natgillin/translations-raw huggingface dataset:
Halimatoz must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body). 
Zdravilo Halimatoz se ne sme uporabljati pri bolnikih z aktivno tuberkulozo ali drugimi hudimi okužbami ali pri bolnikih z zmernim do hudim srčnim popuščanjem (stanjem, pri katerem srce ne zmore črpati dovolj krvi po telesu).
The company that markets Halimatoz must provide educational packs for doctors who prescribe the medicine. 
Podjetje, ki trži zdravilo Halimatoz, mora pripraviti izobraževalno gradivo za zdravnike, ki zdravilo predpisujejo.
Why is Halimatoz authorised in the EU? 
Zakaj je bilo zdravilo Halimatoz odobreno v EU?
What benefits of Halimatoz have been shown in studies? 
Kakšne koristi zdravila Halimatoz so se pokazale v študijah?
The active substance in Halimatoz, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF). 
Učinkovina zdravila Halimatoz, adalimumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da v telesu prepozna snov, imenovano tumorje nekrotizirajoči faktor (TNF), in se veže nanjo.
Other information about Halimatoz 
Druge informacije o zdravilu Halimatoz
What is Halimatoz and what is it used for? 
Kaj je zdravilo Halimatoz in za kaj se uporablja?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Halimatoz 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 Halimatoz upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Like other medicines of its class, Halimatoz may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab. 
Tako kot druga zdravila iz istega razreda tudi zdravilo Halimatoz lahko vpliva na obrambno sposobnost imunskega sistema proti okužbam in raku; pri bolnikih, ki prejemajo adalimumab, so bili namreč zabeleženi nekateri primeri resnih okužb in krvnega raka.
Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition). 
Drugi redki resni neželeni učinki (ki se lahko pojavijo pri največ 1 od 1 000 bolnikov) vključujejo nezmožnost kostnega mozga za proizvodnjo krvnih celic, motnje živčevja, lupus in lupusu podobna obolenja (pri katerih imunski sistem napada bolnikova lastna tkiva, kar povzroča vnetje in poškodbe organov) in Stevens-Johnsonov sindrom (hudo kožno obolenje).
TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Halimatoz is used to treat. 
TNF sodeluje pri povzročanju vnetij in je prisoten v visokih koncentracijah pri bolnikih z boleznimi, za katere se zdravilo Halimatoz uporablja.
What are the risks associated with Halimatoz? 
Kakšna tveganja so povezana z zdravilom Halimatoz?
All these data were considered sufficient to conclude that Halimatoz will behave in the same way as Humira in terms of effectiveness and safety in its approved uses. 
Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Halimatoz pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Humira.
The reference medicine for Halimatoz is Humira. 
Referenčno zdravilo za zdravilo Halimatoz je zdravilo Humira.
The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain. 
Najpogostejši neželeni učinki adalimumaba (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so okužbe (vključno z okužbami nosu, grla in sinusov), reakcije na mestu injiciranja (rdečina, srbenje, krvavenje, bolečina ali oteklina), glavobol ter bolečine v mišicah in kosteh.
Halimatoz is a medicine that acts on the immune system and is used to treat the following conditions: 
Zdravilo Halimatoz učinkuje na imunski sistem in se uporablja za zdravljenje naslednjih bolezni:
For more information on the use of Halimatoz in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Halimatoz pri vseh navedenih boleznih, vključno s tem, kdaj se lahko uporablja pri otrocih, glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Because Halimatoz is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Halimatoz. 
Zdravilo Halimatoz je podobno biološko zdravilo, zato študij o učinkovitosti in varnosti adalimumaba, ki so že bile izvedene z zdravilom Humira, z zdravilom Halimatoz ni treba ponavljati.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Halimatoz has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Halimatoz po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Humira in da se po telesu enako prenaša.
Halimatoz contains the active substance adalimumab and is a ‘biosimilar medicine'. 
Zdravilo Halimatoz vsebuje učinkovino adalimumab in je „podobno biološko zdravilo“.
• polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints); 
• poliartikularnega juvenilnega idiopatskega artritisa in aktivnega artritisa, povezanega z entezitisom (obe bolezni sta redki in povzročata vnetje sklepov);
• axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation; 
• aksialnega spondiloartritisa (vnetja hrbtenice, ki povzroča bolečine v hrbtu), ankilozirajočega spondilitisa in kadar rentgenska slika ne kaže poškodb, so pa prisotni očitni znaki vnetja;
Halimatoz can only be obtained by prescription and treatment must be started and supervised by a doctor who has experience in the treatment of the diseases for which Halimatoz is used. 
Predpisovanje in izdaja zdravila Halimatoz je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik, ki ima izkušnje z zdravljenjem bolezni, za katere se zdravilo Halimatoz uporablja.
For more information about using Halimatoz, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Halimatoz glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
For the full list of side effects and restrictions with Halimatoz, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Halimatoz glejte navodilo za uporabo.
In addition, Halimatoz was as effective as Humira in a study involving 465 patients with moderate or severe plaque psoriasis. 
Poleg tega je bilo zdravilo Halimatoz v študiji, ki je vključevala 465 bolnikov z zmerno do hudo luskavico v plakih, enako učinkovito kot zdravilo Humira.
Therefore, the Agency's view was that, as for Humira, the benefits of Halimatoz outweigh the identified risks and it can be authorised. 
Zato je agencija menila, da koristi zdravila Halimatoz, enako kot pri zdravilu Humira, odtehtajo znana tveganja in se zdravilo lahko odobri.
Eye specialists treating uveitis should also take advice from doctors who have experience of using Halimatoz. 
Zdravniki specialisti za očesne bolezni, ki zdravijo uveitis, se morajo posvetovati z zdravniki, ki imajo izkušnje z uporabo zdravila Halimatoz.
Studies have also shown that giving Halimatoz produces similar levels of the active substance in the body to giving Humira. 
Študije so pokazale tudi, da zdravilo Halimatoz vzpostavi podobne ravni učinkovine v telesu kot zdravilo Humira.
Laboratory studies comparing Halimatoz with Humira have shown that the active substance in Halimatoz is highly similar to that in Humira in terms of structure, purity and biological activity. 
Laboratorijske študije, v katerih so zdravilo Halimatoz primerjali z zdravilom Humira, so pokazale, da je učinkovina zdravila Halimatoz po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Humira.
How is Halimatoz used? 
Kako se zdravilo Halimatoz uporablja?
• hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses 
• obolenja hidradenitis suppurativa (acne inversa), tj. dolgotrajnega obolenja kože, ki povzroča vozliče, abscese (gnojne tvorbe) in kožne brazgotine;
• plaque psoriasis (a disease causing red, scaly patches on the skin); 
• psoriaze v plakih (luskavice - bolezni, ki povzroča nastajanje rdečih, luskastih lis na koži);
In addition, a study in psoriasis has shown that the effects of the medicine are equivalent to those of Humira in this condition. 
Poleg tega je študija luskavice pokazala, da so učinki zdravila Halimatoz pri tej bolezni enakovredni učinkom zdravila Humira.
How does Halimatoz work? 
Kako zdravilo Halimatoz deluje?
The dose and frequency of injection depends on the condition to be treated and the dose for a child is usually calculated according to the child's weight; because Halimatoz is only available in doses of 40 mg, it is not suitable for children who need less than a 40-mg dose. 
Odmerek in pogostnost injiciranja sta odvisna od zdravljene bolezni, odmerek pri otroku pa se običajno izračuna na podlagi njegove telesne mase.
• psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints); 
• psoriatičnega artritisa (bolezni, ki povzroča nastajanje rdečih, luskastih lis na koži in vnetje sklepov);
After training, patients or their carers may inject Halimatoz if their doctor considers it appropriate. 
Ker je zdravilo Halimatoz na voljo le v odmerkih po 40 mg, ni primerno za otroke, ki potrebujejo odmerek, manjši od 40 mg. Bolniki ali njihovi skrbniki lahko po opravljenem usposabljanju sami injicirajo zdravilo Halimatoz, če zdravnik meni, da je to zanje primerno.
Package size blister (PVC/alu) perforated blister (PVC/alu) non perforated 
Velikost pakiranja perforirani pretisni omot (PVC/alumiij)
The full EPAR for Pantecta Control can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pantecta Control je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The recommended dose of Pantecta Control is one tablet once a day until symptoms have stopped. 
Priporočeni odmerek zdravila Pantecta Control je ena tableta enkrat na dan, dokler simptomi ne izzvenijo.
The European Commission granted a marketing authorisation valid throughout the EU for Pantecta Control on 12 June 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Pantecta Control, veljavno po vsej Evropski uniji, odobrila dne 12. junija 2009.
This is a summary of the European public assessment report (EPAR) for Pantecta Control. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pantecta Control.
The most common side effects with Pantecta Control (seen in around 1 patient in 100) are diarrhoea and headache. 
Najpogostejša neželena učinka zdravila Pantecta Control (opažena pri približno 1 bolniku od 100) sta driska in glavobol.
For more information about treatment with Pantecta Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Pantecta Control preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Pantecta Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Pantecta. 
Zdravilo Pantecta Control je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU),
Pantecta Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients. 
Zdravila Pantecta Control ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) pantoprazol, sojo ali katero koli drugo sestavino zdravila.
The CHMP therefore decided that Pantecta Control's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Zato je zaključil, da so koristi zdravila Pantecta Control večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
It is used for long-term treatments and is also used to treat a wider range of gastrointestinal diseases (conditions affecting the gut) than Pantecta Control. 
Uporablja se za dolgotrajno zdravljenje in za zdravljenje širšega spektra bolezni prebavil (stanj, ki prizadenejo črevesje) kot zdravilo Pantecta Control.
In the second study, 70% of the patients taking pantoprazole (121 out of 172) and 59% of those talking ranitidine (102 out of 172) had no heartburn after two weeks of treatment. 
V drugi študiji 70 % (121 od 172) bolnikov, ki so jemali pantoprazol, in 59 % (102 od 172) tistih, ki so jemali ranitidin, po dveh tednih zdravljenja ni
Pantecta Control is used for the short-term treatment of the symptoms of acid reflux in adults. 
Zdravilo Pantecta Control se uporablja za kratkotrajno zdravljenje simptomov kislega refluksa pri odraslih.
The reference medicine, Pantecta, is only available with a prescription. 
Referenčno zdravilo Pantecta se izdaja le na recept.
What benefit has Pantecta Control shown during the studies? 
Kakšne koristi je zdravilo Pantecta Control izkazalo med študijami?
Pantecta Control is a medicine that contains the active substance pantoprazole. 
Zdravilo Pantecta Control je zdravilo, ki vsebuje zdravilno učinkovino pantoprazol.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pantecta Control. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Pantecta Control, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila
It must not be used with atazanavir (a medicine used to treat human immunodeficiency virus [HIV] infection). 
Zdravilo Pantecta Control se ne uporabljati z atazanavirjem (zdravilom za zdravljenje okužbe z virusom človeške imunske pomanjkljivosti [HIV]).
Other information about Pantecta Control 
Druge informacije o zdravilu Pantecta Control:
This prevents the active substance from being destroyed by the acid in the stomach. 
S tem se prepreči, da bi kislina v želodcu
The active substance in Pantecta Control, pantoprazole, is a proton pump inhibitor. 
Zdravilna učinkovina zdravila Pantecta Control, pantoprazol, je zaviralec protonske črpalke.
What is the risk associated with Pantecta Control? 
Kakšna tveganja so povezana z zdravilom Pantecta Control?
Why has Pantecta Control been approved? 
Zakaj je bilo zdravilo Pantecta Control odobreno?
It was also of the opinion that, based on the experience of the use of pantoprazole, the availability of 
Menil je tudi, da je glede na izkušnje z uporabo pantoprazola dostopnost zdravila Pantecta Control brez medicinskega nadzora ustrezna.
How has Pantecta Control been studied? 
Kako je bilo zdravilo Pantecta Control raziskano?
What is Pantecta Control used for? 
Za kaj se zdravilo Pantecta Control uporablja?
How is Pantecta Control used? 
Kako se zdravilo Pantecta Control uporablja?
How does Pantecta Control work? 
Kako zdravilo Pantecta Control deluje?
It is therefore difficult to recommend an optimal method. 
Zato je težko priporočiti optimalno metodo.
Equipment that you need 
Oprema, ki jo potrebujete
These can be taken from you or from a donor. 
Odvzeti jih je možno vam ali darovalcu.
Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful. 
Čeprav tega medsebojnega delovanja formalno niso raziskovali, pa ni nobenih dokazov za to, da je tako medsebojno delovanje škodljivo.
These symptoms generally develop in a rapid fashion. 
Ti simptomi se ponavadi razvijajo zelo hitro.
• think you may be pregnant, or 
• menite, da bi lahko bili noseči ali
From a microbiological point of view, the product should be used immediately. 
Z mikrobiološkega stališča je zdravilo treba uporabiti takoj.
Period of study 
Obdobje študije
International Retrospective Study (2006) 
Mednarodna retrospektivna študija (2006)
cells mean that direct comparison between different studies is difficult. 
pomeni, da je neposredna primerjava med različnimi študijami težavna.
Find a comfortable, well-lit, clean surface and put all the equipment you need within reach. 
Poiščite udobno, dobro osvetljeno, čisto površino in nanjo položite vso opremo, ki jo potrebujete, da je na dosegu roke.
Do not warm Grastofil in any other way (for example, do not warm it in a microwave or in hot water). 
Ne segrevajte zdravila Grastofil na noben drug način (na primer, ne segrevajte ga v mikrovalovni pečici ali v vroči vodi).
Some of the information you require is given at the end of this leaflet, but proper treatment of your disease requires close and constant co-operation with your doctor. 
Nekatere informacije, ki jih potrebujete, najdete na koncu tega navodila, vendar morate za pravilno zdravljenje vaše bolezni tesno in stalno sodelovati z zdravnikom.
As with all therapeutic proteins, there is a potential for immunogenicity. 
Kot pri vseh terapevtskih beljakovinah obstaja možnost nastanka imunogenosti.
Meta-Analysis a 
Meta-analiza a
Overall, reports were more common after intravenous administration. 
Na splošno so bila ta poročila pogostejša po intravenskem dajanju.
Your doctor or nurse will give you instructions on how to do this (see information below on instructions for injecting Grastofil). 
Vaš zdravnik ali medicinska sestra vam bo dala navodila, kako se to opravi (glejte spodnje podatke o navodilih za injiciranje zdravila Grastofil).
Put the needle fully into the skin as shown by your nurse or doctor. 
Iglo dajte popolnoma v kožo, kot vam je pokazala medicinska sestra ali zdravnik.
If you see blood in the syringe, pull the needle out and re-insert it in another place. 
Če vidite kri v brizgi, potegnite iglo ven in jo ponovno vstavite na drugem mestu.
Remove the syringe from the refrigerator. 
Odstranite brizgo iz hladilnika.
In some disease types, however, longer treatment lasting up to about one month may be required. 
Vendar pa je pri nekaterih vrstah obolenj potrebno tudi daljše zdravljenje, ki lahko traja do enega meseca.
The volume of distribution in blood is approximately 150 mL/kg. 
Volumen porazdelitve v krvi je približno 150 ml/kg.
Important: do not try to give yourself an injection unless you have received training from your doctor or nurse. 
Pomembno: ne poskušajte si dati injekcije, če prej niste bili deležni usposabljanja s strani vašega zdravnika ali medicinske sestre.
When the response has been obtained, the minimal effective dose to maintain this level should be established. 
Ko je ta odziv dosežen, je treba določiti najmanjši učinkoviti odmerek za vzdrževanje te ravni.
cell numbers vary depending on the precise methodology used and therefore, recommendations of numbers based on studies in other laboratories need to be interpreted with caution. 
s pretočno citometrijo se razlikujejo glede na dejansko uporabljeno metodologijo, zato je treba priporočila o številu, ki temeljijo na študijah v drugih laboratorijih, razlagati previdno.
It is advisable to wait and see how you feel after receiving Grastofil and before driving or operating machinery. 
Priporočljivo je počakati, da vidite, kako se boste po prejemu zdravila Grastofil počutili, preden začnete voziti ali upravljati stroje.
The timing of leukapheresis: one or two leukaphereses on days 5 and 6 which is often sufficient. 
Časovni razpored levkafereze: eno do dve levkaferezi 5. in 6. dan, kar pogosto zadošča.
Your treatment with Grastofil will usually last for about 14 days. 
Vaše zdravljenje z zdravilom Grastofil bo običajno trajalo približno 14 dni.
After one to two weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response. 
Po enem do dveh tednih zdravljenja je mogoče začetni odmerek podvojiti ali prepoloviti, odvisno od bolnikovega odziva.
Do not take a double dose to make up for a forgotten injection. 
Ne vzemite dvojnega odmerka, da bi nadomestili pozabljeno injiciranje.
Date of first authorisation: 18 October 2013 Date of latest renewal: 4 October 2018 
Datum zadnjega podaljšanja: 4. oktober 2018
If you are a stem cell donor, you must be aged between16 and 60 years. 
Če ste darovalec matičnih celic, morate biti stari med 16 in 60 leti.
Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine. 
Rastni faktorji so beljakovine, ki naravno nastajajo v telesu, mogoče pa jih je izdelati tudi s pomočjo biotehnologije in jih uporabiti kot zdravilo.
Before you inject Grastofil you must do the following: 
Preden boste injicirali zdravilo Grastofil morate narediti naslednje:
Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 10 
Z levkaferezo je treba začeti 5. dan in jo, če je potrebno, nadaljevati do 6. dne, da se zbere 4 x 10
Your healthcare professional should always record the exact medicine you are using. 
Vaš zdravstveni delavec mora vedno natančno zabeležiti, katero zdravilo uporabljate.
Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present. 
Vezavna protitelesa sicer nastajajo, kot je pričakovano pri vseh bioloških zdravilih, vendar jih do zdaj še niso povezali z nevtralizacijsko aktivnostjo.
Contact your doctor to discuss when you should inject the next dose. 
S svojim zdravnikom se posvetujte o tem, kdaj morate injicirati naslednji odmerek.
Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound). 
Zato je treba natančno spremljati velikost vranice (npr. s kliničnim pregledom, ultrazvokom).
This should be considered when interpreting boneimaging results. 
To je treba upoštevati pri razlagi rezultatov slikanja kosti.
Clinical studies with filgrastim have included a small number of elderly patients but special studies have not been performed in this group and therefore specific posology recommendations cannot be made. 
V klinične študije s filgrastimom je bilo vključeno majhno število starejših bolnikov, vendar posebne študije v tej skupini niso bile izvedene in zato ni na voljo posebnih priporočil za odmerjanje.
Once the number of white cells in your blood has returned to normal it may be possible to reduce the dose frequency to less than once per day. 
Ko se število belih krvničk v vaši krvi vrne na običajno, je možno pogostnost uporabe zdravila zmanjšati na manj kot enkrat dnevno.
The choice of route should depend on the individual clinical circumstance. 
Izbira načina dajanja zdravila bi morala biti odvisna od posameznih kliničnih okoliščin.
Thereafter, it is recommended that the ANC is measured at least twice weekly for the first two weeks and subsequently once per week or once every other week during maintenance therapy. 
Pozneje pa je priporočljivo ANC določati vsaj dvakrat na teden prva dva tedna, nato pa enkrat na teden ali enkrat na dva tedna med vzdrževalnim zdravljenjem.