MINIMS atropine sulphate 1% 10 mg/mL eye drops tube

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

atropine sulfate monohydrate, Quantity: 10 mg/mL

Dostopno od:

Bausch & Lomb Australia Pty Ltd

Farmacevtska oblika:

Eye Drops, solution

Sestava:

Excipient Ingredients: hydrochloric acid; purified water

Pot uporabe:

Ophthalmic

Enote v paketu:

20 X 0.5mL single dose units

Razred:

Medicine Registered

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

To produce mydriasis and cycloplegia

Povzetek izdelek:

Visual Identification: A clear colourless solution, reasonably free from visible particulate matter; Container Type: Tube; Container Material: PP; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status dovoljenje:

Registered

Datum dovoljenje:

1991-10-30

Navodilo za uporabo

MINIMS ATROPINE
SULPHATE EYE DROPS
_Atropine sulfate monohydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Minims Atropine
Sulphate 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 benefits and
risks. Your doctor has weighed the
risks of your using Minims Atropine
Sulphate 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 MINIMS ATROPINE
SULPHATE EYE DROPS IS
USED FOR
Minims Atropine Sulphate Eye
Drops belongs to a class of medicines
called antimuscarinic agents. It is
used to dilate (enlarge) the pupil of
the eye and to temporarily paralyse
the lens so that your doctor can
examine your eye(s). It is usually
used at the beginning of an eye
examination.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED TO YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU USE
MINIMS ATROPINE
SULPHATE EYE DROPS
_WHEN YOU MUST NOT USE IT_
DO NOT USE MINIMS ATROPINE
SULPHATE EYE DROPS IF YOU HAVE AN
ALLERGY TO:
•
Any medicine containing atropine
•
Any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
Shortness of breath
•
Wheezing or difficulty breathing
•
Swelling of the face, lips, tongue
or other parts of the body
•
Rash, itching or hives on the skin
DO NOT USE MINIMS ATROPINE
SULPHATE EYE DROPS IF YOU HAVE OR
SUSPECT YOU HAVE ANGLE CLOSURE
GLAUCOMA (HIGH PRESSURE IN THE
EYE).
Atropine can increase the pressure in
the eye.
DO NOT USE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
IF YOU ARE NOT SURE

Lastnosti izdelka

Minims Atropine PI-A20200429 v4
Page 1 of 7 AUSTRALIAN PRODUCT INFORMATION – MINIMS ATROPINE SULPHATE
(ATROPINE SULFATE MONOHYDRATE) EYE DROPS
1
NAME OF THE MEDICINE
Atropine sulfate monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Minims Atropine Eye Drops contain atropine sulfate monohydrate 1% w/v.
No preservatives are
contained in the formulation.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
A single-use eye drops, solution.
Minims Atropine Eye Drops are clear, colourless sterile eye drops. No
preservatives are contained
in the formulation.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Minims Atropine Eye Drops are indicated to produce mydriasis and
cycloplegia.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Adults (including the elderly):
One drop to be instilled into the eye, or as required.
Systemic absorption of atropine may be reduced by compressing the
lacrimal sac at the medial
canthus for a minute during and following the instillation of the
drops. (This blocks the passage of
the drops via the naso-lacrimal duct to the wide absorptive area of
the nasal and pharyngeal
mucosa. It is especially advisable in children.).
Each Minims Atropine Eye Drops unit should be discarded after a single
use.
4.3
C
ONTRAINDICATIONS
Minims Atropine Eye Drops are contraindicated in patients with
hypersensitivity to any of the
components of the preparation.
Minims Atropine Eye Drops are contraindicated in the presence of angle
closure glaucoma or
where angle closure glaucoma is suspected.
Minims Atropine PI-A20200429 v4
Page 2 of 7
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED PRECAUTIONS
Minims Atropine Eye Drops are for topical ophthalmic use only. The
solution should not be
injected.
Due to the risk of precipitating an acute attack, atropine eye drops
should not be used in cases of
confirmed narrow-angle glaucoma or where latent narrow angle glaucoma
is suspected. If in
doubt, it is recommended that an alternative preparation be used.
Atropine eye drops shou