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Risk Minimisation Materials

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Sarclisa

SANOFI

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Sarclisa HCP Brochure

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This brochure contains important information for HCPs & blood banks concerning the appropriate measures to manage isatuximab interference and avoid possible resulting adverse clinical consequences and to inform that isatuximab may interfere with routine blood compatibility tests with potential false positive reactions in the indirect antiglobulin test (indirect Coombs test). For hard copies of this information please contact medical information department on 0800 035 2525 or email [email protected].

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Sarclisa Patient Alert Card

This patient alert card contains important safety information that you need to be aware of before, during, and after treatment with SARCLISA. For hard copies of this information please contact medical information department on 0800 035 2525 or email [email protected].

Sialanar

Proveca Limited

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Checklist for Healthcare Professionals

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These educational materials focus on the provision of advice for the recognition of anticholinergic effects that can be associated with glycopyrronium bromide containing products and how best to manage specific events.

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Healthcare Professional Checklist Labels

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This is a sheet of checklist labels to help record anticholinergic effects in a patient’s notes.

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Reminder Card for Caregivers

These educational materials focus on the provision of advice for the recognition of anticholinergic effects that can be associated with glycopyrronium bromide containing products and how best to manage specific events.

Siklos

Masters Pharmaceuticals Ltd

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Patient's Guide to Siklos

This Siklos Patient Guide contains important information about your treatment, or your child's treatment including advice on preparation and administration of your medicine, disease symptoms, and side effects.

 


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Physicians Guide to Siklos

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This Physician Guide for Siklos contains important recommendations for patient monitoring, dosage adjustments, and the management of serious adverse effects.


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Siklos Dosing Sheet

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Dosing sheet for physicians to illustrate and record patient's individual daily dosage requirements.


Sildenafil

Crescent Pharma Ltd

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Essential Information For The Supply Of Zamantos 50mg film-coated tablets

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Essential information for supplier

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Pharmacy Checklist for Zamantos 50mg film-coated tablets'

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Pharmacy checklist

Simponi

Janssen-Cilag Ltd (a Johnson & Johnson Company)

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Simponi Patient Reminder Card

This Patient Reminder Card contains important safety information that you need to be aware of before and during treatment with Simponi

Skilarence

Almirall Limited

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Healthcare Professional Guideline - Important safety information for Skilarence (dimethyl fumarate)

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This guideline is intended to inform HCPs about the risk of serious infections, mainly opportunistic infections such as progressive multifocal leukoencephalopathy (PML), associated with the use of Skilarence and to provide guidance on how to minimise and manage this risk through appropriate monitoring of lymphocyte and leukocyte count abnormalities.

Sodium oxybate

Aristo Pharma Limited

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How to take Sodium oxybate 500 mg/ml oral solution Brochure

Important risk minimisation information for Patients:

How to take Sodium oxybate 500 mg/ml oral solution Brochure


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Sodium Oxybate 500 mg/ml Oral Solution Frequently Asked Questions (FAQ) Information Sheet

Important risk minimisation information for Patients and Caregivers:

Sodium oxybate 500 mg/ml oral solution

Frequently Asked Questions (FAQ)


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Sodium Oxybate 500 mg/ml oral solution Patient Alert Card

Safety information card for patients, physicians and pharmacists


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Sodium oxybate 500 mg/ml oral solution Treatment Initiation and Follow-Up Visit Form

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Important risk minimisation information for Healthcare Professionals:

Sodium oxybate 500 mg/ml oral solution Treatment Initiation and Follow-Up Visit Form


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Sodium oxybate Guide for Paediatric Patients and their Caregivers

GUIDE FOR PAEDIATRIC PATIENTS AND THEIR CAREGIVERS

IMPORTANT INFORMATION ABOUT SAFE USE AND HANDLING OF SODIUM OXYBATE


AS Kalceks

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Sodium Oxybate 500 mg/ml oral solution, AS Kalceks, Educational Materials, Treatment Initiation and Follow-Up Visit Form

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- Important risk minimisation information for Healthcare Professionals: Treatment Initiation and Follow-Up Visit Form

Reig Jofre UK Ltd

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Frequently Asked Questions SODIUM OXYBATE Oral Solution 500mg/ml 180ml

In this guide the patient is warned about the risks (of respiratory and central nervous system depression, depression, suicide, seizures, abuse, misuse, illicit and criminal use, overdose, dependence/addiction and the interaction of the product with alcohol and the resulting psychosis) and is told how to proceed in the event of experiencing them.


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Guidance for paediatric patients - SODIUM OXYBATE Oral Solution 500mg/ml 180ml

Guidance for paediatric patients and their caregivers - Important information about safe use and handling of Sodium Oxybate 500 mg/ml oral solution (sodium oxybate).


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How to take SODIUM OXYBATE Oral Solution 500mg/ml 180ml

IMPORTANT RISK MINIMISATION INFORMATION FOR PATIENTS:

How to take SODIUM OXYBATE 500mg/ml Oral solution


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Important risk minimisation information for Healthcare Professionals: SODIUM OXYBATE Oral Solution 500mg/ml 180ml

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This treatment initiation form should be completed by Healthcare Professionals as it is essential to ensure the safe and effective use of Sodium Oxybate 500 mg/ml oral solution and the appropriate management of the important risks. All sections of this form need to be completed, signed and dated and retained in the patient's medical records.

This guide contains recommendations to minimise the risks of respiratory and central nervous system depression, depression, suicide, seizures, abuse, misuse, illicit and criminal use, overdose, dependence/addiction and the interaction of the product with alcohol and the resulting psychosis.


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Patient Alert Card SODIUM OXYBATE Oral Solution 500mg/ml 180ml

This guide contains recommendations to avoid the risks (respiratory and central nervous system depression, depression, suicide, seizures, abuse, misuse, illicit and criminal use, overdose, dependence/addiction and the interaction of the product with alcohol and the resulting psychosis) and patients are advised to carry this with them at all times.


Sodium valproate

Seacross Pharmaceuticals Ltd

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Guide for Healthcare professionals

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Educational material for Healthcare Professionals (HCPs) about the Pregnancy Prevention Programme. For hard copies of this information please contact medical information department on +44(0) 2087315273 or email UK-Medicalinformation drug [email protected]

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Patient Guide

Educational material for girls and women of childbearing potential about the Pregnancy Prevention Programme. For hard copies of this information please contact medical information department on +44(0) 2087315273 or email UK-Medicalinformation [email protected]

Strandhaven Limited t/a Somex Pharma

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Valproate - “White Box” Warning Labels

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FOR DISPENSARY USE ONLY. Warning Labels with Valproate Pregnancy Pictogram for Pharmacy to use with white box dispensing of these products. For hard copies of this information please contact medical information department on 0800 035 2525 or email [email protected]

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Valproate - Healthcare professionals (HCPs) Guide Pregnancy prevention programme

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Educational material for Healthcare Professionals (HCPs) about the Pregnancy Prevention Programme. For hard copies of this information please contact medical information department on 0800 035 2525 or email [email protected]

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Valproate - Patient Card - Contraception and Pregnancy Prevention

Educational material for girls and women of childbearing potential about the Pregnancy Prevention Programme. For hard copies of this information please contact medical information department on 0800 035 2525 or email [email protected]

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Valproate Female Annual Risk Acknowledgement Form

THIS INTERACTIVE FORM IS NOT INTENDED FOR HARD COPY USE. Interactive form for use with girls and women of childbearing potential taking this product. It is to be completed with their specialist at least once a year to make sure they know and have understood all the risks related to the use of valproate during pregnancy and the need to avoid becoming pregnant while taking valproate.

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Valproate Male Risk Acknowledgement Form

THIS INTERACTIVE FORM IS NOT INTENDED FOR HARD COPY USE Interactive form for male patients aged under 55 years to complete with their specialists when starting valproate

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Valproate- Patient Guide- Pregnancy prevention programme

Educational material for girls and women of childbearing potential about the Pregnancy Prevention Programme. For hard copies of this information please contact medical information department on 0800 035 2525 or email [email protected]

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Valproate- Poster- Dispensary- Pregnancy Prevention Programme

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FOR DISPENSARY USE ONLY. Dispensary A4 Poster for Pharmacy with key information about the Pregnancy Prevention Programme. For hard copies of this information please contact medical information department on 0800 035 2525 or email [email protected]

Wockhardt UK Ltd

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Valproate - HCP Guide

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Guide about use of valproate in pregnancy

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Valproate - Patient Guide

Guide on use of of valproate during pregnancy

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Valproate - Patient Reminder Card

Patient Reminder Card

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Valproate - Poster

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Warning Poster

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Valproate - Warning Labels

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Warning Labels for Cartons

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Valproate Female ARAF 2023 GB & NI -aRMM

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Patient Risk Acknowledgement Form Female

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Valproate Male RAF GB & NI 2023 - aRMM

Patient Risk Acknowledgement Form Male

Soliris

Alexion Pharma UK Ltd

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Soliris Patient Safety Card

Important Safety Information for Patients Receiving Soliris® Show this card to any doctor involved in your care.

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Soliris Patient/Parent Information

This guide is for adult patients and parents/legal guardians of a child who has been prescribed eculizumab. The guide provides you with important safety information that you must be aware of.

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Soliris Physician's Guide

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The aim of this brochure is to educate and/or remind healthcare professionals about the selected prevention measures, detection, careful monitoring and/or proper management of selected safety concerns associated with eculizumab.

Spravato

Janssen-Cilag Ltd (a Johnson & Johnson Company)

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Spravato (esketamine nasal spray): Healthcare Professional Guide

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This guide informs healthcare professionals about the four identified risks that may occur following Spravato treatment: transient dissociative states and perception disorders (dissociation), disturbances in consciousness (sedation), increased blood pressure and drug abuse. This guide describes the risks and explains how to minimise and manage them.

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Spravato (esketamine nasal spray): Patient Guide

If you are being treated with Spravato, it is important that you understand the possible risks of taking this medicine. This guide will explain these risks and give you information about how you and your healthcare professional can reduce these risks. This guide does not replace the patient information leaflet that comes with your medicine and you should ensure you have read this prior to taking Spravato.

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Spravato (esketamine nasal spray): Readiness-to-leave checklist for healthcare professionals

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The treating healthcare professional should use their clinical judgement and this checklist to decide whether the patient is ready to leave after Spravato administration.

Stamaril

Sanofi Pasteur

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Stamaril - Checklist to complete prior to Administration

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For hard copies please contact our medical information department at 0800 035 2525 or email [email protected]

Strensiq

Alexion Pharma UK Ltd

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Strensiq Injection Guide for Parents/Caregivers

This Injection Guide is for the parents and caregivers of infant patients with paediatric-onset hypophosphatasia who would benefit from long-term enzyme replacement therapy and have been prescribed Strensiq®. The guide gives detailed instructions, with clear diagrams, on how to choose the injection site and how to carry out and record the injection of your infant or child. This guide is designed as a support document to the training given by your healthcare professional. Please contact your healthcare professional if you have any questions.

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Strensiq Self-Injection Guide

This Self-Injection Guide is for patients with paediatric- onset hypophosphatasia who would benefit from long-term enzyme replacement therapy and have been prescribed Strensiq®. The guide gives detailed instructions, with clear diagrams, on how to choose your injection site and how to carry out and record your injection. This guide is designed as a support document to the training given by your healthcare professional. Please contact your healthcare professional if you have any questions.

Strontium ranelate

Aristo Pharma Limited

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Stronium ranelate Aristo Patient Alert Card

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Contains important safety information including possible side effects that patients need to be aware of before and during treatment with Strontium ranelate.

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Stronium ranelate Aristo Prescriber Guide and Checklist

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Important information on minimising cardiovascular risks, venous thromboembolism and skin reactions with strontium ranelate.

Suliqua

SANOFI

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Suliqua- HCP Guide - Important information on dosing

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GUIDE AND CHECKLIST FOR HEALTHCARE PROFESSIONALS Avoiding medication errors with SULIQUA (insulin glargine 100 units/ml + lixisenatide) — available in 2 pre-filled pens containing different dosage strengths.


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Suliqua- Patient Guide - Important information on dosing

This card is provided only as a guide to avoid medication errors. Before using Suliqua®, you must be trained on how to use the Suliqua SoloStar® pen by your doctor, nurse or pharmacist, and you must carefully read the patient leaflet and the instructions for use accompanying the pen


Syonell

Lupin Healthcare (UK) Ltd

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Advice for male patients_MHRA

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This is for healthcare professionals to provide to male patients taking valproate as well as their families and caregivers.


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Annual Risk Acknowledgement Form for Female Patients

THIS INTERACTIVE FORM IS NOT INTENDED FOR HARD COPY USE. Interactive form for use with girls and women of childbearing potential taking this product. It is to be completed with their specialist at least once a year to make sure they know and have understood all the risks related to the use of valproate during pregnancy and the need to avoid becoming pregnant while taking valproate.

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Valproate - Patient Guide

Educational material for patients on important safety information associated with Valproate use.

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Valproate- “White Box” Warning Labels

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FOR DISPENSARY USE ONLY Warning Labels with Valproate Pregnancy Pictogram for Pharmacy to use with white box dispensing of these products.

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Valproate- Healthcare professionals (HCPs) Guide

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Educational material for Healthcare Professionals on important safety information associated with Valproate use.

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Valproate Male Risk Acknowledgement Form

THIS INTERACTIVE FORM IS NOT INTENDED FOR HARD COPY USE. Interactive form for male patients aged under 55 years to complete with their specialists when starting valproate.

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Valproate- Patient Card-Contraception and Pregnancy Prevention

Educational material for girls and women of childbearing potential about the Pregnancy Prevention Programme.

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Valproate- Poster- Dispensary- Pregnancy Prevention Programme

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FOR DISPENSARY USE ONLY. Dispensary A4 Poster for Pharmacy with key information about the Pregnancy Prevention Programme.

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Visual risk communication for HCPs _MHRA

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This information does not replace the overall discussion on risks and benefits which would lead to an informed prescribing decision.


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