Minims Cyclopentolate Hydrochloride 1%

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

CYCLOPENTOLATE HYDROCHLORIDE

Commercializzato da:

Bausch & Lomb UK Limited

Codice ATC:

S01FA04

INN (Nome Internazionale):

CYCLOPENTOLATE HYDROCHLORIDE

Forma farmaceutica:

EYE DROPS, SOLUTION

Composizione:

CYCLOPENTOLATE HYDROCHLORIDE 1 % (W/V)

Tipo di ricetta:

POM

Area terapeutica:

OPHTHALMOLOGICALS

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2005-10-04

Foglio illustrativo

MINIMS® CYCLOPENTOLATE
HYDROCHLORIDE 1% W/V
Eye drops, solution For ocular use
1 sterile single-dose container of 0.5ml
Preservative-free
CYC 1.0
FOR SINGLE USE ONLY,
DISCARD ANY UNUSED SOLUTION
GB241C02-02.15
02/02/15 14:43
1
BN.
EXP.
X00000
00 0000
BAUSCH&LOMB
PL03468/0071
PA555/18/1
POM
CYCLOPENTOLATE
HYDROCHLORIDE
1%
w/v
Eye Drops, Solution
®
CYCLOPENTOLATE
HYDROCHLORIDE
1%
w/v
Eye Drops, Solution
®
85888
C1UKIE01
CYCLOPENTOLATE
HYDROCHLORIDE
1%
w/v
Eye Drops, Solution
®
20 Single-dose containers
Preservative-free
Manufacturer:
Laboratoire Chauvin
Z.I. Ripotier Haut
07200 Aubenas - France
Bausch & Lomb UK Ltd, 106 London Road,
Kingston-Upon-Thames, Surrey KT2 6TN, United Kingdom
Minims is a registered trademark of Bausch & Lomb Incorporated or its
affiliates.
PL 03468/0071 PA 555/18/1 MAL19870979A
HK-08203 SIN4201P MA147/00103
10671GB
Active ingredient:
Each unit (0.5ml) contains cyclopentolate hydrochloride 5mg.
Excipients:
Purified water and hydrochloric acid (for pH-adjustment).
British Pharmacopoeia Evocative Code: CYC 1.0
DOSAGE
Use as directed by medical practitioner.
DIRECTIONS FOR USE
1 Peel the overwrap apart and withdraw the Minims
®
unit.
2 Twist cap and pull off.
3 Squeeze the unit to obtain the number of drops required.
4 FOR SINGLE USE ONLY. DISCARD ANY UNUSED SOLUTION.
For ocular use.
20 sterile single-dose containers of 0.5 ml.
CYCLOPENTOLATE
HYDROCHLORIDE
1%
w/v
Eye Drops, Solution
®
5 027519 000708
One
MINIMS UNIT
One patient
Do not store above 25°C.
Do not freeze.
STORE IN ORIGINAL CONTAINER
TO PROTECT FROM LIGHT.
Keep out of the reach
and sight of children.
minims
cyclopento-
late hydro-
chloride
#1% w/v-
Eye drops,
solution
minims
cyclopento-
late hydro-
chloride
#1% w/v-
Eye drops,
solution
DO NOT DISPENSE
IF SEAL IS BROKEN
BN: A99999
DOM: 99-9999
EXP: 99-9999
DO NOT DISPENSE
IF SEAL IS BROKEN
BN: A99999
DOM: 99-9999
EXP: 99-9999
KARTONIK CARTON
Nazwa produktu Product name
Kraj Country (ISO)
Wymiar komponentu Component size
Kolory nadruku Colours
Dane techniczne Technical data
Kr�

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS 

1.   
TRADE NAME OF THE MEDICINAL PRODUCT   

Minims Cyclopentolate Hydrochloride 1%.   

2.   
QUALITATIVE AND QUANTITATIVE COMPOSITION   

Clear, colourless, sterile eye drops
containing cyclopentolate hydrochloride BP 1% 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   
POSOLOGY 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.   

4.3   
CONTRAINDICATIONS   

Do not use i