Cefuroxime for Injection

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Cefuroxime sodium 789mg equivalent to 750 mg cefuroxime;  

Beschikbaar vanaf:

Viatris Limited

INN (Algemene Internationale Benaming):

Cefuroxime sodium 789 mg (equivalent to 750 mg cefuroxime)

Dosering:

750 mg

farmaceutische vorm:

Powder for injection

Samenstelling:

Active: Cefuroxime sodium 789mg equivalent to 750 mg cefuroxime  

Eenheden in pakket:

Vial, glass, Ph Eur Type III or Type II clear glass,

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

Qilu Antibiotics Pharmaceutical Co Ltd

Product samenvatting:

Package - Contents - Shelf Life: Vial, glass, Type II, 10 mL. Closure: bromobutyl rubber stopper, flip-off Al cap. Manufactured at Sinopharm only - 1 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type I, 15 mL. Closure: bromobutyl rubber stopper, flip-off Al cap. Manufactured at Sinopharm only - 1 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type II, 10 mL. Closure: chlorobutyl rubber stopper, flipoff Al cap. Manufactured at Reig Jofre only - 1 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type II, 10 mL. Closure: chlorobutyl rubber stopper, flipoff Al cap. Manufactured at Reig Jofre only - 10 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type II, 10 mL. Closure: bromobutyl rubber stopper, flip-off Al cap. Manufactured at Sinopharm only - 10 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type I, 15 mL. Closure: bromobutyl rubber stopper, flip-off Al cap. Manufactured at Sinopharm only - 10 dose units - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Autorisatie datum:

1998-12-02

Bijsluiter

Page 1 of 3
NEW ZEALAND CONSUMER MEDICINE INFORMATION
CEFUROXIME FOR INJECTION
_CEFUROXIME SODIUM INJECTION POWDER_
_250 MG, 750 MG, 1.5 G_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CEFUROXIME
INJECTION.
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
CEFUROXIME INJECTION against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT CEFUROXIME
INJECTION IS USED
FOR
CEFUROXIME INJECTION is an
antibiotic used to treat a wide range
of infections caused by bacteria and
also to prevent infections during
surgery. It can be given to adults
and children.
CEFUROXIME INJECTION
contains the active ingredient
cefuroxime sodium_._ It belongs to a
group of medicines called
cephalosporin antibiotics which
targets a wide range of common
bacteria. It works by killing the
bacteria causing the infection or
preventing cell growth.
CEFUROXIME INJECTION is used
in adults and children to treat
bacterial infections of the:

lungs or chest (bronchitis,
pneumonia)

ears, nose and throat
(tonsillitis)

urinary tract

soft tissue

bones and joints
(osteomyelitis)

female reproductive organs

brain (meningitis)

abdomen (peritonitis)

blood (septicaemia)
CEFUROXIME INJECTION can
also be used to:

treat gonorrhoea, a sexually
transmitted infection

prevent infections during
various surgeries
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
CEFUROXIME
INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT_
DO NOT USE CEFUROXIME
INJECTION IF YOU HAVE AN ALLERGY
TO:

any medic

Productkenmerken

Page 1 of 11
NEW ZEALAND DATA SHEET
CEFUROXIME FOR INJECTION
1. PRODUCT NAME
Cefuroxime for injection, 250mg, 750 mg, 1.5 g, powder for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 263 mg, 789 mg or 1.578 g of cefuroxime sodium,
equivalent to 250 mg, 750
mg or 1.5 g of cefuroxime.
3. PHARMACEUTICAL FORM
Cefuroxime is a white to faintly yellow powder to which appropriate
amounts of water are added to
prepare an off-white suspension for intramuscular use or a yellow
solution for intravenous
administration.
Variations in the intensity of this colour do not indicate any change
in either the efficacy or safety of
the product.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Cefuroxime is a bactericidal cephalosporin antibiotic which is
resistant to most _β-_lactamases and is
active against a wide range of Gram-positive and Gram-negative
organisms.
It is indicated for the treatment of infections before the infecting
organism has been identified or
when caused by sensitive bacteria.
Susceptibility to cefuroxime sodium will vary with geography
and time and local susceptibility data should be consulted where
available (see section 5.1).
INDICATIONS INCLUDE:

Respiratory tract infections for example, acute and chronic
bronchitis, infected bronchiectasis, bacterial
pneumonia, lung abscess and post-operative chest infections.

Ear, nose and throat infections for example, sinusitis, tonsillitis,
pharyngitis and otitis media.

Urinary
tract
infections
for
example,
acute
and
chronic
pyelonephritis,
cystitis
and
asymptomatic
bacteriuria.

Soft-tissue infections for example, cellulitis, erysipelas and wound
infections.

Bone and joint infections for example, osteomyelitis and septic
arthritis.

Obstetric and gynaecological infections, pelvic inflammatory diseases.

Gonorrhoea particularly when penicillin is unsuitable.

Other infections including septicaemia, meningitis and peritonitis.

Prophylaxis against infection in abdominal, pelvic, orthopaedic,
cardiac, pulmo