Azitromycine 200 mg/5 ml ratiopharm, poeder voor orale suspensie

Country: Նիդերլանդեր

language: հոլանդերեն

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

active_ingredient:

AZITROMYCINE 2-WATER SAMENSTELLING overeenkomend met ; AZITROMYCINE 0-WATER

MAH:

Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)

ATC_code:

J01FA10

INN:

AZITHROMYCIN 2-WATER COMPOSITION corresponding to ; AZITHROMYCIN 0-WATER

pharmaceutical_form:

Poeder voor oraal gebruik

composition:

BANANENSMAAKSTOF ; HYPROLOSE (E 463) ; KERSENSMAAKSTOF ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; TRINATRIUMFOSFAAT 0-WATER (E 339) ; VANILLESMAAKSTOF ; XANTHAANGOM (E 415),

administration_route:

Oraal gebruik

therapeutic_area:

Azithromycin

leaflet_short:

Hulpstoffen: BANANENSMAAKSTOF; HYPROLOSE (E 463); KERSENSMAAKSTOF; SACCHAROSE; SILICIUMDIOXIDE (E 551); TRINATRIUMFOSFAAT 0-WATER (E 339); VANILLESMAAKSTOF; XANTHAANGOM (E 415);

authorization_date:

2013-04-23

PIL

Azithromycin, NL/H/2455/001, 29.06.23
rvg 111454 EU PIL IA/017/G met NL info-tracked
PACKAGE LEAFLET: INFORMATION FOR THE USER
AZITROMYCINE 200 MG/5 ML RATIOPHARM, POEDER VOOR ORALE SUSPENSIE
azithromycin (as dihydrate)
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 {Product name} is and what it is used for
2.
What you need to know before you take {Product name}
3.
How to take {Product name}
4.
Possible side effects
5.
How to store {Product name}
6.
Contents of the pack and other information
1.
WHAT {PRODUCT NAME} IS AND WHAT IT IS USED FOR
Azithromycin is one of a group of antibiotics called macrolides. It is
used to treat infections caused by
micro-organisms such as bacteria. These infections include:
•
Chest infections such as acute bronchitis and pneumonia
•
Infections in your sinuses, throat, tonsils or ears
•
Mild to moderate skin and soft tissue infections,
_ _
e.g. infection of the hair follicles (folliculitis),
bacterial infection of the skin and its deeper layers (cellulitis),
skin infection with shiny red
swelling (erysipelas)
•
Infections caused by a bacterium called
_Chlamydia trachomatis_
. They can cause inflammations
of the tube that carries urine from your bladder (urethra) or where
your womb joins your vagina
(cervix).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE {PRODUCT NAME}
DO NOT TAKE {PRODUCT NAME}
•
if you are allergic to azithromycin or any of the other ingredients of
this medicine (listed in
section 6).
•
if you are allergic to any other macrolide or k

SPC

Azithromycin, NL/H/2455/001, 29.06.23
1 rvg 111454 EU SPC IA/017/G met NL info-tracked
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Azitromycine 200 mg/5 ml ratiopharm, poeder voor orale suspensien
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml of reconstituted oral suspension contain 200 mg azithromycin (as
dihydrate).
Each ml of reconstituted oral suspension contains 40 mg azithromycin
(as dihydrate).
Excipients with known effect
Benzyl alcohol: 0.65 microgram/5 ml (equivalent to 0.13 microgram/ml)
Sodium: 35.2 mg/5 ml (equivalent to 7.1 mg/ml)
Sucrose: 3.75 g/5 ml (equivalent to 0.75 g/ml)
Sulphites: 0.74 microgram/5 ml (equivalent to 0.148 microgram/ml)
Sulphur dioxide: 0.11 microgram/5 ml (equivalent to 0.02 microgram/ml)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension
White to yellowish-white powder
After reconstitution: Yellowish-white suspension
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of the following infections, when caused by
microorganisms sensitive to
azithromycin (see sections 4.4 and 5.1):
-
Acute bacterial sinusitis
-
Acute bacterial otitis media
-
Pharyngitis, tonsillitis
-
Acute bacterial exacerbation of chronic bronchitis
-
Mild to moderately severe community acquired pneumonia
-
Infections of the skin and soft tissue of mild to moderate severity,
e.g. folliculitis, cellulitis,
erysipelas
-
Uncomplicated
_Chlamydia trachomatis _
urethritis and cervicitis
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
Azithromycin is not the first choice for the empirical treatment of
infections in areas where the
prevalence of resistant isolates is 10% or more (see section 5.1).
Azithromycin
powder for oral suspension
is indicated in children aged 1 year and older (except for
sinusitis treatment), adolescents and adults, see section 4.2.
Azithromycin, NL/H/2455/001, 29.06.23
2 rvg 111454 EU SPC IA/017/G met NL info-tracked
4.2
POSOLOGY AND METHOD OF ADMINISTRA