FrancophonIA/ELRC3.0 huggingface dataset:
English: List of the names, pharmaceutical form, strength of the medicinal product, route of administration, applicant / marketing authorisation holder in the Member States
Estonian: Ravimite nimetuste, ravimvormide, tugevuste ja manustamisviiside ning müügiloa taotlejate ja liikmesriikides müügiloa hoidjate loetelu
English: Ireland Pinewood Laboratories Limited, Ballmacarbry, Clonmel, Co.
Estonian: Laboratories Limited, Ballmacarbry, Clonmel, Co.
English: Applicant
Estonian: Nimetus
English: The application was submitted to Ireland as reference Member State and Austria, Bulgaria, Denmark, Spain, Finland, France, Hungary, the Netherlands, Poland, Portugal, Romania, Sweden, Slovenia as concerned Member States, as well as Iceland and Norway.
Estonian: Viiteliikmesriik oli Iirimaa ning asjaomased liikmesriigid Austria, Bulgaaria, Hispaania, Madalmaad, Poola, Portugal, Prantsusmaa, Rootsi, Rumeenia, Sloveenia, Soome, Taani ja Ungari ning Island ja Norra.
English: Potential serious risks were identified during the decentralised procedure by two concerned Member States regarding the environmental risk assessment (the Netherlands and France).
Estonian: Kaks asjaomast liikmesriiki (Madalmaad ja Prantsusmaa) tõstatasid detsentraliseeritud menetluse ajal võimaliku suure riski küsimuse seoses keskkonnariski hindamisega.
English: Prontax 5 mg/ml pour-on solution for cattle (and associated names) contains doramectin.
Estonian: Prontax 5 mg/ml kriipsulahus veistele (ja sarnased nimetused) sisaldab doramektiini.
English: Based on evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Prontax 5 mg/ml pour-on solution for cattle and associated names is deemed to be positive provided that the recommended risk mitigation measures are added to the product information regarding risk to aquatic organisms and dung fauna.
Estonian: Tuginedes olemasolevatele andmetele, leidis veterinaarravimite komitee, et veterinaarravimi Prontax 5 mg/ml kriipsulahus veistele ning sarnaste nimetuste kasulikkuse ja riski suhet võib pidada positiivseks, kui ravimiteabele lisatakse soovitatavad riski leevendamise meetmed riskide vähendamiseks veeorganismidele ja sõnniku faunale.
English: The applicant, Pfizer Limited, has submitted an application for a decentralised procedure for the above mentioned veterinary medicinal product in the framework of Article 32 of Directive 2001/82/EC, as amended.
Estonian: Taotleja Pfizer Limited esitas muudetud direktiivi 2001/82/EÜ artikli 32 kohaselt veterinaarravimi Prontax 5 mg/ml detsentraliseeritud menetluse taotluse.
English: referral for Prontax 5 mg/ml pour-on solution for cattle and associated names
Estonian: Prontax 5 mg/ml kriipsulahus veistele ja sarnased nimetused
English: Opinion following an Article 33(4)F F referral for Prontax 5 mg/ml pour-on solution for cattle and associated names
Estonian: Arvamus pärast artikli 33 lõike 4F F kohast esildist Prontax 5 mg/ml kriipsulahus veistele ja sarnased nimetused EMA/421637/2012
English: recommending the granting of a Marketing Authorisation for Prontax 5 mg/ml pour-on solution for cattle and associated names.
Estonian: veebruaril 2012 vastu positiivse arvamuse, soovitades anda veterinaarravimi Prontax 5 mg/ml kriipsulahus veistele ja sarnaste nimetuste müügiloa.
English: The active substance in Pioglitazone Teva Generics, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Estonian: Ravimi Pioglitazone Teva Generics toimeaine pioglitasoon suurendab rakkude (rasva-, lihas- ja maksarakud) tundlikkust insuliini suhtes, mis tähendab, et organism kasutab paremini enda toodetavat insuliini.
English: What is Pioglitazone Teva Generics?
Estonian: Mis on Pioglitazone Teva Generics?
English: Because Pioglitazone Teva Generics is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Estonian: Et Pioglitazone Teva Generics on geneeriline ravim, piirdusid patsiendiuuringud katsetega, milles näidati ravimi bioekvivalentsust võrdlusravimiga Actos.
English: Therefore, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Pioglitazone Teva Generics for the treatment of type 2 diabetes.
Estonian: Taotluse tagasivõtmise ajal oli inimravimite komitee andnud seetõttu positiivse arvamuse ning soovitas anda ravimile Pioglitazone Teva Generics II tüüpi diabeedi raviks müügiloa.
English: The CHMP concluded that, in accordance with EU requirements, Pioglitazone Teva Generics had been shown to have comparable quality and to be bioequivalent to Actos.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Pioglitazone Teva Generics võrdväärne kvaliteet ja bioekvivalentsus ravimiga Actos.
English: This means that Pioglitazone Teva Generics is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Estonian: See tähendab, et Pioglitazone Teva Generics on sarnane võrdlusravimiga Actos, millel juba on Euroopa Liidus müügiluba.
English: Pioglitazone Teva Generics was developed as a ‘generic medicine'.
Estonian: Pioglitazone Teva Generics töötati välja geneerilise ravimina.
English: Pioglitazone Teva Generics is a medicine that contains the active substance pioglitazone.
Estonian: Pioglitazone Teva Generics on ravim, mis sisaldab toimeainena pioglitasooni.
English: Pioglitazone Teva Generics was also to be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Estonian: Ravimit Pioglitazone Teva Generics kavatseti kasutada ka koos insuliiniga patsientidel, kellele üksnes insuliini manustamine ei mõju rahuldavalt ja kes ei saa kasutada metformiini.
English: Pioglitazone Teva Generics was to be used to treat type 2 diabetes in adults, particularly those who are overweight.
Estonian: Ravimit Pioglitazone Teva Generics kavatseti kasutada eelkõige ülekaaluliste täiskasvanud patsientide II tüüpi diabeedi raviks Seda kavatseti kasutada koos dieedi ja füüsilise koormusega.
English: On 26 January 2012, TEVA Generics B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone Teva Generics, for the treatment of type 2 diabetes.
Estonian: ametlikult inimravimite komiteele, et soovib tagasi võtta II tüüpi diabeedi raviks ette nähtud ravimi Pioglitazone Teva Generics müügiloa taotluse.
English: Pioglitazone Teva Generics was also to be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone.
Estonian: Ravimit Pioglitazone Teva Generics kavatseti kasutada ka koos metformiiniga patsientidel, kelle haigus ainult metformiini kasutamisel rahuldavalt ravile ei allu.
English: How is Pioglitazone Teva Generics expected to work?
Estonian: Milline on ravimi Pioglitazone Teva Generics eeldatav toime?
English: Pioglitazone Teva Generics was to used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Estonian: Ravimit Pioglitazone Teva Generics kavatseti kasutada ainsa ravimina patsientidel, kellele ei sobi metformiin (samuti diabeediravim).
English: What was Pioglitazone Teva Generics expected to be used for?
Estonian: Milleks kavatseti ravimit Pioglitazone Teva Generics kasutada?
English: BEFORE YOU START
Estonian: ENNE KUI ALUSTATE
English: An observer is someone who:
Estonian: Jälgija on keegi, kes
English: o Your doctor will tell you if you need an observer for longer than 6 months.
Estonian: o Teie arst ütleb teile, kui vajate jälgijat kauem kui 6 kuud.
English: Relatively low titres of IgE has also been observed.
Estonian: Täheldatud on ka suhteliselt väikesi IgE tiitreid.
English: Most people respond within 18 months, but it can sometimes take up to 30 months.
Estonian: Enamikul inimestel tekib ravivastus 18 kuu jooksul, kuid vahel võib kuluda kuni 30 kuud.
English: Duration prior to next dose increase
Estonian: Kestus enne järgmist annuse suurendamist
English: The clinical significance of these findings and functional consequences are unknown.
Estonian: Nende leidude kliiniline olulisus ja funktsionaalsed tagajärjed ei ole teada.
English: Some of these allergic reactions can be more serious, as described below, and will require immediate attention.
Estonian: Mõningad neist allergilistest reaktsioonidest võivad olla tõsisemad, nagu kirjeldatud allpool, ning vajavad kohe ravi.
English: Symptoms of inattention and mood were also evaluated during this period.
Estonian: Sel perioodil hinnati ka tähelepanematuse ja meeleolu sümptomeid.
English: Study 302: Efficacy assessment
Estonian: Uuring 302: efektiivsuse hindamine
English: Tell your doctor that you had a severe allergic reaction.
Estonian: Öelge oma arstile, et teil tekkis raske allergiline reaktsioon.
English: No differences in the safety profile were observed.
Estonian: Ohutusprofiilis erinevusi ei täheldatud.
English: Currently available data on patients aged 16 up to 18 years are described in section 4.8 and 5.1.
Estonian: Praegu kättesaadavaid andmeid 16- kuni 18-aastaste patsientide kohta on kirjeldatud lõikudes 4.8 ja 5.1.
English: See section 4 for details on what to do based on your symptoms.
Estonian: Vt lõigust 4 täpsemalt, mida teha olenevalt teie sümptomitest.
English: These medicines help to reduce the symptoms of an allergic reaction.
Estonian: Need ravimid aitavad vähendada allergilise reaktsiooni sümptomeid.
English: The absolute bioavailability in humans is unknown.
Estonian: Absoluutne biosaadavus inimesel ei ole teada.
English: Do not use a microwave and do not place in hot water.
Estonian: Ärge kasutage mikrolaineahju ega asetage kuuma vette.
English: It can be on the same part of the body or a different part of the body (see Figures E and F).
Estonian: See võib olla samal või muul kehaosal (vt jooniseid E ja F).
English: Long-term extension period
Estonian: Pikaajaline jätkuperiood
English: Individual values for half-life range from 14 to 132 hours.
Estonian: Individuaalsed poolväärtusajad varieeruvad 14 tunnist 132 tunnini.
English: Keep it with you at all times.
Estonian: Kandke seda alati kaasas.
English: Serious side effects include:
Estonian: Tõsised kõrvaltoimed on:
English: • Note: Do not inject multiple injections in the same spot.
Estonian: • Märkus: ärge tehke mitut süsti samasse kohta.
English: Prior to independent self-injection, a healthcare professional should:
Estonian: Enne patsiendi iseseisvat enda süstimist peab tervishoiutöötaja:
English: As a consequence, these patients were more likely to develop hypophenylalaninaemia.
Estonian: Seetõttu oli neil patsientidel hüpofenüülalanineemia tekkimine tõenäolisem.
English: The time to reach a response ranged from 0.5 to 30 months.
Estonian: Ravivastuse saavutamiseni kulus 0,5 kuni 30 kuud.
English: • train the patient and assess patient competency on proper self-administration of this medicinal product.
Estonian: • andma patsiendile väljaõppe ja hindama patsiendi pädevust selle ravimi õigeks manustamiseks;
English: The average molecular mass is approximately 1,000 kDa of which the protein moiety constitutes approximately 248 kDa.
Estonian: Keskmine molekulaarmass on ligikaudu 1000 kDa, millest valgu osa moodustab ligikaudu 248 kDa.
English: The duration of titration varied among patients and was based on patient tolerability (up to 30 weeks).
Estonian: Tiitrimise kestus patsienditi varieerus ja sõltus patsiendi taluvusest (kuni 30 nädalat).
English: If your phenylalanine levels are too high or too low during pregnancy, this may harm you or your baby.
Estonian: Kui teie fenüülalaniini sisaldus on raseduse ajal liiga kõrge või liiga madal, võib see teie last kahjustada.
English: Osmolality: 260 - 290 mOsm/kg
Estonian: Osmolaalsus: 260...290 mOsm/kg
English: Slowly increasing your dose over time allows your body to adjust to this medicine.
Estonian: Annuse aeglane suurendamine aja jooksul võimaldab teie kehal selle ravimiga harjuda.
English: The median duration was 161 days (range: 35, 1408).
Estonian: Mediaanne kestus oli 161 päeva (piirid: 35; 1408).
English: Due to lack of human data, Palynziq should only be administered to breast-feeding women if the potential benefit is considered to outweigh the potential risk to the infant.
Estonian: Andmete puudumise tõttu inimeste kohta võib Palynziqi manustada imetavatele naistele ainult sel juhul, kui sellest saadav potentsiaalne kasu arvatakse ületavat potentsiaalset riski imikule.
English: If the expiry date has passed, do not use the pre-filled syringe in that carton.
Estonian: Kui kõlblikkusaeg on möödunud, ärge selles karbis sisalduvat süstlit kasutage.
English: - Do not warm up the pre-filled syringe in any other way.
Estonian: - Ärge soojendage süstlit mingil muul viisil.
English: No human data are available.
Estonian: Inimeste kohta ei ole andmed kättesaadavad.
English: Date removed from refrigeration: _____/_____/______
Estonian: Külmkapist väljavõtmise kuupäev: _____/_____/______
English: Do not use a Palynziq syringe more than once.
Estonian: Ärge kasutage Palynziqi süstlit rohkem kui üks kord.
English: Prescribing physician should continue or consider resuming use of premedication.
Estonian: Ravi määrav arst peab jätkama eelravi kasutamist või kaaluma selle kasutamise uuesti alustamist.
English: Vacuoles in all tissues, with the exception of the kidney, resolved or were diminished by the end of the recovery period, suggesting partial reversibility.
Estonian: Vakuoolid kõigis kudedes peale neerude kadusid või vähenesid taastumisperioodi lõpuks, mis näitas osalist tagasipöörduvust.
English: Do not wipe it away.
Estonian: Ärge pühkige seda ära.
English: Your doctor will tell you how long to stay at each dose.
Estonian: Arst ütleb teile, kui kaua iga annust kasutada.
English: Injecting cold Palynziq can be uncomfortable.
Estonian: Külma Palynziqi süstimine võib olla ebamugav.
English: Store in a refrigerator (2°C - 8°C).
Estonian: Hoida külmkapis (2 °C ... 8 °C).
English: An additional 7% of patients responded to Palynziq after 18 months of treatment.
Estonian: Veel 7%-l patsientidest tekkis ravivastus Palynziqile pärast 18 ravikuud.
English: Dose titration and time to achieve response
Estonian: Annuse tiitrimine ja aeg ravivastuse saavutamiseni
English: Check with your doctor, pharmacist or nurse about the right way to throw away the container.
Estonian: Küsige oma arstilt, apteekrilt või meditsiiniõelt, kuidas on õige konteinerit ära visata.
English: It is not known if Palynziq has an effect on fertility.
Estonian: Ei ole teada, kas Palynziq mõjutab viljakust.
English: Doses should not be divided over the course of the day (see Method of administration).
Estonian: Annuseid ei tohi päeva peale ära jagada (vt „Manustamisviis“).
English: Seven out of the 16 patients discontinued treatment.
Estonian: Seitse patsienti 16-st lõpetas ravi.
English: Animal studies suggest that women may have difficulty becoming pregnant if their phenylalanine levels are abnormally low.
Estonian: Loomkatsete kohaselt võib naistel olla raske rasestuda, kui nende fenüülalaniini sisaldus on ebanormaalselt madal.
English: • Do not use the pre-filled syringe if it looks damaged or used.
Estonian: • Ärge kasutage süstlit, kui see näib olevat vigastatud või kasutatud.
English: This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say essentially ‘sodium-free'.
Estonian: Ravim sisaldab vähem kui 1 mmol (23 mg) naatriumi süstli kohta, see tähendab põhimõtteliselt „naatriumivaba“.
English: • Physician educational material • Patient information pack
Estonian: • arsti teabematerjal • patsiendi teabepakett
English: These patients received the same induction/titration/maintenance regimen as patients aged 18 years and older in this study.
Estonian: Need patsiendid järgisid selles uuringus sama sissejuhatava ravi / tiitrimise / säilitusravi raviskeemi kui 18-aastased ja vanemad patsiendid.
English: Following a single subcutaneous dose (0.01, 0.03 or 0.1 mg/kg), pegvaliase is absorbed slowly with a median tmax of 3.5 to 4 days (individual range of 2.5 to 7 days).
Estonian: Pärast ühekordset subkutaanset annust (0,01, 0,03 või 0,1 mg/kg) imendub pegvaliaas aeglaselt, mediaanne tmax on 3,5 kuni 4 päeva (individuaalne vahemik 2,5 kuni 7 päeva).
English: Figure F Inject at least 5 cm apart
Estonian: Joonis F Süstida vähemalt 5 cm vahedega
English: - Place each sealed tray on a clean, flat surface out of reach of children and pets.
Estonian: - Asetage iga õhukindlalt suletud alus puhtale, tasasele pinnale lastele ja lemmikloomadele kättesaamatus kohas.
English: Patients previously treated with sapropterin were required to discontinue treatment at least 14 days prior to first dose of Palynziq.
Estonian: Varem sapropteriiniga ravitud patsiendid pidid lõpetama ravi vähemalt 14 päeva enne Palynziqi esimest annust.
English: It is very important to keep your phenylalanine levels under control before and during pregnancy.
Estonian: Väga tähtis on hoida oma fenüülalaniini sisaldust kontrolli all enne rasedust ja raseduse ajal.
English: Efficacy results over time are presented in Table 4 and Figure 1.
Estonian: Efektiivsusega seotud tulemused aja jooksul on esitatud tabelis 4 ja joonisel 1.
English: The potency of this medicinal product should not be compared to any other PEGylated or non-PEGylated protein of the same therapeutic class.
Estonian: Selle ravimi tugevust ei saa võrrelda teiste samasse ravimirühma kuuluvate pegüleeritud või pegüleerimata valkude tugevusega.
English: Check the syringe label to make sure you have the correct strength for your prescribed dose.
Estonian: Kontrollige süstli etiketti, et veenduda, et teil on ettenähtud annuseks õige tugevus.
English: In maintenance phase of the treatment, steady state is expected 4 to 24 weeks after maintenance dose started.
Estonian: Säilitusravi etapil saavutatakse stabiilne olek eeldatavalt 4 kuni 24 nädalat pärast säilitusannusega alustamist.
English: Prior to launch of Palynziq in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Estonian: Enne Palynziqi turuletoomist igas liikmesriigis peab müügiloa hoidja kooskõlastama riikliku pädeva ametiasutusega teavitusprogrammi sisu ja vormi, sealhulgas teabeedastuskanalid, levitamisviisid ja programmi muud aspektid.
English: • Your doctor will need to check your blood phenylalanine monthly to see if this medicine is working for you.
Estonian: • Teie arstil on vaja kontrollida teie vere fenüülalaniini sisaldust iga kuu, et näha, kas see ravim toimib teile.
English: It is not known if Palynziq is safe and effective in children and adolescents less than 16 years of age with PKU and therefore should not be used in people aged less than 16 years.
Estonian: Ei ole teada, kas Palynziq on alla 16-aastastele fenüülketonuuriaga lastele ja noorukitele ohutu ja efektiivne ning seetõttu ei tohi seda alla 16-aastastel kasutada.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Estonian: Esinemissagedused on määratletud järgmiselt: väga sage (≥ 1/10); sage (≥ 1/100 kuni < 1/10); aeg-ajalt (≥ 1/1000 kuni < 1/100); harv (≥ 1/10 000 kuni < 1/1000); väga harv (< 1/10 000); teadmata (ei saa hinnata olemasolevate andmete alusel).
English: For management of adverse reactions, see sections 4.4 and 4.8.
Estonian: Kõrvaltoimete ravi kohta vt lõigud 4.4 ja 4.8.
English: Dose was not changed for 23 (96%) episodes and dose was reduced for 1 (4%) episode.
Estonian: Annust ei muudetud 23 episoodi (96%) puhul ja vähendati 1 episoodi (4%) puhul.
English: Gather your supplies for the injection and place them on a clean flat surface.
Estonian: Koguge kõik süstimiseks vajalikud vahendid kokku ja asetage need puhtale, tasasele pinnale.
English: Date removed from refrigeration: _____/_____/______ Peel here
Estonian: Külmkapist väljavõtmise kuupäev: _____/_____/______ Rebida siit
English: After 6 months of Palynziq treatment, the need for an observer may be reconsidered.
Estonian: Pärast 6-kuulist ravi Palynziqiga võib jälgija vajalikkuse uuesti läbi vaadata.
English: Hold the skin firmly (see Figure K).
Estonian: Hoidke nahka pingul (vt joonis K).
English: If a patient does not reach a clinically relevant blood phenylalanine reduction after 18 months of treatment, continuation should be reconsidered.
Estonian: Kui patsiendil ei saavutata pärast 18 ravikuud vere fenüülalaniini sisalduse kliiniliselt olulist vähenemist, tuleb ravi jätkamine uuesti läbi vaadata.
English: Available toxicological data in animals have shown excretion of pegvaliase in milk.
Estonian: Olemasolevad toksikoloogilised andmed loomadel on näidanud, et pegvaliaas eritub piima.
English: Dispose of the used syringes
Estonian: Kõrvaldage kasutatud süstlid kasutuselt
English: In the pups of these animals, systemic exposure of pegvaliase was not detected.
Estonian: Nende loomade järglastel pegvaliaasi süsteemset saadavust ei leitud.
English: The effects in offspring were associated with maternal toxicity.
Estonian: Järglastel avaldunud toimed olid seotud emasloomal tekkinud toksilisusega.
English: If you have a severe allergic reaction, do not continue to use Palynziq until you have talked with the doctor who prescribes you Palynziq.
Estonian: Raske allergilise reaktsiooni tekkimisel ärge jätkake Palynziqi kasutamist, kuni olete pidanud nõu arstiga, kes teile Palynziqi määras.
English: The mean (SD) time from first dose of pegvaliase to onset was 372 (384) days.
Estonian: Keskmine (standardhälve) aeg pegvaliaasi esimesest annusest kuni reaktsiooni tekkimiseni oli 372 (384) päeva.
English: Angioedema can also present as one of the symptoms of an acute systemic hypersensitivity reaction.
Estonian: Angioödeem võib tekkida ka ägeda süsteemse ülitundlikkusreaktsiooni ühe sümptomina.
English: Patients should be instructed to pre-medicate with an H1-receptor antagonist, H2-receptor antagonist, and antipyretic.
Estonian: Patsientidele tuleb anda juhis kasutada eelravina H1-retseptori antagonisti, H2-retseptori antagonisti ja palavikuvastast ravimit.
English: PEGylated proteins have the potential to elicit an immune response.
Estonian: Pegüleeritud valkudel on võime immuunvastust esile kutsuda.
English: Do not use this medicine after the expiry date which is stated on the syringe label, tray cover, and carton after “EXP”.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud süstli sildil, aluse kaanel ja karbil pärast „EXP“.
English: Colourless to pale yellow, clear to slightly opalescent solution with pH 6.6 - 7.4.
Estonian: Värvitu kuni kahvatukollane, selge kuni veidi opalestseeruv lahus, pH 6,6...7,4.
English: • The physician educational material should contain: o The Summary of Product Characteristics o Guide for healthcare professionals
Estonian: • Arsti teabematerjal peab sisaldama: o ravimi omaduste kokkuvõtet o juhendit tervishoiutöötajatele
English: If more than one syringe is needed:
Estonian: Kui vajate mitut süstlit:
English: • Use each Palynziq pre-filled syringe once only.
Estonian: • Kasutage iga Palynziqi süstlit ainult üks kord.
English: Instructions for the preparation and administration of Palynziq are given in the package leaflet.
Estonian: Juhised Palynziqi valmistamiseks ja manustamiseks on esitatud pakendi infolehel.
English: The long-term clinical consequences of chronic hypophenylalaninaemia are unknown.
Estonian: Kroonilise hüpofenüülalanineemia pikaajalised kliinilised tagajärjed ei ole teada.
English: Allergic reactions occur very commonly (may affect more than 1 in 10 people) and range in severity.
Estonian: Allergilised reaktsioonid on väga sagedad (võib esineda rohkem kui 1 inimesel 10-st) ja erineva raskusastmega.