MITOCIN mitomycin 20 mg powder for injection vial

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

mitomycin, Quantity: 20 mg

Disponível em:

Echo Therapeutics Pty Ltd

Forma farmacêutica:

Injection, powder for

Composição:

Excipient Ingredients: nitrogen; mannitol; hydrochloric acid; sodium hydroxide

Via de administração:

Intravenous, Intravesical

Unidades em pacote:

20mg

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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.

Resumo do produto:

Visual Identification: Grey, lyophilised powder; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status de autorização:

Registered

Data de autorização:

2022-07-25

Folheto informativo - Bula

Mitocin 20mg powder for injection CMI 2.00
1
MITOCIN
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 HAVE I BEEN GIVEN MITOCIN?
Mitocin contains the active ingredient mitomycin. Mitocin is used to
treat advanced cancers. Mitocin is used to prevent
recurrent bladder cancer. For more information, see Section 1. Why
have I been given Mitocin? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN MITOCIN?
Do not receive Mitocin if you have ever had an allergic reaction to
mitomycin or any of the ingredients listed at the end of the
CMI. Do not receive Mitocin if you have an acute infection, low white
or red blood cell counts or platelet counts, any condition
or any blood disorder which causes you to bleed very easily, or you
are breastfeeding. Do not receive Mitocin in the bladder if
you have a perforated bladder.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, YOU ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING, YOU ARE A WOMAN OF CHILDBEARING
POTENTIAL OR A MAN CAPABLE OF FATHERING CHILDREN, OR YOU ARE
ELDERLY.
For more information, see Section 2. What should I know before I am
given Mitocin? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Mitocin and affect how it works. See
Section 3. What if I am taking other medicines? in
the full CMI.
4.
HOW MITOCIN IS GIVEN?
•
Mitocin is given to you in hospital.as an injection into your vein or
directly into the bladder. It will always be given by a
doctor or a nurse.
•
The amount (dose) you will be given depends on a variety of factors
including your size, the type of cancer and any other
chemotherapy you are receiving. Your doctor will work out the right
dose for you and how often you should be given
Mitocin.
More information can be found in Section 4. How Mitocin is given? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN MITOCIN?
TH

Características técnicas

1
AUSTRALIAN PRODUCT INFORMATION
MITOCIN
Ò (MITOMYCIN) POWDER FOR
INJECTION
1 .
NAME OF THE MEDICINE
Mitomycin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mitocin injection is available in single use vials. Each vial contains
20 mg of mitomycin.
One vial of Mitocin 20 mg powder for injection/infusion or
intravesical use contains 20 mg
of mitomycin. After reconstitution with 40 mL water for injections 1
mL of solution for
injection/infusion contains 0.5 mg mitomycin. After reconstitution
with 20 ml solvent 1 mL
of solution for intravesical use contains 1 mg mitomycin.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Powder for injection/infusion or intravesical use
Mitocin is an antibiotic isolated from the broth of _Streptomyces
caespitosus _which has been
shown to have anti-tumour activity. Mitomycin is a blue-violet
crystalline powder slightly
soluble in water, freely soluble in dimethylacetamide, sparingly
soluble in methanol, slightly
soluble in acetone.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
Mitocin 20mg powder for injection PI 2.00
2
4.2 DOSE AND METHOD OF ADMINISTRATION
Mitocin is administered by slow intravenous infusion. Mitocin should
not be given by rapid
intravenous injection.
Mitocin is for single use in one patient only. Discard any unused
portion.
Mitocin should be given intravenously only, using care to avoid
extravasation of the
compound. If extravasation occurs, cellulitis, ulceration and slough
may result.
Each vial contains mitomycin 20 mg. To administer add Sterile Water
for injection 20 mL to
20 mg vials. Shake to dissolve. The reconstituted solution is then
added immediately as a
single dose through a running intravenous infusion of 5 % Glucose,
0.9% Sodium Chloride
or Sodium Lactate Injection IV infusion, for the treatment of all
tumours other than bladder
tumours. I