Medaxonum 500mg powder for solution for injection/infusion

Land: Malta

Språk: engelsk

Kilde: Malta Medicines Authority

Aktiv ingrediens:

CEFTRIAXONE

Tilgjengelig fra:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC-kode:

J01DD04

INN (International Name):

CEFTRIAXONE 500 mg

Legemiddelform:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Sammensetning:

CEFTRIAXONE 500 mg

Resept typen:

POM

Terapeutisk område:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorisasjon status:

Authorised

Autorisasjon dato:

2006-12-28

Informasjon til brukeren

PIL-CEFT-INJ-2.3-MT
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEDAXONUM, 500 MG, POWDER FOR SOLUTION FOR INJECTION/INFUSION
MEDAXONUM, 1 G, POWDER FOR SOLUTION FOR INJECTION/INFUSION
MEDAXONUM, 2 G, POWDER FOR SOLUTION FOR INJECTION/INFUSION
Ceftriaxone (as ceftriaxone sodium)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to you doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Medaxonum is and what it is used for
2.
What you need to know before you take Medaxonum
3.
How to take Medaxonum
4.
Possible side effects
5
How to store Medaxonum
6.
Contents of the pack and other information
1.
WHAT MEDAXONUM IS AND WHAT IT IS USED FOR
Medaxonum is an antibiotic given to adults and children (including
newborn babies). It works by
killing bacteria that cause infections. It belongs to a group of
medicines called cephalosporins
_. _
Medaxonum is used to treat infections of
• the brain (meningitis).
• the lungs.
• the middle ear.
• the abdomen and abdominal wall (peritonitis).
• the urinary tract and kidneys.
• bones and joints.
• the skin or soft tissues.
• the blood.
• the heart.
PIL-CEFT-INJ-2.3-MT
2
It can be given:
• to treat specific sexually transmitted infections (gonorrhoea and
syphilis).
• to treat patients with low white blood cell counts (neutropenia)
who have fever due to bacterial
infection.
• to treat infections of the chest in adults with chronic
bronchitis.
• to treat Lyme disease (caused by tick bites) in adults and
children including newborn babies from 15
days of age.
• to prevent infections during surg

Preparatomtale

SPC-ceftriaxone-v6.1
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Medaxonum, 500 mg, powder for solution for injection/infusion
Medaxonum, 1 g, powder for solution for injection/infusion
Medaxonum, 2 g, powder for solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Medaxonum 500 mg vials contain 500 mg ceftriaxone as ceftriaxone
sodium.
Medaxonum 1 g vials contain 1 g ceftriaxone as ceftriaxone sodium.
Medaxonum 2 g vials contain 2 g ceftriaxone as ceftriaxone sodium.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
Almost white or yellowish crystalline powder.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Medaxonum is indicated for the treatment of the following infections
in adults and children including
term neonates (from birth):
•
Bacterial Meningitis
•
Community acquired pneumonia
•
Hospital acquired pneumonia
•
Acute otitis media
•
Intra-abdominal infections
•
Complicated urinary tract infections (including pyelonephritis)
•
Infections of bones and joints
•
Complicated skin and soft tissue infections
•
Gonorrhoea
•
Syphilis
•
Bacterial endocarditis
SPC-ceftriaxone-v6.1
2
Medaxonum may be used:
•
For treatment of acute exacerbations of chronic obstructive pulmonary
disease in adults
•
For treatment of disseminated Lyme borreliosis (early (stage II) and
late (stage III)) in adults
and children including neonates from 15 days of age
•
For Pre-operative prophylaxis of surgical site infections
•
In the management of neutropenic patients with fever that is suspected
to be due to a bacterial
infection
•
In the treatment of patients with bacteraemia that occurs in
association with, or is suspected to
be associated with, any of the infections listed above
Medaxonum should be co-administered with other antibacterial agents
whenever the possible range of
causative bacteria would not fall within its spectrum (see section
4.4).
Consideration should be given to official guidelines on the
appropriate use of antibacte