Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
CIPROFLOXACIN AS HYDROCHLORIDE; FLUOCINOLONE ACETONIDE
CTS LTD
S03AA07
EAR DROPS
CIPROFLOXACIN AS HYDROCHLORIDE 3 MG / 1 ML; FLUOCINOLONE ACETONIDE 0.25 MG / 1 ML
OTIC
Required
LABORATORIOS SALVAT S.A., SPAIN
CIPROFLOXACIN
CIPROFLOXACIN
Cetraxal 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)caused by ciprofloxacin susceptible microorganisms.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
2019-02-11
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor's prescription only CETRAXAL EAR DROPS ACTIVE INGREDIENTS: 3 mg/ml Ciprofloxacin (as HCl) 0.25 mg/ml Fluocinolone Acetonide For information regarding inactive ingredients and allergens, see section 2 – “Important information about some ingredients of the medicine” and section 6 – “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any other questions, refer to the doctor or the pharmacist. This medicine has been prescribed for treatment of your illness. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for local treatment of an acute inflammation of the outer ear (acute otitis externa) and an inflammation of the middle ear (otitis media) following ear tube surgery, caused by bacteria. The medicine is intended for adults and children over 6 months of age. THERAPEUTIC CLASS: Ciprofloxacin – a fluoroquinolone antibiotic. Ciprofloxacin works by killing infection-causing bacteria. Fluocinolone acetonide – a corticosteroid with anti- inflammatory and pain-relieving properties for treatment of swelling and pain. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive to fluocinolone acetonide, ciprofloxacin, other quinolones, or to any of the additional ingredients the medicine contains (see section 6). • In case of an ear infection caused by a virus or fungus. SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE • If during treatment you develop signs of urticaria (hives), skin rash or other allergy signs (e.g., sudden swelling of the face, throat or eyelids, trouble breathing), you must discontinue treatment immediately and contact your doctor. An immediate emergency treatment may be required if you suffer from severe re Baca dokumen lengkapnya
1 1. NAME OF THE MEDICINAL PRODUCT Cetraxal Ear drops solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 3 mg of ciprofloxacin (as hydrochloride) and 0.25 mg of fluocinolone acetonide. Excipients with known effect: 0.6 mg methyl parahydroxybenzoate per ml. 0.3 mg propyl parahydroxybenzoate per ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ear drops, solution. Clear solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cetraxal 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) caused by ciprofloxacin susceptible microorganisms. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults _ Acute otitis externa and acute otitis media with tympanostomy tubes: Instil 6-8 drops into the affected external ear canal every 12 hours for 7 days. _ _ _Paediatric population _ The dosage in children aged 6 months and older is the same as for adults for both indications. _ _ Method of administration Auricular use. _ _ _Precautions to be taken before handling or administering the medicinal product _ The solution should be warmed before its use, by holding the bottle in the hand for several minutes. This will avoid the discomfort that may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward and then the drops should be instilled pulling several times on the auricle. For patients with 2 acute otitis media with tympanostomy tubes, the tragus should be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for around 1 minute to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear. To prevent contamination of the dropper tip in order to limit bacterial r Baca dokumen lengkapnya