Calcipotriol/Betamethason Sandoz 50 microgram/g + 0,5 mg/g, zalf

Nazione: Paesi Bassi

Lingua: olandese

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

Principio attivo:

BETAMETHASONDIPROPIONAAT SAMENSTELLING overeenkomend met ; BETAMETHASON ; CALCIPOTRIOL 1-WATER SAMENSTELLING overeenkomend met ; CALCIPOTRIOL

INN (Nome Internazionale):

BETAMETHASONDIPROPIONAAT COMPOSITION corresponding to ; BETAMETHASONE ; CALCIPOTRIOL 1-WATER COMPOSITION corresponding to ; CALCIPOTRIOL

Forma farmaceutica:

Zalf

Composizione:

OLEYLALCOHOL ; PARAFFINE, DUNVLOEIBAAR ; TOCOFEROL, DL-ALFA (E 307) ; VASELINE, WIT

Via di somministrazione:

Cutaan gebruik

Data dell'autorizzazione:

2022-11-28

Foglio illustrativo

Sandoz B.V.
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Calcipotriol/Betamethason Sandoz 50 microgram/g + 0,5 mg/g,
zalf
RVG 128819
1313-V1
1.3.1.3 Bijsluiter
November 2022
PACKAGE LEAFLET: INFORMATION FOR THE USER
CALCIPOTRIOL/BETAMETHASON SANDOZ 50 MICROGRAM/G + 0,5 MG/G, ZALF
calcipotriol/betamethasone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 use [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 IS USED FOR
[Nationally completed name] ointment is used on the skin to treat
plaque psoriasis (psoriasis
vulgaris) in adults. Psoriasis is caused by your skin cells being
produced too quickly. This causes
redness, scaling and thickness of your skin.
[Nationally completed name] ointment contains calcipotriol and
betamethasone. Calcipotriol helps
to bring the rate of skin cell growth back to normal and betamethasone
acts to reduce inflammation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE [NATIONALLY COMPLETED NAME]
DO NOT USE
[Nationally completed name]
•
If you are allergic to calcipotriol, betamethasone or any of the other
ingredients of this medicine
(listed in section 6)
•
If you have problems with calcium levels in the body (ask your doctor)
•
If you have certain types of psoriasis: these are erythrodermic,
exfoliative and pustular (ask your
doctor).
S

Scheda tecnica

Sandoz B.V.
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Calcipotriol/Betamethason Sandoz 50 microgram/g + 0,5
mg/g, zalf
RVG 128819
1311-V1
1.3.1.1 Samenvatting van de Productkenmerken
November 2022
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Calcipotriol/Betamethason Sandoz 50 microgram/g + 0,5 mg/g, zalf
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of ointment contains 50 micrograms of calcipotriol (as
monohydrate) and 0.5 mg of
betamethasone (as dipropionate).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Ointment.
Off white.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topical treatment of stable plaque psoriasis vulgaris amenable to
topical therapy in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
[Nationally completed name] ointment should be applied to the affected
area once daily.
The recommended treatment period is 4 weeks. There is experience with
repeated courses of
[Nationally completed name] up to 52 weeks. If it is necessary to
continue or restart treatment after 4
weeks, treatment should be continued after medical review and under
regular medical supervision.
When using calcipotriol containing medicinal products, the maximum
daily dose should not exceed 15
g. The body surface area treated with calcipotriol containing
medicinal products should not exceed 30
% (see section 4.4).
Special populations
_Renal and hepatic impairment _
The safety and efficacy of [Nationally completed name] ointment in
patients with severe renal
insufficiency or severe hepatic disorders have not been evaluated.
Sandoz B.V.
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Calcipotriol/Betamethason Sandoz 50 microgram/g + 0,5
mg/g, zalf
RVG 128819
1311-V1
1.3.1.1 Samenvatting van de Productkenmerken
November 2022
_Paediatric population _
The safety and efficacy of [Nationally completed name] ointment in
children below 18 years have not
been established. Currently available data in children aged 12 to 17
years are described in section 4.8
and 5.1 but no recommendation on a posology can be made.
_ _
_Method of administratio