Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
ceftriaxone sodium, Quantity: 2.159 g (Equivalent: ceftriaxone, Qty 2 g)
AFT Pharmaceuticals Pty Ltd
ceftriaxone sodium
Injection, powder for
Excipient Ingredients:
Intravenous
10 vials, 1 vial, 5 vials
(S4) Prescription Only Medicine
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.
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
Licence status A
2012-02-20
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 Read the complete document
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 Read the complete document