Briglau 2 mg/ml, oogdruppels, oplossing

国: オランダ

言語: オランダ語

ソース: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

有効成分:

BRIMONIDINETARTRAAT SAMENSTELLING overeenkomend met ; BRIMONIDINE

から入手可能:

Medana Pharma Spólka Akcyjna

ATCコード:

S01EA05

INN（国際名）:

Brimonidine tartrate COMPOSITION corresponding to ; BRIMONIDINE

医薬品形態:

Oogdruppels, oplossing

構図:

BENZALKONIUMCHLORIDE ; CITROENZUUR 1-WATER (E 330) ; NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; POLYVINYLALCOHOL (E1203) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; WATER, GEZUIVERD ; ZOUTZUUR (E 507),

投与経路:

Oculair gebruik

治療領域:

Brimonidine

製品概要:

Hulpstoffen: BENZALKONIUMCHLORIDE; CITROENZUUR 1-WATER (E 330); NATRIUMCHLORIDE; NATRIUMHYDROXIDE (E 524); POLYVINYLALCOHOL (E1203); TRINATRIUMCITRAAT 2-WATER (E 331); WATER, GEZUIVERD; ZOUTZUUR (E 507);

承認日:

2012-10-24

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRIGLAU 2 MG/ML, OOGDRUPPELS, OPLOSSING
Brimonidine tartrate
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Briglau is and what it is used for
2.
What you need to know before you use Briglau
3.
How to use Briglau
4.
Possible side effects
5.
How to store Briglau
6.
Contents of the pack and other information
1.
WHAT BRIGLAU IS AND WHAT IT IS USED FOR
Briglau is used to reduce pressure within the eye.
It can be used either alone or with another eye drop to lower the
increased pressure in the eye which
occurs in open angle glaucoma or ocular hypertension.
The active ingredient in Briglau is brimonidine tartrate, which works
by reducing pressure within the
eyeball.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BRIGLAU
DO NOT USE BRIGLAU:
-
if you are allergic to brimonidine tartrate or any of the other
ingredients of this medicine (listed
in section 6).
-
if you are taking monoamine oxidase (MAO) inhibitors or certain
antidepressants, for example
tricyclic antidepressants or mianserin.
If you are already taking an antidepressant drug, ask your doctor if
you can use Briglau.
-
if you are breast-feeding.
-
in infants/babies (from birth until 2 years).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Briglau if you:
-
suffer or have suffered from depression, reduced mental capacity,
reduced blood supply to the
brain, heart problems, a disturbed blood supply of the limbs or a
blood pressure disorder.
-
have or have had in the past kidney or li

製品の特徴

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Briglau 2 mg/ml, oogdruppels, oplossing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml solution contains 2.0 mg brimonidine tartrate, equivalent to
1.3 mg of brimonidine.
Excipient with known effect: benzalkonium chloride. Each ml contains
0.05 mg benzalkonium
chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution
Clear and yellowish-green liquid
Osmolality: 280~330 mOsmol/kg
pH: 5.7 - 6.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure (IOP) in patients with open
angle glaucoma or ocular
hypertension.
-
As monotherapy in patients in whom topical beta-blocker therapy is
contraindicated.
-
As adjunctive therapy to other intraocular pressure lowering
medications when the target IOP is
not achieved with a single agent (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Pasology
_Adults (including the elderly) _
The recommended dose is one drop of Briglau in the affected eye(s)
twice daily, approximately
12 hours apart. No dosage adjustment is required for the use in
elderly patients.
As with any eye drops, to reduce possible systemic absorption, it is
recommended that the lachrymal
sac be compressed at the medial canthus (punctal occlusion) for one
minute. This should be performed
immediately following the instillation of each drop.
If more than one topical ophthalmic drug is to be used, the different
drugs should be instilled
5-15 minutes apart.
_Use in renal and hepatic impairment _
Brimonidine has not been studied in patients with hepatic or renal
impairment (see section 4.4).
2
_Paediatric population _
No clinical studies have been performed in adolescents (12 to 17
years).
Briglau is not recommended for use in children below 12 years and is
contraindicated in neonates and
infants (less than 2 years of age) (see sections 4.3, 4.4 and 4.9). It
is known that severe adverse
reactions can occur in neonates.
The safety and efficacy of br