Atropt

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Aktivni sastojci:

Atropine sulfate monohydrate 1%{relative};  

Dostupno od:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International ime):

Atropine sulfate monohydrate 1% w/v

Doziranje:

1 %

Farmaceutski oblik:

Eye drops, solution

Sastav:

Active: Atropine sulfate monohydrate 1%{relative}   Excipient: Benzalkonium chloride Boric acid Disodium edetate dihydrate Hypromellose Water

Jedinice u paketu:

Bottle, dropper, 15 mL

Razred:

Prescription

Tip recepta:

Prescription

Proizveden od:

Boehringer Ingelheim Pharma GmbH & Co KG

Proizvod sažetak:

Package - Contents - Shelf Life: Bottle, dropper, - 15 mL - 24 months from date of manufacture stored at or below 25°C

Datum autorizacije:

1969-12-31

Uputa o lijeku

1
NEW ZEALAND CONSUMER MEDICINE INFORMATION
ATROPT
_(At-rop-t)_
_Atropine sulphate (at-rop-een sul-fay-t) 0.5%, 1% _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
ATROPT EYE DROPS.
It does not contain all of 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
ATROPT 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 THE
MEDICINE.
You may need to read it again.
WHAT IS ATROPT
The name of your medicine is
ATROPT EYE DROPS.
The active ingredient is called
atropine sulphate.
ATROPT widens the pupil of the
eye and blocks the ability to
change the focus of the eye.
ATROPT EYE DROPS are for use
in the eyes only. They should
not be taken by mouth.
WHAT IS ATROPT EYE
DROPS USED FOR
ATROPT EYE DROPS are used in
eye examinations as well as
other circumstances when the
pupil is to be widened and/or
the accommodation frozen.
Your doctor, however, may
have prescribed ATROPT EYE
DROPS for another purpose.
Ask your doctor if you have
any questions about why
ATROPT EYE DROPS have been
prescribed for you.
If you have any concerns, you
should discuss this with your
doctor or in his/her absence
with your pharmacist.
ATROPT EYE DROPS are
available only on a doctor’s
prescription.
BEFORE YOU USE ATROPT
EYE DROPS
_ _
_When you must not use it _
Do not use ATROPT EYE DROPS
if you are allergic to:
•
Atropine or any of the
ingredients listed at the end
of this leaflet.
Do not use ATROPT EYE DROPS
if you have angle closure
glaucoma or a family history of
glaucoma.
ATROPT like all medicines,
should not be used during
pregnancy unless your doctor
specifically tells you to
(CATEGORY A).
DO NOT USE ATROPT EYE
DROPS AFTER THE EXPIRY DATE
PRINTED ON THE PACK.
If you use it after the expiry
date has passed, it may have
no effect at all, or worse, there
may be an entirely unexpecte

Svojstava lijeka

NEW ZEALAND DATA SHEET
1.
ATROPT EYE DROPS (ATROPINE SULFATE 1%)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL contains 10 mg atropine Sulfate (1 %).
Atropine Sulfate exists as odourless, colourless crystals or white
crystalline powder.
It effloresces in dry air.
Atropine Sulfate is soluble in water (1 in 0.5), in boiling water (1
in 2.5), in alcohol (1
in 5), in glycerol (1 in 2.5), practically insoluble in chloroform and
ether. A 2%
solution in water has a pH of 4.5 to 6.2. Solutions may be sterilised
by autoclave.
Atropine Sulfate is both a mydriatic and cycloplegic and has the
following molecular
formula: (C
17
H
23
NO
3
)
2
, H
2
SO
4
,H
2
O. Relative molecular mass is 694.8.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
ATROPT EYE DROPS contains atropine Sulfate (1%) in a sterile aqueous
base. A
clear, or almost clear, slightly viscous, colourless liquid which
foams on shaking.
Odourless.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ATROPT EYE DROPS are indicated where it is necessary to dilate the
pupil and
paralyse accommodation.
4.2
DOSE AND METHOD OF ADMINISTRATION
Instil one drop into the eye as required for treatment. To minimise
the risk of
systemic absorption, gentle pressure should be applied to the tear
duct for one
minute after application.
4.3
CONTRAINDICATIONS
ATROPT EYE DROPS are contraindicated in the presence of angle closure
glaucoma
or where angle closure glaucoma is suspected. If used in glaucoma
susceptible
patients, an estimation of the depth of the angle of the anterior
chamber should be
performed prior to the initiation of therapy.
Hypersensitivity to any ingredient in ATROPT EYE DROPS.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients treated prior to ophthalmic examination should be escorted to
and from
the surgery.
_ _
_USE IN CHILDREN _
ATROPT EYE DROPS should be used with extreme caution, if at all, in
infants
and small children and in children with spastic paralysis or brain
damage,
due to their increased susceptibility to the systemic e