natgillin/translations-raw huggingface dataset:
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Priligy tablets. 
Evropska agencija za zdravila je zaključila arbitražni postopek po nesoglasju med državami članicami Evropske unije (EU) glede odobritve tablet Priligy.
Why was Priligy reviewed? 
Zakaj je bilo zdravilo Priligy pregledano?
The active substance, dapoxetine, is a selective serotonin re-uptake inhibitor (SSRI) and it works by preventing the neurotransmitter 5-hydroxytryptamine (also called serotonin) from being taken back up into nerve cells in the brain and spinal cord, thereby increasing the amount of serotonin between nerve cells. 
Zdravilna učinkovina, dapoksetin, je selektivni zaviralec ponovnega privzema serotonina (SSRI) in deluje tako, da preprečuje živčnim celicam v možganih in hrbtenjači, da bi ponovno sprejele živčni prenašalec 5-hidroksitriptamin (imenovan tudi serotonin), s tem pa se poveča količina serotonina med živčnimi celicami.
Priligy is believed to increase the time it takes to ejaculate by increasing the amount of a neurotransmitter between the nerve cells. 
Zdravilo Priligy naj bi podaljšalo čas do ejakulacije, tako da poveča količino živčnega prenašalca med živčnimi celicami.
Patients should not start treatment with 60 mg tablets, and may only be switched to 60 mg if they have not responded sufficiently to the 30 mg tablets and have not experienced moderate or severe adverse reactions or symptoms suggestive of syncope. 
Bolniki naj zdravljenja ne začnejo s 60-miligramskimi tabletami in naj 60 mg začnejo uporabljati le v primeru, če se na 30 mg tablete niso ustrezno odzvali in niso izkusili zmernih ali hudih neželenih učinkov ali simptomov, ki so značilni za sinkopo.
Questions and answers on Priligy (dapoxetine, 30 mg and 60 mg tablets) 
Vprašanja in odgovori v zvezi z zdravilom Priligy (dapoksetin, 30 mg in 60 mg tablete)
The company that markets Priligy in Sweden, Janssen-Cilag AB, submitted an application to market Priligy (30 mg and 60 mg tablets) through the mutual recognition procedure based on the initial authorisation granted by Sweden on 6 February 2009. 
Družba Janssen-Cilag AB, ki trži zdravilo Priligy na Švedskem, je vlogo za trženje zdravila Priligy (30 mg in 60 mg tablete) vložila po postopku z medsebojnim priznavanjem, ki temelji na prvotnem dovoljenju, ki ga je Švedska odobrila 6. februarja 2009.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Priligy 60 mg outweigh its risks, and that therefore the marketing authorisation for Priligy (30 mg and 60 mg) should be granted in all concerned Member States. 
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP zaključil, da koristi zdravila Priligy 60 mg odtehtajo z njim povezana tveganja ter da je zato treba dovoljenje za promet z zdravilom Priligy (30 mg in 60mg) odobriti v vseh zadevnih državah članicah.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of the 60 mg tablet (over which there was disagreement) do outweigh its risks and that the marketing authorisation for Priligy granted in Sweden can be recognised in other Member States of the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) Agencije je ugotovil, da koristi 60 mg tablet (v zvezi s katerimi je prišlo do nesoglasja) odtehtajo z njimi povezana tveganja in da se dovoljenje za promet z zdravilom Priligy, ki je odobreno na Švedskem, lahko prizna tudi v drugih državah članicah EU.
The grounds for the referral were concerns over the benefit-risk balance of the 60 mg tablet by some Member States, who considered its additional benefit compared with the 30 mg tablet to be too modest when weighed against the increased risk of severe cases of syncope (fainting) seen in studies with the medicine. 
Razlog za napotitev je bila zaskrbljenost nekaterih držav članic glede razmerja med tveganji in koristmi za 60 mg tablete, saj so menile, da so dodatne koristi 60 mg tablet v primerjavi s 30 mg tabletami preveč skromne v primerjavi s povečanim tveganjem za resne pojave sinkope (omedlevice), ki so bili opaženi v študijah z zdravilom.
Questions and answers on Priligy (dapoxetine, 30 mg and 60 mg tablets) EMA/59013/2012 
Vprašanja in odgovori v zvezi z zdravilom Priligy (dapoksetin, 30 mg in 60 mg tablete) EMA/106784/2012
What is Priligy? 
Kaj je zdravilo Priligy?
Content (concentration) 
Pot uporabe Stična ovojnina Vsebina(koncen tracija)
The marketing authorisation was renewed on 3 May 2001 and on 3 May 2006. 
Dovoljenje za promet z zdravilom je bilo podaljšano dne 3. maja 2001 in 3. maja 2006.
Other information about Puregon: 
Druge informacije o zdravilu Puregon:
It is made by a cell that has received a gene (DNA), which makes it able to produce human FSH. 
Izdela ga celica, ki je prejela gen (DNK), s katerim lahko tvori človeški FSH.
The most common side effects reported are a reaction and pain at the injection site. 
Najpogostejši neželeni učinki, o katerih so poročali, so reakcija ali bolečina na mestu injiciranja.
The dose and frequency of administration of Puregon depend on its use (see above) and the patient's response to treatment. 
Odmerjanje in pogostnost dajanja zdravila Puregon sta odvisna od načina njegove uporabe (glejte zgoraj) in od bolnikovega odziva na zdravljenje.
The European Commission granted a marketing authorisation valid throughout the European Union, for Puregon on 3 May 1996. 
Evropska komisija je dovoljenje za promet z zdravilom Puregon, veljavno po vsej Evropski uniji, odobrila dne 3. maja 1996.
What benefit has Puregon shown during the studies? 
Kakšne koristi je zdravilo Puregon izkazalo med študijami?
Treatment with Puregon should be carried out by a doctor who has experience in the treatment of fertility problems. 
Zdravljenje z zdravilom Puregon mora izvajati zdravnik, ki ima izkušnje z zdravljenjem težav s plodnostjo.
The marketing authorisation holder is N.V. Organon. 
Imetnik dovoljenja za promet z zdravilom je družba N.V.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PUREGON EPAR summary for the public 
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) PUREGON Povzetek EPAR za javnost
The Committee recommended that Puregon be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Puregon odobri dovoljenje za promet.
Puregon was studied in 172 anovulatory women, measuring how many cycles of treatment were needed for these women to ovulate. 
Zdravilo Puregon so proučevali pri 172 ženskah brez ovulacije, merili pa so, koliko ciklov zdravljenja so potrebovale do pojava ovulacije.
• women who are anovulatory (do not produce eggs) and do not respond to treatment with clomiphene citrate (another medicine that stimulates ovulation). 
• pri ženskah z anovulacijo (ki ne proizvajajo jajčec) in ženskah, ki se niso odzvale na zdravljenje s klomifen citratom (drugim zdravilom, ki spodbuja ovulacijo);
Puregon's use in women undergoing fertility treatment has been studied in 981 patients. 
Uporaba zdravila Puregon pri ženskah, ki se zdravijo zaradi neplodnosti, je bila raziskana pri 981 bolnicah.
Puregon should not be used in people who may be hypersensitive (allergic) to follitropin beta or any of the other ingredients. 
Zdravila Puregon ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) na folitropin beta ali katero koli drugo sestavino zdravila.
What is the risk associated with Puregon? 
Kakšna tveganja so povezana z uporabo zdravila Puregon?
• women who are undergoing fertility treatment (assisted reproductive techniques, such as in vitro fertilisation). 
• pri ženskah, ki se zdravijo zaradi neplodnosti (postopki asistirane reprodukcije, kot je in vitro oploditev).
Puregon can also be used to stimulate sperm production in men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease). 
Zdravilo Puregon se prav tako lahko uporablja za spodbujanje proizvajanja semenčic pri moških, ki imajo hipogonadotropni hipogonadizem (redka bolezen pomanjkanja hormonov).
Puregon is given as a ‘subcutaneous' injection (under the skin) or into a muscle. 
Zdravilo Fertavid se daje s subkutano injekcijo (pod kožo) ali v mišico.
Puregon can only be obtained with a prescription. 
Zdravilo Puregon se dobi samo na recept.
In all of the studies, Puregon was compared to the natural FSH hormone that was extracted from urine. 
Pri vseh študijah so zdravilo Puregon primerjali z naravnim hormonom FSH, pridobljenim iz urina.
In 4 % of the women treated with Puregon in clinical studies, signs and symptoms related to ovarian hyperstimulation syndrome (e.g. feeling sick, weight gain, and diarrhoea) have been reported. 
Pri 4 % žensk, ki so v kliničnih študijah prejemale zdravilo Puregon, so poročali o znakih in simptomih, podobnih sindromu hiperstimulacije jajčnikov (kot so občutek slabosti, povečanje telesne mase in driska).
In the body, FSH regulates the reproductive function: in women, it stimulates the production of eggs, and in men, it stimulates the production of sperm by the testicles. 
V telesu FSH uravnava funkcijo reprodukcije: pri ženskah spodbuja nastajanje jajčec, pri moških pa nastajanje semenčic v modih.
The powder should be mixed with the solvent provided just before use. 
Prašek se zmeša s priloženim vehiklom neposredno pred uporabo.
The follitropin beta in Puregon is produced by a method known as ‘recombinant DNA technology'. 
Folitropin beta, ki ga vsebuje zdravilo Puregon, je pridobljen z metodo, znano kot „tehnologija rekombinantne DNK“.
Puregon must not be used in patients with tumours of the ovary, breast, womb, testicle, pituitary gland or hypothalamus. 
Zdravila Puregon ne smejo uporabljati bolniki s tumorji jajčnikov, dojk, maternice, testisov, hipofize ali hipotalamusa.
It is also available as a solution for injection in a vial or a cartridge. 
Na razpolago je tudi v obliki raztopine za injiciranje v viali ali vložku.
Puregon is administered to stimulate the ovaries to produce more than one egg at a time 
Zdravilo Puregon se daje za spodbujanje delovanja jajčnikov, da bi v njih nastalo več kot eno jajčece hkrati.
In men, Puregon was studied to see its effect on sperm production in 49 patients. 
Pri moških so vpliv zdravila Puregon na proizvajanje sperme proučevali pri 49 bolnikih.
Puregon should only be administered by people who have been trained by the doctor and have access to expert advice. 
Zdravilo Puregon lahko dajejo samo osebe, ki jih je za to usposobil zdravnik in ki imajo možnost posvetovati se s strokovnjakom.
Puregon is used to treat infertility in women in the following situations: 
Zdravilo Puregon se uporablja za zdravljenje neplodnosti v naslednjih primerih:
The Committee for Medicinal Products for Human Use (CHMP) decided that Puregon's benefits are greater than its risks in the female for the treatment of infertility, and in the male for deficient spermatogenesis due to hypogonadotrophic hypogonadism. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Puregon pri zdravljenju neplodnosti pri ženskah in nezadostne spermatogeneze zaradi hipogonadotropnega hipogonadizma pri moških, večje od z njim povezanih tveganj.
Why has Puregon been approved? 
Zakaj je bilo zdravilo Puregon odobreno?
Puregon is a powder and solvent to be made up into a solution for injection. 
Zdravilo Puregon sestavljata prašek in topilo za pripravo raztopine za injiciranje.
Puregon contains the active substance follitropin beta. 
Zdravilo Puregon vsebuje zdravilno učinkovino folitropin beta.
The full EPAR for Puregon is available here. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Puregon je na voljo tukaj.
The active substance in Puregon, follitropin beta, is a copy of the natural hormone follicle stimulating hormone (FSH). 
Zdravilna učinkovina zdravila Puregon, folitropin beta je posnetek naravnega folikle stimulirajočega hormona (FSH).
Puregon was as effective as the comparator in all of the studies. 
V vseh študijah je bilo zdravilo Puregon enako učinkovito kot primerjalno zdravilo.
For a full list of all side effects reported with Puregon, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Puregon, glejte navodilo za uporabo.
Puregon was as effective as urinary FSH as a fertility treatment, in producing ovulation and in producing sperm. 
Zdravilo Puregon je bilo pri zdravljenju neplodnosti, spodbujanju ovulacije in nastajanju sperme enako učinkovito kot FSH, pridobljen iz urina.
What is Puregon used for? 
Za kaj se zdravilo Puregon uporablja?
How has Puregon been studied? 
Kako je bilo zdravilo Puregon raziskano?
What is Puregon? 
Kaj je zdravilo Puregon?
How does Puregon work? 
Kako zdravilo Puregon deluje?
How is Puregon used? 
Kako se zdravilo Puregon uporablja?
For a full description of the doses, please see the Package Leaflet. 
Celoten opis odmerjanja najdete v navodilu za uporabo.
Oral use blister (OPA/aluminium/PVC/ aluminium) 
mg filmsko obložena tableta peroralna uporaba pretisni omot (OPA/aluminij/PVC/aluminij)
Film-coated tablet 
Stična ovojnina
Content Package size 
Način uporabe Pakiranje Vsebina Velikost pakiranja
Both studies were similarly designed. 
Obe študiji sta bili podobno zasnovani.
Adult and children (1 to 17 years): 
Odrasli in otroci (1 leto do 17 let):
Date of first authorisation: 4 February 2009 Date of latest renewal: 20 December 2013 
Datum prve odobritve: 4. februar 2009 Datum zadnjega podaljšanja: 20. december 2013
Before you begin 
Preden začnete
IMMEDIATELY continue to step 7. 
NEMUDOMA nadaljujte s 7. korakom.
Perform step 3a before step 3b. 
Opravite korak 3a pred korakom 3b.
Combined studies 1 & 2 
Kombinirani študiji 1 in 2
A summary of the key efficacy endpoints is presented below. 
Spodaj je prikazan povzetek ključnih končnih točk učinkovitosti.
The injection volume may be very small. 
Količina za injiciranje je lahko zelo majhna.
One Amgen Center Drive Thousand Oaks, CA 91320 USA 
One Amgen Center Drive Thousand Oaks, CA 91320 ZDA
The overall safety profile was similar to that seen in adults. 
Celokupen varnostni profil je bil podoben kot pri odraslih.
Component of a multipack, not to be sold separately. 
Sestavine multipakiranja, ki se ne prodajajo ločeno.
The median duration of exposure was 65.4 weeks. 
Mediana trajanja izpostavljenosti je bila 65,4 tedna.
Overall survival was similar to placebo. 
Celokupno preživetje je bilo podobno kot pri placebu.
Patient may not have a weekly response within 8 weeks after receiving any rescue medicinal products. 
Bolnik lahko nima tedenskega odziva v 8 tednih po prejetju kakršnekoli rešilne terapije.
As with all therapeutic proteins, there is a potential for immunogenicity. 
Tako kot pri vseh terapevtskih beljakovinah obstaja možnost imunogenosti.
Do the following: 
Naredite naslednje:
> 150 for two consecutive weeks 
> 150 dva tedna zapored
• allergic reaction; 
• alergična reakcija,
Effects of romiplostim on red and white blood cells 
Učinki romiplostima na rdeče in bele krvne celice
Do not use if frozen. 
Zdravila ne uporabite, če je zmrznjeno.
• protein in the urine. 
• beljakovine v urinu.
Before continuing: 
Pred nadaljevanjem:
• Wash your hands with soap and warm water. 
• Umijte si roke z milom in toplo vodo.
Other pharmaceutical forms/strengths may be more appropriate for administration to this population. 
Za uporabo pri tej populaciji so morda bolj primerne druge farmacevtske oblike/jakosti.
• if you are allergic to romiplostim or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na romiplostim ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• Select a well lit, flat work surface, such as a table. 
• Izberite dobro osvetljeno, ravno delovno površino, kot je na primer miza.
Reassessment of body weight is recommended every 12 weeks. 
Priporočljivo je, da se telesna masa ponovno oceni vsakih 12 tednov.
If necessary push liquid back into the vial to achieve the desired dose. 
Če je treba, potisnite tekočino nazaj v vialo, da boste dosegli želeni odmerek.
Worsening of blood cancers 
Poslabšanje krvnih rakov
• Do check your dose before starting this step. 
• Pred začetkom tega koraka preverite svoj odmerek.
Children (1 to 17 years old): in addition to adjusting your dose based on platelet counts, your doctor will also regularly reassess your body weight in order to adjust your dose. 
Otroci (stari 1 leto do 17 let): vaš zdravnik bo poleg prilagajanja vašega odmerka na osnovi števila trombocitov redno ocenjeval tudi vašo telesno težo in tako prilagajal vaš odmerek.
ITP is a disease in which your body's immune system destroys its own platelets. 
ITP je bolezen, pri kateri telesni imunski sistem uničuje svoje lastne trombocite.
• Do dissolve slowly and carefully. 
• Zdravilo raztopite počasi in pazljivo.
Romiplostim should be used with caution in these populations. 
Romiplostim je treba pri teh populacijah uporabljati previdno.
Do not try to inject yourself if you have not been trained. 
Ne poskušajte si injicirati zdravila, če se za to niste usposobili.
Push slowly and gently 
Potisnite počasi in previdno
The European Medicines Agency has waived the obligation to submit data for children < 1 year. 
Evropska agencija za zdravila je odstopila od zahteve za predložitev podatkov za otroke, mlajše od enega leta.
Progression of existing Myelodysplastic Syndromes (MDS) 
Napredovanje obstoječih mielodisplastičnih sindromov (MDS)
This is a protein product and proteins can be easily damaged by improper mixing and excessive shaking. 
To je zdravilo, ki vsebuje beljakovine, beljakovine pa se med nepravilnim mešanjem in prekomernim stresanjem zlahka poškodujejo.
Multipack: comprising 4 packs Each pack contains: 
Multipakiranje: obsega 4 pakiranja Vsako pakiranje vsebuje:
In general, effects observed during these studies were related to the thrombopoietic activity of romiplostim and were similar regardless of study duration. 
Na splošno so bili učinki, ugotovljeni v teh študijah, povezani s trombopoetskim delovanjem romiplostima in so bili podobni ne glede na trajanje študije.
If the expiry date has passed, do not use. 
Če je rok uporabnosti že potekel, zdravila ne uporabite.
Although high doses were tested in the animal studies, due to differences between the laboratory species and humans with regard to the sensitivity for the pharmacodynamic effect of romiplostim and the effect of neutralising antibodies, safety margins cannot be reliably estimated. 
V študijah na živalih so sicer preizkusili velike odmerke, vendar zaradi razlik med laboratorijskimi vrstami in človekom, kar zadeva občutljivost na farmakodinamične učinke romiplostima in učinek nevtralizirajočih protiteles, meje varnosti ni mogoče zanesljivo oceniti.
9/L for at least 4 weeks without dose adjustment) has been achieved. 
9/l vsaj 4 tedne brez prilagoditve odmerka).
Your doctor will tell you how much you must take. 
Zdravnik vam bo povedal, koliko zdravila morate dobivati.
• Note: The Nplate liquid is highly potent which is why accuracy and dose measurement are important. 
• Opomba: Tekočina zdravila Nplate je izredno močna, zato sta točnost in odmerjanje odmerka pomembna.
However, the data are insufficient to draw any meaningful conclusion relating to the impact of dose and age on the pharmacokinetics of romiplostim. 
Vendar pa so podatki nezadostni za podajanje pomembnih zaključkov o vplivu odmerka in starosti na farmakokinetiko romiplostima.
Before you begin Step 3 please note the following: 
Preden začnete s 3. korakom, bodite pozorni na sledeče:
Before you begin Step 4 please note the following: 
Preden začnete s 4. korakom, bodite pozorni na sledeče:
Treatment should remain under the supervision of a physician who is experienced in the treatment of haematological diseases. 
Zdravljenje mora ves čas potekati pod nadzorom zdravnika, izkušenega v zdravljenju hematoloških bolezni.
No other diluents have been tested. 
Druga redčila niso bila preizkušena.
You do not have to maintain pressure on the plunger for the rest of Step 4. 
Bata vam ni treba ves preostanek 4. koraka držati pritisnjenega.
With the other hand, hold the syringe (like a pencil) at a 45-degree angle to the skin. 
Z drugo roko držite brizgo (kot svinčnik) pod kotom 45 stopinj glede na kožo.
• Make sure you have the following items: Alcohol swab package x4 
• Preverite, da imate naslednji material: 4 x pakiranje alkoholnih zložencev
• trouble sleeping (insomnia); 
• težave s spanjem (nespečnost),
What you need to know before you use Nplate 
Kaj morate vedeti, preden boste uporabili zdravilo Nplate
9/L for at least 4 weeks without dose adjustment may, at the discretion of the supervising physician, self-administer Nplate solution for injection. 
9/l vsaj 4 tedne brez prilagoditve odmerka, si lahko po presoji nadzornega zdravnika sami injicirajo zdravilo Nplate raztopina za injiciranje.
Study 2 splenectomised patients 
Študija 2 Splenektomirani bolniki
= Amount to inject in mL 
= količina za injiciranje v ml
Generally, dissolution of Nplate takes less than 2 minutes. 
Praviloma traja raztapljanje zdravila Nplate manj kot 2 minuti.
What Nplate is and what it is used for 
Kaj je zdravilo Nplate in za kaj ga uporabljamo
Read all instructions for use thoroughly. 
Natančno in v celoti preberite navodila za uporabo.
• Note: If your healthcare professional has instructed you that your Nplate dose requires more than one injection of Nplate, you will need to use more than one self injection kit. 
• Opomba: Če vam je zdravstveni delavec dal navodila, da za svoj odmerek zdravila Nplate potrebujete več kot eno injekcijo zdravila Nplate, boste morali uporabiti več kot le en komplet za samoinjiciranje.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 
Če ste noseči ali dojite, menite, da ste noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
• The product is now ready for injection. 
• Zdravilo je zdaj pripravljeno za injiciranje.
See table 2 below for dose adjustment and monitoring. 
Tabelo 2 za prilagajanje odmerkov in spremljanje.
Toxicokinetic studies showed no interaction of the antibodies with the measured concentrations. 
Toksikokinetične študije niso pokazale interakcije protiteles z merjenimi koncentracijami.
No overall differences in safety or efficacy have been observed in patients < 65 and ≥ 65 years of age (see section 5.1). 
Gledano v celoti se varnost in učinkovitost pri bolnikih, starih < 65 in ≥ 65 let nista razlikovali (glejte poglavje 5.1).
• flu like symptoms (influenza like illness); 
• gripi podobni bolezenski znaki (gripi podobna bolezen),
• If you are at risk of blood clots or if blood clots are common in your family. 
• Če imate tveganje za nastajanje krvnih strdkov ali če so krvni strdki v vaši družini pogosti.
Your doctor, nurse or pharmacist will show you how to inject yourself with Nplate. 
Vaš zdravnik, medicinska sestra ali farmacevt vam bodo pokazali, kako si morate injicirati zdravilo Nplate.
• pain in your hands and feet; 
• bolečine v rokah in nogah,
Although based on these data no adjustment of the dosing regimen is required for older patients, care is advised considering the small number of elderly patients included in the clinical trials so far. 
Čeprav starejšim bolnikom glede na te podatke ni treba prilagoditi odmerne sheme, je glede na majhno število starejših bolnikov, ki so bili doslej vključeni v klinična preskušanja, vseeno priporočljiva previdnost.
In all developmental studies neutralising antibodies were formed, which may have inhibited romiplostim effects. 
V vseh razvojnih študijah so nastajala nevtralizirajoča protitelesa, ki so morda zavrla učinke romiplostima.
The safety and efficacy of romiplostim in children under the age of one year has not been established. 
Varnost in učinkovitost romiplostima pri otrocih, mlajših od 1 leta, nista bili dokazani.
This section contains information on how to give yourself an injection of Nplate. 
To poglavje vsebuje informacije o tem, kako si sami injicirate zdravilo Nplate.