CETRAXAL PLUS Ear drops, solution (2019)
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Περιεχόμενα
1. Name of the medicinal product
Cetraxal Plus 3 mg/ml + 0.25 mg/ml ear drops solution in single-dose container.
2. Qualitative and quantitative composition
Each ml of solution contains ciprofloxacin hydrochloride equivalent to 3 mg ciprofloxacin and 0.25 mg of fluocinolone acetonide.
Each single-dose container (0.25 ml) delivers 0.75 mg of ciprofloxac...
3. Pharmaceutical form
Ear drops, solution in single-dose container (ear drops).
Colourless or slightly yellow, clear aqueous solution.
4.1. Therapeutic indications
Cetraxal Plus is indicated in adults and in children aged 6 months and older for the following infections:
Acute otitis externa (AOE)
Acute otitis media in patients with tympanostomy tubes (AOMT) c...
4.2. Posology and method of administration
Posology
Adults and elderly population
Acute otitis externa and acute otitis media with tympanostomy tubes: Instil the contents of one single-dose container into the affected ear canal every 12 hou...
4.3. Contraindications
Hypersensitivity to the active substances ciprofloxacin or fluocinolone acetonide or any member of the quinolone class of antimicrobial agents or to any of the excipients listed in section 6.1.
Vir...
4.4. Special warnings and precautions for use
This medicinal product is for auricular use only, not for ophthalmic use, inhalation or injection. This medicine should not be swallowed or injected.
If otorrhea persists after a full course of the...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed with Cetraxal Plus. However, due to negligible plasma levels observed after application in the ear (see section 5.2), it is unlikely that ciprofloxacin or...
4.6. Fertility, pregnancy and lactation
Pregnancy
Data available on administration of ciprofloxacin to pregnant women indicates no malformative or foeto/neonatal toxicity. Since systemic exposure to ciprofloxacin will be very low no effe...
4.7. Effects on ability to drive and use machines
Cetraxal Plus has no influence on the ability to drive and use machines due to the route of administration and the conditions of use.
4.8. Undesirable effects
Tabulated summary of adverse events
The following adverse reactions listed in the table below were observed in clinical studies or with post-marketing experience. They are ranked according to syste...
4.9. Overdose
No case of overdose has been reported.
Due to negligible plasma levels observed after application in the ear, it is unlikely that topically applied ciprofloxacin or fluocinolone acetonide may show ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group:
Otological preparations: corticosteroids and antiinfectives in combination
ATC Code:
S02CA05
Fluocinolone acetonide
Fluocinolone acetonide is a synthetic fluorinated c...
5.2. Pharmacokinetic properties
Auricular use
Blood samples were taken in two studies of AOMT to determine the plasma levels of ciprofloxacin and/or fluocinolone acetonide. Pharmacokinetic analysis showed no or negligible plasma ...
5.3. Preclinical safety data
The toxicity of ciprofloxacin has been deeply studied. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Adverse effects on the central nervou...
6.1. List of excipients
Polysorbate 80
Glycerin
Povidone
Purified water
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
Shelf-life after first opening of the pouch: 7 days.
6.4. Special precautions for storage
Store below 30°C. Store the single-dose containers in the pouch in order to protect from light.
After first opening of the single-dose container: use immediately and discard the single-dose contain...
6.5. Nature and contents of container
The solution is contained within a formed low-density polyethylene (LDPE) single-dose container. Each single-dose container delivers 0.25 ml.
The single-dose containers are contained in an aluminiu...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Aspire Pharma Limited, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom
8. Marketing authorization number(s)
PL35533/0133
9. Date of first authorization / renewal of the authorization
23/07/2018
10. Date of revision of the text
09/05/2019
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