Elements for a Public Summary. Overview of disease epidemiology
|
|
- Francis Franklin
- 5 years ago
- Views:
Transcription
1 VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Epidemiology of the disease Incidence and prevalence Increased pressure in the eye occurs in more than 100 million people, and can cause a disease called glaucoma. One form of glaucoma is primary open angle glaucoma (POAG), causing blindness in more than 3 million people worldwide and about 2.4 million new cases occur each year. Increased pressure in the eye is times more common than POAG. PhV Page 70/106
2 Primary congenital glaucoma (PCG) is the commonest glaucoma in children, but it occurs with a different frequency worldwide. Groups that are at higher risk than others age, sex, race/ethnic origin. Gender The risk of developing POAG is the same for both sexes. However, women are at a greater risk than men of developing another form of the disease, angle-closure glaucoma. More women than men have increased pressure in the eye. Age Increasing age is a definite risk factor. As you get older the risk of POAG increases. There are 3-10 times more people over the age of 80 years with POAG than people in their 40s. The risk of developing increased pressure in the eye increases over the age of 40 years. In children with glaucoma, more than 80% patients developed glaucoma within the first year of life, with 25% diagnosed within the first month after birth and 60% within the first 6 months of life. Race African Americans are at greater risk of developing POAG. It occurs 3-6 times more often in African Americans than in whites. Glaucoma usually occurs earlier in African Americans than in whites. African Americans not only are 4-8 times more likely to become blind but also go blind 8 times faster. The frequency of open angle glaucoma in Latinos is higher than in non-hispanic whites, but lower than in Afro-Caribbeans. Less is known about the frequency of increased pressure in the eye. Risk factors for the disease Visual problems, blindness Main treatment options The ideal drug for the treatment of high pressure in the eye should lower the pressure in the eye, have no side effects, be cheap, and have once-a-day dosing. Antiglaucoma, Prostaglandin Agonists (e.g. latanoprost, bimatopost, tafluprost) Antiglaucoma, Beta-Blockers (e.g. betaxolol, carteolol, timolol) Antiglaucoma, Carbonic Anhydrase Inhibitors (e.g. dorzolamide, brinzolamide, acetazolamide, methazolamide) Antiglaucoma, Alpha Agonists (e.g. brimonidine, apraclonidine) Antiglaucoma, Combos (e.g. brimonidine/timolol, timolol/dorzolamide) Surgery is the definitive treatment modality for the control of intraocular pressure (IOP) in paediatric glaucoma, although medical treatment is first line in secondary glaucoma, because it is often successful in reducing IOP short term. Eye problems and blindness Glaucoma Glaucoma is the second most common cause of blindness in the United States, and it is the main cause of blindness in African Americans. Between 80, ,000 people are blind due to glaucoma, and each year, a further 5,500 people are likely to become blind. At least 2.25 million people older than 40 years have glaucoma, but only one half are aware of it and are being treated. Increased pressure in the eye PhV Page 71/106
3 In 3% of patients with increased eye pressure, the blood vessels in the retina may become blocked or damaged resulting in eye problems and blindness. The development of glaucoma is the main reason for problems in the eye which may lead to blindness. Studies have shown that over a 5-year-period, the occurrence of damage caused by glaucoma increases with rising eye pressure levels. VI.2.2 Summary of treatment benefits belongs to a group of medicines called prostaglandin analogues. These medicines lower the pressure in the eye and are used to treat high eye pressure and glaucoma. Like other medicines in this group, reduces the pressure within the eye by improving the flow of eye liquid (called aqueous humor) from the eyes through their drainage channels. significantly reduces eye pressure with an effect lasting throughout a 24 hour period, and still persisting up to 84 hours after using the medicine. provides a safe and effective reduction of pressure in the eye with a convenient once-a-day dose, making the main drug of choice. 26 VI.2.3 Unknowns relating to treatment benefits Based on the information currently available, no further studies are needed on how well travoprost works. There is also no evidence to suggest that factors such as age, sex, race or organ disease affect how well travoprost works in the people most likely to take it. VI.2.4 Summary of safety concerns Important identified risks Risk What is known Preventability Swelling in part of the eye () Changes in eye colour () Excessive hair growth (Hypertrichoses) occurs when a part of the eye called the macula becomes swollen, causing your vision to become blurred or distorted. Less common symptoms include object distortion, objects appearing smaller than they actually are, a blind spot, and intolerance to light. may gradually change the colour of the eye by increasing the amount of pigment in it. This change in eye colour happens especially if your eye colour is mixed i.e., blue-brown, grey-brown, yellow-brown and green-brown; however, this may also happen if your eye colour is brown. These changes appear to be cosmetic and have no harmful effect on your eyesight or health. Most patients using for 6 months or more will experience some degree of eyelash changes (increase in eyelash number/length/thickness). These changes are cosmetic and do not harm your vision or health. Caution should be taken when using travoprost in patients with known risk factors for macular oedema. Patients must be informed before starting treatment that their eye colour may possibly change permanently. If only one eye is treated, the colour of the treated eye may become permanently different from the untreated eye. Reaction included in the SmPC. PhV Page 72/106
4 Inflammation of the iris and eye (Iris and uveal inflammation) Heart and blood vessel problems (Cardiac and vascular disorders) Breathing problems () Allergic reactions (Hypersensitivity reactions) Inflammation of the iris is an uncommon side effect. The inflammation is usually mild and goes away when the patient stops using, with or without the help of anti-inflammatory drugs. Elderly patients and patients with existing heart and blood vessel problems have reported side effects such as irregular heartbeat, palpitations, decrease or increase in blood pressure, low or high blood pressure, and slow or fast heartbeat. However, these are uncommon. such as difficulty breathing, tightening of the air passages, sore throat, cough, voice problems, nasal congestion and throat irritation are uncommon side effects of. must not be given in patients who are allergic to travoprost or any of the other ingredients of this medicine. Allergic reactions such as: eye redness, itchy eye, eye irritation are known common side effects, while eyelid redness, swelling around the eye, eyelid itching may affect up to 1 in 100 people. If you have a history of inflammation in the eye you should use this medicine or other prostaglandin analogues should be used with caution in eyes with a history of iris inflammation, or with risk factors for iris inflammation. Also, it is not advisable to use or other prostaglandin analogues again if they have previously caused iris inflammation. Information regarding cardiovascular disorders is described in the SmPC. Information regarding respiratory disorders is described in the SmPC. Yes, by performing a medical examination before starting the treatment in patients with known drug allergies. Important potential risks Risk Eye/skin cancer (Ocular/skin melanoma) Inflammation of the cornea, which could lead to perforation and blindness What is known (Including reason why it is considered a potential risk) Melanoma is a very serious cancer especially if it spreads to skin or distant lymph nodes. There is no evidence of a link between and eyemelanoma. Benzalkonium chloride is a chemical commonly used to preserve eye medication. This chemical has been reported to cause spots and/or lesions on the cornea. Benzalkonium chloride can accumulate in eye tissue and remain there for a long time, making any side effects last longer in the cornea. PhV Page 73/106
5 Use during pregnancy and lactation Risk between and other drugs Long-term safety in the paediatric population has harmful effects on the mother and child during pregnancy. It is not known if this drug passes into human breast milk. Animal studies have shown that and its metabolites do pass into breast milk. What is known Interactions with other pressure reducing medicines or topical non-steroidal anti-inflammatory drugs (NSAIDs) cannot be ruled out. There are three possible effects from such an interaction, an increase in drug effect a reversed effect, resulting with an increased pressure within the eye (with other pressure reductive agents) a decreased effect (with topical NSAIDs) No interaction studies have been performed. can be used in children from 2 months of age at the same dose as for adults, but it is not recommended to those children under 2 months of age. In a study it was demonstrated that in children and adolescents, the most common side effects seen with travoprost are eye redness and growth of eyelashes. Both side effects were observed with a higher frequency in children and adolescents compared to adults. Long-term safety of travoprost was not studied. VI.2.5 Summary of risk minimisation measures by safety concern All medicines have a Summary of Product Characteristics (SmPC) which provides physicians, pharmacists and other health care professionals with details on how to use the medicine, the risks and recommendations for minimising them. An abbreviated version of this in lay language is provided in the form of the package leaflet (PL). The measures in these documents are known as routine risk minimisation measures. This medicine has no additional risk minimisation measures. VI.2.6 Planned post authorisation development plan No post-authorisation safety or efficacy studies are ongoing or are planned to be conducted for travoprost. VI.2.7 Summary of changes to the Risk Management Plan over time Major changes to the Risk Management Plan over time Version Date Safety Concerns Comment 2.0 Not approved Identified Risks Hypertrichoses PhV Page 74/106
6 Version Date Safety Concerns Comment Cardiovascular disorders Ocular and skin melanoma Long term use of preserved eye drops Pregnancy and lactation 3.0 Not approved Identified Risks Cardiovascular disorders Version 3.0 is an update of version 2.0 in relation to an assessment report from RMS. Ocular and skin melanoma Punctuate and/or toxic ulcerative keratopathy (from long-term use of BAK preserved eye drops) Pregnancy and lactation Safety in patient below 18 years 4.0 Approved Identified Risks Hypertrichoses Cardiac and vascular disorders Version 4.0 is an update of version 3.0 in relation to an assessment report from RMS. Ocular and skin melanoma Corneal damage and hypersensitivity due to long term use of preserved eye drops Use during pregnancy and lactation PhV Page 75/106
7 Version Date Safety Concerns Comment 5.0 Current version Identified Risks Hypertrichoses Cardiac and vascular disorders Hypersensitivity reactions Ocular/skin melanoma Corneal damage and hypersensitivity due to long term use of preserved eye drops Use during pregnancy and lactation Long-term safety in the paediatric population Version 5.0 is an update of version 4.0 in relation to a PRAC PSUR assessment report (procedure no.: EMEA/H/C/PSUSA/ /201502) Two new safety concerns were added: Hypersensitivity reactions (important identified risk) and Long-term safety in the paediatric population (). A new indication in paediatric population has been approved and relevant sections have been updated PhV Page 76/106
[TRAVOPROST] 40 MICROGRAMS/ML, EYE DROPS, SOLUTION RISK MANAGEMENT PLAN. TRAVOPR-v
[TRAVOPROST] 40 MICROGRAMS/ML, EYE DROPS, SOLUTION RISK MANAGEMENT PLAN TRAVOPR-v2-270214 VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Studies estimated that 3-6 million people
More informationElements for a public summary. Overview of disease epidemiology
VI.2 VI.2.1 Elements for a public summary Overview of disease epidemiology Glaucoma is an eye disease that can result in damage to the optic nerve and loss of vision (blindness). It is the major cause
More informationSummary of the risk management plan (RMP) for Izba (travoprost)
EMA/14138/2014 Summary of the risk management plan (RMP) for Izba (travoprost) This is a summary of the risk management plan (RMP) for Izba, which details the measures to be taken in order to ensure that
More informationElements for a public summary. VI.2.1 Overview of disease epidemiology
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Studies estimated that 3-6 million people in the United States alone, including 4-10% of the population older than 40 years, have
More informationThe treatment benefit of latanoprost has not been studied in the following populations/patients:
6.1. ELEMENTS FOR A PUBLIC SUMMARY 6.1.1. Overview of Disease Epidemiology Glaucoma is the second leading cause of blindness worldwide, and affects about 66.8 million people worldwide i,ii. Glaucoma can
More informationElements for a public summary. VI.2.1 Overview of disease epidemiology
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology The term ocular hypertension usually refers to any situation in which the pressure inside the eye, called intraocular pressure,
More informationVI.2.2 Summary of treatment benefits
EU-Risk Management Plan for Bimatoprost V01 aetiology), both OAG and ACG can be secondary conditions. Secondary glaucoma refers to any case in which another disorder (e.g. injury, inflammation, vascular
More informationA. Incorrect! Acetazolamide is a carbonic anhydrase inhibitor given orally or by intravenous injection.
Pharmacology - Problem Drill 20: Drugs that Treat Glaucoma Question No. 1 of 10 1. is a topical carbonic anhydrase inhibitor. Question #01 (A) Acetazolamide (B) Clonidine (C) Dorzolamide (D) Apraclonidine
More informationEast and North Hertfordshire treatment pathway for primary open angle glaucoma and ocular hypertension in adults
East and North Hertfordshire treatment pathway for primary open angle glaucoma and ocular hypertension in adults Introduction Glaucoma is a group of eye diseases causing optic nerve damage. In most cases
More informationSummary of the risk management plan (RMP) for Omidria (phenylephrine / ketorolac)
EMA/368070/2015 Summary of the risk management plan (RMP) for Omidria (phenylephrine / ketorolac) This is a summary of the risk management plan (RMP) for Omidria, which details the measures to be taken
More informationPackage leaflet: Information for the user. Xalatan 50 micrograms/ml Eye drops, solution Latanoprost
Package leaflet: Information for the user Xalatan 50 micrograms/ml Eye drops, solution Latanoprost Read all of this leaflet carefully before you start using this medicine because it contains important
More informationPackage Leaflet: Information for the user. LUMIGAN 0.3 mg/ml, eye drops, solution, in single-dose container Bimatoprost
Package Leaflet: Information for the user LUMIGAN 0.3 mg/ml, eye drops, solution, in single-dose container Bimatoprost Read all of this leaflet carefully before you start using this medicine because it
More informationVision Health: Conditions, Disorders & Treatments GLAUCOMA
Vision Health: Conditions, Disorders & Treatments GLAUCOMA Glaucoma is a disease of the optic nerve, which transmits the images you see from the eye to the brain. The optic nerve is made up of many nerve
More informationPregabalin Aristo Version: RMP-Pregabalin0
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Epilepsy Epilepsy is a long-term condition affecting the brain and is characterised by recurring seizures (or fits). It is one
More informationDorzolamide 20 mg/ml Eye Drops, Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER Dorzolamide 20 mg/ml Eye Drops, Solution (Dorzolamide hydrochloride) Read all of this leaflet carefully before you start using this medicine because it contains
More informationBrimonidine/timolol Version 1.2, 16Oct, Elements for a public summary. VI.2.1 Overview of disease epidemiology
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology The estimated number of people with vision loss from glaucoma range from 5.2 to 6.7 million. This is approximately 10% of the
More information7.2 Part VI.2 Elements for a Public Summary
7.2 Part VI.2 Elements for a Public Summary 7.2.1 Part VI.2.1 Overview of disease epidemiology Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation that is usually
More informationTIMALEN 0.5% eye drops
PACKAGE LEAFLET: INFORMATION FOR THE USER TIMALEN 0.5% eye drops TIMOLOL (AS TIMOLOL MALEATE) This leaflet is a copy of the Summary of Product Characteristics and Patient Information Leaflet for a medicine,
More informationOCULAR PHARMACOLOGY GLAUCOMA. increased intraocular pressure. normally mm Hg. when to Tx no fixed level.
OCULAR PHARMACOLOGY GLAUCOMA increased intraocular pressure normally 12 20 mm Hg. when to Tx no fixed level. literature sets ~21 mm Hg as upper limit of normal. some safe at 30 mm Hg some may have damage
More informationPackage leaflet: Information for the user. Latanoprost Pfizer 50 micrograms/ml Eye drops, solution Latanoprost
Package leaflet: Information for the user Latanoprost Pfizer 50 micrograms/ml Eye drops, solution Latanoprost Read all of this leaflet carefully before you start using this medicine because it contains
More informationTreatments for Open-Angle Glaucoma. A Review of the Research for Adults
Treatments for Open-Angle Glaucoma A Review of the Research for Adults Is This Information Right for Me? Yes, this information is for you if: Your eye doctor has said that you have open-angle glaucoma,
More informationPATIENT INFORMATION LEAFLET
Page 1 of 6 PATIENT INFORMATION LEAFLET SCHEDULING STATUS Schedule 4 Proprietary name, Strength and Pharmaceutical Form LUMIGAN 0,03 % Eye Drops (each ml contains bimatoprost 0,3 mg) Read all of this leaflet
More informationSummary 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
More informationVildagliptin belongs to a group of medicines called oral antidiabetics.
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Vildagliptin belongs to a group of medicines called oral antidiabetics. Vildagliptin is used in a certain form of diabetes (type
More informationProposed PIL NL/H/0653/001/IB/024/G. MONOFREE DEXAMETHASON 1 mg/ml, eye drops, solution in single-dose container Dexamethasone phosphate
Proposed PIL NL/H/0653/001/IB/024/G PACKAGE LEAFLET: INFORMATION FOR THE USER MONOFREE DEXAMETHASON 1 mg/ml, eye drops, solution in single-dose container Dexamethasone phosphate Read all of this leaflet
More informationRISK MANAGEMENT PLAN (RMP) PUBLIC SUMMARY ETORICOXIB ORION (ETORICOXIB) 30 MG, 60 MG, 90 MG & 120 MG FILM-COATED TABLET DATE: , VERSION 1.
RISK MANAGEMENT PLAN (RMP) PUBLIC SUMMARY ETORICOXIB ORION (ETORICOXIB) 30 MG, 60 MG, 90 MG & 120 MG FILM-COATED TABLET DATE: 07-10-2016, VERSION 1.2 VI.2 Elements for a Public Summary Etoricoxib Orion
More informationElements for a Public Summary. Overview of disease epidemiology
VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Gout i Gout has a worldwide distribution. In the United Kingdom from 2000 to 2007, the estimated occurrence of gout is 5.9% in
More informationPackage leaflet: Information for the user. GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution Bimatoprost/timolol
Package leaflet: Information for the user GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution Bimatoprost/timolol Read all of this leaflet carefully before you start using this medicine because it contains
More informationPackage leaflet: Information for the patient. Latanoprost 50 micrograms/ml eye drops, solution latanoprost
PACKAGE LEAFLET 18 Package leaflet: Information for the patient Latanoprost 50 micrograms/ml eye drops, solution latanoprost Read all of this leaflet carefully before you start using this medicine because
More informationINDICATIONS ACULAR 0,5 % is indicated for the relief of inflammation following ocular surgery.
Page 1 of 5 SCHEDULING STATUS Schedule 3 PROPRIETARY NAME (AND DOSAGE FORM) ACULAR 0,5 % COMPOSITION ACULAR 0,5 % contains: Preservatives: Benzalkonium chloride 0,01 % m/v Disodium edetate 0,1 % m/v PHARMACOLOGICAL
More informationSummary of the risk management plan (RMP) for Pregabalin Pfizer (pregabalin)
EMA/247834/2014 Summary of the risk management plan (RMP) for Pregabalin Pfizer (pregabalin) Overview of disease epidemiology Epilepsy Epilepsy is a long-term condition affecting the brain and is characterised
More informationSouth East London Area Prescribing Committee Chronic Open Angle Glaucoma and Ocular Hypertension Treatment Pathway
Proceed to 2 nd line treatment if further reduction in IOP required and there is good response to PGAs or (& no South East London Area Prescribing Committee Chronic Open Angle Glaucoma and Ocular Hypertension
More informationSummary of safety concerns Important identified risks
Valley VI.2 Elements for a public summary NL/H/3661/001-002/DC - Ivabradin Medical VI.2.1 Overview of disease epidemiology Ivabradine is a medicine used for two long-term (chronic) heart conditions: to
More informationPackage leaflet: Information for the user. AZOPT 10 mg/ml eye drops, suspension Brinzolamide
Package leaflet: Information for the user AZOPT 10 mg/ml eye drops, suspension Brinzolamide Read all of this leaflet carefully before you start using this medicine because it contains important information
More informationINDICATIONS ACULAR 0,4% ophthalmic solution is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery.
Page 1 SCHEDULING STATUS Schedule 4 PROPRIETARY NAME (and dosage form) ACULAR 0,4% COMPOSITION ACULAR 0,4% ophthalmic solution contains: Ketorolac tromethamine: 4 mg/ml Preservative: Benzalkonium chloride
More informationAPPROVED PACKAGE INSERT FOR XALATAN EYE DROPS. Each millilitre contains latanoprost 50 µg and benzalkonium chloride 0,02 % m/v as preservative.
SCHEDULING STATUS: S4 APPROVED PACKAGE INSERT FOR XALATAN EYE DROPS PROPRIETARY NAME (and dosage form): XALATAN Eye Drops COMPOSITION: Each millilitre contains latanoprost 50 µg and benzalkonium chloride
More informationPackage leaflet: Information for the user. NEVANAC 1 mg/ml eye drops, suspension Nepafenac
Package leaflet: Information for the user NEVANAC 1 mg/ml eye drops, suspension Nepafenac Read all of this leaflet carefully before you start using this medicine because it contains important information
More informationPackage leaflet: Information for the patient. Brinzolamide 10 mg/ml Eye Drops, Suspension brinzolamide
Package leaflet: Information for the patient Brinzolamide 10 mg/ml Eye Drops, Suspension brinzolamide Read all of this leaflet carefully before you start using this medicine because it contains important
More informationPackage leaflet: Information for the user. GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container Bimatoprost/timolol
Package leaflet: Information for the user GANFORT 0.3 mg/ml + 5 mg/ml eye drops, solution, in single-dose container Bimatoprost/timolol Read all of this leaflet carefully before you start using this medicine
More informationMedical Treatment in Pediatric Glaucoma
Medical Treatment in Pediatric Glaucoma By Nader Bayoumi, MD Lecturer of Ophthalmology Ophthalmology Department Alexandria University Alexandria, Egypt ESG 2012 Pediatric glaucoma is a surgical disease
More informationA study conducted in Norway found the combined estimate for panic and generalized anxiety disorder was 1.10 per 1,000 person-years.
VI.2 Elements for a public summary For sake of completeness, with reference to article 11 of the Directive 2001/83, the applicant retains the option to carve out the patented indication in the national
More informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 28 May 2008
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 28 May 2008 COSOPT 20 mg/5 mg/ml, eye drops, solution in single dose container Box of 60 0.2 ml single dose containers
More informationGlaucoma. What is glaucoma? Eye Words to Know. What causes glaucoma?
2014 2015 Glaucoma What is glaucoma? Glaucoma is a disease that damages your eye s optic nerve. It usually happens when fluid builds up in the front part of your eye. That extra fluid increases the pressure
More informationScience & Technologies. UNWANTED SIDE EFFECTS OF TRAVOPROST Gazepov Strahil 1, Iljaz Ismaili 2, Goshevska Dashtevska Emilija 2
UNWANTED SIDE EFFECTS OF TRAVOPROST Gazepov Strahil 1, Iljaz Ismaili 2, Goshevska Dashtevska Emilija 2 1 Clinical Hospital, Shtip 2 University Eye Clinic,Skopje Introduction: Glaucoma is a chronical progressive
More information13.2 Elements for a Public Summary
13.2 Elements for a Public Summary 13.2.1 Overview of disease epidemiology The common cold is one of the most prevalent diseases in humans and is the most common condition for which family doctors are
More informationPackage leaflet: Information for the patient. Brimonidine Biogaran 2 mg/ml eye drops, solution. brimonidine tartrate
Package leaflet: Information for the patient Brimonidine Biogaran 2 mg/ml eye drops, solution brimonidine tartrate Read all of this leaflet carefully before you start using this medicine because it contains
More informationElements for a Public Summary Overview of disease epidemiology
VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Indication: Treatment of blood clots Blood clots in the large veins of the legs, known as deep vein thrombosis (DVT), are a common
More informationDERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC)
Guidelines for the medical treatment of chronic open angle glaucoma and ocular hypertension Summary: DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) Diagnosis and management of ocular hypertension (OHT)
More informationPackage leaflet: Information for the user. Optilamid 10 mg/ml, oogdruppels, suspensie Brinzolamide
Package leaflet: Information for the user Optilamid 10 mg/ml, oogdruppels, suspensie Brinzolamide Read all of this leaflet carefully before you start taking this medicine because it contains important
More informationPackage leaflet: information for the user. OZURDEX 700 micrograms intravitreal implant in applicator dexamethasone
Package leaflet: information for the user OZURDEX 700 micrograms intravitreal implant in applicator dexamethasone Read all of this leaflet carefully before you are given this medicine because it contains
More informationPATIENT INFORMATION LEAFLET. PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM LUMIGAN 0,01 %, bimatoprost 0,1 mg/ml eye drops
Page 1 of 6 SCHEDULING STATUS Schedule 4 PATIENT INFORMATION LEAFLET PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM LUMIGAN 0,01 %, bimatoprost 0,1 mg/ml eye drops Read all of this leaflet carefully
More informationProphylaxis 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
More informationEtoricoxib STADA 30 mg, 60 mg, 90 mg and 120 mg film-coated tablets , Version V1.2 PUBLIC SUMMARY OF THE RISK MANAGEMENT PLAN
Etoricoxib STADA 30 mg, 60 mg, 90 mg and 120 mg film-coated tablets 23.5.2016, Version V1.2 PUBLIC SUMMARY OF THE RISK MANAGEMENT PLAN VI.2 Elements for a Public Summary Etoricoxib STADA 30 mg film-coated
More informationElements for a public summary
VI.2 Elements for a public summary Part VI.2 Elements for a public summary is applicable for all products that are covered by this RMP, except from the important potential risk of Medication error with
More informationGet a grip on your glaucoma Booklet 1
Information for Patients Glaucoma services Welcome! Get a grip on your glaucoma Booklet 1 Group-based Glaucoma information Course Session 1 What happens in session 1? Finding out what questions you have
More informationIOP measurements: 8.00 am (trough drug levels) and am (peak drug levels)(2 hours post dose)
This overview of 2% eye drops was presented by Dr. Ravin N. Das, at Hotel Satya Ashoka, on 19-6-2004 in place of Dr. H. S. Ray due to unforseen circumstances. This dinner meeting was sponsored by Cipla
More informationFinancial Disclosure. Prostaglandin Analogs (PGs) The Glaucoma Grab Bag: Practical Guidelines for Effective Glaucoma Therapy
The Glaucoma Grab Bag: Practical Guidelines for Effective Glaucoma Therapy Danica J. Marrelli, OD, FAAO University of Houston College of Optometry Financial Disclosure I have received I have received speaking
More informationVI.2 Elements for a public summary
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Product therapeutic indications: Myocardial infarction is the medical term for an event commonly known as a heart attack. It happens
More informationRisk Management Plan
Management Plan Active substance: VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Hypertension is generally defined as blood pressure higher than 140/90 mmhg. Hypertension may
More informationPackage leaflet: Information for the patient BETAXOLOL 0.5% EYE DROPS. Betaxolol (as hydrochloride)
Package leaflet: Information for the patient BETAXOLOL 0.5% EYE DROPS Betaxolol (as hydrochloride) Read all of this leaflet carefully before you starts to using this medicine because it contains important
More informationPatient Information COSOPT PF (CO-sopt PEA EHF) (dorzolamide hydrochloride-timolol maleate ophthalmic solution) 2%/0.5%
Patient Information COSOPT PF (CO-sopt PEA EHF) (dorzolamide hydrochloride-timolol maleate ophthalmic solution) 2%/0.5% Read this information before you start using COSOPT PF and each time you get a refill.
More informationManaging the Patient with POAG
Managing the Patient with POAG Vision Institute Annual Fall Conference Mitchell W. Dul, OD, MS, FAAO mdul@sunyopt.edu Richard J. Madonna, MA, OD, FAAO rmadonna@sunyopt.edu Ocular Hypertension (OHT) Most
More informationBrightFocus Foundation is the new name for American Health Assistance Foundation.
In this section, you will find the following: Glaucoma Medications Laser Therapies Conventional Surgical Procedures In the second section, you will find information on how to search for potential treatments
More informationPART VI: SUMMARY OF THE RISK MANAGEMENT PLAN
PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN VI.1 Summary of activities in the risk management plan The summary below was prepared based on the information included in Part II, IV and V of the present
More informationOlmesartan is used for treating high blood pressure (hypertension) in adult patients.
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Olmesartan is used for treating high blood pressure (hypertension) in adult patients. Essential hypertension 1 Worldwide, it is
More informationILUVIEN 190 micrograms intravitreal implant in applicator (fluocinolone acetonide)
ILUVIEN 190 micrograms intravitreal implant in applicator (fluocinolone acetonide) Read all of this information carefully before you are given this medicine because it contains important information for
More informationPackage leaflet: Information for the user XATABLOC. 50 micrograms/ml + 5 mg/ml eye drops, solution latanoprost / timolol
Package leaflet: Information for the user XATABLOC 50 micrograms/ml + 5 mg/ml eye drops, solution latanoprost / timolol Read all of this leaflet carefully before you start using this medicine because it
More informationPACKAGE LEAFLET: INFORMATION FOR THE USER Nicorandil 10 mg Tablets Nicorandil 20 mg Tablets nicorandil
PACKAGE LEAFLET: INFORMATION FOR THE USER Nicorandil 10 mg Tablets Nicorandil 20 mg Tablets nicorandil Read all of this leaflet carefully before you start taking this medicine because it contains important
More informationGlaucoma Clinical Update. Barry Emara MD FRCS(C) Giovanni Caboto Club October 3, 2012
Glaucoma Clinical Update Barry Emara MD FRCS(C) Giovanni Caboto Club October 3, 2012 Objectives Understand the different categories of glaucoma Recognize the symptoms and signs of open angle and angle-closure
More informationElements for a Public Summary. Overview of disease epidemiology. Cardiovascular Events
VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Cardiovascular Events Each year cardiovascular disease (CVD) causes 3.9 million deaths in Europe and over 1.8 million deaths in
More informationElements for a Public Summary
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Chronic lymphocytic leukaemia 1 Chronic lymphocytic leukemia (CLL) is a condition characterized by a progressive accumulation
More informationAnnex 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) Scientific conclusions Taking into account the PRAC Assessment Report on the PSUR for bimatoprost,
More informationPackage Leaflet: Information for the user. NEVANAC 3 mg/ml eye drops, suspension nepafenac
Package Leaflet: Information for the user NEVANAC 3 mg/ml eye drops, suspension nepafenac Read all of this leaflet carefully before you start using this medicine because it contains important information
More informationGlaucoma. How is Glaucoma Diagnosed? Glaucoma Testing
Glaucoma How is Glaucoma Diagnosed? Glaucoma Testing There is no single test for glaucoma. The diagnosis is made by evaluating the patient from a number of perspectives, using specialized instruments.
More informationPACKAGE LEAFLET: INFORMATION FOR THE USER ACULAR 0.5% w/v EYE DROPS, SOLUTION (Ketorolac trometamol)
PACKAGE LEAFLET: INFORMATION FOR THE USER ACULAR 0.5% w/v EYE DROPS, SOLUTION (Ketorolac trometamol) Read all of this leaflet carefully before you start using this medicine. - Keep this leaflet. You may
More informationElements for a Public Summary Overview of disease epidemiology
VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Acute pain usually responds to medication and should settle in less than three months. Inadequate pain relief may lead to other
More informationRMP version 3.0 Aripiprazole
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Schizophrenia The prevalence (proportion of the population found to have a disease) of schizophrenia (a disease characterised
More informationVI.2 Elements for a Public Summary. VI.2.1 Overview of disease epidemiology
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Febuxostat is a medicine used in adults with gout to reduce high levels of uric acid in the blood. Gout results from a build up
More informationPATIENT INFORMATION LEAFLET. PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM OZURDEX, dexamethasone 700 μg intravitreal implant
Page 1 of 6 SCHEDULING STATUS Schedule 4 PATIENT INFORMATION LEAFLET PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM, dexamethasone 700 μg intravitreal implant Read all of this leaflet carefully before
More informationGlaucoma. Glaucoma. Glaucoma. Trevor Arnold, MS, DVM, DACVO
Glaucoma Trevor Arnold, MS, DVM, DACVO Glaucoma Physiology of Aqueous Humor Produced in the ciliary body Flows out the iridocorneal angle and ciliary cleft High intraocular pressures are caused by a decreased
More informationSummary of the risk management plan (RMP) for Budesonide/Formoterol Teva (budesonide / formoterol)
EMA/639304/2014 Summary of the risk management plan (RMP) for Budesonide/Formoterol Teva (budesonide / formoterol) This is a summary of the risk management plan (RMP) for Budesonide/Formoterol Teva, which
More informationMild NPDR. Moderate NPDR. Severe NPDR
Diabetic retinopathy Diabetic retinopathy is the most common cause of blindness in adults aged 35-65 years-old. Hyperglycaemia is thought to cause increased retinal blood flow and abnormal metabolism in
More informationZerlinda (MRP DK/H/2265/001)
Zerlinda (MRP DK/H/2265/001) VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Prevention of bone complications, e.g. fractures, in adult patients with bone metastases (spread
More informationLOWPROST Eye Drops (Bimatoprost Ophthalmic Solution 0.01%)
Published on: 14 Apr 2017 LOWPROST Eye Drops (Bimatoprost Ophthalmic Solution 0.01%) For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only Composition Each ml contains: Bimatoprost...
More informationDivakar Gupta Glaucoma Fellow, Duke Eye Center 5/14/16
Divakar Gupta Glaucoma Fellow, Duke Eye Center 5/14/16 Pathophysiology of glaucoma Consider risk factors of glaucoma Understand the side effects of glaucoma medications Diagnostic testing Leading cause
More informationRisk What is known Preventability Increased symptoms of congestion when the effects of
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Nasal congestion Nasal congestion and rhinorrhoea (runny nose) are symptoms that commonly occur together. The most common causes
More informationSummary of the risk management plan (RMP) for Ivabradine Anpharm (ivabradine)
EMA/518024/2015 Summary of the risk management plan (RMP) for Ivabradine Anpharm (ivabradine) This is a summary of the risk management plan (RMP) for Ivabradine Anpharm, which details the measures to be
More informationElements for a public summary
VI.2 VI.2.1 Elements for a public summary Overview of disease epidemiology Malaria is caused by mosquito bites whereby the malaria parasites can enter the body and then live in body tissues such as red
More informationSummary of the risk management plan (RMP) for Vylaer Spiromax (budesonide / formoterol)
EMA/675937/2014 Summary of the risk management plan (RMP) for Vylaer Spiromax (budesonide / formoterol) This is a summary of the risk management plan (RMP) for Vylaer Spiromax, which details the measures
More informationVolume 9; Number 6 May 2015 PRESCRIBING FOR CHRONIC OPEN ANGLE GLAUCOMA (COAG) AND OCULAR HYPERTENSION (OHT)
Greater East Midlands Commissioning Support Unit in association with Lincolnshire Clinical Commissioning Groups, Lincolnshire Community Health Services, United Lincolnshire Hospitals Trust and Lincolnshire
More informationSummary of the risk management plan (RMP) for Nucala (mepolizumab)
EMA/671186/2015 Summary of the risk management plan (RMP) for Nucala (mepolizumab) This is a summary of the risk management plan (RMP) for Nucala, which details the measures to be taken in order to ensure
More informationRisk Management Plan Etoricoxib film-coated tablets
VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Osteoarthritis (OA): OA is a condition in which the cartilage of the joints is broken down. This causes stiffness, pain and leads
More information9 PM Eye Drops (Latanoprost 0.005%)
Published on: 10 Jul 2014 9 PM Eye Drops (Latanoprost 0.005%) Composition Each ml contains: Latanoprost... 50 mcg Benzalkonium Chloride, NF... 0.02%w/v (as preservative) aqueous vehicle... q.s. Dosage
More informationDUOTRAV Eye Drops travoprost 0.004% and timolol 0.5%
DUOTRAV Eye Drops travoprost 0.004% and timolol 0.5% Alcon (Australia) Pty Ltd Consumer Medicine Information What is in this Leaflet This leaflet answers some common questions about DUOTRAV Eye Drops.
More informationVI.2 Elements for a public summary
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Leukaemia is a cancer that starts in the blood-forming cells of the bone marrow. Chronic lymphocytic leukaemia (CLL) is a type
More informationSwiss Summary of the Risk Management Plan (RMP) for Nucala (Mepolizumab)
Swiss Summary of the Risk Management Plan (RMP) for Nucala (Mepolizumab) RMP Summary: Version 1, March 2017 EU RMP: Version 2, 26.5.2016 The Risk Management Plan (RMP) is a comprehensive document submitted
More informationPackage Leaflet: Information for the user. Xalacom 50 micrograms/ml and 5 mg/ml Eye Drops, Solution Latanoprost + Timolol
Package Leaflet: Information for the user Xalacom 50 micrograms/ml and 5 mg/ml Eye Drops, Solution Latanoprost + Timolol Read all of this leaflet carefully before you start using this medicine because
More informationDrug Prescribing Pattern & Adverse Drug Effects Of Anti Glaucoma Medication for Primary Glaucoma at Tertiary Care Hospital
IOSR Journal of Dental and Medical Sciences (IOSR-JDMS) e-issn: 2279-0853, p-issn: 2279-0861.Volume 16, Issue 11 Ver. III (Nov. 2017), PP 36-41 www.iosrjournals.org Drug Prescribing Pattern & Adverse Drug
More informationD90 (27/10/2005) Final SmPC NL/H/653/01
1/6 1. NAME OF THE MEDICINAL PRODUCT MONOFREE DEXAMETHASON 1 mg/ml, eye drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 1 mg of dexamethasone phosphate as dexamethasone
More informationElements for a public summary
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Nevirapine is used for antiretroviral combination therapy of Human Immunodeficiency Virus (HIV) infection. Human immunodeficiency
More information