natgillin/translations-raw huggingface dataset:
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/dL, is unclear because few patients with these characteristics were included in the data reviewed.
Ni pa jasno, v kolikšni meri bi te ugotovitve lahko veljale za uporabo rekombinantnega eritropoetina pri bolnikih z rakom, ki dobivajo kemoterapijo, če je ciljna koncentracija hemoglobina manjša od 130 g/l; analizirani podatki so namreč obsegali le malo bolnikov s takšnimi značilnostmi.
This study supports 500 mcg once every three weeks being comparable to once weekly administration with respect to the incidence of subjects receiving at least one red blood cell transfusion from week 5 to the end of treatment phase.
Študija potrjuje, da je uporaba 500 µg enkrat na tri tedne primerljiva uporabi enkrat na teden, kar zadeva incidenco preiskovancev, ki so od 5. tedna do konca faze zdravljenja dobili vsaj eno transfuzijo eritrocitov.
In order to correct your anaemia, your initial dose will be
Za odpravljanje anemije boste dobili začetni odmerek
If you want to stop using Aranesp, you should discuss it with your doctor first.
Če želite prenehati uporabljati zdravilo Aranesp, se pred tem posvetujte z zdravnikom.
If you need to use the same injection site, just make sure it is not the same spot on that site you used last time.
Če morate uporabiti enako mesto injiciranja, zagotovite, da na tem mestu ne uporabite iste točke kot pri zadnjem injiciranju.
In all paediatric CRF studies, there were no additional adverse reactions identified for paediatric patients compared to those previously reported for adult patients (see section 5.1).
V vseh študijah pri pediatričnih bolnikih s kronično odpovedjo ledvic niso ugotovili dodatnih neželenih učinkov pri pediatričnih bolnikih v primerjavi s tistimi, ki so bili že pred tem opisani pri odraslih bolnikih (glejte poglavje 5.1).
If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.
Če želite uporabiti isto mesto za injiciranje, se prepričajte, da ne boste injicirali na isti točki kot ste pri predhodnem injiciranju.
Name and address of the manufacturers responsible for batch release
Ime in naslov proizvajalcev, odgovornih za sproščanje serije
For adult patients not on dialysis, 1.5 micrograms/kg once monthly may also be used as the initial dose.
Za odrasle bolnike, ki niso na dializi, je mogoče kot začetni odmerek uporabiti tudi 1,5 mikrograma/kg enkrat na mesec.
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients (see section 4.2).
Zdravljenje simptomatske anemije, povezane s kronično odpovedjo ledvic pri odraslih in pri pediatričnih bolnikih (glejte poglavje 4.2).
Aranesp should also be used with caution in those patients with sickle cell anaemia.
Prav tako morate zdravilo Aranesp uporabljati previdno pri bolnikih z anemijo srpastih celic.
What Aranesp is and what it is used for What you need to know before you use Aranesp How to use Aranesp
Kaj je zdravilo Aranesp in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Aranesp Kako uporabljati zdravilo Aranesp Možni neželeni učinki
Before you use the Aranesp SureClick pre-filled pen, read this important information: Storing your Aranesp SureClick pre-filled pens
Pred uporabo napolnjenega injekcijskega peresnika zdravila Aranesp preberite te pomembne informacije: Shranjevanje napolnjenega injekcijskega peresnika zdravila Aranesp
The MAH shall agree the final educational material with the national competent authority where the pre-filled pen is marketed.
Imetnik dovoljenja za promet z zdravilom se mora o končnem izobraževalnem gradivu dogovoriti s pristojnim nacionalnim organom države, v kateri se napolnjeni injekcijski peresnik trži.
How do I prepare my Aranesp injection?
Kako pripravim injekcijo zdravila Aranesp?
Convulsions
konvulzije
If it occurs, appropriate dose adjustment should be made as provided.
Če se to vseeno zgodi, morate odmerek ustrezno prilagoditi.
Dosing should be titrated as necessary to maintain the haemoglobin target.
Odmerjanje je treba prilagajati, kot je potrebno za vzdrževanje ciljne koncentracije hemoglobina.
Do not use any Aranesp that is left in the syringe.
Ne uporabljajte preostanka zdravila Aranesp, ki je ostal v brizgi.
Caution should be exercised when prescribing Aranesp to pregnant women.
Pri predpisovanju zdravila Aranesp nosečnicam je potrebna previdnost.
Significantly fewer patients received RBC transfusions in the epoetin alfa plus SOC arm (5.8% versus 11.4%); however, significantly more patients had thrombotic vascular events in the epoetin alfa plus SOC arm (2.8% versus 1.4%).
Značilno manj bolnikov je prejelo transfuzije eritrocitov v skupini z epoetinom alfa in standardno oskrbo (5,8 % v primerjavi z 11,4 %); vendar pa je imelo značilno več bolnikov trombotične žilne dogodke v skupini z epoetinom alfa in standardno oskrbo (2,8 % v primerjavi z 1,4 %).
In the event of polycythaemia, Aranesp should be temporarily withheld (see section 4.2).
V primeru policitemije je treba uporabo zdravila Aranesp prehodno prekiniti (glejte poglavje 4.2).
If Aranesp is given concomitantly with any of these treatments, blood levels of these substances should be monitored and the dosage adjusted as the haemoglobin rises.
Če zdravilo Aranesp dajete sočasno s temi zdravili, je treba koncentracijo teh snovi v krvi kontrolirati in odmerke prilagajati, ko se koncentracija hemoglobina zvišuje.
Your doctor will check that your haemoglobin does not exceed a certain level, as high haemoglobin concentrations could put you at risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
Zdravnik bo preverjal, da vam koncentracija hemoglobina ne bo presegla določene vrednosti, kajti visoke koncentracije hemoglobina vas lahko izpostavijo tveganju za težave s srcem ali ožiljem in vam povečajo tveganje za srčni infarkt, možgansko kap in smrt.
If you develop a serious rash or another of these skin symptoms, stop taking Aranesp and contact your doctor or seek medical attention immediately.
Če se vam pojavi resen izpuščaj ali kakšen drug od teh kožnih simptomov, takoj prenehajte uporabljati zdravilo Aranesp in se nemudoma posvetujte s svojim zdravnikom ali nemudoma poiščite zdravniško pomoč.
Overall survival outcome in the trials could not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human erythropoietin and those in the control group.
Rezultata celotnega preživetja v teh preskušanjih ni mogoče zadovoljivo pojasniti z različno incidenco tromboze in sorodnih zapletov med bolniki, ki so dobivali rekombinantni humani eritropoetin, in bolniki v kontrolni skupini.
Healthcare Providers only Remove and save the pre-filled syringe label.
Samo za zdravstveno osebje Odstranite in shranite nalepko z napolnjene injekcijske brizge.
If clinically indicated, phlebotomy may be performed.
Narediti je mogoče flebotomijo, če je klinično indicirana.
4 single use vials
4 viale za enkratno uporabo
Remove the pre-filled syringe from the refrigerator.
Vzemite napolnjeno injekcijsko brizgo iz hladilnika.
Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater in vivo activity.
Zaradi večje vsebnosti ogljikovih hidratov je terminalni razpolovni čas darbepoetina alfa daljši kot terminalni razpolovni čas r-HuEPO, zato je njegova aktivnost in vivo večja.
Misuse of Aranesp by healthy persons may lead to an excessive increase in packed cell volume.
Zloraba zdravila Aranesp pri zdravih osebah lahko povzroči čezmerno zvečanje hematokrita.
In case PRCA is diagnosed, therapy with Aranesp must be discontinued and patients should not be switched to another recombinant erythropoietic protein (see section 4.4).
Če je diagnosticirana čista aplazija rdečih celic, morate zdravljenje z zdravilom Aranesp prekiniti, bolnika pa ne smete prevesti na drugo rekombinantno eritropoetično beljakovino (glejte poglavje 4.4).
Patients were randomised to receive Aranesp at 500 mcg once every three weeks or 2.25 mcg/kg once weekly.
Bolnike so randomizirali na prejemanje zdravila Aranesp 500 µg enkrat na tri tedne ali 2,25 µg/kg enkrat na teden.
Use a new pre-filled syringe and call your doctor or healthcare provider.
Uporabite novo napolnjeno injekcijsko brizgo in se posvetujte z zdravnikom ali zdravstvenim delavcem.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.65 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 0,65 ml
EPO-ANE-3010, a randomised, open-label, multicentre study was conducted in 2,098 anaemic women with metastatic breast cancer, who received first line or second line chemotherapy.
V randomizirani, odprti, multicentrični študiji EPO-ANE-3010 je sodelovalo 2.098 slabokrvnih žensk z metastatskim rakom dojke, ki so prejemale kemoterapijo v prvi ali drugi liniji.
The pharmacokinetics of darbepoetin alfa has been studied clinically in chronic renal failure patients following intravenous and subcutaneous administration.
Farmakokinetiko darbepoetina alfa so raziskali pri bolnikih s kronično odpovedjo ledvic po intravenski in subkutani uporabi.
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema neznana2
• Stomach area (abdomen), except for a 5 cm (2-inch) area right around your navel
• področje želodca (trebuh), razen 5 cm okoli popka
In kidney failure, the kidney does not produce enough of the natural hormone erythropoietin which can often cause anaemia.
Pri odpovedi ledvic v ledvicah ne nastaja dovolj naravnega hormona eritropoetina; pogosta posledica tega je anemija.
Appropriate dose titration between 500 mcg, 300 mcg, and 150 mcg should be considered.
V poštev pride ustrezno titriranje odmerka med 500 µg, 300 µg in 150 µg.
If your doctor has decided to change your treatment from r-HuEPO (erythropoietin produced by gene-technology) to Aranesp, they will choose whether you should receive your Aranesp injection once weekly or once every two weeks.
Če se zdravnik odloči, da vam namesto r-HuEPO (genskotehnološko pridobljenega eritropoetina) predpiše zdravilo Aranesp, bo tudi določil, ali morate injekcijo zdravila Aranesp dobiti enkrat na teden ali enkrat na dva tedna.
Convulsions were common in the placebo groups.
V skupinah s placebom so bile konvulzije pogoste.
Insert the needle fully into the skin as shown by your doctor, nurse or pharmacist.
Zabodite iglo do konca v kožo, kot so vam pokazali zdravnik, medicinska sestra ali farmacevt.
Do not try to warm the pre-filled pen by using a heat source such as hot water or microwave.
Ne poskušajte ogrevati brizge z viri toplote kot sta vroča voda ali mikrovalovna pečica.
Per the Guideline on Summary of Product Characteristics (Revision 2, September 2009), frequency of ADRs identified in the post marketing setting was determined using the “Rule of three”.
V skladu z dokumentom Guideline on Summary of Product Characteristics (revizija 2, september 2009) je bila pogostnost neželenih učinkov, prepoznanih v obdobju trženja zdravila, določena z uporabo “pravila trojke”.
Push the plunger with a slow constant pressure, always keeping your skin pinched, until the syringe is empty.
Kožo ves čas držite ter s počasnim in stalnim pritiskom potiskajte bat, dokler brizge ne izpraznite.
Correction of anaemia in paediatric patients with once monthly Aranesp dosing frequency has not been studied.
Odpravljanje anemije z uporabo zdravila Aranesp enkrat na mesec pri pediatrični populaciji ni raziskano.
In studies performed in rats and rabbits no clinically relevant evidence of harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development was observed.
V študijah na podganah in kuncih niso opazili klinično pomembnih znakov škodljivih učinkov, kar zadeva brejost, razvoj zarodka/ploda, skotitev ali postnatalni razvoj.
In patients with a poor haemoglobin response to Aranesp, alternative explanations for the poor response should be considered (see sections 4.4 and 5.1).
Pri bolnikih, ki imajo slab odziv hemoglobina na zdravilo Aranesp, je treba upoštevati druge možne vzroke za slab odziv (glejte poglavji 4.4 in 5.1).
Put the original package with any unused pre-filled syringes back in the refrigerator.
Položite originalno pakiranje s še ne uporabljenimi napolnjenimi injekcijskimi brizgami nazaj v hladilnik.
Aranesp is administered either subcutaneously or intravenously as described in the posology.
Zdravilo Aranesp se uporablja subkutano ali intravensko, kot je opisano v poglavju Odmerjanje.
In all cases, call your doctor or healthcare provider.
V vsakem od teh primerov se posvetujte z zdravnikom ali zdravstvenim delavcem.
- Your doctor should try to keep your haemoglobin between 10 and 12 g/dL.
- Zdravnik si mora prizadevati, da bi vam hemoglobin ohranil med 100 in 120 g/l.
Thereafter the haemoglobin can be measured at longer intervals.
Potem lahko hemoglobin kontrolirate v daljših presledkih.
PHARMACEUTICAL FORM AND CONTENTS 1 single use pre-filled syringe.
FARMACEVTSKA OBLIKA IN VSEBINA 1 napolnjena injekcijska brizga za enkratno uporabo.
Contents of the pack and other information Instructions for injecting with the Aranesp pre-filled syringe
Vsebina pakiranja in dodatne informacije Navodila za injiciranje z napolnjeno injekcijsko brizgo Aranesp
Remove the needle and let go of your skin.
Izvlecite iglo in kožo spustite.
Production of endogenous erythropoietin is impaired in patients with chronic renal failure and the primary cause of their anaemia is due to erythropoietin deficiency.
Nastajanje endogenega eritropoetina je okvarjeno pri kronični odpovedi ledvic; primarni vzrok anemije pri takšnih bolnikih je pomanjkanje eritropoetina.
The pharmacokinetics of darbepoetin alfa in paediatric patients (2 to 16 years) with CRF who were either receiving or not receiving dialysis was assessed for sampling periods up to 2 weeks (336 hours) after one or two subcutaneous or intravenous doses.
Farmakokinetiko darbepoetina alfa pri pediatričnih bolnikih (starih od 2 do 16 let) s kronično boleznijo ledvic, ki so bili ali niso bili na dializi, so preučili v obdobju vzorčenja do 2 tednov (336 ur) po enem ali dveh subkutanih ali intravenskih odmerkih.
• an observed 9% increase in risk for PD or death in the epoetin alfa plus SOC group from a primary analysis and a 15% increased risk that cannot be statistically ruled out in patients with metastatic breast cancer receiving chemotherapy when administered to achieve a haemoglobin concentration range of 10 to 12 g/dL (6.2 to 7.5 mmol/L).
• povzročila opaženo 9 % povečanje tveganja za napredovanje bolezni ali smrt v skupini z epoetinom alfa in standardno oskrbo iz primarne analize in 15 % povečanje tveganja, ki ga statistično ni mogoče izključiti, pri bolnicah z metastatskim rakom dojke, zdravljenih s kemoterapijo, kadar so prejemale odmerke za doseganje razpona koncentracije hemoglobina od 100 do 120 g/l (od 6,2 do 7,5 mmol/l).
With the grey cap off, place the pre-filled pen on your skin at 90 degrees.
Sivi pokrovček mora biti odstranjen; prislonite napolnjeni injekcijski peresnik na kožo pod kotom 90 stopinj.
Do not recycle the pre-filled pen or sharps disposal container or throw them into household rubbish.
Ne reciklirajte napolnjenega injekcijskega peresnika ali vsebnika za ostre odpadke ter ju ne vrzite med gospodinjske odpadke.
Window Medicine Make sure the medicine in the window is a clear and colourless liquid.
Prepričajte se, da je zdravilo v okencu bistra in brezbarvna tekočina.
In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
V odprti študiji ni bilo razlike v celotnem preživetju bolnikov, zdravljenih z rekombinantnim humanim eritropoetinom, in bolnikov v kontrolni skupini.
Clinical studies have demonstrated that adult patients receiving r-HuEPO one, two or three times weekly may be converted to once weekly or once every other week Aranesp.
Klinične študije so pokazale, da lahko odrasli bolniki, ki dobivajo r-HuEPO enkrat, dvakrat ali trikrat na teden, preidejo na zdravilo Aranesp enkrat na teden ali enkrat na dva tedna.
• Additional risk minimisation measures for Aranesp solution for injection in pre-filled pen
• Dodatni ukrepi za zmanjševanje tveganj za zdravilo Aranesp v obliki raztopine za injiciranje v napolnjenem injekcijskem peresniku
H Firmly push the pre-filled pen down onto your skin until it stops moving.
H Trdno pritisnite napolnjeni injekcijski peresnik ob kožo, dokler se ne neha premikati.
Clinical data in paediatric patients has demonstrated that patients receiving r-HuEPO two or three times weekly may be converted to once weekly Aranesp, and those receiving r-HuEPO once weekly may be converted to once every other week Aranesp.
Klinični podatki pri pediatričnih bolnikih kažejo, da lahko tisti, ki dobivajo r-HuEPO dvakrat ali trikrat na teden, preidejo na zdravilo Aranesp enkrat na teden, tisti, ki dobivajo r-HuEPO enkrat na teden, pa na zdravilo Aranesp enkrat vsak drugi teden.
The syringes may be presented in either blistered (1- and 4-pack), with or without an automatic needle guard or non-blistered packaging (1-pack only).
Brizge so lahko v pakiranju s pretisnimi omoti (pakiranje po 1 oz. 4) z avtomatičnim ščitnikom igle ali brez njega, ali v pakiranju brez pretisnih omotov (samo pakiranje po 1).
A Discard the used pre-filled syringe and other supplies in a sharps disposal container.
A Zavrzite uporabljeno injekcijsko brizgo in drugo opremo v vsebnik za ostre odpadke.
How to use Aranesp
Kako uporabljati zdravilo Aranesp
Aranesp should not affect your ability to drive or use machinery.
Zdravilo Aranesp ne bi smelo vplivati na vašo sposobnost upravljanja vozil in strojev.
If you forget to use Aranesp
Če ste pozabili uporabiti zdravilo Aranesp
In patients with solid tumours or lymphoproliferative malignancies, if the haemoglobin value exceeds 12 g/dL (7.5 mmol/L), the dosage adaptation described in section 4.2 should be closely respected, in order to minimise the potential risk of thromboembolic events.
Če hemoglobin pri bolnikih s čvrstimi tumorji ali limfoproliferativnimi malignomi preseže 120 g/l (7,5 mmol/l), natančno upoštevajte prilagoditev odmerka, opisano v poglavju 4.2, da boste zmanjšali morebitno tveganje za trombembolične incidente.
Rotate the injection sites and inject slowly to avoid discomfort at the site of injection.
Mesto injiciranja krožno menjajte, zdravilo pa injicirajte počasi, da se boste izognili neprijetnemu občutku na mestu injiciranja.
What Aranesp looks like and contents of the pack
Izgled zdravila Aranesp in vsebina pakiranja
AUC(0-∞) was similar between adult and paediatric patients with CRF following subcutaneous administration.
AUC(0-∞) po subkutani uporabi je bila pri odraslih in pediatričnih bolnikih s kronično boleznijo ledvic podobna.
In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered (see sections 4.2 and 5.1).
Pri bolnikih, ki imajo slab odziv hemoglobina na epoetine, je treba upoštevati druge možne vzroke za slab odziv (glejte poglavji 4.2 in 5.1).
The syringes are provided either with (1- and 4-pack) or without (1-pack) a blister-wrapping.
Brizge so opremljene v pretisnih omotih (pakiranje po 1 in 4) ali brez njih (pakiranje po 1).
If you stop using Aranesp
Če ste prenehali uporabljati zdravilo Aranesp
The median (quartile 1, quartile 3) time to achieve haemoglobin correction (≥ 10.0 g/dL and ≥ 1.0 g/dL increase from baseline) was 5 weeks for both once every two week (3, 7 weeks) and once monthly dosing (3, 9 weeks).
Mediani (1. kvartil, 3. kvartil) čas do dosežene odprave anemije (≥ 100 g/l in porast za ≥ 10 g/l od izhodišča) je bil 5 tednov tako med uporabo enkrat na dva tedna (3 tedne, 7 tednov) kot med uporabo enkrat na mesec (3 tedne, 9 tednov).
Aranesp is used to treat symptomatic anaemia that is associated with chronic renal failure (kidney failure) in adults and children.
Zdravilo Aranesp uporabljamo za zdravljenje simptomatske anemije, ki spremlja kronično odpoved ledvic, pri odraslih in otrocih.
Following monthly administration of darbepoetin alfa, at subcutaneous doses ranging from 0.6 to 2.1 mcg/kg, the terminal half-life was 73 hours (SD 24).
Po uporabi darbepoetina alfa enkrat na mesec v subkutanih odmerkih od 0,6 do 2,1 µg/kg je bil terminalni razpolovni čas 73 ur (standardni odklon 24).
Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid the puncture of peripheral veins.
Pri bolnikih, ki niso na hemodializi, ima prednost subkutana uporaba, ker tako ni potrebno zbadanje perifernih ven.
Window turns yellow when the injection is done
Ko je injiciranje končano, postane okence rumeno
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for the cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10,441 patients).
Metaanaliza celotnih podatkov o preživetju je pokazala točkovno oceno razmerja ogroženosti 1,06 v korist kontrolnih oseb (95 % IZ: 1,00, 1,12; 53 preskušanj in 13.933 bolnikov); za bolnike z rakom, ki so dobivali kemoterapijo, je bilo razmerje ogroženosti za celotno preživetje 1,04 (95 % IZ: 0,97, 1,11; 38 preskušanj in 10.441 bolnikov).
It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse or pharmacist.
Pomembno je, da si injekcij ne poskušate dajati sami, dokler vas tega ne nauči zdravnik, medicinska sestra ali farmacevt.
• Sharps disposal container
• vsebnik za odlaganje ostrih odpadkov
In patients with cancer receiving chemotherapy the etiology of anaemia is multifactorial.
Pri onkoloških bolnikih, ki dobivajo kemoterapijo, je v etiologijo anemije vpletenih več dejavnikov.
• Blood clots (thrombosis)
• krvni strdki (tromboza)
Cancer patients receiving chemotherapy
Onkološki bolniki, ki dobivajo kemoterapijo
In a prospective, randomised double-blind, placebo-controlled study conducted in 314 lung cancer patients receiving platinum containing chemotherapy there was a significant reduction in transfusion requirements (p < 0.001).
V prospektivni, randomizirani, dvojno slepi, s placebom kontrolirani študiji pri 314 bolnikih z rakom na pljučih, ki so dobivali kemoterapijo s platino, so ugotovili značilno zmanjšanje potreb po transfuziji (p < 0,001).
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients
Zdravljenje simptomatske anemije pri odraslih in pediatričnih bolnikih s kronično odpovedjo ledvic
The active substance of Aranesp is darbepoetin alfa produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
Učinkovina v zdravilu Aranesp je darbepoetin alfa, pridobljen z gensko tehnologijo v ovarijskih celicah kitajskega hrčka (CHO-K1).
Important: Always keep the sharps disposal container out of the sight and reach of children.
Pomembno: Vsebnik za ostre odpadke vedno shranjujte nedosegljivega otrokom.
Half-life was also similar between adult and paediatric patients with CRF following both intravenous and subcutaneous administration.
Tudi razpolovni čas je bil pri odraslih in pediatričnih bolnikih s kronično boleznijo ledvic podoben, tako po intravenski kot po subkutani uporabi.
- The other ingredients are sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 and water for injections.
- Druge sestavine zdravila so natrijev hidrogenfosfat, natrijev dihidrogenfosfat, natrijev klorid, polisorbat 80 in voda za injekcije.
Do not use the pre-filled pen if the medicine is cloudy or discoloured or contains flakes or particles.
Ne uporabite napolnjenega injekcijskega peresnika, če je zdravilo motno ali obarvano ali vsebuje kosmiče ali delce.