Pharmacovigilance Paediatric Perspective
|
|
|
- Harry Moris Parsons
- 5 years ago
- Views:
Transcription
1 Pharmacovigilance Paediatric Perspective To give insight into the specifics of reviewing pharmacovigilance reports for children Kristina Star, RN, PhD May 30, 2013
2 Patient harm Medicines can cause patient harm resulting from pharmacological effect (adverse effect) individual patient idiosyncrasy (adverse reaction) suboptimal medication use and practice 2 Kristina Star. Uppsala Monitoring Centre
![sattva]/freedigitalphotos.](/docs-images/89/98648268/images/3-5.jpg "net and http://animalphotos.")
3 Pre-marketing activities (most often) Candidate drug tested in animals Study on healthy volunteers Studies on patients homogeneity Image courtesy of [stockimages, africa, Stuart Miles, sattva]/freedigitalphotos.net and 3 Kristina Star. Uppsala Monitoring Centre
4 Lack of product information If children are excluded in clinical studies Limited product information specific for children dosing warnings precautions adverse drug reactions (ADR) extra consideration! 4 Kristina Star. Uppsala Monitoring Centre
5 Constant change during childhood Image courtesy of africa, sattva / FreeDigitalPhotos.net 5 Kristina Star. Uppsala Monitoring Centre
6 Children are not small adults Differ biologically Medicine absorption, distribution, metabolism and excretion 1 Hormone activity 2 Differ psychosocially Dependence to independence Limited communicational skills to full ability Impact dosing, administering and monitoring 1) Kearns GL et al. N Engl J Med. 2003; 349(12): ) Kennedy M. Clin Pharmacol Ther (6): Kristina Star. Uppsala Monitoring Centre
7 Medication in paediatrics Calculation for each individual child Dilution Small amounts Extemporaneous preparations Different risk benefit profile Long term effects 7 Kristina Star. Uppsala Monitoring Centre Image courtesy of Sura Nualpradid/ FreeDigitalPhotos.net
8 Situation in Paediatrics Off-label use (use not supported by product description) % in hospital care 11 31% in out-patient care Lack of age-suitable dosage forms 22-25% of medications indicated for children lacked appropriate dosage forms 2 1) Kimland E, Odlind V. Clin Pharmacol Ther. 2012; 91(5): (Review of studies) 2) Tan E et al. Med J Aust. 2003; 179(4): (Australian study) 8 Kristina Star. Uppsala Monitoring Centre
9 Example: Captopril 12.5 mg tablets.... Initial starting dose Children: 0.3 mg/kg Premature, newborn and infants: 0.15 mg/kg.. 9 Kristina Star. Uppsala Monitoring Centre
10 Situation in Paediatrics Potentially harmful medication errors occur more within paediatrics than in adult care 1 Incidence of ADRs in children % ( ) of inpatients 1.0% ( ) in primary care 1.8% ( ) of hospital admissions 1) Kaushal R et al. JAMA. 2001; 285(16): US prospective study 2) Clavenna A, Bonati M. Arch Dis Child. 2009; 94(9): Review of 8 prospective studies (primarily EU) 10 Kristina Star. Uppsala Monitoring Centre
11 Background calls for action Medicines need to be developed and studied specifically in children Monitoring for ADRs important Pharmacovigilance reports valuable 11 Kristina Star. Uppsala Monitoring Centre
12 Results from a review on reports for children worldwide 12 Kristina Star. Uppsala Monitoring Centre
13 Objective Explore VigiBase data to prepare for routine screening of reports for children 1. To characterise reports for children 2. Type of adverse reactions recently reported with a greater frequency by age group (2005 -Feb 2010 compared with ) 13 Kristina Star. Uppsala Monitoring Centre
14 Overall ADR review A low proportion of reports for children (0-17 years) 7.7% of VigiBase reports, vaccine reports excluded A higher proportion of reports for children in Latin America (15%), Africa (15%), Asia (14%) than in North America (7%), Oceania (7%), Europe (7%) Most reported reactions and medicines in children Skin reactions (35%) Anti-infective medicines (33%) 14 Kristina Star. Uppsala Monitoring Centre
15 Pattern of reported reactions by age group reported more frequently during recent years 0 to 27 days 28 days to 23 months 15 Kristina Star. Uppsala Monitoring Centre 2 to 11 years 12 to 17 years Premature baby Erythema Drug ineffective Drug ineffective Neutropenia Pruritus Erythema Suicidal ideation Neonatal disorder Irritability Decreased appetite Suicide attempt Anaemia Medication error Psychomotor hyperactivity Completed suicide Blood lactic acid increased Drug ineffective Abdominal pain upper Depression Foetal growth retardation Accidental overdose Aggression Erythema Medication error Drug toxicity Somnolence Nausea Hypertriglyceridaemia Lethargy Crying Intentional overdose Feeding disorder neonatal Eyelid oedema Suicidal ideation Loss of consciousness Anaemia macrocytic Respiratory arrest Medication error Feeling abnormal Age groups defined according to European Medicines Agency. ICH Topic E 11. Clinical Investigation of Medicinal Products in the Paediatric Population. January 2001 CPMP/ICH/2711/99.
16 Conclusion Reports for children worldwide Planned screening of VigiBase reports for children will give particular focus to: serious skin reactions events related to medication errors psychotropic medicines geographical regions with higher reporting for children 16 Kristina Star. Uppsala Monitoring Centre
17 Reflections on reports for children Reports concerning congenital birth defects often lacked age or was recorded with mother age E2B parent-child/foetus reports preferred Prematurity not determined by age field weight field and narrative important Strength, route of administration and dosage form important to report for children 17 Kristina Star. Uppsala Monitoring Centre
18 Reflections on reports for children High proportion of vaccine reports 46% for ages 0-17 years (data up to Feb 2010) Quantatively challenging to differentiate reports concerning problems in newborns resulting from drug exposure in utero via breast milk newborns own drug intake 18 Kristina Star. Uppsala Monitoring Centre
19 Planning for signal detection in VigiBase data for children Retrospective review of signals: 4% concerned children The aim of signal detection in VigiBase data for children will be to Take advantage of the uniqueness of VigiBase (reports on children in each nation might be few) Avoid doing duplicate work along with the national centres Current routine signal detection focuses on New drugs (old drugs commonly used for children) Not labelled reactions (might not be known for children) 19 Kristina Star. Uppsala Monitoring Centre
20 Planning for signal detection in VigiBase data for children Contributing with further knowledge for rare and serious reactions (known or unknown) Detecting the unexpected and unrecognised by child age group 20 Kristina Star. Uppsala Monitoring Centre
21 Safety, medicines and medication in paediatrics A medicine can be considered safe but is it safe for children? Considerations on medication use and practice in paediatrics is important! 21 Kristina Star. Uppsala Monitoring Centre
Agreed Core Safety Profile for Budesonide nasal spray suspension and Budesonide nasal powder
CSP Drug Budesonide Substance Date 13 Oct 2011 rev 11Nov Supersedes 18 Aug 2011 Agreed Core Safety Profile for DK/H/PSUR/0041/001 TABLE OF CONTENTS PAGE TITLE PAGE... 1 TABLE OF CONTENTS... 2 Introduction...
PACKAGE LEAFLET: INFORMATION FOR THE USER
PACKAGE LEAFLET: INFORMATION FOR THE USER 250 mg film-coated tablets. 500 mg film-coated tablets. 750 mg film-coated tablets. 1000 mg film-coated tablets. Levetiracetam
Pharmacotherapy Issues in the Pediatric Population
Pharmacotherapy Issues in the Pediatric Population Continuing Professional Pharmacy Development Dr. Shane Pawluk, PharmD Dr. Andrea Cartwright, PharmD Dr. Maryam Khaja March 26, 2014 Outline Didactic Session
PRODUCT INFORMATION. SUDAFED Sinus 12 Hour Relief Tablets
PRODUCT INFORMATION SUDAFED Sinus 12 Hour Relief Tablets NAME OF THE MEDICINE Pseudoephedrine Hydrochloride CAS 2 Registry Number: 345-78-8 DESCRIPTION SUDAFED Sinus 12 Hour Relief prolonged-release tablets
Annex I. Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
Annex I Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) 1 Scientific conclusions Taking into account the PRAC Assessment Report on the PSUR(s) for topiramate,
Core Safety Profile. Pharmaceutical form(s)/strength: Capsules, Tablets / 5 mg, 10 mg ES/H/PSUR/0013/001 Date of FAR:
Core Safety Profile Active substance: Flunarizine Pharmaceutical form(s)/strength: Capsules, Tablets / 5 mg, 10 mg P RMS: ES/H/PSUR/0013/001 Date of FAR: 13.12.2010 4.3 Contraindications Flunarizine is
The safety concerns defined with the reference product apply to Buprenorphine-Naloxone 2/0.5 mg, 8/2 mg, sublingual tablets.
These products are indicated in the substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter
Core Safety Profile. Pharmaceutical form(s)/strength: solution 1%, spray 1%, cream 1%, gel 1% SK/H/PSUR/0005/001 Date of FAR:
Core Safety Profile Active substance: Terbinafine Pharmaceutical form(s)/strength: solution 1%, spray 1%, cream 1%, gel 1% P-RMS: SK/H/PSUR/0005/001 Date of FAR: 08.06.2012 4.3 Contraindications Hypersensitivity
GlaxoSmithKline Biologicals Rotarix WHO PACKAGE INSERT. Rotarix TM 1 WHO Package insert
GlaxoSmithKline Biologicals Rotarix WHO PACKAGE INSERT Rotarix TM 1 WHO Package insert GlaxoSmithKline Biologicals Rotarix Method of administration Rotarix is for oral use only. ROTARIX SHOULD UNDER NO
Core Safety Profile. Pharmaceutical form(s)/strength: Dry Powder Inhaler, Nebuliser Suspension, pressurised Metered Dose Inhaler (pmdi)
Core Safety Profile Active substance: Budesonide Pharmaceutical form(s)/strength: Dry Powder Inhaler, Nebuliser Suspension, pressurised Metered Dose Inhaler (pmdi) P - RMS: DK/H/PSUR/0041/001 Date of FAR:
M0BCore Safety Profile
M0BCore Safety Profile Active substance: Aciclovir Pharmaceutical form(s)/strength: Tablets 200, 400 or 800 mg Dispersible tablets 200, 400 or 800 mg Oral suspensions 200 mg or 400 mg per 5 ml. Freeze
Package leaflet: Information for the user Zirtek Allergy Relief 10 mg film-coated tablets Cetirizine dihydrochloride
Package leaflet: Information for the user Zirtek Allergy Relief 10 mg film-coated tablets Cetirizine dihydrochloride Read all of this leaflet carefully before you start taking this medicine because it
Congenital hypothyroidism and your child
Congenital hypothyroidism and your child Contributed by Sirisha Kusuma. B Consultant Pediatric Endocrinologist Rainbow Children s hospital What is Thyroid? The thyroid is a small butterfly shaped endocrine
VENTOLIN RESPIRATOR SOLUTION
VENTOLIN RESPIRATOR SOLUTION Salbutamol QUALITATIVE AND QUANTITATIVE COMPOSITION VENTOLIN Respirator Solution contains 5mg salbutamol, as sulphate, per ml of solution and is supplied in 10 ml bottles.
Concomitant antiretroviral therapy : Avifanz must be given in combination with other antiretroviral medications.
Avifanz Tablet Description Avifanz is the brand name for Efavirenz. Efavirenz, a synthetic antiretroviral agent, is a non-nucleoside reverse transcriptase inhibitor. While Efavirenz is pharmacologically
Package leaflet: Information for the patient. Cetirizin Sandoz 10 mg film-coated tablets. cetirizine dihydrochloride
Package leaflet: Information for the patient Cetirizin Sandoz 10 mg film-coated tablets cetirizine dihydrochloride [For medicine available only on prescription:] Read all of this leaflet carefully before
1. NAME OF THE MEDICINAL PRODUCT. Lamisil 1% cutaneous solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1. NAME OF THE MEDICINAL PRODUCT Lamisil 1% cutaneous solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: 10 mg terbinafine hydrochloride per 1 g solution (1% w/w). Excipient(s) with
Summary of Product Characteristics
Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT Terbinafine Dermapharm, 10 mg/g, cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of cream contains 10 mg of terbinafine hydrochloride.
Salapin: Salbutamol BP 2mg as sulphate in each 5mL of a raspberry cola flavoured, sugar free syrup.
Salapin Salbutamol Syrup 2mg/5mL Qualitative and quantitative composition Salapin: Salbutamol BP 2mg as sulphate in each 5mL of a raspberry cola flavoured, sugar free syrup. Clinical particulars Therapeutic
Package leaflet: Information for the patient. Morphine Unimedic 1 mg/ml solution for injection morphine hydrochloride trihydrate
Package leaflet: Information for the patient Morphine Unimedic 1 mg/ml solution for injection morphine hydrochloride trihydrate Read all of this leaflet carefully before you start using this medicine because
NEW ZEALAND DATA SHEET
NEW ZEALAND DATA SHEET ALANASE Beclometasone dipropionate Aqueous Nasal Spray 50 µg & 100 µg per actuation Presentation ALANASE Aqueous Nasal Spray (50 micrograms per actuation) is an almost white opaque
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Citanest with Octapressin Dental 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains Prilocaine Hydrochloride 30 mg (54 mg/1.8
M0BCore Safety Profile
M0BCore Safety Profile Active substance: Clindamycin Pharmaceutical form(s)/strength: 300mg/2 ml Ampulle, 600 mg/4 ml Ampulle, 900 mg/6 ml Ampulle, 75 mg/5 ml Granulat für orale Lösung, 150 mg Kapselnn,
Fecal shedding of rotavirus vaccine in premature babies in the neonatal unit
Fecal shedding of rotavirus vaccine in premature babies in the neonatal unit Dr. Manish Sadarangani Director, Vaccine Evaluation Center, BC Children s Hospital Research Institute Assistant Professor, Division
Cetirizine Proposed Core Safety Profile
Cetirizine Proposed Core Safety Profile Posology and method of administration Elderly subjects: data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function
Neurodevelopmental Risk?
Normal Newborn During transitional hypoglycemia normal newborns have an enhanced ketogenic response to fasting. Newborn brains have enhanced capability to use ketone bodies for fuel Allows newborns to
0BCore Safety Profile. Pharmaceutical form(s)/strength: Cream 1% DK/H/PSUR/0009/005 Date of FAR:
0BCore Safety Profile Active substance: Pimecrolimus Pharmaceutical form(s)/strength: Cream 1% P-RMS: DK/H/PSUR/0009/005 Date of FAR: 06.06.2013 4.3 Contraindications Hypersensitivity to pimecrolimus,
SUMMARY TABLE OF SEXUALLY TRANSMITTED INFECTIONS
1 of 5 SUMMARY TABLE OF SEXUALLY TRANSMITTED INFECTIONS Sexually Transmitted Infections How is it spread? How do I get tested? Can it be cured? fertility? pregnancy? a newborn? Can the mother breastfeed
Depression in Pregnancy
TREATING THE MOTHER PROTECTING THE UNBORN A MOTHERISK Educational Program The content of this program reflects the expression of a consensus on emerging clinical and scientific advances as of the date
Core Safety Profile. Pharmaceutical form(s)/strength: Sterile eye drops 1%, 2% Date of FAR:
Core Safety Profile Active substance: Carteolol Pharmaceutical form(s)/strength: Sterile eye drops 1%, 2% P - RMS: SK/H/PSUR/0002/002 Date of FAR: 16.03.2012 4.1 THERAPEUTIC INDICATIONS Ocular hypertension
Pharmaceutical form(s)/strength: Solution: 5 mg/ml Suspensions: 2.5 and 5 mg/ml P-RMS:
0BCore Safety Profile Active substance: Betaxolol eyedrops Pharmaceutical form(s)/strength: Solution: 5 mg/ml Suspensions: 2.5 and 5 mg/ml P-RMS: HU/H/PSUR/0010/002 Date of FAR: 20.03.2013 4.2 Posology
P-RMS: FR/H/PSUR/0036/001
Core Safety Profile Active substance: Alprazolam Pharmaceutical form(s)/strength: Tablet uncoated, sugar coated, film coated, 0.25mg Tablet uncoated, 0.4 mg Tablet uncoated, sugar coated, film coated,
Elements for a Public Summary. Overview of disease epidemiology. Epidemiology of the disease
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Epidemiology of the disease Cytomegalovirus is found throughout all geographic locations and socioeconomic groups, and infects
METFORMIN HYDROCHLORIDE PROLONGED RELEASE TABLETS IP
For 0 the use only of a Registered Medical Practitioner or hospital or a laboratory This package insert is continually updated: Please read carefully before using a new pack METFORMIN HYDROCHLORIDE PROLONGED
SUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Alburex 5, 50 g/l, solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Alburex 5 is a solution containing 50 g/l of total
Existing WHO work on Medicines Safety & Safe Use. Department of Essential Medicines and Health Products World Health Organization
Existing WHO work on Medicines Safety & Safe Use Department of Essential Medicines and Health Products World Health Organization WHO Pharmacovigilance & Medicines Safety Programme How it started Thalidomide
SUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Comfora 595 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains: glucosamine sulphate
Package leaflet: Information for the user. Cetiristad 10 mg film-coated tablets Cetirizine dihydrochloride
Package leaflet: Information for the user Cetiristad 10 mg film-coated tablets Cetirizine dihydrochloride Read all of this leaflet carefully before you start taking this medicine because it contains important
Metformin Hydrochloride
Metformin Hydrochloride 500 mg, 850 mg, 500 mg LA and 750 mg LA Tablet Description Informet is a preparation of metformin hydrochloride that belongs to a biguanide class of oral antidiabetic drugs. Metformin
Emergency contraception is an occasional method. It should in no instance replace a regular contraceptive method.
1. NAME OF THE MEDICINAL PRODUCT: Levonorgestrel Tablets 1.5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each tablet contains levonorgestrel 1.5 mg. Excipient with known effect: Each tablet contains
Body weight more than 30kg : 10ml (10mg) of the syrup once daily.
1. Name of the medicinal product Clarityn Allergy 1mg/ml Syrup 2. Qualitative and quantitative composition Each ml of syrup contains 1mg loratadine. Excipients with known effect. The quantity of sucrose
Supplementary Appendix
Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Kraft WK, Adeniyi-Jones SC, Chervoneva I, et al. Buprenorphine
PACKAGE INSERT TEMPLATE FOR PARACETAMOL SUPPOSITORIES
PACKAGE INSERT TEMPLATE FOR PARACETAMOL SUPPOSITORIES Brand or Product Name [Product name] Suppositories mg Name and Strength of Active Substance(s) Eg Paracetamol 500mg Paracetamol 250mg Paracetamol 125mg
4.4 Special warnings and precautions for use
SUMMARY OF PRODUCT CHARACTERISTICS 4.3 Contraindications Durogesic is contraindicated in patients with known hypersensitivity to fentanyl or to the excipients present in the patch. Acute or postoperative
Drugs Regulatory Unit Ministry of Health PHARMACOVIGILANCE GUIDELINES
Drugs Regulatory Unit Ministry of Health PHARMACOVIGILANCE GUIDELINES THIRD EDITION 2017 0 CONTENTS Introduction 2 Definition and Terminologies..3 Rationale of ADR Monitoring.4 Pharmacovigilance...4 Reporting
Product Labeling to Communicate Benefits and Risks of Treatment for Opioid Use Disorder in Pregnant Women. Hendrée E. Jones, PhD
1 The National Academies of Sciences, Engineering and Medicine Regulatory Strategies of address prescription opioidrelated harms 4 th of November, 2016 Washington DC Product Labeling to Communicate Benefits
SUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fungasil 10 mg/g cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of cream contains 10 mg of terbinafine hydrochloride. Excipients
KELFER Deferiprone. COMPOSITION KELFER-250 Capsules Each capsule contains Deferiprone 250 mg
KELFER Deferiprone COMPOSITION KELFER-250 Capsules Each capsule contains Deferiprone 250 mg KELFER-500 Capsules Each capsule contains Deferiprone 500 mg DOSAGE FORM Capsules PHARMACOLOGY Pharmacodynamics
Clinical Guideline MANAGEMENT OF INFANTS BORN TO MOTHERS WITH GRAVES DISEASE AND AT RISK OF THYROTOXICOSIS
Clinical Guideline MANAGEMENT OF INFANTS BORN TO MOTHERS WITH GRAVES DISEASE AND AT RISK OF THYROTOXICOSIS Date of First Issue 18/07/2016 Approved 28/09/2017 Current Issue Date 16/06/2017 Review Date 01/09/2019
Vinita Rane Supervisor: Maryza Graham
Old bug, new tricks Vinita Rane Supervisor: Maryza Graham 6 week old female Initial presentation (outside Monash): Unwell since 3/52 old Cough, associated with cyanotic episodes Coryza Lethargy Vomiting
Maternal and Child Health, Substance Abuse Ohio Department of Health, Bureau of Maternal Child and Family Health
Maternal and Child Health, Substance Abuse Ohio Department of Health, Bureau of Maternal Child and Family Health Columbus, Ohio Assignment Description The rapid advance of the opiate crisis has had far
Prophylaxis of acute transplant rejection in patients receiving allogeneic renal transplants:
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Prophylaxis of acute transplant rejection in patients receiving allogeneic renal transplants: Over 1 million people worldwide
Farmadol. Paracetamol 10 mg/ml INFUSION SOLUTION
Farmadol Paracetamol 10 mg/ml INFUSION SOLUTION Composition Each ml contains: Paracetamol 10 mg Pharmacology Pharmacodynamic properties The precise mechanism of the analgesic and antipyretic properties
European PSUR Work Sharing Project CORE SAFETY PROFILE. Lendormin, 0.25mg, tablets Brotizolam
European PSUR Work Sharing Project CORE SAFETY PROFILE Lendormin, 0.25mg, tablets Brotizolam 4.2 Posology and method of administration Unless otherwise prescribed by the physician, the following dosages
KELFER Capsules (Deferiprone)
Published on: 22 Sep 2014 KELFER Capsules (Deferiprone) Composition KELFER-250 Capsules Each capsule contains Deferiprone 250 mg KELFER-500 Capsules Each capsule contains Deferiprone 500 mg Dosage Form
Epatite B: fertilità, gravidanza ed allattamento, aspetti clinici e terapeutici. Ivana Maida
Epatite B: fertilità, gravidanza ed allattamento, aspetti clinici e terapeutici Ivana Maida Positivity for HBsAg was found in 0.5% of tested women In the 70s and 80s, Italy was one of the European countries
Report Information from ProQuest
Report Information from ProQuest 17 May 2015 07:36 17 May 2015 ProQuest Table of contents 1. Antidepressants in pregnancy... 1 17 May 2015 ii ProQuest Document 1 of 1 Antidepressants in pregnancy Author:
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory. Light Liquid Paraffin and White Soft Paraffin Cream
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory OILATUM CREAM / KIDS CREAM Light Liquid Paraffin and White Soft Paraffin Cream QUALITATIVE AND QUANTITATIVE COMPOSITION
Guidance on format of the risk management plan (RMP) in the EU part II: Module SIV - Populations not studied in clinical trials
25 July 2013 EMA/465927/2013 Rev.1 Patient Health Protection Guidance on format of the risk management plan (RMP) in the EU part II: Module SIV - Populations not studied in clinical trials Active substance
Core Safety Profile. AT/H/PSUR/0013/002 Date of FAR:
ore afety Profile Active substance: Methylprednisolon aceponate Pharmaceutical form(s)/strength: ream / 0.1 % Fatty ointment / 0.1 % utaneous emulsion / 0.1 % intment / 0.1 % utaneous solution / 0.1 %
Excipients with known effect: Each gramme of gel contains 1 mg methyl parahydroxybenzoate (E-218) and 0.5 mg propyl parahydroxybenzoate (E-216).
VENOSMIL 1. NAME OF THE MEDICINAL PRODUCT VENOSMIL 200 mg hard capsules VENOSMIL 20 mg/g gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION VENOSMIL 200 mg hard capsules Each capsule contains 200 mg hidrosmin.
Summary of the risk management plan (RMP) for Pregabalin Mylan (pregabalin)
EMA/285074/2015 Summary of the risk management plan (RMP) for Pregabalin Mylan (pregabalin) This is a summary of the risk management plan (RMP) for Pregabalin Mylan, which details the measures to be taken
NEW ZEALAND DATA SHEET
1. PRODUCT NAME Sudomyl, Tablet, 60 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Name and strength of the active substance Pseudoephedrine Hydrochloride 60mg Excipient(s) with known effect For the full
Posology. Posology and Dosage Regimen: Factors Affecting Drug Dosage: 08/09/ ) Age: 1. Young s Rule, based on age:
Posology and Dosage Regimen: Posology Posology: (Derived from the Greek posos- how much, and logos- science) is the branch of medicine/pharmacy dealing with doses. Posology is a branch of medical science
SUMMARY OF PRODUCT CHARACTERISTICS. Human proteins g/l g/l of which human immunoglobulin at least to. 180 IU/ml 180 IU/vial
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT UMAN BIG 180 IU/ml Solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human hepatitis B immunoglobulin. UMAN BIG 180 IU/1
Module 1: HIV epidemiology, transmission and prevention
Session 1 Module goals Module 1 Participants will be able to: -offer an insight into the epidemiological situation in the country and worldwide -present the HIV transmission modes and the broad approaches
Annex I. Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
Annex I Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) 1 Scientific conclusions Taking into account the PRAC Assessment Report on the PSUR(s) for magnesium
M0BCore Safety Profile. Active substance: Bromazepam Pharmaceutical form(s)/strength: Tablets 6 mg FR/H/PSUR/0066/001 Date of FAR:
M0BCore Safety Profile Active substance: Bromazepam Pharmaceutical form(s)/strength: Tablets 6 mg P-RMS: FR/H/PSUR/0066/001 Date of FAR: 26.11.2013 4.3 Contraindications Bromazepam must not be administered
Summary of the risk management plan (RMP) for Aripiprazole Mylan Pharma (aripiprazole)
EMA/370707/2016 Summary of the risk management plan (RMP) for Aripiprazole Mylan Pharma (aripiprazole) This is a summary of the risk management plan (RMP) for Aripiprazole Mylan Pharma, which details the
Annex I: Proposed Core Safety Profile (CSP) 4.3 Contraindications
Annex I: Proposed Core Safety Profile (CSP) 4.3 Contraindications Hypersensitivity to cefuroxime or to any of the excipients listed in section 6.1. Patients with known hypersensitivity to cephalosporin
Paediatric Clinical Chemistry
Paediatric Clinical Chemistry Dr N Oosthuizen Dept Chemical Pathology UP 2011 Paediatric biochemistry The child is not a miniature adult Physiological development Immature organ systems Growing individual
SUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Libromide 325 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet contains: Active substance: Potassium
Neonatal Hypoglycemia
PedsCases Podcast Scripts This is a text version of a podcast from Pedscases.com on Neonatal Hypoglycemia. These podcasts are designed to give medical students an overview of key topics in pediatrics.
Page 1 of 5 VERZENIO abemaciclib tablet Eli Lilly and Company AddendaIndex Summary View All Sections HIGHLIGHTS OF PRESCRIBING INFORMATION FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE
PATIENT INFORMATION LEAFLET. Calcichew* 500 mg Chewable Tablets calcium carbonate
PATIENT INFORMATION LEAFLET Calcichew* 500 mg Chewable Tablets calcium carbonate Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bolamyn SR 500 mg Prolonged Release Tablets (metformin hydrochloride) Almus Bolamyn SR 500 mg Prolonged Release Tablets (metformin hydrochloride)
Science = Solutions For Substance Use Disorders and Infant Outcomes. Wilson M. Compton, M.D., M.P.E. Deputy Director National Institute on Drug Abuse
Science = Solutions For Substance Use Disorders and Infant Outcomes Wilson M. Compton, M.D., M.P.E. Deputy Director National Institute on Drug Abuse Science = Solutions Increased Opioid Mortality: Greater
HYPOGLYCAEMIA OF THE NEWBORN ON BIRTHING SUITE AND POSTNATAL WARD
HYPOGLYCAEMIA OF THE NEWBORN ON BIRTHING SUITE AND POSTNATAL WARD INTRODUCTION Healthy term infants are able to mobilise energy stores through a process known as counter regulation and are unlikely to
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TRANSISOFT 8.5 g powder for oral solution in sachet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 8.5 g of macrogol
This indication includes the temporary relief of burning, irritation, and/or discomfort due to dryness of the eye.
Page 1 of 5 SCHEDULING STATUS Schedule 0 PROPRIETARY NAME AND DOSAGE FORM REFRESH LIQUIGEL COMPOSITION REFRESH LIQUIGEL lubricant eye drops contain carboxymethylcellulose sodium 10 mg/ml. Preservative:
Opioid Use Disorder in Pregnancy. Neonatal Abstinence Syndrome
Opioid Use Disorder in Pregnancy Neonatal Abstinence Syndrome Opioid Use Disorder and Pregnancy Cont. 4.6 million women (or 3.8 percent) ages 18 and older misused prescription drugs in 2013. One-third
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology VI.2.2 Summary of treatment benefits
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Nausea and vomiting are common ailments had by many individuals. Nausea is defined as the unpleasant, painless sensation that
Package leaflet: Information for the user
Package leaflet: Information for the user Hepavax-Gene TF, suspension for injection Hepatitis B vaccine (rdna) 20 micrograms of hepatitis B surface antigen (HBsAg)/1.0 ml; 1 dose (1.0 ml) Read all of this
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory ZODERM E CREAM. Oxiconazole Nitrate Cream
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory ZODERM E CREAM Oxiconazole Nitrate Cream QUALITATIVE AND QUANTITATIVE COMPOSITION ZODERM E CREAM contains: Oxiconazole
SUMMARY OF PRODUCT CHARACTERISTICS. A 2.5ml single-dose bottle containing IU Cholecalciferol (equivalent to 625 micrograms vitamin D 3 )
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fultium 25 000 IU Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION A 2.5ml single-dose bottle containing 25 000 IU Cholecalciferol
Migraleve, Migraleve Pink and Migraleve Yellow Product Information
Migraleve, Migraleve Pink and Migraleve Yellow Product Information Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard Adverse events should also
Emergent Issues Affecting Early Intervention/ Early Childhood. Workforce Development for Inclusion in Early Childhood November 4, 2017 Washington, DC
Emergent Issues Affecting Early Intervention/ Early Childhood Workforce Development for Inclusion in Early Childhood November 4, 2017 Washington, DC Conversation Points Changing Demographics Emergent Trends
Diseases in which appear swelling, redness, pain and heat; aspects of the immune system (Inflammatory and immunologic conditions-imid)
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Prednisolone is generally preferred amongst glucocorticoids for anti-inflammatory and immunosuppressive treatment. There are three
Annex III. Amendments to relevant sections of the summary of product characteristics and package leaflets
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets Note: These amendments to the relevant sections of the Summary of Product Characteristics and package
Package leaflet: Information for the user Zirtek Allergy Relief 10 mg Film Coated Tablets Cetirizine dihydrochloride
Package leaflet: Information for the user Zirtek Allergy Relief 10 mg Film Coated Tablets Cetirizine dihydrochloride Read all of this leaflet carefully before you start taking this medicine because it
if you are allergic (hypersensitive) to levetiracetam or any of the other ingredients of this medicine (listed in section 6).
Package Leaflet: Information for the patient Desitrend 250 mg coated granules in sachet Desitrend 500 mg coated granules in sachet Desitrend 750 mg coated granules in sachet Desitrend 1000 mg coated granules
Chapter 2 Hepatitis B Overview
Chapter 2 Hepatitis B Overview 23 24 This page intentionally left blank. HEPATITIS B OVERVIEW Hepatitis B Virus The hepatitis B virus (HBV) belongs to the Hepadnaviridae family and is known to cause both
Medical Marijuana Unintentional & Pediatric. Exposures Self-Learning Module
Medical Marijuana Unintentional & Pediatric PURPOSE Exposures Self-Learning Module This Self-Learning Module has been developed for EMS provider training. The intent is to provide consistent and concise
DBL MAGNESIUM SULFATE CONCENTRATED INJECTION
DBL MAGNESIUM SULFATE CONCENTRATED INJECTION NAME OF MEDICINE Magnesium Sulfate BP DESCRIPTION DBL Magnesium Sulfate Concentrated Injection is a clear, colourless, sterile solution. Each ampoule contains
Irbenida H 150mg/12,5mg film-coated tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER Irbenida H 150mg/12,5mg film-coated tablets IRBESARTAN/HYDROCHLOROTHIAZIDE This leaflet is a copy of the Summary of Product Characteristics and Patient Information
Package leaflet: Information for the user
Package leaflet: Information for the user Hepavax-Gene TF, suspension for injection Hepatitis B vaccine (rdna) 10 micrograms of hepatitis B surface antigen (HBsAg)/0.5 ml; 1 dose (0.5 ml) Read all of this
Package leaflet: Information for the user. ELEVIT PRONATAL film-coated tablets 12 vitamins and 7 minerals and trace elements
Package leaflet: Information for the user ELEVIT PRONATAL film-coated tablets 12 vitamins and 7 minerals and trace elements Read all of this leaflet carefully before you start taking this medicine because