INVANZ ertapenem (as sodium) 1g powder for injection vial

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

ertapenem, Quantity: 1 g (Equivalent: ertapenem sodium, Qty 1.046 g)

Mevcut itibaren:

Merck Sharp & Dohme (Australia) Pty Ltd

Farmasötik formu:

Injection, powder for

Kompozisyon:

Excipient Ingredients: sodium hydroxide; sodium bicarbonate

Uygulama yolu:

Intravenous, Intramuscular

Paketteki üniteler:

1 x 1g vial

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

INVANZ is indicated for the treatment of adult patients with moderate to severe infections caused by susceptible strains of microorganisms, which are suspected or proven to be resistant to all other antibiotics, or for patients unable to tolerate other antibiotics. INVANZ is also indicated for initial empiric therapy for the treatment of complicated intra-abdominal infections and acute pelvic infections including post-partum endomyometritis, septic abortion and post-surgical gynaecological infections. Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to ertapenem. Therapy with INVANZ may be initiated empirically before the results of these tests are known; once these results become available, antimicrobial therapy should be adjusted accordingly.,INVANZ is indicated for the treatment of patients, aged 3 months or more, with moderate to severe infections (except meningitis, see PRECAUTIONS) caused by susceptible strains of micro-organisms which are suspected or proven to be resistant to all other antibiotics, or for patients unable to tolerate other antibiotics. INVANZ is also indicated for initial empiric therapy for the treatment of complicated intra-abdominal infections and acute pelvic infections including post-partum endomyometritis, septic abortion and post-surgical gynaecological infections. INVANZ is also indicated for Treatment of diabetic foot infections, which require parenteral antibiotic therapy and are caused by susceptible bacterial pathogens which are suspected or proven to be resistant to all other registered antibiotics, or for patients unable to tolerate other antibiotics. Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to ertapenem. Therapy with INVANZ may be initiated empirically before the results of these tests are known; once these results become available, antimicrobial therapy should be adjusted accordingly.

Ürün özeti:

Visual Identification: Solid, white to off-white, essentially uniform cake.; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Yetkilendirme durumu:

Licence status A

Yetkilendirme tarihi:

2002-06-11

Bilgilendirme broşürü

INVANZ
®
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®
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 AM I BEING GIVEN INVANZ?
INVANZ contains the active ingredient Ertapenem. INVANZ is used to
treat infections caused by bacteria (germs). These infections
include: infections within the abdomen (stomach), pelvic infections,
diabetic foot infections in patients without osteomyelitis
For more information, see Section 1. Why am I being given INVANZ? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN INVANZ?
You should not be given INVANZ if you have ever had an allergic
reaction to INVANZ or any of the ingredients listed at the end of
the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given INVANZ? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with INVANZ and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW WILL I BE GIVEN INVANZ?
INVANZ can be given in two ways:
•
as a slow injection into a vein, known as an intravenous infusion
•
as a deep injection into a large muscle, known as an intramuscular
injection.
INVANZ must only be given by a doctor or nurse.
More instructions can be found in Section 4. How will I be given
INVANZ? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN INVANZ?
THINGS YOU
SHOULD DO
CALL YOUR DOCTOR STRAIGHT AWAY IF YOU:
•
Develop severe diarrhoea
•
Develop a severe skin reaction such as painful red areas, fluid filed
bumps, large blisters, or peeling
layers of skin whilst being given INVANZ
DRIVING
OR USING
MACHINES
•
INVANZ may cause dizziness or sleepiness in some patients. Make sure
you know how you react to
INVANZ before you drive a car, operate machinery or do anything else
t

Ürün özellikleri

Page 1 of 21
AUSTRALIAN PRODUCT INFORMATION
INVANZ
™
(ERTAPENEM SODIUM)
POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Ertapenem sodium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ertapenem sodium is a white to off-white hygroscopic, weakly
crystalline powder. It is soluble
in water and 0.9% sodium chloride solution, practically insoluble in
ethanol, and insoluble in
isopropyl acetate and tetrahydrofuran.
INVANZ is supplied as a sterile lyophilised powder for intravenous
infusion or intramuscular
injection containing 1 g ertapenem as free acid.
Each vial contains 1.046 g ertapenem sodium, equivalent to 1 g
ertapenem.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
INVANZ
(ertapenem
sodium)
is
supplied
as
sterile,
synthetic,
lyophilised
powder
for
intravenous infusion after reconstitution with appropriate diluent
(see SECTION 4.2 DOSE AND
METHOD OF ADMINISTRATION) for transfer to 50 mL 0.9% Sodium Chloride
Injection or
intramuscular injection following reconstitution with 1% lidocaine
(lignocaine) hydrochloride.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TREATMENT
INVANZ is indicated for the treatment of patients, aged 3 months or
more, with moderate to
severe infections (except meningitis, see SECTION 4.4 SPECIAL WARNINGS
AND PRECAUTIONS
FOR USE) caused by susceptible strains of microorganisms which are
suspected or proven to
be resistant to all other antibiotics, or for patients unable to
tolerate other antibiotics.
INVANZ is also indicated for initial empiric therapy for the treatment
of complicated intra-
abdominal infections and acute pelvic infections including post-partum
endomyometritis,
septic abortion and post-surgical gynaecological infections.
INVANZ is also indicated for the treatment of diabetic foot
infections, which require parenteral
antibiotic therapy and are caused by susceptible bacterial pathogens
which are suspected or
proven to be resistant to all other registered antibiotics, or for
patients unable to tolerate other
antibiotics.
Appropriate