natgillin/translations-raw huggingface dataset:
In all three studies, patients with CKD and iron deficiency anaemia were randomized to treatment with Rienso or oral iron.
V vseh treh študijah so bili bolniki s kronično ledvično boleznijo in anemijo zaradi pomanjkanja železa randomizirani v zdravljenje z zdravilom Rienso ali peroralnim železom.
Iron then either enters the intracellular storage iron pool (e.g., ferritin) or is transferred to plasma transferrin for transport to erythroid precursor cells for incorporation into haemoglobin.
Železo nato bodisi vstopa v intracelularne zaloge železa (npr. feritin) ali pa se prenese v plazemski transferin za transport v eritroidne prekurzorske celice za vključitev v hemoglobin.
Patients should be monitored for signs and symptoms of hypotension following each Rienso administration.
Bolnike je treba nadzirati glede znakov in simptomov hipotenzije po vsakem dajanju zdravila Rienso.
Serious hypersensitivity or hypotensive reactions are uncommon (less than 1 case per 100 patients) and were reported in 0.2% (3/1562) of subjects with CKD who received Rienso during the clinical studies.
Resna preobčutljivost ali hipotenzivne reakcije so občasne (manj kot 1 primer na 100 bolnikov) in so o njih poročali pri 0,2 % (3/1.562) preiskovancev s kronično ledvično boleznijo, ki so med kliničnimi študijami prejeli zdravilo Rienso.
The healthcare professional checklist shall contain the following messages:
Obrazec za zdravstvene delavce mora vsebovati naslednje sporočilo:
Rienso is available in packs sizes of 1, 2, 6 or 10 vials.
Zdravilo Rienso je na voljo v velikostih pakiranja po 1, 2, 6 ali 10 vial.
This includes the Baseline and mean change to Day 35 in haemoglobin (Hgb, g/dl), transferrin saturation (TSAT, %) and ferritin (ng/ml) as well as the proportion of subjects who were Hgb Responders at Day 35 (defined as proportion of subjects with an increase in Hgb of at least 1.0 g/dl) in each treatment group for Studies 1, 2, and 3.
Ta vključuje izhodišče in srednjo spremembo glede na 35. dan za hemoglobin (Hgb, g/dl), nasičenost transferina (TSAT, %) in feritin (ng/ml) ter razmerje Hgb-odzivnih oseb na 35. dan (opredeljeno kot delež oseb s povečanjem Hgb za vsaj 1,0 g/dl) za vsako skupino zdravljenih v študijah 1, 2, in 3.
Life-threatening Anaphylactic/Anaphylactoid reactions*
življenje ogrožajoče anafilaktične/ anafilaktoidne reakcije*
Before administration, the vials will be inspected by the person administering the medicine for signs of damage or deterioration.
Pred uporabo bo oseba, ki vam bo zdravilo dala, vialo pregledala za znake poškodb ali kvarjenja.
Ethanol and sodium content
Etanol in vsebnost natrija
For dilution instructions, please see section 4.2.
Za navodila glede redčenja glejte poglavje 4.2.
The recommended course of Rienso is based on the patient's pre-treatment haemoglobin and body weight as provided in Table 1.
Priporočeni potek zdravljenja z zdravilom Rienso temelji na vrednosti hemoglobina pred zdravljenjem in telesni masi bolnika, kot je prikazano v preglednici 1.
Oral Iron n = 76
Peroralno železo n = 76
17 ml of solution in a vial (type I glass) with a stopper (chlorobutyl rubber) and an aluminium crimp-on seal.
17 ml razopine v eni viali (steklo tipa I) z zamaškom (klorobutilna guma) in aluminijasto zaporko.
Before you were prescribed Rienso, the doctor will have carried out a blood test to make sure that you have iron deficiency anaemia.
Preden vam bo zdravnik predpisal zdravilo Rienso, bo opravil preiskave krvi za potrditev, da ste slabokrvni zaradi pomanjkanja železa.
Rienso n = 228
Zdravilo Rienso n = 228
It is unknown whether Rienso is excreted in human milk.
Ni znano, ali se zdravilo Rienso izloča v materino mleko.
Rienso n = 114
Zdravilo Rienso n = 114
• Administer a single vial as an infusion.
• Dajte le eno vialo v obliki infuzije.
The pharmacokinetic (PK) behaviour of Rienso has been examined in healthy subjects and in patients with CKD stage 5D on haemodialysis.
Farmakokinetično vedenje zdravila Rienso so ovrednotili pri zdravih prostovoljcih in pri bolnikih s kronično ledvično boleznijo stopnje 5D na hemodializi.
• The checklist should include tick-boxes to check and document: o Confirmation on appropriate settings (emergency resuscitation equipment available ) prior to administration of ferumoxytol o Semi-reclined position during administration o Duration of monitoring of patients after administration.
• Obrazec mora vključevati okvirčke za preverjanje in mora dokumentirati: o potrditev ustreznih pogojev (razpoložljiva oprema za oživljanje v nujnem primeru) pred o trajanje spremljanja bolnikov po dajanju zdravila
Rate of infusion had no influence on Rienso PK parameters.
Hitrost infundiranja ni vplivala na farmakokinetične parametre zdravila Rienso.
If you are breast-feeding, ask your doctor for advice before you are given Rienso.
Če dojite, se posvetujte s svojim zdravnikom, preden dobite zdravilo Rienso.
Rienso should not be administered to patients with iron overload.
Zdravila Rienso se ne sme dajati bolnikom, preobremenjenim z železom.
It includes iron oxide particles with an iron oxide core surrounded by a polyglucose sorbitol-carboxymethylether shell.
Vključuje delce železovega oksida z jedrom železovega oksida, obdanim z ovojnico iz poliglukoze-sorbitolkarboksimetiletra.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Label (1, 2, 6 or 10 vial pack)
PODATKI NA ZUNANJI OVOJNINI Nalepka na škatli (pakiranje z 1, 2, 6 ali 10 vialami)
*Fatal and life-threatening hypersensitivity reactions have been observed with Rienso in the post marketing setting (see sections 4.3 and 4.4).
*V obdobju trženja zdravila Rienso so opazili smrtne in življenjsko nevarne preobčutljivostne reakcije (glejte poglavji 4.3 in 4.4).
Excessive administration of Rienso may lead to accumulation of iron in storage sites potentially leading to haemosiderosis.
Pretirana uporaba zdravila Rienso lahko povzroči kopičenje železa na mestih shranjevanja, ki lahko povzroči hemosiderozo.
510 mg iron (1 vial)
510 mg železa (1 viala)
Oral Iron n = 116
Peroralno železo n = 116
Clinical presentation has included anaphylactic type reactions presenting with cardiac arrest/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness (see section 4.8).
Klinični znaki so vključevali reakcije anafilaktičnega tipa, ki so se manifestirale kot zastoj srca/zastoj srca in dihanja, klinično pomembna hipotenzija, sinkopa in neodzivnost (glejte poglavje 4.8).
Dosing should begin when blood pressure is stable and the patient has completed at least one hour of haemodialysis.
Odmerjanje naj se začne, ko je krvni tlak stabilen in je bil bolnik že vsaj eno uro na hemodializi.
Intravenous use by infusion.
Način uporabe intravenska uporaba v obliki infuzije
In a 4 week repeated dose toxicity study in rats after a recovery of 26 weeks hepatic changes (focal or multifocal haemorrhage, hemorrhagic necrosis, chronic inflammation, and/or bile duct hyperplasia) were seen in the female animals (the cumulative HED of the dose groups compares to a safety multiple of 5.1 and 10.5 to the cumulative human therapeutic dose (2 x 510 mg Fe) in a 60 kg human).
V 4-tedenski študiji toksičnosti pri ponavljajočih odmerkih na podganah so po 26 tednih okrevanja ugotovili spremembe na jetrih (fokalne ali multifokalne krvavitve, hemoragično nekrozo, kronično vnetje in/ali hiperplazijo žolčnih vodov) pri samicah (kumulativni ekvivalentni človeški odmerek za uporabljeni skupini odmerkov ustreza varnostnima količnikoma 5,1 in 10,5 glede na kumulativni terapevtski človeški odmerek (2 x 510 mg Fe) za človeka s telesno maso 60 kg).
What Rienso looks like and contents of the pack
Izgled zdravila Rienso in vsebina pakiranja
Table 2 presents all adverse experiences observed during the clinical studies in which 1562 subjects with CKD received two injections of 510 mg of Rienso separated by an interval of 2 to 8 days and post-marketing experience.
V preglednici 2 so predstavljeni vsi neželeni učinki, ki so jih opazili med kliničnimi študijami, v katerih je 1.562 oseb s kronično ledvično boleznijo prejelo dve injekciji po 510 mg zdravila Rienso v intervalu 2 do 8 dni in v obdobju trženja.
Rienso can affect the interpretation of your blood iron test results.
Zdravilo Rienso lahko vpliva na razlago izvidov preiskave železa v krvi.
Lacrimation increased Vision blurred
Očesne bolezni povečano solzenje zemegljen vid
Rienso should only be administered when staff trained to evaluate and manage anaphylactic reactions are immediately available.
Zdravilo Rienso se sme dati samo, če je osebje, usposobljeno za vrednotenje in zdravljenje anafilaktičnih reakcij, lahko takoj dosegljivo.
The MAH is of the opinion that the current EU SmPC accurately reflects the current literature and provides appropriate guidance to EU practitioners.
Imetnik dovoljenja za promet z zdravilom je mnenja, da trenutni povzetek glavnih značilnosti zdravila za EU natančno podaja trenutno razpoložljive vire in ustrezno usmerja zdravnike v EU.
Anticipated MR imaging studies should be conducted prior to the administration of Rienso.
Načrtovane študije slikanja z magnetno resonanco je treba opraviti pred dajanjem zdravila Rienso.
However, caution should be exercised in interpreting serum iron levels in the 24 hours following administration of Rienso as laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in Rienso.
Vendar pa je potrebna previdnost pri razlaganju ravni železa v serumu v 24 urah po dajanju zdravila Rienso, saj lahko laboratorijski testi pokažejo zvišano železo v serumu in železo, vezano na transferin, zaradi sočasnega merjenja železa v zdravilu Rienso.
Shelf-life after first opening and after dilution for infusion:
Rok uporabnosti po prvem odprtju in redčenju pred infundiranjem:
In a prenatal and postnatal developmental study in rats adverse effects on sexual maturation and on the ability to produce a litter were noted in the F1-generation (see section 5.3).
V študiji prenatalnega in postnatalnega razvoja pri podganah so opazili neželene učinke na spolno dozorevanje in na reproduktivno sposobnost v generaciji F1 (glejte poglavje 5.3).
In rabbits administration of Rienso during organogenesis induced decreased foetal weights and external and/or soft tissue malformations (malrotated or flexed fore- and malrotated hindlimbs, internal hydrocephaly, absent brains, cleft palate and microglossia) at the high dose of 45.3 mg Fe/kg/day (HED of 14.6 mg Fe/kg/day), a dose which induced only minimal maternal toxicity.
Dajanje zdravila Rienso kuncem med organogenezo je povzročilo zmanjšano telesno maso plodov in zunanje deformacije in/ali deformacije mehkega tkiva (nepravilno obrnjene ali upognjene sprednje in obrnjene zadnje okončine, interni hidrocefalus, odsotnost možgan, palatoshiza in mikroglosija) pri velikem odmerku 45,3 mg Fe/kg/dan (kar ustreza odmerku 14,6 mg Fe/kg/dan pri človeku), odmerku, ki je le minimalno toksičen za mater.
The aim of Rienso therapy is to replenish the body's iron stores.
Cilj zdravljenja z zdravilom Rienso je napolniti zaloge železa v telesu.
Rienso is indicated for the intravenous treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD).
Zdravilo Rienso je indicirano za intravensko zdravljenje anemije zaradi pomanjkanja železa pri odraslih bolnikih s kronično ledvično boleznijo.
The estimated values of CL and Vd following two 510 mg doses of Rienso administered intravenously within 24 hours were 69.1 ml/hr and 3.3 l, respectively.
Po uporabi dveh 510 mg odmerkov zdravila Rienso, danih intravensko v roku 24 ur, je bila ocenjena vrednost očistka 69,1 ml/uro in Vd 3,3L.
Taking into account the PRAC Assessment Report on the PSUR for Rienso, the scientific conclusions of PRAC are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednega posodobljenega poročila o varnosti zdravila (PSUR) za zdravilo Rienso je odbor PRAC sprejel naslednje znanstvene zaključke:
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, local tolerance and immunotoxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, lokalne tolerance in imunotoksičnosti ne kažejo posebnega tveganja za človeka.
No gender differences in Rienso PK parameters were observed.
Razlik med spoloma pri farmakokinetičnih parametrih zdravila Rienso niso opazili.
In the 24 hours following administration of Rienso, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in the Rienso complex.
V 24 urah po dajanju zdravila Rienso lahko laboratorijski testi pokažejo previsoko vrednost železa v serumu in železa vezanega na transferin, ker izmerijo tudi železo v kompleksu zdravila Rienso.
5.2 Pharmacokinetic Properties
5.2 Farmakokinetične lastnosti
Adverse reactions observed during clinical studies and post-marketing
Preglednica 2: Neželeni učinki, ki so jih opazili med kliničnimi študijami in v obdobju trženja ORGANSKI
UNCOMMON (≥ 1/1,000 to
OBČASNI (≥1/1.000 do
It is not recommended to administer Rienso to patients with ongoing bacteraemia.
Dajanja zdravila Rienso bolnikom, ki imajo bakteriemijo, se ne priporoča.
Rienso is an iron preparation, containing the active substance ferumoxytol, which is given by infusion into a vein.
Zdravilo Rienso je zdravilo z železom, ki vsebuje zdravilno učinkovino ferumoksitol, ki se daje z infuzijo v veno.
Rienso was administered as two 510 mg intravenous injections (separated by 2 to 8 days) and oral iron (ferrous fumarate) was administered at a total daily dose of 200 mg elemental iron for 21 days.
Zdravilo Rienso so dali v obliki dveh 510 mg intravenskih injekcij (v razmiku 2 do 8 dni), peroralno železo (železov fumarat) pa so dajali 21 dni v skupnem dnevnem odmerku 200 mg elementarnega železa.
No carcinogenicity studies were performed with Rienso.
Z zdravilom Rienso niso izvajali študij kancerogenosti.
The iron is then released intracellularly from the iron-carbohydrate complex within vesicles in macrophages.
Železo se potem sprošča intracelularno iz kompleksa železo-ogljikov hidrat v veziklih makrofagov.
Tachycardia/Arrhythmia, Cardiac arrest Cardio-respiratory arrest Myocardial infarction Cyanosis
Srčne bolezni tahikardija/aritmija zastoj srca zastoj srca in dihanja miokardni infarkt cianoza kongestivno srčno popuščanje
Administration of Rienso during organogenesis in rats at maternally toxic doses of 100 mg Fe/kg/day caused a decrease in foetal weights.
Dajanje zdravila Rienso med organogenezo pri podganah z odmerki 100 mg Fe/kg/dan, toksičnimi za mater, so povzročili manjšo telesno maso zarodkov.
• No other intravenous dilution solutions and therapeutic agents should be used.
• Uporabiti se ne sme nobene druge raztopine za redčenje ali drugega zdravila za intravensko
The Cmax and time of maximum concentration (tmax) were 206 mcg/ml and 0.32 hr, respectively.
Cmax je bil 206 mcg/ml in čas največje koncentracije (tmax) 0,32 ur.
MR images are interpretable earlier by readers aware of the recent administration of Rienso or by the use of T1- or proton density-weighted MR pulse sequences.
Slikanje z magnetno resonanco je mogoče razlagati prej, če je oseba, ki izsledke odčitava, seznanjena z nedavno aplikacijo zdravila Rienso ali z uporabo pulznega zaporedja magnetnoresonančnega slikanja, poudarjenega s T1 ali protoni.
No data from clinical trials are available regarding overdose of Rienso in humans.
Podatkov iz kliničnih preskušanj za preveliko odmerjanje zdravila Rienso pri ljudeh ni na voljo.
Any suspected adverse reactions should be reported via the national reporting system listed in Appendix V.
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema eozinofilija
For patients receiving two doses, the second 510 mg infusion is to be administered 2 to 8 days later as per Table1.
Bolniki, ki prejmejo dva odmerka, morajo drugo 510 mg intravensko infuzijo prejeti 2 do 8 dni kasneje, kot je navedeno v preglednici 1.
Rienso is a colloidal iron-carbohydrate complex.
Zdravilo Rienso je koloidni kompleks železa-ogljikovih hidratov.
He or she will also monitor your blood test results to avoid iron accumulation.
Zdravnik bo nadziral tudi vaše izvide krvnih preiskav, da se železo ne začne kopičiti.
Rienso is a black to reddish-brown solution for infusion.
Zdravilo Rienso je črna do rdečkasto-rjava raztopina za infundiranje.
The clearance (CL) was decreased with increased doses of Rienso.
Očistek se je z večanjem odmerka zdravila Rienso manjšal.
In a pre-natal and post-natal development study in rats sexual maturation was delayed in male pups in the high dose of 60 mg Fe/kg/day (HED of 9.7 mg Fe/kg/day).
V študiji prenatalnega in postnatalnega razvoja pri podganah je bila spolna zrelost podgan pri podganjih samčkih pri visokih odmerkih 60 mg Fe/kg/dan (kar ustreza odmerku 9,7 mg Fe/kg/dan pri človeku) zakasnjena.
Talk to your doctor, pharmacist or nurse before receiving Rienso: - if you have a history of medicine allergy.
Preden boste prejeli zdravilo Rienso, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro: - če ste v preteklosti že imeli alergične reakcije.
A careful risk/benefit evaluation is therefore required before use during pregnancy and Rienso should not be used during pregnancy unless clearly necessary (see section 4.4).
Zdravila Rienso med nosečnostjo ne smete uporabljati, razen če je nujno potrebno (glejte poglavje 4.4).
A second vial of the medicine should be administered as an infusion two to eight days later if indicated.
Drugo vialo zdravila je treba dati v obliki infuzije dva do osem dni kasneje, če je to indicirano.
In Study 3, the mean age of patients was 60 years (range, 24 to 87); 43% were female; 34% were Caucasian, 59% were Black, and 7% were other races.
Povprečna starost bolnikov v študiji 3 je bila 60 let (razpon 24 do 87); 43 % je bilo žensk, 34 % je bilo belcev, 59 % temnopoltih in 7 % so bile druge rase.
• Patients should be carefully monitored for signs and symptoms of hypersensitivity reactions including monitoring of blood pressure and pulse during and for at least 30 minutes following each infusion of Rienso.
• Bolnike je treba skrbno nadzirati glede pojava znakov in simptomov preobčutljivostnih reakcij, vključno s spremljanjem krvnega tlaka in srčnega utripa med vsakim infundiranjem zdravila Rienso in še najmanj 30 minut po njem.
Baseline Hgb (mean ± SD, g/dl)
Izhodiščni Hgb (srednja vrednost ± SD, g/dl)
Magnetic Resonance (MR) Imaging
Slikanje z magnetno resonanco
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per 17 ml vial.
To zdravilo vsebuje majhne količine etanola (alkohola), in sicer manj kot 100 mg na 1 vialo (17 ml).
In Study 2, the mean age of patients was 65 years (range, 31 to 96); 61% were female; 58% were Caucasian, 35% were Black, and 7% were other races.
Povprečna starost bolnikov v študiji 2 je bila 65 let (razpon 31 do 96); 61 % je bilo žensk, 58 % je bilo belcev, 35 % temnopoltih in 7 % so bile druge rase.
Within this PSUR, a further literature review has been provided by the MAH identifying 9 relevant publications addressing ferumoxytol and MRI.
V tem poročilu PSUR je imetnik dovoljenja za promet z zdravilom navedel pregled dodatnih virov z 9 zadevnimi objavami o ferumoksitolu in MRI.
Administration of Rienso may transiently affect the diagnostic ability of MR imaging.
Dajanje zdravila Rienso lahko prehodno vpliva na diagnostično sposobnost slikanja z magnetno resonanco.
Solution for infusion 1 vial
raztopina za infundiranje 1 viala
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per 17 ml vial.
To zdravilo vsebuje majhne količine etanola (alkohola), in sicer manj kot 100 mg na vialo (17 ml).
Patients should be carefully monitored for signs and symptoms of hypersensitivity reactions including monitoring of blood pressure and pulse during and for at least 30 minutes following each infusion of Rienso.
Bolnike je treba skrbno nadzirati glede pojava znakov in simptomov preobčutljivostnih reakcij, vključno s spremljanjem krvnega tlaka in srčnega utripa med vsakim infundiranjem zdravila Rienso in še najmanj 30 minut po njem.
≤ 50 kg Body Weight
hemoglobin telesna masa ≤ 50 kg telesna masa > 50 kg
Treatment Course
Potek zdravljenja
In Study 1, the mean age of patients was 66 years (range, 23 to 95); 60% were female; 65% were Caucasian, 32% were Black, and 2% were other races.
Povprečna starost bolnikov v študiji 1 je bila 66 let (razpon 23 do 95); 60 % je bilo žensk, 65 % je bilo belcev, 32 % temnopoltih in 2 % so bile druge rase.
No other intravenous dilution solutions and therapeutic agents should be used.
Uporabiti se ne sme nobene druge raztopine za redčenje ali drugega zdravila za intravensko uporabo.
Rienso must not be given to patients if their haemoglobin is greater than 12 g/dl, serum Transferrin Saturation (TSAT) is greater than 50% or ferritin is greater than 800 ng/ml (see section 4.2).
Zdravila Rienso se ne sme dajati bolnikom, če je njihov hemoglobin večji kot 12 g/dl, nasičenost transferina v serumu (TSAT) večja kot 50 % ali ki imajo vrednost feritina višjo od 800 ng/ml (glejte poglavje 4.2).
Rienso should be administered as an infusion in 50-250 ml of sterile 0.9% sodium chloride or sterile 5% glucose for at least 15 minutes (see sections 6.3 and 6.6).
Zdravilo Rienso je treba aplicirati v obliki infuzije v 50-250 ml sterilne 0,9-odstotne raztopine natrijevega klorida ali sterilne 5-odstotne raztopine glukoze najmanj 15 minut (glejte poglavji 6.3 in
For patients receiving haemodialysis, Rienso should be administered once the blood pressure is stable and the patient has completed at least one hour of haemodialysis.
Bolniki na hemodializi lahko zdravilo Rienso prejmejo, ko se krvni tlak stabilizira in je bil bolnik vsaj eno uro na hemodializi.
Rienso-treated patients included hypotension, infusion site swelling, increased serum ferritin levels, chest pain, diarrhoea, dizziness, ecchymosis, pruritis, chronic renal failure and urticaria.
V kliničnih preskušanjih so neželeni učinki, ki so povzročili prekinitev zdravljenja in so se pojavili pri ≥ 2 bolnikih, zdravljenih z zdravilom Rienso, vključevali hipotenzijo, oteklino na mesto infundiranja, povečane ravni feritina v serumu, bolečino v prsih, drisko, omotico, ekhimozo, pruritis, kronično ledvično odpoved in urtikarijo.
In addition, patients should be placed in a reclining or semi-reclining position during infusion and for at least 30 minutes thereafter.
Poleg tega morajo biti bolniki med infundiranjem in še najmanj 30 minut po njem nameščeni v ležeč ali polležeč položaj.
No adverse effects on fertility or general reproductive performance were noted in adult rats (see Section 5.3).
Pri odraslih podganah niso opazili neželenih učinkov na plodnost ali splošno sposobnost razmnoževanja (glejte poglavje 5.3).
Justification for not including Braille is accepted
PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna
Common side effects (may affect up to 1 in 10 people): - bleeding, swelling, bruising, pain, rash, irritation or warmth at infusion/injection site
Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov): - krvavitev, oteklina, modrice, bolečina, izpuščaj, draženje ali občutek toplote na mestu infundiranja/injiciranja.
You will be carefully observed during the infusion and for at least 30 minutes after each infusion by your doctor or nurse.
Med vsakim infundiranjem in še najmanj 30 minut po njem vas bosta zdravnik ali medicinska sestra skrbno nadzirala.
• Hypersensitivity to the active substance, to Rienso or any of its excipients listed in section 6.1
• preobčutljivosti za zdravilno učinkovino, zdravilo Rienso ali katero koli pomožno snov,
SYSTEM ORGAN CLASS
ORGANSKI SISTEMI