Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Tropicamide; Phenylephrine hydrochloride; Lidocaine Hydrochloride Monohydrate
Laboratoires Thea
S01FA; S01FA56
Tropicamide; Phenylephrine hydrochloride; Lidocaine Hydrochloride Monohydrate
0.2 mg/ml + 3.1 mg/ml + 10 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may be renewed (B)
Anticholinergics; tropicamide, combinations
Marketed
2015-08-28
2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FYDRANE 0.2 MG/ML + 3.1 MG/ML + 10 MG/ML SOLUTION FOR INJECTION _ _ tropicamide / phenylephrine hydrochloride / lidocaine hydrochloride monohydrate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What FYDRANE is and what it is used for 2. What you need to know before you are given MYDRANE 3. How FYDRANE is administered 4. Possible side effects 5. How to store FYDRANE 6. Contents of the pack and other information 1. WHAT FYDRANE IS AND WHAT IT IS USED FOR WHAT FYDRANE IS This medicine is a solution which is injected into the eye. It contains three active substances: • tropicamide which belongs to a group of medicines blocking the passage of impulses through particular nerves (known as anticholinergics), • phenylephrine (as phenylephrine hydrochloride) which belongs to a group of medicines mimicking the effects of impulses conveyed through particular nerves (known as alpha sympathomimetics), • lidocaine (as lidocaine hydrochloride monohydrate) which belongs to a class of drugs called amide type local anaesthetics. WHAT IT IS USED FOR This medicine is used in adults only. It will be administered by your ophthalmic surgeon by injection into the eye at the beginning of cataract surgery (cloudiness of the lens), in order to enlarge the pupil of your eye (mydriasis) and to obtain anaesthesia in your eye during the surgical procedure. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FYDRANE YOU SHOULD NOT BE GIVEN FYDRANE: • if you are allergic to tropicamide, phenylephrine hydrochloride and/or lidocaine hydrochloride monohydrate or to any of the other ingredients of this medicine (listed in se Leggi il documento completo
Health Products Regulatory Authority 22 September 2023 CRN00D4ZF Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml, solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution for injection contains 0.2 mg of tropicamide, 3.1 mg of phenylephrine hydrochloride and 10 mg of lidocaine hydrochloride monohydrate. One dose of 0.2 ml solution contains 0.04 mg of tropicamide, 0.62 mg of phenylephrine hydrochloride and 2 mg of lidocaine hydrochloride monohydrate. Excipient with a known effect: sodium (0.59 mg per dose; see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear and slightly brownish-yellow solution, practically free from visible particles. pH: 6.9 - 7.5 Osmolality: 290 – 350 mosmol/kg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fydrane is indicated for cataract surgery to obtain mydriasis and intraocular anaesthesia, during the surgical procedure. Fydrane is indicated in adults only. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Intracameral use. One ampoule for single eye use. Fydrane must be administered by an ophthalmic surgeon. Posology Fydrane should only be used in patients who have already demonstrated, at pre-operative assessment, a satisfactory pupil dilation with topical mydriatic therapy. _Adults:_ Slowly inject, by intracameral route, 0.2 ml of Fydrane in only one injection, at the start of the surgical procedure. Special population _Elderly:_ No dose adjustment is necessary. _Paediatric population:_ The safety and efficacy of Fydrane in children aged 0 to 18 years have not been established. _Patients with renal impairment:_ Considering the low dose and the very low systemic exposure (see section 5.2), no dose adjustment is necessary (see section 4.4). _Patients with hepatic impairment:_ Considering the low dose and the very low systemic exposure (see section 5.2), no dose adjustment is necessary. Health Products Regulatory Authority 22 S Leggi il documento completo