ALPHAGAN PURITE SOLUTION

Страна: Южна Африка

Език: английски

Източник: South African Health Products Regulatory Authority (SAHPRA)

Предлага се от:

Abbvie (Pty) Ltd

дозиране:

See ingredients

Лекарствена форма:

SOLUTION

Композиция:

EACH 1,0 ml SOLUTION CONTAINS BRIMONIDINE TARTRATE 1,5 mg

Статус Оторизация:

Registered

Дата Оторизация:

2007-05-10

Листовка

Allergan Pharmaceuticals (Pty) Ltd
Alphagan
®
Purite
®
Brimonidine tartrate 1,5 mg/ml
Ophthalmic solution
1.3.2 Patient Information Leaflet
Page 1
Submitted: 13 Jul 2016; Ref: mcc-80.2016; Approved: 18 Oct 2016
(SR-PIN)
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
Schedule 3
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
ALPHAGAN
® PURITE
®
, BRIMONIDINE TARTRATE 1,5 mg/ml ophthalmic solution
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING ALPHAGAN
® PURITE
®
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist.
•
ALPHAGAN
®
Purite
®
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.
1.
WHAT ALPHAGAN
® PURITE
® CONTAINS
•
The active substance is brimonidine tartrate
•
The other ingredients are boric acid, calcium chloride, magnesium
chloride, potassium
chloride,
purified
water,
sodium
borate,
sodium
carboxymethylcellulose,
sodium
chloride and Purite
®
(stabilised oxychloro complex) 0,005 % m/v_ _as preservative.
2.
WHAT ALPHAGAN
® PURITE
® IS USED FOR
ALPHAGAN
®
Purite
®
ophthalmic solution helps fluid flow out of the eye chamber and also
decreases the fluid produced by the eye. This lowers the pressure in
the eye. ALPHAGAN
®
Purite
®
can be used either alone or with another eye drop which lowers
pressure in the eye
for the treatment of high pressure in the eye in glaucoma or ocular
hypertension.
3.
BEFORE YOU USE ALPHAGAN
® PURITE
®
DO NOT USE ALPHAGAN
® PURITE
®
•
If you are hypersensitive (allergic) to brimonidine tartrate or any of
the ingredients of
ALPHAGAN
®
Purite
®
.
ALPHAGAN
®
Purite
®
should not be used in neonates and infants under the age of 2 years.
TAKE SPECIAL CARE WITH ALPHAGAN
® PURITE
®
•
If you have any diseases associated with the heart.
•
If you have any diseases that affect the kidney or liver.
•
If you suffer or have suffered from depression, reduced

Данни за продукта

Allergan Pharmaceuticals (Pty) Ltd
Alphagan
®
Purite
®
Brimonidine tartrate 1,5 mg/ml
Ophthalmic solution
1.3.1.1 Package Insert
Page 1
Submitted: 13 Jul 2016; Ref: mcc-80.2016; Approved: 18 Oct 2016
(SR-PIN)
SCHEDULING STATUS
Schedule 3
PROPRIETARY NAME AND DOSAGE FORM
ALPHAGAN
® PURITE
®
Ophthalmic solution
COMPOSITION
Each ml contains: Brimonidine tartrate 1,5 mg
Excipients: Boric acid, calcium chloride dehydrate, magnesium chloride
hexahydrate; potassium
chloride, purified water, sodium borate decahydrate, sodium
carboxymethylcellulose, sodium
chloride.
Preservative: Purite
®
(stabilised oxychloro complex) 0,005 % m/v
PHARMACOLOGICAL CLASSIFICATION
A.15.4 Ophthalmic preparations. Other.
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Brimonidine tartrate is a selective alpha-2-adrenergic receptor
agonist. Topical administration of
brimonidine decreases intraocular pressure (IOP) in humans with a peak
ocular hypotensive
effect occurring at two hours post-dosing. Fluorophotometric studies
in animals and humans
suggest that brimonidine tartrate has a dual mechanism of action by
reducing aqueous humour
production and increasing uveoscleral outflow.
.
PHARMACOKINETIC PROPERTIES
_Absorption _
After ocular administration of either a 0,1 % or 0,2 % solution,
plasma concentrations peaked
within 0,5 to 2,5 hours and declined with a systemic half-life of
approximately 2 hours.
_Distribution _
The protein binding of brimonidine has not been studied.
_Metabolism _
In humans brimonidine is extensively metabolised by the liver.
_Elimination _
Urinary
excretion is the major route of elimination of the medicine and its
metabolites.
Approximately 87 % of an orally-administered radioactive dose was
eliminated within 120
hours, with 74 % found in the urine.
INDICATIONS
ALPHAGAN
®
Purite
®
is indicated for the lowering of intraocular pressure in patients with
open-
Allergan Pharmaceuticals (Pty) Ltd
Alphagan
®
Purite
®
Brimonidine tartrate 1,5 mg/ml
Ophthalmic solution
1.3.1.1 Package Insert
Page 2
Submitted: 13 Jul 20