Apo-Azithromycin

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Azithromycin dihydrate 522.04mg equivalent to 500 mg azithromycin

Предлага се от:

Apotex NZ Ltd

INN (Международно Name):

Azithromycin dihydrate 522.04 mg (equivalent to 500 mg azithromycin)

дозиране:

500 mg

Лекарствена форма:

Film coated tablet

Композиция:

Active: Azithromycin dihydrate 522.04mg equivalent to 500 mg azithromycin Excipient: Calcium hydrogen phosphate dihydrate Croscarmellose sodium Hyprolose Magnesium stearate Opadry white 31K58875 Purified water

Броя в опаковка:

Blister pack, white opaque PVC/aluminium 2 tablets, 2 tablets

Клас:

Prescription

Вид предписание :

Prescription

Произведено от:

Alembic Pharmaceuticals Limited (API Division)

Терапевтични показания:

Azithromycin is indicated for use in adults for the treatment of the following infections of mild to moderate severity: 1. Lower respiratory tract infections (Acute bacterial bronchitis, Community acquired pneumonia). 2. Upper respiratory tract infections (Acute sinusitis, Acute streptococcal pharyngitis, Acute otitis media). 3. Uncomplicated skin and skin structure infections (Uncomplicated infections, Sexually transmitted diseases, Pelvic Inflammatory Disease). 4. Chlamydia trachomatis conjunctivitis and trachoma. 5. Prevention of infection due to Mycobacterium avium-intracellulare Complex (MAC) disease. Azithromycin is indicated for use in children for the treatment of the following infections: 1. Lower respiratory tract infections (Acute bacterial bronchitis, Community acquired pneumonia). 2. Upper respiratory tract infections (Acute sinusitis, Acute streptococcal pharyngitis, Acute otitis media). 3. Uncomplicated skin and skin structure infections (Uncomplicated infections, Sexually transmitted diseases, Pelvic Inflammatory Disease). 4. Prevention of infection due to Mycobacterium avium-intracellulare Complex (MAC) disease. 5. Acute streptococcal pharyngitis/tonsillitis. 6. Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. The 20 mg/kg azithromycin dose appears to be as effective as penicillin in the treatment of streptococcal pharyngitis. However, substantial data establishing the efficacy of azithromycin in the subsequent prevention of rheumatic fever are not available at present. 7. Chlamydia trachomatis conjunctivitis and trachoma in children 12 months or older.

Каталог на резюме:

Package - Contents - Shelf Life: Blister pack, white opaque PVC/aluminium 2 tablets - 2 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, white, round HDPE with blue PP 'lift'n'peel' cap closure 30 tablets - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, white, round HDPE with blue PP 'lift'n'peel' cap closure 500 tablets - 500 tablets - 24 months from date of manufacture stored at or below 25°C

Дата Оторизация:

2008-08-01

Листовка

APO-AZITHROMYCIN TABLETS
1
APO-AZITHROMYCIN TABLETS
_Contains the active ingredient azithromycin (as azithromycin
dihydrate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Azithromycin. 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 Azithromycin
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 YOUR
MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Azithromycin is used to treat
infections in different parts of the
body caused by bacteria. It is
commonly used to treat Chlamydia.
Azithromycin is also used to prevent
infections by a bacterium called
Mycobacterium Aviumintracellulare
Complex (MAC) in some people.
Azithromycin is an antibiotic, which
belongs to a group of medicines
called azalides. The azalides are a
sub-class of a group of antibiotics
called macrolides.
Azithromycin works by killing or
stopping the growth of bacteria
causing your infection.
Azithromycin will not work against
viral infections such as colds or flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY AZITHROMYCIN
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
_USE IN CHILDREN _
There is not enough information to
recommend the use of azithromycin
tablets in children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE AZITHROMYCIN IF YOU
ARE ALLERGIC TO:
•
azithromycin
•
any other macrolide or
ketolide antibiotics (e.g.,
clarithromycin,
erythromycin,
roxithromycin,
telithromycin)
•
any of the ingredients listed
at the end of this leaflet.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing

Данни за продукта

NEW ZEALAND DATA SHEET
APO-AZITHROMYCIN
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 21
1. APO-AZITHROMYCIN (250MG AND 500MG TABLETS)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Azithromycin 250mg and 500mg (as dihydrate)
Excipient(s) of known effect
APO-AZITHROMYCIN does not contain gluten or lactose.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Apo-Azithromycin 250mg tablets are white, oval, film coated tablets
embossed “AZ250”
one side and “APO” on the other. Each tablet contains azithromycin
dihydrate equivalent
to azithromycin 250mg.
Apo-Azithromycin 500mg tablets are white, oval, film coated tablets
embossed “AZ500”
one side and “APO” on the other. Each tablet contains azithromycin
dihydrate equivalent
to azithromycin 500mg.”
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azithromycin is indicated for use in ADULTS for the treatment of the
following infections
of mild to moderate severity:
1. LOWER RESPIRATORY TRACT INFECTIONS:
ACUTE
BACTERIAL
BRONCHITIS
due
to
_Streptococcus _
_pneumoniae, _
_Haemophilus _
_influenza _or _Moraxella catarrhalis _
COMMUNITY
ACQUIRED
PNEUMONIA
due
to
_Streptococcus _
_pneumoniae _
or
_Haemophilus influenzae _in patients suitable for outpatient oral
treatment.
COMMUNITY ACQUIRED PNEUMONIA caused by susceptible organisms in
patients who
require initial intravenous therapy. In clinical studies efficacy has
been demonstrated
against _Chlamydia pneumoniae, Haemophilus influenzae, Legionella
pneumophilia, _
_Moraxella _
_catarrhalis, _
_Mycoplasma _
_pneumoniae, _
_Staphylococcus _
_aureus _
and
_Streptococcus pneumoniae_.
2. UPPER RESPIRATORY TRACT INFECTIONS:
ACUTE SINUSITIS due to _Streptococcus pneumoniae _or _Haemophilus
influenzae_.
APO-AZITHROMYCIN
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 2 of 21
ACUTE STREPTOCOCCAL PHARYNGITIS. Note: Penicillin is the usual drug of
choice in the
treatment of _ Streptococcus pyogenes _ pharyngitis,