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Risk Minimisation Materials

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Lamzede

Chiesi Limited

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Lamzede® (Velmanase Alfa) IMPORTANT INFORMATION on minimising the risk of hypersensitivity reactions and medication errors in home settings

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Information for Healthcare Professionals Version No: 0.3 Date: March 2023


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Lamzede® (Velmanase Alfa) IMPORTANT INFORMATION on minimising the risk of hypersensitivity reactions and medication errors during home infusion. Infusion diary booklet

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March 2023 This diary is designed to assist with the administration of velmanase alfa. The diary should be kept as a record of when velmanase alfa is administered.


Lariam

Neon Healthcare Ltd

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Checklist for Healthcare Professionals

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Checklist for the prescription, supply or recommendation of Lariam® (mefloquine) for malaria chemoprophylaxis


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Guide for Healthcare Professionals

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This guide is intended to provide you with information regarding side effects which may be associated with chemoprophylactic use of Lariam® (mefloquine).


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Patient Alert Card

Lariam Patient Alert Card


Leandra

Thornton & Ross Ltd

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Healthcare Professional (HCP) Guide

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Pregnancy Prevention Programme guide for HCP's.


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Patient Guide

Pregnancy Prevention Programme guide for patients.


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Patient Pocket Information Card

Patient Pocket Information Card for patients and HCP's.


Leflunomide

Rivopharm UK Ltd

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Leflunomide - Physician Leaflet

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This leaflet is to highlight the important risks associated with Leflunomide and to emphasize the need for counselling patients about these risks


Sandoz Limited

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Leflunomide 10 mg and 20 mg Film-coated Tablets: Specific safety information for Phsyicians

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This educational material is intended to minimize several risks identified in the frame of the European risk management plan established for Leflunomide. The most important risks you should be aware of when prescribing Leflunomide include: • Risk of hepatotoxicity, including very rare cases of severe liver injury, which may be fatal. • Risk of hematotoxicity, including rare cases of pancytopenia, leucopenia, eosinophilia and very rare cases of agranulocytosis. • Risks of infections including rare cases of severe uncontrolled infections (sepsis), which may be fatal. • Risk of serious birth defects when administered during pregnancy. Counselling of patients, careful monitoring and following recommendations regarding the wash-out procedure are required to minimise these risks. Complete prescribing information is provided in the approved Summary of Product Characteristics (SmPC) for Leflunomide.


medac GmbH

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Leflunomide medac - RMP Patient Leaflet

Risk Management Educational Material


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Leflunomide medac - RMP Physician Leaflet

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In addition to the Summary of Product Characteristics, this leaflet was developed by the marketing authorisation holder to inform you about all delicate issues potentially arising from Leflunomide medac therapy. Counselling patients on important risks associated with Leflunomide medac therapy and appropriate precautions when using the medicine is required.


Mylan

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Leflunomide Patient Leaflet

Leflunomide Patient Leaflet - Patient leaflet containing important safety information for Leflunomide


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Leflunomide Physician Leaflet

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This leaflet is to highlight the most important risks associated with Leflunomide and to emphasize the need for counselling patients about those important risks


Tillomed Laboratories Ltd

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Leflunomide Tillomed 10mg & 20mg Tablets - Prescriber's Guide

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Prescriber's Guide


Lemtrada

SANOFI

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Lemtrada (alemtuzumab) - Healthcare Professional (HCP) Guide - Risk Minimisation Information for Healthcare Professionals

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This guide has been developed for prescribers and healthcare professionals (HCPs) involved in the care of patients treated with Lemtrada (alemtuzumab), to provide further information about the potential serious risks associated with the use of this medicine. For hard copies of this information please contact medical information department on 0800 035 2525 or email [email protected]


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Lemtrada (alemtuzumab) - Patient Alert Card - Risk Minimisation Information for Patients

The card should be provided to patients prior to treatment by the prescribing physician and is designed to alert other HCPs that the patient has been prescribed Lemtrada (alemtuzumab) and includes details on the associated risks of treatment and contact details of the prescriber. For hard copies of this information please contact medical information department on 0800 035 2525 or email [email protected]


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Lemtrada (alemtuzumab) - Patient Guide - Risk Minimisation Information for Patients

The guide should be provided to patients prior to treatment by the prescribing physician and includes a description of the risks of treatment, guidance on what to do in the event of risks occurring including your doctors contact details and an overview of treatment monitoring. For hard copies of this information please contact medical information department on 0800 035 2525 or email [email protected]


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Lemtrada (alemtuzumab) – Prescriber check list - Risk Minimisation Information for Healthcare Professionals

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Describes required initial screening tests, pre-treatment vaccination course, premedication, general health, and pregnancy and contraception checks immediately before treatment and the subsequent monitoring activities. For hard copies of this information please contact medical information department on 0800 035 2525 or email [email protected]


Lenalidomide

Amarox Limited

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Lenalidomide - Pathfinder Patient Guide

Lenalidomide Pregnancy Prevention Programme Information for Patients taking Lenalidomide


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Lenalidomide - Pathfinder Healthcare Professional (HCP) Guide

Lenalidomide Pregnancy Prevention Programme And Information for Healthcare Professionals Prescribing or Dispensing Lenalidomide


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Lenalidomide - Pathfinder Patient Pocket Information Card

Lenalidomide - Information for Patients and Healthcare Professionals


Glenmark Pharmaceuticals Europe Ltd

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Frequently Asked Questions (FAQs)

Frequently Asked Questions (FAQs)


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Important Contact Information

Important Contact Information


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Introduction to Lenalidomide Healthcare Professional’s Information Pack

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It is a requirement of the Pregnancy Prevention Programme that all healthcare professionals ensure that they have read and understood risk minimisation materials before prescribing or dispensing lenalidomide for any patient. Please also refer to the Summary of Product Characteristics (SmPC) for lenalidomide.


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Lenalidomide Adverse Event, Pregnancy and Pregnancy Outcome Report Forms

The safe use of lenalidomide is of paramount importance. Adverse events and cases of suspected or confirmed pregnancy or foetal exposure should be immediately reported to Glenmark Pharmaceuticals Europe Ltd. You can also report the event via the Yellow Card website: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.


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Lenalidomide Information for Healthcare Professionals

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This brochure contains the information needed for prescribing and dispensing lenalidomide, including information about the Pregnancy Prevention Programme (PPP). Please also refer to the Summary of Product Characteristics (SmPC) for lenalidomide.


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Lenalidomide Information for Patients

This brochure should be given to patients receiving treatment with lenalidomide, as it provides important information about the lenalidomide Pregnancy Prevention Programme, including what a patient needs to be aware of before, during and after taking lenalidomide and how to report side effects.


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Lenalidomide Patient Alert Card

This card should be given to all patients as it reminds patients of the key educational information and risks of treatment with lenalidomide.


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Lenalidomide Pharmacy Registration Form

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This Pharmacy Registration Form must be completed by the Chief Pharmacist or appointed deputy to be able to order and dispense lenalidomide. In order to ensure that the actions to minimise the risk of foetal exposure are carried out for all patients, dispensing of lenalidomide will only be allowed from pharmacies registered with Glenmark Pharmaceuticals Europe Ltd.


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Lenalidomide Prescription Authorisation Form

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A newly completed Prescription Authorisation Form must accompany each lenalidomide prescription to confirm that the patient has been counselled about the teratogenic risk of lenalidomide and the required contraceptive methods, continues to use effective contraception and in the case of a woman of childbearing potential, is having a pregnancy test every 4 weeks before each prescription to ensure they are not pregnant. Completion of this information is mandatory for ALL patients.


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Lenalidomide Treatment Checklists and Algorithm

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This checklist is to assist you with counselling a patient before they commence lenalidomide treatment in order to ensure it is used safely and correctly. The Algorithm provides high level steps for prescribing and dispensing of lenalidomide.


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Lenalidomide Treatment Initiation Forms

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Woman of Childbearing Potential Treatment Initiation Form must be completed for each woman of childbearing potential prior to the initiation of their lenalidomide treatment. Woman of Non-Childbearing Potential Treatment Initiation Form must be completed for each woman of non-childbearing potential prior to the initiation of their lenalidomide treatment. Male Treatment Initiation Form must be completed for each male patient prior to the initiation of their lenalidomide treatment.


Teva UK Limited

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HCP Lenalidomide RMM

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HCP Lenalidomide RMM


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Lenalidomide Patient Pocket Information Card

Lenalidomide Patient Pocket Information Card


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Patient Lenalidomide RMM

Patient Lenalidomide RMM


Thornton & Ross Ltd

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Healthcare Professional (HCP) Guide

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Pregnancy Prevention Programme guide for HCP's.


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Patient Guide

Pregnancy Prevention Programme guide for patients.


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Patient Pocket Information Card

Patient Pocket Information Card for patients and HCP's.


ADVANZ Pharma

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Healthcare Professional (HCP) Guide

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Healthcare Professionals involved in the prescribing or dispensing of lenalidomide must read and understand the information contained within this brochure. For complete safety information please refer to the Summary of Product Characteristics (SmPC) for lenalidomide,


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Patient Guide

Information for Patients taking Lenalidomide. This Brochure Contains Information About Preventing harm to unborn babies If lenalidomide is taken during pregnancy.


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Patient Pocket Information Card

Information for Patients and Healthcare Professionals


Ranbaxy (UK) Limited a Sun Pharmaceutical Company

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Lenalidomide - Pathfinder Healthcare Professional (HCP) Guide

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Lenalidomide Pregnancy Prevention Programme And Information for Healthcare Professionals Prescribing or Dispensing Lenalidomide


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Lenalidomide - Pathfinder Patient Guide

Lenalidomide Pregnancy Prevention Programme Information for Patients taking Lenalidomide


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Lenalidomide - Pathfinder Patient Pocket Information Card

Lenalidomide - Information for Patients and Healthcare Professionals


Zentiva

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Lenalidomide Adverse Effects reporting form

Lenalidomide Adverse Effects reporting form Pregnancy prevention programme


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Lenalidomide Combined checklist

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Lenalidomide Combined checklist Pregnancy prevention programme


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Lenalidomide Pharmacy Registration Form

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Lenalidomide Pharmacy Registration Form Pregnancy Prevention programme


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Lenalidomide Pocket Info

Lenalidomide pocket information for patients and HCP's


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Lenalidomide PPP HCP Guide

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Pregnancy Prevention Programme guide for HCP's


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Lenalidomide PPP Patient booklet

Pregnancy prevention programme booklet for patients


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Lenalidomide pregnancy specific questionnaire

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Lenalidomide pregnancy specific questionnaire


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Lenalidomide prescription authorisation form

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Lenalidomide prescription authorisation form


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Lenalidomide Treatment Initiation form - Men

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Lenalidomide Pregnancy prevention programme, treatment initiation form for males


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Lenalidomide Treatment Initiation form - WNCBP

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Lenalidomide Pregnancy Prevention programme for Women Of Non child bearing potential


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Lenalidomide Treatment Initiation form - WOCBP

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Lenalidomide Pregnancy prevention programme Treatment Initiation form - Women Of Child Bearing Potential


Mylan

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Lenalidomide HCP Prescribing and Dispensing Guide

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Lenalidomide Pregnancy Prevention Programme and information for HCPs prescribing or dispensing Lenalidomide


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Lenalidomide Patient booklet

Lenalidomide Pregnancy Prevention Programme: information for patients taking Lenalidomide


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Lenalidomide pocket information card

Lenalidomide pocket information card for patients and HCPs


Sandoz Limited

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Lenalidomide Healthcare Professional Guide

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Information for Healthcare Professionals Prescribing or Dispensing Lenalidomide: This guide contains the info needed for the prescribing and dispensing of lenalidomide, including information about the Pregnancy Prevention Programme and important safety information. This guide ensures you know what to do before prescribing and dispensing lenalidomide. If lenalidomide is taken during pregnancy it is expected to cause severe birth defects or death to an unborn baby. This Programme is designed to make sure that unborn babies are not exposed to lenalidomide. It is a requirement of the Pregnancy Prevention Programme that all healthcare professionals (HCPs) ensure that they have read and understood the Healthcare Professionals Information guide before prescribing or dispensing lenalidomide for any patient. You must ensure that your patients fully understand what you have told them about lenalidomide and that they have completed the Treatment Initiation Form, before starting treatment.


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Lenalidomide Patient Guide: Pregnancy Prevention Programme

This brochure contains information about: - Preventing harm to unborn babies. If lenalidomide is taken during pregnancy it is expected to cause severe birth defects or death to an unborn baby. - The Lenalidomide Pregnancy Prevention Programme, designed to ensure that unborn babies are not exposed to Lenalidomide. It will provide you with information about what to expect from your treatment, and explain the risks and your responsibilities. - Lenalidomide passes into men’s semen, and is expected to cause severe birth defects or death to an unborn baby. So there is a risk if you have unprotected sex with a woman who can become pregnant. - This brochure will help you understand what to do before, during and after taking lenalidomide. For your own health and safety, please read this brochure as well as the Package Leaflet that comes with your medicine, carefully. If you do not understand something, please ask your prescriber for further explanation.


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Lenalidomide Patient Pocket Information Card

Contains safety information regarding the risks to an unborn baby from Lenalidomide. Has information for the HCP to complete regarding treatment details and patient specifics (are they male or female, are they receiving counselling, contraception use). Contains emergency contact details.


Levest

Morningside Healthcare Ltd

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Checklist for Prescribers - Levest

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Please use this checklist in conjunction with the SPC during combined hormonal contraceptives consultations. Risk of Thromboembolism.


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Important Information for Women - Levest Tablets

This is a bit more information about the recommendations of combined hormonal contraceptives, in particular the risk of blood clots. Includes key points to bear in mind.


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Patient Card - Levest

Important information for women about the risk of blood clots with the combined hormonal contraceptives.


Levetiracetam

Aurobindo Pharma - Milpharm Ltd.

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Levetiracetam oral solution - Risk of medication errors associated with overdose

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Levetiracetam overdose can lead to serious adverse event. With every prescription, physicians and pharmacists should advise the patient and/or caregiver on how to measure the prescribed dose


Levobunolol

Aspire Pharma Ltd

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Dispensing guide

An aide-mémoire for pharmacists dispensing Librachrom to ensure the unique features of the product are explained to patients.


Levonelle

Bayer plc

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Levonelle One Step Patient Questionnaire Checklist

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Instructions for Pharmacists supplying Levonelle One Step 1500 microgram tablet as emergency contraception


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Levonorgestrel Patient Sheet

Levonorgestrel emergency contraception: important information for women taking other medicines


Levonorgestrel

Lupin Healthcare (UK) Ltd

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Advice for women taking Levonorgestrel tablets

Advice for women taking Levonorgestrel tablets Levonorgestrel 1.5mg Tabletsl PL35507-0126


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Checklist for Pharmacists

Checklist for Pharmacists Levonorgestrel 1.5mg Tablets PL 35507-0126


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Levonorgestrel Patient Sheet

Levonorgestrel emergency contraception: important information for women taking other medicines. Some medicines or herbal remedies that contain the ingredient St. John's wort, might reduce how well levonorgestrel emergency contraception works. Tell the doctor, pharmacist or nurse if you are currently taking a medicine to treat any of the following, or if you have used one in the past 4 weeks: epilepsy, tuberculosis, HIV, a fungal infection, or if you have taken any herbal remedies that contain the ingredient St. John's wort.


Gedeon Richter (UK) Ltd

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Levonorgestrel Patient Sheet

Levonorgestrel emergency contraception: important information for women taking other medicines.


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Postinor 1500mcg Patient Questionnaire checklist

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Instructions for Pharmacists supplying Postinor 1500 microgram tablet as emergency contraception


Levosert

Gedeon Richter (UK) Ltd

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Levosert HCP Educational Brochure

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This educational brochure is intended to minimise the risk of application errors due to confusion of different types of IUS and to reduce the risk of ectopic pregnancies.


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Levosert Patient Card

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Levosert Patient Card


Liberate

Teva UK Limited

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Essential information for the supply of Liberize

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UK Essential information for the supply of Liberize (sildenafil)


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Liberize Pharmacy Checklist

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UK Liberize (sildenafil) Pharmacy Checklist


Libtayo

Regeneron UK Limited

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LIBTAYO 350 mg concentrate for solution for infusion Patient Alert Card

Important safety information to minimise the risks of immune-mediated adverse reactions. This Patient Alert Card will help you identify and report side effects from your treatment with cemiplimab.


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LIBTAYO 350 mg concentrate for solution for infusion Patient Guide

Important safety information to minimise complications from immune-mediated adverse reactions. This Patient Guide will help you identify and report side effects from your treatment with cemiplimab.


Litfulo

Pfizer Limited

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Litfulo (ritlecitinib) Prescriber Guide

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Prescriber guide to provide a checklist for assessments prior to prescribing, management, monitoring and safety considerations related to the Risk Management Plan


Lixiana

Daiichi Sankyo UK Limited

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Lixiana (edoxaban) Patient Alert Card

Every patient prescribed Lixiana will receive a Patient Alert Card in the medication pack. This will inform doctors, dentists, pharmacists and other healthcare professionals about the patient’s anticoagulation treatment, along with emergency contact details. Encourage patients to have this card with them at all times and to show it to healthcare professionals prior to any consultation or procedure. Patients should be reminded of the importance of compliance to their treatment regimen, the need to watch for signs and symptoms of bleeding and when to seek medical advice. Patient Alert Cards are available from [email protected] or by calling 08000285122.


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Lixiana (edoxaban) Prescriber Guide

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This risk minimisation material has been developed for Lixiana for all indications. Please ensure that you are familiar with this material as it contains important safety information. In particular, it is aimed at increasing awareness about the potential risk of bleeding during treatment with Lixiana and providing guidance on how to manage that risk.


Lizinna

Morningside Healthcare Ltd

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Checklist for Prescribers - Lizinna

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Please use this checklist in conjunction with the SPC during combined hormonal contraceptives consultations. Risk of thromboembolism.


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Important Information for Women - Lizinna

This is more information on recommendations of safety of combined hormonal contraceptives, in particular the risk of blood clots.


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Patient Card - Lizinna

Important Information for women about risk of blood clots with combined hormonal contraceptives.


Logynon

Bayer plc

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CHCs - Checklist for Prescribers

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Combined Hormonal Contraceptives - checklist for prescribers


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CHCs - Q&A on Important Info for Women

Combined hormonal contraceptives: Q&As about the important information for women.


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CHCs - Risk of Blood Clots with CHCs

Important Information for women about risk of blood clots with combined hormonal contraceptives.


Logynon ED

Bayer plc

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CHCs - Checklist for Prescribers

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Combined Hormonal Contraceptives - checklist for prescribers


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CHCs - Q&A on Important Info for Women

Combined hormonal contraceptives: Q&As about the important information for women.


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CHCs - Risk of Blood Clots with CHCs

Important Information for women about risk of blood clots with combined hormonal contraceptives.


Lojuxta

Amryt Pharmaceuticals DAC

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Lojuxta (lomitapide) Healthcare Professional Guide

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Healthcare professional guide contains information on the serious risks associated with Lojuxta and how to help mitigate these risks.


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Lojuxta Alert Card

The purpose of the patient alert card is to inform health care professionals of potential drug-drug interactions before any additional medicinal product is taken. Patients will be instructed to carry this card and show it to all doctors and pharmacists involved in their treatment.


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Lojuxta Patient Care Guide

Patient care guide containing important safety information for patients treated with Lojuxta (lomitapide).


Losartan+Hydrochlorothiazide

Mylan

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Direct HCP Communication: Hydrochlorothiazide, risk of non‐melanoma skin cancer

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Direct Healthcare Professional Communication Hydrochlorothiazide: Risk of non‐melanoma skin cancer


Aurobindo Pharma - Milpharm Ltd.

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Losartan/HCTZ- HCP letter- Hydrochlorothiazide and the risk of non-melanoma skin cancer

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The prescriber should inform the patients taking hydrochlorothiazide (HCTZ) containing medicines of the risk of non-melanoma skin cancer. Patients should be advised to limit the exposure to sunlight and UV rays and use adequate protection when exposed to sunlight and UV rays to minimise the risk of skin cancer


Lovima

Maxwellia Limited

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Healthcare Professional Training

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To support the Healthcare Professional in conducting effective, patient-specific, clinical consultations on contraception, and enable them to appropriately supply Lovima® 75 microgram film-coated tablets (desogestrel).


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Optional Pharmacist Checklist

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• Use of this checklist is optional and this consultation checklist is provided to act as a reminder for pharmacists. • It covers the key considerations when determining suitability of Lovima 75 microgram film-coated tablets for women who request them and advice to provide when supply is made.


Lucentis

Novartis Pharmaceuticals UK Ltd

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Lucentis (ranibizumab) - Patient information booklet (AMD) - for patients

A booklet containing important safety information for patients treated with Lucentis (ranibizumab) in wet (neovascular) age related macular degeneration (nAMD). An audio version is available on eMC.


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Lucentis (ranibizumab) - Patient information booklet (CNV) - for patients

A booklet containing important safety information for patients treated with Lucentis (ranibizumab) with visual impairment due to choroidal neovascularisation (CNV)secondary to pathological myopia. An audio version is available on eMC.


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Lucentis (ranibizumab) - Patient information booklet (DMO/PDR) - for patients

A booklet containing important safety information for patients treated with Lucentis (ranibizumab) with proliferative diabetic retinopathy (PDR) and/or visual impairment due to diabetic macular oedema (DMO). An audio version is available on eMC.


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Lucentis (ranibizumab) - Patient information booklet (RVO) - for patients

A booklet containing important safety information for patients treated with Lucentis (ranibizumab) with visual impairment due to retinal vein occlusion (RVO). An audio version is available on eMC.


Lucette

Gedeon Richter (UK) Ltd

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Checklist for Prescribers

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Checklist in conjunction with the Summary of Product Characteristics during combined hormonal contraceptive (CHC) consultations.


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Patient User Card

Important information for women about risk of blood clots with combined hormonal contraceptives (CHC).


Lunsumio

Roche Products Limited

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Important Safety Information for Patients receiving Lunsumio® (mosunetuzumab)

This material is provided by Roche Products Ltd as a licence requirement for this medicine and forms part of the Risk Management Plan.


Lutathera

Advanced Accelerator Applications

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Lutathera Patient Guide

Patient guide for Lutathera treatment procedure


Luxturna

Novartis Pharmaceuticals UK Ltd

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Luxturna (voretigene neparvovec) - Patient Alert card - for Patients

Patient card to track treatment and provide useful contact details


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Luxturna (voretigene neparvovec) - Pharmacy training material - for Healthcare Professionals

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Pharmacy manual for dose preparation of Luxturna


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Luxturna (voretigene neparvovec) - Surgical training material - for Healthcare Professionals

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Surgical manual for the administration of Luxturna


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