natgillin/translations-raw huggingface dataset:
Furthermore CEPROTIN is used to prevent thrombosis in patients with severe congenital protein C deficiency if one or more of the following conditions are met: • surgery or invasive therapy is imminent • while initiating coumarin (anticoagulant medication, blood thinner) therapy • when coumarin therapy alone is not sufficient • when coumarin therapy is not feasible.
Zdravilo CEPROTIN se poleg tega uporablja tudi za preprečevanje tromboze pri bolnikih s hudim prirojenim pomanjkanjem proteina C, če je izpolnjen eden ali več od naslednjih pogojev: • če je nujen takojšen kirurški poseg ali invazivna terapija, • pri uvedbi kumarinske terapije (antikoagulantnega zdravila, imenovanega kumarin), • če sama kumarinska ne zadošča, • če kumarinska terapija ni izvedljiva.
36 Take special care with CEPROTIN,
Bodite posebno pozorni pri prejemanju zdravila CEPROTIN,
The preparation may contain traces of heparin and/ or mouse protein as a result of the manufacturing process.
36 in/ ali mišjih beljakovin kot posledica procesa izdelave.
The dose, administration frequency and duration of treatment depend on the severity of the protein C deficiency as well as on your clinical condition and on your plasma level of protein C.
37 Odmerek, pogostnost uporabe in trajanje zdravljenja so odvisni od stopnje pomanjkanja proteina C vašega kliničnega stanja ter vaše plazemske koncentracije proteina C.
38 CEPROTIN should be administered at a maximum injection rate of 2 ml per minute.
Zdravilo CEPROTIN smemo injicirati s hitrostjo največ 2 ml na minuto.
If you use more CEPROTIN than you should
38 Če ste prejeli večji odmerek zdravila CEPROTIN, kot bi smeli
Medicines should not be disposed of via wastewater or household waste.
39 Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
40 For any information about this medicine, please contact the local representative of BAXTER AG given below.
40 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo družbe BAXTER AG, ki je navedeno spodaj.
Ref.
London, 19. julij 2007 Sklic na dok.
EMEA/ 318692/ 2007
EMEA/ 382244/ 2007
Glioma is a type of brain tumour that begins in ‘ glial’ cells (the cells that surround and support nerve cells).
Gliom je vrsta možganskega tumorja, ki se prične v nevroglijski celici (celici, ki obkroža in podpira živčno celico).
Cerepro contains the gene for the enzyme ‘ thymidine kinase’ from the herpes virus.
Zdravilo Cerepro vsebuje gen za encim „ timidin kinazo “ iz virusa herpesa.
The gene is carried within a ‘ vector’, a type of virus that has been altered genetically so that it can carry a gene (DNA) into the cells of the body.
Gen se prenaša s pomočjo „ vektorja “, vrste virusa, ki je bila genetsko spremenjena tako, da lahko prenaša gen (DNA) v celice telesa.
The virus in Cerepro is an ‘ adenovirus’ that has been engineered so that it cannot make copies of itself and therefore does not cause infections in humans.
Virus, uporabljen pri zdravilu Cerepro, je „ adenovirus “, ki je bil gensko spremenjen tako, da se ne more podvojevati in posledično v ljudeh ne more povzročiti okužbe.
(44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What was the recommendation of the CHMP at that time?
(44- 20) 74 18 84 00 Fax (44- 20) 75 23 71 29 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kakšno je bilo takrat mnenje CHMP?
Based on the review of the data and the company’ s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Cerepro for the treatment of patients with operable high-grade glioma.
Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj CHMP je v času umika vloge CHMP izrazil negativno mnenje in ni priporočil odobritve dovoljenja za promet za zdravilo Cerepro, namenjeno zdravljenju bolnikov z operabilnimi visoko malignimi gliomi.
Therefore, at the time of the withdrawal, the CHMP’ s view was that a benefit of Cerepro had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
CHMP je zato v času umika menil, da koristi zdravila Cerepro niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
Cerezyme is a powder to be made up into a solution for infusion (a drip into a vein).
Zdravilo Cerezyme je prašek za pripravo raztopine za infundiranje (kapalna infuzija v veno).
Cerezyme contains the active substance imiglucerase.
Zdravilo Cerezyme vsebuje zdravilno učinkovino imiglucerazo.
Cerezyme is used as long-term enzyme replacement therapy in patients with Gaucher disease.
Zdravilo Cerezyme se uporablja za dolgotrajno encimsko nadomestno zdravljenje bolnikov z Gaucherjevo boleznijo.
Gaucher disease is a rare inherited disorder.
Gaucherjeva bolezen je redka dedna napaka.
People with the disease do not have enough of an enzyme, glucocerebrosidase.
Ljudje s to boleznijo nimajo dovolj encima glukocerebrozidaze.
This enzyme normally breaks down a fatty waste product called glucocerebroside.
Ta encim razgrajuje maščobni odpadni produkt, imenovan glukocerebrozid.
Without the enzyme, glucocerebroside builds up in the body, typically in the liver, spleen and bone marrow, and this produces the symptoms of the disease: anaemia (low blood count), tiredness, easy bruising and a tendency to bleed, an enlarged spleen and liver, and bone pain and fractures.
Ob odsotnosti encima se glukocerebrozid kopiči v telesu, običajno v jetrih, vranici in kostnem mozgu, to pa vodi do nastanka simptomov bolezni: anemije (znižane koncentracije rdečih krvničk), utrujenosti, povečane verjetnosti za nastanek hematomov in nagnjenosti h krvavitvam, povečane vranice in povečanih jeter ter bolečin v kosteh in zlomov.
Cerezyme is used in patients who have type 1 (non-neuronopathic) or type 3 (chronic neuronopathic) Gaucher disease and who have one or more of the following conditions caused by the disease: • anaemia (low red blood cell counts), • thrombocytopenia (a decrease in the number of platelets in the blood), • bone disease, • hepatomegaly (enlarged liver) or splenomegaly (enlarged spleen).
Zdravilo Cerezyme se uporablja pri bolnikih, ki imajo Gaucherjevo bolezen tipa 1 (ne- nevropatsko) ali tipa 3 (kronično nevropatsko) ter imajo eno ali več izmed naslednjih stanj, pogojenih z boleznijo: • anemijo (znižano število rdečih krvničk), • trombocitopenijo (znižano število trombocitov v krvi), • bolezen kosti, • hepatomegalijo (povečana jetra) ali splenomegalijo (povečano vranico).
Cerezyme should be given by doctors experienced in the management of patients with Gaucher disease.
Zdravljenje z zdravilom Cerezyme mora uvesti, ki ima izkušnje z zdravljenjem bolnikov z Gaucherjevo boleznijo.
It is given by infusion over one to two hours every two weeks with higher doses at first.
Zdravilo se daje z 1 do 2 uri trajajočo infuzijo vsaka dva tedna, pri čemer so odmerki na začetku zdravljenja večji.
The doses are then adjusted according to how the patient responds to the treatment.
Odmerke se zatem prilagodi v skladu z odzivom bolnika na zdravljenje.
Cerezyme is designed for long-term use.
Zdravilo Cerezyme je predvideno za dolgotrajno uporabo.
Gaucher disease has previously been treated using an enzyme, alglucerase, prepared from human placentae.
Gaucherjevo bolezen s v preteklosti zdravili z encimom alglucerazo, pridobljenim iz človeške posteljice.
Imiglucerase, the active substance in Cerezyme, is a copy of this enzyme, produced by a method known as ‘ recombinant DNA technology’: the enzyme is made by a cell which has received a gene (DNA) that makes it able to produce the enzyme.
Imigluceraza, zdravilna učinkovina zdravila Cerezyme, je kopija tega encima, proizvedena po metodi, imenovani „ rekombinantna DNA tehnologija “, kar pomeni, da encim tvori celica, ki je prejela gen (DNA), s katerim postane sposobna tvoriti encim.
Imiglucerase helps (catalyses) the break down of glucocerebroside and stops it building up in the body.
Imigluceraza prispeva k (katalizira) razgradnji glukocerebrozida ter zaustavi njegovo kopičenje v telesu.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Cerezyme been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Cerezyme raziskano?
For type 1 Gaucher disease, Cerezyme has been studied in three studies, and in a total of 40 patients (this is an acceptable number because the disease is very rare).
Za uporabo pri Gaucherjevi bolezni tipa 1 so zdravilo Cerezyme preučevali v okviru treh študij ter pri skupno 40 bolnikih (to število je sprejemljivo, saj gre za zelo redko bolezen).
The studies examined Cerezyme’ s effectiveness in controlling the symptoms of Gaucher disease, such as normalising (increasing) the number of red blood cells and platelets in the blood, and normalising (decreasing) the size of the liver and spleen.
V študijah so preučili učinkovitost zdravila Cerezyme pri nadzoru simptomov Gaucherjeve bolezni, kot je normaliziranje (povečanje) števila rdečih krvničk in krvnih ploščic v krvi ter normaliziranje (zmanjšanje) velikosti jeter in vranice.
Cerezyme was compared to alglucerase.
Zdravilo Cerezyme so primerjali z alglucerazo.
For type 3 Gaucher disease (which is an extremely rare form of the disease), data from published articles and from the special register of Gaucher’ s patients were used.
Za uporabo zdravila pri Gaucherjevi bolezni tipa 3 (ki je izredno redka oblika bolezni) so bili uporabljeni podatki iz objavljenih člankov in iz posebnega registra bolnikov z Gaucherjevo boleznijo.
What benefit has Cerezyme shown during the studies?
Kakšne koristi je zdravilo Cerezyme izkazalo med raziskavami?
It has also been shown that patients may safely switch from alglucerase to imiglucerase treatment.
Ravno tako je bilo dokazano, da lahko bolniki varno preidejo z zdravljenja z alglucerazo na zdravljenje z imiglucerazo.
The most common side effects with Cerezyme (seen in between 1 and 10 patients in 100) are respiratory symptoms, urticaria or angioedema (hives), pruritus (itching) and rash.
Najpogostejši neželeni učinki zdravila Cerezyme (opaženi pri 1 do 10 bolnikov izmed 100) so respiratorni simptomi, urtikarija ali angioedem (koprivnica), pruritus (srbenje) in izpuščaji.
Patients can develop antibodies (proteins that are produced in response to Cerezyme and can affect treatment) and they should be monitored for any allergic reaction to Cerezyme during the first year of treatment.
Bolniki lahko razvijejo protitelesa (beljakovine, ki se tvorijo kot odziv na zdravilo Cerezyme in ki lahko vplivajo na zdravljenje), tako da je v teku prvega leta zdravljenja potrebno nadzorovati ali prihaja do morebitnih alergičnih reakcij na zdravilo Cerezyme.
Cerezyme should be used carefully in people who may be hypersensitive (allergic) to imiglucerase or any of the other ingredients.
Zdravilo Cerezyme je potrebno uporabljati posebej previdno pri ljudeh, ki utegnejo biti preobčutljivi za (alergični na) imiglucerazo ali katero koli drugo sestavino zdravila.
The Committee for Medicinal products for Human Use (CHMP) decided that Cerezyme gives effective control of the symptoms of types 1 and 3 Gaucher disease.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da zdravilo Cerezyme zagotavlja učinkovit nadzor nad simptomi Gaucherjeve bolezni tipa 1 in 3.
The Committee decided that Cerezyme’ s benefits are greater than its risks and recommended that Cerezyme be given marketing authorisation.
Odbor je odločil, da so koristi zdravila Cerezyme večje od z njim povezanih tveganj, zato je za zdravilo Cerezyme priporočil odobritev dovoljenja za promet.
The European Commission granted a marketing authorisation valid throughout the European Union for Cerezyme to Genzyme Europe B. V. on 17 November 1997.
Evropska komisija je dovoljenje za promet z zdravilom Cerezyme, veljavno po vsej Evropski uniji, odobrila družbi Genzyme Europe B. V. dne 17. novembra 1997.
The marketing authorisation was renewed on 17 November 2002 and on 17 November 2007.
Dovoljenje za promet z zdravilom je bilo podaljšano 17. novembra 2002 in 17. novembra 2007.
The full EPAR for Cerezyme can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Cerezyme je na voljo tukaj.
EU-number
Vsebina
Trade name
Velikost pakiranja
Strength
Številka EU
Pharmaceutical Form
Izmišljeno ime
Content (concentration)
Ovojnina
Packaging size
(koncentracija)
200U
200 e
5 ml (40U/ ml)
5 ml (40 e/ ml)
400U
400 e
10 ml (40U/ ml)
10 ml (40 e/ ml)
Cerezyme 200 U Powder for concentrate for solution for infusion
Cerezyme 200 enot prašek za koncentrat za raztopino za infundiranje
Each vial contains 200 units* of imiglucerase**.
Vsaka viala vsebuje 200 enot * imigluceraze **.
After reconstitution, the solution contains 40 units of imiglucerase per ml (200 U/ 5 ml).
Po rekonstituciji vsebuje raztopina 40 enot imigluceraze na ml (200 e/ 5 ml).
* An enzyme unit (U) is defined as the amount of enzyme that catalyses the hydrolysis of one micromole of the synthetic substrate para-nitrophenyl β -D-glucopyranoside (pNP-Glc) per minute at 37°C. ** modified form of glucocerebrosidase produced in Chinese Hamster Ovary cells by recombinant DNA technology.
* 1 enota encima (e.) je količina encima, ki v 1 minuti katalizira hidrolizo 1 mikromola sintetičnega substrata para- nitrofenil β- D- glukopiranozida (pNP- Glc) pri temperaturi 37° C. ** spremenjene oblika glukocerebrozidaze, pridobljene s tehnologijo rekombinantne DNK v celicah jajčnika kitajskega hrčka.
This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
To zdravilo vsebuje natrij in se aplicira v intravenski 0, 9% - tni raztopini natrijevega klorida (glejte poglavje 6. 6).
After reconstitution, the solution contains 0.62 mmol sodium (200 U/ 5 mL).
Po rekonstituciji vsebuje raztopina 0, 62 mmol natrija (200 e/ 5 mL).
Cerezyme (imiglucerase) is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease and who exhibit clinically significant non-neurological manifestations of the disease.
Zdravilo Cerezyme (imigluceraza) je indicirano za dolgotrajno encimsko nadomestno zdravljenje bolnikov s potrjeno diagnozo ne- nevronopatske (tip 1) ali kronično nevronopatske (tip 3) Gaucherjeve bolezni, ki kažejo klinično pomembne ne- nevrološke manifestacije te bolezni.
The non-neurological manifestations of Gaucher disease include one or more of the following conditions: • anaemia after exclusion of other causes, such as iron deficiency • thrombocytopenia • bone disease after exclusion of other causes such as Vitamin D deficiency • hepatomegaly or splenomegaly
Pri ne- nevroloških manifestacijah Gaucherjeve bolezni se pojavlja eden ali več naslednjih simptomov: • anemija, ko smo izključili druge vzroke zanjo, kot npr. pomanjkanje železa, • trombocitopenija, • bolezen kosti, ko smo izključili druge vzroke zanjo, kot npr. pomanjkanje vitamina D, • hepatomegalija ali splenomegalija.
Therapy should be directed by physicians knowledgeable in the management of Gaucher disease.
Zdravljenje mora voditi zdravnik, ki ima izkušnje z zdravljenjem Gaucherjeve bolezni.
Posology for Adults, Children and Elderly Due to the heterogeneity and the multi-systemic nature of Gaucher disease, dosage should be individualised for each patient based on a comprehensive evaluation of the clinical manifestations of the disease.
Odmerjanje za odrasle, otroke in starejše bolnike Zaradi genske raznolikosti Gaucherjeve bolezni in obolelosti večih telesnih sistemov moramo odmerjanje individualno prilagajati za vsakega bolnika glede na celovito oceno kliničnih simptomov bolezni.
A range of dosage regimens has proven effective towards some or all of the non-neurological manifestations of the disease.
Vrsta odmernih režimov se je izkazala za učinkovito zoper nekatere ali vse izmed ne- nevroloških manifestacij bolezni.
Initial doses of 60 U/ kg of body weight once every 2 weeks have shown
Pri zdravljenju z začetnimi odmerki po 60 enot/ kg telesne mase enkrat vsaka 2 tedna so se hematološki in visceralni parametri zboljšali v 6 mesecih, nadaljnje zdravljenje pa je bodisi zaustavilo napredovanje bolezni kosti ali zboljšalo njeno bolezensko stanje.
Administration of doses as low as 2.5 U/ kg of body weight three times a week or 15 U/ kg of body weight once every 2 weeks has been shown to improve haematological parameters and organomegaly, but not bone parameters.
2 Zdravljenje z zelo majhnimi odmerki, po 2, 5 enot/ kg telesne mase trikrat na teden ali po 15 enot/ kg telesne mase enkrat vsaka 2 tedna, je zboljšalo hematološke parametre in visceromegalijo, ne pa tudi kostnih parametrov.
The usual, and for the patient, most convenient frequency of infusion is once every 2 weeks; this is the frequency of infusion for which the most data are available.
Večina podatkov se nanaša prav na tako vrsto odmerjanja.
Patient responses must be routinely evaluated and dosages should only be adjusted (up or down) based on a comprehensive evaluation of patient response relating to all clinical manifestations of the disease.
Pred vsako spremembo odmerka (povečanjem ali zmanjšanjem) moramo oceniti celovit bolnikov odziv na zdravljenje in upoštevati vse klinične znake bolezni.
Once individual patient response for all relevant clinical manifestations is well-established and stabilised, dosages may be adjusted for continued effective therapy, while continuing to closely monitor response parameters and patient well-being.
Ves čas zdravljenja skrbno spremljamo bolnikovo odzivanje na zdravljenje in njegovo počutje.
Usual monitoring intervals range from 6 to 12 months.
Običajno potrebujejo bolniki kontrolne preglede na 6 do 12 mesecev.
The efficacy of Cerezyme on neurological symptoms of chronic neuronopathic Gaucher patients has not been established and no special dosage regimen can be recommended for these manifestations (see section 5.1).
Za to manifestacijo ne moremo priporočiti posebnega režima odmerjanja (glejte poglavje 5. 1).
After reconstitution and dilution (see section 6.6) the preparation is administered by intravenous infusion over 1 to 2 hours.
Po rekonstituciji in razredčitvi (glejte poglavje 6. 6) se pripravek aplicira z intravenskim infundiranjem, ki traja 1 do 2 uri.
Alternatively, the appropriate dose of Cerezyme may be administered at a rate not exceeding 1 unit per kg body weight per minute.
Ustrezni odmerek zdravila Cerezyme lahko alternativno apliciramo tudi tako, da hitrost infundiranja ne presega 1 enote na kilogram telesne mase na minuto.
Medical or healthcare professionals are encouraged to register Gaucher patients, including those with chronic neuronopathic manifestations of the disease, in the “ ICGG Gaucher Registry” (see section 5.1).
Zdravstvene strokovnjake spodbujamo k temu, da vpišejo vse paciente z Gaucherjevo boleznijo, vključno s tistimi s kroničnimi nevronopatskimi manifestacijami bolezni, v register 'ICGG Gaucher Registry' (glejte poglavje 5. 1).
Hypersensitivity to the active substance or to any of the excipients (see section 4.4).
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (glejte poglavje 4. 4).
Hypersensitivity Current data suggest that, during the first year of therapy, IgG antibodies to imiglucerase are formed in approximately 15% of the treated patients.
Preobčutljivost Po sedanjih podatkih se pri približno 15% bolnikov prvo leto zdravljenja razvijejo protitelesa IgG za imiglucerazo.
It appears that patients who will develop IgG antibody are most likely to do so within 6 months of treatment and will rarely develop antibodies to Cerezyme after 12 months of therapy.
Kaže, da se pri bolnikih, pri katerih se protitelesa IgG razvijejo, le- ta zelo verjetno razvijejo v 6 mesecih in le redko po 12 mesecih zdravljenja.
Patients with antibody to Cerezyme (imiglucerase) have a higher risk of hypersensitivity reactions (see section 4.8).
Pri bolnikih s protitelesi za zdravilo Cerezyme (imiglucerazo) se poveča tveganje za preobčutljivostne reakcije (glejte poglavje 4. 8).
As with any intravenous protein product, severe allergic-type hypersensitivity reactions are possible.
Kot z vsemi intravenskimi proteinskimi proizvodi so možne resne preobčutljivostne reakcije alergijske vrste.
Pulmonary hypertension Pulmonary hypertension is a known complication of Gaucher disease.
Pljučna hipertenzija Pljučna hipertenzija je znan zaplet Gaucherjeve bolezni.
It has been observed both in patients receiving and not receiving enzyme replacement therapy.
Pojavlja se tako pri bolnikih, ki prejemajo nadomestno encimsko zdravljenje, kot pri tistih, ki ga ne.
No causal relationship with enzyme replacement therapy has been established.
Vzročne povezanosti z encimskim nadomestnim zdravljenjem niso ugotovili.
Patients with respiratory symptoms should be evaluated for the presence of pulmonary hypertension.
Pri bolnikih, ki imajo respiratorne simptome, je treba opraviti preiskave za pljučno hipertenzijo.
3 Excipients This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
3 Pomožne snovi To zdravilo vsebuje natrij in se aplicira v 0, 9% intravenski raztopini natrijevega klorida (glejte poglavje 6. 6).
No animal studies have been carried out with respect to assessing the effects of Cerezyme on pregnancy, embryonal/ foetal development, parturition and postnatal development.
Študije na živalih, za oceno učinkov zdravila Cerezyme na nosečnost, razvoj zarodka/ plodu, porod in postanatalni razvoj, niso bile izvedene.
Close monitoring of the pregnancy and clinical manifestations of Gaucher disease is necessary for the individualization of dose according to the patient ’ s needs and therapeutic response.
Za individualizacijo odmerkov glede na bolnikove potrebe in odziv na zdravljenje je treba skrbno nadzirati nosečnost in klinične manifestacije Gaucherjeve bolezni.
It is not known whether this active substance is excreted in human milk, however, the enzyme is likely to be digested in the child ’ s gastrointestinal tract
Ni znano, ali se ta zdravilna učinkovina izloča v materino mleko, vendar se bo encim verjetno presnovil v otrokovih prebavilih.
Adverse drug reactions are listed by system organ class and frequency (common (≥ 1/ 100 to < 1/ 10) and uncommon (≥ 1/ 1,000 to < 1/ 100)) in the table below.
V spodnji preglednici so neželeni učinki navedeni po organskih sistemih in pogostosti (pogosti (≥1/ 100 do < 1/ 10) in občasni (≥1/ 1. 000 do < 1/ 100)).
Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Znotraj vsake skupine pogostnosti so neželeni učinki na zdravilo navedeni po padajoči resnosti.
4 Nervous system disorders Uncommon:
4 Bolezni živčevja Občasno:
Dizziness, headache, paraesthesia Cardiac disorders Uncommon:
Omotica, glavobol, parestezija Srčne bolezni Občasno:
Tachycardia, cyanosis Vascular disorders
Ttahikardija, cianoza Žilne bolezni
Flushing, hypotension
Nnavali vročine, hipotenzija
Respiratory symptoms
Respiratorni simptomi
Musculoskeletal and connective tissue disorders
Bruhanje, navzea, krči v trebuhu, diareja
Urticaria/ angioedema, pruritus, rash
Urtikarija/ angioedem, pruritus, izpuščaj