MITOMYCIN OMEGAPHARM mitomycin powder for injection 2mg vial

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

mitomycin, Quantity: 2 mg

Доступна с:

Omegapharm

ИНН (Международная Имя):

Mitomycin

Фармацевтическая форма:

Injection, powder for

состав:

Excipient Ingredients: mannitol

Администрация маршрут:

Intravenous, Intravesical

Штук в упаковке:

1 vial

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

Mitomycin is indicated in the palliative treatment of carcinoma of the stomach, pancreas, colon, lung (non-small cell), breast, cervix, head and neck, liver and bladder.

Обзор продуктов:

Visual Identification: blue violet cake or powder in amber glass vial; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Статус Авторизация:

Licence status A

Дата Авторизация:

2016-03-08

тонкая брошюра

Version 1.1
Page 1 of 3
MITOMYCIN OMEGAPHARM
Powder for injection, 2 mg/vial, 10 mg/vial and 20 mg/vial
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common
questions
about
Mitomycin
Omegapharm
but
it
does not contain all the available
information. 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
treating
you
with
Mitomycin
Omegapharm
against
the
benefits
they
expect
it
will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING
TREATED
WITH
MITOMYCIN
OMEGAPHARM
ASK
YOUR
DOCTOR
OR PHARMACIST.
KEEP
THIS
LEAFLET,
BECAUSE
YOU
MAY NEED TO READ IT AGAIN.
WHAT MITOMYCIN OMEGAPHARM
IS USED FOR
Mitomycin Omegapharm contains
mitomycin,
which
is
an
anti-
cancer agent. It is used to treat
cancer of the stomach, pancreas,
colon,
lung
(non-small
cell),
breast,
cervix,
head
and
neck,
liver and bladder.
Mitomycin
Omegapharm
works
by
stopping
cancer
cells
from
growing.
Ask your doctor if you have any
question
about
why
Mitomycin
Omegapharm was prescribed for
you.
BEFORE YOU ARE GIVEN
MITOMYCIN
OMEGAPHARM
_WHEN YOU MUST NOT BE GIVEN _
_MITOMYCIN OMEGAPHARM _
_ _

You must not take Mitomycin
Omegapharm
if
you
have
a
history
of
severe
allergic
reactions to mitomycin or to
any of the ingredients listed at
the end of this leaflet.
Symptoms
of
a
severe
allergic
reaction may include; chills, fever,
fast
heart
beat,
wheezing
or
coughing,
difficulty
breathing,
dizziness, flushing, sweating and
swelling
of
the
face,
tongue
or
other parts of the body. You must
not take Mitomycin Omegapharm
if you have any condition or any
blood disorder which causes you
to bleed very easily.
_ BEFORE YOU ARE GIVEN MITOMYCIN _
_OMEGAPHARM _
You must tell your doctor if;

you have ever had an allergic
reaction
to
any
medicine,
or
other substances such as food,
preservatives or dyes.

you have ever had a condition
which
caused
you
to
bleed
very easily.

you have an infection now or
had one recently.

you have ever

Характеристики продукта

MITOMYCIN OMEGAPHARM
Mitomycin powder for injection, 2 mg/vial, 10 mg/vial and 20 mg/vial
V2.0 Page 1 of 9
PRODUCT INFORMATION
MITOMYCIN OMEGAPHARM
NAME OF THE MEDICINE:
MITOMYCIN OMEGAPHARM (mitomycin C)
DESCRIPTION
MITOMYCIN OMEGAPHARM is an antibiotic isolated from the broth of
_Streptomyces caespitosus _
which has been shown to have anti-tumour activity. Mitomycin C is a
blue-violet crystalline
powder slightly soluble in water, freely soluble in dimethylacetamide,
sparingly soluble
in
methanol, slightly soluble in acetone. The CAS number for Mitomycin C
is 50-07-7. The structure
is:
[(1aS,8S,8aR,8bS)-6-Amino-8a-methoxy-5-methyl-4,7-dioxo-,1a,2,4,7,8,8a,8boctahydroazirino
[2’,3’:3,4] pyrrolo[1,2-a]-indol-8-yl]methyl carbamate
Molecular weight: 334.3
Molecular formula:
C
15
H
18
N
4
O
5
MITOMYCIN OMEGAPHARM injection is available in single use vials. Each
vial contains either
2 mg, 10 mg or 20 mg of mitomycin C. In addition each vial contains 4
mg, 20 mg or 40 mg
respectively of mannitol.
PHARMACOLOGY
Mitomycin inhibits the synthesis of deoxyribonucleic acid (DNA). The
guanine and cytosine
correlates with the degree of mitomycin induced cross-linking. At high
concentrations of the drug,
cellular RNA and protein synthesis are also suppressed. In humans,
mitomycin is rapidly cleared
from
the
serum
after
intravenous
administration.
Time
required
to
reduce
the
serum
concentration by 50 % after a 30 mg bolus injection is 17 minutes.
After injection of 30 mg, 20 mg
or 10 mg IV, the maximal serum concentrations were 2.4 microgram/mL,
1.7 microgram/mL and
MITOMYCIN OMEGAPHARM
Mitomycin powder for injection, 2 mg/vial, 10 mg/vial and 20 mg/vial
V2.0 Page 2 of 9
0.52 microgram/mL respectively. Clearance is effected primarily by
metabolism in the liver, but
metabolism occurs in other issues as well. The rate of clearance is
inversely proportional to the
maximal serum concentration because, it is thought of saturation of
the degradative pathways.
Approximately 10 % of a dose of mitomycin is excreted unchanged in the
ur