Hospira Vincristine Sulfate 1 mg/1mL injection USP

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

vincristine sulfate, Quantity: 1 mg/mL

Disponible des:

Hospira Australia Pty Ltd

Designació comuna internacional (DCI):

Vincristine sulfate

formulario farmacéutico:

Injection

Composición:

Excipient Ingredients: mannitol; water for injections; sulfuric acid; sodium hydroxide

Vía de administración:

Intravenous

Unidades en paquete:

1 X 1 mL

clase:

Medicine Listed (Export Only)

tipo de receta:

Not scheduled. Not considered by committee

indicaciones terapéuticas:

Vincristine sulfate is indicated in the treatment of acute leukemia. It has also been used in combination with other antineoplastic drugs in Hodgkin's disease, soft-tissue sarcoma, bony-tissue sarcoma, sarcomas of specialized structures, breast cancer, small cell cancer of the lung, cancer of uterine cervix, malignant melanoma, colorectal cancer, non-Hodgkin's lymphoma, and Wilm's tumor.

Resumen del producto:

Visual Identification: A clear colourless solution.; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Estat d'Autorització:

Licence status A

Data d'autorització:

2007-08-30

Informació per a l'usuari

1
BENPEN
™
_Benzylpenicillin (as benzylpenicillin sodium) Powder for Injection_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
BENPEN
TM
.
It does not contain all the
available information.
It does not take the place of
talking to your doctor and
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
BENPEN
TM
against the benefits
this medicine is expected to have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet. You may need
to read it again.
WHAT
BENPEN™
IS
USED FOR
BENPEN
TM
is an antibiotic used
to treat some infections in
different parts of the body caused
by bacteria.
BENPEN
TM
may also be used to
prevent infections before, during
and after surgery.
BENPEN
TM
will not work
against infections caused by
viruses, such as colds or the flu.
BENPEN
TM
is an antibiotic that
belongs to a group of medicines
called penicillins. These
antibiotics work by killing the
bacteria that are causing your
infection.
Your doctor may have prescribed
BENPEN
TM
for another reason.
Ask your doctor why
BENPEN
TM
has been prescribed
for you.
This medicine is available only
with a doctors prescription.
There is no evidence that
BENPEN
TM
is addictive.
BEFORE YOU ARE GIVEN
BENPEN™
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE BENPEN
TM IF:
•
YOU HAVE AN ALLERGY TO
BENPEN
TM OR OTHER
PENICILLINS.
•
Some of the symptoms of an
allergic reaction may include
skin rash, itching and difficult
breathing.
•
YOU HAVE HAD AN ALLERGIC
REACTION TO CEPHALOSPORINS.
•
You may have an increased
chance of being allergic to
BENPEN
TM
if you are
allergic to cephalosporins.
•
THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING.
•
THE EXPIRY DATE PRINTED ON
THE PACK OR VIAL, HAS PASSED.
IF YOU TAKE THIS MEDICINE
AFTER THE EXPIRY DATE HAS
PASSED, IT MAY NOT WORK.
If you are not sure whether you
should be given BENPEN
TM
,
talk to your doctor.
_BEFORE YOU ARE GIVEN IT_
TELL YOUR DOCTOR

Fitxa tècnica

Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION – BENPEN
 BENZYLPENICILLIN
(AS BENZYLPENICILLIN SODIUM), POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Benzylpenicillin (as benzylpenicillin sodium)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BENPEN

(benzylpenicillin sodium) is the sodium salt of (2
_S_
,5
_R_
,6
_R_
)-3,3-dimethyl-7-oxo-6-
[(phenylacetyl) amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic
acid.
BENPEN

contains no antiseptic or buffering agent nor are there any
excipients. Each 600 mg
dose of BENPEN

contains 41.4 mg of sodium.
3
PHARMACEUTICAL FORM
BENPEN

is a fine white to off-white homogenous powder, which is soluble in
water. The
injection is prepared by the addition of the appropriate volume of
Water for Injections to give
the desired concentration of benzylpenicillin.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of infections caused by benzylpenicillin sensitive
organisms. These include
_Streptococcus pyogenes_
and most other Gram-positive organisms. It is also indicated for the
treatment of syphilis. BENPEN

may also be used for the prevention of bacterial endocarditis
in dental and upper respiratory tract procedures and prevention of
wound infections and sepsis
in surgical procedures where Streptococci are the likely pathogens.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The initial dose of BENPEN

should be sufficient to achieve a bactericidal concentration in
the blood as rapidly as possible in order to prevent the emergence of
resistant strains.
Precise dosage levels cannot be stated. The nature of the infection
and the patients’ response to
therapy should determine the dose of BENPEN

and its frequency of administration.
Benzylpenicillin may be given by intramuscular or intravenous
injection.
Page 2 of 12
The minimum dosage should be:
AGE
MINIMUM DOSE
Adults and Children

10 years
300 mg 6 hourly
Children 3 - 10 years
150 to 300 mg 6 hourly
Children < 3 years
60 mg 6 hourly
Premature babies and neonates
30 to 60 mg 12 hourly
A reduc