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

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

ceftriaxone sodium, Quantity: 1193 mg (Equivalent: ceftriaxone, Qty 1000 mg)

Saadav alates:

Alphapharm Pty Ltd

INN (Rahvusvaheline Nimetus):

ceftriaxone sodium

Ravimvorm:

Injection, powder for

Koostis:

Excipient Ingredients:

Manustamisviis:

Intramuscular, Intravenous

Ühikuid pakis:

5 Vials, 1 Vial, 10 Vial

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

Ceftriaxone Viatris is indicated 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.

Toote kokkuvõte:

Visual Identification: A white to slightly yellow crystalline powder.; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Volitamisolek:

Licence status A

Loa andmise kuupäev:

2012-01-20

Infovoldik

CEFTRIAXONE
ALPHAPHARM
_ceftriaxone_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ceftriaxone
Alphapharm.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Ceftriaxone
Alphapharm against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT CEFTRIAXONE
ALPHAPHARM IS USED
FOR
Ceftriaxone Alphapharm 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.
Ceftriaxone Alphapharm is used to
treat infections in different parts of
the body caused by bacteria.
Ceftriaxone Alphapharm is also used
to prevent infections before, during
and after surgery.
Ceftriaxone Alphapharm will not
work against infections caused by
viruses such as colds or the flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CEFTRIAXONE
ALPHAPHARM HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
Ceftriaxone Alphapharm for another
reason.
This medicine is available only with
a doctor’s prescription.
Ceftriaxone Alphapharm is not
addictive.
BEFORE YOU ARE GIVEN
CEFTRIAXONE
ALPHAPHARM
_WHEN YOU MUST NOT GIVEN IT_
DO NOT USE CEFTRIAXONE
ALPHAPHARM 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 Alphapharm if you

Toote omadused

AUSTRALIAN PRODUCT INFORMATION
CEFTRIAXONE ALPHAPHARM
_Ceftriaxone sodium powder for injection _
1
NAME OF THE MEDICINE
Ceftriaxone sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Ceftriaxone Alphapharm powder for injection vial contains
ceftriaxone sodium equivalent to either 250
mg, 500 mg, 1000 mg or 2000 mg of ceftriaxone as a single ingredient.
Ceftriaxone sodium contains approximately 83 mg (3.6 mEq) of sodium
per gram of ceftriaxone activity.
The product contains no excipients or preservatives.
3
PHARMACEUTICAL FORM
Ceftriaxone Alphapharm
1000 mg
:
For intramuscular injection. For intravenous injection and infusion.
A white to slightly yellow crystalline powder for injection vial.
Ceftriaxone Alphapharm
2000 mg
:
For intravenous infusion.
A white to slightly yellow crystalline powder for injection vial.
Ceftriaxone Alphapharm
250 mg
:
For intramuscular injection. For intravenous injection and infusion.
A white to slightly yellow crystalline powder for injection vial.
Ceftriaxone Alphapharm
500 mg
:
For intramuscular injection. For intravenous injection and infusion.
A white to slightly yellow crystalline powder for injection vial.
The colour of ceftriaxone sodium solutions ranges from light yellow to
amber, depending on the length of
storage, concentration and diluent used.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ceftriaxone Alphapharm is indicated 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 speci