CEFTRIAXONE INJECTION ceftriaxone 250mg (as sodium) powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ceftriaxone sodium, Quantity: 298.3 mg (Equivalent: ceftriaxone, Qty 250 mg)

Available from:

Generic Health Pty Ltd

INN (International Name):

ceftriaxone sodium

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intravenous, Intramuscular

Units in package:

10 vials, 1 vial, 5 vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of the following infections when caused by susceptible aerobic organisms. LOWER RESPIRATORY TRACT INFECTIONS. caused by Strep. pneumoniae, Streptococcus sp. (excluding Enterococci), methicillin sensitive Staph. aureus, H. influenzae, H. Parainfluenzae, Klebsiella sp. (including K. pneumoniae), E. coli, E. aerogenes, P. mirabilis and Serratia marcescens. SKIN AND SKIN STRUCTURE INFECTIONS. caused by methicillin sensitive Staph. aureus, methicillin sensitive Staph. epidermidis, Streptococcus group B, Streptococcus group G, Strep. pyogenes, Strep. viridans, Streptococcus sp. (excluding Enterococci), Peptostreptococcus sp., E. coli, E. cloacae, Klebsiella sp . (including K. pneumoniae and K. oxytoca), P. mirabilis, M morganii and S. marcescens. URINARY TRACT INFECTIONS (complicated and uncomplicated). Caused by E. coli, P. mirabilis, P. vulgaris, M morganii and Klebsiella sp. (including K. pneumoniae). UNCOMPLICATED GONORRHOEA (cervical/ urethral and rectal). Caused by N. gonorrhoeae, including both pencillinase and nonpenicillinase producing strains. BACTERIAL SEPTICAEMIA. Caused by Strep. pneumoniae, E. coli and H. influenzae. BONE INFECTIONS. Caused by methicillin sensitive Staph. aureus, methicillin sensitive Staph. epidermidis, Streptococcus group B, Strep. pneumoniae, Streptococcus sp. (excluding Enterococci), E. coli, Enterobacter sp., P. mirabilis and K. pneumoniae. JOINT INFECTIONS. Caused by methicillin sensitive Staph. aureus, Strep. pneumoniae, Streptococcus sp. (excluding Enterococci), E. coli, P. mirabilis, K. pneumoniae and Enterobacter sp. MENINGITIS. The initial treatment, as a single agent, of meningitis in children and immunocompetent adults when presumed or proven to be caused by H. influenzae type b, N. meningitidis, Strep. pneumoniae or Enterobacteriaceae pending culture and sensitivity results. SURGICAL PROPHYLAXIS. The preoperative administration of a single 1 g dose of ceftriaxone may reduce the incidence of postoperative infections in patients undergoing vaginal or abdominal hysterectomy or cholecystectomy in high risk patients, surgical procedures which are classified as contaminated or potentially contaminated, and patients undergoing coronary artery bypass surgery. Although ceftriaxone has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo controlled trials have been conducted. Susceptibility testing. Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing.

Product summary:

Visual Identification: Clear glass vial containing a white to yellowish crystalline powder.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2004-07-22

Patient Information leaflet

Page 1 of 3
CONSUMER MEDICINE INFORMATION
CEFTRIAXONE INJECTION
_Ceftriaxone sodium_
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Ceftriaxone 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
being given Ceftriaxone Injection
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 CEFTRIAXONE
INJECTION IS USED FOR
Ceftriaxone Injection is an
antibiotic used to treat infections
in different parts of the body
caused by bacteria.
Ceftriaxone Injection is also used
to prevent infections before,
during and after surgery.
Ceftriaxone Injection will not work
against infections caused by
viruses such as colds or the flu.
Ceftriaxone Injection belongs to a
group of antibiotics called
cephalosporins. These antibiotics
work by killing the bacteria that
are causing your infection or by
stopping bacteria from growing.
Your doctor may have prescribed
Ceftriaxone Injection for another
reason.
Ask your doctor if you have any
questions why Ceftriaxone
Injection has been prescribed for
you.
This medicine is available only
with a doctor's prescription.
Ceftriaxone Injection is not
addictive.
BEFORE YOU ARE GIVEN
CEFTRIAXONE INJECTION
WHEN YOU MUST NOT BE GIVEN IT
Do not use Ceftriaxone Injection
if:

You have had an allergic
reaction to ceftriaxone, other
cephalosporins or any of the
ingredients listed at the end of
this leaflet. Some of the
symptoms of an allergic
reaction may include severe
skin rash, itching, hives, dry
skin, swelling of the face, lips,
mouth or throat which may
cause difficulty in swallowing or
breathing, swelling of the
hands, feet or ankles.

You have had a serious allergic
reaction to penicillins. You may
have an increased chance of
being allergic to Ceftriaxone
Injection if yo