Claritromycine Sandoz 250 mg/5 ml, granulaat voor orale suspensie

Země: Nizozemsko

Jazyk: nizozemština

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

Aktivní složka:

CLARITROMYCINE 50 mg/ml

Dostupné s:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC kód:

J01FA09

INN (Mezinárodní Name):

CLARITROMYCINE 50 mg/ml

Léková forma:

Granulaat voor orale suspensie

Složení:

COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; FRUIT-PUNCH SMAAKSTOFPOEDER ; GLYCEROLMONOSTEARAAT (E 471) ; HYPROMELLOSE (E 464) ; KALIUMSORBAAT (E 202) ; MACROGOL 6000 ; MALTODEXTRINE ; MALTOL (E 636) ; NATRIUMZETMEELOCTENYLSUCCINAAT (E 1450) ; POLOXAMEER 188 ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505) ; XANTHAANGOM (E 415),

Podání:

Oraal gebruik

Terapeutické oblasti:

Clarithromycin

Přehled produktů:

Hulpstoffen: COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); FRUIT-PUNCH SMAAKSTOFPOEDER; GLYCEROLMONOSTEARAAT (E 471); HYPROMELLOSE (E 464); KALIUMSORBAAT (E 202); MACROGOL 6000; MALTODEXTRINE; MALTOL (E 636); NATRIUMZETMEELOCTENYLSUCCINAAT (E 1450); POLOXAMEER 188; POLYSORBAAT 80 (E 433); POVIDON K 30 (E 1201); SACCHAROSE; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505); XANTHAANGOM (E 415);

Datum autorizace:

1900-01-01

Informace pro uživatele

Sandoz B.V.
Page 1/11
Claritromycine Sandoz
®
125 mg/5 ml,
Claritromycine Sandoz
®
250 mg/5 ml,
granulaat voor orale suspensie
RVG 30789-30791
1311-V11
1.3.1.3 Bijsluiter
Maart 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CLARITROMYCINE SANDOZ® 125 MG/5 ML, GRANULAAT VOOR ORALE SUSPENSIE
CLARITROMYCINE SANDOZ® 250 MG/5 ML, GRANULAAT VOOR ORALE SUSPENSIE
clarithromycin
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
Clarithromycin is an antibiotic which belongs to the group of
macrolide antibiotics. It stops the growth
of certain bacteria.
[Nationally completed name] is used to treat:
•
Throat and sinus infections
•
Middle ear infections in children
•
Chest infections, such as bronchitis and pneumonia
•
Skin and soft-tissue infections
•
Gastric ulcers caused by the bacterium Helicobacter pylori.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [
N
ATIONALLY COMPLETED NAME]
•
if you are
ALLERGIC
to clarithromycin, other macrolide antibiotics or any of the other
ingredients of
this medicine (listed in section 6)
•
if you or someone in your family has a history of
HEART RHYTHM DISORDERS
(ventricular
arrhyth

Charakteristika produktu

Sandoz B.V.
Page 1/25
Claritromycine Sandoz 125 mg/5 ml, Claritromycine
Sandoz 250 mg/5 ml, granulaat voor orale suspensie
RVG 30789-30791
1311-V8
1.3.1.1 Samenvatting van de Productkenmerken
Maart 2021
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Claritromycine Sandoz 125 mg/5 ml, granulaat voor orale suspensie
Claritromycine Sandoz 250 mg/5 ml, granulaat voor orale suspensie
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution 1 ml oral suspension contains 25 mg of
clarithromycin, 5 ml oral suspension
contain 125 mg of clarithromycin.
Excipient with known effect:
Each 5 ml ready-for-use suspension contains 2.4 g of sucrose.
After reconstitution 1 ml oral suspension contains 50 mg of
clarithromycin, 5 ml oral suspension
contain 250 mg of clarithromycin.
Excipient with known effect:
Each 5 ml ready-for-use suspension contains 2.4 g of sucrose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Granules for oral suspension.
White to beige granules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] is indicated in adults, adolescents and
children, 6 months to 12 years, for
the treatment of the following acute and chronic infections, when
caused by clarithromycin susceptible
organisms.
•
Infections of the upper respiratory tract such as
tonsillitis/pharyngitis, as an alternative when
beta lactam antibiotics are not appropriate.
•
Acute otitis media in children.
•
Infections of the lower respiratory tract such as community acquired
pneumonia.
•
Sinusitis and acute exacerbation of chronic bronchitis in adults and
adolescents over 12 years of
age
•
Skin infections and soft tissue infections of mild to moderate
severity.
Sandoz B.V.
Page 2/25
Claritromycine Sandoz 125 mg/5 ml, Claritromycine
Sandoz 250 mg/5 ml, granulaat voor orale suspensie
RVG 30789-30791
1311-V8
1.3.1.1 Samenvatting van de Productkenmerken
Maart 2021
In appropriate combination with antibacterial therapeutic regimens and
an appropriate ulcer healing
medicinal