Dotevatrol 50 micrograms/g + 0.5 mg/g Ointment

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Betamethasone; Calcipotriol, anhydrous

から入手可能:

Teva Pharma B.V.

ATCコード:

D05AX; D05AX52

INN（国際名）:

Betamethasone; Calcipotriol, anhydrous

投薬量:

50 + 0.5

医薬品形態:

Ointment

処方タイプ:

Product subject to prescription which may not be renewed (A)

治療領域:

Other antipsoriatics for topical use; calcipotriol, combinations

認証ステータス:

Not marketed

承認日:

2013-12-09

情報リーフレット

1
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOTEVATROL 50 MICROGRAM/G + 0.5 MG/G OINTMENT
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 or
nurse.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Dotevatrol Ointment is and what it is used for
2.
What you need to know before you use Dotevatrol Ointment
3.
How to use Dotevatrol Ointment
4.
Possible side effects
5.
How to store Dotevatrol Ointment
6.
Contents of the pack and other information
1.
WHAT DOTEVATROL OINTMENT IS AND WHAT IT IS USED FOR
Dotevatrol 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. Dotevatrol 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 DOTEVATROL OINTMENT
DO NOT USE DOTEVATROL OINTMENT:
• 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).
As Dotevatrol Ointment contains a strong steroid do NOT use on skin
affected by
• infections caused by viruses (e.g. cold sores or chicken pox)
• infections caused by a fungus (e.g. athlete’s foot or ringworm)
• infectio

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dotevatrol 50 micrograms/g + 0.5 mg/g Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of ointment contains 50 micrograms of calcipotriol
(anhydrous) and 0.5 mg of betamethasone (as 0.643 mg
betamethasone dipropionate).
Excipient(s) with known effect:
One gram of ointment contains 50 micrograms of butylhydroxytoluene
(E321)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment.
Off-white to yellow
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
Dotevatrol 50 micrograms/g + 0.5mg/g Ointment should be applied to the
affected area once daily.
The recommended treatment period is 4 weeks. There is experience with
repeated courses of
calcipotriol/betamethasone 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 calcipotriol/betamethasone ointment in
patients with severe renal insufficiency or severe
hepatic disorders have not been evaluated.
_Paediatric population_
The safety and efficacy of calcipotriol/betamethasone 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.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__