Zithromax

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Azithromycin dihydrate 40 mg/g;  ;  

から入手可能:

Pfizer New Zealand Limited

INN（国際名）:

Azithromycin dihydrate 40 mg/g

投薬量:

200 mg/5mL

医薬品形態:

Powder for oral suspension

構図:

Active: Azithromycin dihydrate 40 mg/g     Excipient: Ar crema vaniglia (vanilla) n11489 (SC613737) flavour Aroma ciliegia (cherry) n11929 (10805307) flavour Banana flavour N15223 (10805500) Hyprolose Sodium phosphate, tribasic Sucrose Xanthan gum

パッケージ内のユニット:

Bottle, plastic, HDPE, 15 mL

クラス:

Prescription

処方タイプ:

Prescription

製:

Pfizer Asia Pacific Pte Ltd

製品概要:

Package - Contents - Shelf Life: Bottle, plastic, HDPE - 15 mL - 60 months from date of manufacture stored at or below 30°C 10 days reconstituted stored at or below 30°C - Bottle, plastic, HDPE - 22.5 mL - 60 months from date of manufacture stored at or below 30°C 10 days reconstituted stored at or below 30°C - Bottle, plastic, HDPE - 30 mL - 60 months from date of manufacture stored at or below 30°C 10 days reconstituted stored at or below 30°C - Bottle, plastic, HDPE - 37.5 mL - 60 months from date of manufacture stored at or below 30°C 10 days reconstituted stored at or below 30°C

承認日:

1990-12-14

情報リーフレット

ZITHROMAX
®
1
ZITHROMAX
®
TABLETS AND ORAL SUSPENSION
_Azithromycin (a-zithro-my-sin)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zithromax. 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 Zithromax
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 ZITHROMAX IS
USED FOR
Zithromax is used to treat infections
in different parts of the body caused
by bacteria.
It is commonly used to treat
Chlamydia. Zithromax is also used
to prevent infections by a bacterium
called Mycobacterium Avium-
intracellulare Complex (MAC) in
some people.
Zithromax 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.
Zithromax works by killing or
stopping the growth of bacteria
causing your infection.
Zithromax will not work against viral
infections such as colds or flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ZITHROMAX
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Zithromax is only available with a
doctor's prescription.
This medicine is not addictive.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU TAKE
ZITHROMAX
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ZITHROMAX 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 or difficulty breathing;
swelling of the face, lips, tongue or
other parts of the body; rash, itching
or hives on the skin.

製品の特徴

Version: pfdzithb10922
Supersedes: pfdzithb11121
Page 1 of 23
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
ZITHROMAX
®
250 mg, 500 mg and 600 mg tablets, film-coated
ZITHROMAX
®
40 mg/mL powder for oral suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
TABLETS
Tablets
contain
azithromycin
dihydrate
equivalent
to
250
mg,
500 mg
or
600 mg of
azithromycin.
POWDER FOR ORAL SUSPENSION
Powder for oral suspension (POS) contains azithromycin dihydrate
equivalent to 40 mg/mL
azithromycin solution following reconstitution.
EXCIPIENTS WITH KNOWN EFFECTS
Excipient(s) with known effect in tablets: lactose
Excipient(s) with known effect in powder for oral suspension:
sugars
(each 5 mL of
reconstituted product contains approximately 3.87 g of sucrose) and
milk products
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
TABLETS
ZITHROMAX 250 mg tablets are white to off-white, unscored, modified
capsule shaped film
coated tablets, engraved with “Pfizer” on one side and “ZTM
250” on the other side.
ZITHROMAX 500 mg tablets are white to off-white, unscored, modified
capsule shaped film
coated tablets, engraved with “Pfizer” on one side and “ZTM
500” on the other side.
ZITHROMAX 600 mg tablets are white to off-white, scored, modified oval
film coated
tablets engraved with “ZTM 600” on one side and “PFIZER” on
the other side.
POWDER FOR ORAL SUSPENSION
ZITHROMAX powder for oral suspension (POS) is a white to off-white
powder.
Version: pfdzithb10922
Supersedes: pfdzithb11121
Page 2 of 23
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
ADULTS
Azithromycin is indicated for use in adults for the treatment of the
following infections of mild
to moderate severity:
LOWER RESPIRATORY TRACT INFECTIONS
_ACUTE BACTERIAL BRONCHITIS_
Due to _Streptococcus pneumoniae, Haemophilus influenzae_ or
_Moraxella catarrhalis_.
_COMMUNITY ACQUIRED PNEUMONIA_
Due to _Streptococcus pneumoniae_ or _Haemophilus influenzae_ in
patients suitable for outpatient
oral treatment.
Community acquired pneumonia caused