OLIMEL' N4E
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INSTRUCTIONS for medical use of the medicinal product FLOXIMED (FLOXIMED)
Composition
active substance: ciprofloxacin; 1 ml of solution contains ciprofloxacin (in the form of hydrochloride) 3 mg; excipients: sodium acetate, trihydrate; mannitol (E 421); disodium edetate; benzalkonium chloride; glacial acetic acid; purified water.
Pharmaceutical form
Eye and ear drops, solution.
Main physical and chemical properties
Transparent solution from colorless to greenish-yellow.
Pharmacotherapeutic group
Agents for use in ophthalmology and otology. Antimicrobial agents. ATC code S03A A07.
Pharmacological properties
Pharmacodynamics
Mechanism of action
The medicinal product contains ciprofloxacin from the class of quinolones. The bactericidal action of quinolones, which mainly affects the synthesis of bacterial DNA, is expressed by inhibiting DNA gyrase.
Ciprofloxacin has high activity in vitro against most gram-negative microorganisms, including Pseudomonas aeruginosa. It is also effective against aerobic gram-positive microorganisms, such as staphylococci and streptococci.
Susceptibility to microorganisms
Use in ophthalmology
Both in vitro and in clinical use in eye infections, it has been proven that ciprofloxacin is active against most strains of the following organisms.
| Aerobic gram-positive microorganisms: Staphylococcus aureus (including methicillin-sensitive and methicillin-resistant strains); Staphylococcus epidermidis; Staphylococcus spp., other coagulase-negative species Staphylococcus spp., including S. haemolyticus and S. hominis; Corynebacterium spp.; Streptococcus pneumoniae; Streptococcus group Viridans. |
| Aerobic gram-negative microorganisms: Acinetobacter spp.; Haemophilus influenzae; Pseudomonas aeruginosa; Moraxella spp. (including M. catarrhalis). |
Use in otology
Ciprofloxacin has high activity in vitro against most aerobic gram-negative microorganisms, including Pseudomonas aeruginosa. It is also effective against aerobic gram-positive microorganisms, such as staphylococci and streptococci.
| Bacterial species | Isolates N = | MIC min (μg / ml) | MIC50 (μg / ml) | MIC90 (μg / ml) | MIC max (μg / ml) |
| Pseudomonas aeruginosa | 1089 | 0.03 | 0.13 | 0.25 | 16 |
| Staphylococcus aureus | 221 | 0.13 | 0.50 | 1.0 | 128 |
| Staphylococcus epidermidis | 257 | 0.06 | 0.25 | 0.50 | 128 |
| Staphylococcus caprae | 75 | 0.13 | 0.50 | 0.50 | 2.0 |
| Enterococcus faecalis | 53 | 0.50 | 1.0 | 2.0 | 4.0 |
| Enterobacter cloacae | 45 | 0.004 | 0.016 | 0.032 | 0.25 |
Limit values of microbial growth inhibition zones
Use in ophthalmology
Ciprofloxacin has been shown to be active in vitro against most strains of the following microorganisms; however, the clinical significance of these data in ophthalmic infections is unknown.
| Aerobic gram-positive microorganisms: Bacillus species. |
| Aerobic gram-negative microorganisms: Acinetobacter calcoaceticus; Enterobacter aerogenes; Escherichia coli; Haemophilus parainfluenzae; Klebsiella pneumoniae; Neisseria gonorrhoeae; Proteus mirabilis; Proteus vulgaris; Serratia marcescens. |
| Others: Peptococcus spp.; Peptostreptococcus spp.; Propionibacterium acnes; Clostridium perfringens. |
Insensitive species
Some strains of Burkholderia cepacia and Stenotrophomonas maltophilia are resistant to ciprofloxacin, as well as some anaerobic bacteria, especially Bacteroides fragilis.
Preclinical safety data
Ciprofloxacin and other quinolones cause the development of arthropathy in young animals of most species studied after oral administration.
Clinical characteristics
Indications
Corneal ulcers and superficial eye infections (eyes) and their appendages, caused by bacterial strains sensitive to ciprofloxacin.
Acute otitis externa, as well as acute otitis media with drainage through a tympanostomy tube, caused by bacterial strains sensitive to ciprofloxacin.
Contraindications
Increased sensitivity to ciprofloxacin, other quinolones, and/or excipients of the medicinal product.
Interaction with other medicinal products and other types of interactions
No interaction studies were conducted.
Special warnings and precautions for use
General
The medicinal product is intended for local use (in the conjunctival sac or in the external auditory canal).
For eye drops
Clinical experience with ciprofloxacin eye drops in children under 1 year of age, especially newborns, is quite limited.
For ear drops
The efficacy and safety of ciprofloxacin ear drops in children under 1 year of age have not been evaluated.
Use during pregnancy or breastfeeding
Pregnancy
There are no adequate data on the local use of ciprofloxacin in pregnant women.
Breastfeeding
When administered orally, ciprofloxacin was found in breast milk.
Ability to affect reaction rate when driving vehicles or operating machinery
Ciprofloxacin for local use does not have or has a negligible effect on the ability to drive vehicles or operate machinery.
Method of administration and dosage
Use in ophthalmology
Dosage
Adolescents and adults, including elderly patients.
Corneal ulcers. The medicinal product should be used at the following intervals, including at night:
· on the 1st day, instill 2 drops into the conjunctival sac(s) of the affected eye(s) every 15 minutes for the first 6 hours, then 2 drops every 30 minutes during the first day;
· on the 2nd day, instill 2 drops into the conjunctival sac(s) of the affected eye(s) every hour;
· from the 3rd to the 14th day, instill 2 drops into the conjunctival sac(s) of the affected eye(s) every 4 hours.
Method of administration
To prevent contamination of the dropper tip and solution, care should be taken not to touch the eyelids, adjacent areas, or other surfaces with the edge of the dropper bottle.
Use in otology
Dosage
Adults, including elderly patients.
The medicinal product is used in a dose of 4 drops into the ear canal 2 times a day.
Method of administration
The external auditory canal should be carefully cleaned.
Overdose
Symptoms. Given the characteristics of this medicinal product, intended for local use, no toxic effect is expected when used in ophthalmology/otology in the recommended doses, as well as in the event of accidental ingestion of the contents of 1 bottle.
Adverse reactions
Adverse effects observed after application of ciprofloxacin to the eye
| Infections and invasions | Rarely — barley, rhinitis |
| Immune system disorders | Rarely — increased sensitivity |
| Nervous system disorders | Often — dysgeusia; Rarely — headache; Rarely — dizziness |
| Eye disorders | Often — deposits on the cornea, feeling of discomfort in the eye, hyperemia of the eye; Rarely — keratopathy, infiltrates of the cornea, discoloration of the cornea, photophobia, decreased visual acuity, swelling of the eyelids, blurred vision, eye pain, dryness of the eye, swelling of the eyes, itching of the eye, feeling of a foreign body in the eye, increased lacrimation, discharge from the eye, formation of scales on the edges of the eyelids, peeling of the eyelids, swelling of the conjunctiva, erythema of the eyelids; Rarely — eye toxicity, punctate keratitis, keratitis, conjunctivitis, dysfunction of the cornea, epithelial defect of the cornea, diplopia, hypesthesia of the eye, asthenopia, irritation of the eye, inflammation of the eye, hyperemia of the conjunctiva |
| Ear and labyrinth disorders | Rarely — ear pain |
| Respiratory, thoracic, and mediastinal disorders | Rarely — hypersecretion of the paranasal sinuses |
| Gastrointestinal disorders | Rarely — nausea; Rarely — diarrhea, abdominal pain |
| Skin and subcutaneous tissue disorders | Rarely — dermatitis |
| Musculoskeletal and connective tissue disorders | Frequency unknown — tendon damage |
| General disorders | Rarely — intolerance to the medicinal product |
| Laboratory studies | Rarely — deviation from normal laboratory test results |
Adverse reactions observed after application of ciprofloxacin to the ear
| Nervous system disorders | Rarely — crying, headache |
| Ear and labyrinth disorders | Rarely — ear pain, ear fullness, otorrhea, itching in the ear; Frequency unknown — tinnitus |
| Skin and subcutaneous tissue disorders | Rarely — dermatitis |
| General disorders | Rarely — hyperthermia |
Shelf life
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging and out of reach of children.
Packaging
5 ml of solution in a dropper bottle; 1 dropper bottle in a cardboard box.
Release category
By prescription.
Manufacturer
S.C. Rompharm Company S.R.L., Romania / K.O. Rompharm Comp ani S.R.L., Romania.
Location of the manufacturer and address of the place of business
Otopeni city, Eroilor str. № 1A, 075100, Ilfov county / м. Отопень, вул. Ероілор № 1А, 075100, округ Ілфов.
Applicant
WORLD MEDICINE, LLC, Ukraine / ТОВ «УОРЛД МЕДИЦИН», Україна.
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- Zamienniki OLIMEL' N4EPostać farmaceutyczna: emulsion, 1440 ml, or 1920 ml, or 2400 mlSubstancja czynna: combinationsProducent: Фрезеніус Кабі АБWymaga receptyPostać farmaceutyczna: emulsion, 300 mlSubstancja czynna: combinationsProducent: Бакстер С.А.Wymaga receptyPostać farmaceutyczna: emulsion, 500 mlSubstancja czynna: combinationsProducent: Бакстер С.А.Wymaga recepty
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