Ibiamox

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

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Herunterladen Gebrauchsinformation (PIL)
25-07-2022
Herunterladen Fachinformation (SPC)
25-07-2022

Wirkstoff:

Amoxicillin sodium 1000mg;  

Verfügbar ab:

Douglas Pharmaceuticals Limited

INN (Internationale Bezeichnung):

Amoxicillin sodium 1000 mg

Dosierung:

1000 mg

Darreichungsform:

Powder for injection

Zusammensetzung:

Active: Amoxicillin sodium 1000mg  

Einheiten im Paket:

Vial, 10 x 1000mg, 10 g

Klasse:

Prescription

Verschreibungstyp:

Prescription

Hergestellt von:

Sandoz GmbH

Anwendungsgebiete:

Amoxicillin should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data. Amoxicillin is indicated for the treatment of infections at the following sites, when caused by sensitive organism: · Upper respiratory tract including ear, nose and throat infections, e.g. tonsillitis, sinusitis, otitis media. · Lower respiratory tract, e.g. acute exacerbations of chronic bronchitis, lobar and bronchopneumonia. · Gastrointestinal tract, e.g. typhoid fever. · Genito-urinary tract, e.g. cystitis, urethritis, pyelonephritis, bacteriuria in pregnancy, gonorrhoea, septic abortion, puerperal sepsis. · Other infections including Borreliosis (Borrelia burgdorferi) (Lyme disease). · Prophylaxis of endocarditis: amoxicillin may be used for the prevention of bacteraemia associated with the development of endocarditis. · Skin and soft tissue infecitons (SSTIs). Susceptibility to amoxicillin with vary with geography and time and local susceptibility data should be consulted where available and microbiological sampling and susceptibility testing performed where necessary.

Produktbesonderheiten:

Package - Contents - Shelf Life: Vial, - 10 dose units - 36 months from date of manufacture stored at or below 25°C - Vial, - 1000 mg - 36 months from date of manufacture stored at or below 25°C

Berechtigungsdatum:

1982-12-09

Gebrauchsinformation

                                CONSUMER MEDICINE INFORMATION
1
IBIAMOX®
_Amoxicillin 250 mg, 500 mg, 1000 mg _
_Powder for Injection_
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START
USING IBIAMOX.
This leaflet answers some common questions
about Ibiamox. 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 taking
Ibiamox 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 THE MEDICINE. YOU MAY
NEED TO READ IT AGAIN.
WHAT IBIAMOX IS USED FOR
Ibiamox is used to treat a range of bacterial
infections in adults and children.
Ibiamox may be used in:
•
ear, nose and throat infections
•
lung infections and airway infections
•
stomach and intestines infection
•
skin and soft tissue infections
•
infections of the urinary system and
reproductive organs
•
other infections including Lyme Disease
(infection spread through ticks)
•
prevention of heart’s inner lining
inflammation as a result of bacteria
entering the blood during procedures
such as dental extraction.
Ibiamox belongs to a group of medicines called
beta-lactam antibiotics. It works by killing the
bacteria which causes the infection.
Your doctor may have prescribed Ibiamox for
another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT
WHY IBIAMOX HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with a doctor's
prescription.
BEFORE YOU USE IBIAMOX
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE IBIAMOX IF YOU HAVE AN ALLERGY TO:
•
any medicine containing amoxicillin or a
class of medicines called penicillins and
cephalosporins
•
any of the ingredients listed at the end of
this leaflet
Some of the symptoms of an allergic reaction
may include:
•
difficulty in breathing or wheezing
•
shortness of breath
•
swelling of the face, tongue, lips, or other
parts of the body
•
hives on the s
                                
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Fachinformation

                                1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Ibiamox® 250 mg Powder for injection
Ibiamox® 500 mg Powder for injection
Ibiamox® 1000 mg Powder for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The amoxicillin is present as the sodium salt in Ibiamox (1059 mg of
amoxicillin sodium is
equivalent to approximately 1000mg of amoxicillin).
Ibiamox 250 mg Powder for injection contains 250 mg amoxicillin.
Ibiamox 500 mg Powder for injection contains 500 mg amoxicillin.
Ibiamox 1000 mg Powder for injection contains 1000 mg amoxicillin.
3.
PHARMACEUTICAL FORM
Ibiamox vials: white to cream powder packed in clear glass vials for
reconstitution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Amoxicillin should be used in accordance with local official
antibiotic-prescribing guidelines and
local susceptibility data.
Amoxicillin is indicated for treatment of infections in adults and
children at the following sites,
when caused by sensitive organisms:
•
upper respiratory tract including ear, nose and throat infections,
e.g., tonsillitis, sinusitis,
otitis media
•
lower
respiratory
tract,
e.g.,
acute
exacerbations
of
chronic
bronchitis,
lobar
and
bronchopneumonia
•
gastrointestinal tract, e.g., typhoid fever
•
genito-urinary
tract,
e.g.,
cystitis,
urethritis,
pyelonephritis,
bacteriuria
in
pregnancy,
gonorrhoea, septic abortion, puerperal sepsis
•
other infections including Borreliosis (Borrelia burgdorferi) (Lyme
Disease)
•
prophylaxis of endocarditis: amoxicillin may be used for the
prevention of bacteraemia
associated with the development of endocarditis (see table in section
4.2 Dose and method
of administration)
•
Skin and soft tissue infections (SSSIs).
Susceptibility to amoxicillin will vary with geography and time and
local susceptibility data should
be consulted where available and microbiological sampling and
susceptibility testing performed
where necessary (see section 5.1 Pharmacodynamic properties).
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSE
Parenteral therapy is indicated if the
                                
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