Austrapen 1g powder for injection vial

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

ampicillin, Quantity: 1 g

Disponível em:

Alphapharm Pty Ltd

Forma farmacêutica:

Injection, powder for

Composição:

Excipient Ingredients:

Via de administração:

Intraarticular, Intramuscular, Intravenous, Intrapleural, Intraperitoneal

Unidades em pacote:

5 x 1g

Classe:

Medicine Registered

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Treatment of infections due to susceptible strains of Gram-positive and Gram-negative organisms. Bacteriological studies to determine the organism and its sensitivity should be undertaken.

Resumo do produto:

Visual Identification: A white or almost white powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status de autorização:

Registered

Data de autorização:

1991-11-04

Folheto informativo - Bula

AUSTRAPEN
_ampicillin (as sodium)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AUSTRAPEN.
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 you receiving
AUSTRAPEN 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 AUSTRAPEN IS
USED FOR
AUSTRAPEN is an antibiotic used
to treat infections in different parts of
the body caused by bacteria.
AUSTRAPEN will not work against
infections caused by viruses, such as
colds or the flu.
AUSTRAPEN 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
AUSTRAPEN for another reason.
Ask your doctor why AUSTRAPEN
has been prescribed for you.
This medicine is available only with
a doctor's prescription.
There is no evidence that
AUSTRAPEN is addictive.
BEFORE YOU ARE GIVEN
AUSTRAPEN
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE AUSTRAPEN IF:
•
YOU HAVE AN ALLERGY TO
AUSTRAPEN OR OTHER
PENICILLINS
Some of the symptoms of an
allergic reaction may include skin
rash, itching and difficulty
breathing.
•
YOU HAVE HAD AN ALLERGIC
REACTION TO CEPHALOSPORINS
You may have an increased
chance of being allergic to
AUSTRAPEN if you are allergic
to cephalosporins.
•
THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING
•
THE EXPIRY DATE ON THE PACK HAS
PASSED. IF YOU TAKE IT AFTER THE
EXPIRY DATE, IT MAY HAVE NO
EFFECT AT ALL, OR WORSE, AN
UNEXPECTED EFFECT.
If you are not sure whether you
should be given AUSTRAPEN, talk
to your doctor.
_BEFORE YOU ARE GIVEN IT_
YOU MUST TELL YOUR DOCTOR IF:
•
YOU HAVE AN ALLERGY TO
AUSTRAPEN OR ANY OTHER
PENICILLIN.
•
YOU HAVE ANY TYPE OF ALLERGIC
REACTION TO CEPHALOSPORIN
ME

Características técnicas

AUSTRALIAN PRODUCT INFORMATION
AUSTRAPEN
_Ampicillin (as sodium) Powder for Injection _
_ _
1
NAME OF THE MEDICINE
Ampicillin (as sodium).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ampicillin (as sodium) is a white or almost white powder.
Austrapen contains ampicillin (as sodium) as the active ingredient and
is available in 2 strengths:
Each Austrapen 1000 mg powder for injection contains 1000 mg of
ampicillin (as sodium) as the active
ingredient.
Each Austrapen 500 mg powder for injection contains 500 mg of
ampicillin (as sodium) as the active
ingredient.
Each one gram of monograph substance represents 2.7 mmol of sodium.
Both Austrapen 1000 mg powder for injection and Austrapen 500 mg
powder for injection contain no
antiseptic or buffering agent nor are there any excipients.
3
PHARMACEUTICAL FORM
Powder for injection.
Presentations:
AUSTRAPEN powder for injection is a fine white to off-white powder
that is soluble in water.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of infections due to susceptible strains of Gram-positive
and Gram-negative organisms (see
section
5.1 PHARMACODYNAMIC PROPERTIES - MECHANISM OF ACTION,
MICROBIOLOGY
).
Bacteriological studies to determine the organism and its sensitivity
should be undertaken.
4.2
DOSE AND METHOD OF ADMINISTRATION
AUSTRAPEN may be given by intramuscular injection, by intravenous
infusion or by SLOW
intravenous injection.
RESPIRATORY TRACT INFECTIONS
Adults:
250 to 500mg six hourly.
Children:
25 to 50mg/kg/day in equally divided doses, six hourly.
CHRONIC BRONCHITIS
Adults:
500mg six hourly. (High dosage therapy - 1g six hourly).
AUSTRAPEN – AUSTRALIAN PRODUCT INFORMATION
2
URINARY TRACT INFECTIONS
Adults:
500mg six hourly.
Children:
50mg/kg/day in equally divided doses, six hourly.
GASTROINTESTINAL TRACT INFECTIONS
Adults:
500 to 750mg six hourly.
Children:
50 to 70mg/kg/day in equally divided doses, six hourly
The children’s dosage is intended for individuals whose weight will
not cause a dosage to be calculated
greater than that recommended