natgillin/translations-raw huggingface dataset:
Do not use in pregnant or lactating bitches or in dogs intended for breeding (see section 5).
Ne uporabite pri brejih ali psicah v laktaciji ali pri psih namenjenih za razplod (glej poglavje 5).
Each tablet also contains lactose monohydrate, cellulose microcrystalline, magnesium stearate, silica colloidal anhydrous and Crospovidone.
Vsaka tableta vsebuje tudi laktozo monohidrat, celulozo, mikrokristalinično, magnezijev stearat, silicijev dioksid, koloidni in krospovidon.
Palladia 10 mg: Round shaped, blue coloured tablets Palladia 15 mg: Round shaped, orange coloured tablets Palladia 50 mg: Round shaped, red coloured tablets
Palladia 10 mg: okrogle oblike, tablete modre barve Palladia 15 mg: okrogle oblike, tablete oranžne barve Palladia 50 mg: okrogle oblike, tablete rdeče barve
MARKETING AUTHORISATION NUMBER(S) EU/2/09/100/001
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/100/001
The tablets must be administered as a whole and should not be divided, broken or ground.
Tablete morajo biti dane cele in se ne smejo razpoloviti, lomiti ali drobiti.
Dose reductions and/or dose interruptions may be needed to manage adverse events.
Po potrebi se bo odmerek znižal in/ali prekinil zaradi obvladovanja neželenih učinkov.
Also seen commonly but with less severe effects, were localised or general pain, nausea, flatulence, tachypnea, polydipsia, fever, urinary tract infection, increased bilirubin, increased creatinine.
Pogosto opazni toda z manj resnim učinkom so bili lokalna ali generalizirana bolečina, slabost, flatulenca, tahipneja, polidipsija, vročina, infekcije urinarnega trakta, povečan bilirubin, povišan kreatinin.
In rare cases, serious and sometimes fatal gastrointestinal complications including gastrointestinal perforation have occurred in dogs treated with Palladia.
V redkih primerih so se pri psih zdravljenih z zdravilom Palladia pojavili resni ali včasih smrtni gastrointestinalni zapleti, ki so vključevali gastointestinalno perforacijo.
Wash hands thoroughly with soap and water following handling of the product, and disposing of vomit, urine, or faeces of treated dogs.
Po ravnanju z zdravilom si temeljito operite roke z milom in vodo ter po odstranjevanju izbruhane vsebine, urina ali iztrebkov zdravljenih psov.
• ALT or AST <3 X upper normal limit
• ALT ali AST <3 X nad zgornjo referenčno mejo
There was also a significant advantage of Palladia over placebo in the secondary efficacy endpoint, time to tumour progression.
Statistično značilno boljša je bil tudi sekundarna učinkovitost zdravila Palladia pred placebo, čas brez ponovitve bolezni.
Discontinue treatment until clinical signs and clinical pathology have normalised.
Zdravljenje se prekine do izboljšanja kliničnih znakov oziroma dokler znaki klinične patologije popolnoma ne izzvenijo.
Lactose monohydrate Cellulose, microcrystalline Magnesium stearate Silica, colloidal anhydrous Crospovidone
Laktoza monohidrat Celuloza, mikrokristalinična Magnezijev stearat Silicijev dioksid, koloidni Krospovidon
Do not use in pregnant or lactating bitches or in dogs intended for breeding.
Ne uporabite v primeru brejosti ali laktacije pri psici ali pri psih namenjenih za vzrejo.
Discontinue treatment until >26%, then decrease dose by 0.5 mg/kg
Prekiniti zdravljenje dokler >26 %, nato znižati odmerek za 0.5 mg/kg
Do not use this veterinary medicinal product after the expiry date which is stated on the carton after “EXP”.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini po EXP. Za shranjevanje ni posebnih navodil.
DOSING TABLE: PALLADIA TABLETS:- 3.25 mg/kg BODYWEIGHT
TABELA ZA ODMERJANJE: TABLETE PALLADIA: 3.25 mg/kg TELESNE TEŽE
Manufacturer responsible for the batch release:
Izdelovalec, odgovoren za sproščanje serij:
In cases of accidental ingestion of Palladia, you may experience stomach discomfort, including vomiting or diarrhoea.
V primeru nenamernega zaužitja zdravila Palladia se lahko pojavijo želodčne motnje vključno z bruhanjem ali diarejo.
Macrogol, Titanium dioxide (E171), Lactose monohydrate, Triacetin, Hypromellose, Sunset Yellow Lake (E110), Iron oxide red (E172)
Makrogol, titanijev dioksid (E171), laktoza monohidrat, triacetin, hipomeloza, Sunset Yellow lake (E110), Iron oxide rdeča (E172)
Canine mast cell tumour growth is frequently driven by an activating mutation in c-Kit.
Mastocitomi pri psih pogosto napredujejo v rasti prav pod vplivom mutirane c-Kit.
Maintain dose level and institute supportive care
Ohraniti enak odmerek in začeti podporno terapijo
• If you are pregnant, you should not routinely administer Palladia; however, if you choose to give these tablets to your dog, you should be particularly careful and follow the handling procedures described below.
Če se odločite dajati tablete vašemu psu, bodite posebno pozorni in sledite spodaj opisanim postopkom rokovanja.
Disposal: read package leaflet
Odstranjevanje: preberite navodilo za uorabo.
The initial recommended dose is 3.25 mg/kg bodyweight, administered every second day (see Dosing table for details).
Začeten priporočen odmerek je 3.25 mg toceraniba/kg telesne teže, odmerjen vsak drugi dan (za podrobnosti glej tabelo za odmerjanje).
MARKETING AUTHORISATION NUMBER(S) EU/2/09/100/001 (10 mg tablets)
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/100/001 (10 mg tablets)
• Localised or general pain, nausea, tachypnea, polydipsia, flatulence, pyrexia, nasal depigmentation; changes in coat colour, alopecia, urinary tract infection; increased bilirubin, increased creatinine.
• lokalna ali generalizirana bolečina, slabost, tahipneja, polidipsija, flatulenca, pireksija, depigmentacija nosu; spremembe v barvi dlake, alopecija, infekcije urinarnega trakta; povečan bilirubin, povečan kreatinin.
The initial dose is approximately 3.25 mg/kg bodyweight, given every second day (see dosing table for details).
Začetni odmerek je 3.25 mg toceraniba/kg telesne teže, odmerjen vsak drugi dan (za podrobnosti glej tabelo za odmerjanje).
DOSING TABLE: PALLADIA TABLETS AT 3.25 MG/KG BODYWEIGHT
TABELA ZA ODMERJANJE: TABLETE PALLADIA V ODMERKU 3.25 MG/KG TELESNE TEŽE
Macrogol, Titanium dioxide (E171), Lactose monohydrate, Triacetin, Hypromellose, Talc, Iron oxide red (E172)
Makrogol, titanijev dioksid (E171), laktoza monohidrat, triacetin, hipomeloza, smukec, Iron oxide rdeča (E172)
Each film-coated tablet contains toceranib phosphate equivalent to 10 mg, 15 mg or 50 mg of toceranib.
Vsaka filmsko obložena tableta vsebuje toceranibov fosfat ekvivalenten 10 mg, 15 mg ali 50 mg toceraniba.
Palladia tablets should be given to your dog immediately after they are removed from the blister and should not be left around where they could be handled/swallowed by children.
• Ko ravnate s tabletami: o Ne lomite ali drobite tablet o Palladia tablete dajte vašemu psu takoj po odstranitvi iz pretisnega omota in jih ne puščajte na mestih, kjer lahko pride do stika/ zaužitja pri otrocih.
Palladia 15 mg tablets:
Palladia 15 mg tablete:
Palladia 50 mg tablets:
Palladia 50 mg tablete:
>3X upper normal limit
>3X nad zgornjo referenčno mejo
Each film-coated tablet contains toceranib phosphate equivalent to 10 mg, 15 mg or 50 mg of toceranib as active substance.
Vsaka filmsko obložena tableta vsebuje toceranibov fosfat ekvivalenten 10 mg, 15 mg ali 50 mg toceraniba kot zdravilno učinkovino.
NAME OF THE VETERINARY MEDICINAL PRODUCT Palladia 10 mg film-coated tablets for Dogs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Palladia 10 mg filmsko obložene tablete za pse
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