DOVOBET OINTMENT

Страна: Южна Африка

Език: английски

Източник: South African Health Products Regulatory Authority (SAHPRA)

Предлага се от:

Adcock Ingram Limited

дозиране:

See ingredients

Лекарствена форма:

OINTMENT

Композиция:

EACH 1,0 g OINTMENT CONTAINS BETAMETHASONE DIPROPIONATE EQUIVALENT TO BETAMETHASONE 0,5 mg CALCIPOTRIOL 50,0 ug

Статус Оторизация:

Registered

Дата Оторизация:

2007-08-06

Листовка

PATIENT INFORMATION LEAFLET
Date of approval: 28 July 2023
SCHEDULING STATUS:
DOVOBET 50 MICROGRAMS/G + 0,5 MG/G OINTMENT
CALCIPOTRIOL/BETAMETHASONE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING DOVOBET
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor, pharmacist,
nurse or other
healthcare provider.
• DOVOBET has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
WHAT IS IN THIS LEAFLET:
1. What DOVOBET is and what it is used for
2. What you need to know before you use DOVOBET
3. How to use DOVOBET
4. Possible side effects
5. How to store DOVOBET
6. Contents of the pack and other information
1. WHAT DOVOBET IS AND WHAT IT IS USED FOR
DOVOBET 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.
DOVOBET 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 DOVOBET
DO NOT USE DOVOBET:
• If you are hypersensitive (allergic) to calcipotriol,
betamethasone or any of the other
S4
PATIENT INFORMATION LEAFLET
Date of approval: 28 July 2023
ingredients in DOVOBET (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)
• If your kidneys or liver do not work properly
• If you are pregnant.
As DOVOBET contains a strong steroid do NOT use on skin affected by
• skin infections caused by viruses (e.g. cold sores or chicken pox)
• skin infections caused by a fungus (e.g. athlete’s foot or
ringworm)
• skin infections caused by bacteria
• skin infections caused by parasites (e.g. scabies)

Данни за продукта

Professional Information
Date of approval: 28 July 2023
SCHEDULING STATUS
1. NAME OF THE MEDICINE
DOVOBET
® ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains calcipotriol 50 µg (as hydrate 52,2 µg) and
betamethasone 0,5 mg (as
dipropionate 0,643 mg).
For the full list of excipients, see section 6.1._ _
3.
PHARMACEUTICAL FORM
Ointment.
Off-white to yellow.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of psoriasis vulgaris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
DOVOBET should be applied to the affected area once daily. The
recommended treatment
period is 4 weeks.
There is experience with repeated courses of DOVOBET up to 52 weeks.
If it is necessary to
continue or restart treatment after 4 weeks, treatment should be
continued under medical
review and under regular medical supervision.
The maximum daily dose should not exceed 15 g, and the maximum weekly
dose should not
exceed 100 g. The treated area should not be more than 30 % of the
body surface.
CHILDREN
There is no experience of use in children and adolescents below the
age of 18 years.
S4
Professional Information
Date of approval: 28 July 2023
METHOD OF ADMINISTRATION
DOVOBET ointment should be applied to the affected area. In order to
achieve optimal effect,
it is not recommended to take a shower or bath immediately after
application of DOVOBET
ointment.
4.3 CONTRAINDICATIONS
•
Known hypersensitivity to calcipotriol, betamethasone or to any of the
excipients listed in
section 6.1.
•
DOVOBET is contraindicated in erythrodermic, exfoliative and pustular
psoriasis.
•
DOVOBET is contraindicated in patients with known disorders of calcium
metabolism due
to the content of calcipotriol (see section 4.4).
•
Due to the content of corticosteroid, DOVOBET is contraindicated in
the following
conditions: viral (e.g., herpes or varicella) lesions of the skin,
fungal or bacterial skin
infections, parasitic infections, skin manifestations in relation to
tuberculosis, perioral
dermatitis, atrophic skin, striae atrop