natgillin/translations-raw huggingface dataset:
common (may affect up to 1 in 10 people) - respiratory infection - abnormal vision - weight gain - numbness uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia)
- otopelost občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - vnetje sinusov (sinusitis)
What Pioglitazone Teva Pharma contains - The active substance is pioglitazone.
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Pioglitazon Teva Pharma - Zdravilna učinkovina je pioglitazon.
UAB “Sicor Biotech” Tel: +370 5 266 0203
Tel: +370 5 266 0203
common
SOB
What Pioglitazone Teva Pharma is and what it is used for
Kaj je zdravilo Pioglitazon Teva Pharma in za kaj ga uporabljamo Zdravilo Pioglitazon Teva Pharma vsebuje pioglitazon.
Fluid retention and cardiac failure
Srčne bolezni srčno popuščanje pogosti
The recommended starting dose is 2.5 mg once a week for 4 weeks.
Priporočeni začetni odmerek je 2,5 mg enkrat na teden prve štiri tedne.
During treatment, monthly measurements are recommended.
Med zdravljenjem je priporočljivo opravljati mesečne meritve.
Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu309708.
Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/medicines/human/orphan-designations/eu309708.
The most significant allergic reactions include acute systemic allergic reaction, angioedema (swelling under the skin in areas such as the face, throat, arms and legs), and serum sickness (allergic reaction caused by animal proteins or serum).
Najpomembnejše alergijske reakcije so akutna sistemska alergijska reakcija, angioedem (otekanje pod kožo na območjih, kot so obraz, grlo, roke in noge), in serumska bolezen (alergijska reakcija, ki jo povzročijo živalske beljakovine ali serum).
The European Medicines Agency therefore decided that Palynziq's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Palynziq večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Palynziq must be used with stringent measures to manage any serious allergic reactions, especially in the first few months.
Zdravilo Palynziq se mora uporabljati s strogimi ukrepi za obvladovanje kakršnih koli resnih alergijskih reakcij, zlasti v prvih mesecih.
Further information on Palynziq can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Palynziq.
Nadaljnje informacije o zdravilu Palynziq so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Palynziq.
The dose and frequency of injection are then increased gradually (up to a maximum dose of 60 mg once a day) to achieve adequate control of phenylalanine blood levels.
Nato se odmerek in pogostnost vbrizgavanja postopoma povečujeta (do največjega odmerka v jakosti 60 mg enkrat na dan), da se doseže ustrezni nadzor nad ravnmi fenilalanina v krvi.
What measures are being taken to ensure the safe and effective use of Palynziq?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Palynziq?
The safety of Palynziq is considered acceptable, and important side effects such as allergic reactions are considered manageable with additional stringent measures (see below).
Varnost zdravila Palynziq se šteje za sprejemljivo, pomembni neželeni učinki, kot so alergijske reakcije, pa veljajo za obvladljive z dodatnimi strogimi ukrepi (glej spodaj).
The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in treating PKU.
Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem fenilketonurije.
Palynziq was designated an ‘orphan medicine' (a medicine used in rare diseases) on 28 January 2010.
Zdravilo Palynziq je bilo 28. januarja 2010 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
During the first part, all patients were given Palynziq at a dose of 20 or 40 mg for up to 13 weeks.
V prvem delu so vsi bolniki do 13 tednov prejemali zdravilo Palynziq v odmerku 20 mg ali 40 mg.
Palynziq is available as pre-filled syringes (2.5, 10 and 20 mg) for injection under the skin.
Zdravilo Palynziq je na voljo v napolnjenih injekcijskih brizgah (2,5 mg, 10 mg in 20 mg) za podkožno injiciranje.
As for all medicines, data on the use of Palynziq are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Palynziq stalno spremljajo.
For more information about using Palynziq, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Palynziq glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Palynziq is a medicine that is used to treat phenylketonuria (PKU) in adults and adolescents from 16 years of age.
Palynziq je zdravilo, ki se uporablja za zdravljenje s fenilketonurijo (PKU) pri odraslih in mladostnikih, starejših od 16 let.
The most common side effects with Palynziq (which may affect more than 7 in 10 people) are reactions at the injection site, pain in the joints and allergic reactions.
Najpogostejši neželeni učinki zdravila Palynziq (ki se lahko pojavijo pri največ 7 bolnikih od 10) so reakcije na mestu injiciranja, bolečina v sklepih in alergijske reakcije.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Palynziq have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Palynziq upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Why is Palynziq authorised in the EU?
Zakaj je bilo zdravilo Palynziq odobreno v EU?
An overview of Palynziq and why it is authorised in the EU
Pregled zdravila Palynziq in zakaj je odobreno v EU
The enzyme in pegvaliase is ‘pegylated' (attached to a chemical called PEG), allowing it to remain in the body and to act for longer.
Encim v pegvaliazi je „pegiliran“ (vezan na kemikalijo, imenovano polietilenglikol), da lahko dlje ostane in deluje v telesu.
Palynziq is intended for long-term use.
Zdravilo Palynziq je namenjeno dolgotrajni uporabi.
Side effects reported with Palynziq are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Palynziq, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What is Palynziq and what is it used for?
Kaj je zdravilo Palynziq in za kaj se uporablja?
What benefits of Palynziq have been shown in studies?
Kakšne koristi je zdravilo Palynziq izkazalo v študijah?
The company that markets Palynziq will provide information material for doctors and for patients and carers about the risk of allergic reactions with Palynziq, including how to identify them promptly and what to do in case such a reaction occurs.
Podjetje, ki trži zdravilo Palynziq, bo priskrbelo informativno gradivo za zdravnike ter bolnike in negovalce o tveganju za alergijske reakcije pri uporabi tega zdravila, vključno s tem, kako jih prepoznati takoj in kako ravnati.
Palynziq must not be used in patients who have had an allergic reaction to pegvaliase, to any of the other components of Palynziq or to any other pegylated medicine.
Zdravilo Palynziq se ne sme uporabljati pri bolnikih, ki so imeli alergijsko reakcijo na pegvaliazo, katero koli drugo sestavino zdravila Palynziq ali katero koli drugo pegilirano zdravilo.
Throughout the study, patients were required to maintain a constant level of dietary protein intake, to ensure that changes in blood phenylalanine levels could be attributed to treatment rather than to changes in protein intake.
V študiji so morali bolniki ohranjati stalno raven vnosa beljakovin v prehrani, da bi lahko spremembe ravni fenilalanina v krvi pripisali zdravljenju, ne pa spremembam vnosa beljakovin.
Other information about Palynziq
Druge informacije o zdravilu Palynziq
It was shown that for the majority of patients continued treatment with Palynziq for 18 months was effective at keeping blood phenylalanine levels under control (below 600 micromoles per litre).
Dokazano je bilo, da je bilo za večino bolnikov 18-mesečno nadaljevanje zdravljenja z zdravilom Palynziq učinkovito pri uravnavanju ravni fenilalanina v krvi pod nadzorom (pod 600 mikromolov na liter).
What are the risks associated with Palynziq?
Kakšna tveganja so povezana z zdravilom Palynziq?
Eighty-six patients who responded to treatment (i.e. whose blood phenylalanine levels were reduced by at least 20%) where then either kept on the same dose of Palynziq or were given placebo (a dummy treatment).
Šestinosemdeset bolnikov, ki so se odzvali na zdravljenje (tj. pri katerih so se ravni fenilalanina v krvi zmanjšale za najmanj 20 %), je nato bodisi še naprej prejemalo enak odmerek zdravila Palynziq bodisi so prejeli placebo (zdravilo brez učinkovine).
After 8 weeks of treatment, blood phenylalanine levels remained under control in patients taking Palynziq but they returned to pre-treatment levels in patients on placebo, showing that Palynziq was more effective than placebo in reducing blood phenylalanine levels and keeping them within an acceptable range.
Po osmih tednih zdravljenja so ravni fenilalanina v krvi ostale pod nadzorom pri bolnikih, ki so jemali zdravilo Palynziq, vendar so se pri bolnikih, ki so prejemali placebo, vrnili na ravni pred zdravljenjem, kar kaže, da je bilo zdravilo Palynziq pri zniževanju ravni fenilalanina v krvi učinkovitejše od placeba in jih ohranja v sprejemljivem razponu.
The active substance in Palynziq, pegvaliase, is a bacterial enzyme that can break down phenylalanine, thereby stopping phenylalanine from building up in the body and helping to relieve the symptoms of phenylketonuria.
Učinkovina v zdravilu Palynziq, pegvaliaza, je bakterijski encim, ki lahko razgrajuje fenilalanin, s čimer preprečuje kopičenje fenilalanina v telesu in pomaga ublažiti simptome fenilketonurije.
Palynziq is used in patients whose blood levels of phenylalanine have not been adequately controlled with other treatments.
Zdravilo Palynziq se uporablja pri bolnikih, pri katerih ravni fenilalanina v krvi niso bile ustrezno uravnane z drugimi oblikami zdravljenja.
Patients with this genetic disease cannot process the amino acid phenylalanine from dietary protein, and as a result the amino acid builds up in the blood to abnormally high levels, causing problems in the nervous system.
Bolniki s to dedno boleznijo ne morejo razgraditi aminokisline fenilalanin, ki je prisotna v beljakovinah v hrani, zaradi česar se ta kopiči v krvi in dosega neobičajno visoko raven, kar povzroča težave z živčnim sistemom.
Palynziq contains the active substance pegvaliase.
Zdravilo Palynziq vsebuje učinkovino pegvaliaza.
Palynziq was shown to be effective at reducing levels of blood phenylalanine and keeping them under control.
Dokazano je bilo, da je zdravilo Palynziq učinkovito pri zniževanju ravni fenilalanina v krvi in jih ohranja pod nadzorom.
The main study investigating Palynziq in patients with PKU consisted of different parts.
Glavna študija, v kateri so zdravilo Palynziq proučevali pri bolnikih s fenilketonurijo, je bila sestavljena iz dveh delov.
In the extension phase of the study patients received an individual optimized dose of Palynziq.
V podaljšanem obdobju študije so bolniki prejemali odmerek zdravila Palynziq, prilagojen vsakemu posamezniku.
Phenylalanine blood levels must be measured before starting treatment.
Pred začetkom zdravljenja je treba izmeriti ravni fenilalanina v krvi.
How is Palynziq used?
Kako se zdravilo Palynziq uporablja?
How does Palynziq work?
Kako zdravilo Palynziq deluje?
For the full list of side effects of Palynziq, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Palynziq, glejte navodilo za uporabo.
They must also not be used in patients who are allergic to aniseed or to plants of the Apiaceae family (Umbelliferae) (caraway, celery, coriander, dill, fennel) or anethole.
Prav tako se ne smejo uporabljati pri bolnikih, ki so alergični na janež, rastline iz družine Apiaceae (Umbelliferae) (kumino, zeleno, koriander, koper, komarček) ali anetol.
Aniseed oil medicines must not be used in children and adolescents under 18 years.
Zdravila, ki vsebujejo eterično olje janeža, se ne smejo uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
Anise oil medicines should only be used in adults and should not be taken for longer than two weeks.
Zdravila, ki vsebujejo eterično olje janeža, se smejo uporabljati samo pri odraslih in se ne smejo uporabljati več kot dva tedna.
In addition they can be used as an expectorant (a medicine that helps bring up phlegm) for coughs associated with colds.
Poleg tega se lahko uporabljajo kot ekspektoransi (zdravila za lažje izkašljevanje sluzi) pri kašlju, povezanem s prehladom.
This summary is not intended to provide practical advice on how to use medicines containing anise oil.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo eterično olje janeža.
Anise oil is the common name for the essential oil obtained from the dry ripe fruits of the plant Pimpinella anisum L.
Eterično olje janeža je splošno ime za eterično olje, ki se pridobiva iz suhih zrelih plodov rastline Pimpinella anisum L.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of anise oil.
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo eteričnega olja janeža.
Herbal medicines containing these anise oil preparations are usually available in solid or liquid forms to be taken by mouth.
Zdravila rastlinskega izvora, ki vsebujejo te pripravke z eteričnim oljem janeža, so navadno na voljo v trdni ali tekoči obliki za jemanje skozi usta.
Further information on the risks associated with these anise oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o tveganjih, povezanih s temi zdravili, ki vsebujejo eterično olje janeža, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
What is anise oil?
Kaj je eterično olje janeža?
In its assessment, the HMPC considered studies in laboratory tests which showed anise oil to have a relaxing effect on the muscle of the gut and airways.
V svoji oceni je odbor HMPC upošteval študije z laboratorijskimi preskusi, ki so pokazale, da ima eterično olje janeža relaksacijski učinek na mišice črevesja in dihalnih poti.
Allergic reactions to aniseed oil that affect the skin or airways may occur.
Lahko se pojavijo alergijske reakcije na eterično olje janeža, ki prizadenejo kožo ali dihalne poti.
The HMPC conclusions on the use of these anise oil medicines for indigestion complaints and coughs are based on their ‘traditional use' .
Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo eterično olje janeža, za zdravljenje prebavnih težav in kašlja temeljijo na njihovi „tradicionalni uporabi“.
Further information on the HMPC assessment of anise oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o oceni zdravil, ki vsebujejo eterično olje janeža, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
Information on the use and licensing of anise oil medicines in EU Member States should be obtained from the relevant national authorities.
Za informacije o uporabi in registraciji zdravil, ki vsebujejo eterično olje janeža, v državah članicah EU se obrnite na pristojni nacionalni organ.
Any applications for the licensing of medicines containing anise oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo eterično olje janeža, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
Anise oil preparations may also be found in combination with other herbal substances in some herbal medicines.
Pripravki z eteričnim oljem janeža so v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
The HMPC conclusions only cover anise oil preparations which are obtained by steam distillation of the dry ripe fruits.
Zaključki odbora HMPC zajemajo samo pripravke z eteričnim oljem janeža, ki se pridobivajo z destilacijo suhih zrelih plodov.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing anise oil.
Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo eterično olje janeža.
How are anise oil medicines approved in the EU?
Kako so zdravila, ki vsebujejo eterično olje janeža, odobrena v EU?
The HMPC concluded that, on the basis of its long-standing use, these anise oil preparations can be used for treating symptoms of mild indigestion complaints including bloating and flatulence.
Odbor HMPC je na podlagi dolgotrajne uporabe zaključil, da se lahko ti pripravki, ki vsebujejo eterično olje janeža, uporabljajo za zdravljenje simptomov blagih prebavnih težav, vključno z napihnjenostjo in napenjanjem.
What evidence supports the use of anise oil medicines?
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo eterično olje janeža?
Detailed instructions on how to take anise oil medicines and who can use them can be found in the package leaflet that comes with the medicine.
Podrobna navodila o jemanju zdravil, ki vsebujejo eterično olje janeža, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
Other information about anise oil medicines
Druge informacije o zdravilih, ki vsebujejo eterično olje janeža
For more information about treatment with anise oil medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravili, ki vsebujejo eterično olje janeža, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with anise oil medicines?
Kakšna tveganja so povezana z zdravili, ki vsebujejo eterično olje janeža?
For practical information about using anise oil medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
If symptoms last or get worse during the use of the medicine, a doctor or a qualified healthcare practitioner should be consulted.
treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem.
Healthy people should not use Eporatio.
Zdravi ljudje ne smejo uporabljati zdravila Eporatio.
Do not warm Eporatio in any other way (for example, do not warm it in a microwave or in hot water).
Zdravila Eporatio ne grejte na noben drug način (na primer ne segrevajte ga v mikrovalovni pečici ali vroči vodi).
Do not increase the dose your doctor has given you.
Ne povečajte odmerka, ki vam ga je predpisal zdravnik.
Do not use it if the date has passed the last day of the month shown.
Ne uporabite, če je ta pretekel zadnji dan navedenega meseca.
Date of latest renewal: 11 September 2014.
Datum prve odobritve: 29. oktober 2009 Datum zadnjega podaljšanja: 11. september 2014
The safety and efficacy of Eporatio in children and adolescents aged up to 17 years have not yet been established.
Pediatrična populacija Varnost in učinkovitost zdravila Eporatio pri otrocih in mladostnikih, starih do 17 let, nista bili dokazani.
PRCA means that the body has stopped or reduced the production of red blood cells which causes severe anaemia.
PRCA pomeni, da je telo prenehalo ali zmanjšalo tvorbo rdečih krvničk, kar povzroča hudo anemijo.
Do not attempt to give this medicine to yourself without this training.
Zdravila Eporatio si ne poskušajte dati sami brez usposabljanja.
Eporatio has not been tested in pregnant women.
Zdravila Eporatio niso preizkusili pri nosečnicah.
If your doctor suspects or confirms that you have this condition, you must not be treated with Eporatio or another epoetin.
Če zdravnik sumi na to stanje ali ga potrdi, se ne smete zdraviti z zdravilom Eporatio ali drugim epoetinom.
Other medicines and Eporatio
Druga zdravila in zdravilo Eporatio
Eporatio is used for the treatment of anaemia accompanied by symptoms (for example fatigue, weakness and shortness of breath).
Zdravilo Eporatio se uporablja za zdravljenje anemije s simptomi (na primer utrujenost, šibkost in kratka sapa).
Treatment with Eporatio is normally a long-term therapy.
Zdravljenje z zdravilom Eporatio je navadno dolgotrajno.
If you do not respond adequately to Eporatio, your doctor will check your dose and will inform you if you need to change doses of Eporatio.
Če se na zdravilo Eporatio ne odzovete ustrezno, bo zdravnik vaš odmerek preveril in vas obvestil, ali je treba odmerke zdravila Eporatio zamenjati.
You will usually receive Eporatio until 1 month after the end of chemotherapy.
Zdravilo Eporatio boste navadno prejemali do enega meseca po koncu kemoterapije.
As a precautionary measure, it is preferable to avoid the use of Eporatio during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Eporatio bolje izogibati.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Eporatio therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Eporatio, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Contents of the pack and other information What Eporatio contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Eporatio
Check again to make sure the correct dose of Eporatio is in the syringe.
Ponovno preverite, ali je v brizgi ustrezen odmerek zdravila Eporatio.
If you are a patient with chronic renal failure, and particularly if you do not respond properly to Eporatio, your doctor will check your dose of Eporatio because repeatedly increasing your dose of Eporatio if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
Če imate kronično ledvično odpoved, in še zlasti, če se na zdravilo Eporatio niste ustrezno odzvali, bo zdravnik večkrat preverjal vaš odmerek zdravila Eporatio, saj lahko, če se na zdravljenje ne odzivate, stalno povečevanje odmerka zdravila Eporatio poveča možnost za težave s srcem ali krvnimi žilami in lahko poveča tveganje za srčni infarkt, možgansko kap ali smrt.
Push the plunger up to the number (IU) on the syringe that matches the dose of Eporatio that your doctor prescribed.
Bat potisnite do številke (i.e.), ki ustreza odmerku zdravila Eporatio, ki ga je predpisal zdravnik.