Active ingredients: Collagenase
NORUXOL® 10g Ointment
NORUXOL® 30g Ointment
Why is Noruxol used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Preparation with healing action for wounds and ulcerations.
THERAPEUTIC INDICATIONS
Enzymatic cleansing of necrotic sores including leg ulcers and pressure ulcers.
Contraindications When Noruxol should not be used
Hypersensitivity to the active substance (collagenase) or to any of the excipients of the ointment.
Precautions for use What you need to know before taking Noruxol
Contact with eyes and mucous membranes should be avoided. In patients with severe burns, the use of NORUXOL® must take place on the recommendation and under the supervision of the specialist. In diabetic patients, dry gangrene should be moistened taking care to avoid its transformation into wet gangrene. If no reduction of the gangrene is observed. necrotic component within 14 days from the start of therapy with NORUXOL®, it is recommended to stop the treatment and to adopt alternative methods of debridement.
Interactions Which drugs or foods can modify the effect of Noruxol
NORUXOL® should not be used in the presence of antiseptics, heavy metals, detergents and soaps as they inhibit their enzymatic activity. Products based on silver and silver sulphadiazine can however be used together with NORUXOL® without altering their enzymatic activity. Tyrotricin, gramicidin and tetracyclines should not be used topically with NORUXOL®.
Warnings It is important to know that:
The repeated use of topical products can give rise to sensitization phenomena. Whenever an infection is present, appropriate antibiotic treatment should be considered. Chloramphenicol, neomycin, framycetin, bacitracin, gentamicin, polymyxin B and macrolides - for example erythromycin - they proved to be compatible with collagenase.
Use in pregnancy and during lactation
Although no teratogenic effects have been shown, NORUXOL® should only be administered during the first three months of pregnancy when strictly indicated. Since collagenase does not enter the systemic circulation it is unlikely that it will be excreted by breast milk.
Effects on ability to drive and use machines
There are no prerequisites for negative interference on these capabilities.
Dose, Method and Time of Administration How to use Noruxol: Posology
To ensure the enzymatic success of wound treatment with NORUXOL®, there must be sufficient moisture in the wound area. Therefore, in dry wounds, the base of the wound must be moistened with physiological saline (0.9% NaCl) or other solutions that are well tolerated by the tissue (eg glucose). Dry, hard crusts should first be softened by applying a wet dressing. A layer of NORUXOL® approximately 2 mm thick should be applied with the dressing or directly on the slightly moistened area , once a day. Cover the surface of the sore to ensure contact. It is not necessary to apply an abundant layer of product on the sore as this does not favor the progress of cleansing. It is generally sufficient to change the dressing once a day unless otherwise advised by the doctor. After the first opening, the product can no longer be considered sterile. Therefore, any residue must not be used, but must be eliminated.
Overdose What to do if you have taken too much Noruxol
Accidental ingestion of the drug is unlikely, but if it occurs, it must be removed from the stomach by vomiting and if necessary by gastric lavage.
Side Effects What are the side effects of Noruxol
Side effects can include local pain, itching, burning and erythema. In case of severity of reactions, discontinuation of therapy should be considered.
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. After the first opening, the product can no longer be considered sterile. Therefore, any residue must not be used, but must be eliminated according to current legislation.
Store below 25 ° C
Composition and pharmaceutical form
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of ointment contains:
0.52 ¸ 3.75 mg of collagenase N * containing:
Clostridiopeptidase A of not less than 1.2 Units; Protease not less than 0.24 Units.
Excipients: liquid paraffin; white petroleum jelly.
(* The active ingredient, collagenase N, is a lyophilisate of purified ultrafiltrate from Clostridium histolyticum culture. The active ingredient consists of the collagenolytic enzyme clostridiopeptidase A (EC 3.4.24.3) and other proteases.)
PHARMACEUTICAL FORM AND CONTENT
Ointment. 10 and 30 gram tube.
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
NORUXOL UNGUENTO
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of Noruxol contains:
Active principle:
0.52 ÷ 3.75 mg of collagenase N containing:
• Clostridiopeptidase A of not less than 1.2 Units
• Associated proteases of not less than 0.24 Units
For excipients, see 6.1.
03.0 PHARMACEUTICAL FORM
Ointment
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Enzymatic cleansing of necrotic sores including leg ulcers and pressure ulcers.
04.2 Posology and method of administration
To ensure the success of enzymatic skin lesion treatment with Noruxol, there must be sufficient moisture in the lesion area.
Therefore, in dry wounds, the base of the wound should be moistened with physiological saline (0.9% NaCl) or other solutions well tolerated by the tissue (eg glucose).
Dry, hard scabs should first be softened by applying a wet bandage.
An approximately 2mm thick layer of Noruxol should be applied with the dressing or directly to the slightly moistened area, once a day.
Cover the wound surface to ensure contact.
It is not necessary to apply an abundant layer of product on the lesion as this does not favor the progress of cleansing.
It is generally sufficient to change the dressing once a day unless otherwise advised by the doctor.
04.3 Contraindications
Hypersensitivity to the active substance (collagenase) or to any of the excipients of the ointment.
04.4 Special warnings and appropriate precautions for use
The repeated use of products for topical use can give rise to sensitization phenomena.
Whenever an infection is present, appropriate antibiotic treatment should be considered. Chloramphenicol, neomycin, framycetin, bacitracin, gentamicin, polymyxin B and macrolides - for example erythromycin - have been shown to be compatible with collagenase.
Contact with eyes and mucous membranes should be avoided.
In patients with severe burns, Noruxol should be used on the advice and under the supervision of the specialist.
In diabetic patients, dry gangrene should be moistened taking care to avoid its transformation into wet gangrene.
If a reduction in the necrotic component is not observed within 14 days of initiating therapy with Noruxol, it is recommended that treatment be discontinued and alternative debridement methods adopted.
After the first opening, the product can no longer be considered sterile.
Any residue, therefore, must not be used, but must be eliminated.
04.5 Interactions with other medicinal products and other forms of interaction
Noruxol should not be used in the presence of antiseptics, heavy metals, detergents and soaps, as they inhibit their enzymatic activity.
Products based on silver and silver sulphadiazine can however be used together with Noruxol without altering its enzymatic activity.
Tyrotricin, gramicidin and tetracyclines should not be used topically with Noruxol.
04.6 Pregnancy and lactation
Although no teratogenic effects have been shown, NORUXOL should only be administered during the first three months of pregnancy when strictly indicated.
Since collagenase does not enter the systemic circulation it is unlikely that it will be excreted by breast milk.
04.7 Effects on ability to drive and use machines
There are no prerequisites for negative interference on these capabilities.
04.8 Undesirable effects
Side effects can include local pain, itching, burning and erythema. In case of severity of reactions, discontinuation of therapy should be considered.
04.9 Overdose
Accidental ingestion of the drug is unlikely, but if it occurs it must be removed from the stomach by vomiting and if necessary by gastric lavage.
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.
The active ingredient, collagenase N, is a lyophilisate of the purified ultrafiltrate from Clostridium histolyticum culture. The active ingredient consists of the collagenolytic enzyme clostridiopeptidase A (EC 3.4.24.3) and other proteases.
The wound healing process occurs more rapidly if the necrotic tissue, normally present at the bottom of the wound anchored to the surface, through the native collagen fibers, is removed.
The specific collagenase present in Noruxol is capable of digesting native collagen fibers which are broken down into low molecular weight peptides.
The presence in the preparation of collagen peptidase and non-specific proteases allows the further digestion of the peptides derived from collagen and the digestion of other protein fractions such as fibrins and globular proteins, present in the necrotic tissue.
05.2 "Pharmacokinetic properties
No anti-collagenase or collagenase antibodies were detected in the blood of patients with skin lesions (varicose veins, ulcers, etc.) treated topically with collagenase ointment for a period of nine weeks.
Clinical researchers who treated patients with an enzyme preparation of Clostridium histolyticum in the form of an ointment (Santyl with 2.08 U / g in the hexapeptide test) reported the same results. There is also no evidence of collagenase uptake in a four-week study in monkeys (Macaca arctoides) with standard skin trauma. No serum samples from these animals revealed precipitates of anti-collagenase antibodies. Thus collagenase is not absorbed through the inflamed necrotic skin.
From the data it therefore appears to be completely inactivated and digested at the level of the ulcerative lesion itself. Probably the degradation products of collagenase consist of endogenous peptides and amino acids.
05.3 Preclinical safety data
From a toxicological point of view, collagenase is well tolerated. The threshold for acute toxicity is difficult to identify, and the healthy mucosa or skin is not irritated. No signs of allergic or systemic potential for intolerability reactions were observed after topical application to intact or scarified skin.
According to the results of immunological studies, collagenase is not absorbed through intact or inflamed skin.
Further animal experiments are not required given the clinical confirmations in humans evidenced in considerable experience over many years.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Liquid paraffin, white petroleum jelly.
06.2 Incompatibility
See 4.5 "Interactions with other medicinal products and other forms of interaction"
06.3 Period of validity
3 years.
After the first opening, the product can no longer be considered sterile.
Any residue, therefore, must not be used, but must be eliminated in accordance with current legislation.
06.4 Special precautions for storage
Store below 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
• Aluminum tube with polyethylene cap containing 10 g of ointment
• Aluminum tube with polyethylene cap containing 30 g of ointment
06.6 Instructions for use and handling
See 4.2 "Posology and method of administration"
07.0 MARKETING AUTHORIZATION HOLDER
Smith & Nephew S.r.l. - Via De Capitani 2A - 20864 AGRATE BRIANZA (MB)
08.0 MARKETING AUTHORIZATION NUMBER
• NORUXOL 10 g ointment - A.I.C. n. 028039016
• NORUXOL 30 g ointment - A.I.C. n. 028039028
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
First authorization: 31.10.1994
Authorization renewal: 16.11.2009
10.0 DATE OF REVISION OF THE TEXT
November 2009