For the local treatment of infections caused by neomycin-sensitive and/or bacitracin-sensitive germs:

 

-        Small-scale bacterial infections, e.g.:

          bacterially infected herpes simplex, herpes zoster blisters / varicella blisters, exudative impetigo contagiosa, infected leg ulcers, infected eczema, bacterially infected nappy dermatitis;

 

-        Prevention of umbilical infections in neonates;

 

-        After surgical (dermatological) interventions as adjunctive therapy for

- excisions and cauterisations;

- treatment of rhagades;

- perineal tear;

- episiotomy;

- exudative wounds and scars.

 

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

 

Posology

In general, Baneocin Powder is applied twice to four times daily in adults and children.

No more than 1% of the body surface (corresponding to the size of a palm of a hand) should be treated.

 

Method of administration

For cutaneous application.

Apply a thin layer of powder to the affected area. A dressing may be used.

Treatment duration should be limited to 7 days.

 

Patients with hepatic and/or renal impairment

When using doses that are much higher than the recommended doses, nephrotoxic and/or ototoxic changes must be considered, because of the increased risk of possible absorption of the active substances, in particular in patients with hepatic and/or renal impairment. Corresponding urine and blood tests or audiometric tests are recommended (see also section 4.4).

 

Elderly patients (aged 65 and over)

No dose adjustment is required in elderly patients.

 

• Hypersensitivity to the active substances, other aminoglycoside antibiotics, or to any of the excipients listed in section 6.1. • Use in severe, large-scale wounds should be avoided as absorption can cause ototoxic side effects with hearing loss. • In severe cardiogenic or nephrogenic excretion disorders and pre-impairment of the vestibular and/or cochlear organ, the use of Baneocin Powder is not indicated if there is a possibility of uncontrolled absorption. • Do not use in the external auditory canal if the tympanic membrane is perforated. • Baneocin Powder should not be used on the eye.

Baneocin Powder must not be used in the mouth – especially in children.

 

When using doses that are much higher than the recommended doses, nephrotoxic and/or ototoxic changes must be considered, because of possible absorption of the active substances.

 

This risk is increased in patients with hepatic and/or renal impairment, and therefore in this case urine and blood tests or audiometric tests are recommended prior to and during intensive therapy.

 

In uncontrolled Baneocin absorption the possibility of neuromuscular blockade, especially in acidosis, myasthenia gravis or other neuromuscular diseases, should be considered. Calcium or cholinesterase inhibitors (neostigmine) can counteract such a blockade.

 

In prolonged use, be particularly vigilant for overgrowth of resistant germs, especially fungi. In these cases appropriate therapeutic measures must be taken.

 

The medicine must be discontinued in the event of allergies and superinfections.

In the event of absorption, nephrotoxicity may be enhanced in the event of concomitant administration of cephalosporins or other aminoglycoside antibiotics.

 

Enhanced ototoxicity or nephrotoxicity is possible in the event of concomitant administration of diuretics such as ethacrynic acid or furosemide.

 

In the event of absorption, the use of narcotics, anaesthetics or muscle relaxants can enhance neuromuscular blockade.

Pregnancy and breast-feeding

In the event of potential absorption of Baneocin Powder, caution must be exercised in pregnancy and during the breast-feeding period. Like all aminoglycoside antibiotics, neomycin passes the placenta.

At high systemic aminoglycoside doses fetal hearing impairment has been described. The medicinal product should therefore only be administered if the potential outweighs the fetal risk.

 

Fertility

No fertility studies have been performed. Studies in animals have shown no effects on fertility (see section 5.3).

 

Not applicable.

The undesirable effects below are classified according to body system and frequency as follows:

 

Very common: ≥ 1/10

Common:        ≥ 1/100, < 1/10

Uncommon:    ≥ 1/1000, < 1/100

Rare:               ≥ 1/10,000, < 1/1000

Very rare:        < 1/10,000

Not known:      frequency cannot be estimated from available data

 

Immune system disorders

Rare:                   In approximately 50% of cases of neomycin allergy, there is also a cross-allergy to other aminoglycoside antibiotics.

Not known:          Sensitisation: Compared to healthy skin, use in chronic dermatoses (e.g. stasis dermatitis or chronic otitis media) promotes sensitisation to many different substances including neomycin. Under certain circumstances the allergy can manifest simply as a failure to heal.

 

Nervous system disorders

Not known:          Vestibular damage, neuromuscular blockade

 

Ear and labyrinth disorders

Not known:          Hearing impairment

 

Skin and subcutaneous tissue disorders

Rare:                   Allergies, mainly apparent as contact eczema.

Not known:          With long-term use, allergic reactions can develop, such as skin redness, drying and flaking, rash and itching. Spread of lesions or failure to heal may be allergy-related.

 

Renal and urinary disorders

Not known:          Kidney damage

When using doses that are much higher than the recommended doses, nephrotoxic and/or ototoxic changes must be considered, because of possible absorption of the active substances.

Pharmacotherapeutic group: Dermatologicals; other antibiotics for topical use

ATC code: D06AX

 

Baneocin is an antibiotic combination intended for topical treatment only. It contains two antibacterial, high-potency (bactericidal) substances, neomycin and bacitracin, which complement each other synergistically.

 

Bacitracin:

Above all in gram-positive bacteria (and some gram-negative bacteria), murein synthesis is inhibited in the cell wall.

Bacitracin primarily affects gram-positive bacteria such as haemolysing Streptococci, Staphylococci, Clostridia, Corynebacterium diphtheriae and Treponema pallidum, and a few gram-negative pathogens such as Neisseria and Haemophilus influenzae. It is also effective against actinomyetes and fusobacteria. Resistance to bacitracin is extremely rare.

 

Neomycin sulphate:

The effect is partly due to the increase in cell membrane permeability and partly due to ribosome protein synthesis inhibition. Neomycin sulphate acts against both gram-positive and gram-negative pathogens, such as Staphylococci, Proteus, Enterobacter aerogenes, Klebsiella pneumoniae, Salmonella, Shigella, Haemophilus influenzae, Pasteurella, Neisseria meningitidis, Vibrio cholerae, Bordetella pertussis, Bacillus anthracis, Corynebacterium diphtheriae, Streptococcus faecalis, Listeria monocytogenes, Escherichia coli and Mycobacterium tuberculosis. Borrelia and Leptospira interrogans (L. icterohaemorrhagiae) are also suppressed. Some strains of Staphylococci are neomycin-resistant.

 

Thanks to the combined effect, a broad-spectrum effect is achieved. Pseudomonas, nocardia, fungi and viruses are not included.

 

Tolerance and tissue tolerance are good; inactivation due to secretion, blood or tissue parts does not occur either. In the event of application over a large area, contrary to the dosage recommendation, the possibility of absorption and its potential consequences must be taken into account (see sections 4.3, 4.4, 4.5 and 4.8).

 

The powder formulation promotes natural insensible perspiration, thereby producing a cooling, soothing effect.

When used as intended, Baneocin acts locally at the site of application. If absorption has nevertheless occurred, the serum half-life of neomycin or bacitracin is approximately 2-3 hours.

The following general pharmacokinetic data apply to the individual active substances of Baneocin:

Bacitracin is virtually not absorbed by mucous membranes and skin. In open wounds, however, absorption must be borne in mind.

Only small amounts of neomycin are absorbed by intact skin. Neomycin is rapidly absorbed when the keratin layer is damaged (ulcers, wounds, burns etc.) and in inflamed or damaged skin.

Any quantities absorbed through a non-intact epithelium are eliminated via the urine.

No data are available on carcinogenic or mutagenic effects after long-term administration of bacitracin in animal studies. Treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 µg/ml) tested. The relevance of this observation in topical application and practically negligible absorption appears debatable. After oral administration of bacitracin (100 g/ton of food) in rabbits, no adverse effect on fertility, size of offspring and survival time was observed.

Sterilised powder base (amylum maydis, magnesium oxide)

Not applicable.

3 years

Store below 25°C.

Keep in original packaging.

PE container with snap-on lid containing 6 g and 10 g.

 

Not all pack sizes may be marketed.

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.