Active ingredients: Collagenase, Chloramphenicol
IRUXOL 1% + 60 I.U. 30G ointment
Why is Iruxol used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Cicatrizing
Contraindications When Iruxol should not be used
THERAPEUTIC INDICATIONS
Cleansing of sores of any origin and location:
- ulcerations and necrosis (varicose, postphlebitic and pressure ulcers, gangrene of the extremities, especially diabetic and frostbite gangrene);
- numb sores (post-operative, from X-rays, from accidents);
- before skin transplants.
Precautions for use What you need to know before taking Iruxol
Individual ascertained hypersensitivity to the product
Avoid applying disinfectant preparations at the same time (such as denatured alcohol, ether, hydrogen peroxide, permanganate, merbromin, quaternary ammonium salts) medicated soaps and in general all those deproteinizing preparations, capable of inactivating the protein-enzymatic component of IRUXOL®, since the its effectiveness would be compromised.
Interactions Which drugs or foods can modify the effect of Iruxol
There have never been reports of negative interactions with other drugs administered
Warnings It is important to know that:
The use, especially if prolonged, of topical preparations can give rise to irritation or sensitization phenomena. In this case, treatment must be suspended and suitable therapy instituted. The same applies to the development of non-sensitive germs. Rare cases have been described. of bone marrow hypoplasia following prolonged use of chloramphenicol for topical use; for this reason the product should be used for short periods, unless explicitly indicated by the doctor. In pregnant women and in very early childhood, the product should be administered in cases of recognized and elective indication, under direct medical supervision.
Effects on ability to drive and use machines
No effects on the ability to drive and use machines have ever been reported.
Dose, Method and Time of Administration How to use Iruxol: Posology
To obtain the best results with the enzymatic cleansing of wounds using IRUXOL®, the following rules must be observed:
- IRUXOL® ointment must be placed evenly in contact with the surface of the sores, applying it with a thickness of a few millimeters. In case of rebellious necrosis, the effect of IRUXOL® can be improved by incising them at the margins or in the middle, trying in this way to apply part of the ointment below the necrosis. You should avoid drying the surface of the sore since the presence humidity increases enzymatic activity. Therefore, completely dry crusts, as well as hardened ones, should first be softened with a moist bandage.
- The dressing with IRUXOL® must be renewed every day. By applying it twice a day it is possible to increase its enzymatic effect.
- When changing the dressing, the detached necrotic material must be removed with tweezers, spatula, swab, curette and with baths. It is advisable to cover the periwound area with zinc oxide paste or similar preparations: this in general or for existing ones. irritative phenomena.
- Cleanse the skin lesion with physiological solution or sterile distilled water, before applying IRUXOL®.
- The application of IRUXOL® is suspended when the sore is cleansed and a good granulation has begun. The treatment is continued as usual with ointments that promote granulation and re-epithelialization. In the therapy of varicose and postphlebitic ulcers, in addition to the use of IRUXOL®, compressive bandages and, in arterial blood flow disorders, the appropriate drugs can be advantageously used.
EXTERNAL USE .
Overdose What to do if you have taken too much Iruxol
To date, no cases of problems related to an overdose of the active ingredients contained in the preparation have been reported.
Side Effects What are the side effects of Iruxol
Local irritation or sensitization phenomena may occur or, in case of prolonged application in high doses and on large surfaces, secondary systemic phenomena of the antibiotic (alterations of the blood count).
If undesirable effects other than those described above occur, it is advisable to report them to the doctor
Expiry and Retention
Do not use the medicine after the expiry date indicated on the package. The expiry date indicated refers to the product in intact packaging, correctly stored.
Store below 25 ºC.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of ointment contains:
collagenase (clostridiopeptidase A) 60 units, chloramphenicol 1 g.
Excipients: liquid paraffin, white petroleum jelly.
PHARMACEUTICAL FORM
30 g 1% + 60 I.U. ointment.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
IRUXOL 1% + 60 I.U. OIL 30 G
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of ointment contains:
Active principle:
Collagenase (Clostridiopeptidase A) 60 units
Chloramphenicol 1 g
03.0 PHARMACEUTICAL FORM
1% + 60 I.U. Ointment
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Cleansing of sores of any origin and location:
• ulcerations and necrosis (varicose, post-phlebitic and pressure ulcers, gangrene of the extremities, especially diabetic and frostbite gangrene);
• numb sores (post-operative, from X-rays, from accidents);
• before skin transplants.
04.2 Posology and method of administration
To obtain the best results with the enzymatic cleansing of wounds using IRUXOL, the following rules must be observed:
IRUXOL ointment must be placed evenly in contact with the surface of the sores, applying it with a thickness of a few millimeters.
In case of rebellious necrosis, the effect of IRUXOL can be improved by cutting at the edges or in the middle, trying in this way to apply part of the ointment below the necrosis.
Drying of the wound surface should be avoided as the presence of moisture increases enzyme activity. Therefore, completely dry as well as hardened scabs should first be softened with a moist bandage.
The dressing with IRUXOL must be renewed every day. Applying it twice a day it is possible to increase its enzymatic effect.
When changing the dressing, the detached necrotic material should be removed with tweezers, spatula, swab, curette and with baths. It is advisable to cover the periwound area with zinc oxide paste or similar preparations: this in general or for existing irritative phenomena.
Disinfect the skin lesion with physiological solution or sterile distilled water before applying IRUXOL.
The application of IRUXOL is suspended when the sore is cleansed and a good granulation has begun. The treatment is continued as usual with ointments that promote granulation and re-epithelialization.
In the therapy of varicose and post-phlebitic ulcers, in addition to the use of IRUXOL, compression bandages and, in the case of arterial blood flow disorders, the appropriate drugs can be advantageously used.
EXTERNAL USE
04.3 Contraindications
Individual ascertained hypersensitivity to the product.
04.4 Special warnings and appropriate precautions for use
The use, especially if prolonged, of topical preparations can give rise to irritation or sensitization phenomena. In this case it is necessary to suspend the treatment and institute a suitable therapy.
The same applies to the development of non-sensitive germs.
Rare cases of bone marrow hypoplasia have been described following prolonged use of topical chloramphenicol; for this reason the product should be used for short periods, unless explicitly indicated by the doctor.
04.5 Interactions with other medicinal products and other forms of interaction
There have never been reports of negative interactions with other drugs administered.
04.6 Pregnancy and lactation
In pregnant women and in very early childhood, the product should be administered in cases of recognized and elective indication, under direct medical supervision.
04.7 Effects on ability to drive and use machines
No effects on the ability to drive and use machines have ever been reported.
04.8 Undesirable effects
Local irritation or sensitization phenomena may occur or, in case of prolonged application in high doses and on large surfaces, secondary systemic phenomena of the antibiotic (alterations of the blood count).
04.9 Overdose
To date, no cases of problems related to an overdose of the active ingredients contained in the preparation have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Preparations for the treatment of wounds and ulcerations - Proteolytic enzymes - Clostridiopeptidases, combinations. ATC code D03BA52
IRUXOL is an enzymatic preparation obtained from a bacterial strain of Clostridium histolyticum: as the main component it contains collagenase (Clostridiopeptidase A) as well as, as complementary enzymes, other non-specific peptidases formed during the manufacture of the preparation. After application on the injured part, the active principle spreads by digesting and breaking up the necrotic fibers present at the bottom of the skin lesion; in particular, the native collagen that fixes the necrotic material to the bottom of the lesion is demolished. Collagenase has its specific point of attack in the apolar zone of the collagen fibers, consisting of numerous tripeptides. By demolishing the apolar zone, the collagen fiber is broken down into low molecular weight peptides which are then completely destroyed by collagenopeptidases and associated non-specific proteases. it is a broad spectrum antibiotic with bacteriostatic action. It has the advantage of being poorly soluble in aqueous environment and practically insoluble in a lipid environment. For topical applications, the concentration at 1% has been shown to be optimal.
05.2 Pharmacokinetic properties
The determination of serum chloramphenicol levels was performed on 12 patients with large crural ulcers. After 5 days of treatment with IRUXOL, 10 g on 100 cm2 of injured surface, values below the dosable limits (serum) were found.
05.3 Preclinical safety data
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Liquid paraffin, white petroleum jelly.
06.2 Incompatibility
Avoid applying disinfectant preparations at the same time (such as denatured alcohol, ether, hydrogen peroxide, permanganate, merbromin, quaternary ammonium salts), medicated soaps and in general all those deproteinizing preparations, capable of inactivating the protein-enzymatic component of IRUXOL, since the its effectiveness would be compromised.
06.3 Period of validity
3 years
06.4 Special precautions for storage
Store below 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
Carton containing an aluminum tube with 30 g of ointment
06.6 Instructions for use and handling
See section 4.2 "Posology and method of administration"
07.0 MARKETING AUTHORIZATION HOLDER
TJ Smith & Nephew Ltd - Hull (Great Britain)
Representative for Italy:
Smith & Nephew S.r.l. - Via De Capitani 2A - 20041 AGRATE BRIANZA (MB)
08.0 MARKETING AUTHORIZATION NUMBER
A.I.C .: n. 023905021
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
09.01.1979 / 01.06.2010
10.0 DATE OF REVISION OF THE TEXT
July 2010
