Azitromycine Sandoz 100 mg/5 ml, poeder voor orale suspensie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

AZITROMYCINE 2-WATER 21 mg/ml SAMENSTELLING overeenkomend met ; AZITROMYCINE 0-WATER 20 mg/ml

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

J01FA10

INN (Algemene Internationale Benaming):

AZITROMYCINE 2-WATER 21 mg/ml SAMENSTELLING overeenkomend met ; AZITROMYCINE 0-WATER 20 mg/ml

farmaceutische vorm:

Poeder voor orale suspensie

Samenstelling:

ASPARTAAM (E 951) ; BANANENSMAAKSTOF ; GLYCEROLTRIACETAAT (E 1518) ; HYPROLOSE (E 463) ; KERSENSMAAKSTOF ; MALTODEXTRINE ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRINATRIUMFOSFAAT 0-WATER (E 339) ; VANILLESMAAKSTOF ; XANTHAANGOM (E 415), ASPARTAAM (E 951) ; BANANENSMAAKSTOF ; GLYCEROLTRIACETAAT (E 1518) ; HYPROLOSE (E 463) ; KERSENSMAAKSTOF ; MALTODEXTRINE ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450) ; PROPYLEENGLYCOL (E 1520) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRINATRIUMFOSFAAT 0-WATER (E 339) ; VANILLESMAAKSTOF ; XANTHAANGOM (E 415), 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:

1900-01-01

Bijsluiter

Sandoz B.V.
Page 1/12
Azitromycine Sandoz 100 mg/5 ml, poeder
voor orale suspensie; RVG 32016
1313-V22a
1.3.1. Package Leaflet
Oktober 2022
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
AZITROMYCINE SANDOZ
® 100 MG/5 ML, POEDER VOOR ORALE SUSPENSIE
azithromycin
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]
Sandoz B.V.
Page 2/12
Azitromycine Sandoz 100 mg/5 ml, poeder
voor orale suspensie; RVG 32016
1313-V22a
1.3.1. Package Leaflet
Oktober 2022
DO NOT TAKE [NATIONALLY COMPLETED NAME] IF YOU ARE ALLERGIC
(HYPERSENSITIVE) TO:
•
azithromycin
•
erythromycin
•
other macrolide or ketolide antibiotic
•
any of the other ingredients of t

Productkenmerken

Sandoz B.V.
Page 1/23
Azitromycine Sandoz 100 mg/5 ml, poeder voor orale
suspensie; RVG 32016
1311-V26a
1.3.1.1 Summary of Product Characteristics
Oktober 2022
1.
NAAM VAN HET GENEESMIDDEL
[Azitromycine Sandoz 100 mg/5 ml, poeder voor orale suspensie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each 5 ml reconstituted suspension contains 104.80 mg of azithromycin
dihydrate equivalent to 100
mg of azithromycin.
Each 1 ml reconstituted suspension contains 20.96 mg of azithromycin
dihydrate equivalent to 20 mg
of azithromycin.
Excipients with known effect
Each 5 ml reconstituted suspension contains 3.82 g of sucrose, 0.030 g
of aspartame (E 951), up to
410 nanograms of benzyl alcohol, and up to 85 nanograms of sulphites.
Each 5 ml reconstituted suspension contains 209.6 mg of azithromycin
dihydrate equivalent to 200 mg
of azithromycin.
Each 1 ml reconstituted suspension contains 41.92 mg of azithromycin
dihydrate equivalent to 40 mg
of azithromycin.
Excipients with known effect
Each 5 ml reconstituted suspension contains 3.71 g of sucrose, 0.030 g
of aspartame (E 951), up to
410 nanograms of benzyl alcohol and up to 85 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):
−
acute bacterial sinusitis (adequately diagnosed)
Sandoz B.V.
Page 2/23
Azitromycine Sandoz 100 mg/5 ml, poeder voor orale
suspensie; RVG 32016
1311-V26a
1.3.1.1 Summary of Product Characteristics
Oktober 2022
−
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_
urethrit