Apo-Clarithromycin

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Clarithromycin 250mg; Clarithromycin 250mg

Disponibil de la:

Apotex NZ Ltd

INN (nume internaţional):

Clarithromycin 250 mg

Dozare:

250 mg

Forma farmaceutică:

Film coated tablet

Compoziție:

Active: Clarithromycin 250mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Iron oxide yellow Macrogol 8000 Magnesium stearate Microcrystalline cellulose Titanium dioxide Active: Clarithromycin 250mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Iron oxide yellow Macrogol 8000 Magnesium stearate Microcrystalline cellulose Titanium dioxide

Unități în pachet:

Blister pack, PVC/PVdC/Al blister, 2 tablets

Clasă:

Prescription

Tip de prescriptie medicala:

Prescription

Produs de:

Ind-Swift Laboratories Limited

Indicații terapeutice:

Clarithromycin is indicated for treatment of infections caused by susceptible organisms. Such infections include: 1. Respiratory tract infections including bronchitis, pneumonia, tonsillitis, sinusitis and pharyngitis. 2. Skin and soft tissue infections such as folliculitis, cellulitis and erysipelas. 3. Disseminated or localized mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare. Localized infections due to Mycobacterium chelonae, Mycobacterium fortuitum or Mycobacterium kansasii. 4. Prevention of disseminated Mycobacterium avium complex infection in HIV-infected patients with CD4 lymphocyte counts less than or equal to 100/mm3.

Rezumat produs:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al blister - 2 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVdC/Al blister - 14 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVdC/Al blister - 28 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVdC/Al blister - 100 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle with a PP cap - 14 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle with a PP cap - 28 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE bottle with a PP cap - 100 tablets - 24 months from date of manufacture stored at or below 30°C

Data de autorizare:

2009-07-20

Prospect

APO-CLARITHROMYCIN TABLET
1
APO-CLARITHROMYCIN TABLET
_Contains the active ingredient clarithromycin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Apo-Clarithromycin.
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
Apo-
Clarithromycin against the benefits
it is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
TALK
TO
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Apo-Clarithromycin is used to treat
certain bacterial infections, including
the following:
•
Respiratory tract infections
•
Skin infections
•
Ear infections
•
Peptic ulcer
Apo-Clarithromycin is also used to
prevent a specific bacterial infection
associated with HIV infection.
Your doctor, however, may have
prescribed clarithromycin for another
purpose. Ask your doctor if you have
any questions about why
clarithromycin has been prescribed
for you.
Apo-Clarithromycin 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.
Apo-Clarithromycin will not work
against infections caused by virus,
such as colds or flu.
Apo-Clarithromycin is available
only with a doctor’s prescription.
_APO-CLARITHROMYCIN TO TREAT _
_PEPTIC ULCER _
Peptic ulcers are associated with an
infection
in
the
intestine
and
stomach caused by a bacteria
called
Helicobacter
pylori
(H.
pylori).
Nearly all patients with peptic ulcers
are infected with this bacterium.
The
H.
pylori
infection
can
be
treated
with
a
combination
of
clarithromycin
and
other
appropriate antibiotic and stomach
acid
control
treatments.
Your
doctor
will
determine
the
best
combination for you.
If
your symptoms return,
consult
your
doctor.
It
is
possible
that
clarithromycin
may
no
long

Caracteristicilor produsului

NEW ZEALAND DATA SHEET
APO-CLARITHROMYCIN
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 27
1. PRODUCT NAME
APO-CLARITHROMYCIN (250mg and 500mg film coated tablets)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 250mg film coated tablet contains 250mg of clarithromycin.
Each 500mg film coated tablet contains 500mg of clarithromycin.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Apo-Clarithromycin 250 mg tablets are pale yellow, oval, biconvex,
film-coated tablets
engraved “CLA250” on one side, “APO” on the other side.
Apo-Clarithromycin 500 mg tablets are pale yellow, capsule-shaped,
biconvex, film-
coated tablets engraved “CLA500” on one side, “APO” on the
other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clarithromycin tablets are indicated for treatment of infections
caused by
susceptible organisms. Such
infections include:
•
Respiratory tract infections including bronchitis, pneumonia,
tonsillitis, sinusitis
and
pharyngitis (see section 4.4 and 5.1 regarding Sensitivity testing).
•
Skin and soft tissue infections such as folliculitis, cellulitis and
erysipelas (see
section 4.4
and 5.1 regarding Sensitivity testing).
•
Disseminated
or
localized
mycobacterial
infections
due
to
_Mycobacterium _
_avium _
or
_Mycobacterium _
_intracellulare_.
Localized
infections
due
to
_Mycobacterium chelonae_,
_Mycobacterium fortuitum_, or _Mycobacterium kansasii_.
•
Prevention of disseminated _ Mycobacterium avium _ complex infection
in HIV-
infected patients
with CD4 lymphocyte counts less than or equal to 100/mm
3
.
•
Clarithromycin in the presence of acid suppression is indicated for
the treatment of
duodenal
ulcer and in reducing the rate of ulcer recurrence (see section 5.1).
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
APO-CLARITHROMYCIN
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 2 of 27
4.2 DOSE AND METHOD OF