Iruxol Mono 1.2U/g Ointment
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
13-04-2018
Summary of Product characteristics
(SPC)
13-04-2018
Active ingredient:
Clostridiopeptidase a; Protease
Available from:
T.J. Smith & Nephew
ATC code:
D03BA; D03BA52
INN (International Name):
Clostridiopeptidase a; Protease
Dosage:
1.2 unit(s)/gram
Pharmaceutical form:
Ointment
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Proteolytic enzymes; collagenase, combinations
Authorization status:
Marketed
Authorization date:
1990-09-03
Patient Information leaflet
PACKAGE LEALFET: INFORMATION FOR THE USER
IRUXOL® MONO 1.2 U/G OINTMENT
CLOSTRIDIOPEPTIDASE A
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm
them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1. What IRUXOL® Mono is and what it is used for
2. Before you use IRUXOL® Mono
3. How to use IRUXOL® Mono
4. Possible side effects
5. How to store IRUXOL® Mono
6. Contents of the pack and other information
1. WHAT IRUXOL® MONO IS AND WHAT IT IS USED FOR
IRUXOL® Mono ointment contains clostridiopeptidase (a collagenase
enzyme) and protease
enzymes. Each gram of ointment contains not less than 1.2 units of
Clostridiopeptidase A and
not less than 0.24 units of associated proteases as active
ingredients. These enzymes can be
used to remove dead tissue (debride) from wounds such as leg ulcers,
diabetic ulcers and
pressure sores. By removing the dead tissue, IRUXOL® Mono ointment
cleanses the wound
and speeds up wound healing.
2. BEFORE YOU USE IRUXOL® MONO
DO NOT USE IRUXOL® MONO OINTMENT if you are allergic to protease
enzymes or any of the
other ingredients of this medicine (listed in section 6).
TAKE SPECIAL CARE WITH IRUXOL® MONO OINTMENT IF:
• you are diabetic and have been told that the wound contains dry
gangrenous material.
IF YOU ARE USING OTHER MEDICINES PLEASE SEE FOLLOWING SECTION.
USING OTHER MEDICINES
IRUXOL® Mono ointment should NOT be used if you are applying other
products to the
wound that may interfere with the medicine such as:
• antiseptics
• antibiotics (tyrothricin, gramicidin and tetracyclines)
• heavy metals
• detergents
• soaps
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Iruxol Mono 1.2U/g Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of ointment contains not less than 1.2 units of
clostridiopeptidase A and not less than 0.24 units of
associated proteases.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment.
A brown, lipophilic ointment with a faint characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Iruxol Mono is indicated for the enzymatic debridement of necrotising
wounds, including leg and decubital ulcers.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical administration.
A layer of approximately 2 mm of ointment should be applied to the
dressing or directly to the slightly moistened area
to be treated once daily. Close contact to the wound surface should be
assured. Occasionally, twice daily use may be
required.
It
is unnecessary to apply too great
an amount
of the product
to the wound.
With this,
the cleaning process is not
improved.
In general,
it
will
suffice to change the dressing once daily.
An increase of activity may possibly be obtained by
applying the ointment twice daily.
The treatment of varicose ulcers with Iruxol Mono ointment will be
usefully supplemented by a pressure bandage and
in arterial circulatory disorders, ulcers of diabetic or neurologic
etiology, by appropriate drug treatment.
To ensure successful enzymatic wound treatment with Iruxol Mono
ointment, sufficient moisture must be present in the
wound area during therapy.
In dry wounds, the wound base must therefore be moistened with
physiological saline (0.9% NaCl) or other solutions
which are well tolerated by the tissue (e.g. glucose). Dry and hard
crusts should first be softened by applying a moist
dressing.
Treatment with Iruxol Mono should be discontinued when the whole
surface of the wound is clean.
Whenever infection is present, an appropriate antibiotic treatment
should be considered.
Chloramphenicol, neomycin, framycetin, bacitracin, gentamicin,
polymyxin B and
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