Primaxin imipenem 500mg and cilastatin 500 (as sodium) injection

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

imipenem, Quantity: 500 mg; cilastatin, Quantity: 500 mg

Dostupné s:

Merck Sharp & Dohme (Australia) Pty Ltd

Léková forma:

Injection, powder for

Složení:

Excipient Ingredients: sodium bicarbonate

Podání:

Intravenous

Jednotky v balení:

1 vial of powder - 500mg:500mg

Třída:

Medicine Registered

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

PRIMAXIN is indicated for the treatment of serious infections caused by susceptible strains of micro-organisms in the diseases listed below: 1. Lower respiratory tract infections. 2 Intra-abdominal infections. 3. Gynaecological infections. 4. Bacterial septicaemia. 5. Bone and joint infections. 6. Skin and skin structure infections. 7. Endocarditis. 8. Polymicrobial infections. PRIMAXIN is indicated for polymicrobial infections including those in which S. pneumoniae (pneumonia, septicaemia), Group A beta-haemolytic streptococcus (skin and skin structure), or non-penicillinase-producing S. aureus is one of the causative organisms. However monobacterial infections due to these organisms are usually treated with narrower spectrum antibiotics, such as penicillin G. Efficacy against polymicrobial infection in the immunocompromised host has not yet been established. Although clinical improvement has been observed in patients with cystic fibrosis, chronic pulmonary disease, and lower respiratory tract infections cau

Přehled produktů:

Visual Identification: White powder; Container Type: Vial; Container Temperature: Store below 25 degrees Celsius

Stav Autorizace:

Registered

Datum autorizace:

1991-07-22

Informace pro uživatele

PRIMAXIN
®
_Imipenem/Cilastatin sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PRIMAXIN. 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 using PRIMAXIN
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT PRIMAXIN IS
USED FOR
PRIMAXIN is an antibiotic which is
used to treat serious infections
caused by bacteria. These infections
may occur in many different parts of
the body.
PRIMAXIN is sometimes given in
addition to other antibiotics.
PRIMAXIN works by killing the
bacteria causing the infection.
BEFORE YOU ARE GIVEN
PRIMAXIN
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE PRIMAXIN IF YOU HAVE
AN ALLERGY TO PRIMAXIN OR ANY OF
THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET
_BEFORE YOU ARE GIVEN IT_
TELL YOUR DOCTOR IF:
1.
YOU ARE PREGNANT OR ARE BREAST-
FEEDING
Your doctor will discuss the
possible risks and benefits of
using PRIMAXIN during
pregnancy and breast-feeding.
PRIMAXIN passes into breast
milk and may be passed on to the
baby.
2.
YOU HAVE ANY MEDICAL
CONDITIONS, ESPECIALLY THE
FOLLOWING:
•
colitis or any other
gastrointestinal disease
•
any central nervous system
disorders, such as localised
tremors, or seizures (fits)
•
kidney or urinary problems
•
bowel problems
3.
YOU HAVE ANY ALLERGIES TO OTHER
ANTIBIOTICS, IN PARTICULAR,
PENICILLINS AND CEPHALOSPORINS
If you are allergic to any of these,
you may be allergic to
PRIMAXIN.
4.
IF YOU HAVE ANY ALLERGIES TO ANY
OTHER MEDICINES OR ANY OTHER
SUBSTANCES, SUCH AS FOODS,
PRESERVATIVES OR DYES.
IF YOU HAVE NOT TOLD YOUR DOCTOR
ABOUT ANY OF THE ABOVE, TELL THEM
BEFORE YOU ARE GIVEN PRIMAXIN.
PRIMAXIN SHOULD NOT BE USED IN
CHILDREN UNDER 3 MONTHS OF AGE OR
CHILDREN WITH KIDNEY PROBLEMS.
_TAKING OTHER

Charakteristika produktu

Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
PRIMAXIN
®
(IMIPENEM AND CILASTATIN SODIUM)
POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Imipenem and cilastatin sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PRIMAXIN (Imipenem-Cilastatin Sodium)
is
a
formulation
of
imipenem,
a thienamycin
antibiotic, and cilastatin sodium, the inhibitor of the renal
dipeptidase, dehydropeptidase l, with
sodium bicarbonate added as a buffer. PRIMAXIN is a potent broad
spectrum antibacterial
agent for intravenous administration.
PRIMAXIN is supplied as Imipenem 500 mg and cilastatin sodium
equivalent to cilastatin 500
mg.
Excipient with known effect:
PRIMAXIN contains 37.5 mg of sodium (1.6mEq).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
PRIMAXIN is supplied as a sterile powder mixture in a vial.
PRIMAXIN is buffered to provide solutions in the pH range of 6.5 to
8.5. There is no significant
change in pH when solutions are prepared and used as directed. (See
SECTION 4.2 DOSE AND
METHOD OF ADMINISTRATION, COMPATIBILITY AND STABILITY.) Solutions of
PRIMAXIN range from
colourless to yellow. Variations of colour within this range do not
affect the potency of the
product.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PRIMAXIN is indicated for the treatment of serious infections caused
by susceptible strains of
micro-organisms in the diseases listed below:
1. Lower respiratory tract infections.
2. Intra-abdominal infections.
3. Gynaecological infections.
4. Bacterial septicaemia.
5. Bone and joint infections.
6. Skin and skin structure infections.
7. Endocarditis.
Page 2 of 16
8. Polymicrobial infections. PRIMAXIN is indicated for polymicrobial
infections including those
in which _S. pneumoniae_ (pneumonia, septicaemia), Group A
beta-haemolytic streptococcus
(skin and skin structure), or non-penicillinase-producing _ S. aureus_
is one of the causative
organisms. However, monobacterial infections due to these organisms
are usually treated with
narrower spectrum antibiotics, such as penic