natgillin/translations-raw huggingface dataset:
Anti-arrhythmics and anti-seizure medicinal products Patients taking anti-arrhythmic medicinal products for the control of arrhythmias and anti-seizure medicinal products for the control of seizure disorders were excluded from clinical trials.
Bolesnici koji uzimaju antiaritmike za kontrolu aritmija i lijekove protiv napadaja za kontrolu napadaja nisu bili uključeni u klinička ispitivanja.
*post-marketing experience
*iskustvo nakon stavljanja lijeka u promet
Tasermity should only be given to pregnant or breast-feeding women if clearly needed.
Tasermity se smije davati trudnicama i dojiljama samo kada je to prijeko potrebno.
Uncommon (may affect up to 1 in 100 people): increased acidity of the blood.
Manje često (mogu se javiti u do 1 na 100 osoba): povećana kiselost krvi
Ciclosporin, mycophenolate mofetil and tacrolimus in transplant patients Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant patients when coadministered with sevelamer hydrochloride without any clinical consequences (i.e graft rejection).
Ciklosporin, mikofenolat mofetil i takrolimus u transplantiranih bolesnika Zabilježene su snižene vrijednosti ciklosporina, mikofenolat mofetila i takrolimusa u transplantiranih bolesnika kod istodobne primjene sevelamerklorida, bez kliničkih posljedica (npr. odbacivanja presatka).
Talk to your doctor before taking Tasermity if any of the following applies to you:
Upozorenja i mjere opreza Obratite se svom liječniku prije nego što uzmete Tasermity ako se nešto od navedenog odnosi na Vas:
Inflammatory Gastrointestinal Disorders
Upalni gastrointestinalni poremećaji
Adult patients whose kidneys have failed and who are undergoing haemodialysis or peritoneal dialysis are not able to control the level of serum phosphate in their blood.
Odrasli bolesnici sa zatajenjem bubrega koji su na hemodijalizi ili peritonealnoj dijalizi ne mogu kontrolirati razinu serumskog fosfata u krvi.
You should expect to be monitored more carefully for problems with low levels of vitamins A, D, E, K and folic acid.
Trebate očekivati da će se provoditi pažljivije kontrole kako bi se uočili mogući problemi zbog niskih razina vitamina A, D, E, K i folne kiseline.
Very rare (may affect up to 1 in 10000 people): hypersensitivity.
Vrlo rijetko (mogu se javiti u manje od 1 na 10000 osoba): preosjetljivost.
In the clinical studies in haemodialysis patients, sevelamer hydrochloride alone did not have a consistent and clinically significant effect on serum intact parathyroid hormone (iPTH).
U kliničkim ispitivanjima u bolesnika na hemodijalizi sevelamerklorid sam nije imao konzistentan i klinički značajan učinak na razinu intaktnog paratiroidnog hormona (iPTH) u serumu.
However, the causality of the sevelamer crystals in initiating such disorders has not been demonstrated.
Međutim, uzročno posljedična poveznost između prisustva kristala sevelamera i razvoja ovakvih poremećaja nije dokazana.
Depending on diet intake and the nature of end stage renal failure, dialysis patients may develop low vitamin A, D, E and K levels.
Ovisno o unosu hrane i naravi terminalne faze zatajenja bubrega, u bolesnika na dijalizi mogu se razviti niske razine vitamina A, D, E i K.
In preclinical studies in rats and dogs, sevelamer at a dose of 10 times the maximum human doses reduced absorption of fat soluble vitamins D, E and K, and folic acid.
U pretkliničkim ispitivanjima na štakorima i psima sevelamer u dozi 10 puta većoj od maksimalne doze za ljude smanjio je apsorpciju vitamina D, E i K topivih u mastima i folne kiseline.
If you do not take multivitamin supplements you may also develop low levels of vitamins A, E, K and folic acid in your blood and therefore your doctor may monitor these levels and prescribe supplemental
Ako ne uzimate multivitaminske dodatke prehrani, mogu se sniziti vrijednosti vitamina A, E i K te folne kiseline u krvi, te će ih stoga liječnik možda pratiti i po potrebi Vam propisati vitaminsku dopunu.
Serum chloride may increase during sevelamer hydrochloride treatment as chloride may be exchanged for phosphorus in the intestinal lumen.
Količina klorida u serumu može se povećati tijekom liječenja sevelamerkloridom jer se klorid može zamijeniti fosforom u crijevnom lumenu.
He/she will base the dose on your serum phosphate level.
On će odrediti Vašu dozu na temelju razine fosfata u serumu.
In the 12 week study involving peritoneal dialysis patients however, similar iPTH reductions were seen compared with patients receiving calcium acetate.
Međutim, u 12-tjednom ispitivanju koje je uključivalo bolesnike na peritonealnoj dijalizi, uočena su podjednaka smanjenja vrijednosti iPTH-a kao u bolesnika koji su primali kalcijev acetat.
Tasermity tablets are film-coated, off-white, oval tablets with “SH800” imprinted on one side.
Tasermity tablete su filmom obložene, bjelkaste, ovalne tablete, s otisnutom oznakom „SH800“ na jednoj strani.
The safety and efficacy of this product have not been established in patients below the age of 18 years.
Pedijatrijska populacija Sigurnost primjene i djelotvornost ovog lijeka nisu ustanovljene u bolesnika mlađih od 18 godina.
In a clinical trial of one-year duration, sevelamer hydrochloride had no adverse effect on bone turnover or mineralisation compared to calcium carbonate.
U kliničkom ispitivanju u trajanju od jedne godine sevelamerklorid nije imao štetne učinke na koštanu pregradnju ni mineralizaciju u usporedbi s kalcijevim karbonatom.
Many of these cases involved patients with co-morbid conditions including swallowing disorders or oesophageal abnormalities.
Mnogi od tih slučajeva odnosili su se na bolesnike s popratnim bolestima, uključujući poremećaje gutanja i anomalije usta i jednjaka.
It cannot be excluded that sevelamer hydrochloride can bind fat-soluble vitamins contained in ingested food.
Ne može se isključiti mogućnost da sevelamerklorid veže vitamine topive u mastima iz konzumirane hrane.
For patients previously on phosphate binders, Sevelamer hydrochloride should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.
Bolesnicima koji su prethodno uzimali vezače fosfata sevelamerklorid se mora davati gram po gram uz praćenje razina fosfora u serumu kako bi se osigurala primjena optimalnih dnevnih doza.
The possibility of an interaction cannot be excluded and a close monitoring of blood concentrations of mycophenolate mofetil, ciclosporin and tacrolimus should be considered during the use of combination and after its withdrawal.
Ne može se isključiti mogućnost interakcije te treba razmotriti pozorno praćenje koncentracija mikofenolat mofetila, ciklosporina i takrolimusa u krvi tijekom i nakon kombinirane primjene sa sevelamerkloridom.
Tasermity contains sevelamer, a non-absorbed phosphate binding poly (allylamine hydrochloride) polymer, free of metal and calcium.
Tasermity sadrži sevelamer, neapsorbirajući poli (alilamin klorid) polimer koji veže fosfate, a ne sadrži metale ni kalcij.
Additional monitoring of vitamins and folic acid is recommended in patients receiving peritoneal dialysis, since in the clinical study, vitamin A, D, E and K levels were not measured in these patients.
U bolesnika na peritonealnoj dijalizi preporučuje se dodatno praćenje razine vitamina i folne kiseline jer se u kliničkom ispitivanju u tih bolesnika nisu mjerile vrijednosti vitamina A, D, E i K.
Closer monitoring of patients with hypothyroidism co-administered with sevelamer hydrochloride and levothyroxine is recommended (see section 4.5).
Preporučuje se pozornije praćenje bolesnika koji pate od hipotireoze i istodobno uzimaju sevelamerklorid i levotiroksin (vidjeti dio 4.5).
Iron oxide black (E172) Propylene glycol Hypromellose (E464)
Tinta za označavanje: željezov oksid, crni (E172) propilenglikol hipromeloza (E464)
In a study in rats, administering sevelamer in 15-30 x the human dose, an increase in serum copper was detected.
U ispitivanju na štakorima kojima je primijenjen sevelamer u dozi 15-30 puta većoj od doze za ljude utvrđeno je povećanje koncentracije bakra u serumu.
Sevelamer hydrochloride should only be given to pregnant women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the foetus (see section 5.3).
Sevelamerklorid se smije davati trudnicama samo ako je to prijeko potrebno i nakon pažljive analize rizika i koristi kako za majku tako i za fetus (vidjeti dio 5.3).
Worsening of acidosis has been reported upon switching from other phosphate binders to sevelamer in a number of studies where lower bicarbonate levels in the sevelamer-treated patients compared to patients treated with calcium-based binders were observed.
U više je ispitivanja zabilježeno pogoršanje acidoze nakon prelaska s drugih vezača fosfata na sevelamer, pri čemu su opažene niže razine bikarbonata u bolesnika liječenih sevelamerom u usporedbi s bolesnicima liječenima vezačima na bazi kalcija.
Serum calcium levels should be monitored as is done in normal follow-up of a dialysis patient.
Potrebno je nadzirati razine kalcija u serumu kako je to uobičajeno kod praćenja bolesnika na dijalizi.
Sevelamer hydrochloride treatment should be re-evaluated in patients who develop severe gastrointestinal symptoms.
Liječenje sevelamerkloridom treba ponovno razmotriti u bolesnika koji razviju teške gastrointestinalne simptome.
Uncommon Very Rare
Vrlo rijetko
By binding phosphate in the gastrointestinal tract, sevelamer lowers the phosphate concentration in the serum.
Vezujući fosfate u gastrointestinalnom traktu sevelamer snižava koncentraciju fosfora u serumu.
Sevelamer hydrochloride should only be given to breast-feeding women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the infant (see section 5.3).
Sevelamerklorid se smije davati dojiljama samo ako je to prijeko potrebno i nakon pažljive analize rizika i koristi kako za majku tako i za dojenče (vidjeti dio 5.3).
How to take Tasermity
Kako uzimati Tasermity
EU/1/14/953/001
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/953/001
• If you are taking medicine such as omeprazole, pantoprazole, or lansoprazole to treat heartburn, gastroesophageal reflux disease (GERD), or gastric ulcers, you should consult your doctor when taking Tasermity.
• Ako uzimate lijekove za liječenje žgaravice, gastroezofagealne refluksne bolesti (GERB) ili čira na želucu, kao što su omeprazol, pantoprazol ili lanzoprazol, morate se savjetovati sa svojim liječnikom kad uzimate Tasermity.
Patients should take sevelamer hydrochloride with meals and adhere to their prescribed diets.
Bolesnici moraju uzimati sevelamerklorid uz obroke i pridržavati se propisane dijete.
Patients taking Tasermity should adhere to their prescribed diet and liquid intake.
Bolesnici koji uzimaju Tasermity se moraju pridržavati propisane dijete i unosa tekućine.
Patients who are constipated should be monitored carefully while being treated with sevelamer hydrochloride.
Bolesnike koji pate od konstipacije treba pomno nadzirati tijekom liječenja sevelamerkloridom.
Tasermity 800 mg film-coated tablets
Tasermity 800 mg filmom obložene tablete sevelamerklorid
Common (may affect up to 1 in 10 people): diarrhoea, indigestion, abdominal pain, constipation, flatulence.
Često (mogu se javiti u do 1 na 10 osoba): proljev, probavne tegobe, bol u trbuhu, zatvor, vjetrovi.
• The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used in transplant patients) may be reduced by Tasermity.
• Tasermity može umanjiti učinke lijekova kao što su ciklosporin, mikofenolat mofetil i takrolimus (lijekova koji se primjenjuju u bolesnika s presatkom organa).
The safety of Tasermity has not been established in pregnant or breast-feeding women.
Sigurnost primjene lijeka Tasermity u trudnica i dojilja nije ustanovljena.
• patients with a history of major gastrointestinal surgery
• koji su prethodno podvrgnuti velikom operativnom zahvatu gastrointestinalnog trakta
In interaction studies in healthy volunteers, sevelamer hydrochloride decreased the bioavailability of ciprofloxacin by approximately 50% when co-administered with sevelamer hydrochloride in a single dose study.
U ispitivanjima interakcija u zdravih dobrovoljaca, prilikom istodobne primjene sevelamerklorida i ciprofloksacina u ispitivanju s primjenom jedne doze, sevelamerklorid je smanjio bioraspoloživost ciprofloksacina za približno 50%.
• if you have prolonged diarrhoea or pain in the abdomen (symptoms of active inflammatory bowel disease)
• ako imate dugotrajni proljev ili bol u trbuhu (simptomi aktivne upalne bolesti crijeva) • ako ste imali veliku operaciju želuca ili crijeva.
Sevelamer hydrochloride alone is not indicated for the control of hyperparathyroidism.
Sevelamerklorid sam nije indiciran za kontrolu hiperparatireoze.
Sevelamer hydrochloride does not contain calcium.
Sevelamerklorid ne sadrži kalcij.
The tablets are packed in high density polyethylene bottles with a child resistant polypropylene closure and an induction seal.
Tablete su pakirane u boce od polietilena visoke gustoće s polipropilenskim sigurnosnim čepom za djecu i zalijepljenom zaštitnom folijom.
Tasermity contains sevelamer as the active ingredient.
Tasermity sadrži djelatnu tvar sevelamer.
• gastrointestinal motility disorders including untreated or severe gastroparesis, diverticulosis,
• s poremećajima motiliteta gastrointestinalnog trakta uključujući i neliječenu ili tešku gastroparezu, divertikulozu, retenciju želučanog sadržaja te neuobičajenu ili nepravilnu peristaltiku crijeva
Tasermity is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Tasermity je indiciran za kontrolu hiperfosfatemije u odraslih bolesnika koji su na hemodijalizi ili peritonealnoj dijalizi.
Sevelamer hydrochloride has no or negligible influence on the ability to drive and use machines.
Sevelamerklorid ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
The safety of sevelamer hydrochloride has not been established in pregnant women.
Sigurnost primjene sevelamerklorida u trudnica nije ustanovljena.
During post marketing experience, very rare cases of increased thyroid stimulating hormone (TSH) levels have been reported in patients co-administered sevelamer hydrochloride and levothyroxine.
Nakon stavljanja lijeka u promet prijavljeni su vrlo rijetki slučajevi povećanih razina tireostimulirajućeg hormona (TSH) u bolesnika koji su istodobno uzimali sevelamerklorid i levotiroksin.
Film-coated tablet (tablet) The off-white, oval tablets are imprinted with “SH800” on one side.
Bjelkaste, ovalne tablete na jednoj strani imaju otisnutu oznaku “SH800”.
Each tablet contains 800 mg sevelamer hydrochloride.
Jedna tableta sadrži 800 mg sevelamerklorida.
How to store Tasermity
Kako čuvati Tasermity
In parallel design studies involving 244 haemodialysis patients with treatment duration of up to 54 weeks and 97 peritoneal dialysis patients with treatment duration of 12 weeks were conducted Adverse reactions from these studies (299 patients), from uncontrolled clinical trials (384 patients) and that were spontaneously reported from post-marketing experience are listed by frequency in the table below.
Provedena su usporedna ispitivanja u kojima su sudjelovala 244 bolesnika na hemodijalizi čije je liječenje trajalo najdulje 54 tjedna i 97 bolesnika na peritonealnoj dijalizi čije je liječenje trajalo najdulje 12 tjedana.
Tел: +359 2 9705300
SANOFI BULGARIA Tел: +359 2 9705300
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/953/001 DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
180 film-coated tablets
OBLIK I SADRŽAJ 180 filmom obloženih tableta
Tasermity is used to control the levels of phosphate in the blood of adult kidney failure patients on haemodialysis or peritoneal dialysis treatment.
Tasermity se koristi za reguliranje razina fosfata u krvi u odraslih bolesnika sa zatajenjem bubrega koji su na hemodijalizi ili peritonealnoj dijalizi.
Old Kilmeaden Road
IDA Industrial Park Old Kilmeaden Road Waterford
In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with sevelamer hydrochloride.
U vrlo rijetkim slučajevima su tijekom liječenja sevelamerkloridom u bolesnika opaženi opstrukcija crijeva i ileus/subileus.
nausea and/or vomiting
D i/ili vitamina
What you need to know before you take Tasermity Do not take Tasermity:
Što morate znati prije nego što počnete uzimati Tasermity
In clinical trials, sevelamer hydrochloride has been shown to be effective in reducing serum phosphorus in patients receiving haemodialysis or peritoneal dialysis.
Kliničkim je ispitivanjima dokazano da sevelamerklorid djelotvorno smanjuje koncentracije fosfora u serumu u bolesnika koji su na hemodijalizi ili peritonealnoj dijalizi.
During post-marketing experience, very rare cases of increased phosphate levels have been reported in patients taking proton pump inhibitors co-administered with sevelamer hydrochloride.
Nakon stavljanja lijeka u promet, prijavljeni su vrlo rijetki slučajevi povećanih vrijednosti fosfata u bolesnika koji su istodobno uzimali inhibitore protonske pumpe i sevelamerklorid.
Therefore caution should be exercised when sevelamer hydrochloride is used in patients with these disorders.
Stoga je potreban oprez pri primjeni sevelamerklorida u bolesnika s tim poremećajima.
You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal dialysis.
Posebna napomena za bolesnike na peritonealnoj dijalizi Možete razviti peritonitis (infekcija tekućine u trbuhu) povezan s peritonealnom dijalizom.
Caution should be exercised when prescribing sevelamer hydrochloride to patients also taking these medicinal products.
Potreban je oprez pri propisivanju sevelamerklorida bolesnicima koji uzimaju navedene lijekove.
Therefore, in patients not taking these vitamins, monitoring vitamin A, D and E levels and assessing vitamin K status through the measurement of thromboplastin time should be considered and the vitamins should be supplemented if necessary.
Stoga je u bolesnika koji ne uzimaju navedene vitamine potrebno razmotriti praćenje razina vitamina A, D i E i procjenu statusa vitamina
- The active substance is sevelamer hydrochloride.
- Djelatna tvar je sevelamerklorid.
Sevelamer hydrochloride treatment should be re-evaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Treba ponovno procijeniti nastavak liječenja sevelamerkloridom u bolesnika u kojih dođe do teške konstipacije ili se jave drugi teški gastrointestinalni simptomi.
Elemental calcium should be given as a supplement in case of hypocalcaemia.
U slučaju hipokalcijemije potrebno je propisati nadoknadu elementarnog kalcija.
Studies in animals have shown that sevelamer did not impair fertility in male or female rats at exposures at a human equivalent dose
Istraživanja na životinjama pokazala su da sevelamer nije štetno utjecao na plodnost mužjaka ni ženki štakora pri ekspoziciji dozama koje odgovaraju dvostrukoj maksimalnoj dozi za ljude iz kliničkih ispitivanja od 13 g/dan, temeljeno na usporedbi relativne površine tijela.
Sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Sevelamerklorid treba primjenjivati u sklopu multiterapijskog pristupa, koji može uključivati nadomjestke kalcija i 1,25-dihidroksi vitamin D3 ili neki od njegovih analoga, kako bi se kontrolirao razvoj bubrežne osteodistrofije.
In patients with secondary hyperparathyroidism sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to lower the intact parathyroid hormone (iPTH) levels.
Bolesnici sa sekundarnom hiperparatireozom trebaju uzimati sevelamerklorid u sklopu multiterapijskog pristupa koji može uključivati nadomjestke kalcija te primjenu 1,25-dihidroksi vitamina D3 ili nekog od njegovih analoga kako bi se snizila razina intaktnog paratiroidnog hormona (iPTH).
In patients with secondary hyperparathyroidism sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25-dihydroxy Vitamin D3 or one of its analogues to lower the iPTH levels.
Bolesnici sa sekundarnom hiperparatireozom trebaju uzimati sevelamerklorid u sklopu multiterapijskog pristupa, koji može uključivati nadomjestke kalcija te primjenu 1,25-dihidroksi vitamina D3 ili nekog od njegovih analoga kako bi se snizila razina iPTH-a.
Uncommon reports of difficulty swallowing the sevelamer hydrochloride tablet have been reported.
Manje često su prijavljene poteškoće s gutanjem tableta sevelamerklorida.
Caution should be exercised when sevelamer hydrochloride is used in patients with difficulty swallowing.
Potreban je oprez kad se sevelamerklorid primjenjuje u bolesnika koji otežano gutaju.
Abdominal pain, intestinal obstruction, ileus/subileus, diverticulitis, intestinal perforation
Poremećaji probavnog sustava mučnina, povraćanje proljev, dispepsija, flatulencija, bol u gornjem bol u abdomenu, opstrukcija crijeva, ileus/subileus, divertikulitis i perforacija crijeva
Renal impairment The safety and efficacy of this product have not been established in predialysis patients.
Sigurnost primjene i djelotvornost ovog lijeka nisu ustanovljene u bolesnika koji još nisu bili na dijalizi.
Acidosis, increased chloride
Poremećaji metabolizma i prehrane acidoza, povećane razine klorida u serumu
Tasermity may be used with other medicines which include calcium or vitamin D supplements to control the development of renal bone disease.
Tasermity se može primijeniti uz druge lijekove koji uključuju nadomjestke kalcija ili vitamina
Silica, colloidal anhydrous Stearic acid
Jezgra tablete: silicijev dioksid, koloidni, bezvodni stearatna kiselina
HDPE bottles, with a child resistant polypropylene closure and a foil induction seal.
Boce od polietilena visoke gustoće (HDPE) s polipropilenskim sigurnosnim čepom za djecu i zalijepljenom zaštitnom folijom.
Starting dose of Sevelamer hydrochloride 800 mg tablets
Početna doza tableta sevelamerklorida od 800 mg
Serum phosphate level in patients not on
Razina fosfata u serumu u bolesnika koji ne uzimaju vezače fosfata
The following side effects have been reported in patients taking Tasermity: Very common (may affect more than 1 in 10 people): nausea, vomiting
Vrlo često (mogu se javiti u više od 1 na 10 osoba): mučnina, povraćanje.
Sevelamer hydrochloride is not absorbed from the gastrointestinal tract according to a single dose pharmacokinetic study in healthy volunteers.
Prema farmakokinetičkom ispitivanju jedne doze u zdravih dobrovoljaca, sevelamerklorid se ne apsorbira iz gastrointestinalnog trakta.
Metabolism and nutrition disorders
Antiaritmici i lijekovi protiv napadaja
Paediatric population
FARMAKOLOŠKA SVOJSTVA
The safety of sevelamer hydrochloride has not been established in breast-feeding women.
Sigurnost primjene sevelamerklorida u dojilja nije ustanovljena.
• if you have bowel obstruction.
• ako patite od blokade crijeva
Contents of the pack and other information What Tasermity contains
16. PODACI NA BRAILLEOVOM PISMU Tasermity
Fat-soluble vitamins
Vitamini topivi u mastima
Name and address of the manufacturers responsible for batch release Genzyme Ireland Limited
Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet
Waterford
FARMACEUTSKI
The main measure of effectiveness was the duration of severe neutropenia.
Glavna mjera učinkovitosti bilo je trajanje teške neutropenije.
What is Nivestim and what is it used for?
Što je Nivestim i za što se koristi?
Further information on Nivestim can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nivestim.
Više informacija o lijeku Nivestim dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/nivestim.