natgillin/translations-raw huggingface dataset:
There were other side effects that are seen commonly (more than 1 but less than 10 animals in 100 animals treated) which have severe effects, these are vomiting, diarrhoea, anorexia, lethargy, dehydration, skin necrosis, fever, blood in faeces/haemorrhagic diarrhoea/gastrointestinal bleeding and ulcers, nausea, septicaemia, weight loss, increased alanine aminotransferase and decreased haematocrit. 
Pogosto opazni neželeni učinki (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali),ki so imeli resne učinke so bruhanje, diareja, anoreksija, letargičnost, dehidracija, nekroza kože, vročina, kri v iztrebkih/hemoragična diareja, gastrointestinalne krvavitve in ulkusi, slabost, septikemija, izguba teže povišana alanin aminotransferaza, znižan hematokrit
Discontinue treatment until >1.5 g/dl and clinical signs normal, then decrease dose by 0.5 mg/kg 
Prekiniti zdravljenje dokler >1.5 g/dl in normalni klinični znaki, nato znižati odmerek za 0.5 mg/kg
Avoid skin contact with the tablets, faeces, urine, and vomit of treated dogs. 
Izogibajte se stiku kože s tabletami, iztrebki, urinom in izbruhano vsebino pri zdravljnih psih.
• There were two further deaths; however, relation to treatment could not be established. 
• Pri dveh sledečih poginih povezave z zdravljenjem ni bilo mogoče dokazati.
• Vomiting, diarrhoea, anorexia, lethargy, dehydration, pyrexia, blood in faeces/haemorrhagic diarrhoea/gastrointestinal bleeding, duodenal ulceration, nausea, septicaemia, skin necrosis, weight loss; increased alanine aminotransferase, decreased haematocrit. 
• bruhanje, diareja, anoreksija, letargičnost, dehidracija, pireksija, kri v iztrebkih/hemoragična diareja/gastrointestinalne krvavitve, ulkus duodenuma, slabost, septikemija, nekroza kože, izguba teže, povišana alanin aminotransferaza, znižan hematokrit
Discontinue treatment until >1000/µl and clinical signs normal, then decrease dose by 0.5 mg/kg 
Prekiniti zdravljenje dokler >1000/µl in normalni klinični znaki, nato znižati odmerek za 0.5 mg/kg
Pharmacotherapeutic group: Antineoplastic Agents - Protein-kinase inhibitors ATC vet code: QL01XE91 
Farmakoterapevtska skupina proti neoplastični agensi - inhibitorji protein-kinaze.
• Diarrhoea, neutropenia, weight loss, blood in faeces/hemorrhagic diarrhoea/gastrointestinal bleeding, anorexia, lethargy, vomiting; lameness / musculoskeletal disorder, dehydration, dermatitis, pruritus; increased alanine aminotransferase, thrombocytopenia, decreased albumin, decreased haematocrit. 
• diareja, neutropenija, izguba teže, kri v iztrebkih/hemoragična diareja/gastrointestinalne krvavitve, anoreksija, letargičnost, bruhanje; šepanje / mišično skeletne motnje, dehidracija, dermatitis, srbenje; povečana alanin aminotransferaza, trombocitopenija, znižan albumin, znižan hematokrit
Mild to moderate: 
Blagi do srednji:
Discontinue treatment and institute supportive care until resolution of all clinical signs of blood in stool, then decrease dose by 0.5 mg/kg 
Prekiniti zdravljenje in začeti s podpornim zdravljenjem, dokler vsi klinični znaki krvi v iztrebku ne izginejo, nato znižati odmerek za 0.5 mg/kg
Some very common (more than 1 in 10 animals treated displaying adverse reaction(s)) adverse reactions associated with Palladia tablets are weight loss, diarrhoea, neutropenia (low number of white blood cells), blood in faeces/ haemorrhagic diarrhoea/gastrointestinal bleeding, anorexia, lethargy, vomiting, lameness/ musculoskeletal disorder, dehydration, dermatitis, pruritus (skin irritation/scratching), increased alanine aminotransferase, thrombocytopenia, decreased albumin, decreased haematocrit. 
Nekateri zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali), povezani s Palladia tabletami so izguba teže, diareja, neutropenija (nizko število belih krvnih celic), kri v iztrebkih, hemoragična diareja/gastrointestinalne krvavitve, anoreksija, letargičnost, bruhanje, šepanje/mišično skeletne motnje, dehidracija, dermatitis, srbenje (vnetje kože, praskanje); povečana alanin aminotransferaza, trombocitopenija, znižan albumin in znižan hematokrit.
Common (more than 1 but less than 10 animals in 100 animals treated) 
Pogosti (pojavijo se pri 1 od 10 živali od 100 zdravljenih živali)
Discontinue treatment and institute dietary modification ± supportive care until food intake improves, then decrease dose by 0.5 mg/kg 
Prekiniti zdravljenje in spremeniti prehrano ± podporna terapija, dokler se ješčnost ne popravi, nato znižanje odmerka za 0.5 mg/kg
The blister should always be returned to the cardboard carton once a tablet or tablets have been removed. 
o Ko odstanite tableto, pretisni omot vsakokrat vrnite v kartonasto škatlo.
Each tablet contains 10 mg toceranib (as toceranib phosphate). 
Vsaka tableta vsebuje 10 mg toceraniba (kot toceranibov fosfat) Vsaka tableta vsebuje 15 mg toceraniba (kot toceranibov fosfat) Vsaka tableta vsebuje 50 mg toceraniba (kot toceranibov fosfat)
Hepatic Toxicity (ALT, AST) >1X - 3X upper normal limit 
Jetrna toksičnost (ALT, AST) >1X - 3X nad zgornjo referenčno mejo Ohraniti enak odmerek; prekiniti uporabo hepatotoksičnih zdravil, če se uporabljajo
Discontinue treatment until formed stools and institute supportive care, then decrease dose by 0.5 mg/kg 
Prekiniti zdravljenje dokler se iztrebki ne oblikujejo in začeti s podpornim zdravljenjem, nato znižati odmerek za 0.5 mg/kg
Palladia 10 mg tablets for dogs. 
Palladia 10 mg tablete za pse.
• Blood urea nitrogen <1.5 X upper normal limit 
• Sečnina v serumu < 1.5 X nad zgornjo mejo BUN
Palladia 15 mg tablets for dogs. 
Palladia 15 mg tablete za pse.
Palladia 50 mg tablets for dogs. 
Palladia 50 mg tablete za pse.
Gastrointestinal discomfort such as vomiting or diarrhoea may occur if this drug is accidentally ingested. 
V primeru nenamernega zaužitja zdravila za uporabo v veterinarski medicini se lahko pojavijo gastrointestinalne motnje kot sta bruhanje ali diareja.
Very common (more than 1 in 10 animals treated displaying adverse reaction(s)) 
Zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali)
Keep children away from faeces, urine or vomit of treated dogs. 
Otroci ne smejo priti v stik z iztrebki, urinom ali izbruhano vsebino zdravljenih psov.
Palladia 10 mg film-coated tablets for dogs. 
Palladia 10 mg filmsko obložene tablete za pse.
Uncommon (more than 1 but less than 10 animals in 1,000 animals treated) 
Občasni (pojavijo se pri 1 od 10 živali od 1.000 zdravljenih živali)
Palladia 15 mg film-coated tablets for Dogs 
Palladia 15 mg filmsko obložene tablete za pse
Palladia 50 mg film-coated tablets for Dogs 
Palladia 50 mg filmsko obložene tablete za pse
Palladia 50 mg film-coated tablets for dogs. 
Palladia 50 mg filmsko obložene tablete za pse.
Palladia 15 mg film-coated tablets for dogs. 
Palladia 15 mg filmsko obložene tablete za pse.
Discontinue treatment until <1.25 X upper normal limit, then decrease dose by 0.5 mg/kg 
Ledvična toksičnost (kreatinin) <1.25 X nad zgornjo referenčno mejo Ohraniti enak odmerek ≥1.25 X nad zgornjo referenčno mejo Prekiniti zdravljenje dokler <1.25 X nad normalno mejo, nato znižati odmerek za 0.5 mg/kg
Black tarry stools 
PODATKI NA ZUNANJI OVOJNINI
Docetaxel Teva Pharma is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3). 
Zdravilo Docetaxel Teva Pharma se uporablja le, kadar je število nevtrofilcev (raven vrste belih krvnih celic v krvi) običajno (vsaj 1 500 celic/mm
It can also be used with cisplatin (another anticancer medicine) in patients who have not yet received any treatment for their cancer; 
Uporablja se lahko tudi s cisplatinom (drugim zdravilom proti raku) pri bolnikih, ki se zaradi raka še niso zdravili;
The full EPAR for Docetaxel Teva Pharma 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 Docetaxel Teva Pharma je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Docetaxel blocks the ability of cells to destroy the internal ‘skeleton' that allows them to divide and multiply. 
Docetaksel zavira sposobnost celic, da uničijo notranji „skelet“, s čimer se celicam omogoči deljenje in razmnoževanje.
The company has provided data from the published literature on docetaxel. 
Družba je predstavila podatke o docetakselu iz objavljene literature.
For more information about treatment with Docetaxel Teva Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Docetaxel Teva Pharma preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
It is available as a concentrate and a solvent that are made up into a solution for infusion (drip into a vein). 
Na voljo je v obliki koncentrata in vehikla za pripravo raztopine za infundiranje (kapalne infuzije v veno).
This is a summary of the European public assessment report (EPAR) for Docetaxel Teva Pharma. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Docetaxel Teva Pharma.
Because Docetaxel Teva Pharma is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Docetaxel Teva Pharma generično zdravilo, se šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
This means that Docetaxel Teva Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Taxotere.
Docetaxel Teva Pharma is given as a one-hour infusion every three weeks. 
Zdravilo Docetaxel Teva Pharma se daje v obliki enourne infuzije vsake tri tedne.
Docetaxel Teva Pharma docetaxel 
Docetaxel Teva Pharma docetaksel
Dexamethasone (an anti-inflammatory medicine) should also be given to the patient, starting on the day before the Docetaxel Teva Pharma infusion. 
Bolniku je treba dati tudi deksametazon (protivnetno zdravilo), in sicer dan pred infuzijo zdravila Docetaxel Teva Pharma.
Docetaxel Teva Pharma should be used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy. 
Zdravilo Docetaxel Teva Pharma je treba uporabljati na specializiranih oddelkih za kemoterapijo (na katerih uporabljajo zdravila proti raku) in se sme dajati le pod nadzorom zdravnika, usposobljenega za uporabo kemoterapije.
Docetaxel Teva Pharma is used to treat the following types of cancer: 
Zdravilo Docetaxel Teva Pharma se uporablja za zdravljenje naslednjih vrst raka:
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 Docetaxel Teva Pharma. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Docetaxel Teva Pharma, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What are the benefits and risks of Docetaxel Teva Pharma? 
Kakšne so koristi in tveganja, povezani z zdravilom Docetaxel Teva Pharma?
The CHMP concluded that, in accordance with EU requirements, Docetaxel Teva Pharma has been shown to be comparable to Taxotere. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Docetaxel Teva Pharma primerljivo z zdravilom Taxotere.
The company also showed that the Docetaxel Teva Pharma solution for infusion has comparable quality to that of Taxotere. 
Poleg tega je predstavila študije, s katerimi je dokazala, da ima raztopina za infundiranje zdravila Docetaxel Teva Pharma primerljivo kakovost kot zdravilo Taxotere.
The active substance in Docetaxel Teva Pharma, docetaxel, belongs to the group of anticancer medicines known as the taxanes. 
Zdravilna učinkovina zdravila Docetaxel Teva Pharma, docetaksel, spada v skupino zdravil proti raku, imenovanih taksani.
The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Teva Pharma to Teva Pharma B.V. on 21 January 2011. 
Evropska komisija je dovoljenje za promet z zdravilom Docetaxel Teva Pharma, veljavno po vsej Evropski uniji, odobrila družbi Teva Pharma B.V.
Other information about Docetaxel Teva Pharma 
Druge informacije o zdravilu Docetaxel Teva Pharma:
The Committee recommended that Docetaxel Teva Pharma be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Docetaxel Teva Pharma odobri dovoljenje za promet.
Docetaxel Teva Pharma is a medicine that contains the active substance docetaxel. 
Docetaxel Teva Pharma je zdravilo, ki vsebuje zdravilno učinkovino docetaksel.
Docetaxel Teva Pharma is used with prednisone or prednisolone (anti-inflammatory medicines); 
Zdravilo Docetaxel Teva Pharma se uporablja s prednizonom ali prednizolonom (protivnetnima zdraviloma).
Docetaxel Teva Pharma is a ‘generic medicine'. 
Zdravilo Docetaxel Teva Pharma je „generično zdravilo“.
Why has Docetaxel Teva Pharma been approved? 
Zakaj je bilo zdravilo Docetaxel Teva Pharma odobreno?
Docetaxel Teva Pharma can be used on its own after other treatments have failed. 
Zdravilo Docetaxel Teva Pharma se lahko uporablja kot monoterapija po neuspešnih drugih oblikah zdravljenja.
Docetaxel Teva Pharma is used on its own after other treatments have failed; 
Zdravilo Docetaxel Teva Pharma se lahko uporablja kot monoterapija po neuspešnih drugih oblikah zdravljenja;
No additional studies were needed as Docetaxel Teva Pharma is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Taxotere. 
Ker je zdravilo Docetaxel Teva Pharma generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Taxotere, niso bile potrebne nobene dodatne študije.
How has Docetaxel Teva Pharma been studied? 
Kako je bilo zdravilo Docetaxel Teva Pharma raziskano?
How does Docetaxel Teva Pharma work? 
Kako zdravilo Docetaxel Teva Pharma deluje?
What is Docetaxel Teva Pharma? 
Kaj je zdravilo Docetaxel Teva Pharma?
What is Docetaxel Teva Pharma used for? 
Za kaj se zdravilo Docetaxel Teva Pharma uporablja?
How is Docetaxel Teva Pharma used? 
Kako se zdravilo Docetaxel Teva Pharma uporablja?
days or longer if clinically needed. 
10 dni, ali tudi dlje, če je to klinično potrebno.
No interaction studies have been performed. 
Raziskave interakcij niso bile izvedene.
Standard recommendations 
Standardna priporočila
- Patients should be informed that they have received Refludan. 
- Bolniki morajo biti obveščeni, da so dobili Refludan.
- The aPTT should be monitored at least once daily. 
- aPTT je potrebno preverjati vsaj enkrat dnevno.
The optimal dose regimen of Refludan in these circumstances is not known. 
Optimalen način odmerjanja Refludana v teh okoliščinah ni znan.
The aPTT should be determined again 4 hours later. 
Vrednost aPTT se ponovno določa 4 ure kasneje.
Very common (>1/10); Common (>1/100, <1/10); Uncommon (>1/1,000 <1/100); Rare (>1/10,000 <1/1,000); Very Rare (<1/10,000) 
Zelo pogosti (>1/10); Pogosti (>1/100, <1/10); Občasni (>1/1.000 <1/100); Redki (>1/10.000 <1/1.000); Zelo redki (<1/10.000)
Intravenous injection is to be carried out slowly. 
Intravensko injekcijo je treba aplicirati počasi.
- Paediatric Use: Safety and effectiveness in paediatric patients have not been established. 
- Uporaba v pediatriji: Varnosti in učinkovitosti uporabe pri pediatričnih bolnikih niso ugotavljali.
General recommendations - Reconstitution and further dilution must be carried out under sterile conditions. 
Splošna priporočila - Rekonstituiranje in nadaljnje redčenje je treba izvajati v sterilnih pogojih.
Age alone causes a 7 % reduction in clearance from the age of 30 to 70 years. 
Sam dejavnik starosti vpliva na 7 % zmanjšanje očistka v starosti med 30 do 70 let.
About 35 % of the dose is excreted as unchanged compound. 
približno 35 % odmerka se izloči v nespremenjeni obliki.
Your doctor will determine and control the dosage and duration of your treatment with Refludan according to your clinical condition, your body weight, and certain laboratory values. 
Vaš zdravnik bo določil in nadziral odmerjanje in trajanje vašega zdravljenja z Refludanom glede na vaše klinično stanje, telesno maso in določene laboratorijske vrednosti.
Very common (at least 1 in 10 people) - Bleeding 
Zelo pogosti (pojavijo se pri najmanj 1 od 10 ljudi) - krvavitve
The majority of undesirable effects experienced by patients treated with Refludan were generally related to bleeding (>1/10). 
Večina neželenih učinkov, ki so se pojavili pri bolnikih, zdravljenih z Refludanom, je bila večinoma povezana s krvavitvami (>1/10).
The specific activity of lepirudin is approximately 16,000 ATU/mg. 
Specifična aktivnost lepirudina je približno 16.000 ATe/mg.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed. 
Prosimo, povejte svojemu zdravniku ali farmacevtu, če jemljete ali ste v zadnjem času jemali katerakoli druga zdravila, tudi takšna, ki niso na recept.
The parenteral agent can be discontinued when the International Normalised Ratio (INR) stabilises within the desired target range. 
Parenteralno sredstvo se lahko ukine, ko se internacionalno normalizirano razmerje (INR) stabilizira znotraj zaželenega območja.
It constitutes a certain kind of allergy towards heparin. 
Povzroča neke vrste alergijo na heparin.
WHAT REFLUDAN IS AND WHAT IT IS USED FOR 
KAJ JE ZDRAVILO REFLUDAN IN ZA KAJ GA UPORABLJAMO
In all other cases the dose adjustment is based on the creatinine value. 
V vseh drugih primerih se odmerek prilagaja na podlagi vrednosti kreatinina.
In severe cases these may lead to shock and death. 
V hujših primerih lahko zaradi tega nastopi šok ali smrt.
This is valid up to a body weight of 110 kg. 
To velja za telesno maso do 110 kg.
This may additionally lead to deposition of clots in organs. 
To lahko nadalje privede do nalaganja strdkov v organih.
Therefore, these recommendations are only tentative. 
Ta priporočila je zato treba jemati s pridržkom.
Monitoring and modification of the Refludan dosage regimen 
Spremljanje in prilagajanje sheme odmerjanja Refludana
Results from studies in pigs showed that the application of von Willebrand Factor (vWF, 66 I.U./kg body weight) markedly reduced the bleeding time. 
Rezultati študij na prašičih so pokazali, da je uporaba von Willebrandovega faktorja (vWF, 66 i.e./kg telesne mase) opazno skrajšala čas krvavitve.
Creatinine value [mg/l (mol/l)] 
Vrednost kreatinina [mg/l (mol/l)]
HIT type II is an illness which can occur after you have received heparin containing medicines. 
HIT tipa II je bolezen, ki se lahko pojavi po tem, ko ste dobivali zdravila, ki vsebujejo heparin.
Refludan is available in packs of 1 or 10 vials. 
Refludan je na voljo v pakiranjih z 1 oziroma 10 vialami.
Reconstitute the lyophilisate as described in section 6.6. 
Način dajanja Rekonstituirajte liofilizat, kot je opisano v poglavju 6.6.
Adjusted infusion rate [% of original dose] 
Prilagojeni pretok infuzije [ % originalnega odmerka]
Normally, the dosage depends on the patient's body weight. 
Običajno je odmerjanje odvisno od bolnikove telesne mase.
The majority of the difference in clearance between young and elderly patients is due to the differences in renal function. 
Večino razlik v očistku med mlajšimi in starejšimi bolniki gre pripisati razliki v delovanju ledvic.
Cough Stridor Dyspnea 
Kašelj Stridor Dispneja
Therefore, strict monitoring of aPTT is necessary also during prolonged therapy. 
Zato je potrebno strogo spremljanje vrednosti aPTT tudi med dolgotrajnim zdravljenjem.
Monitoring: - In general, the dosage (infusion rate) should be adjusted to the activated partial thromboplastin time, aPTT. 
Spremljanje: - Na splošno mora biti odmerjanje (hitrost indundiranja) prilagojena aktiviranemu parcialnemu tromboplastinskemu času (aPTT).
After reconstitution: use immediately. 
Po rekonstituciji: uporabiti takoj.
More frequent determinations may be necessary, for example, in patients with renal impairment or with an increased risk of bleeding. 
Bolj pogoste meritve so lahko potrebne npr. pri bolnikih z okvaro ledvic ali s povečanim tveganjem za pojav krvavitev.
Since the risk of serious bleeding is considerable in this situation, the dosage of Refludan should be substantially reduced. 
Ker je v takih primerih tveganje za pojav hude krvavitve precejšnje, je treba odmerek Refludana bistveno zmanjšati.
If you have the impression that the effect of Refludan is too strong or too weak, talk to your doctor or pharmacist. 
Če imate občutek, da je učinek Refludana premočan ali prešibak, se pogovorite z vašim zdravnikom ali farmacevtom.
One anti-thrombin unit (ATU) is the amount of hirudin that neutralises one unit of WHO preparation 89/588 of thrombin. 
Ena antitrombinska enota (ATe) je količina hirudina, ki nevtralizira eno enoto WHO preparata trombina 89/588.
Adverse events reported on Refludan are shown in the table below: 
Neželeni učinki Refludana, o katerih so poročali, so prikazani v spodnji tabeli:
- With other reagents, the upper limit of the therapeutic aPTT window should be reduced to 2.5 fold prolongation of the normal control value. 
- Pri ostalih reagentih mora biti zgornja meja terapevtskega okna aPTT zmanjšana na 2,5kratno podaljšanje normalnih kontrolnih vrednosti.
- In general, an infusion rate of 0.21 mg/kg/hour should not be exceeded without checking for coagulation abnormalities which might be preventing an appropriate aPTT response. 
- Na splošno pa hitrost infundiranja ne sme presegati 0,21 mg/kg/h brez predhodnega ugotavljanja morebitnih koagulacijskih nepravilnosti, ki bi lahko preprečevale ustrezen odgovor aPTT.
The polypeptide composed of 65 amino acids has a molecular weight of 6979.5 Dalton. 
Polipeptid, ki ga sestavlja 65 aminokislin, ima molekulsko maso 6979,5 daltonov.
Lepirudin is a highly specific direct inhibitor of thrombin. 
Lepirudin je visoko specifičen neposredni zaviralec trombina.
- For injection only polypropylene syringes may be used. 
- Za injiciranje se smejo uporabljati le polipropilenske brizge.
- The perfusor syringe must be changed at least every 12 hours after the start of the infusion. 
- Brizgo perfuzorja je treba zamenjati vsaj vsakih 12 ur po začetku infuzije.
Distribution is essentially confined to extra-cellular fluids and is characterised by an initial half-life of approximately 10 minutes. 
Porazdelitev je v glavnem omejena na zunajcelično tekočino, začetna razpolovna doba pa znaša približno 10 minut.
As lepirudin is almost exclusively excreted and metabolised renally (see also section 5.2), the patient's renal function should be considered prior to administration. 
Ker se lepirudin izloča in presnavlja skoraj izključno preko ledvic (glejte tudi poglavje 5.2), je treba pred dajanjem upoštevati bolnikovo ledvično funkcijo.
- If the confirmed aPTT value is below the target range, the infusion speed should be increased by 20 %. 
- Če je potrjena vrednost aPTT pod ciljnim območjem, je treba hitrost infundiranja povečati za 20 %.
Mutagenicity Lepirudin was not mutagenic or clastogenic in standard assays for such effects. 
Mutagenost Lepirudin ni bil mutagen ali klastogen v standardnih testih teh učinkov.
Allergic Skin Reactions (including rash) Pruritus 
Alergijske kožne reakcije (vključno z izpuščajem) Pruritus
- Anaphylaxis: Refludan may cause allergic reactions including anaphylaxis and shock (see section 4.8). 
- Anafilaksa: Refludan lahko povzroči alergijske reakcije, vključno z anafilakso in šokom (glejte poglavje 4.8).
In female patients the systemic clearance is about 25 % lower as compared to male patients. 
Pri ženskih bolnicah je sistemski očistek za približno 25 % nižji kot pri moških.
INFORMATION IN BRAILLE 
PODATKI V V BRAILLOVI PISAVI