FrancophonIA/ELRC3.0 huggingface dataset:
English: It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Slovenian: da si ne poskušate injicirati zdravila, če vas zdravnik ali medicinska sestra za to nista posebej usposobila.
English: Inject the liquid into the tissue slowly and evenly, always keeping your skin pinched (see picture 11).
Slovenian: Tekočino v tkivo iztisnite počasi in enakomerno, pri čemer naj bo koža ves čas med palcem in kazalcem (glejte sliko 11).
English: If someone else is injecting you, they can also use the back and side of your upper arms (see grey areas in picture 6).
Slovenian: Če injiciranje opravlja druga oseba, lahko uporabi tudi zadnji in stranski del nadlakti (glejte siva območja na sliki 6).
English: Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 8).
Slovenian: Z alkoholnim čistilnim robčkom razkužite mesto injiciranja ter kožo primite med palcem in kazalcem, ne da bi jo ob tem stisnili (glejte sliko 8).
English: Erythropoietin is produced in your kidneys and stimulates your bone marrow to produce red blood cells.
Slovenian: Eritropoetin se tvori v ledvicah in spodbuja tvorbo rdečih krvničk v kostnem mozgu.
English: The pre-filled syringes are for single use only.
Slovenian: Napolnjene injekcijske brizge namenjene samo enkratni uporabi.
English: ≥ 1/10,000 to < 1/1,000;
Slovenian: ≥ 1/10.000 do < 1/1000
English: Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, aluminium intoxication, underlying haematological diseases or bone marrow fibrosis may also compromise the erythropoietic response.
Slovenian: Eritropoetski odziv lahko ogrozijo tudi interkurentne okužbe, vnetne ali travmatske epizode, okultna izguba krvi, hemoliza, zastrupitev z aluminijem, osnovne hematološke bolezni ali fibroza kostnega mozga.
English: Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 7).
Slovenian: Z alkoholnim čistilnim robčkom razkužite mesto injiciranja ter kožo primite med palcem in kazalcem, ne da bi jo ob tem stisnili (glejte sliko 7).
English: Discontinuation of treatment with epoetin theta should be taken into account.
Slovenian: Treba je pretehtati možnost prekinitve zdravljenja z epoetinom theta.
English: In cancer patients with non-myeloid malignancies receiving chemotherapy epoetin theta should be administered by the subcutaneous route only.
Slovenian: Pri bolnikih z nemieloidnimi malignostmi, ki prejemajo kemoterapijo, se lahko epoetin theta daje samo subkutano.
English: Biopoin contains sodium
Slovenian: Zdravilo Biopoin vsebuje natrij
English: Subcutaneous administration
Slovenian: Subkutana uporaba
English: The haemoglobin values in your blood should not exceed a value of 12 g/dl (7.45 mmol/l).
Slovenian: Vrednosti hemoglobina v krvi ne smejo preseči 12 g/dl (7,45 mmol/l).
English: If the haemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l) a doubling of the weekly dose to 40,000 IU should be considered.
Slovenian: Če se vrednost hemoglobina ni povečala za vsaj 1 g/dl (0,62 mmol/l), je treba razmisliti o podvojitvi odmerka na 40.000 i.e.
English: Symptoms of influenza-like illness such as fever, chills and asthenic conditions have been reported.
Slovenian: Poročali so tudi o simptomih bolezni, podobnih gripi, kot so zvišana telesna temperatura, mrzlica in astenična stanja.
English: The maximum dose should not exceed 60,000 IU per week.
Slovenian: Največji odmerek ne sme preseči 60.000 i.e. na teden.
English: Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy 409 cancer patients receiving chemotherapy were included in two prospective, randomised double-blind, placebo-controlled studies.
Slovenian: 409 bolnikov z rakom, ki so prejemali kemoterapijo, so vključili v dve prospektivni, randomizirani,
English: Anaemia caused by chronic renal failure
Slovenian: Anemija, ki jo povzroča kronična ledvična odpoved
English: ≥ 1/1,000 to < 1/100;
Slovenian: ≥ 1/1000 do < 1/100
English: Merckle GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Slovenian: Merckle GmbH Graf-Arco-Straße 3 89079 Ulm
English: In the clinical studies, pre-dialysis patients were treated once-weekly with epoetin theta, 174 patients in the maintenance phase study and 111 patients in the long-term study.
Slovenian: 174 bolnikov v študiji vzdrževalne faze in 111 bolnikov v dolgotrajni študiji.
English: For both routes of administration, the maximum dose should not exceed 700 IU/kg body weight per week.
Slovenian: Pri obeh poteh uporabe največji odmerek ne sme preseči 700 i.e./kg telesne mase na teden.
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji škatli in napolnjeni injekcijski brizgi poleg oznake Uporabno do. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Hypertensive crisis*
Slovenian: Žilne bolezni hipertenzija*
English: In two long-term studies, the efficacy of epoetin theta was evaluated in 124 haemodialysis patients and 289 patients not yet undergoing dialysis.
Slovenian: V dveh dolgotrajnih študijah so učinkovitost epoetina theta ocenili pri 124 bolnikih na hemodializi in
English: Take one blister with a pre-filled syringe out of the refrigerator.
Slovenian: Iz hladilnika vzemite en pretisni omot z napolnjeno injekcijsko brizgo.
English: This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, i.e. essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na napolnjeno injekcijsko brizgo, kar v bistvu pomeni ‘brez natrija'.
English: Please speak with your doctor if you belong to one of these patient groups: - patients with liver problems, - patients with pathological changes in their red blood cells (homozygous sickle cell anaemia).
Slovenian: Posvetujte se z zdravnikom, če spadate v eno od naslednjih skupin bolnikov: - bolniki s težavami z jetri,
English: Epoetin theta should be administered either subcutaneously or intravenously in order to increase haemoglobin level to not greater than 12 g/dl (7.45 mmol/l).
Slovenian: Epoetin theta je treba dajati subkutano ali intravensko, da zvišanje ravni hemoglobina ne preseže 12 g/dl (7,45 mmol/l).
English: If, after 12 weeks of therapy, the haemoglobin value has not increased by at least 1 g/dl (0.62 mmol/l), response is unlikely and treatment should be discontinued.
Slovenian: Če se po 12 tednih zdravljenja vrednost hemoglobina ne poveča za vsaj 1 g/dl (0,62 mmol/l), odziv ni verjeten, zato je treba zdravljenje prekiniti.
English: For instructions on how to inject the medicinal product, see package leaflet.
Slovenian: Za navodila o injiciranju zdravila glejte navodilo za uporabo.
English: Some of the information required for using the pre-filled syringe can be found at the end of this package leaflet (see section “7.
Slovenian: Nekaj informacij o uporabi napolnjene injekcijske igle je na koncu teh navodil za uporabo (glejte poglavje »Informacije o samostojnem injiciranju«).
English: In these patients, erythropoietin deficiency and a reduced response of erythroid progenitor cells to endogenous erythropoietin both contribute significantly towards their anaemia.
Slovenian: Pri teh bolnikih k anemiji pomembno prispevata pomanjkanje eritropoetina in zmanjšan odziv eritroidnih progenitorskih celic na endogeni eritropoetin.
English: A rise in haemoglobin of greater than 2 g/dl (1.24 mmol/l) over a four week period should be avoided.
Slovenian: Treba se je izogibati povečanju vrednosti hemoglobina za več kot 2 g/dl (1,24 mmol/l), v štirih tednih.
English: Where your injection should be given
Slovenian: Kam si morate injicirati zdravilo
English: Press the injection site with a piece of gauze bandage or a sterile gauze swab for several seconds.
Slovenian: Na mesto injiciranja za več sekund pritisnite košček povoja iz gaze ali sterilno vatno blazinico.
English: Remove the tip cap from the pre-filled syringe (see picture 2).
Slovenian: Z napolnjene injekcijske brizge odstranite vrhnjo zaporko (glejte sliko 2).
English: If, after 4 weeks of therapy, the haemoglobin value has increased by at least 1 g/dl (0.62 mmol/l), the current dose should be continued.
Slovenian: Če se po 4 tednih zdravljenja vrednost hemoglobina poveča za vsaj 1 g/dl (0,62 mmol/l), je treba nadaljevati s trenutnim odmerkom.
English: Attach the needle to the syringe (see picture 3).
Slovenian: Na brizgo pritrdite iglo (glejte sliko 3).
English: Information for injecting yourself
Slovenian: Informacije za samostojno injiciranje
English: TEVA GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Slovenian: TEVA GmbH Graf-Arco-Straße 3 89079 Ulm
English: Biopoin 10,000 IU/1 ml, Biopoin 20,000 IU/1 ml and Biopoin 30,000 IU/1 ml: Each pre-filled syringe contains 1 ml of solution.
Slovenian: Biopoin 10.000 i.e./1 ml, Biopoin 20.000 i.e./1 ml in Biopoin 30.000 i.e./1 ml: ena napolnjena injekcijska brizga vsebuje 1 ml raztopine.
English: If you have hardening of the blood vessels in your kidneys (nephrosclerosis) but do not need to undergo dialysis, your doctor will consider whether treatment is suitable for you.
Slovenian: Če so krvne žile v ledvicah otrdele (nefroskleroza), vendar ne potrebujete dialize, bo zdravnik pretehtal, ali je to zdravljenje primerno za vas, saj ni mogoče zagotovo izključiti morebitne pospešitve napredovanja ledvične bolezni.
English: Dispose of syringes with a safety device as instructed by your doctor, pharmacist or nurse.
Slovenian: Injekcijske brizge z varnostnim pripomočkom odstranite skladno z navodili zdravnika, farmacevta ali medicinske sestre.
English: Biopoin 1,000 IU/0.5 ml, Biopoin 2,000 IU/0.5 ml, Biopoin 3,000 IU/0.5 ml, Biopoin 4,000 IU/0.5 ml and Biopoin 5,000 IU/0.5 ml: Each pre-filled syringe contains 0.5 ml of solution.
Slovenian: Biopoin 1000 i.e./0,5 ml, Biopoin 2000 i.e./0,5 ml, Biopoin 3000 i.e./0,5 ml, Biopoin 4000 i.e./0,5 ml in Biopoin 5000 i.e./0,5 ml: ena napolnjena injekcijska brizga vsebuje 0,5 ml raztopine.
English: If typical causes of non-response are excluded, and the patient has a sudden drop in haemoglobin associated with reticulocytopenia, an examination of anti-erythropoietin antibodies and the bone marrow for diagnosis of pure red cell aplasia should be considered.
Slovenian: Čista aplazija rdečih krvničk (PRCA) Če ste izključili značilne vzroke neodzivnosti in se je pri bolniku pojavilo nenadno zmanjšanje hemoglobina, povezano z retikulocitopenijo, je treba razmisliti o preiskavi protiteles proti eritropoetinu in kostnega mozga za diagnosticiranje čiste aplazije rdečih krvničk.
English: Non-clinical data with epoetin theta reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Slovenian: Predklinični podatki za epoetin theta na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
English: Symptomatic anaemia associated with chronic renal failure
Slovenian: Simptomatska anemija, povezana s kronično ledvično odpovedjo
English: In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered (see sections 4.2 and
Slovenian: Pri bolnikih s slabim odzivom hemoglobina na epoetin theta je treba razmisliti o možnih drugih razlagah za slab odziv (glejte poglavji 4.2 in 5.1).
English: Depending on your individual situation a blood transfusion may be preferable.
Slovenian: Morda bo boljša krvna transfuzija, kar je odvisno od vašega stanja kot posameznika.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja kožne reakcije*
English: To give yourself an injection into the tissue under the skin you will need: - a pre-filled syringe of Biopoin, - an alcohol wipe, - a piece of gauze bandage or a sterile gauze swab, - a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can dispose of used syringes safely.
Slovenian: - alkoholni čistilni robček, - košček povoja iz gaze ali sterilno vatno blazinico, - vsebnik, odporen proti vbodom (plastični vsebnik, ki ga dobite v bolnišnici ali lekarni), da lahko varno zavržete uporabljene brizge.
English: Open the blister and take the pre-filled syringe and the needle container out of the blister.
Slovenian: Odprite pretisni omot in napolnjeno injekcijsko brizgo in vsebnik za iglo vzemite iz pretisnega omota.
English: Non-response to therapy with epoetin theta should prompt a search for causative factors.
Slovenian: Če se bolnik ne odziva na zdravljenje z epoetinom theta, je treba poiskati vzročne dejavnike.
English: Open the blister and take the pre-filled syringe and the needle bag out of the blister.
Slovenian: Odprite pretisni omot in napolnjeno injekcijsko brizgo in vrečko za iglo vzemite iz pretisnega omota.
English: The dose should be adjusted as necessary to maintain the individual target haemoglobin level between 10 g/dl (6.21 mmol/l) to 12 g/dl (7.45 mmol/l), whereby a haemoglobin level of 12 g/dl (7.45 mmol/l) should not be exceeded.
Slovenian: Po potrebi je treba odmerek prilagoditi, da se pri posamezniku vzdržuje ciljna raven hemoglobina od 10 g/dl (6,21 mmol/l) do 12 g/dl (7,45 mmol/l), pri čemer pa se ne sme preseči raven hemoglobina
English: Tlf: +45 44 98 55 11
Slovenian: Teva Denmark A/S Tlf: +45 44 98 55 11
English: Erythropoietin is a growth factor that primarily stimulates red cell production.
Slovenian: Epoetin alfa je rastni faktor, ki primarno stimulira tvorbo rdečih krvničk.
English: Stop using Biopoin if you develop these symptoms and contact your doctor or seek medical attention immediately.
Slovenian: Če se pri vas pojavijo ti simptomi, prenehajte uporabljati zdravilo Biopoin in se takoj posvetujte z zdravnikom ali poiščite zdravniško pomoč.
English: How to use Biopoin
Slovenian: Kako uporabljati zdravilo Biopoin
English: Biopoin contains the active substance epoetin theta, which is almost identical to erythropoietin, a natural hormone produced by your body.
Slovenian: Zdravilo Biopoin vsebuje zdravilno učinkovino epoetin theta, ki je skoraj enaka eritropoetinu,
English: Hypertensive crisis with encephalopathy-like symptoms (e.g. headaches, confused state, speech disturbances, impaired gait) and related complications (seizures, stroke) may also occur in individual patients with otherwise normal or low blood pressure (see section 4.4).
Slovenian: poslabšana hoja) in povezanimi zapleti (epileptični napadi, kap) se lahko pojavijo tudi pri posameznikih, pri katerih je krvni tlak drugače normalen ali nizek (glejte poglavje 4.4).
English: - Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Slovenian: - Zdravljenje simptomatske anemije pri odraslih rakavih bolnikih z nemieloidnimi malignostmi, ki prejemajo kemoterapijo.
English: Epoetins are not approved in the management of anaemia associated with hepatitis C.
Slovenian: Epoetini niso odobreni za zdravljenje anemije,
English: Each pre-filled syringe is for single use only.
Slovenian: Ena napolnjena injekcijska brizga je samo za enkratno uporabo.
English: Do not use this medicine if you notice it is cloudy or there are particles in it. Do not throw away any medicines via wastewater or household waste.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je motno ali so v njem delci.
English: In reproductive toxicity studies performed with other epoetins, effects interpreted as being secondary to decreased maternal body weight were observed at doses sufficiently in excess to the recommended human dose.
Slovenian: zadostno večjih od priporočenega odmerka pri človeku, opazili učinke, ki so jih pripisali zmanjšani telesni masi matere.
English: This leaflet was last approved in .
Slovenian: Navodilo je bilo odobreno.
English: Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy
Slovenian: Simptomatska anemija pri rakavih bolnikih z nemieloidnimi malignostmi, ki prejemajo kemoterapijo
English: Intravenous administration: The initial posology is 40 IU/kg body weight 3 times per week.
Slovenian: Intravenska uporaba: začetno odmerjanje je 40 i.e./kg telesne mase 3-krat na teden.
English: Caution should be exercised with escalation of epoetin theta doses in patients with chronic renal failure.
Slovenian: Pri zviševanju odmerkov epoetina theta bolnikom s kronično ledvično odpovedjo je potrebna pozornost.
English: General
Slovenian: Splošne
English: Further increases of 25% of the previous dose may be made at monthly intervals until the individual target haemoglobin level is obtained.
Slovenian: Dokler se pri posamezniku ne doseže ciljna raven hemoglobina, se lahko odmerek povečuje za 25 % v mesečnih presledkih.
English: Common (may affect up to 1 in 10 people) - Headache; - High blood pressure; - Flu-like symptoms, such as fever, chills, feeling of weakness, tiredness; - Skin reactions, such as rash, itching or reactions around the injection site.
Slovenian: - simptomi, podobni gripi, kot so zvišana telesna temperatura, občutek šibkosti, utrujenost; - kožne reakcije, kot so izpuščaj, srbenje ali reakcije okoli mesta injiciranja.
English: How Biopoin is used
Slovenian: Kako se uporablja zdravilo Biopoin
English: Subcutaneous administration: The initial posology is 20 IU/kg body weight 3 times per week.
Slovenian: Subkutana uporaba: začetno odmerjanje je 20 i.e./kg telesne mase 3-krat na teden.
English: The maximum dose should not exceed 700 IU/kg body weight per week.
Slovenian: Največji odmerek ne sme presegati 700 i.e./kg telesne mase na teden.
English: In patients with chronic renal failure, neutralising anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA) associated with epoetin theta therapy has been reported in post marketing setting.
Slovenian: Pri posameznih bolnikih s kronično ledvično odpovedjo so v obdobju trženja zdravila poročali o čisti aplaziji rdečih krvničk (PRCA - pure red cell aplasia), ki so jo sprožila nevtralizirajoča protitelesa proti eritropoetinu, in je bila povezana z zdravljenjem z epoetinom theta.
English: The dose of Biopoin (expressed in International Units or IU) depends on your disease condition, your body weight and the way the injection is given (under the skin [subcutaneous injection] or into a vein [intravenous injection]).
Slovenian: telesne mase in načina injiciranja (pod kožo [subkutano injiciranje] ali v veno [intravensko injiciranje]).
English: Misuse
Slovenian: Zloraba
English: The initial dose for injections under the skin is 20 IU per kg of bodyweight, given 3 times per week.
Slovenian: Začetni odmerek za injiciranje pod kožo je 20 i.e. na kg telesne mase trikrat na teden.
English: An increased relative risk of thromboembolic events (RR 1.67, 95% CI: 1.35, 2.06; 35 trials and 6,769 patients) was observed in patients treated with recombinant human erythropoietin.
Slovenian: Pri bolnikih, ki so se zdravili z rekombinantnim humanim eritropoetinom, so opazili povečano relativno tveganje trombemboličnih dogodkov (RT 1,67, 95-odstotni IZ: 1,35, 2,06; 35 preskušanj in
English: Non-clinical data with other epoetins reveal no special hazard for humans based on conventional studies of genotoxicity and toxicity to reproduction.
Slovenian: Predklinični podatki za druge epoetine na osnovi običajnih študij genotoksičnosti in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
English: Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe
Slovenian: Biopoin 1000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Biopoin 2000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Biopoin 3000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Biopoin 4000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Biopoin 5000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Biopoin 10.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Biopoin 20.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Biopoin 30.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
English: If the haemoglobin level continues to increase, therapy should be interrupted until the haemoglobin level begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the previously administered dose.
Slovenian: Če se raven hemoglobina še vedno viša, je treba zdravljenje prekiniti, dokler se raven hemoglobina ne začne nižati.
English: The needle shield will retract completely when you insert the needle into the skin (see picture 10).
Slovenian: Zaščita igle se bo povsem umaknila, ko boste iglo vstavili v kožo
English: - Put used syringes into the puncture-proof container and keep this container out of the sight and reach of children.
Slovenian: - Uporabljene igle dajte v vsebnik, odporen proti vbodom, in ga shranjujte nedosegljivo otrokom.
English: Put everything you need within easy reach (the Biopoin pre-filled syringe, an alcohol wipe and a piece of gauze bandage or a sterile gauze swab).
Slovenian: Vse potrebne pripomočke imejte pri roki (napolnjeno injekcijsko brizgo z zdravilom Biopoin, alkoholni čistilni robček in košček povoja iz gaze ali sterilno vatno blazinico).
English: Put everything you need within easy reach (the Biopoin pre-filled syringe, an alcohol wipe, a piece of gauze bandage or a sterile gauze swab and the puncture-proof container).
Slovenian: Vse potrebne pripomočke imejte pri roki (napolnjeno injekcijsko brizgo z zdravilom Biopoin, alkoholni čistilni robček, košček povoja iz gaze ali sterilno vatno blazinico in vsebnik, odporen proti vbodom).
English: If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of epoetin theta, treatment with epoetin theta must not be restarted in this patient at any time.
Slovenian: Če je pri bolniku zaradi uporabe epoetina theta prišlo do hude kožne reakcije, kot sta SJS ali TEN,
English: In the case of overdose, polycythaemia can occur.
Slovenian: Ob prevelikem odmerjanju se lahko pojavi policitemija.
English: To give yourself an injection into the tissue under the skin you will need: - a pre-filled syringe of Biopoin, - an alcohol wipe, - a piece of gauze bandage or a sterile gauze swab.
Slovenian: Za injiciranje zdravila v tkivo pod kožo boste potrebovali: - napolnjeno injekcijsko brizgo zdravila Biopoin,
English: Allergic reactions such as skin rash, raised areas of the skin that itch and severe allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported (not known, frequency cannot be estimated from the available data).
Slovenian: poročali so (neznana, pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) o alergijskih reakcijah, kot so kožni izpuščaj in izbočena srbeča območja na koži, ter hudih alergijskih reakcijah s šibkostjo, padcem krvnega tlaka, oteženim dihanjem in otekanjem obraza.
English: Blood pressure should be controlled adequately before initiation and during therapy to avoid acute complications, such as hypertensive crisis with encephalopathy-like symptoms (e.g. headaches, confused state, speech disturbances, impaired gait) and related complications (seizures, stroke), which may also occur in individual patients with otherwise normal or low blood pressure.
Slovenian: Pred začetkom zdravljenja in med njim je treba zadostno nadzorovati krvni tlak, da se izognete akutnim zapletom, kot so hipertenzivna kriza s simptomi, podobnimi encelopatiji, (npr. glavoboli,