Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tropicamide; Phenylephrine hydrochloride; Lidocaine hydrochloride
Thea Pharmaceuticals Ltd
Tropicamide; Phenylephrine hydrochloride; Lidocaine hydrochloride
200microgram/1ml ; 3.1mg/1ml ; 10mg/1ml
Solution for injection
Intracameral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 11080200; GTIN: 3662042003462
N2380A20L03/X1217 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 MYDRANE is and what it is used for 2. What you need to know before you are given MYDRANE 3. How MYDRANE is administered 4. Possible side effects 5. How to store MYDRANE 6. Contents of the pack and other information 1. WHAT MYDRANE IS AND WHAT IT IS USED FOR What MYDRANE 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) 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 MYDRANE You should not be given MYDRANE: • if you are allergic to tropicamide, phenylephrine hydrochloride and/or lidocaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6), • if you are allergic to anaesthetics of the amide type, • if you are allergic to atropine derivatives. Warnings and precautions MYDRANE is not recommended: • in combined cataract surge Прочитайте повний документ
OBJECT 1 MYDRANE Summary of Product Characteristics Updated 05-Jun-2018 | Thea Pharmaceuticals Ltd 1. Name of the medicinal product Mydrane 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. 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. 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 Mydrane is indicated for cataract surgery to obtain mydriasis and intraocular anaesthesia during the surgical procedure. Mydrane is indicated in adults only. 4.2 Posology and method of administration Intracameral use. One ampoule for single eye use. Mydrane must be administered by an ophthalmic surgeon. Posology Mydrane 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 Mydrane in one injection, at the start of the surgical procedure. Special population _Elderly:_ No dose adjustment is necessary. _Paediatric population:_ The safety and efficacy of Mydrane 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. Method of administration Intracameral use. The following procedure should be foll Прочитайте повний документ