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Risk Minimisation Materials

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Talvey

Janssen-Cilag Ltd

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TALVEY HCP Educational Material

TALVEY HCP Educational Material


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Talvey Patient Card

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TALVEY Patient Card


Tecartus

Gilead Sciences Ltd

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TECARTUS_Handling Guide

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Guide to handling and method of administration, and sampling recommendation for secondary malignancy: To minimize the potential risk of decrease in viability of the product loss of efficacy due to inappropriate preparation of the Tecartus infusion.


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TECARTUS_HCP Educational Guide

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Healthcare provider (HCP) educational material - To inform HCPs on how to monitor and manage symptoms associated with CRS and serious neurologic adverse reactions, and provide guidance on reporting these serious adverse reactions associated with Tecartus.


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TECARTUS_Patient Alert Card

Patient Alert Card - To inform patients of the risks of CRS and serious neurologic adverse reactions, associated with Tecartus.


Tecentriq

Roche Products Limited

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Tecentriq (atezolizumab) Patient Card

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


Tecvayli

Janssen-Cilag Ltd

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TECVAYLI Patient Card

Patient Card for TECVAYLI


Tegsedi

Akcea Therapeutics UK Ltd

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Patient Alert Card

Tegsedi Patient Alert Card


Tenofovir

Cipla EU Ltd

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Educational Material: TENOFOVIR DISOPROXIL FOR ADOLESCENT CHILDREN WITH CHRONIC HEPATITIS B

RENAL RISK MINIMISATION MATERIAL: TENOFOVIR DISOPROXIL FOR ADOLESCENT CHILDREN WITH CHRONIC HEPATITIS B


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Educational material: TENOFOVIR DISOPROXIL FOR CHILDREN AND ADOLESCENTS WITH HIV-1

RENAL AND BONE EFFECTS RISK MINIMISATION MATERIAL: TENOFOVIR DISOPROXIL FOR CHILDREN AND ADOLESCENTS WITH HIV-1


Dr. Reddy's Laboratories (UK) Ltd

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Renal and Bone Effects Risk Minimisation Material: Tenofovir Disoproxil for Children and Adolescents with HIV-1

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HIV-1 Renal & bone effects education brochure - children


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Renal Risk Minimisation Material Tenofovir Disoproxil for Adolescent Children with Chronic Hepatitis B

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HBV renal education brochure - children


Sandoz Limited

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Renal and bone effects risk minimisation material: Tenofovir disoproxil for children and adolescents with HIV-1

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This brochure provides important advice on the management of potential renal and bone effects of tenofovir disoproxil in HIV-1 infected children and adolescents aged 2 to <18 years, and on the dosing recommendations for tenofovir disoproxil in this population.


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Renal Risk Minimisation Material: Tenofovir Disoproxil for adolescent children with chronic hepatitis B

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This brochure provides important advice on the management of potential renal and bone effects of tenofovir disoproxil in adolescent patients with chronic hepatitis B aged 12 to <18 years, and on the dosing recommendations for tenofovir disoproxil in this population.


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TENOFOVIR DISOPROXIL FOR ADULTS WITH CHRONIC HEPATITIS B

RENAL RISK MINIMISATION MATERIAL: TENOFOVIR DISOPROXIL FOR ADULTS WITH CHRONIC HEPATITIS B


Aristo Pharma Limited

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Tenofovir disoproxil for adolescent children with chronic hepatitis B

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Renal risk minimisation material: Tenofovir disoproxil for adolescent children with chronic hepatitis B


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Tenofovir disoproxil for children and adolescents with HIV-1

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Renal and bone effects risk minimisation material: Tenofovir disoproxil for children and adolescents with HIV-1


Teriflunomide

axunio Pharma GmbH

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Teriflunomide Healthcare Professional Education/Discussion Guide

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At first prescription, the prescriber/healthcare professional (HCP) should discuss with the patient the risks described within the discussion guide. The guide is aimed at increasing awareness about the potential risk of haematological effects and liver effects, risk of hypertension, serious infections and teratogenicity with teriflunomide and providing guidance on how to manage that risk. For hard copies of this information, please contact axunio Pharma via email to [email protected].


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Teriflunomide Patient Card

This patient card provides important information on the risks of teriflunomide. At first prescription, the prescriber should provide this card. Please show this card to any doctor or healthcare professional involved in your medical care (e.g., in case of an emergency). For hard copies, please contact axunio Pharma via email to [email protected].


Mylan

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TERIFLUNOMIDE MYLAN HEALTHCARE PROFESSIONAL EDUCATION/DISCUSSION GUIDE

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Educational Risk Minimisation Materials to help reduce the risk associated with using this medicine.


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TERIFLUNOMIDE MYLAN PATIENT CARD

Educational Risk Minimisation Materials to help reduce the risk associated with using this medicine.


Thalidomide

Bristol Myers Squibb Pharmaceuticals limited

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Thalidomide BMS® Adverse Event Form

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The safe use of Thalidomide BMS® is of paramount importance. Adverse events (and cases of suspected or confirmed pregnancy or foetal exposure) should be reported to BMS. You can also report the event online 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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Thalidomide BMS® Healthcare Professional’s Information Pack

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This pack contains the all the additional Risk Minimisation Materials required to prescribe and dispense Thalidomide BMS®. It also contains important reporting forms, information for patients, prescribing tools, and the Pharmacy Registration Form. 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 Thalidomide BMS® for any patient.


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Thalidomide BMS® Information for Healthcare Professionals

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


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Thalidomide BMS® Information for Patients

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


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Thalidomide BMS® Male Treatment Initiation Form

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This Treatment Initiation Form must be completed for each male patient prior to the initiation of their Thalidomide BMS® treatment. It is mandatory that male patients receive counselling and education to be made aware of the risks of Thalidomide BMS®. The aim of the Treatment Initiation Form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse effects associated with the use of Thalidomide BMS®.


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Thalidomide BMS® Patient Pocket Information Card

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


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Thalidomide BMS® 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 Thalidomide BMS®. In order to ensure that the actions to minimise the risk of foetal exposure are carried out for all patients, dispensing of Thalidomide BMS® will only be allowed from pharmacies registered with BMS.


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Thalidomide BMS® Pregnancy Outcome Form

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The safe use of Thalidomide BMS® is of paramount importance. Any cases of suspected or confirmed pregnancy or foetal exposure should be immediately reported to BMS. 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. Use this form to provide information about the outcome of pregnancy.


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Thalidomide BMS® Pregnancy Reporting Form

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The safe use of Thalidomide BMS® is of paramount importance. Any cases of suspected or confirmed pregnancy or foetal exposure should be immediately reported to BMS. 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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Thalidomide BMS® Prescription Authorisation Form

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A newly completed Prescription Authorisation Form must accompany each Thalidomide BMS® prescription to confirm that the patient has been counselled about the teratogenic risk of Thalidomide BMS® 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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Thalidomide BMS® Treatment Checklists and Algorithm

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


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Thalidomide BMS® Woman of Childbearing Potential Treatment Initiation Form

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This Treatment Initiation Form must be completed for each woman of childbearing potential prior to the initiation of their Thalidomide BMS® treatment. It is mandatory that women of childbearing potential receive counselling and education to be made aware of the risks of Thalidomide BMS®. The aim of the Treatment Initiation Form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse effects associated with the use of Thalidomide BMS®.


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Thalidomide BMS® Woman of Non-Childbearing Potential Treatment Initiation Form

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This Treatment Initiation Form must be completed for each woman of non-childbearing potential prior to the initiation of their Thalidomide BMS® treatment. It is mandatory that women of non-childbearing potential receive counselling and education to be made aware of the risks of Thalidomide BMS®. The aim of the Treatment Initiation Form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse effects associated with the use of Thalidomide BMS®.


Tibsovo

Servier Laboratories Limited

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Patient Alert Card

Information for the patient treated for acute myeloid leukaemia This Patient Alert Card contains important information for you and healthcare professionals about Tibsovo


Toctino

Stiefel

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Alitretinoin Patient Card

To be given by the dermatologist, specialist dermatology nurses, or prescribing GP to reinforce the key safety messages around risks.


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Alitretinoin Pharmacist Checklist

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To be used as an aide memoire by pharmacists when dispensing oral retinoid medicines.


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Alitretinoin Prescriber Checklist

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To be used by the dermatologist, specialist dermatology nurse, or a prescribing GP with a special interest in dermatology to record the discussion of risks with the patient.


Tolvaptan

Teva UK Limited

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Tolvaptan Teva HCP Educational Guide

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Tolvaptan Teva is a specialist product and additional training is required prior to prescribing. Please visit https://www.tevauk.com/healthcare-professionals/tolvaptan-hcp/ to register and complete the training. Training must be completed prior to prescribing Tolvaptan Teva. This guide has been developed for prescribers and healthcare professionals (HCPs) involved in the treatment of patients using Tolvaptan Teva. This document summarises important information on the potential risk of hepatic toxicity and provides guidance on how to manage this risk. In addition, it provides important information about pregnancy prevention before and during the treatment with Tolvaptan Teva.


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Tolvaptan Teva Patient Alert Card

Tolvaptan Teva is a specialist product and additional training is required prior to prescribing. Please visit https://www.tevauk.com/healthcare-professionals/tolvaptan-hcp/ to register and complete the training. Training must be completed prior to prescribing Tolvaptan Teva. This patient alert card should be used by patients who have been prescribed medicines containing tolvaptan, and should carry with them at all times when taking this medicine. This card contains important safety information that patient needs to be aware of before, during, and after treatment with Tolvaptan Teva.


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Tolvaptan Teva Patient/Carer Education Brochure

Tolvaptan Teva is a specialist product and additional training is required prior to prescribing. Please visit https://www.tevauk.com/healthcare-professionals/tolvaptan-hcp/ to register and complete the training. Training must be completed prior to prescribing Tolvaptan Teva. The guide should be provided to patients by the prescribing physician and includes a description of the risks of treatment, guidance on what to do in the event of risks occurring and an overview of treatment monitoring.


Toujeo

SANOFI

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Toujeo 300 units/ml, solution for injection in a pre-filled pen - Guide for Healthcare Professionals

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This document is submitted as a guide to avoid medication errors and includes information which must be written on each prescription for Toujeo and key safety elements when switching from or to an insulin with a different strength. For hard copies please contact our medical information department at 0800 035 25251 or email [email protected].


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Toujeo 300 units/ml, solution for injection in a pre-filled pen - Guide for patients and/or carers

This document includes information such as what Toujeo is and how to use it. It is to be used as a guide alongside the full Instructions For Use leaflet which accompanies the pen. For hard copies please contact our medical information department at 0800 035 2525 or email [email protected].


Treposuvi

AOP Orphan Ltd

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Treposuvi Solution for Infusion - Healthcare Professional Guide

This guide details the risk of central venous catheter related blood stream infections and sepsis associated with the intravenous route of administration of Treprosuvi Solution For Infusion


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Treposuvi Solution for Infusion - Patient Brochure

This guide details the risk of central venous catheter related blood stream infections and sepsis associated with the intravenous route of administration of Treposuvi Solution For Infusion


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Treposuvi Solution for Infusion - Patient Questionnaire

A questionnaire for patients treated with intravenous Treposuvi via an external infusion pump and central venous catheter (CVC)


Treprostinil

Dr. Reddy's Laboratories (UK) Ltd

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Healthcare Professional Guide

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Guidelines on the safe administration of Treprostinil Solution For Infusion by continuous intravenous infusion via an external infusion pump and central venous catheter (CVC) to prevent catheter‐related blood stream infections (CR‐BSI)


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Treprostinil Solution For Infusion Patient Questionnaire

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A questionnaire for patients treated with intravenous Treprostinil via an external infusion pump and central venous catheter


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Treprostinil Solution For Infusion Patient Brochure

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Administration of Treprostinil as intravenous infusion via an external pump and central venous catheter (CVC) (directly into a large vein)


Tillomed Laboratories Ltd

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Treprostinil Tillomed Solution for Infusion - Healthcare Professional Guide

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The guide details the risk of central venous catheter related blood stream infections and sepsis associated with the intravenous route of administration of Treprostinil Tillomed Solution For Infusion


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Treprostinil Tillomed Solution for Infusion - Patient Brochure

This guide details the risk of central venous catheter related blood stream infections and sepsis associated with the intravenous route of administration of Treprostinil Tillomed Solution For Infusion


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Treprostinil Tillomed Solution for Infusion - Patient Questionnaire

A questionnaire for patients treated with intravenous Treprostinil via an external infusion pump and central venous catheter (CVC)


Tresiba

Novo Nordisk Limited

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Tresiba® 100U and 200U FlexTouch® correct use of Tresiba® (insulin degludec)-to-minimise-medication-errors

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Direct Healthcare Professional Communication for Tresiba® 100U and 200U FlexTouch® correct use of Tresiba® (insulin degludec)- association of insulin degludec (Tresiba®) with the risk of mixing up two strengths


Triumeq

ViiV Healthcare UK Ltd

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Abacavir Hypersensitivity Website for Healthcare Professionals

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Abacavir Hypersensitivity Website for Healthcare Professionals


Trizivir

ViiV Healthcare UK Ltd

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Abacavir Hypersensitivity Website for Healthcare Professionals

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Abacavir Hypersensitivity Website for Healthcare Professionals


Truvada

Gilead Sciences Ltd

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Tenofovir Disoproxil Fumarate (TDF)) HIV Paediatric Educational Brochure

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Brochure providing important advice on the management of potential renal and bone effects of TDF in children and adolescent patients with HIV-1 aged 2 to <18 years, and on the dosing recommendations for TDF in this population.


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Truvada 200 mg/245 mg film-coated tablets (emtricitabine/tenofovir disoproxil fumarate) - PrEP Educational Materials - Checklist For Prescribers

Checklist For Prescribers from the Physician educational pack for Truvada® (emtricitabine 200mg/ tenofovir disoproxil fumarate 245mg) for pre-exposure prophylaxis (PrEP) in patients at risk of sexually acquired HIV-1 infection


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Truvada 200 mg/245 mg film-coated tablets (emtricitabine/tenofovir disoproxil fumarate) - PrEP Educational Materials - Patient Leaflet

Patient Leaflet from the Physician educational pack for Truvada® (emtricitabine 200mg/ tenofovir disoproxil fumarate 245mg) for pre-exposure prophylaxis (PrEP) in patients at risk of sexually acquired HIV-1 infection. It contains Important Information About Truvada® (emtricitabine/tenofovir disoproxil fumarate) to Reduce the Risk of Getting Human Immunodeficiency Virus (HIV) Infection for individuals who have been prescribed Truvada® for Pre-Exposure Prophylaxis (PrEP)


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Truvada 200 mg/245 mg film-coated tablets (emtricitabine/tenofovir disoproxil fumarate) - PrEP Educational Materials - Prescribers Leaflet

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Important Safety Information for Prescribers About Truvada® (emtricitabine/tenofovir disoproxil fumarate) for a Pre-exposure Prophylaxis (PrEP) Indication


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Truvada 200 mg/245 mg film-coated tablets (emtricitabine/tenofovir disoproxil fumarate) - PrEP Educational Materials - Reminder Card

Reminder Card for patients from the Physician educational pack for Truvada® (emtricitabine 200mg/ tenofovir disoproxil fumarate 245mg) for pre-exposure prophylaxis (PrEP) in patients at risk of sexually acquired HIV-1 infection.


Truxima

Celltrion Healthcare UK Limited

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Truxima Patient Reminder Card

Patient Reminder Card


Tysabri

Biogen Idec Ltd

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Patient Alert Card

This alert card contains important safety information that you need to be aware of before, during and after stopping treatment with Tysabri (natalizumab). Hard copies can be requested by contacting Biogen at [email protected] or by telephone on 0800 008 7401.


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Physician Information and Management Guidelines for Patients with Multiple Sclerosis receiving TYSABRI Therapy

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This guidance document has been developed for those physicians initiating and supervising TYSABRI in accordance with the conditions of the Marketing Authorisation of the drug.


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Treatment Continuation Form

This form should be read carefully before continuing TYSABRI treatment for more than 2 years.


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Treatment Discontinuation Form

This form should be read carefully before discontinuing treatment with TYSABRI.


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Treatment Initiation Form

This form should be read carefully before starting treatment with TYSABRI.


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