Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Lidocaine
Gedeon Richter Plc
N01BB02
Lidocaine
42 milligram(s)/millilitre
Intrauterine gel
lidocaine
Not marketed
2020-11-06
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LIDBREE 42 MG/ML INTRAUTERINE GEL lidocaine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING 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. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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 Lidbree is and what it is used for 2. What you need to know before you use Lidbree 3. How to use Lidbree 4. Possible side effects 5. How to store Lidbree 6. Contents of the pack and other information 1. WHAT LIDBREE IS AND WHAT IT IS USED FOR Lidbree is a numbing gel used to prevent pain from gynaecological procedures, such as placement of contraceptive devices into the womb (uterus) and sampling biopsies for laboratory evaluation at gynaecological examinations, in adults and adolescents from 15 years of age. It contains the active substance lidocaine, an amide type local anaesthetic (that numbs the parts of the body it is applied to). HOW LIDBREE WORKS After application of gel it takes 2 to 5 minutes before the genital area (the mucosa) is numb. The gel has been shown to reduce the pain during gynaecological procedures and up to at least 30 minutes after the procedure. After 1 hour the pain relieving effect has worn off. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LIDBREE _ _ DO NOT USE LIDBREE if you are allergic to lidocaine or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS For cervical and intrauterine use only. After use of the gel for the placement of intrauterine contraceptives (intrauterine contraceptive devices, IUDs), in some cases bleeding and/or exceptional pain may occur after difficult insert Citiți documentul complet
Health Products Regulatory Authority 13 July 2021 CRN00CCQJ Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lidbree 42 mg/mL intrauterine gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lidocaine 42 mg/mL Excipients with known effect: Each mL of gel contains 284 mg of macrogolglycerol ricinoleate (castor oil polyoxyl) and up to 28 micrograms of butylated hydroxytoluene (E 321). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Intrauterine gel. Sterile, clear to almost clear, slightly brown-yellow viscous liquid that is a gel at body temperature. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lidbree is indicated for topical anaesthesia for moderate acute pain during cervical and intrauterine procedures, in adults and adolescents from 15 years of age. See section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Cervical procedures_ Apply 2 to 3 mL in a thick layer to the portio, and 3 mL into the cervical canal using the sterile applicator 5 minutes before start of procedure. _Intrauterine procedures_ Using the sterile applicator, apply 1 to 2 mL to the anterior lip of the portio, and 2 to 3 mL into the cervical canal. Wait 2 minutes for the onset of effect at the inner meatus. Thereafter insert the applicator into the uterine cavity and introduce 3 to 5 mL, 5 minutes before the procedure. The applicator is marked with a centimetre scale. A smaller volume can be administered, e.g. in nulliparous patients, if the patient experiences discomfort before the whole volume has been given. A single intrauterine dose should not exceed a total of 10 mL. _Paediatric population from 15 years of age_ In low-weight adolescents below 30 kg body weight the dose should be proportionally reduced, and a single dose should not exceed the maximum recommended parenteral dose (6 mg/kg lidocaine hydrochloride, corresponding to 5.2 mg/kg lidocaine base in Lidbree, i.e. 1.2 mL per 10 kg body weight). In adolescents with a body weight of 30 kg the maximum dose of Lidbree is 3.6 Citiți documentul complet