natgillin/translations-raw huggingface dataset:
More severe cases have been observed with long-acting epoetins.At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
U trenutku propisivanja lijeka bolesnike je potrebno savjetovati o znakovima i simptomima te pomno pratiti imaju li kožne reakcije.
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dl (6.2 mmol/l) to 12 g/dl (7.5 mmol/l).
Varijabilnost hemoglobina treba rješavati korekcijom doze, uzimajući u obzir da je ciljni raspon hemoglobina od 10 g/dl (6,2 mmol/l) do 12 g/dl (7,5 mmol/l).
blood volume [ml] = 44 [ml/kg] x body weight [kg] + 1600 [ml] (body weight ³ 45 kg)
volumen krvi [ml] = 44 [ml/kg] x tjel. masa [kg] + 1600 [ml]
NeoRecormon 2000 IU solution for injection in pre-filled syringe NeoRecormon 3000 IU solution for injection in pre-filled syringe NeoRecormon 4000 IU solution for injection in pre-filled syringe NeoRecormon 5000 IU solution for injection in pre-filled syringe NeoRecormon 6000 IU solution for injection in pre-filled syringe NeoRecormon 10,000 IU solution for injection in pre-filled syringe NeoRecormon 20,000 IU solution for injection in pre-filled syringe NeoRecormon 30,000 IU solution for injection in pre-filled syringe
NeoRecormon 500 IU otopina za injekciju u napunjenoj štrcaljki NeoRecormon 2000 IU otopina za injekciju u napunjenoj štrcaljki NeoRecormon 3000 IU otopina za injekciju u napunjenoj štrcaljki NeoRecormon 4000 IU otopina za injekciju u napunjenoj štrcaljki NeoRecormon 5000 IU otopina za injekciju u napunjenoj štrcaljki NeoRecormon 6000 IU otopina za injekciju u napunjenoj štrcaljki NeoRecormon 10 000 IU otopina za injekciju u napunjenoj štrcaljki NeoRecormon 20 000 IU otopina za injekciju u napunjenoj štrcaljki NeoRecormon 30 000 IU otopina za injekciju u napunjenoj štrcaljki
Take hold of the stem and snap off away from you.
Primite vrh ampule i odlomite ga u smjeru od sebe.
After 4 weeks, the doctor will do tests and, if the treatment response is not sufficient, your dose may be raised to 40 IU/kg per injection, given three times per week.
Nakon 4 tjedna liječnik će napraviti pretrage i ako odgovor na terapiju nije zadovoljavajuć, doza se može povećati na 40 IU/kg po injekciji, tri puta tjedno.
Pre-filled syringe (Type I glass) with a tip cap and a plunger stopper (teflonised rubber).
Napunjena štrcaljka (staklo tip I) sa zatvaračem vrha i čepom klipa (guma obložena teflonom).
- Treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving chemotherapy.
Liječenje simptomatske anemije u odraslih bolesnika s nemijeloičnim zloćudnim bolestima koji primaju kemoterapiju.
· Pull the rubber cap off the end of the syringe (A).
Povucite gumeni zatvarač sa štrcaljke (A).
Remove one needle from the pack, fix it on the syringe and remove the protective cap from the needle.
Izvadite jednu iglu iz pakiranja, pričvrstite je na štrcaljku i uklonite pokrov s igle.
Clean the injection port as instructed by the provider.
Kateter očistite prema uputama dobavljača.
Epoetin beta treatment-related headache and hypertension which can be treated with drugs are common (see section 4.4).
Glavobolja i hipertenzija, povezane s liječenjem epoetinom beta, koje se mogu liječiti lijekovima su česte (vidjeti dio 4.4)
NeoRecormon should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 12 g/dl (7.5 mmol/l).
NeoRecormon treba davati ili supkutano ili intravenski kako bi se razina hemoglobina povećala na razinu koja nije viša od 12 g/dl (7, 5 mmol/l).
In a randomised, double-blind, placebo-controlled study of 4,038 chronic renal failure patients not on dialysis with type 2 diabetes and haemoglobin levels ≤ 11 g/dL, patients received either treatment with darbepoetin alfa to target haemoglobin levels of 13 g/dL or placebo (see section 4.4).
bolesnika s kroničnim zatajenjem bubrega i dijabetesom tipa 2 koji nisu bili na dijalizi, a razine hemoglobina su im bile ≤ 11 g/dl, bolesnici su primali ili darbepoetin alfa radi podizanja ciljnih razina hemoglobina na 13 g/dl, ili placebo (vidjeti dio 4.4).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS/AMPOULE
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICE/AMPULA
Withdraw all the solvent into the syringe.
Izvucite svu količinu otapala u štrcaljku.
The liquid should be clear and colorless.
Ona mora biti prozirna i bezbojna.
Shunt thromboses may occur, especially in patients who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e.g. stenoses, aneurisms), see section 4.4.
Može doći do tromboze šanta, poglavito u bolesnika sklonih hipotenziji ili u onih s komplikacijama arteriovenske fistule (npr. stenoze, aneurizme), vidjeti dio 4.4.
After 4 weeks, the doctor will do tests and, if the treatment response is not sufficient, your dose may be raised to 80 IU/kg per injection, given three times per week.
Nakon 4 tjedna, liječnik će napraviti pretrage i ako odgovor na terapiju nije zadovoljavajući, doza se može povećati na 80 IU/kg po injekciji, tri puta tjedno.
Labelling of the stand
Označavanje na kartonskom stalku
This leaflet was last revised in
Ova uputa je zadnji puta revidirana u <{MM/GGGG}> <{mjesec GGGG}.>
· Check the expiration date on the syringe and the needle.
Provjerite rok valjanosti na štrcaljki i igli.
Analysis of the individual components of the composite endpoints showed the following HR (95% CI): death 1.05 (0.92, 1.21), stroke 1.92 (1.38, 2.68), congestive heart failure (CHF) 0.89 (0.74, 1.08), myocardial infarction (MI) 0.96 (0.75, 1.23), hospitalisation for myocardial ischaemia 0.84 (0.55, 1.27), ESRD 1.02 (0.87, 1.18).
(1,38; 2,68), kongestivno zatajenje srca 0,89 (0,74; 1,08), infarkt miokarda 0,96 (0,75; 1,23), hospitalizacija zbog ishemije miokarda 0,84 (0,55; 1,27), završna faza bolesti bubrega 1,02 (0,87;
Caution should be exercised when prescribing to pregnant women.
Potreban je oprez prilikom propisivanja lijeka NeoRecormon trudnicama.
· Do not use if the expiration date has passed, if the syringe is dropped or damaged, or if the carton appears to be tampered with.
● Nemojte upotrijebiti štrcaljku ako je istekao rok valjanosti, ako je štrcaljka pala ili je oštećena te ako postoje znakovi neovlaštenog rukovanja kutijom.
Only solutions which are clear or slightly opalescent, colourless and practically free of visible particles may be injected.
Koristiti se smije samo otopina koja je bistra ili blago opalescentna, bezbojna i skoro potpuno bez vidljivih čestica.
· Keep this leaflet.
Sačuvajte ovu uputu.
Clean the skin at the site of injection using an alcohol wipe.
Očistite kožu na mjestu injiciranja vaticom natopljenom alkoholom.
Serum potassium and phosphate levels should be monitored regularly during NeoRecormon therapy.
Vrijednosti kalija i fosfata u serumu tijekom primjene lijeka NeoRecormon moraju se redovito kontrolirati.
NeoRecormon 500 IU NeoRecormon 2000 IU NeoRecormon 3000 IU NeoRecormon 4000 IU NeoRecormon 5000 IU NeoRecormon 6000 IU NeoRecormon 10,000 IU NeoRecormon 20,000 IU NeoRecormon 30,000 IU solution for injection in pre-filled syringe Epoetin beta
NeoRecormon 500 IU NeoRecormon 2000 IU NeoRecormon 3000 IU NeoRecormon 4000 IU NeoRecormon 5000 IU NeoRecormon 6000 IU NeoRecormon 10 000 IU NeoRecormon 20 000 IU NeoRecormon 30 000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
In chronic renal failure patients an increase in heparin dose during haemodialysis is frequently required during the course of therapy with NeoRecormon as a result of the increased packed cell volume.
Tijekom terapije lijekom NeoRecormon u bolesnika s kroničnim zatajenjem bubrega često je za vrijeme hemodijalize potrebna viša doza heparina, kao rezultat porasta hematokrita.
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA
The single dose thus determined is administered twice weekly over 4 weeks.
Tako određena pojedinačna doza se daje dva puta tjedno kroz 4 tjedna.
· Do not touch the tip of the syringe.
Nemojte dirati vrh štrcaljke.
The initial dose for injections under the skin is 20 IU per injection for every 1 kg of your body weight, given three times per week.
Početna doza za injekcije pod kožu iznosi 20 IU na svaki kilogram Vaše tjelesne mase po injekciji, primijenjeno tri puta tjedno.
Misuse of NeoRecormon by healthy people may lead to an increase in blood cells and consequently thicken the blood.
Zlouporaba lijeka NeoRecormon u zdravih ljudi može dovesti do povećanja broja vlastitih krvnih stanica i tako zgusnuti krv, što može dovesti do po život opasnih komplikacija na srcu ili krvnim žilama.
Caution should be exercised with escalation of NeoRecormon doses in patients with chronic renal failure.
Potreban je oprez prilikom povećanja doza lijeka NeoRecormon u bolesnika s kroničnim zatajenjem bubrega.
If the haemoglobin exceeds 12 g/dl (7.5 mmol/l), the dose should be reduced by approximately 25 to 50 %.
Ako hemoglobin prelazi razinu od 12 g/dl (7,5 mmol/l), dozu treba smanjiti za otprilike 25 do 50%.
Premature infants who have been transfused before the start of treatment with NeoRecormon are not likely to benefit as much as untransfused infants.
Nedonoščad koja je prethodno primila transfuziju, najvjerojatnije neće imati onoliku korist od liječenja lijekom NeoRecormon kao nedonoščad koja nije primila transfuziju.
Hypertensive crisis with encephalopathy-like symptoms (e.g. headaches and confused state, sensorimotor disorders - such as speech disturbance or impaired gait - up to tonoclonic seizures) may also occur in individual patients with otherwise normal or low blood pressure (see section 4.4).
U pojedinih bolesnika s normalnim ili niskim krvnim tlakom, može doći do hipertenzivnih kriza sa simptomima sličnim encefalopatiji (npr. glavoboljama i konfuznim stanjem, poremećajima osjeta i motorike - poput poremećaja govora ili nesigurnog hoda - sve do toničko-kloničkih napadaja) (vidjeti dio 4.4).
In order to ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and during treatment and supplementary iron therapy may be necessary and conducted in accordance with therapeutic guidelines.
Da bi se omogućila učinkovita eritropoeza, u svih bolesnika prije i tijekom liječenja valja provjeravati vrijednosti željeza.
Roche
France Roche
In the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases, the weekly increase in Hb and the target Hb should be determined individually taking into account the clinical picture.
U slučaju hipertenzije, ili postojećih kardiovaskularnih i cerebrovaskularnih bolesti, ili bolesti perifernih krvnih žila, tjedni porast Hb te ciljnu vrijednost
The recommended initial dose is 30,000 IU per week (corresponding to approximately 450 IU/kg body weight per week, based on an average weighted patient).
Preporučena početna doza iznosi 30 000 IU tjedno (što za bolesnika prosječne mase iznosi otprilike
(2) Place a 26G needle onto an appropriate single-use syringe (max.1 ml).
(2) Na odgovarajuću štrcaljku za jednokratnu uporabu (najviše 1 ml) postavite 26G iglu.
Cytotoxic actions of epoetin beta on bone marrow or on human skin cells were not detected.
Nije zapaženo citotoksično djelovanje epoetina beta na koštanu srž i stanice kože u ljudi.
If an elevated or rising potassium level is observed then consideration should be given to ceasing administration of NeoRecormon until the level has been corrected.
Ukoliko se zamijete povećane ili rastuće vrijednosti kalija, treba razmisliti o prekidu terapije lijekom NeoRecormon, sve dok se ne izvrši korekcija kalija.
The initial dose for injections into veins is 40 IU per injection for every 1 kg of your body weight, given three times per week.
Početna doza za injekcije u venu iznosi 40 IU na svaki kilogram Vaše tjelesne mase po injekciji, primijenjeno tri puta tjedno.
10 Wipe the injection site with an alcohol swab and let it air dry for 10 seconds.
Očistite mjesto injiciranja tupferom natopljenim alkoholom i pričekajte 10 sekundi da se koža sama osuši.
PRCA caused by neutralising anti-erythropoietin antibodies has been reported in association with erythropoietin therapy, including NeoRecormon.
PRCA uzrokovana neutralizirajućim antieritropoetinskim antitijelima zabilježena je vezano uz terapiju eritropoetinom, uključujući NeoRecormon.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodiumfree”.
Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. u osnovi ne sadrži natrij.
Men:
Muškarci:
Adverse reactions are listed in Table 3 below.
Nuspojave su navedene u Tablici 3 dalje u tekstu.
White lyophilisate and clear, colourless solvent.
Bijeli liofilizat i bistro, bezbojno otapalo.
15 Pinch the selected injection site and fully insert the needle at a 45° to 90° angle with a quick, firm action.
15. Uhvatite nabor kože na odabranom mjestu injiciranja te brzim i odlučnim pokretom ubodite iglu cijelom dužinom pod kutom od 45° do 90°.
(8.7 mmol/l), - shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/dl (7.5-8.7 mmol/l), - increased risk of death when administered to target a haemoglobin of 12 g/dl (7.5 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
- skraćuju ukupno preživljenje i povećava smrtnost povezanu s napredovanjem bolesti nakon četiri mjeseca u bolesnika s metastatskim rakom dojke koji primaju kemoterapiju, kada se daju radi postizanja ciljne razine hemoglobina od 12 - 14 g/dl (7,5 - 8,7 mmol/l), povećavaju rizik od smrti kada se daju radi postizanja ciljne razine hemoglobina od 12 g/dl (7,5 mmol/l) u bolesnika s aktivnom zloćudnom bolesti koji se ne liječe ni kemoterapijom ni radioterapijom.
· Dispose of the rubber cap in a puncture-resistant or sharps container immediately.
Gumeni zatvarač odmah odložite u neprobojni spremnik ili spremnik za oštre predmete.
Each pack contains one vial with 50,000 IU epoetin beta, 1 ampoule with 10 ml solvent, 1 reconstitution and withdrawal device, 1 needle (21G2) and 1 disposable syringe.
Jedno pakiranje sadrži jednu bočicu s 50 000 IU epoetina beta, 1 ampulu s 10 ml otapala, 1 nastavak za pripremu i izvlačenje pripremljene otopine, 1 iglu (21G2) i 1 štrcaljku za jednokratnu uporabu.
· Periodic Safety Update Reports
Periodička izvješća o neškodljivosti
Adverse reactions are listed in Table 2 below.
Nuspojave su navedene u Tablici 2 dalje u tekstu.
· Remove the needle from its blister.
Izvadite iglu iz blistera.
· Do not try to take the syringe apart at any time.
Nikada nemojte pokušavati rastaviti štrcaljku.
· An increase in the occurrence of blood clots has been observed.
Primijećena je povećana pojava krvnih ugrušaka.
NeoRecormon is indicated for: - Treatment of symptomatic anaemia associated with chronic renal failure in adult and paediatric patients.
KLINIČKI PODACI 4.1 Terapijske indikacije NeoRecormon je indiciran za: Liječenje simptomatske anemije povezane s kroničnim zatajenjem bubrega u odraslih i pedijatrijskih bolesnika.
- shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/dl (8.7 mmol/l), - shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/dl (7.5-8.7 mmol/l), - increased risk of death when administered to target a haemoglobin of 12 g/dl (7.5 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
- skraćuje ukupno preživljenje i povećava smrtnost povezanu s napredovanjem bolesti nakon četiri mjeseca u bolesnika s metastatskim rakom dojke koje primaju kemoterapiju, kada se lijekovi daju radi postizanja ciljne razine hemoglobina od 12 - 14 g/dl (7,5 - 8,7 mmol/l), povećava rizik od smrti kada se daje radi postizanja ciljne razine hemoglobina od 12 g/dl (7,5 mmol/l) u bolesnika s aktivnom zloćudnom bolesti koji se ne liječe ni kemoterapijom ni radioterapijom.
NeoRecormon 30,000 IU 1 prefilled syringe with one needle (27G1/2) or 4 pre-filled syringes with 4 needles (27G1/2).
NeoRecormon 30 000 IU 1 napunjena štrcaljka s jednom iglom (27G1/2) ili 4 napunjene štrcaljke s 4 igle (27G1/2).
Clean the skin above the vein with an alcohol swab and let dry.
Kožu iznad vene očistite tupferom natopljenim alkoholom i pustite da se sama osuši.
NeoRecormon 10,000 IU, 20,000 IU and 30,000 IU: Each pre-filled syringe contains 0.6 ml solution.
NeoRecormon 10 000 IU, 20 000 IU i 30 000 IU: Svaka napunjena štrcaljka sadrži 0,6 ml otopine.
Packs of 1 vial containing 50,000 IU epoetin beta, 1 ampoule containing 10 ml solvent, 1 reconstitution and withdrawal device, 1 needle (21G2, stainless steel) and 1 disposable syringe (polypropylene and polyethylene).
Pakiranja sadrže 1 bočicu s 50 000 IU epoetina beta, 1 ampulu s 10 ml otapala, 1 nastavak za pripremu i izvlačenje pripremljene otopine, 1 iglu (21G2, nehrđajući čelik) i 1 štrcaljku (polipropilen i polietilen) za jednokratnu uporabu.
Ask your doctor or pharmacist for advice before taking any medicine.
Prije uzimanja bilo kakvog lijeka upitajte liječnika ili ljekarnika za savjet.
The weekly dose can be given once per week, or divided into three or seven doses per week.
Tjedna se doza može primijeniti jednom tjedno ili podijeliti u tri ili sedam doza tjedno.
If the rate of rise in haemoglobin is greater than 2 g/dl (1.25 mmol/l) in one month or if the haemoglobin level is increasing and approaching 12 g/dl (7.45 mmol/l), the dose is to be reduced by approximately 25 %.
Ako je brzina porasta hemoglobina unutar jednog mjeseca veća od 2 g/dl (1,25 mmol/l) ili ako vrijednost hemoglobina raste i približava se vrijednosti od 12 g/dl (7,45 mmol/l), dozu je potrebno smanjiti za otprilike 25%.
NeoRecormon in pre-filled syringe contains up to 0.3 mg phenylalanine/syringe as an excipient.
Pomoćne tvari NeoRecormon u napunjenim štrcaljkama sadrži kao pomoćnu tvar do 0,3 mg fenilalanina po štrcaljki,
5000 IU/ ml 500 IU 1000 IU 1500 IU 2000 IU 2500 IU 3000 IU 3500 IU 4000 IU 4500 IU 5000 IU 0.1 ml 0.2 ml 0.3 ml 0.4 ml 0.5 ml 0.6 ml 0.7 ml 0.8 ml 0.9 ml
Za svaku dozu koristite sterilne štrcaljke i igle za jednokratnu uporabu 5000 IU / ml 500 IU 1000 IU 1500 IU 2000 IU 2500 IU 3000 IU 3500 IU 4000 IU 4500 IU 5000 IU 0,1 ml 0,2 ml
NeoRecormon 500 IU, 2000 IU, 3000 IU, 4000 IU, 5000 IU and 6000 IU: Each pre-filled syringe contains 0.3 ml solution.
NeoRecormon 500 IU, 2000 IU, 3000 IU, 4000 IU, 5000 IU i 6000 IU: Svaka napunjena štrcaljka sadrži 0,3 ml otopine.
This NeoRecormon presentation contains white lyophilisate and solvent.
Ovaj pripravak lijeka NeoRecormon sadrži bijeli liofilizat i otapalo.
One ml solution for injection contains 33,333 IU epoetin beta.
Jedan mililitar otopine za injekciju sadrži 33 333 IU epoetina beta.
· Take the carton with the syringe(s) and needle(s) out of the refrigerator
Izvadite kutiju sa štrcaljkom(ama) i iglom(ama) iz hladnjaka.
What you need to know before you use NeoRecormon Do not use NeoRecormon · if you are allergic to epoetin beta or any of the other ingredients of this medicine (listed in section 6)
● ako ste alergični na epoetin beta ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
Once opened, the reconstituted solution may be stored for maximum of one month at 2°C - 8°C.
Jednom otvorena, pripremljena otopina može se čuvati najdulje mjesec dana na 2°C - 8°C
In very rare cases, neutralising anti-erythropoietin antibodies with or without pure red cell aplasia (PRCA) occurred during rHuEPO therapy.
U vrlo rijetkim slučajevima tijekom terapije rekombinantnim humanim eritropoetinom (rHuEPO) došlo je do pojave neutralizirajućih antieritropoetinskih antitijela s ili bez izolirane aplazije crvene krvne loze (PRCA).
Misuse by healthy persons may lead to an excessive increase in packed cell volume.
Zlouporaba u zdravih osoba može dovesti do prekomjernog povećanja hematokrita, što može dovesti do po život opasnih komplikacija kardiovaskularnog sustava.
Remove the needle and syringe from the injection site at the same angle as inserted.
Izvucite iglu i štrcaljku iz mjesta injiciranja pod istim kutom pod kojim ste ih uveli.
If the rise in haemoglobin is greater than 2 g/dl (1.3 mmol/l) in 4 weeks, the dose should be reduced by 25 to 50 %.
Ako je porast hemoglobina veći od 2 g/dl (1,3 mmol/l) u 4 tjedna, dozu treba smanjiti za 25 do 50%.
NeoRecormon Multidose is a lyophilisate and solvent for solution for injection.
NeoRecormon Multidose je liofilizat i otapalo za otopinu za injekciju.
How to use NeoRecormon
Kako primjenjivati NeoRecormon
This is because one cannot rule out a possible acceleration of progression of kidney disease with absolute certainty.
Ne može se, naime, sa sigurnošću isključiti mogućnost ubrzanog pogoršanja bolesti bubrega.
· Instructions for Use and a package leaflet.
Upute za uporabu i uputa o lijeku.
If, after 4 weeks of therapy, the haemoglobin value has increased by at least 1 g/dl (0.62 mmol/l), the current dose should be continued.
Ako se nakon 4 tjedna terapije razina hemoglobina poveća za barem 1 g/dl (0,62 mmol/l), treba nastaviti liječenje istom dozom.
· Pure red cell aplasia (PRCA) caused by neutralising antibodies has been observed during erythropoietin therapy, including in isolated cases during therapy with NeoRecormon.
Izolirana aplazija crvene krvne loze (engl. pure red cell aplasia- PRCA) uzrokovana neutralizirajućim antitijelima zabilježena je tijekom terapije eritropoetinom, uključujući, u izoliranim slučajevima, i za vrijeme terapije lijekom NeoRecormon.
Do not inject yourself unless you have received training.
Nemojte sami injicirati NeoRecormon ako niste dobili odgovarajuću edukaciju.
3 Take one syringe out of the carton and one needle from the needle box.
Izvadite jednu štrcaljku iz pakiranja te jednu iglu iz kutije s iglama.
This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy.
PRCA znači da je došlo do prestanka ili smanjene proizvodnje crvenih krvnih stanica u tijelu što uzrokuje tešku anemiju sa simptomima koji uključuju neuobičajeni umor i nedostatak energije.
INSTRUCTIONS ON USE (on the cover inside) Handling steps
(Na poklopcu kutije iznutra) Upute za rukovanje Vidjeti uputu o lijeku
You can press a dry sterile pad over the injection site.
Mjesto injiciranja možete pritisnuti suhom sterilnom gazom.
The initial dosage is 3 x 40 IU/kg per week.
Početna doza iznosi 3 x 40 IU/kg tjel. mase tjedno.
Side effects which can affect any patient · Most people (very common, may affect more than 1 in 10 people) get lower levels of iron in their blood.
U većine bolesnika (vrlo često, mogu se javiti u više od 1 na 10 osoba) dolazi do smanjenja razine željeza u krvi.
Treatment of symptomatic chemotherapy-induced anaemia in cancer patients NeoRecormon should be administered by the subcutaneous route to patients with anaemia (e.g. haemoglobin concentration ≤ 10g/dl (6.2 mmol/l).
Bolesnicima koji boluju od anemije NeoRecormon treba davati supkutano (npr. koncentracija hemoglobina ≤ 10 g/dl (6,2 mmol/l)).
One ml solution for injection contains 13,333 IU epoetin beta.
Jedan mililitar otopine za injekciju sadrži 13 333 IU epoetina beta.
· Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with epoetin treatment.
Prijavljeni su ozbiljni kožni osipi, uključujući Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu, povezani s liječenjem epoetinom.
PHARMACEUTICAL FORM Lyophilisate and solvent for solution for injection.
Liofilizat i otapalo za otopinu za injekciju.
If you think you have missed an injection, or been injected too little, talk to your doctor.
Ako ste zaboravili primijeniti NeoRecormon Ako mislite da ste propustili injekciju ili da Vam je ubrizgana premala doza, obratite se svom liječniku.