Mirvaso
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
19-04-2023
Produktets egenskaber
(SPC)
19-04-2023
Offentlige vurderingsrapport
(PAR)
14-03-2014
Aktiv bestanddel:
brimonidine tartrate
Tilgængelig fra:
Galderma International
ATC-kode:
D11AX21
INN (International Name):
brimonidine
Terapeutisk gruppe:
Other dermatological preparations
Terapeutisk område:
Skin Diseases
Terapeutiske indikationer:
Mirvaso is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients.
Produkt oversigt:
Revision: 13
Autorisation status:
Authorised
Autorisation dato:
2014-02-20
Indlægsseddel
22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MIRVASO 3 MG/G GEL
brimonidine
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.
-
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Mirvaso is and what it is used for
2.
What you need to know before you use Mirvaso
3.
How to use Mirvaso
4.
Possible side effects
5.
How to store Mirvaso
6.
Contents of the pack and other information
1.
WHAT MIRVASO IS AND WHAT IT IS USED FOR
Mirvaso contains the active substance brimonidine which belongs to a
group of medicines commonly
referred to as “alpha agonists”.
It is applied to the skin of the face to treat redness due to rosacea
in adult patients.
Redness of the face due to rosacea is caused by high levels of blood
flow in the facial skin, which is
the result of enlargement (dilation) of the small blood vessels of the
skin.
When applied, Mirvaso acts to narrow these blood vessels again which
reduces the excess blood flow
and redness.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MIRVASO
DO NOT USE MIRVASO:
-
if you are allergic to brimonidine or any of the other ingredients of
this medicine (listed in
section 6).
-
in children below 2 years of age, as they may be at greater risk of
side effects from any of the
medicine absorbed through the skin.
-
if you are taking certain medicines used for depression or
Parkinson’s disease including
so-called monoamine oxidase (MAO) inhibitors (for example selegiline
or moclobemide)
or tricyclic antidepressants (such as imipramine) or tetracyclic
antidepressants (such as
maprotiline, mianserin or mirtazapin). Use of Mirvaso when tak
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Mirvaso 3 mg/g gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of gel contains 3.3 mg of brimonidine, equivalent to 5 mg of
brimonidine tartrate.
Excipient(s) with known effect:
One gram of gel contains 1 mg methylparahydroxybenzoate (E218) and 55
mg propylene glycol
(E1520).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel.
White to light yellow opaque aqueous gel.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mirvaso is indicated for the symptomatic treatment of facial erythema
of rosacea in adult patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One application per 24 hours, at any time suitable for the patient,
for as long as facial erythema is
present.
The maximum daily recommended dose is 1 g of gel in total weight,
which corresponds to
approximately five pea sized amounts.
Treatment should be initiated with a smaller amount of gel (less than
the maximum) for at least one
week. The amount of gel can then be increased gradually based on
tolerability and patient response.
_Special populations_
_Elderly patients_
The experience of use of Mirvaso in patients aged above 65 years is
limited (see also section 4.8). No
dose adjustment is necessary.
_Hepatic and renal impairment_
Mirvaso has not been studied in patients with hepatic and renal
impairment.
_Paediatric population_
The safety and efficacy of Mirvaso in children and adolescents aged
less than 18 years have not been
established. No data are available.
3
Mirvaso is contraindicated in children aged less than 2 years because
of serious systemic safety risk
(see section 4.3). Safety concerns related to the systemic absorption
of brimonidine have also been
identified for the age group 2 to 12 years (see section 4.9). Mirvaso
should not be used in children or
adolescents aged 2 to 18 years.
Method of administration
Cutaneous use only.
Mirvaso should be applied smoothly and evenly as a thin layer across
the entire face (forehead,
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