Mirvaso

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Brimonidine tartrate 5 mg/g equivalent to 3.3mg/g brimonidine;  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Brimonidine tartrate 5 mg/g (equivalent to 3.3mg/g brimonidine)

Dosage:

3.3 mg/g

Pharmaceutical form:

Topical gel

Composition:

Active: Brimonidine tartrate 5 mg/g equivalent to 3.3mg/g brimonidine   Excipient: Carbomer 974 Glycerol Methyl hydroxybenzoate Phenoxyethanol Propylene glycol Sodium hydroxide Titanium dioxide

Prescription type:

Prescription

Manufactured by:

Farmak a.s.

Therapeutic indications:

Mirvaso is indicated for the treatment of facial erythema of rosacea in adult patients

Product summary:

Package - Contents - Shelf Life: Tube, polyfoil type A, including head of tube, HDPE-copolymer-Al-copolymer-PE; physician sample - 2 g - 24 months from date of manufacture stored at or below 25°C. do not freeze 6 months opened stored at or below 25°C. do not freeze - Tube, polyfoil type B, including head of tube, HDPE+LLDPE-copolymer-Al-copolymer-PE - 10 g - 24 months from date of manufacture stored at or below 25°C. do not freeze 6 months opened stored at or below 25°C. do not freeze - Tube, polyfoil type A, including head of tube, HDPE-copolymer-Al-copolymer-PE - 10 g - 24 months from date of manufacture stored at or below 25°C. do not freeze 6 months opened stored at or below 25°C. do not freeze - Tube, polyfoil type B, including head of tube, HDPE+LLDPE-copolymer-Al-copolymer-PE - 30 g - 24 months from date of manufacture stored at or below 25°C. do not freeze 6 months opened stored at or below 25°C. do not freeze - Tube, polyfoil type A, including head of tube, HDPE-copolymer-Al-copolymer-PE - 30 g - 24 months from date of manufacture stored at or below 25°C. do not freeze 6 months opened stored at or below 25°C. do not freeze - Tube, plastic, laminated body with HDPE head and PP cap; physician sample - 2 g - 24 months from date of manufacture stored at or below 25°C. do not freeze - Tube, plastic, laminated body with HDPE head and PP child resistant cap - 10 g - 24 months from date of manufacture stored at or below 25°C. do not freeze 6 months opened stored at or below 25°C. do not freeze - Tube, plastic, laminated body with HDPE head and PP child resistant cap - 30 g - 24 months from date of manufacture stored at or below 25°C. do not freeze 6 months opened stored at or below 25°C. do not freeze

Authorization date:

2014-12-12

Patient Information leaflet

MIRVASO Consumer Medicine Information version 6_ _
_Page _1 of 4
MIRVASO
 GEL

_Brimonidine 3.3mg/g_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about
MIRVASO
. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits
.
Your doctor has weighed the risks of
you using
MIRVASO
against the
benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR MEDICINE.
You may need to read it again.
WHAT MIRVASO IS USED
FOR
MIRVASO
contains the active
ingredient brimonidine tartrate that
belongs to a group of substances known
as alpha
2
-adrenergic receptor agonists.
MIRVASO
is used for treating skin of
the face affected by redness due to
rosacea in adult patients.
When applied to the skin,
MIRVASO
gel passes through the skin and acts
specifically on the blood vessels of the
face to decrease the redness of rosacea.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY MIRVASO HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
MIRVASO
is not addictive.
MIRVASO
is available only with a
doctor’s prescription.
BEFORE YOU USE
MIRVASO
_WHEN YOU MUST NOT USE IT _
DO NOT USE MIRVASO:

for any child or adolescents under 18
years of age

if you are breast-feeding

if you are taking medicines for
depression called monoamine
oxidase inhibitors (eg. Nardil,
Parnate) or tricyclic antidepressants
(such as imipramine) or tetracyclic
antidepressants (such as maprotiline,
mianserin or mirtazapine).

if you have an allergy to any
medicine containing brimonidine
tartrate

if you have an allergy to any of the
ingredients listed at the end of this
leaflet
Some of the symptoms of an allergic
reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue or
other parts of the body

rash, itchin

Summary of Product characteristics

1
NEW ZEALAND DATASHEET
1 PRODUCT NAME
MIRVASO
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Brimonidine 3.3 mg/g gel
3 PHARMACEUTICAL FORM
MIRVASO is a white to light-yellow opaque gel. One gram of MIRVASO gel
contains
brimonidine tartrate equivalent to brimonidine 3.3 mg.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
MIRVASO is indicated for the treatment of facial erythema of rosacea
in adult patients.
4.2 Dosage and method of administration
Once daily application. Cutaneous use only.
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.
MIRVASO should be applied in five small pea-size amounts, the total
estimated to be no more
than 1 g, are applied to the main areas of the face (ie. forehead,
chin, nose, each cheek)
once daily after the usual cleansing routine. No more than 1g of gel
per day should be used,
and application to the eyes, eyelids, lips, mouth and membrane of the
inner nose should also
be avoided.
For optimal facial treatment, it is recommended that application is
smooth and even across all
areas of the face (forehead, chin, nose and both cheeks) to avoid
accidental omission of areas,
and minimise noticeable contrast between treated and untreated areas.
Mirvaso should be applied to the face only. Hands should be washed
immediately after
applying MIRVASO.
Other creams or lotions such as cosmetics and sunscreen may be applied
after the application
of MIRVASO. These products should not be applied immediately before
the daily application
of Mirvaso; they may be used only after the applied Mirvaso has dried.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients;
children under 18
years
of age; therapy with concomitant monoamine oxidase inhibitor (MAOI),
tricyclic or tetracyclic
antidepressants, which affect noradrenergic transmission.
4.4 Special warnings and precautions for use
A definite diagnosis of rosacea should be