SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
PAMYCON for sterile solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Neomycini sulfas 66 000 IU,
Bacitracinum 5 000 IU in 1 vial.
(Weight amount is calculated always on the base of efficacy of antibiotic).
3. PHARMACEUTICAL FORM
Powder for preparation of sterile solution.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
In surgery – for treatment of infected wounds and injuries, fistulas after pulmonary surgeries with mixed infection, acute ostheomyelitis, pyogenic bursitis, panaritium, purulent intra-articular inflammations, incidental abscesses and phlegmonas etc.
In obstetrics and gynecology – for treatment of breast nipple rhagades, mastitis and abscesses during lactation, bacterial fluorine in indicated cases and for pre-operative vaginal preparation.
In ophthalmology - for treatment of acute conjunctivitis (including pyogenic conjunctivitis of neonates), acute inflamed cornea, infected corneal erosions, dacryocystitis, blepharoconjunctivitis, hordeolosis and for preoperative preparation for intra-ophthalmic surgery.
In otorhinolaryngology - for treatment of otitis externa, otitis media suppurativa chronica, sinusitis maxillaries, infections of mucosa of upper and lower airways and in bronchiectasis, for postoperative care after ear surgery.
In urology – for adjuvant treatment of specific and non-specific urethritis, cystitis, cystopyelitis.
In stomatology – for treatment of some ulcerations of oral mucosa.
4.2 Posology and method of administration
The medicinal product is intended for preparation of sterile solution for use in health centers. It is dissolved by adding 20 mL of sterile 0.9% sodium chloride solution or 5% glucose solution.
1 mL of prepared solution contains 3.3 mg of neomycin (in sulfate form) and 250 IU of bacitracin.
Solution is intended for topical application only. It is dropped or injected on infected site or gauze strips soaked with Pamycon solution are applied to infected sites and by dropping of Pamycon solution the gauze strips are kept wet continually.
Using injection syringe it is possible to apply the solution to urinary bladder. It can be also used as an aerosol (2 mL of the solution together with mineral water) for inhalation. Administration is repeated 2-4 times daily as necessary, maximal daily dose is 5 mL of solution. Usually the 1-3 day treatment is chosen, if the treatment is prolonged, the dose is reduced.
In stomatological indications the solution at a standard concentration or also the solution diluted to a half-concentration are used.
Hypersensitivity to neomycin and bacitracin.
The medicament cannot be applied parenterally, neither to extensive areas, especially if they are eroded and madescent, varicose field below the knee because of risk of possible sensitization risk to neomycin.
Instillation into body cavities (peritoneal, intrapleural) because of possible incidence of serious toxic effects is not recommended.
4.4 Special warnings and precautions for use
Pamycon cannot be applied in infectious processes induced by insensitive microflora, e.g. yeasts and moulds or nosocomial strains resistant to neomycin. Rational therapy with Pamycon should be based on the results of microbiological examination and antibiograms which should be performed not only at the beginning, but also during treatment. If after the application of the medicament skin irritation occurs, it is probably the case of hypersensitivity which can be proven by skin patch test with ointment or solution of Pamycon (eventually neomycin). In case of positive result the treatment has to be discontinued and the patient should be warned of that he must not be treated with Pamycon even in the future.
4.5. Interaction with other medicinal products and other forms of interaction
At external application the drug substances contained in Pamycon do not get into blood circulation, and therefore there is no risk of mutual influence of interaction with other drug substance.
4.6 Fertility, pregnancy and lactation
In recommended method of application the unfavorable effect on fetus during pregnancy is not expected. Use during application is not connected with incidence of undesirable effects in infants, because in local use the active substances do not get into breast-milk. Application of Pamycon for treatment of nipple rhagades in mother is not connected with occurrence of undesirable effects (ototoxicity, affection of intestinal microflora) in infants, because concentration of active substances in duly prepared solution is low.
4.7 Effects on ability to drive and use machines
Pamycon has no effect on ability to drive and use machines, because the active substances are not absorbed.
4.8 Undesirable effects
In about 5 to 15 % of treated patients occurred allergic reactions (contact dermatitis, allergic conjunctivitis, also risk of anaphylactic shock), sensibilization (especially to neomycin) particularly in long-time treatment or in repeated local application. After absorption of higher amount of Pamycon the symptoms of nephrotoxicity are possible (by effect of neomycin and bacitracin), irreversible damage of auditory branch of 8th cranial nerve with partial to total deafness (after neomycin).
After intrapleural or intraperitoneal application of bigger volume of solution the risk of neuromuscular blockage is connected with respiratory blockage (curareform effects of neomycin).
At recommended application method the intoxication is not expected.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: antibiotic for external use
ATC code: D06AX
Action of neomycin is based on incorrect reading of genetic bacterial code, what disturbs the process of protein synthesis. Bacitracin inhibits biosynthesis of cell wall. So the double sided effect on bacterial cell is developed. Besides this additive effect there was observed in both bactericidal components of the drug the so called synergism for example against the growth of streptococci, enterococci, pneumococci and some staphylococci. Neomycin is effective against gram-positive and especially against gram-negative pathogens.
Spectrum of activity of bacitracin contains particularly gram-positive bacteria and cocci, but also gram-negative cocci and some gram-negative bacteria.
5.2 Pharmacokinetic properties
Pamycon is a mixture of antibiotics for local use, which are not applied systemically. Absorption of the drug substances neomycin and bacitracin through undisturbed skin is only minimal. So the high concentration of active substances on application site is reached.
5.3 Preclinical safety data
In acute toxicity tests the LD50 value in rats after per oral application of neomycin was determined to 2.75 g/kg and 510 000 IU/kg in mice after per oral application of bacitracin.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.3 Shelf life
Substance: 24 months
Prepared solution has to be used on day of preparation.
6.4 Special precautions for storage
Store below 15 ºC, on dry place, protect from light.
6.5 Nature and contents of container
Vial with glued label, rubber stopper, aluminium cap, package leaflet: information for the user, paper box.
Package size: 10 vials
6.6 Special precautions for disposal and other handling
Pamycon is intended for preparation of sterile solution for use in health centers.
It does not contain isotonisation agent.
The medicament, as it is, is not intended for immediate use and must be dissolved before it is applied. Into vial add 20 mL of sterile 0.9% sodium chloride and 5% glucose solution.
1 mL of solution contains 3.3 mg of neomycin (in sulfate form) and 250 IU of bacitracin.
7. MARKETING AUTHORISATION HOLDER
Biotika a.s., 976 13 Slovenská Ľupča 566, Slovak Republic
8. MARKETING AUTHORISATION NUMBER
15 / 0057 / 84 - S
9. DATE OF FIRST REGISTRATION / RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT