natgillin/translations-raw huggingface dataset:
Halagon EMA/664633/2016 
EMA/848943/2016 Halagon stran 2/2
The medicine contains the active substance halofuginone. 
Zdravilo vsebuje zdravilno učinkovino halofuginon.
Why is Halagon approved? 
Zakaj je bilo zdravilo Halagon odobreno?
Because Halagon is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Halagon generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
This is a parasite belonging to the ‘protozoa' family that invades the digestive system, causing diarrhoea. 
To je parazit, ki spada v družino protozojev in vdre v prebavni sistem ter povzroča drisko.
Other information about Halagon? 
Druge informacije o zdravilu Halagon
It also limits the spread of the disease by preventing the formation of oocysts, which are a stage in the lifecycle of the parasite that are passed in the faeces. 
Prav tako omejuje širjenje bolezni, tako da preprečuje nastajanje oocist, tj. stopnje v življenjskem ciklu
For more information about treatment with Halagon, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za več informacij o zdravljenju z zdravilom Halagon naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Safety information has been included in the summary of product characteristics and the package leaflet for Halagon, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers when using Halagon. 
V povzetek glavnih značilnosti zdravila in navodilo za uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
Because Halagon is a generic medicine and is bioequivalent to the reference medicine the precautions are the same as for the reference medicine. 
Ker je zdravilo Halagon generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
For practical information about using Halagon, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za praktične informacije o uporabi zdravila Halagon naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Therefore, the CVMP's view was that, as for Halocur, the benefits outweigh the identified risks. 
Zato je menil, da njegove koristi enako kot pri zdravilu Halocur odtehtajo znana tveganja.
How does Halagon work? 
Kako zdravilo Halagon deluje?
No additional studies were needed as Halagon is a water based oral solution containing the same active substance and other ingredients as the reference medicine, in the same concentrations. 
Ker je zdravilo Halagon peroralna raztopina na osnovi vode, ki vsebuje enako zdravilno učinkovino in sestavine v enakih koncentracijah kot referenčno zdravilo, niso bile potrebne nobene dodatne študije.
How is Halagon used? 
Kako se zdravilo Halagon uporablja?
The European Commission granted a marketing authorisation valid throughout the EU for Halagon on 13 December 2016. 
Evropska komisija je dovoljenje za promet z zdravilom Halagon, veljavno po vsej Evropski uniji, izdala
How has Halagon been studied? 
Kako je bilo zdravilo Halagon raziskano?
Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the member states 
Pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila, ki jih izvajajo države članice
The Healthcare Professional Guide should contain the following key messages: 
Priročnik za zdravstveno osebje mora vsebovati naslednja ključna sporočila:
The Member States shall agree the final educational material with the Marketing Authorization Holder (MAH) prior to launch of the product in their territory. 
Države članice se dogovorijo o končnem izobraževalnem gradivu z imetnikom dovoljenja za promet pred začetkom trženja zdravila na njihovem območju.
• That Vibativ has a risk of nephrotoxicity including increased risk of mortality in patients with pre existing acute renal failure and is therefore contraindicated in patients with pre-existing acute renal failure and in patients with creatinine clearance < 30ml/min, including patients undergoing haemodialysis. 
• Da se pri zdravilu Vibativ pojavlja tveganje za nefrotoksičnost, vključno s povečanim tveganjem smrtnosti pri bolnikih s predhodno akutno ledvično odpovedjo in je zato kontraindicirano pri bolnikih s predhodno akutno ledvično odpovedjo ter pri bolnikih z očistkom kreatinina < 30ml/min, vključno z bolniki na hemodializi.
• Healthcare professionals should be aware that the administration of Vibativ may interfere with some coagulation laboratory tests and qualitative and quantitative urine protein tests. 
• Zdravstveno osebje se mora zavedati, da lahko uporaba zdravila Vibativ ovira nekatere teste koagulacije in kakovostne in količinske analize beljakovin v urinu.
• The need to counsel patients on important risks associated with Vibativ therapy and appropriate precautions when using the medicine. 
• Potreba po svetovanju bolnikom o pomembnih tveganjih, ki so povezana z zdravljenjem z zdravilom Vibativ ter ustrezni varnostni ukrepi ob uporabi zdravila.
• That there is a potential risk of teratogenicity and Vibativ is contraindicated during pregnancy. 
• Da obstaja potencialno tveganje za teratogenost in da je zdravilo Vibativ v času nosečnosti kontraindicirano.
• That there is an identified risk of ototoxicity and patients developing ototoxicity signs or symptoms or patients receiving other drugs with ototoxic potential should be carefully evaluated and monitored. 
• Da obstaja ugotovljeno tveganje za ototoksičnost ter da je potrebno bolnike, pri katerih se razvijejo znaki ali simptomi ototoksičnosti oz. bolnike, ki prejemajo druga zdravila z ototoksičnim potencialom, pozorno oceniti in nadzorovati.
• That patients' renal function should be assessed and monitored and initial dose and dosage adjustments should be calculated based on the creatinine 
• Da je potrebno oceniti in spremljati delovanje ledvic, začetni odmerek in prilagoditve odmerka pa je potrebno izračunati na podlagi očistka kreatinina.
• There is a risk of QTc prolongation and Vibativ should be used with caution in patients taking drugs known to prolong the QT interval. 
• Obstaja tveganje za podaljšanje QTc, zato je potrebno zdravilo Vibativ uporabljati previdno pri bolnikih, ki jemljejo zdravila, za katera je znano, da podaljšujejo interval QTc.
• That the benefit risk balance for the Complicated Skin and Soft Tissue Infections indication was assessed as negative by the Committee for Medicinal Products for Human Use (CHMP), therefore Vibativ should not be used in this or other indications not approved. 
• Da je Odbor za zdravila za humano uporabo (CHMP) ocenil kot negativno razmerje med koristmi in tveganji za indikacijo zapletenih okužb kože in mehkega tkiva, zato zdravila Vibativ ne smete uporabljati za to in za druge neodobrene indikacije,.
• The role and use of the Prescriber Checklist sticker included in the product package to document the established pregnancy status prior to dosing. 
• Vloga in uporaba kontrolnega seznama za zdravnika, ki predpiše zdravilo je vključena v pakiranje za evidentiranje ugotavljene nosečnosti pred dajanjem zdravila.
• The existence and scope of the pregnancy register and details of how to 
• Obstoj in obseg registra nosečnosti ter podatki za vnos bolnic vanj.
The Member States shall ensure that the MAH provides all physicians who are expected to prescribe or use Vibativ a Direct Healthcare Professional Communication letter, the text of which is appended to the CHMP assessment report. 
Imetnik dovoljenja za promet zagotovi, da bo ob začetku trženja zdravila Vibativ priskrbel vsem zdravnikom, za katere se pričakuje, da bodo predpisovali ali uporabljali zdravilo Vibativ, informacije (Direct Healthcare Professional Communication letter DHPC), ki so vključene kot dodatek k poročilu Odbora za zdravila za humano uporabo (CHMP) o oceni zdravila.
• That there is a risk of infusion related reactions including red man syndrome-like reactions. 
• Da obstaja tveganje za reakcije, povezane z infundiranjem, vključno z reakcijami, ki so
The Member States shall ensure that the MAH provides all physicians who are expected to prescribe or use Vibativ a health care professional educational pack 
Imetnik dovoljenja za promet zagotovi vsem zdravnikom, za katere se lahko pričakuje, da bodo predpisovali zdravilo Vibativ, izobraževalni paket za zdravstveno osebje, ki vsebuje naslednje:
The pregnancy status of women of childbearing potential must be established prior to dosing with telavancin and women of childbearing potential must use effective contraception 
Pred uvajanjem terapije s telavancinom je potrebno preveriti, ali je bolnica v rodni dobi noseča; bolnice v rodni dobi pa morajo v času zdravljenja uporabljati
Vibativ should be used with caution with other 
Zdravilo Vibativ je potrebno uporabljati previdno, če uporabljate druga nefrotoksična zdravila.
Then continue your treatment as before. 
Nato nadaljujte z vašim zdravljenjem kot prej.
No fatalities occurred, and all patients recovered. 
Smrtnih primerov ni bilo in vsi bolniki so okrevali.
• if you are seriously overweight (especially if you're a woman). 
• če imate prekomerno telesno težo (še posebej, če ste ženska).
Patients at increased risk should be followed closely. 
Bolnike s povečanim tveganjem je treba pozorno spremljati.
You need to keep taking it every day to stop your illness getting worse. 
Morate ga jemati redno in vsak dan, da se vaša bolezen ne bo slabšala.
If you notice any of these symptoms: 
Če opazite katerega od teh simptomov:
It is rare; if it happens, it usually develops after a few months of treatment. 
Je zelo redka; če se pojavi, se ponavadi razvije po nekaj mesecih zdravljenja.
Do not drive or operate machines unless you are feeling well. 
Ne upravljajte vozil in strojev, če se ne počutite dobro.
The tablet can be divided into equal halves. 
Tableto je mogoče razdeliti na enaki polovici.
• deep, rapid, difficult breathing 
• globoko, hitro, oteženo dihanje,
It also increases the CD4 cell count in your blood. 
Poleg tega tudi poveča število celic CD4 v vaši krvi.
See Section 4 for more information. 
Za več informacij glejte poglavje 4.
So it is very important to talk to your doctor about any changes in your health. 
Zato je zelo pomembno, da se s svojim zdravnikom pogovorite o vseh spremembah, ki jih opazite glede vašega zdravja.
The list below should not be considered exhaustive but is representative of the classes studied. 
Spodnji seznam ni izčrpen, temveč reprezentativen za raziskovane skupine.
Stay in regular contact with your doctor 
Bodite v rednem stiku z vašim zdravnikom
ANTIHISTAMINES (HISTAMINE H1 RECEPTOR ANTAGONISTS) 
ANTIHISTAMINIKI (ANTAGONISTI HISTAMINSKIH RECEPTORJEV H1)
The effect of food on the rate and extent of absorption was also studied. 
Prav tako so proučevali učinek hrane na hitrost in obseg absorpcije.
Combination not recommended. 
Kombinacija ni priporočljiva.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
• if they drink alcohol 
• ki uživajo alkohol;
Your doctor will monitor the effectiveness of your treatment. 
Vaš zdravnik bo kontroliral učinovitost vašega zdravljenja.
The observed lamivudine half-life of elimination is 5 to 7 hours. 
Opazovan eliminacijski razpolovni čas lamivudina znaša 5 do 7 ur.
• methadone, used as a heroin substitute 
• metadon, ki se uporablja kot nadomestek heroina;
There are no data on their affect on human female fertility. 
Podatkov o njunem vplivu na plodnost žensk ni.
Do not take other medicines for the infection without your doctor's advice. 
Ne jemljite drugih zdravil za zdravljenje okužbe, brez nasveta vašega zdravnika.
The adverse reactions profile appears similar for adults and adolescents. 
Profil neželenih učinkov je bil podoben pri odraslih in mladostnikih.
Autoimmune disorders may occur many months after the start of treatment. 
Avtoimunske bolezni se lahko pojavijo veliko mesecev po začetku zdravljenja.
Clinically significant interaction unlikely. 
Klinično pomembno medsebojno delovanje ni verjetno.
You may have problems with your bones 
Pojavijo se lahko težave s kostmi
If you have any of the symptoms listed above, or any other symptoms that worry you: 
Če imate katerikoli simptom, ki je naveden zgoraj, ali katerikoli drug simptom, ki vas skrbi:
Indeed, the available clinical data are very limited and preclude any reliable conclusion in the field. 
Razpoložljivi klinični podatki so zelo omejeni in ne omogočajo zanesljivih zaključkov na tem področju.
If you're breast-feeding, or thinking about breast-feeding: 
Če dojite ali razmišljate o dojenju:
Recent findings indicate that exposure in children <6 years of age may be reduced by about 30 % compared with other age groups. 
Najnovejše ugotovitve kažejo, da je izpostavljenost pri otrocih, mlajših od 6 let, lahko za približno 30 % manjša od izpostavljenosti pri drugih starostnih skupinah.
These haematological effects are not usually observed before four to six weeks therapy. 
Ti hematološki učinki se navadno ne pojavijo prej kot po štirih do šestih tednih zdravljenja.
However it is not clear whether these cases were due to the antiretroviral treatment or to the underlying HIV disease. 
Vendar ni pojasnjeno, če so bili ti primeri posledica protiretrovirusnega zdravljenja ali posledica osnovne HIV bolezni.
Tell your doctor if you notice any loss of fat from your legs, arms, and face. 
Povejte svojemu zdravniku, če opazite kakršno koli izgubo maščevja na nogah, rokah in obrazu.
You may still develop other infections and illnesses linked to HIV infection. 
Lahko pa, da se bodo razvile druge okužbe ali bolezni povezane z okužbo s HIV.
In vitro susceptibility testing has not been standardised and results may vary according to methodological factors. 
Testiranje občutljivosti in vitro ni standardizirano in rezultati se glede na metodološke dejavnike lahko spreminjajo.
Depending on the overall condition of the patient, blood tests may be performed less often, for example every one to three months. 
Odvisno od splošnega stanja bolnika se lahko krvne preiskave opravljajo tudi redkeje, na primer od enkrat mesečno do enkrat na tri mesece.
Drugs by Therapeutic Area Interaction Geometric mean change (%) (Possible mechanism) 
Medsebojno delovanje geometrijska sredina spremembe (%) (možni mehanizem)
• probenecid, to treat gout and similar conditions, and given with some antibiotics to make them more effective 
• probenecid, za zdravljenje putike in podobnih stanj in se ga da skupaj z nekaterimi antibiotiki, da se doseže boljšo učinkovitost;
• difficulty in sleeping (insomnia) 
• težave s spanjem (insomnija),
Consideration should be given to replacing zidovudine in a combination ART regimen if this is already established. 
Razmisliti je treba o zamenjavi zidovudina v shemi ART, če je ta že vpeljana.
It can be life-threatening, causing failure of internal organs. 
Lahko je smrtno nevarna, ker lahko povzroči odpoved notranjih organov.
• tiredness, lack of energy 
• utrujenost, pomanjkanje energije,
Clinical Experience 
Klinične izkušnje
While the clinical relevance of these findings is unknown, these data suggest that a carcinogenic risk to humans is outweighed by the potential clinical benefit. 
Ker klinična pomembnost teh ugotovitev ni znana, ti podatki kažejo na to, da pri človeku potencialna klinična korist prevlada nad tveganjem zaradi karcinogenosti.
Zidovudine had a similar effect in both species, but only at very high systemic exposures. 
Zidovudin je imel na obe vrsti živali podoben učinek, vendar le pri izredno visoki sistemski izpostavljenosti učinkovini.
No special requirements for disposal. 
Ni posebnih navodil za odstranjevanje.
Take the tablets at regular times, leaving approximately 12 hours between each tablet. 
Tablete vzemite ob običajnem času, približno na 12 ur.
• if they are also taking anti-inflammatory medicines called corticosteroids 
• ki jemljejo tudi protivnetna zdravila imenovana kortikosteroidi;
• serious allergic reaction causing swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing 
• resna alergijska reakcija, ki se kaže kot oteklina obraza, jezika ali grla, kar lahko povzroči težave pri požiranju in dihanju,
• enlarged breasts in men. 
• povečanje prsi pri moških.
HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). 
Okužba s HIV se širi s spolnim stikom z okuženo osebo ali s prenosom okužene krvi (npr. s skupno uporabo injekcijskih igel).
Additionally, lamivudine has activity against hepatitis B virus (HBV). 
Poleg tega lamivudin učinkuje tudi proti virusu hepatitisa B (HBV).
Sorbitol solution (3.2g , 10.2 g, 13.4 g)/ Lamivudine 
Raztopina sorbitola (3,2g , 10,2 g, 13,4 g)/lamivudin
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV. 
Te ugotovitve ne vplivajo na trenutna nacionalna priporočila o uporabi protiretrovirusnega zdravljenja pri nosečnicah za preprečitev vertikalnega prenosa okužbe z virusom
Pharmacotherapeutic group: Antivirals for treatment of HIV infections, combinations, ATC Code: J05AR01 
Farmakoterapevtska skupina: Antivirusna zdravila za zdravljenje HIV, kombinacije; Oznaka ATC: J05AR01
• difficulty moving. 
• oteženo gibanje.
• if you have kidney disease 
• če imate bolezen ledvic;
In vitro antagonism of anti-HIV activity between stavudine and zidovudine could result in decreased efficacy of both drugs. 
In vitro antagonizem anti-HIV aktivnosti med stavudinom in zidovudinom bi lahko povzročil zmanjšano učinkovitost obeh zdravil.
Lactic acidosis is a rare but serious side effect 
Laktacidoza je redek, vendar resen neželeni učinek
Like all medicines, this medicine can cause side effects, but not everybody gets them. 
Kot vsa zdravila, ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Signs of lactic acidosis include: 
Znaki laktacidoze vključujejo:
These symptoms are probably caused by the body's immune system becoming stronger, so that the body starts to fight these infections. 
Ti simptomi so verjetno posledica okrepitve imunskega sistema in se organizem zopet prične boriti proti tem okužbam.
Abbreviations: ↑ = Increase; ↓=decrease; ↔= no significant change; AUC=area under the concentration versus time curve; Cmax=maximum observed concentration; CL/F=apparent oral clearance 
Okrajšave: ↑ = povečanje, ↓= zmanjšanje, ↔= ni pomembne spremembe, AUC = površina pod krivuljo koncentracije po času, Cmax = največja opažena koncentracija, CL/F = navidezni peroralni očistek
Children who weigh between 14 and 21 kg 
Otroci, ki so težki od 14 - 21 kg
If you are pregnant, if you become pregnant or if you are planning to become pregnant talk to your doctor about the risks and benefits to you and your baby of taking Lamivudine/Zidovudine Teva. 
Če ste noseči, zanosite ali če načrtujete nosečnost, se posvetujte s svojim zdravnikom o tveganjih in koristih jemanja zdravila Lamivudin/zidovudin Teva za vas in vašega otroka.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products. 
V primeru sočasnega protivirusnega zdravljenja hepatitisa B ali C upoštevajte tudi relevantne podatke o teh zdravilih.
• vincristine, vinblastine or doxorubicin, to treat cancer. 
• vinkristin, vinblastin ali doksorubicin, za zdravljenje raka.
In addition, two transplacental carcinogenicity studies have been conducted in mice. 
Razen tega so na miših izvedli še dve raziskavi transplacentalne karcinogenosti.
- if you are allergic to lamivudine or zidovudine or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na lamivudin ali zidovudin ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
Tell your doctor if you are taking phenytoin. 
Zdravniku morate povedati, če jemljete fenitoin.
Your doctor will decide if the active substances are suitable for you. 
Vaš zdravnik se bo odločil, ali so učinkovine primerne za vas.
Date of first authorisation: 02 March 2011 Date of latest renewal: 19 November 2015 
Datum zadnjega podaljšanja: 19.11.2015
When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. 
Ko ti bolniki začnejo zdravljenje, se jim lahko razplamtijo stare, prikrite okužbe in povzročijo znake ali simptome vnetja.
• if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop Lamivudine/Zidovudine Teva without your doctor's advice, as your hepatitis may come back) 
• če ste kdaj imeli bolezen jeter, vključno s hepatitisom B ali C (če ste okuženi z virusom hepatitisa B, ne prenehajte z jemanjem zdravila Lamivudin/zidovudin Teva brez zdravnikovega navodila, kajti vaš hepatitis se lahko ponovi);
Therefore, there is little potential for interactions with antiretroviral protease inhibitors, non-nucleosides and other medicinal products metabolised by major P450 enzymes. 
Torej obstaja le majhna možnost za interakcije s protiretrovirusnimi zaviralci proteaz, z nenukleozidi in drugimi zdravili, ki se presnavljajo z glavnimi encimi iz skupine P450.
Some medicines can make it more likely that you'll have side effects, or make side effects worse. 
Nekatera zdravila lahko povečajo verjetnost, da boste imeli neželene učinke, ali pa da bodo neželeni učinki hujši.
The M184V RT mutant shows a <4-fold decrease in susceptibility to didanosine; the clinical significance of these findings is unknown. 
Mutant M184V RT kaže < 4-kratno zmanjšanje občutljivosti za didanozin; klinični pomen teh ugotovitev ni znan.
Pharmacokinetics in children: In children over the age of 5-6 months, the pharmacokinetic profile of zidovudine is similar to that in adults. 
Farmakokinetika pri otrocih: Pri otrocih, starejših od 5-6 mesecev, je farmakokinetični profil zidovudina podoben farmakokinetičnemu profilu pri odraslih.
Insufficient data to recommend dosage adjustment. 
Za priporočilo o prilagoditvi odmerjanja ni dovolj podatkov.
During your treatment, your doctor will monitor you for signs of lactic acidosis. 
Med zdravljenjem vas bo vaš zdravnik opazoval glede znakov laktacidoze.
Lactic acidosis generally occurred after a few or several months of treatment. 
Na splošno se je laktacidoza pojavila že po nekaj ali pa šele po večih mesecih zdravljenja.
Lamivudine and zidovudine are well absorbed from the gastrointestinal tract. 
Lamivudin in zidovudin se dobro absorbirata iz gastrointestinalnega trakta.
You may need extra check-ups, including blood tests, while you are taking your medicine. 
Morda boste med jemanjem tega zdravila potrebovali dodatne preglede, vključno s preiskavami krvi.
CD4 cells are a type of white blood cells that are important in helping your body to fight infection. 
celice so vrsta belih krvnih celic, ki so pomembne za premagovanje okužb.
Children who weigh between 21 and 30 kg 
Otroci, ki so težki od 21 - 30 kg
The second study thus provided no evidence that zidovudine acts as a transplacental carcinogen. 
Tako druga raziskava ni pokazala, da bi zidovudin deloval kot transplacentalni karcinogen.