Irlanda - anglès - HPRA (Health Products Regulatory Authority)

santen oy - levofloxacin; dexamethasone - eye drops, solution - 5+1 milligram(s)/millilitre - dexamethasone and antiinfectives

Estats Units - anglès - NLM (National Library of Medicine)

proficient rx lp - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - ciprodex is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: acute otitis media (aom) in pediatric patients (age 6 months and older) with tympanostomy tubes due to staphylococcus aureus , streptococcus pneumoniae , haemophilus influenzae , moraxella catarrhalis , and pseudomonas aeruginosa . acute otitis externa (aoe) in pediatric (age 6 months and older), adult and elderly patients due to staphylococcus aureus and pseudomonas aeruginosa . teratogenic effects. pregnancy category c: no adequate and well controlled studies with ciprodex have been performed in pregnant women. caution should be exercised when ciprodex is used by a pregnant woman. animal reproduction studies have not been conducted with ciprodex. reproduction studies with ciprofloxacin have been performed in rats and mice using oral doses of up to 100 mg/kg and intravenous (iv) doses up to 30 mg/kg, and have revealed no evidence of harm to the fetus.

Estats Units - anglès - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u), dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - ciprodex® is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: - acute otitis media (aom) in pediatric patients (age 6 months and older) with tympanostomy tubes due to staphylococcus aureus , streptococcus pneumoniae , haemophilus influenzae , moraxella catarrhalis , and pseudomonas aeruginosa . - acute otitis externa (aoe) in pediatric (age 6 months and older), adult and elderly patients due to staphylococcus aureus and pseudomonas aeruginosa . - ciprodex is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication. - use of this product is contraindicated in viral infections of the external canal, including herpes simplex infections and fungal otic infections. risk summary there are no available data on ciprodex use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse ma

Singapur - anglès - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - ciprofloxacin hydrochloride eqv to ciprofloxacin; dexamethasone - solution - 0.30% - ciprofloxacin hydrochloride eqv to ciprofloxacin 0.3%; dexamethasone 0.1%

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

max health limited - dexamethasone sodium phosphate 4.37 mg/ml equivalent to dexamethasone phosphate 4 mg/ml - solution for injection - 4 mg/ml - active: dexamethasone sodium phosphate 4.37 mg/ml equivalent to dexamethasone phosphate 4 mg/ml excipient: disodium edetate nitrogen propylene glycol sodium hydroxide water for injection - dexamethasone has predominantly glucocorticoid activity and therefore is not a complete replacement therapy in cases of adrenocortical insufficiency. dexamethasone should be supplemented with salt and/or a mineralocorticoid. when so supplemented, dexamethasone is indicated in: · acute adrenocortical insufficiency - addison's disease, bilateral adrenalectomy; · relative adrenocortical insufficiency - prolonged administration of adrenocortical steroids can produce dormancy of the adrenal cortex. the reduced secretory capacity gives rise to a state of relative adrenocortical insufficiency which persists for a varying length of time after therapy is discontinued. should a patient be subjected to sudden stress during this period of reduced secretion (for up to two years after therapy has ceased) the steroid output may not be adequate. steroid therapy should therefore be reinstituted to help cope with stress such as that associated with surgery, trauma, burns, or severe infections where specific antibiotic therapy is available; · primary and secondary adrenocortical insufficiency.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - ciprofloxacin hydrochloride, quantity: 3.5 mg/ml (equivalent: ciprofloxacin, qty 3 mg/ml) - ear drops, solution - excipient ingredients: mannitol; purified water; benzalkonium chloride; sodium hydroxide; disodium edetate; sodium acetate; hydrochloric acid; glacial acetic acid - treatment of chronic suppurative otitis media caused by organisms susceptible to ciprofloxacin in adults and children one month of age or older.

Kenya - anglès - Pharmacy and Poisons Board

unisel pharma (k) ltd 4th parkland avenue, parklands, apricot suites, - ciprofloxacin usp and dexamethasone usp - ophthalmic solution - ciprofloxacin 0.3%w/v & dexamethasone usp 0.1%w/v - ophthalmologicals

Regne Unit - anglès - MHRA (Medicines & Healthcare Products Regulatory Agency)

base) 3.3mg/1ml solution for injection ampoules (hameln pharma ltd - dexamethasone sodium phosphate - solution for injection - 3.3mg/1ml

Regne Unit - anglès - MHRA (Medicines & Healthcare Products Regulatory Agency)

consilient health ltd - dexamethasone; ciprofloxacin hydrochloride - ear drops - 1mg/1ml ; 3mg/1ml

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

pharmaco (nz) ltd - ciprofloxacin hydrochloride 0.33%{relative} equivalent to 0.3% ciprofloxacin; dexamethasone 1%{relative};   - ear drops - 0.33%/1% - active: ciprofloxacin hydrochloride 0.33%{relative} equivalent to 0.3% ciprofloxacin dexamethasone 1%{relative}   excipient: acetic acid benzalkonium chloride boric acid disodium edetate hydrochloric acid hyetellose purified water sodium acetate trihydrate sodium chloride sodium hydroxide tyloxapol - cilodex is indicated for the topical treatment of acute otitis media in patients with tympanostomy tubes and acute otitis externa in patients caused by strains of bacteria susceptible to ciprofloxacin.