FrancophonIA/ELRC3.0 huggingface dataset:
English: You may experience the following uncommon side effects: headache feeling dizzy feeling anxious feeling sick (nausea) chest discomfort low blood sugar (symptoms: hunger, headache)
Estonian: Võite kogeda järgmisi aeg-ajalt ilmnevaid kõrvaltoimeid: peavalu; pearinglus; ärevus; iiveldus; ebamugavustunne rindkeres; madal veresuhkru tase (sümptomid: higistamine, peavalu); seljavalu; kuuma- või külmatunne; kiirenenud hingamine;
English: See special handling precautions in section 6.6.
Estonian: Erihoiatused ravimpreparaadi käsitlemiseks vt lõik 6.6.
English: However, VIZAMYL may cause transient dizziness and vertigo.
Estonian: VIZAMYL võib siiski põhjustada mööduvat pearinglust ning peapööritust.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VIZAMYL 400 MBq/mL solution for injection flutemetamol (18F)
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) VIZAMYL 400 MBq/ml süstelahus flutemetamool (18F) i.v.
English: Skin tightness Swelling face
Estonian: Naha pingulolek Näoturse
English: Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Estonian: Manustamisprotseduurid tuleb läbi viia nii, et ravimpreparaadi saaste- ja kasutajate kiirgusoht oleks minimaalne.
English: No carcinogenicity and reproductive toxicology studies have been performed with flutemetamol (18F).
Estonian: Flutemetamooliga (18F) ei ole tehtud kartsinogeensuse ja reproduktsioonitoksilisuse uuringuid.
English: • The material should include VIZAMYL PET demonstration cases with correct PET scan interpretation by an experienced reader; VIZAMYL-PET scans for self-assessment; and a selfqualification procedure to be offered to each trainee.
Estonian: • Materjalide hulka peavad kuuluma VIZAMYL-i PET näidisjuhud koos korrektse PET skaneeringu interpretatsiooniga kogemustega lugeja poolt.
English: Serious side effects Tell your doctor straight away, if you notice any of the following, as you may need urgent medical treatment: Allergic reactions - the signs may include swelling of your face or eyes, having pale, itchy or tight skin or having a rash, feeling short of breath, tightness in the chest, irritation in your throat or being sick.
Estonian: Allergilised reaktsioonid - tunnusteks võivad olla näo või silmade turse, kahvatu, sügelev või pingul nahk või lööve, hingeldustunne, pigistustunne rinnus, kõriärritus või iiveldus.
English: Flutemetamol (18F) binds to β-amyloid neuritic plaques in the brain.
Estonian: Flutemetamool (18F) seondub ajus beeta-amüloid neuriitiliste naastudega.
English: Each mL of solution contains flutemetamol (18F) 400 MBq at reference date and time.
Estonian: Üks ml lahust sisaldab flutemetamooli (18F) 400 MBq referentskuupäeval ja -kellaajal.
English: Dyspnoea Hyperventilation Throat irritation
Estonian: Düspnoe Hüperventilatsioon
English: Radiation protection precautions in accordance with national regulations must be taken.
Estonian: Arvestada tuleb kohalike eeskirjadega kiirguskaitse ettevaatusabinõude osas.
English: What VIZAMYL is and what it is used for What you need to know before VIZAMYL is used How VIZAMYL is used
Estonian: 1. Mis ravim on VIZAMYL ja milleks seda kasutatakse 2. Mida on vaja teada enne VIZAMYL-i kasutamist 3.
English: Dizziness Headache Hypoaesthesia Hypotonia Dysgeusia Tremor
Estonian: Pearinglus Peavalu Hüpesteesia Hüpotoonia Düsgeusia Värinad
English: Renal/hepatic impairment The pharmacokinetics in patients with renal or hepatic impairment have not been characterised.
Estonian: Neeru-/maksakahjustus Neeru- ja maksakahjustustega patsientidel ei ole farmakokineetikat kirjeldatud.
English: Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
Estonian: Radiofarmatseutilisi preparaate tuleb säilitada vastavalt kohalikele radioaktiivsete ainete käsitsemise eeskirjadele.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT xx.x mL YYYY MBq at reference time
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI xx,x ml
English: VIZAMYL is a radioactive medicinal product that emits positrons, which annihilate with electrons to produce gamma rays, and must be handled with safety measures to minimise radiation exposure to clinical personnel and patients.
Estonian: VIZAMYL on radioaktiivne ravimpreparaat, mis kiirgab positrone, mis annihileeruvad elektronidega gammakiirte loomiseks.
English: VIZAMYL contains the active substance flutemetamol (18F) )and is used to help diagnose Alzheimer's disease and other causes of memory loss.
Estonian: VIZAMYL sisaldab toimeainena flutemetamooli (18F) ja seda kasutatakse aitamaks diagnoosida
English: Red marrow
Estonian: Punane luuüdi Nahk
English: The effective dose is approximately 5.9 mSv when the maximal recommended activity of 185 MBq of flutemetamol (18F) is administered.
Estonian: Efektiivdoos maksimaalse soovitatava aktiivsuse 185 MBq flutemetamooli (18F)
English: You should avoid any close contact with young children and pregnant women for 24 hours following the injection.
Estonian: 24 tunni jooksul pärast süstimist tuleb hoiduda igasugusest lähikontaktist väikelaste ja rasedate naistega.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / 10 mL
Estonian: MINIMAALSED ANDMED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
English: Contact your nuclear medicine doctor if you have any questions.
Estonian: Küsimuste korral pöörduge oma nukleaarmeditsiini arsti poole.
English: Image acquisition
Estonian: Kujutiste visualiseerimine
English: Close contact with infants and pregnant women should be restricted during the initial 24 hours following the injection.
Estonian: Pärast protseduuri 24 tunni jooksul pärast süstimist tuleb piirata lähikontakti väikelaste ja rasedatega.
English: A negative scan indicates none or a sparse density of cortical β-amyloid neuritic plaques.
Estonian: Negatiivne kujutis näitab kortikaalsete beeta-amüloid neuriitiliste naastude puudumist või hõredust.
English: Close contact with infants should be restricted during the initial 24 hours following injection.
Estonian: 24 tunni jooksul pärast süstimist tuleb piirata lähikontakti imikutega.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING SHIELD LABEL / 10 mL
Estonian: KIIRGUSVARJEGA KONTEINERI SILT / 10 ml
English: How VIZAMYL is stored
Estonian: Kuidas VIZAMYL-i sälitada
English: There is no evidence of flutemetamol (18F) binding to soluble forms of
Estonian: Flutemetamooli (18F) seondumise kohta Aβ lahustuvate vormidega ei ole tõendeid leitud.
English: Healthy controls show low levels of flutemetamol (18F) retention in cerebral cortex.
Estonian: Tervete kontrollisikute puhul esines flutemetamooli (18F) peetumist ajukoores vähesel määral.
English: The sulcal and gyral pattern is not discernible in the positive images on the right.
Estonian: Parempoolsetel positiivsetel kujutistel ei ole vao ja kurru muster eristatav.
English: Resuming breast-feeding should be in agreement with the nuclear medicine doctor who will supervise the procedure.
Estonian: Imetamist võib jätkata, kui seda lubab nukleaarmeditsiini arst, kes protseduuri jälgib.
English: Biomedics M.B.
Estonian: AAAA MBq referentsajal.
English: Pallor
Estonian: Püreksia
English: If you have any further questions on the use of this medicine, please ask your nuclear medicine doctor who supervises the procedure.
Estonian: Lisaküsimuste korral selle ravimi kasutamise kohta pöörduge protseduuri eest vastutava nukleaarmeditsiini arsti poole.
English: This may need to be taken into consideration by patients on a controlled sodium diet.
Estonian: Nende kogustega tuleb arvestada madala naatriumisisaldusega dieedil olevate inimeste puhul.
English: A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. For the limitations in the interpretation of a positive scan, see sections 4.4 and 5.1.
Estonian: Negatiivne skaneering viitab vähestele naastudele või nende puudumisele, mis tähendab, et Alzheimeri tõbe diagnoosida ei saa.
English: Muscle tightness Musculoskeletal pain
Estonian: Naatriumdivesinikfosfaatdihüdraat
English: Flushing
Estonian: Lihaspinge
English: Nausea
Estonian: Kahvatus
English: Renal and hepatic impairment
Estonian: Näo hüpesteesia Sügelus
English: Upper large intestine Bladder
Estonian: Jämesoole ülaosa Kusepõis
English: Onpattro (patisiran)
Estonian: Onpattro (patisiraan)
English: The recommended dose is 300 micrograms per kilogram body weight once every 3 weeks.
Estonian: Soovitatav annus on 300 mikrogrammi kehakaalu kilogrammi kohta üks kord iga 3 nädala järel.
English: What measures are being taken to ensure the safe and effective use of Onpattro?
Estonian: Mis meetmed võetakse, et tagada Onpattro ohutu ja efektiivne kasutamine?
English: What is Onpattro and what is it used for?
Estonian: Mis on Onpattro ja milleks seda kasutatakse?
English: The European Medicines Agency therefore decided that Onpattro's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Onpattro kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: The most common side effects with Onpattro (which may affect more than 1 in 10 people) are peripheral oedema (swelling, especially of the ankles and feet) and infusion-related reactions including pain, nausea (feeling sick), headache, tiredness, dizziness, cough and breathing problems, reddening of the skin, rapid heartbeat, low or high blood pressure and swelling of the face.
Estonian: Onpattro kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on perifeerne ödeem (turse, eriti pahkluudel ja jalalabadel) ning infusioonireaktsioonid, sh valu, iiveldus, peavalu, väsimus, peapööritus, köha ja hingamisprobleemid, nahapunetus, südame löögisageduse kiirenemine, madal või kõrge vererõhk ja näoturse.
English: As for all medicines, data on the use of Onpattro are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Onpattro kasutamise kohta pidevat järelevalvet.
English: Further information on Onpattro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave Onpattro kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Onpattro
Estonian: Muu teave Onpattro kohta
English: Regarding safety, the most serious side effects are infusion-related reactions and these can be managed with premedication and changes to infusion speed.
Estonian: Seoses ohutusega on kõige raskemad kõrvalnähud infusioonireaktsioonid, mida on võimalik hallata premedikatsiooniga ja infusioonikiiruse muutmisega.
English: Side effects reported with Onpattro are carefully evaluated and any necessary action taken to protect patients.
Estonian: Onpattro kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: This reduces production of defective transthyretin, thereby reducing the formation of amyloids and relieving the symptoms of hATTR amyloidosis.
Estonian: See vähendab defektse transtüretiini tootmist, vähendades omakorda amüloidide teket ja leevendades hATTR-amüloidoosi sümptomeid.
English: For more information about using Onpattro, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Onpattro kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: What are the risks associated with Onpattro?
Estonian: Mis riskid Onpattroga kaasnevad?
English: The company that markets Onpattro will provide educational materials for doctors and patients with information about how to give the medicine safely when at home and how to manage side effects.
Estonian: Onpattro turustaja tagab arstidele ja patsientidele teabematerjalid, milles kirjeldatakse, kuidas manustada ravimit ohutult kodus ning kuidas hallata kõrvalnähte.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Onpattro have also been included in the summary of product characteristics and the package leaflet.
Estonian: Onpattro ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: The active substance in Onpattro, patisiran, is a ‘small interfering RNA' (siRNA), a very short piece of synthetic genetic material that has been designed to attach to and block the genetic material of the cell responsible for producing transthyretin.
Estonian: Onpattro toimeaine patisiraan on väike interfereeriv RNA (siRNA) - väga lühike sünteetiline geneetiline materjal, mis seondub transtüretiini tootva raku geneetilise materjaliga ja blokeerib selle.
English: After 18 months of treatment, the mNIS+7 score decreased on average by 6 points with Onpattro (from around 81 to around 75 points), indicating a slight improvement of the patients' condition.
Estonian: 18 ravikuu järel olid mNIS+7-skoorid Onpattroga vähenenud keskmiselt 6 punkti võrra (ligikaudu 81-lt ligikaudu 75-le), mis viitab patsientide seisundi mõningasele paranemisele.
English: To reduce the risk of infusion-related reactions, patients should be given corticosteroid medicines, paracetamol and medicines known as H1 and H2 blockers before receiving Onpattro.
Estonian: Infusioonireaktsioonide riski vähendamiseks tuleb patsientidele enne Onpattro andmist manustada kortikosteroide, paratsetamooli ning H1- ja H2-blokaatoreid (teatud ravimid).
English: How is Onpattro used?
Estonian: Kuidas Onpattrot kasutatakse?
English: Onpattro is used in adult patients in the first two stages of the nerve damage (stage 1, when the patient is able to walk unaided, and stage 2, when the patient can still walk but needs help).
Estonian: Onpattrot kasutatakse täiskasvanud patsientidel, kellel närvikahjustus on esimeses või teises staadiumis (1. staadium: patsient suudab abita kõndida; 2. staadium: patsient suudab kõndida, kuid vajab abi).
English: For the full list of side effects and restrictions with Onpattro, see the package leaflet.
Estonian: Onpattro kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: The broken protein forms amyloid deposits in tissues and organs around the body, including around nerves, where it interferes with their normal functions.
Estonian: Lagunenud valgust tekivad amüloidiladestused kudedesse ja elunditesse kogu organismis, sealhulgas närvide ümber, kus see häirib normaalset närvitalitlust.
English: In one main study involving 225 hATTR amyloidosis patients with stage 1 or 2 nerve damage, Onpattro was shown to be more effective than placebo (a dummy treatment) at slowing down the nerve damage caused by the disease.
Estonian: Põhiuuringus, milles osales 225 hATTR-amüloidoosiga patsienti, kellel oli 1. või 2. staadiumi närvikahjustus, oli Onpattro haigusest tingitud närvikahjustuse aeglustamisel efektiivsem kui platseebo (näiv ravim).
English: Onpattro contains the active substance patisiran.
Estonian: Onpattro sisaldab toimeainena patisiraani.
English: In patients with hATTR amyloidosis, a protein called transthyretin which circulates in the blood is defective and breaks easily.
Estonian: hATTR-amüloidoosiga patsientidel on veres ringlev valk transtüretiin defektne ja laguneb kergesti.
English: Onpattro may be given at home by a healthcare professional if the patient has had at least 3 infusions given in hospital without problems.
Estonian: Kui patsiendil ei ole vähemalt 3 infusioonil haiglas tekkinud probleeme, tohib tervishoiutöötaja manustada Onpattrot patsiendile kodus.
English: Onpattro was shown to be effective at slowing down nerve damage in hATTR amyloidosis patients with stage 1 or stage 2 nerve damage; available data were not sufficient to assume a beneficial effect in stage 3 patients (those confined to a wheelchair).
Estonian: On tõendatud, et Onpattro oli efektiivne 1. või 2. staadiumi närvikahjustusega hATTR-amüloidoosiga patsientide närvikahjustuse aeglustamisel, kuid kättesaadavatest andmetest ei piisanud kasuliku toime tõendamiseks 3. staadiumi närvikahjustusega (ratastoolis) patsientidel.
English: How does Onpattro work?
Estonian: Kuidas Onpattro toimib?
English: What benefits of Onpattro have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Onpattro kasulikkus?
English: Onpattro can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the treatment of patients with amyloidosis.
Estonian: Ravi peab alustama ja jälgima amüloidoosiga patsientide ravis kogenud arst.
English: hATTR amyloidosis is rare, and Onpattro was designated an ‘orphan medicine' (a medicine used in rare diseases) on 15 April 2011.
Estonian: hATTR-amüloidoos esineb harva ja Onpattro nimetati 15. aprillil 2011 harvikravimiks.
English: An overview of Onpattro and why it is authorised in the EU
Estonian: Ülevaade ravimist Onpattro ja ELis müügiloa väljastamise põhjendus
English: This compares with an increase on average by 28 points with placebo (from around 75 to around 101 points), indicating that nerve damage got worse in these patients.
Estonian: Platseebot kasutanud patsientide skoorid suurenesid keskmiselt 28 punkti võrra (ligikaudu 75-lt ligikaudu 101-le), mis viitab närvikahjustuse süvenemisele nendel patsientidel.
English: The main measure of effectiveness was the change in the patients' nerve damage, as measured using a standard scale called ‘mNIS+7', with scores ranging from 0 to 304 (a higher score indicates more severe nerve damage).
Estonian: Seda muutust mõõdeti standardskaalal mNIS+7, mille skooriskaala oli vahemikus 0-304 (suurem skoor tähendab raskemat närvikahjustust).
English: Patients should also take vitamin A supplements during treatment with Onpattro.
Estonian: Onpattro-ravi ajal peavad patsiendid võtma lisaks A-vitamiini.
English: The medicine is available as a solution for infusion (drip) into a vein.
Estonian: Ravimit turustatakse veeniinfusioonilahusena.
English: Onpattro is a medicine used to treat nerve damage caused by hereditary transthyretin (hATTR) amyloidosis, a disease in which abnormal proteins called amyloids build up in tissues around the body including around the nerves.
Estonian: hATTR-amüloidoos on haigus, mille korral ladestuvad kogu organismi kudedesse, sealhulgas närvide ümber teatud ebanormaalsed valgud, amüloidid.
English: Why is Onpattro authorised in the EU?
Estonian: ELis Onpattrole väljastatud müügiloa põhjendus
English: − If you are older than 70 years
Estonian: − kui teie vanus on üle 70 aasta
English: This is a very rare reaction, which can be serious if it occurs.
Estonian: See on väga harv reaktsioon, ent võib olla ohtlik, kui see tekib.
English: Overall conclusion on benefit/risk
Estonian: Üldine järeldus kasulikkuse/riski kohta
English: − If you regularly drink a large amount of alcohol
Estonian: − kui te tarvitate regulaarselt suurtes kogustes alkoholi
English: OTHER SPECIAL WARNING(S), IF NECESSARY Sealed for your protection.
Estonian: TEISED ERIHOIATUSED (VAJADUSEL) Suletud teie kaitseks.
English: − during pregnancy
Estonian: − raseduse ajal
English: Common: allergic reactions.
Estonian: Sage: allergilised reaktsioonid.
English: The following side effects are important and will require immediate action if you experience them:
Estonian: Alljärgnevad kõrvaltoimed on olulised ja nõuavad kohest tegutsemist, kui need peaksid tekkima:
English: This is one of the most common causes of heart disease.
Estonian: See on üks peamisi südamehaiguste põhjuseid.
English: The safety profile of atorvastatin in the MIRACL study was consistent with what is described in Section 4.8.
Estonian: Atorvastatiini ohutusprofiil MIRACL-i uuringus vastas sellele, mida on kirjeldatud lõigus 4.8.
English: − This medicine has been prescribed for you.
Estonian: − Ravim on välja kirjutatud teile.
English: {PRODUCT NAME} is contraindicated in patients:
Estonian: {Väljamõeldud nimetus} on vastunäidustatud patsientidel:
English: Recommendations of the Second Joint Task Force of European and Other Societies on Coronary Prevention” in Atherosclerosis 140 (1998) 199-270.
Estonian: Töörühma Second Joint Task Force of European and Other Societies on Coronary Prevention soovitused, mis on avaldatud ajakirjas Atherosclerosis 140 (1998) 199-270.
English: The safety of atorvastatin in pregnancy and lactation has not yet been proven.
Estonian: Atorvastatiini ohutus raseduse ja imetamise ajal ei ole veel tõestatud.
English: From these 46 patients, the mean percent reduction in LDL-C was approximately 21%.
Estonian: Nendel 46 patsiendil vähenes LDL-C väärtus umbes 21%.
English: Do not take {PRODUCT NAME} if you are pregnant, if you think you may be pregnant, or if you are trying to become pregnant.
Estonian: Ärge võtke {Väljamõeldud nimetus}, kui te olete rase, arvate, et olete rase või plaanite rasestuda.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ATORVASTATIN (Sortis and associated names - see Annex I)
Estonian: ATORVASTATIINI TEADUSLIKU HINDAMISE ÜLDKOKKUVÕTE (Sortis ja sellega seotud nimetused - vt I lisa)
English: Increases and decreases in blood sugar levels have also been seen (If you have diabetes you should continue careful monitoring of your blood sugar levels).
Estonian: On täheldatud vere suhkrusisalduse suurenemist või vähenemist (kui te põete diabeeti peate hoolikalt jälgima oma vere suhkrusisaldust).
English: - Section 5.1 has been updated to include the results of the ASCOT-LLA and CARDS trials as follows:
Estonian: - punkti 5.1 on ASCOT-LLA ja CARDS uuringute tulemuste lisamiseks ajakohastatud järgmiselt:
English: At the December plenary meeting, the CHMP adopted a LoQ centred on the following points:
Estonian: Inimtervishoius kasutatavate ravimite komitee võttis täiskogu istungil detsembris vastu kvantifitseerimisläve, mis keskendus järgmistele punktidele:
English: Cholesterol is a naturally occurring substance in the body necessary for normal growth.
Estonian: Kolesterool on kehaomane aine, mis on vajalik organismi normaalseks arenguks.
English: Pharmacotherapeutic group: HMG-CoA-reductase inhibitors, ATC code: C10AA05
Estonian: Farmakoterapeutiline grupp: HMG-CoA reduktaasi inhibiitorid, ATC-kood: C10AA05
English: In a compassionate-use study of 64 patients there were 46 patients for whom confirmed LDL receptor information was available.
Estonian: Ravimi tasuta kasutamise uuringus 64 patsiendiga oli teave LDL-retseptori kohta kättesaadav 46 patsiendil.
English: − Previous history of liver disease and/or where substantial quantities of alcohol are consumed
Estonian: − varasem maksahaigus ja/või kui tarbitakse suurtes kogustes alkoholi
English: {PRODUCT NAME} should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.
Estonian: {Väljamõeldud nimetus} tuleb kasutada ettevaatlikult patsientidel, kes tarbivad suurtes kogustes alkoholi ja/või kellel on varem esinenud maksahaigust.
English: However, if there is too much cholesterol in your blood it can be deposited on the walls of the blood vessels, which may eventually become blocked.
Estonian: Kui kolesterooli on veres liiga palju, siis võib see ladestuda veresoonte seintele, mis seetõttu võivad lõpuks täiesti ummistuda.
English: The appropriate place for dose recommendations is section 4.2 of the SPC, not section 4.1, and adequate dosing recommendations have been added.
Estonian: Sobiv koht annuse soovituste jaoks on ravimi omaduste kokkuvõtte punkt 4.2, mitte punkt 4.1, ning kokkuvõttesse on lisatud nõuetekohased annustamissoovitused.
English: • the CHMP considered the referral made under article 6.12 of Commission Regulation (EC) No 1084/2003, for atorvastatin (Sortis and associated names - see Annex I),
Estonian: • inimtervishoius kasutatavate ravimite komitee kaalus komisjoni määruse (EÜ) nr 1084/2003 artikli 6 lõike 12 alusel esitatud esildist atorvastatiini (Sortis ja sellega seotud nimetused - vt I lisa) kohta,
English: Uncommon: peripheral neuropathy.
Estonian: Aeg-ajalt: perifeerne neuropaatia.