CLARITHROMYCIN SANDOZ clarithromycin 250 mg film-coated tablets blister pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

clarithromycin, Quantity: 250 mg

Boleh didapati daripada:

Sandoz Pty Ltd

INN (Nama Antarabangsa):

Clarithromycin

Borang farmaseutikal:

Tablet, film coated

Komposisi:

Excipient Ingredients: titanium dioxide; powdered cellulose; magnesium stearate; hypromellose; macrogol 4000; croscarmellose sodium; microcrystalline cellulose; colloidal anhydrous silica; lactose monohydrate

Laluan pentadbiran:

Oral

Unit dalam pakej:

100, 14

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

CLARITHROMYCIN SANDOZ clarithromycin is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: Acute streptococcal pharyngitis; Community acquired pneumonia due to Chlamydia pneumoniae, Mycoplasma pneumoniae, Legionella pneumophilia and Streptococcus pneumoniae;Uncomplicated skin and skin structure infections due to Staphylococcus aureus or Streptococcus pyogenes;Disseminated or localised mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare and skin and skin structure infections due to Mycobacterium chelonae. Clarithromycin should be used in combination with other anti mycobacterial agents.Prevention of disseminated Mycobacterium avium complex infection in HIV infected adults with CD4 lymphocyte counts <75 cells/mm 3 (See Precautions). Disseminated infection due to Mycobacterium avium complex should be excluded by a negative blood culture prior to commencement of prophylaxis.Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae;Combination therapy for the treatment of peptic ulcer disease associated with Helicobacter pylori infection. CLARITHROMYCIN SANDOZ clarithromycin is indicated for use in children for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro organisms in the conditions listed below:Acute streptococcal pharyngitis and tonsillitis caused by Streptococcus pyogenes; Community acquired pneumonia including infections due to Chlamydia pneumoniae, Mycoplasma pneumoniae and Legionella pneumophila; Skin and skin structure infections (eg impetigo); Disseminated or localised infections due to Mycobacterium avium or Mycobacterium intracellulare in immunocompromised children, including those with HIV Infection or AIDS. Acute otitis media.Note:1. Penicillins are the drug of first choice in the treatment of acute otitis media. 2. Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections including prophylaxis of rheumatic fever. Clarithromycin appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx, however substantial data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present. 3. There is insufficient evidence of efficacy to support the use of Clarithromycin in acute bronchitis in young children. 4. The data presented on infections of skin and skin structure were confined largely to mild to moderate infections such as impetigo.

Ringkasan produk:

Visual Identification: White, oblong, convex tablets, scored on both faces; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status kebenaran:

Licence status A

Tarikh kebenaran:

2005-08-29

Risalah maklumat

CLARITHROMYCIN SANDOZ
®
1
CLARITHROMYCIN
SANDOZ
®
_Clarithromycin (kla-ree-thro-MY-sin) tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Clarithromycin
Sandoz. 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 risk of you taking Clarithromycin
Sandoz against the benefits it is
expected to 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 want to read it again.
WHAT
CLARITHROMYCIN
SANDOZ IS USED
FOR
Clarithromycin Sandoz is used to
treat certain bacterial infections,
including the following:
•
respiratory tract infections
(throat, airways and lungs)
•
ear infections
•
skin infections
•
peptic ulcer
Clarithromycin Sandoz is also used
to prevent a specific bacterial
infection associated with HIV
infection.
Clarithromycin Sandoz is an
antibiotic that belongs to the group of
medicines called macrolides. These
medicines work by killing or
stopping the growth of bacteria
which cause infections. It contains
the active ingredient clarithromycin.
Your doctor, however, may have
prescribed Clarithromycin Sandoz
for another purpose. Ask your doctor
if you have any questions about why
Clarithromycin Sandoz has been
prescribed for you.
Clarithromycin Sandoz will not work
against infections caused by viruses,
such as colds or flu.
CLARITHROMYCIN SANDOZ TO TREAT
PEPTIC ULCER
Peptic ulcers are associated with an
infection in the intestine and stomach
by a bacteria called Helicobacter
pylori (H. pylori). Nearly all patients
with peptic ulcers are infected with
this bacteria.
The H. pylori infection can be treated
with a combination of
Clarithromycin Sandoz
(clarithromycin), another appropriate
antibiotic and stomach acid control
treatments.
However, the best combination of
tablets to treat H. pylori infection is
yet to be determined.

Ciri produk

130819-Clarithromycin-sandoz-pi
Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION
CLARITHROMYCIN SANDOZ
® (CLARITHROMYCIN)
1
NAME OF THE MEDICINE
Clarithromycin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Clarithromycin Sandoz 250 mg contains 250 mg clarithromycin.
Each Clarithromycin Sandoz 500 mg contains 500 mg clarithromycin.
_Not all strengths may be marketed in Australia. _
_Excipient with known effect: _
lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Clarithromycin Sandoz 250 mg film-coated tablets are white, oblong,
convex tablets, scored
on both faces.
Clarithromycin Sandoz 500 mg film-coated tablets are white, oblong,
convex tablets scored on
both faces.
_ _
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Clarithromycin Sandoz (clarithromycin) is indicated for use in adults
and children older than
12 years for the treatment of mild to moderately severe infections
caused by susceptible strains
of the designated micro-organisms in the conditions listed below:
1. Acute streptococcal pharyngitis
2.
Community
acquired
pneumonia
due
to
_Chlamydia _
_pneumoniae, _
_Mycoplasma _
_pneumoniae, Legionella pneumophila _
and
_Streptococcus pneumoniae _
(See Section 4.4
Special warnings and precautions for use regarding sensitivity
testing)
3. Uncomplicated skin and skin structure infections due to
_Staphylococcus aureus _
or
_Streptococcus pyogenes _
(See Section 4.4 Special warnings and precautions for use regarding
sensitivity testing)
4. Disseminated or localised mycobacterial infections due to
_ Mycobacterium avium _
or
_Mycobacterium intracellulare_
and skin and skin structure infections due to
_Mycobacterium _
_chelonae_
. Clarithromycin should be used in combination with other
antimycobacterial
agents
5. Prevention of disseminated
_Mycobacterium avium_
complex infection in HIV-infected
adults with CD4 lymphocyte counts < 75 cells/mm
3
(see Section 4.4 Special warnings and
precautions for use). Disseminated infection due to
_Mycobacterium aviu