DOVATE OINTMENT

País: África do Sul

Língua: inglês

Origem: South African Health Products Regulatory Authority (SAHPRA)

Disponível em:

Pharmacare Limited û Woodmead

Dosagem:

See ingredients

Forma farmacêutica:

OINTMENT

Composição:

EACH 5 g OINTMENT CONTAINS CLOBETASOL PROPIONATE 2,5 mg

Status de autorização:

Registered

Data de autorização:

1994-05-05

Folheto informativo - Bula

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1.3.2 PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
DOVATE OINTMENT 2,5 MG/5,0 G
CLOBETASOL PROPIONATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING DOVATE
OINTMENT
•
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.
•
DOVATE OINTMENT 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 DOVATE OINTMENT is and what it is used for
2.
What you need to know before you use DOVATE OINTMENT
3.
How to use DOVATE OINTMENT
4.
Possible side effects
5.
How to store DOVATE OINTMENT
6.
Contents of the pack and other information
1.
WHAT DOVATE OINTMENT IS AND WHAT IT IS USED FOR
DOVATE OINTMENT belongs to a group of medicines called topical
corticosteroids and is
for short-term use in the treatment of skin problems such as:
seborrhoeic dermatitis, atopic
dermatitis, lichen chronicus simplex, pruritus ani, psoriasis, later
phase of allergic contact
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dermatitis, later phase of irritant dermatitis, discoid lupus
erythematosus and lichen planus
which do not response to treatment with steroids that are less potent.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DOVATE OINTMENT
DO NOT USE DOVATE OINTMENT:
•
If you are hypersensitive (allergic) to clobetasol propionate or any
of the other
ingredients of DOVATE OINTMENT (listed in section 6).
•
if you are hypersensitive (allergic) to other corticosteroids.
•
if you currently have bacterial (including tuberculous), fungal or
viral infections of the
skin.
•
if you have ulcerative skin lesions or rosacea (a skin condition
affecting the face).
•
if you intend to apply it to ulcers of the leg.
•
if you have diabetes mellitus or tuberculosis and intend to use this
medicine long
term.
•
if

Características técnicas

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1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS S4
1. NAME OF THE MEDICINE
DOVATE OINTMENT 2,5 MG/5,0 G
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5,0 g of DOVATE OINTMENT contains 2,5 mg of clobetasol
propionate.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
DOVATE OINTMENT is a soft, smooth off-white ointment.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
DOVATE OINTMENT is indicated for:
Short term use in the treatment of steroid responsive dermatoses
resistant to other less potent
topical corticosteroids such as: seborrhoeic dermatitis, atopic
dermatitis, lichen chronicus
simplex, pruritus ani, psoriasis, later phase of allergic contact
dermatitis, later phase of irritant
dermatitis, discoid lupus erythematosus and lichen planus.
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4.2. POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults _
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Apply once or twice daily sparingly to the affected area until
improvement occurs. Therapy should
be discontinued when control is achieved.
In the more responsive conditions this may be within a few days. If a
longer course is necessary,
it is recommended that treatment should not be continued for longer
than four weeks without the
patient’s condition being reviewed.
Repeated short courses of DOVATE OINTMENT may be used to control
exacerbations. If
continuous steroid treatment is necessary, a less potent preparation
should be used.
In very resistant lesions, especially where there is hyperkeratosis,
the treatment area must be
occluded for part of each 24 hours. Thereafter improvement can usually
be maintained by
application without occlusion.
METHOD OF ADMINISTRATION
For topical administration.
4.3. CONTRAINDICATIONS
DOVATE OINTMENT is contraindicated in:
•
Patients with hypersensitivity to clobetasol propionate or to any
excipients in DOVATE
OINTMENT (see section 6.1).
•
Known sensitivity to corticosteroids.
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