natgillin/translations-raw huggingface dataset:
Considering the incidence of adverse events in PTSD, the CHMP agreed that the safety of sertraline in the treatment of PTSD is similar to that of major depressive disorder and does not present any new issues. 
Ob upoštevanju pojavnosti neželenih učinkov pri posttravmatski stresni motnji se je CHMP strinjal, da je varnost sertralina pri zdravljenju posttravmatske stresne motnje podobna kot pri hudi depresivni motnji in ne pomeni nikakršnih novih zadržkov.
The CHMP considered that patients with significant hepatic impairment are not strictly contraindicated with sertraline and that appropriate warnings are provided in the concerning section of the product information. 
CHMP je ocenil, da huda okvara jeter pri bolnikih ni strogo kontraindicirana za uporabo sertralina in da so v zadevnem poglavju podatkov o zdravilu prisotna ustrezna opozorila.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Zoloft in the European Union and the European Economic Area (EEA). 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da je treba v Evropski uniji (EU) in v Evropskem gospodarskem prostoru (EGP) uskladiti podatke o predpisovanju zdravila Zoloft.
Zoloft contains the active substance sertraline. 
Zdravilo Zoloft vsebuje zdravilno učinkovino sertralin.
Company responses provided on: 22 February 2008, 10 September 2008, 09 December 2008 Opinion date: 
22. februarja 2008, 10. septembra 2008, 9. decembra 2008
Regarding the use of sertraline in Hepatic Insufficiency and in Renal Insufficiency, the CHMP agreed with the wording proposed by the MAH for harmonisation. 
Glede uporabe sertralina pri jetrni insuficienci in ledvični insuficienci se je CHMP strinjal z besedilom, ki ga je za usklajevanje predlagal imetnik dovoljenja za promet z zdravilom.
Regarding the dosing of paediatric patients with OCD, the CHMP requested the insertion of the following wording in this section: 
Glede odmerjanja pri pediatričnih bolnikih z obsesivno kompulzivno motnjo je CHMP zahteval, da se v to poglavje doda besedilo:
The clinical programme for the indication OCD was submitted and sertraline demonstrated a modest short-term effect and no safety concerns. 
Predložen je bil klinični program za indikacijo obsesivne kompulzivne motnje, dokazan pa je bil skromen kratkotrajni učinek sertralina brez varnostnih zadržkov.
The CHMP endorsed the following: “Concomitant intake of pimozide is contraindicated (see section 4.5)” 
CHMP je odobril sledeče: „Sočasno uživanje pimozida je kontraindicirano (glejte poglavje
Obsessive Compulsive Disorder in paediatric patients .In order to support the paediatric indication, one single study was submitted including children and adolescents aged 6-17. 
V podporo pediatrični indikaciji je bila predložena le ena študija, ki je vključevala otroke in mladostnike, stare od 6 do 17 let.
Paediatric-onset OCD shares important similarities with the adult disorder but also shows important differences. 
Obsesivno kompulzivna motnja z začetkom v otroštvu kaže pomembne podobnosti z motnjo pri odraslih, a tudi pomembne razlike.
The CHMP, considered the benefit/risk balance, approved the following indication: “Sertraline is indicated for the treatment of social anxiety disorder”. 
CHMP je ob upoštevanju razmerja med koristmi in tveganji odobril naslednjo indikacijo: „Sertralin je indiciran za zdravljenje socialne anksiozne motnje“.
Therefore the CHMP endorsed the following indication: “Sertraline is indicated for the treatment of obsessive compulsive disorder (OCD) in adults”, 
Zato je CHMP je odobril naslednjo indikacijo: „Sertralin je indiciran za zdravljenje obsesivno kompulzivne motnje pri odraslih“,
The CHMP endorsed the harmonised indication: “Sertraline is indicated for the treatment of post traumatic stress disorder (PTSD)”, 
CHMP je odobril usklajeno indikacijo: „Sertralin je indiciran za zdravljenje posttravmatske stresne motnje“,
Prevention of relapse and recurrence was proposed during the assessment by the CHMP. 
Med ocenjevanjem, ki ga je izvedel CHMP, so predlagali preprečevanje vrnitve in ponovnega pojava bolezni.
Sertraline is a selective serotonin re-uptake inhibitor (SSRI), It works by preventing the neurotransmitter serotonin from being taken back up into nerve cells in the brain and spinal cord. 
Deluje tako, da v možganih in hrbtenjači preprečuje ponovni privzem nevrotransmiterja serotonina v živčne celice.
Zoloft has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)). 
Usklajevalna skupina za postopek medsebojnega priznavanja in decentralizirane postopke (CMD(v)) je ugotovila, da je za zdravilo Zoloft potrebno usklajevanje.
Although the safety profile of sertraline is acceptable, the CHMP implemented the section ‘Posology and Method of Administration' of the SPC, to indicate that the need for continued treatment should be regularly evaluated. 
dopolnil poglavje „Odmerjanje in način uporabe“ povzetka glavnih značilnosti zdravila, da bi navedel potrebo po stalnem ocenjevanju nadaljevanja zdravljenja.
Hepatic Impairment. 
Okvara jeter.
These measures should help to protect the environment. 
Ti ukrepi naj bi pomagali varovati okolje.
In the event of such reactions, treatment may be needed. 
V primeru takih reakcij je potrebno zdravljenje.
In post marketing experience: 
V postmarketinških izkušnjah:
This veterinary medicinal product contains mineral oil. 
To zdravilo za uporabo v veterinarski medicini vsebuje mineralno olje.
30938 Burgwedel GERMANY 
30938 Burgwedel Nemčija
In very rare cases anaphylactic-type reactions can occur, which may be life-threatening. 
V zelo redkih primerih se lahko pojavijo reakcije anafilaktičnega tipa, ki so lahko življenjsko ogrožujoče.
In such cases it is advised to perform PCV2 serology, using suitable diagnostics, to select the most appropriate vaccination schedule. 
V takšnih primerih je priporočeno opraviti serološki test za PCV2 ob ustrezni diagnostiki, na podlagi katerega izberemo najprimernejšo shemo cepljenja.
4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary) 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
Vaccination may result in a transient impairment of growth rate in the immediate period after administration of the vaccine. 
Zaradi cepljenja se lahko v takojšnjem obdobju po dajanju cepiva prehodno zmanjša hitrost rasti.
22 weeks. 
22 tednov
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/). 
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na spletni strani Evropske agencije za zdravila (http://www.ema.europa.eu)
A transient increase in body temperature, normally not exceeding 1 °C, was very commonly observed until 2 days after vaccination. 
Prehodno povišanje telesne temperature, običajno ne za več kot 1°C, je bilo zelo pogosto opaženo do 2 dni po cepljenju.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12/01/2009. 
Datum prvega dovoljenja za promet: 12/01/2009 Datum zadnjega podaljšanja: 13/12/2013
Avoid use of vaccination equipment with rubber parts. 
Izogibajte se uporabi opreme za cepljenje z gumijastimi deli.
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
SPC tabela 1 (dovoljene snovi), za katere tabela 1 priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo (ES) št.
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS 
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer
In case of doubt, apply the two shot vaccination schedule. 
V primeru dvoma uporabite shemo cepljenja z dvema odmerkoma.
25 mg dl-α-tocopheryl acetate 
25 mg dl-α-tokoferil acetata
Before using the vaccine allow it to reach room temperature (15-25 °C) and shake well before use. 
Preden cepivo uporabite, naj se ogreje na sobno temperaturo (15 °C - 25 °C), nato ga dobre pretresite.
When it is expected that higher levels of maternally derived antibodies against PCV2 are present, the following schedule of two vaccinations is advised: the first injection (2 ml) can be given from an age of 3-5 days, the second injection (2 ml) 2-3 weeks later. 
Če je pričakovana raven materinih protiteles proti PCV2 višja, cepimo dvakrat po naslednji shemi: prvi odmerek (2 ml) lahko damo od starosti 3 do 5 dni, drugega (2 ml) pa 2 do 3 tedne pozneje.
SPECIAL WARNING(S), IF NECESSARY Accidental self-injection is dangerous. 
POSEBNA OPOZORILA, ČE JE POTREBNO Nenamerno injiciranje je nevarno.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you. 
Če vam je bil ta proizvod nenamerno injiciran, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina, in mu pokažite navodilo za uporabo.
Following the administration of a double dose of vaccine no side effects other than those described in section 4.6 have been observed. 
Po dajanju dvojnega odmerka cepiva niso opazili neželenih učinkov, ki bi se razlikovali od učinkov, opisanih v poglavju 4.6.
No data are available on the use of the vaccine in breeding boars. 
Ni podatkov o uporabi cepiva pri plemenskih merjascih.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/). 
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na spletni strani Evropske agencije za zdravila (http://www.ema.europa.eu)
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription. 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Na veterinarski recept.
Shelf-life after first opening the container: 8 hours. 
Rok uporabnosti po prvem odpiranju vsebnika: 8 ur.
346 mg light liquid paraffin. 
346 mg redko tekočega parafina
Before using the vaccine, allow it to reach room temperature and shake well before use. 
Preden cepivo uporabite, naj se ogreje na sobno temperaturo, nato ga dobre pretresite.
Vaccine to stimulate active immunity against porcine circovirus type 2. 
Cepivo za vzbujanje aktivne imunosti proti cirkovirusu prašičev tipa 2
Do not use this veterinary medicinal product after the expiry date (EXP) which is stated on the carton and the vial. 
Zdravila za uporabo v veterinarski medicini ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini in viali.
Transient local reactions at the injection site were very commonly observed after vaccination mainly in the form of a hard, warm and sometimes painful swelling (diameter up to 10 cm). 
Prehodne lokalne reakcije na mestu injiciranja, večinoma v obliki trde, tople in včasih boleče otekline (premera do 10 cm) so se zelo pogosto pojavile po cepljenju.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International BV 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Intervet International BV
Administer one dose (2 ml), by intramuscular injection in the neck in the area behind the ear, according to the following schedule: 
Cepite z enim odmerkom (2 ml) intramuskularno na vratu v predelu za ušesom po naslednji shemi:
Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and, in rare cases, could result in the loss of the affected finger if prompt medical attention is not given. 
Nenamerno injiciranje/samoinjiciranje lahko povzroči hude bolečine in otekline, zlasti ob injiciranju v sklep ali prst, in lahko v izjemnih primerih, če ni zagotovljena takojšnja zdravniška oskrba, privede do izgube prizadetega prsta.
In some piglets depression and a reduced feed intake for up to 5 days were uncommonly observed. 
Pobitost in zmanjšan vnos hrane v trajanju do 5 dni so občasno opazili pri nekaterih pujskih.
4.2 Indications for use, specifying the target species For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to reduce mortality and weight loss associated with PCV2 infection occurring during the fattening period. 
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Za aktivno imunizacijo prašičev z namenom zmanjšati virusno breme v krvi in limfnih tkivih ter pogin in hujšanje pri okužbi s PCV2 v obdobju pitanja Začetek imunosti:
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2 °C - 8 °C). 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 °C - 8 °C).
EU/2/08/091/003 100 ml EU/2/08/091/004 200 ml EU/2/08/091/005 500 ml EU/2/08/091/006 10 x 20 ml EU/2/08/091/007 10 x 50 ml EU/2/08/091/008 10 x 100 ml EU/2/08/091/009 10 x 200 ml EU/2/08/091/010 10 x 500 ml 
EU/2/08/091/006 10 x 20 ml EU/2/08/091/007 10 x 50 ml EU/2/08/091/008 10 x 100 ml
Administer one dose of 2 ml by intramuscular injection in the neck, in the area behind the ear, according to the following schedule: 
Cepite z enim odmerkom po 2 ml intramuskularno na vratu v predelu za ušesom po naslednji shemi:
In individual animals, an increase of rectal temperature of 2.5 °C lasting less than 24 hours was uncommonly observed. 
Povišanje telesne temperature za 2,5 °C, ki je trajalo manj kot 24 ur, je bilo pri posameznih živalih občasno opaženo.
For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to reduce mortality and weight loss associated with PCV2 infection occurring during the fattening period. 
Za aktivno imunizacijo prašičev z namenom zmanjšati virusno breme v krvi in limfnih tkivih ter pogin in hujšanje pri okužbi s PCV2 v obdobju pitanja
Immediate systemic hypersensitivity-like reactions were commonly observed after vaccination, resulting in minor neurological symptoms such as tremors and/or excitation, which normally resolve within minutes without requiring treatment. 
Takojšnje sistemske, preobčutljivostnim podobne reakcije z blagimi nevrološkimi simptomi, kot sta tremor in/ali ekscitacija, ki običajno minejo v nekaj minutah brez zdravljenja, so se pogosto pojavile po cepljenju..
High levels of MDA may be expected when sows/gilts are vaccinated against PCV2 virus or when sows/gilts have recently been exposed to high levels of PCV2 virus. 
Raven materinih protiteles je visoka, če so bile svinje oziroma mladice cepljene proti virusu PCV2 ali nedavno izpostavljene visokim ravnem virusa PCV2.
Do not mix with any other veterinary medicinal product. 
Inkompatibilnosti Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
Store in a refrigerator (2 °C - 8 °C). 
Shranjujte v hladilniku (2°C - 8°C).
Opalescent white, with brown resuspendable sediment. 
Opalescentna bela z rjavo usedlino, ki jo lahko ponovno suspendiramo.
In the case of low to medium levels of maternally derived antibodies against PCV2 a single vaccination (2 ml) to pigs from an age of 3 weeks onwards is advised. 
Če je raven materinih protiteles proti PCV2 nizka do srednje visoka, cepimo prašiče enkrat (2 ml), in sicer od starosti 3 tednov.
Pack sizes: cardboard boxes with either 1 or 10 vials of 20, 50, 100, 200 or 500 ml (10, 25, 50, 100 or 250 doses). 
DRUGE INFORMACIJE Velikosti pakiranja: škatle z 1 ali 10 vialami po 20, 50, 100, 200 ali 500 ml (10/25/50/100 ali 250
METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use. 
NAČIN IN POT(I) UPORABE Intramuskularna uporaba Pred uporabo preberite navodilo za uporabo.
Special precautions for use in animals: Vaccinate only healthy animals. 
Posebna opozorila za uporabo pri živalih Cepite samo zdrave živali.
Each dose of 2 ml contains: 
Vsak odmerek po 2 ml vsebuje:
4.7 Use during pregnancy, lactation or lay 
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Ne uporabite v obdobju brejosti in laktacije.
Shelf life after first opening the immediate packaging: 8 hours. 
Rok uporabnosti po prvem odpiranju stične ovojnine: 8 ur.
MARKETING AUTHORISATION NUMBER(S) EU/2/08/091/001-010 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/08/091/001-010
MARKETING AUTHORISATION NUMBER(S) EU/2/08/091/001 
ŠTEVILKE DOVOLJENJ ZA PROMET EU/2/08/091/001
Do not use during pregnancy and lactation. 
Brejost in laktacija Ne uporabite v obdobju brejosti in laktacije.
Dl-α-tocopheryl acetate 
Dodatka: Dl-α-tokoferilacetat
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS 
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI
From the data provided, it can be concluded that a single dose regimen of vaccination breaks through up to medium levels and double dose regimen through medium to high levels of maternally derived antibodies in piglets. 
4.4 Posebna opozorila za vsako ciljno živalsko vrsto Na podlagi pridobljenih podatkov lahko sklepamo, da je pri shemi cepljenja z enim odmerkom raven materinih protiteles pri pujskih srednja, pri shemi cepljenja z dvojnim odmerkom pa srednja do visoka.
NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV emulsion for injection for pigs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Porcilis PCV, emulzija za injiciranje za prašiče
Porcine circovirus type 2 ORF2 subunit antigen: at least 4.5 log2 ELISA units (as determined in the in vivo potency test in chickens) 
Cirkovirus prašičev, tip 2, antigenska podenota ORF2: najmanj 4,5 log2 enot ELISA (kot je določeno z in vivo preskusom učinkovitosti pri piščancih).
PCV2 ORF2 subunit antigen: ≥ 4.5 log2 ELISA units. 
PCV2, antigenska podenota ORF2: ≥ 4.5 log2 enot ELISA
Following the administration of a double dose of vaccine no side effects other than those described under “adverse reactions” have been observed. 
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) Po dajanju dvojnega odmerka cepiva niso opazili neželenih učinkov, ki bi se razlikovali od učinkov, opisanih v odstavku ''neželeni učinki''.
Simethicon 
OVOJNINAH
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes {20, 50, 100, 200 and 500 ml} 
PODATKI NA ZUNANJI OVOJNINI Škatla (20, 50, 100, 200 in 500 ml)
PACKAGE LEAFLET FOR: Porcilis PCV emulsion for injection for pigs 
NAVODILO ZA UPORABO PORCILIS PCV emulzija za injiciranje za prašiče
IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Inactivated porcine circovirus vaccine. 
Farmakoterapevtska skupina: inaktivirano cepivo proti cirkovirusu prašičev Oznaka ATCvet: QI09AA07
Cardboard boxes with either 1 or 10 PET vials of 20, 50, 100, 200 or 500 ml. 
Kartonske škatle z 1 vialo ali z 10 vialami iz PET po 20, 50, 100, 200 ali 500 ml Viale so zaprte z zamaški iz nitrilne gume in aluminijasto zaporko z oznako.
Dl-α-tocopheryl acetate Light liquid paraffin Polysorbate 80 
DL-α-tokoferilacetat redko tekoči parafin polisorbat 80 simetikon voda za injekcije
Porcine circovirus type 2 ORF2 subunit antigen: ≥ 4.5 log2 ELISA units. 
cirkovirus prašičev, tip 2, antigenska podenota ORF2: ≥ 4.5 log2 enot ELISA
NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV emulsion for injection 
Porcilis PCV emulzija za injiciranje
EXPIRY DATE EXP {month/year} Once broached, use within 8 hours. 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
Excipients. 
odmerkov)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vials {100, 200 and 500 ml} 
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Viale (100, 200 in500 ml}
STATEMENT OF ACTIVE AND OTHER SUBSTANCES One dose of 2 ml contains: 
En odmerek po 2 ml vsebuje:
Porcine circovirus type 2 ORF2 subunit antigen: at least 4.5 log2 ELISA units* * Antibody titre obtained according to the in vivo potency test in chickens. 
Zdravilna učinkovina: Cirkovirus prašičev, tip 2, antigenska podenota ORF2: najmanj 4,5 log2 enot ELISA*
QUANTITY OF THE ACTIVE SUBSTANCE(S) Per 2 ml dose: 
V odmerku 2 ml:
OTHER INFORMATION 
INDIKACIJA
EMEA-number Invented Name Strength Pharmaceutical Form 
Lastniško ime Jakost Farmacevtska oblika
0.5 mg/ml Oral suspension Dogs amber glass bottle (type III), 2 polypropylene dosing syringes. 
0.5 mg/ml Peroralna suspenzija.
It is given once a week as an injection under the skin. 
Daje se enkrat tedensko kot injekcija v podkožje.
The European Commission granted a marketing authorisation valid throughout the European Union for Nplate on 4 February 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Nplate, veljavno po vsej Evropski uniji, izdala 4. februarja 2009.
What measures are being taken to ensure the safe and effective use of Nplate? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nplate?
Other information about Nplate 
Druge informacije o zdravilu Nplate
What benefits of Nplate have been shown in studies? 
Kakšne koristi je zdravilo Nplate izkazalo v študijah?
What is Nplate and what is it used for? 
Kaj je zdravilo Nplate in za kaj se uporablja?
It is not intended to provide practical advice on how to use Nplate. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Why is Nplate approved? 
Zakaj je bilo zdravilo Nplate odobreno?
This is a summary of the European public assessment report (EPAR) for Nplate. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Nplate.
Romiplostim has been designed to attach to and stimulate the same targets (receptors) as thrombopoietin. 
Romiplostim je bil zasnovan za vezavo in spodbujanje istih tarč (receptorjev) kot trombopoetin.
What are the risks associated with Nplate? 
Kakšna tveganja so povezana z zdravilom Nplate?
Nplate is used when treatment with medicines such as corticosteroids or immunoglobulins has not worked. 
Zdravilo Nplate se uporablja, kadar zdravljenje z zdravili, kot so kortikosteroidi ali imunoglobulini, ni bilo učinkovito.
The European Medicines Agency decided that Nplate's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Evropska agencija za zdravila je sklenila, da so koristi zdravila Nplate večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
The summary of the opinion of the Committee for Orphan Medicinal Products for Nplate can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote za zdravilo Nplate je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Nplate can only be obtained with a prescription and treatment with it should be supervised by a doctor who has experience in treating blood disorders. 
Predpisovanje in izdaja zdravila Nplate je le na recept, zdravljenje z njim pa mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem krvnih bolezni.
Adults whose platelet levels are stable may inject the medicine themselves after they have been properly trained. 
Odrasli, pri katerih je število trombocitov stabilno, si lahko zdravilo injicirajo sami, potem ko so bili za to ustrezno usposobljeni.
Doctors can also receive a home administration training pack, which includes materials on training patients who will inject themselves with Nplate, and materials for patients on how to prepare the medicine for injection. 
Zdravniki bodo prejeli tudi komplet za usposabljanje za uporabo na domu, ki vsebuje gradivo o tem, kako usposobiti bolnike, ki si bodo zdravilo Nplate sami injicirali, ter gradivo za bolnike o tem, kako pripraviti zdravilo za injiciranje.
Patients were treated for 24 weeks and the main measure of effectiveness was the increase in platelet count above a threshold of 50 million platelets per millilitre of blood during at least 6 of the last 8 weeks of treatment. 
Bolniki so bili zdravljeni 24 tednov, glavno merilo učinkovitosti pa je bilo povečanje števila trombocitov nad prag 50 milijonov trombocitov na mililiter krvi v vsaj šestih od zadnjih osmih tednov zdravljenja.