NOUMED AMOXICILLIN amoxicillin 500 mg (as trihydrate) capsule blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

amoxicillin trihydrate (Equivalent: amoxicillin, Qty mg)

Dostupné s:

AVALLON PHARMACEUTICALS PTY LTD

Léková forma:

Capsule, hard

Složení:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; iron oxide yellow; titanium dioxide; Gelatin

Podání:

Oral

Jednotky v balení:

20 capsules

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

Treatment of the following infections due to susceptible strains of sensitive organisms: Note: Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. Amoxicillin alone or in combination with another antibiotic, may be used in an emergency where the causative has not been identified. ? Respiratory tract infections (acute and chronic): H. influenzae; Streptococcus; S. pneumoniae; Staphylococcus, nonpenicillinase producing; E. coli (see Microbiology). ? Urogenital infections (complicated and uncomplicated, acute and chronic): E. coli (see Microbiology), P. mirabilis and Strep. faecalis. ? Gonorrhoea: N. gonorrhoea (nonpencillinase producing). ? Skin and skin structure infections: Staphylococcus, nonpenicillinase producing; Streptococcus; E. coli (see Microbiology). ? Prophylaxis of endocarditis: Amoxicillin may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with a prosthetic heart valve or those who have previously had endocarditis. Infections caused by pathogens with established penicillin G susceptibility should preferentially be treated with penicillin G.

Přehled produktů:

Visual Identification: Yellow, opaque, hard gelatin capsules, size no. 0 (length approx. 21.5mm, diameter approx 7.5mm); Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizace:

Registered

Datum autorizace:

2018-02-26

Informace pro uživatele

NOUMED AMOXICILLIN CAPSULES
1
NOUMED AMOXICILLIN
CAPSULES
_amoxicillin trihydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Noumed Amoxicillin
capsules.
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 this medicine
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 THIS MEDICINE IS
USED FOR
The name of your medicine is
Noumed Amoxicillin. It contains the
active ingredient amoxicillin
trihydrate.
Amoxicillin is an antibiotic that
belongs to a group of medicines
called penicillins. These antibiotics
work by killing the bacteria that
cause infections.
Noumed Amoxicillin is used to treat
infections in different parts of the
body caused by bacteria. These may
be infections of the chest
(pneumonia), tonsils (tonsillitis),
sinuses (sinusitis), urinary and
genital tract, skin and fleshy tissues.
It is also used to prevent infections
before, during and after surgery.
Noumed Amoxicillin will not work
against infections caused by viruses
such as colds or the flu.
Your doctor may have prescribed this
medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor’s prescription.
Noumed Amoxicillin is not
addictive.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
NOUMED AMOXICILLIN MUST NOT BE
TAKEN IF YOU HAVE AN ALLERGY TO:
•
amoxicillin
•
any β-lactam antibiotics (e.g.
penicillins, cephalosporins,
carbapenem or monobactam)
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face,

Charakteristika produktu

Product Information - Australia
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION – NOUMED
AMOXICILLIN CAPSULES
(AMOXICILLIN TRIHYDRATE)
1. NAME OF THE MEDICINE
Amoxicillin trihydrate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Noumed Amoxicillin capsule contains 250 mg or 500 mg amoxicillin
(as trihydrate).
For the full list of excipients, see _section 6.1 List of excipients_.
3. PHARMACEUTICAL FORM
Noumed Amoxicillin Capsules are white to cream powder in an opaque
yellow hard gelatin capsule.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of the following infections due to susceptible strains of
sensitive organisms:
Note:
Therapy should be guided by bacteriological studies, including
sensitivity tests, and by clinical response.
Amoxicillin alone or in combination with another antibiotic, may be
used in an emergency where the causative has
not been identified.
RESPIRATORY TRACT INFECTIONS (ACUTE AND CHRONIC):
_H. _
_influenzae; _
Streptococcus;
_S. _
_pneumoniae; _
Staphylococcus,
non-penicillinase
producing;
_E. _
_coli _
(see
_Microbiology_).
UROGENITAL INFECTIONS (COMPLICATED AND UNCOMPLICATED, ACUTE AND
CHRONIC):
_E. coli _(see _Microbiology_), _P. mirabilis and Strep. faecalis. _
GONORRHOEA:
_N. gonorrhoea _(non-pencillinase producing).
SKIN AND SKIN STRUCTURE INFECTIONS:
Staphylococcus, non-penicillinase producing; Streptococcus; _E. coli
_(see _Microbiology_).
PROPHYLAXIS OF ENDOCARDITIS:
Amoxicillin may be used for the prophylaxis of bacterial endocarditis
in individuals at particular risk, such as those
with a prosthetic heart valve or those who have previously had
endocarditis.
Infections caused by pathogens with established penicillin G
susceptibility should preferentially be treated with
penicillin G.
Product Information - Australia
Page 2 of 11
4.2 DOSE AND METHOD OF ADMINISTRATION
Amoxicillin suspensions are unavailable in this brand, however are
available in other brands.
Where correct dosing requires amoxicillin suspension formulations,
other brands should be used.
NORMAL RENAL FU