CEFTRIAXONE-AFT ceftriaxone (as sodium) 1g powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ceftriaxone sodium, Quantity: 1.079 g (Equivalent: ceftriaxone, Qty 1 g)

Available from:

AFT Pharmaceuticals Pty Ltd

INN (International Name):

ceftriaxone sodium

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intramuscular, Intravenous

Units in package:

5 vials, 1 vial, 10 vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of the following infections when caused by susceptible aerobic organisms: = Lower Respiratory Tract Infections caused by S. pneumoniae, Streptococcus species (excluding enterococci), methicillin sensitive S. aureus, H. influenzae, H. parainfluenzae, Klebsiella species (including K. pneumoniae), E. coli, E. aerogenes, Proteus mirabilis and Serratia marcescens. = Skin And Skin Structure Infections caused by methicillin sensitive S. aureus, methicillin sensitive S. epidermidis, Streptococcus Group B, Streptococcus Group G, Streptococcus pyogenes, Streptococcus viridans, Streptococcus species (excluding enterococci), Peptostreptococcus species, E. coli, E. cloacae, Klebsiella species (including K. pneumoniae, K. oxytoca), Proteus mirabilis, Morganella morganii, Serratia marcescens. = Urinary Tract Infections (complicated and uncomplicated) caused by E. coli, Proteus mirabilis, Proteus vulgaris, M. morganii and Klebsiella species (including K. pneumoniae). = Uncomplicated Gonorrhoea (cervical/urethral and rectal) caused by Neisseria gonorrhoea, including both penicillinase and non penicillinase producing strains. = Bacterial Septicemia caused by S. pneumoniae, E. coli and H. influenzae. = Bone Infections caused by methicillin sensitive S. aureus, methicillin sensitive S. epidermidis, Streptococcus Group B, S. pneumoniae, Streptococcus species (excluding enterococci), E. coli, Enterobacter species, P. mirabilis and K. pneumoniae. = Joint Infections caused by methicillin sensitive S. aureus, S. pneumoniae, Streptococcus species (excluding enterococci), E. coli, P. mirabilis, K. pneumoniae and Enterobacter species. = Meningitis: The initial treatment, as a single agent, of meningitis in children and immunocompetent adults when presumed or proven to be caused by Haemophilus influenzae type b, Neisseria meningitidis, Streptococcus 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 post-operative 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: Almost white or yellowish crystalline powder; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Restricted flow insert

Authorization status:

Licence status A

Authorization date:

2012-02-20

Patient Information leaflet

CEFTRIAXONE-AFT
Ceftriaxone sodium equivalent to Ceftriaxone 500 mg, 1 g and 2 g,
powder for
injection
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Ceftriaxone-AFT.
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 will have
considered risks of you
being given Ceftriaxone-AFT against the benefits they expect it will
have for you..
IF YOU HAVE ANY CONCERNS OR QUESTIONS ABOUT BEING GIVEN THIS MEDICINE,
ASK
YOUR DOCTOR OR PHARMACIST.
Keep this leaflet. You may need to read it again.
WHAT CEFTRIAXONE-AFT IS USED FOR
Ceftriaxone-AFT is an antibiotic used to treat infections in different
parts of the body
caused by bacteria. Ceftriaxone-AFT is also used to prevent infections
before, during
and after surgery. It will not work against infections caused by
viruses such as colds
and flus.
Ceftriaxone-AFT belongs to a group of antibiotics called
cephalosporins. They work
by killing the bacteria that are causing your infection or by stopping
the bacteria from
growing.
IF YOU ARE NOT SURE IF YOU ARE UNCERTAIN WHY CEFTRIAXONE-AFT HAS BEEN
PRESCRIBED FOR YOU, TALK TO YOUR DOCTOR. They may have prescribed it
for another
reason.
BEFORE YOU ARE GIVEN CEFTRIAXONE-AFT
_WHEN YOU MUST NOT BE GIVEN IT_
You must not use Ceftriaxone-AFT if you:
•
Have had an allergic reaction to Ceftriaxone-AFT or any other
cephalosporin
antibiotic
•
Have had an allergic reaction to any penicillin
Symptoms of allergic reactions include severe skin rash, itching,
hives, dry skin,
swelling of the face, lips, mouth, throat which may cause difficulty
in swallowing or
breathing, swelling of the hands, feet or ankles.
You may have an increased risk of being allergic to Ceftriaxone-AFT if
you are
allergic to penicillins.
Ceftriaxone-AFT should not be given to newborn infants if they need or
are expected
to need treatment with calcium containing intravenous solutions
including intravenous
nutrition.
Ceftriaxone-A

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION - CEFTRIAXONE-AFT
(CEFTRIAXONE SODIUM)
1
NAME OF THE MEDICINE
Ceftriaxone sodium, powder for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ceftriaxone-AFT 500 mg: each vial contains ceftriaxone sodium
equivalent to ceftriaxone 500 mg.
Ceftriaxone-AFT 1 g: each vial contains ceftriaxone sodium equivalent
to ceftriaxone 1 g.
Ceftriaxone-AFT 2 g: each vial contains ceftriaxone sodium equivalent
to ceftriaxone 2 g.
Ceftriaxone sodium is a white to yellowish-orange crystalline powder
which is readily soluble in water,
sparingly soluble in methanol and very slightly soluble in ethanol.
The pH of a 5% aqueous solution is
approximately 6-8. The colour of ceftriaxone sodium solutions ranges
from light yellow to amber,
depending on the length of storage, concentration and diluent used.
Ceftriaxone-AFT contains approximately 83 mg (3.6 mEq) of sodium per
gram of ceftriaxone activity.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ceftriaxone-AFT is indicated in the treatment of the following
infections when caused by susceptible
aerobic organisms:
_LOWER RESPIRATORY TRACT INFECTIONS_
Caused by _ S. pneumoniae, _
Streptococcus spp (excluding enterococci), methicillin
sensitive _ S,_
_ _
_aureus_,
_H. _
_influenzae, _
_H. _
_parainfluenzae, _
_Klebsiella _
_sp _
(including
_K. _
_pneumoniae_)_, _
_E. _
_coli, _
_E._
_ _
_aerogenes, Proteus mirabilis _and _Serratia marcesens_.
_SKIN AND SKIN STRUCTURE INFECTIONS_
Caused by methicillin sensitive
_S. aureus _
and
_S. epidermidis, _
Streptococcus Group B, Streptococcus
Group G,
_Streptococcus pyogenes, Streptococcus viridans, _
Streptococcus spp (excluding enterococci),
Peptostreptococcus spp,
_E. coli, E. cloacae, Klebsiella_
spp (including
_K. pneumoniae, K. oxytoca_
),
_Proteus mirabilis, Morganella morganii, Serratia marcescens._
2
_URINARY TRACT INFECTIONS_
Complicated and uncomplicated caused by
_E. coli, Proteus.mirabilis, Proteus vulgar