SIMBRINZA

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

BRIMONIDINE TARTRATE; BRINZOLAMIDE

Dostupné z:

NOVARTIS ISRAEL LTD

ATC kód:

S01EC54

Forma lieku:

EYE DROPS SUSPENSION

Zloženie:

BRIMONIDINE TARTRATE 2 MG / 1 ML; BRINZOLAMIDE 10 MG / 1 ML

Spôsob podávania:

OCULAR

Typ predpisu:

Required

Výrobca:

ALCON RESEARCH LTD., USA

Terapeutické oblasti:

BRINZOLAMIDE, COMBINATIONS

Terapeutické indikácie:

Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.

Dátum Autorizácia:

2017-06-27

Príbalový leták

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
)PREPARATIONS( - 1986
The medicine is dispensed with
a doctor’s prescription only
SIMBRINZA
EYE DROPS, SUSPENSION
Active ingredients:
Brimonidine tartrate 2 mg/ml
Brinzolamide 10 mg/ml
Inactive ingredients in the preparation appear
in section 6 - ”Further Information” and in the
section ”Important information about some of
the ingredients of the medicine”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THE MEDICINE. This leaflet
contains concise information about the
medicine. If you have further questions, refer
to the doctor or pharmacist. This medicine
has been prescribed for the treatment of your
ailment. Do not pass it on to others. It may
harm them, even if it seems to you that their
medical condition is similar.
The medicine is intended for use by adults
over the age of 18.
1. WHAT IS THE MEDICINE INTENDED
FOR?
The medicine is intended for the reduction of
intraocular pressure in adults )over 18 years
of age( in cases of glaucoma or intraocular
hypertension in patients who do not fully
respond to treatment for intraocular pressure
with a single medicine.
THERAPEUTIC GROUP:
Brimonidine tartrate – alpha-2 adrenergic
receptor agonist.
Brinzolamide – carbonic anhydrase inhibitor.
Both ingredients work together to reduce
intraocular pressure.
2. BEFORE USING THE MEDICINE
X DO NOT USE THIS MEDICINE IF:
∙ You have a known sensitivity )allergy(
to brinzolamide or brimonidine tartrate
or to any of the other ingredients of the
medicine )see section 6(.
∙ You are sensitive )allergic( to medicines
from the sulphonamide group )such as
medicines for the treatment of diabetes,
for the treatment of infections and
diuretics(.
∙ You are taking medicines that inhibit
the enzyme monoamine oxidase
)such as medicines for the treatment
of depression or Parkinson’s disease(
or certain anti-depressants. You must
inform the doctor if you are taking any
anti-depressants.
∙ You suffer from severe kidney problems.
∙ You suffer

Súhrn charakteristických

SIM API APR22 V1.1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
SIMBRINZA
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of suspension contains 10 mg of brinzolamide and 2 mg of
brimonidine tartrate
equivalent to 1.3 mg of brimonidine.
Excipient with known effect:
Each mL of suspension contains 0.03 mg of benzalkonium chloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops suspension
White to off-white uniform suspension, pH 6.5 (approximately).
4.CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Decrease of elevated intraocular pressure (IOP) in adult patients with
open-angle
glaucoma or ocular hypertension for whom monotherapy provides
insufficient IOP
reduction (see section 5.1).
_ _
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Use in adults, including the elderly_
_ _
The recommended dose is one drop of SIMBRINZA in the affected eye(s)
two times
daily.
_Missed dose_
_ _
If a dose is missed, treatment should be continued with the next dose
as planned.
_nal impairment_
_Hepatic and/or re_
_ _
SIMBRINZA has not been studied in patients with hepatic impairment and
caution is
therefore recommended in this population (see section 4.4).
SIMBRINZA has not been studied in patients with severe renal
impairment (CrCl <
30 mL/min) or in patients with hyperchloraemic acidosis. Since the
brinzolamide
component of SIMBRINZA and its metabolite are excreted predominantly
by the
kidney, SIMBRINZA is contraindicated in such patients (see section
4.3).
SIM API APR22 V1.1
_Paediatric population_
_ _
_ _
_ _
The safety and efficacy of SIMBRINZA in children and adolescents aged
2 to 17
.
not been established. No data are available
ve
ha
years
_ _
SIMBRINZA is contraindicated in neonates and infants aged less than 2
years in the
decrease of elevated intraocular pressure (IOP) with open-angle
glaucoma or ocular
hypertension for whom monotherapy provides insufficient IOP reduction
because of
safety concerns (see section 4.3).
Method of administration
For ocular use.
P