natgillin/translations-raw huggingface dataset:
In study I, 404 patients were randomly assigned to receive placebo (138 patients), rasagiline 1 mg/day (134 patients) or rasagiline 2 mg/day (132 patients) and were treated for 26 weeks, there was no active comparator. 
I su 404 bolesnika metodom slučajnog odabira bili raspodijeljeni da prime placebo (138 bolesnika), razagilin 1 mg/dan (134 bolesnika) ili razagilin 2 mg/dan (132 bolesnika) i bili su liječeni 26 tjedana, nije bilo aktivnog komparatora.
The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.4). 
Nužno je izbjegavati istodobnu primjenu razagilina i fluoksetina ili fluvoksamina (vidjeti dio 4.4).
At least five weeks should elapse between discontinuation of fluoxetine and initiation of treatment with rasagiline. 
Mora proći najmanje 5 tjedana između prestanka primjene fluoksetina i početka liječenja razagilinom.
At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with fluoxetine or fluvoxamine. 
Mora proći najmanje 14 dana između prestanka primjene razagilina i početka liječenja fluoksetinom ili fluvoksaminom.
The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets and in perforated blister packs containing 7 x 1, 10 x 1, 28 x 1, 30 x 1, 100 x 1 and 112 x 1 tablets. 
Tablete su dostupne u blister pakiranjima od 7, 10, 28, 30, 100 i 112 tableta ili perforiranim blisterima, djeljivima na jedinične doze koji sadrži od 7 x 1, 10 x 1, 28 x 1, 30 x 1, 100 x 1 ili 112 x 1 tableta.
Uncommon: cerebrovascular accident (0.5% vs. 0.3%) Cardiac disorders 
Manje često: cerebrovaskularni događaj (0,5% naspram 0,3%) Srčani poremećaji
Serious adverse reactions are known to occur with the concomitant use of SSRIs, SNRIs, tricyclic/tetracyclic antidepressants and MAO inhibitors. 
Poznato je da se ozbiljne nuspojave javljaju uz istodobnu primjenu SSRI-a, SNRI-a, tricikličkih/tetracikličkih antidepresiva i MAO inhibitora.
The concomitant administration of rasagiline and pethidine is contraindicated (see section 4.3). 
Istodobna primjena razagilina i petidina je kontraindicirana (vidjeti dio 4.3).
Uncommon: angina pectoris (0.5% vs. 0%) 
Manje često: angina pektoris (0,5% naspram 0%) Krvožilni poremećaji
How to store Rasagiline Mylan 6. 
Kako čuvati Rasagiline Mylan 6.
Serious adverse reactions have been reported with the concomitant use of SSRIs, SNRIs, tricyclic/tetracyclic antidepressants and MAO inhibitors. 
Prijavljene su ozbiljne nuspojave kod istodobne primjene SSRI-a, SNRI-a, tricikličkih/tetracikličkih antidepresiva i MAO inhibitora.
• prolonged muscle contractions (dystonia) 
• produljene mišićne kontrakcije (distonija)
• general feeling of being unwell (malaise) 
• opće loše osjećanje (malaksalost)
Common: allergy (1.3% vs. 0.7%) 
Često: alergija (1,3% naspram 0,7%)
Common: influenza (4.7% vs. 0.7%) 
Često: influenca (4,7% naspram 0,7%)
Neoplasms benign, malignant and unspecified (including cysts and polyps) Common: skin carcinoma (1.3% vs. 0.7%) Blood and lymphatic system disorders Common: leucopenia (1.3% vs. 0%) 
Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Često: karcinom kože (1,3% naspram 0,7%) Poremećaji krvi i limfnog sustava
• fall 
• pad
Do not take the following medicines while taking Rasagaline Mylan: - monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson's disease, 
Nemojte uzimati sljedeće lijekove dok uzimate Rasagiline Mylan: inhibitore monoaminooksidaze (MAO) (npr. za liječenje depresije ili Parkinsonove bolesti ili za bilo koju drugu indikaciju), uključujući lijekove i prirodne preparate bez recepta npr. gospinu travu petidin (snažan lijek protiv boli).
Common: conjunctivitis (2.7% vs. 0.7%) 
Često: konjunktivitis (2,7% naspram 0,7%)
• flatulence 
• nadutost
Therefore, in view of the MAO inhibitory activity of rasagiline, concomitant administration of rasagiline and sympathomimetics such as those present in nasal and oral decongestants or cold medicinal products, containing ephedrine or pseudoephedrine, is not recommended (see section 4.4). 
Stoga se, s obzirom na MAO inhibitornu aktivnost razagilina, ne preporučuje istodobna primjena razagilina i simpatomimetika poput onih sadržanih u nazalnim i oralnim dekongestivima ili lijekovima za prehladu koji sadrže efedrin ili pseudoefedrin (vidjeti dio 4.4).
At least 14 days must elapse between discontinuation of rasagiline and initiation of treatment with MAO inhibitors or pethidine. 
Mora proći najmanje 14 dana između prestanka primjene razagilina i početka liječenja MAO inhibitorima ili petidinom.
Common: orthostatic hypotension (3.9% vs. 0.8%) Gastrointestinal disorders 
Često: ortostatska hipotenzija (3,9% naspram 0,8%)
Mylan S.p.A Tel: + 39 02 612 46921 
Tel: +39 02 612 46921
• Rare (may affect up to 1 in 1,000 people) 
• Rijetko (mogu se javiti u 1 na 1000 osoba)
Česká republika Mylan Pharmaceuticals s.r.o. 
Mylan Pharmaceuticals S.L.
Rasagiline use in patients with severe hepatic impairment is contraindicated (see section 4.3). 
Kontraindicirana je primjena razagilina u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
How to take Rasagiline Mylan 
Kako uzimati Rasagiline Mylan
In case patients progress from mild to moderate hepatic impairment, rasagiline should be stopped (see section 
U slučajevima bolesnikove progresije od blagog do umjerenog oštećenja jetre razagilin je potrebno ukinuti (vidjeti dio 5.2).
Rasagiline Mylan 1 mg tablets 
NAZIV GOTOVOG LIJEKA Rasagiline Mylan 1 mg tablete
• Very common (may affect more than 1 in 10 people) 
• Vrlo često (mogu se javiti u više od 1 na 10 osoba)
• Very rare (may affect up to 1 in 10,000 people) 
• Vrlo rijetko (mogu se javiti u 1 na 10 000 osoba)
In case patients progress from mild to moderate hepatic impairment rasagiline should be stopped (see section 4.4). 
U slučajevima bolesnikove progresije od blagog do umjerenog oštećenja jetre, razagilin je potrebno ukinuti (vidjeti dio 4.4).
Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon: skin melanoma (0.5% vs. 0.3%) 
Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Manje često: melanom kože (0,5% naspram 0,3%) Poremećaji metabolizma i prehrane
The efficacy of rasagiline was established in three studies: as monotherapy treatment in study I and as adjunct therapy to levodopa in the studies II and III. 
I i kao dodatna terapija levodopi u ispitivanjima II i III.
General disorders and administration site conditions Common: fever (2.7% vs. 1.3%), malaise (2% vs. 0%) 
Opći poremećaji i reakcije na mjestu primjene Često: vrućica (2,7% naspram 1,3%), slabost (2% naspram. 0%)
Musculoskeletal and connective tissue disorders Common: arthralgia (2.4% vs. 2.1%), neck pain (1.3% vs. 0.5%) 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često: atralgija (2,4% naspram 2,1%), bol u vratu (1,3% naspram 0,5%) Pretrage
Rasagiline may be taken with or without food. 
Razagilin se može uzimati s hranom ili bez nje.
Warnings and precautions Talk to your doctor before taking Rasagiline Mylan. 
Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete Rasagiline Mylan. ako imate blage do umjerene probleme s jetrom ako imate bilo kakve sumnjive promjene na koži.
The secondary measures of efficacy included global assessments of improvement by the examiner, Activities of Daily Living (ADL) subscale scores when OFF and UPDRS motor while ON. Rasagiline produced statistically significant benefit compared to placebo. 
Sekundarne mjere djelotvornosti su uključivale opće procjene istraživača o poboljšanju, zbrojeve podljestvice aktivnosti svakodnevnog življenja (engl.
• bloodshot eyes (conjunctivitis) 
• crvenilo očiju (konjunktivitis)
Common: decreased weight (4.5% vs. 1.5%) Injury, poisoning and procedural complications Common: fall (4.7% vs. 3.4%) 
Ozljede, trovanja i proceduralne komplikacije Često: pad (4,7% naspram 3,4%)
Rasagiline use in patients with moderate hepatic impairment should be avoided. 
Primjenu razagilina u bolesnika s umjerenim oštećenjem jetre nužno je izbjegavati.
In post-marketing experience these symptoms have also been observed in Parkinson's disease patients treated with rasagiline. 
Ovi simptomi su opaženi i tijekom razdoblja nakon stavljanja lijeka u promet u bolesnika s Parkinsonovom bolešću liječenih razagilinom.
How to store Rasagiline Mylan 
Kako čuvati Rasagiline Mylan
In study II, patients were randomly assigned to receive placebo (229 patients), or rasagiline 1 mg/day (231 patients) or the catechol-O-methyl transferase (COMT) inhibitor, entacapone, 200 mg taken along with scheduled doses of levodopa (LD)/decarboxylase inhibitor (227 patients), and were treated for 18 weeks. 
COMT), entakapon, 200 mg uzet zajedno s redovitim dozama levodope (LD)/inhibitora dekarboksilaze (227 bolesnika), i bili su liječeni 18 tjedana.
Common: decreased appetite (2.4% vs. 0.8%) 
Često: smanjen apetit (2,4% naspram 0,8%) Psihijatrijski poremećaji
Common: abdominal pain (4.2% vs. 1.3%), constipation (4.2% vs. 2.1%), nausea and vomiting (8.4% vs. 6.2%), dry mouth (3.4% vs. 1.8%) 
2,1%), mučnina i povraćanje (8,4% naspram 6,2%), suha usta (3,4% naspram 1,8%) Poremećaji kože i potkožnog tkiva Često: osip (1,1% naspram 0,3%)
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release 
Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments. 
Kod bolesnika liječenih agonistima dopamina i/ili drugim dopaminergičkim lijekovima mogu se pojaviti patološko kockanje, povećan libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, prejedanje i kompulzivno jedenje.
Cellulose, microcrystalline Tartaric acid 
6.1 Popis pomoćnih tvari celuloza, mikrokristalična tartaratna kiselina kukuruzni škrob škrob, prethodno geliran kukuruzni talk stearatna kiselina
Musculoskeletal and connective tissue disorders Common: musculoskeletal pain (6.7% vs. 2.6%), neck pain (2.7% vs. 0%), arthritis (1.3% vs.0.7%) Renal and urinary disorders 
Često: mišićno-koštana bol (6,7% naspram 2,6%), bol u vratu (2,7% naspram 0%), artritis (1,3%
Uncommon: myocardial infarction (0.7% vs. 0%) Respiratory, thoracic and mediastinal disorders Common: rhinitis (3.4% vs. 0.7%) 
Često: angina pektoris (1,3% naspram 0%); Manje često: infarkt miokarda (0,7% naspram 0%) Poremećaji dišnog sustava, prsišta i sredoprsja
4.7 Effects on ability to drive and use machines 
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Nisu provedene studije utjecaja na sposobnost upravljanja vozilima i rada sa strojevima.
Very common: headache (14.1% vs. 11.9%) Uncommon: cerebrovascular accident (0.7% vs. 0%) 
Vrlo često: glavobolja (14,1% naspram 11,9%)
Mylan Pharmaceuticals, S.L Tel: + 34 900 102 712 
Česká republika Mylan Pharmaceuticals s.r.o. Tel: + 420 222 004 400
• Common (may affect up to 1 in 10 people) 
• Često (mogu se javiti u 1 na 10 osoba)
Caution should be exercised when rasagiline is administered to a breast-feeding mother. 
Nužan je oprez kod primjene razagilina u dojilja.
Tel: + 386 1 236 31 85 
GSP Proizvodi d.o.o. Tel: +386 1 236 31 85
C-labelled rasagiline is approximately 60 to 
Vezanje za proteine plazme nakon pojedinačne oralne doze 14C-obilježenog razagilina je približno 60 do
Common: flatulence (1.3% vs.0%) 
Često: leukopenija (1,3% naspram 0%)
• headedness (orthostatic hypotension) 
(ortostatska hipotenzija)
How to take Rasagiline Mylan 4. 
Kako uzimati Rasagiline Mylan 4. Moguće nuspojave
• Uncommon (may affect up to 1 in 100 people) 
• Manje često (mogu se javiti u 1 na 100 osoba)
OTHER 
DODATAK
Rasagiline Mylan 
Što Rasagiline Mylan sadrži
• blistering rash (vesiculobullous rash) 
• upala zglobova (artritis)
Common: rash (1.1% vs. 0.3%) 
Često: rinitis (3,4% naspram 0,7%)
Common: urinary urgency (1.3% vs. 0.7%). 
Poremećaji bubrega i mokraćnog sustava Često: urgencija mokrenja (1,3% naspram 0,7%).
Deutschland Mylan dura GmbH 
V.J. Salomone Pharma Ltd
Similar reports of ICDs have also been received post-marketing with rasagiline. 
U postmarketinškom razdoblju su zaprimljene slične prijave poremećaja kontrole impulsa sa razagilinom.
Synthon s.r.o Brněnská 32/čp. 
Synthon s.r.o, Brněnská 32/čp. 597 678 01 Blansko Češka Republika
Salomone Pharma Ltd Tel: + 356 21 22 01 74 
Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599
Investigations 
U ispitivanju
• joint inflammation (arthritis) 
• bol u zglobovima (artralgija)
Date of first authorisation: April 2015 
Datum prvog odobrenja: Travanj 2015
• At the request of the European Medicines Agency; 
• Na zahtjev Europske agencije za lijekove
Turn over to continue… 
Okrenuti za nastavak…
Always take Ristempa exactly as your doctor has told you. 
Uvijek primijenite Ristempu točno onako kako Vam je rekao liječnik.
If you use more Ristempa than you should 
Ako primijenite više Ristempe nego što biste trebali
Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made 
Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1. i 5.2, međutim nije moguće dati preporuku o doziranju.
Check the appearance of Ristempa. 
Provjerite izgled Ristempe.
• Outer area of upper arm (only if someone else is giving you the injection). 
• Vanjsko područje nadlaktice (samo ako vam netko drugi daje injekciju).
What Ristempa is and what it is used for 
Što je Ristempa i za što se koristi
Before you inject Ristempa you must do the following: 
Prije injiciranja Ristempe morate učiniti sljedeće:
Before you use a Ristempa pre-filled syringe with automatic needle guard, read this important information: 
Prije korištenja Ristempa napunjene štrcaljke s automatskim štitnikom za iglu, pročitajte ove važne informacije:
For more information, see section 5.1 
Za više informacija vidjeti dio 5.1.
Other medicines and Ristempa 
Drugi lijekovi i Ristempa
Do not warm Ristempa in any other way (for example, do not warm it in a microwave or in hot water). 
Ne zagrijavajte Ristempu ni na bilo koji drugi način (primjerice, u mikrovalnoj pećnici ili u vrućoj vodi).
9/l or greater have been observed in less than 1% of patients receiving Ristempa. 
9/l ili više primijećen je u manje od 1% bolesnika koji su primali Ristempu.
How do you, or the person injecting you, use Ristempa pre-filled syringe? 
Kako ćete Vi ili osoba koja Vam daje injekciju koristiti Ristempa napunjenu štrcaljku?
Do not shake Ristempa vigorously as this may affect its activity. 
Ne tresite snažno Ristempu jer to može utjecati na njezinu aktivnost.
Ristempa has not been tested in pregnant women. 
Ristempa nije ispitivana u trudnica.
The safety and efficacy of Ristempa in children has not yet been established. 
Sigurnost i djelotvornost Ristempe u djece nisu još ustanovljene.
RELEASE your thumb. 
OTPUSTITE palac.
Long term outcome was not studied (see section 4.4). 
Dugoročni ishod nije ispitivan (vidjeti poglavlje 4.4).
Ristempa is for use in adults aged 18 and over. 
Ristempa se primjenjuje u odraslih osoba starijih od 18 godina.
If you forget to inject Ristempa 
Ako ste zaboravili injicirati Ristempu
Read other side first 
Strana 2 Prvo pročitajte drugu stranu
See section “Description of selected adverse reactions” below. 
“Opis odabranih nuspojava“ ispod.
If you become pregnant during Ristempa treatment, please inform your doctor. 
Ukoliko zatrudnite tijekom primjene Ristempe, molimo obavijestite liječnika.
The potency of this product should not be compared to the potency of another pegylated or nonpegylated protein of the same therapeutic class. 
Potentnost ovog lijeka ne smije se uspoređivati s potentnošću drugih pegiliranih ili nepegiliranih proteina iste terapijske skupine.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Ristempa therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
Nužno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Ristempa uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
Talk to your doctor, pharmacist or nurse before using Ristempa: 
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije primjene Ristempe:
Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Ristempa. 
Slučajno jednokratno izlaganje temperaturama zamrzavanja u razdoblju kraćem od 24 sata ne utječe nepovoljno na stabilnost Ristempe.
Side 1 
Strana 1
• if you are allergic to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of this medicine. 
• ako ste alergični na pegfilgrastim, filgrastim, proteine dobivene iz E. coli ili neki drugi sastojak ovog lijeka.
Do not try to warm the syringe by using a heat source such as hot water or microwave. 
Ne pokušavajte ugrijati štrcaljku korištenjem izvora topline kao što su vruća voda ili
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• Uoči svake izmjene sustava upravljanja rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
The frequency category was estimated from a statistical calculation based upon 1576 patients receiving Ristempa in nine randomized clinical trials. 
Kategorija učestalosti je procijenjena statističkim izračunom na temelju 1576 bolesnika koji su Ristempu primali u devet randomiziranih kliničkih ispitivanja.
What should I do before I give myself a subcutaneous injection of Ristempa? 
Što trebam učiniti prije samoprimjene potkožne injekcije Ristempe?
Local representative contact details are provided in section 6 of this leaflet. 
Podatke o kontaktu lokalnog predstavnika nalaze se u dijelu 6 ove upute.
What Ristempa is and what it is used for What you need to know before you use Ristempa 
Što je Ristempa i za što se koristi Što morate znati prije nego počnete primjenjivati Ristempu
Specific interaction or metabolism studies have not been performed, however, clinical trials have not indicated an interaction of Ristempa with any other medicinal products. 
Nisu provedena specifična ispitivanja interakcija ili metabolizma, no klinička ispitivanja nisu upućivala na interakciju Ristempe s bilo kojim drugim lijekovima.
Ristempa left at room temperature for more than 72 hours should be discarded. 
Ristempa ostavljena na sobnoj temperaturi dulje od 72 sata se mora ukloniti.
• Ristempa is given as an injection into the tissue just under the skin (subcutaneous injection). 
• Ristempa se daje u obliku injekcije u tkivo odmah ispod kože (potkožna injekcija)
Your doctor will check your blood and urine regularly as Ristempa can harm the tiny filters inside your kidneys (glomerulonephritis). 
Vaš će liječnik redovito provjeravati Vašu krv i mokraću jer Ristempa može oštetiti sitne filtere unutar Vaših bubrega (glomerulonefritis).
Ristempa therapy should be initiated and supervised by physicians experienced in oncology and/or haematology. 
Liječenje Ristempom mora započeti i nadzirati liječnik s iskustvom u onkologiji i/ili hematologiji.
Your doctor may decide that it would be more convenient for you to inject Ristempa yourself. 
Vaš liječnik može odlučiti da će Vama biti pogodnije ako si sami injicirate Ristempu.
Single doses of 300 µg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions. 
Jednokratna doza od 300 g/kg primijenjena je supkutano ograničenom broju zdravih dobrovoljaca i bolesnika s rakom pluća ne-malih stanica bez pojave ozbiljnih reakcija.
In animal models concomitant administration of Ristempa and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression. 
Na životinjskim modelima se pokazalo da je istodobna primjena Ristempe i 5-fluorouracila (5-FU) ili drugih antimetabolita potencirala mijelosupresiju.
What you need to know before you use Ristempa 
Što morate znati prije nego počnete primjenjivati Ristempu
After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle. 
Nakon što ste oslobodili klip, sigurnosni štitnik napunjene štrcaljke će prekriti iglu za injekciju.
9/l after the expected nadir, this medicine should be discontinued immediately. 
9/l, liječenje ovim lijekom treba odmah prekinuti.
If you develop or are likely to develop cancers of the blood, you should not use Ristempa, unless instructed by your doctor. 
Ukoliko imate ili postoji neposredna opasnost od razvoja oblika raka krvi, ne biste trebali primjenjivati Ristempu, osim u slučaju da je to savjet Vašeg liječnika.
The most common adverse reaction reported was bone pain (see section 5.1 and 5.2). 
Najčešće prijavljena nuspojava bila je bol u kostima (vidjeti dio 5.1 i 5.2).
For further instructions on how to inject yourself with Ristempa, please read the section at the end of this leaflet. 
Dodatne upute o tome kako samostalno injicirati Ristempu potražite u dijelu na kraju ove Upute o lijeku.
Do not use any Ristempa that is left in the syringe. 
Ne koristite Ristempu koja je ostala u štrcaljki.
• It is important that you do not try to give yourself the injection unless you have received training from your doctor or healthcare provider. 
• Važno je da ne pokušavate dati sebi injekciju ukoliko niste prošli obuku kod svojeg liječnika ili zdravstvenog djelatnika
This can be a sign of Acute Respiratory Distress Syndrome (ARDS) 
To može biti znak akutnog respiratornog distres sindroma odraslih (ARDS);
However, the long-term effects of Ristempa have not been established in acute myeloid leukaemia; therefore, it should be used with caution in this patient population. 
Međutim, dugoročni učinci Ristempe na akutnu mijeloičnu leukemiju nisu ustanovljeni, stoga se lijek mora primjenjivati s oprezom u toj populaciji bolesnika.
Therefore, physicians should use caution when prescribing Ristempa in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicine with splenic enlargement and vaso-occlusive crisis. 
Stoga liječnici trebaju s oprezom prepisivati Ristempu u bolesnika s nasljednim obilježjem srpastih stanica ili s bolesti srpastih stanica, pažljivo pratiti odgovarajuće kliničke i laboratorijske parametre te paziti na moguću povezanost ovog lijeka s povećanjem slezene i vazookluzivnom krizom.
Important: read the package leaflet before handling pre-filled syringe. 
Važno: Pročitajte Uputu o lijeku prije rukovanja napunjenom štrcaljkom.
The mechanism of vasculitis in patients receiving Ristempa is unknown. 
Mehanizam nastanka vaskulitisa u bolesnika koji primaju Ristempu nije poznat.
Ristempa may be used if it is accidentally frozen for a single period of less than 24 hours. 
Ristempa se može upotrijebiti ako je bio slučajno zamrznut jednokratno i kraće od 24 sata.
Sweet's syndrome (acute febrile dermatosis) Cutaneous vasculitis 
Sweetov sindrom (akutna febrilna dermatoza) Kožni vaskulitis
Ristempa is not recommended during pregnancy and in women of childbearing potential not using contraception. 
Ne preporučuje se koristiti lijek Ristempa tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu 
Detaljne informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu
Ristempa contains sorbitol (a type of sugar). 
Ristempa sadrži sorbitol (jedan oblik šećera).