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Risk Minimisation Materials

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Padcev

Astellas Pharma Ltd

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Padcev Patient Card

Every Padcev pack contains a Patient Card. The purpose of the patient card is to provide: - Information for patients that Padcev treatment may cause severe skin reactions - Description of symptoms of the safety concern and when to seek medical care - Information for healthcare professionals treating the patient at any time, including in conditions of emergency, that the patient is being treated with Padcev which can cause severe skin reactions - Contact details of the treating physician who has prescribed Padcev Patients should carry the Patient Card at all times and present it to any healthcare professional they might interact with.


Palfium

Aimmune Therapeutics UK Limited

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Caregiver safety educational booklet

Educational booklet for caregivers/parents containing important safety information about PALFORZIA


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HCP Instruction Manual

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Instruction manual providing guidance on appropriate use of PALFORZIA treatment and related safety.


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Patient Alert Card

Patient card for the patient to carry to inform healthcare personnel should emergency care be needed in the case of anaphylaxis/systemic allergic reactions


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Patient safety educational booklet (12-17 years old)

Educational booklet for patients aged 12-17 years old containing important safety information about PALFORZIA


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Patient safety educational booklet (4-6 years old)

Educational booklet for patients aged 4-6 years old containing important safety information about PALFORZIA


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Patient safety educational booklet (7-11 years old)

Educational booklet for patients aged 7-11 years old containing important safety information about PALFORZIA


Pamidronate Disodium

Hospira UK Ltd

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Pamidronate Patient Reminder Card

contains important safety information that patients need to be aware of before and during treatment with pamidronate disodium injections


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Pamidronate Patient Reminder Card Cover Letter

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is a letter which should be viewable only by the HCP. It details the requirement for the dispensing pharmacist to discuss the contents of the Patient Reminder Card with the patient prior to dispensing.


PecFent

Grunenthal Meds

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PecFent - UK Patient and Carer guide

Patient/carer’s guide to PecFent® (fentanyl citrate) nasal spray


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PecFent - UK Pharmacists Brochure

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Pharmacist’s guide to dispensing PecFent® (fentanyl citrate) nasal spray


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PecFent - UK Prescribers Brochure

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Physician’s guide to prescribing PecFent® (fentanyl citrate) nasal spray


Penthrox

Galen Limited

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Penthrox Administration Checklist-HCP use

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'Checklist to aid HCPs in the selection of appropriate patients for treatment with Penthrox’ Further copies of the educational materials and training on the administration of Penthrox are available from Galen on request (tel 028 38334974 or email [email protected]).


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Penthrox Administration Guide-HCP use

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Penthrox Administration Guide-HCP use Further copies of the educational materials and training on the administration of Penthrox are available from Galen on request (tel 028 38334974 or email [email protected]).


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Penthrox Patient Alert Card-Patient Use

Penthrox Patient Alert Card-Patient Use


Peyona

Chiesi Limited

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Peyona (caffeine citrate) 20 mg/ml Solution for Infusion and Oral Solution Laminated Card

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Before using Peyona (caffeine citrate) 20 mg/ml either intravenously or orally, in addition to reading the Summary of Product Characteristics, please check the following points:


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Peyona (caffeine citrate) 20mg/ml solution for infusion and oral solution

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Information on the safe use of Peyona (caffeine citrate) 20mg/ml solution for infusion and oral solution


Piqray

Novartis Pharmaceuticals UK Ltd

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Piqray-Educational material - Guide for healthcare professionals - Management of risk of hyperglycaemia - digital version

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The objective of these materials is to raise awareness of the increased risk of hyperglycaemia associated with alpelisib treatment, as well as to provide information concerning: - signs and symptoms of severe hyperglycaemia (including ketoacidosis) - monitoring required before and during treatment - management of hyperglycaemia associated with alpelisib


Pirfenidone

Sandoz Limited

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Pirfenidone 267mg and 801mg Prescribers Guide

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Pirfenidone 267mg and 801mg Safety Checklist for Prescribers. This educational material is provided to alert the prescribing physician of Drug-induced liver injury (DILI) and Photosensitivity reactions and rash associated with the use of pirfenidone and to guide healthcare professionals in managing these risks with their patients.


Teva UK Limited

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Pirfenidone Prescriber's Checklist

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Prescriber's checklist for Teva's Pirfenidone 267mg and 801mg Film-Coated Tablets.


Laboratorios Liconsa, S.A.

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Pirfenidone Safety Checklist

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SAFETY CHECKLIST FOR PRESCRIBING PHYSICIAN


Celix Pharma Ltd

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Pirfenidone Safety Checklist for Prescribers

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Safety checklist contains key elements to follow when prescribing Pirfenidone Film-coated Tablets


Glenmark Pharmaceuticals Europe Ltd

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Pirfenidone Safety Checklist for Prescribing Physician

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The safety checklist contains key elements to follow when prescribing Pirfenidone


Dr. Reddy's Laboratories (UK) Ltd

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Pirfenidone Safety Checklist for Prescribing Physicians

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Safety checklist contains key elements to follow when prescribing Pirfenidone Film-Coated Tablets


Lupin Healthcare (UK) Ltd

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SAFETY CHECKLIST FOR PRESCRIBING

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This safety checklist contains key elements to follow when prescribing Pirfenidone Film-Coated Tablets


Amarox Limited

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SAFETY CHECKLIST FOR PRESCRIBING PHYSICIAN

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SAFETY CHECKLIST FOR PRESCRIBING PHYSICIAN


axunio Pharma GmbH

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Safety Checklist for Prescribing Physician

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The safety checklist contains important key elements on photosensitivity and drug-induced liver injury that are to follow during treament with pirfenidone.


MSN Laboratories Europe Ltd

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Safety Checklist for Prescribing Physician

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This safety checklist contains key elements to follow when prescribing Pirfenidone


Pombiliti

Amicus Therapeutics UK Ltd

Ponvory

Janssen-Cilag Ltd

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Patient Caregiver Guide

This guide contains important information to ensure the safe and effective use of Ponvory and appropriately manage selected risks. Read this guide thoroughly before starting treatment.


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Pregnancy Reminder Card

Information for female patients of childbearing potential.


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Prescriber's Checklist

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This guide provides essential information on the most important identified and potential risks associated with Ponvory and the activities required to minimise these risks.


Powergel

A. Menarini Farmaceutica Internazionale SRL

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Checklist for the Prescriber

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Specific Patient Information

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Pradaxa

Boehringer Ingelheim Limited

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Pradaxa (dabigatran etexilate) coated granules Patient Alert Card

Every patient prescribed Pradaxa in the medication package will receive a Patient Alert Card. As the card contains important information the patient should be instructed to carry the patient alert card at all times and present it when seeing a health care professional. The patient should be counselled about the need for compliance and signs of bleeding and when to seek medical attention.


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Pradaxa (dabigatran etexilate) Patient Alert Card

Every patient prescribed Pradaxa will receive a Patient Alert Card in the medication pack. As the card contains important information the patient should be instructed to carry the patient alert card at all times and present it when seeing a health care professional. The patient should be counselled about the need for compliance and signs of bleeding and when to seek medical attention.


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Pradaxa (dabigatran etexilate) Prescriber guide for paediatric use for the treatment of venous thromboembolic events (VTE) and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age (paed. VTE)

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This risk minimisation material provides recommendations for the use of Pradaxa for the treatment of venous thromboembolic events (VTE) and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age (paed. VTE) in order to minimise the risk of bleeding. Please ensure 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 Pradaxa in the paediatric population and providing guidance on how to manage that risk. For hard copies please contact our medical information department at 01344 424600 or email: [email protected]


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Pradaxa (dabigatran etexilate) Prescriber guide for primary prevention of venous thromboembolic events (VTE) following elective hip or knee replacement surgery

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This risk minimisation material provides recommendations for the use of Pradaxa in VTE (orthopaedic) in order to minimise the risk of bleeding. Please ensure 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 Pradaxa and providing guidance on how to manage that risk. For hard copies please contact our medical information department at 01344 424600 or email: [email protected]


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Pradaxa (dabigatran etexilate) Prescriber Guide for stroke prevention in non-valvular atrial fibrillation (NVAF) and for the treatment and secondary prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE)

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This risk minimisation material provides recommendations for the use of Pradaxa in NVAF and DVT/PE in order to minimise the risk of bleeding. 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 Pradaxa and providing guidance on how to manage that risk. For hard copies please contact our medical information department at 01344 424600 or email: [email protected]


Prasugrel

Sovereign Medical

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Educational-material-Prasugrel Waymade 5mg and 10 mg film-coated tablets

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This is an educational material for Prasugrel 5mg and 10mg fim-coated tablets


Prenoxad

Martindale Pharma, an Ethypharm Group Company

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Prenoxad® Injection Client's Guide

This booklet is for anyone who has been supplied with Prenoxad® Injection


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Prenoxad® Injection Issuer’s Guide

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Please review this document carefully before issuing Prenoxad® Injection.


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Prenoxad® Injection Training Checklist

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This Training Checklist can be used to help with delivery of ‘refresher’ training, and when making first or replacement supplies of Prenoxad Injection.


Procysbi

Chiesi Limited

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PROCYSBI - AE Follow Up Form for Fibrosing Colonopathy

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Pharmacovigilance follow up form for suspected ADR after PROCYSBI - questionnaire for detailed follow-up of possible signs suggestive of fibrosing colonopathy


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PROCYSBI - AE Follow Up Form for Pregnancy

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Pharmacovigilance follow up form for pregnancy after PROCYSBI


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Procysbi - Safety Checklist for Prescribing Physicians

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The Safety Checklist is intended to ensure the safe and effective use of Procysbi. It addresses specifically the following potential risks associated with the use of this product: Fibrosing colonopathy, teratogenicity.


Produodopa

AbbVie Ltd

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Produodopa Patient Guide

Patient guide essential to ensure the safe and effective use of the product and provides guidance on preventing and managing the risk of infusion site side effects (infection and reaction).


Pro-Epanutin

Pfizer Limited

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Pro-Epanutin in Status Epilepticus. Dosing Aid For Adults Only

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This dosing aid is designed to help you administer a loading dose of fosphenytoin. Use the equations and/or consult the dosing table to determine the appropriate dosing information based on patient weight.


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Pro-Epanutin in Status Epilepticus. Dosing Aid For Children 5 years and older

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For Children 5 years and older. This dosing aid is designed to help you administer a loading dose of fosphenytoin. Use the equations and/or consult the dosing table to determine the appropriate dosing information based on patient weight.


Prolia

Amgen Ltd

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Prolia patient reminder card

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This reminder card contains important safety information that patients need to be aware of before and during treatment with denosumab (Prolia), which is used to treat osteoporosis and bone loss. A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported rarely (may affect up to 1 in 1,000 people) in patients receiving Prolia for osteoporosis. ONJ can also occur after stopping treatment. It is important to try to prevent ONJ developing as it may be a painful condition that can be difficult to treat. In order to reduce the risk of developing ONJ, there are some precautions patients should take. To request a copy of the patient card, please contact Amgen Medical Information on +44 (0) 1223 436441


Prometax

Novartis Pharmaceuticals UK Ltd

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Rivastigmine patch (Exelon/Prometax) - Instructions for use and patient diary - for patients

Instructions for use and a patient diary including medication record sheets for patients that have been prescribed Exelon Patch or Prometax Patch (rivastigmine transdermal system) to ensure the correct use of the patch.


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