STREPTOSIL NEOMICINA UNG 20G

STREPTOSIL WITH NEOMICHINE

active ingredients

10 g of powder contain: sulphateazole 9,95 g and neomycin sulphate 0.05 g. 20 g ointment contain: sulphateazole 0.4 g and neomycin sulphate 0.1 g.

Excellent

skin powder: nobody. ointment: vaseline oil, white vaseline, white wax.

Therapeutic indications

Surface skin infections (folliculitis, forunculous, small burns and infected wounds).

Contraindications

STREPTOSIL with NEOMICINA is contraindicated in patients with: - Hypersensitivity to active ingredients or any of the excipients listed in the paragraph 6.1. - Infections of the ear canal in case of perforation of the timpanic membrane.

Population

Skin powder Lift the coloured cap, press rhythmically and thoroughly the two sides of the bottle holding it horizontally or slightly oblique; slightly sprinkle with powder the affected region and cover with sterile gauze; renew the application twice a day. It is recommended to practice light sprinkling, using the minimum dust required to avoid the formation of crusts and allow rapid solubility and diffusion of components. Do not exceed the recommended doses. Ointment Apply a thin layer of ointment 2-3 times a day. Do not exceed the recommended doses.

Conservation

No special precaution for conservation.

Warnings

STREPTOSIL with NEOMICINA is not for ophthalmic use; is indicated only for external use. The application of STREPTOSIL with NEOMICINA on the skin lesa extensively and deeply, such as in secondary skin infections with extensive burns and trophic ulcers, could promote the systemic absorption of its active ingredients, exposing patients with serious secondary effects, such as nephrotoxicity and ototoxicity. The medicine should not be used in ear canal infections in the case of tympane drilling since in these cases the topical use of neomycin can cause deafness (see par. 4.3) As for other aminoglycosides, one must avoid the simultaneous and/or sequential systemic or topic administration of other nephrotoxic drugs. Duration of treatment The use, especially if prolonged, of products for topical use, can give rise to phenomena of sensitization. As with other antibiotics, prolonged use of neomycin can determine the development of resistant microorganisms, including fungi. If this occurs, it is necessary to stop the treatment and establish adequate therapy. After a short period of treatment without appreciable results, or in case of worsening of patient conditions, it is necessary to assess the suspension of treatment. Pediatric population In early childhood the product should be administered in cases of actual need, under the direct control of the doctor. The application of neomycin on large skin areas and for prolonged periods, can determine systemic absorption; such eventuality occurs more easily when using occlusive bandage, in particular, in infants, since the diaper can act as an occlusive bandage.

Interactions

Neomycin for topical use has demonstrated a crusade sensitivity with other aminoglycosides; the simultaneous administration of another aminoglycoside, especially by systemic means, is not recommended due to the potential ototoxic and nephrotoxic effects. The topical application of sulphateazole can give rise to awareness and preclude the next systemic use of sulfamidics.

Effects

Following the use of STREPTOSIL with NEOMICINA, the undesirable effects indicated below can occur. The frequency of such unwanted effects is not known. Infections and infestations Bacterial and fungal overinfections. Immune system disorders Hypersensitivity reactions Pathologies of skin and subcutaneous tissue Prurito. Systemic pathologies and conditions for administration Inflator, redness. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

In the event of prolonged applications on extended surfaces or lesions, a systemic absorption of the medicinal product may occur with the circulation of sulphateazole and/or neomycin. In case of suspicion of overdose, the treatment must be stopped.

Pregnancy The safety of topical use of sulfamidics or neomycin during pregnancy has not been established. In pregnant women the product should be administered in cases of actual need, under the direct control of the doctor. Food Adequate studies are not available to assess the effects in women during breastfeeding and to determine the risk in infants. The product must be used in nursing women only if strictly necessary, under the direct control of the doctor. Fertility Studies have not been conducted to assess the effects on fertility in man.

Source: Farmadati