Minims Atropine Sulphate 1%
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
30-06-2018
Summary of Product characteristics
(SPC)
27-05-2024
Active ingredient:
ATROPINE SULFATE
Available from:
Bausch & Lomb UK Limited
ATC code:
S01FA01
INN (International Name):
ATROPINE SULFATE
Pharmaceutical form:
EYE DROPS, SOLUTION
Composition:
ATROPINE SULFATE 1 % (W/V)
Prescription type:
POM
Therapeutic area:
OPHTHALMOLOGICALS
Authorization status:
Authorised
Authorization date:
2005-10-04
Patient Information leaflet
minims
atropine
sulphate
#1% w/v
Eye drops,
solution
minims
atropine
sulphate
#1% w/v
Eye drops,
solution
85881
C1UKIE01
Active ingredient:
Each unit (0.5ml) contains atropine sulphate 5mg.
Excipients:
Purified water and hydrochloric acid (for pH-adjustment).
British Pharmacopoeia Evocative Code: ATR 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.
Manufacturer:
Laboratoire Chauvin
Z.I. Ripotier Haut
07200 Aubenas - France
PL 03468/0068 PA 555/17/1 MAL19861687A
HK-08619 SIN4317P MA 147/00101
10668GB
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.
5 027519 000302
ATROPINE SULPHATE
1%
w/v
Eye Drops, Solution
®
20 Single-dose containers
Preservative-free
ATROPINE SULPHATE
1%
w/v
Eye Drops, Solution
®
ATROPINE SULPHATE
1%
w/v
Eye Drops, Solution
®
ATROPINE SULPHATE
1%
w/v
Eye Drops, Solution
®
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.
KARTONIK CARTON
Nazwa produktu Product name
Kraj Country (ISO)
Wymiar komponentu Component size
Kolory nadruku Colours
Dane techniczne Technical data
Krój czcionki Fonts Used
Kod kreskowy Barcode _(EAN, PZN etc.)_
Wielkość opakowania Pack size
Kod farmaceutyczny Pharmacode
Kod wersji Valeant code version
Nr Wykrojnika Spec. No.
Kod Wytwórcy Manufacturer code
Data Date
Nr korekty Proof Nr
Komentarze Comments
_(Reason for the change)_
Rozmiar czcionki Font size
MINIMUM 5,84 PT
Graphics&Packing Technology Section
ICN Polfa Rzeszów S.A.
_MAH transfer from Chauvin Pharmaceuticals Ltd UK to B+L UK Ltd_
_PMR_ICN-14-0723-A_
_Packing Site: Aubenas Plant_
Opracowane pr
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Minims Atropine Sulphate 1%.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clear, colourless, sterile eye drops containing Atropine Sulphate
Ph Eur 1% w/v.
3.
PHARMACEUTICAL FORM
Sterile, single-use 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)_:
One drop to be instilled into the eye, or as required.
4.3
CONTRA-INDICATIONS
Hypersensitivity to any component of the preparation.
Due to the risk of precipitating an acute attack, do not use 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 is used.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The protracted mydriasis which is difficult to reverse,
may be a disadvantage.
Systemic absorption 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.)
4.5
INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS
OF INTERACTION
None known.
4.6
PREGNANCY AND LACTATION
The safety for use in pregnancy a
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