Betagan

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Levobunolol hydrochloride 0.5%{relative};  ;  ;  

Mevcut itibaren:

AbbVie Limited

INN (International Adı):

Levobunolol hydrochloride 0.5% w/v

Doz:

0.5 %

Farmasötik formu:

Eye drops, solution

Kompozisyon:

Active: Levobunolol hydrochloride 0.5%{relative}       Excipient: Benzalkonium chloride Dibasic sodium phosphate heptahydrate Disodium edetate Hydrochloric acid Monobasic potassium phosphate Polyvinyl alcohol Purified water Sodium chloride Sodium hydroxide Sodium metabisulfite

Paketteki üniteler:

Bottle, dropper, 1x5mL, 5 mL

Sınıf:

Prescription

Reçete türü:

Prescription

Tarafından üretildi:

Piramal Enterprises Limited

Ürün özeti:

Package - Contents - Shelf Life: Bottle, dropper, - 5 mL - 24 months from date of manufacture stored at or below 25°C protect from light 4 weeks opened stored at or below 25°C protect from light

Yetkilendirme tarihi:

1985-12-05

Bilgilendirme broşürü

1
BETAGAN
® EYE DROPS 0.5%
(LEVOBUNOLOL HYDROCHLORIDE 5 MG PER ML)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BETAGAN
®
eye
drops, including how to use the eye
drops. 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 BETAGAN
®
eye drops against the benefits they
expect it will have for you.
If you have any concerns about
using this medicine, ask your doctor
or pharmacist.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT BETAGAN
® EYE DROPS ARE
USED FOR
BETAGAN
®
eye drops
are a beta
blocking agent used to lower
increased pressure in the eye.
Your doctor has prescribed
BETAGAN
®
eye drops to control
increased pressure in the eye or to
treat an acute increase in pressure
that can occur after eye operations.
Sometimes your doctor may give
you another medicine or eye drop
as well as BETAGAN
®
eye drops to
help you.
Glaucoma is a condition in which
the pressure of fluid in the eye may
be high. However, some people
with glaucoma may have normal
eye pressure. Glaucoma is usually
caused by a build up of the fluid
which flows through the eye. This
build up occurs because the fluid
drains out of your eye more slowly
than it is being pumped in. Since
new fluid continues to enter the eye,
joining the fluid already there, the
pressure continues to rise. This
raised pressure may damage the
back of the eye resulting in gradual
loss of sight. Damage can
progress so slowly that the person
is not aware of this gradual loss of
sight. Sometimes even normal eye
pressure is associated with damage
to the back of the eye.
There are usually no symptoms of
glaucoma. The only way of
knowing that you have glaucoma is
to have your eye pressure, optic
nerve and visual field checked by
an eye specialist or optometrist. If
glaucoma is not treated it can lead
to serious problems, including total
blindnes

Ürün özellikleri

BETAGAN
®
5% levobunolol hydrochloride Datasheet Version 3.0
DATA SHEET
1.
PRODUCT NAME
BETAGAN
®
5mg/mL eye drops
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
levobunolol hydrochloride 5mg/mL
For full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Clear, colourless to slightly yellow, sterile ophthalmic solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Control of intraocular pressure in patients with open angle glaucoma.
Control of ocular hypertension.
Treatment of acute increased intraocular pressure following laser
capsulotomy and
extra-capsular cataract extraction.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
The recommended dose is one drop of BETAGAN
®
0.5% eye drops in the affected
eye(s) twice a day. Studies have also shown that IOP is controlled in
many patients
with one drop of BETAGAN
®
0.5% eye drops in the affected eye(s) once a day.
Careful monitoring of patients is advised, particularly in the first
few days after starting
treatment or if the dose of BETAGAN
®
eye drops is increased.
Dosages above one drop of BETAGAN
®
0.5% eye drops twice daily are not generally
more effective. If the patient's IOP is not at a satisfactory level on
this regimen,
concomitant therapy with dipivefrine and/or adrenaline, and/or
pilocarpine and other
miotics,
and/or
systemically
administered carbonic
anhydrase
inhibitors,
such
as
acetozolamide, can be instituted.
In order to minimise systemic absorption of BETAGAN
®
eye drops, apply pressure to
the tear duct immediately following administration of the drug._ _
PAEDIATRIC POPULATION
Safety and effectiveness in children have not been established.
4.3 CONTRAINDICATIONS
BETAGAN
®
eye drops are contraindicated in those individuals with bronchial
asthma
or with a history of bronchial asthma or severe chronic obstructive
pulmonary disease
(see 4.4 Special Warnings and Precautions for use); sinus bradycardia;
sick sinus
syndrome (including sino-atrial nodal block); second or third degree
atrioventricular
block not controlled with a