Azitromycine 200 mg/5 ml, poeder voor orale suspensie

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

AZITROMYCINE 1-WATER SAMENSTELLING overeenkomend met ; AZITROMYCINE 0-WATER

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

J01FA10

INN (Algemene Internationale Benaming):

AZITHROMYCIN 1-WATER COMPOSITION corresponding to ; AZITHROMYCIN 0-WATER

farmaceutische vorm:

Poeder voor orale suspensie

Samenstelling:

ASPARTAAM (E 951) ; HYPROLOSE (E 463) ; NATUURLIJKE EN KUNSTMATIGE SMAAKSTOFFEN ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRINATRIUMFOSFAAT 0-WATER (E 339) ; XANTHAANGOM (E 415),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Azithromycin

Product samenvatting:

Hulpstoffen: ASPARTAAM (E 951); HYPROLOSE (E 463); NATUURLIJKE EN KUNSTMATIGE SMAAKSTOFFEN; SACCHAROSE; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); TRINATRIUMFOSFAAT 0-WATER (E 339); XANTHAANGOM (E 415);

Autorisatie datum:

2006-10-19

Bijsluiter

Sandoz BV
Page 1/12
Azitromycine 200 mg/5 ml, poeder voor
orale suspensie; RVG 34290
V17
1.3.1.3 Package Leaflet
Juni 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AZITROMYCINE 200 MG/5 ML, POEDER VOOR ORALE SUSPENSIE
azitromycine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
Azithromycin is an antibiotic. It belongs to a group of antibiotics
called macrolides. It is used to treat
infections caused by bacteria.
This medicine is usually prescribed to treat:
-
chest infections such as chronic bronchitis, pneumonia
-
infections of the tonsils, throat (pharyngitis) and sinuses
-
ear infections (acute otitis media)
-
skin and soft tissue infections, with exception of infected burn
wounds
-
urethra and cervix infections caused by chlamydia.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME] IF YOU ARE ALLERGIC
(HYPERSENSITIVE) TO:
•
azithromycin
Sandoz BV
Page 2/12
Azitromycine 200 mg/5 ml, poeder voor
orale suspensie; RVG 34290
V17
1.3.1.3 Package Leaflet
Juni 2020
•
erythromycin
•
other macrolide or ketolide antibiotic
•
any of the other ingredients of this medicine (listed in section 6).
WAR

Productkenmerken

Sandoz B.V.
Page 1/23
Azitromycine 200 mg/5 ml,
poeder voor orale suspensie;
RVG 34290
V18
1.3.1.1 Summary of Product
Characteristics
Juni 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Azitromycine 200 mg/5 ml, poeder voor orale suspensie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each 5 ml reconstituted suspension contains 102.4 mg of azithromycin
monohydrate equivalent to
100 mg of azithromycin.
Each 1 ml reconstituted suspension contains 20.48 mg of azithromycin
monohydrate equivalent to 20
mg of azithromycin.
Excipients with known effect
Each 5 ml reconstituted suspension contains 3.81 g of sucrose, 0.030 g
of aspartame (E 951) and up to
130 nanograms of sulphites.
Each 5 ml reconstituted suspension contains 204.8 mg of azithromycin
monohydrate equivalent to
200 mg of azithromycin.
Each 1 ml reconstituted suspension contains 40.96 mg of azithromycin
monohydrate equivalent to 40
mg of azithromycin.
Excipients with known effect
Each 5 ml reconstituted suspension contains 3.70 g of sucrose, 0.030 g
of aspartame (E 951) and up to
130 nanograms of sulphites.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension.
White to off-white crystalline powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azithromycin powder for oral suspension is indicated for the treatment
of the following infections,
when caused by micro-organisms sensitive to azithromycin (see section
4.4 and 5.1):
Sandoz B.V.
Page 2/23
Azitromycine 200 mg/5 ml,
poeder voor orale suspensie;
RVG 34290
V18
1.3.1.1 Summary of Product
Characteristics
Juni 2020
−
acute bacterial sinusitis (adequately diagnosed)
−
acute bacterial otitis media (adequately diagnosed)
−
pharyngitis, tonsillitis
−
acute exacerbation of chronic bronchitis (adequately diagnosed)
−
mild to moderately severe community acquired pneumonia
−
skin and soft tissue infections
−
uncomplicated
_Chlamydia trachomatis_
urethritis and cervicitis
Considerations should be given to official guidance o