DOVOBET 50 + 0.5 Gel

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

CALCIPOTRIOL, BETAMETHASONE

Prieinama:

LTT Pharma Limited

ATC kodas:

D05AX52

INN (Tarptautinis Pavadinimas):

CALCIPOTRIOL, BETAMETHASONE

Dozė:

50 + 0.5

Vaisto forma:

Gel

Recepto tipas:

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

Gydymo sritis:

Other antipsoriatics for topical use

Autorizacija statusas:

Authorised

Leidimo data:

2014-01-31

Pakuotės lapelis

•
Skin rash with inflammation or swelling
(allergic contact dermatitis)
WHAT DOVOBET
®
LOOKS LIKE AND THE CONTENTS OF
THE PACK
PACKAGE LEAFLET: INFORMATION FOR THE USER
®
Ref: 103/001/161017/1/F
•
Golden coloured gel-filled bumps (colloid
milia)
•
Lightening of skin colour (depigmentation).
Dovobet
®
is an almost clear, colourless to slightly
off-white gel filled in
high-density polyethylene bottles with a
DOVOBET 50 MICROGRAMS/G + 0.5 MG/G
GEL
(calcipotriol/betamethasone)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
•
Inflammation or swelling of the hair root
(folliculitis).
Less serious side effects known to be caused
by calcipotriol include the following
•
Dry skin
•
Sensitivity of the skin to light resulting in a
rash
•
Eczema
•
Itching
•
Skin irritation
•
Burning and stinging sensation
•
Redness of the skin due to widening of the
small blood vessels (erythema)
•
Rash
•
Rash with inflammation of the skin (dermatitis)
•
Worsening of psoriasis.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via HPRA
Pharmacovigilance, Earlsfort Terrace, IRL – Dublin
2; Tel: [phone]; Fax: [phone].
Website: www.hpra.ie; e-mail: [e-mail].
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO
STORE
DOVOBET
®
Keep this medicine out of the sight and reach of
children.
Do not refrigerate. Keep the bottle in the outer
carton in order to protect from light.
Discard the bottle with any remaining gel 3 months
after first opening.
low-density polyethylene nozzle and a high-density
screw cap.
The bottles are placed in cartons.
Pack size: 2 x 30 g.
THE PARALLEL PRODUCT AUTHORISATION HOLDER IS:
LTT Pharma Limited, Unit 18 Oxleasow Road,
East Moons Moat, Redditch, Worcestershire,
B98 0RE, UK.
RE-PACKAGED BY:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch,

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dovobet 50 microgram/g + 0.5 mg/g gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of gel contains 50 micrograms of calcipotriol (as
monohydrate) and 0.5 mg of betamethasone (as
dipropionate).
Excipient with known effect
Butylhydroxytoluene (E321)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gel.
_Product imported from Italy_
An almost clear, colourless to slightly off-white gel.
4 CLINICAL PARTICULARS
As per PA1025/001/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1025/001/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Paraffin, liquid
Polyoxypropylene-11 stearyl ether
Castor oil, hydrogenated
Butylhydroxytoluene (E321)
All-rac-
-tocopherol
6.2 INCOMPATIBILITIES
In the absence of compatibility studies, this medicinal product must
not be mixed with other medicinal products.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
After first opening the bottle: 3 months.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not refrigerate.
Keep the bottle in the outer carton in order to protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
High-density polyethylene bottles with a low-density