Primaxin

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Cilastatin sodium 571mg equivalent to 500 mg cilastatin acid. (Includes 4.6% overage).; Imipenem monohydrate 560mg equivalent to 500 mg Imipenem. (Includes 4.6% overage).;  

Dostupné z:

Merck Sharp & Dohme (New Zealand) Limited

INN (Medzinárodný Name):

Cilastatin sodium 571 mg (=500 mg cilastatin acid. (Includes 4.6% overage).)

Dávkovanie:

500mg/500mg

Forma lieku:

Powder for infusion

Zloženie:

Active: Cilastatin sodium 571mg equivalent to 500 mg cilastatin acid. (Includes 4.6% overage). Imipenem monohydrate 560mg equivalent to 500 mg Imipenem. (Includes 4.6% overage).   Excipient: Sodium bicarbonate

Počet v balení:

Vial, glass, 1x13ml =1dose unit, 13 mL

Trieda:

Prescription

Typ predpisu:

Prescription

Výrobca:

Merck Sharp & Dohme Corp

Prehľad produktov:

Package - Contents - Shelf Life: Vial, glass, 500mg/500mg - 1 dose units - 24 months from date of manufacture stored at or below 25°C 4 hours reconstituted stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Dátum Autorizácia:

1986-05-15

Príbalový leták

PRIMAXIN
®
_imipenem/cilastatin sodium_
500 mg/500 mg Vial for injection
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 he or she expects 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
(germs). 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
Your doctor must know about all of the following before you are given
PRIMAXIN, if you
have or have had:
•
any allergies to other antibiotics, in particular, penicillins and
cephalosporins
•
allergies to any other substances, such as foods, preservatives, or
dyes
If you have any of these allergies you may be allergic to PRIMAXIN.
•
a history of seizures or fits, or brain disease
•
kidney disease or urinary problems
•
any other medical conditions, including problems with your bowels
Tell your doctor if you are taking a medicine containing valproic
acid.
If 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.
Some medicines may affect the way other medicines work, and some
should not be used
together at all as they may harm people.
If you have not told your doctor about any of the above, tell them
before you are giv

Súhrn charakteristických

1
NAME OF MEDICINE
PRIMAXIN
®
_imipenem/cilastatin_
500 mg /500 mg injection
PRESENTATION
PRIMAXIN for intravenous use is supplied as a white sterile powder in
13 mL vials. Each
vial contains 500 mg of imipenem equivalent and 500 mg cilastatin
equivalent. The
reconstituted solution is clear (however variations in colour from
colourless to yellow do
not affect the potency of the product).
Note: PRIMAXIN for intramuscular use is not available in New Zealand.
THERAPEUTIC CLASS
Cilastatin is a competitive, reversible and specific inhibitor of
dehydropeptidase-I enzyme.
INDICATIONS
The activity of PRIMAXIN against an unusually broad spectrum of
pathogens makes it
particularly useful in the treatment of polymicrobic mixed
aerobic/anaerobic infections as
well as initial therapy prior to the identification of the causative
organisms. PRIMAXIN is
indicated for the treatment of the following infections due to
susceptible organisms:
•
Intra-abdominal infections
•
Lower respiratory tract infections
•
Gynaecological infections
•
Septicaemia
•
Genitourinary tract infections
•
Bone and joint infections
•
Skin and soft tissue infections
•
Endocarditis
PRIMAXIN is indicated for the treatment of mixed infections caused by
susceptible strains
of aerobic and anaerobic bacteria. The majority of these mixed
infections are associated
with contamination by faecal flora or flora originating from the
vagina, skin and mouth. In
these mixed infections, _Bacteroides fragilis _is the most commonly
encountered anaerobic
pathogen and is usually resistant to aminoglycosides, cephalosporins
and penicillins.
However, _Bacteroides fragilis _is usually susceptible to PRIMAXIN.
PRIMAXIN has demonstrated efficacy against many infections caused by
aerobic and
anaerobic gram-positive and gram-negative bacteria resistant to the
cephalosporins,
including cefazolin, cefoperazone, cephalothin, cefoxitin, cefotaxime,
moxalactam,
cefamandole, ceftazidime and ceftriaxone. Similarly, many infections
caused by
organisms resistant to aminoglycosi