEMATOLOGICAL
than those measured in plasma.
Very common: Myelosuppression (delayed; usually
EXCRETION
occurs 4 to 6 weeks after drug administration and is
Approximately 60 to 70% of a total dose is excreted in
dose related). Platelet nadirs occur at 4 to 5 weeks;
the urine in 96 hours and about 10% as respiratory
leucocyte nadirs occur at 5 to 6 weeks post therapy.
carbon
dioxide.
The
fate
of
the
remainder
is
Thrombocytopenia is generally more severe than
undetermined.
leucopenia (both may be dose limiting); anaemia.
Common:
Cumulative
myelosuppression
after
5.3 PRECLINICAL SAFETY DATA
repeated
doses
(manifested
by
more
depressed
GENOTOXICITY
indices or longer duration of suppression).
No data available.
Rare: Acute leukaemia and bone marrow dysplasias
CARCINOGENICITY
following long term therapy; thrombosis
Carmustine is carcinogenic in rats and mice,
producing a marked increase in tumour incidence in
GASTROINTESTINAL
doses approximately those employed clinically.
Very common: Nausea: vomiting (occurs within 2
hours,
usually
lasts
4-6
hours
and
is
dose
Nitrosourea therapy does have carcinogenic
dependant).
potential. The occurrence of acute leukaemia and
HEPATIC
bone marrow dysplasias have been reported in
Uncommon:
Elevated
transaminases,
alkaline
patients following nitosourea therapy.
phosphatase and bilirubin.
6 PHARMACEUTICAL PARTICULARS
Rare: Fatal hepatic toxicity (cumulative doses over
2
6.1 LIST OF EXCIPIENTS
1200-1500mg/m ) has occurred.
Carmustine, Dehydrated Alcohol
RENAL
6.2 INCOMPATIBILITIES
Uncommon: Decrease in kidney size; progressive
Incompatibilities were either not assessed or not
azotaemia; renal failure.
identified as part of the registration of