Minims Cyclopentolate Hydrochloride

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Cyclopentolate hydrochloride 1%;  

Prieinama:

Bausch & Lomb (NZ) Ltd

INN (Tarptautinis Pavadinimas):

Cyclopentolate hydrochloride 1%

Dozė:

1 %

Vaisto forma:

Eye drops, solution

Sudėtis:

Active: Cyclopentolate hydrochloride 1%   Excipient: Hydrochloric acid Purified water

Vienetai pakuotėje:

Single use dropper, 0.5ml, 20 dose units

Klasė:

Prescription

Recepto tipas:

Prescription

Pagaminta:

Union Quimico Farmaceutica SA (Uquifa SA)

Terapinės indikacijos:

As a topical mydriatic and cycloplegic.

Produkto santrauka:

Package - Contents - Shelf Life: Single use dropper, 0.5ml - 20 dose units - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Leidimo data:

1988-12-01

Pakuotės lapelis

MINIMS
®
CYCLOPENTOLATE EYE DROPS
1
MINIMS
® CYCLOPENTOLATE
EYE DROPS
_Cyclopentolate Hydrochloride Eye Drops _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Minims
Cyclopentolate 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 you using Minims
Cyclopentolate 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
CYCLOPENTOLATE EYE
DROPS IS USED FOR
Minims Cyclopentolate 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
CYCLOPENTOLATE EYE
DROPS
_WHEN YOU MUST NOT USE IT _
DO NOT USE MINIMS CYCLOPENTOLATE
EYE DROPS IF YOU HAVE AN ALLERGY
TO:
*
Any medicine containing
cyclopentolate
*
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 CYCLOPENTOLATE
EYE DROPS IF YOU HAVE OR SUSPECT
YOU HAVE ANGLE CLOSURE GLAUCOMA
(HIGH PRESSURE IN THE EYE).
Cyclopentolate can increase the
pressure in the eye.
DO NOT USE THIS MEDICINE IN
NEONATES OR INFANTS LESS THAN 3
MONTHS OLD.
DO NOT USE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERIN

Prekės savybės

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
MINIMS CYCLOPENTOLATE HYDROCHLORIDE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clear, colourless, sterile eye drops containing cyclopentolate
hydrochloride BP 0.5%
w/v or 1.0% w/v.
3.
PHARMACEUTICAL FORM
Single-use, sterile eye drops.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As a topical mydriatic and cycloplegic.
4.2
DOSE AND METHOD OF ADMINISTRATION
Adults (including the elderly):
Instil dropwise into eye according to the recommended dosage.
One or two drops as required. Maximum effect is induced in 30 - 60
minutes after
instillation.
For refraction and examination of the back of the eye: 1 drop of
solution, which may
be repeated after five minutes, is usually sufficient.
For anterior and posterior uveitis (if associated with signs of
anterior uveitis) and for
the breakdown of posterior synechiae: 1 - 2 drops are instilled every
6 - 8 hours.
Resistance to cycloplegia can occur in young children, in patients
with dark skin and/or
patients with dark irides, therefore, the strength of cyclopentolate
used should be
adjusted accordingly.
Children:
< 3 months:
Not recommended
3 months - 12 years: 1 drop of a 1% solution to each eye.
12 years - adult:
1 drop of 0.5% solution to each eye repeated after
10 minutes if necessary.
Children should be observed for 45 minutes after instillation.
2
4.3
CONTRAINDICATIONS
Do not use in patients with a known hypersensitivity to any component
of the
preparation.
Do not use in patients with narrow-angle glaucoma or in those with a
shallow anterior
chamber (see section 4.4 Special warnings and precautions for use).
Do not use in geriatric patients and other patients who may be
predisposed to an
increased intraocular pressure.
Do not use in sensitive patients, especially infants, premature
births, small children,
adults over 65 years old and patients with Down’s syndrome, as well
as in children with
brain damage (see section 4.4 Special warnings and precautions for
use).
Do not use in children with organic brain syndromes, includ