NORUXOL UNG 10G

NORUXOL UNGUENT

active ingredients

1 g of Noruxol contains: Active ingredient: 0.52 ÷ 3.75 mg collagenase N containing: • Clostridiopeptidase A not less than 1.2 Units • Associated proteases not less than 0.24 Units For excipients, see 6.1.

Excellent

Liquid paraffin, white vaseline.

Therapeutic indications

Enzymatic detersion of necrotic sores including leg ulcers and decubital ulcers.

Contraindications

Hypersensitivity to the active ingredient (collagenase) or any of the ointment excipients.

Population

To ensure the success of the enzymatic treatment of skin lesions with Noruxol, sufficient humidity must be present in the lesion area. Therefore, in dry wounds, the base of the lesion must be moistened with saline physiological solution (0.9% NaCl) or other solutions well tolerated by the tissue (eg glucose). Dry and hard crusts should first be softened by applying a wet bandage. A layer of Noruxol about 2 mm thick must be applied with the dressing or directly on the slightly moistened area, once a day. Cover the surface of the lesion to ensure contact. It is not necessary to apply a abundant layer of product on the lesion since this does not favor the progress of the detersion. Generally it is sufficient to change the dressing once a day unless different advice of the doctor.

Conservation

Store at a temperature below 25°C.

Warnings

The repeated use of topical products can give rise to awareness phenomena. Whenever there is an infection, it must be considered an appropriate antibiotic treatment. Cloramfenicolo, neomycin, framicetine, bacitracin, gentamycin, polymixine B and macrolides – erythromycin example – have been shown to be compatible with collagenase. It should be avoided contact with eyes and mucosa. In patients with severe burns, the use of Noruxol must take place on indication and under control of the specialist. In diabetic patients, dry gangrene should be moistened, having the precaution to avoid its transformation into wet gangrene. If you do not see a reduction in the 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 fastening. After the first opening the product can no longer be considered sterile. Any residue, therefore, should not be used, but must be eliminated.

Interactions

Noruxol should not be used in the presence of antiseptics, heavy metals, detergents and soaps, since they inhibit enzymatic activity. Silver and silver sulfadiazine products can be used together with Noruxol without altering its enzymatic activity. Tirotricina, gramicidine and tetracycline should not be used locally with Noruxol.

Effects

Side effects may include local pain, itching, burning and erythema. In case of the severity of the reactions, the interruption of therapy must be considered.

Overdosing

The accidental intake of the drug is unlikely, but if it happens it must be removed from the stomach with vomiting and if necessary with gastric lavender.

Although no teratogenic effects have been shown, NORUXOL must be administered during the first three months of pregnancy only when strictly indicated. Since collagenase does not enter the systemic circulation, it is unlikely that it is excreted by breast milk.

Source: Farmadati