natgillin/translations-raw huggingface dataset:
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.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nplate have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Nplate upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Therefore, in patients with intact spleens, the possibility of removing the spleen should be evaluated periodically.
Zato je treba pri bolnikih z nepoškodovano vranico občasno oceniti možnost za njeno odstranitev.
Long-term studies involving over 1,000 patients, some treated for longer than 5 years, confirmed that Nplate remained effective both in patients whose spleen had been removed and those who had their spleen.
Dolgoročne študije, v katere je bilo vključenih čez 1 000 bolnikov, od katerih so se nekateri zdravili več kot pet let, so potrdile, da je zdravilo Nplate ostalo učinkovito pri bolnikih, pri katerih je bila vranica odstranjena, in pri tistih, ki so vranico še vedno imeli.
A platelet count below 30 million per millilitre puts patients at risk of bleeding while the normal count is 150 to 400 million per millilitre.
Pri številu trombocitov, ki je manjše od 30 milijonov na mililiter, so bolniki izpostavljeni tveganju za pojav krvavitve, normalno število trombocitov pa se giblje od 150 do 400 milijonov na mililiter.
For more information about treatment with Nplate, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Nplate preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The first study involved 63 patients whose disease was not controlled despite removal of their spleen.
V prvo študijo je bilo vključenih 63 bolnikov, pri katerih bolezen kljub odstranitvi vranice ni bila nadzorovana.
The improvement in platelet count was long-lasting and clinically relevant in both groups, although the treatment only manages symptoms and is not a cure.
Povečanje števila trombocitov je bilo dolgotrajno in klinično pomembno pri obeh skupinah, čeprav to zdravljenje samo lajša simptome in bolezni ne ozdravi.
Because the number of patients with ITP is low, the disease is considered ‘rare', and Nplate was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 May 2005.
Ker je bolnikov z imunsko trombocitopenično purpuro malo, velja ta bolezen za redko, zato je bilo zdravilo Nplate 27. maja 2005 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Nplate must not be used in people who are hypersensitive (allergic) to romiplostim, any of the other ingredients, or proteins produced by Escherichia coli (a bacterium).
Zdravila Nplate ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) romiplostim, katero koli drugo sestavino zdravila ali beljakovine, ki jih tvori bakterija Escherichia coli.
The most common side effects in children include infections of the nose and throat, runny nose, cough, fever, mouth and throat pain, abdominal (belly) pain, diarrhoea, rash and bruising.
Najpogostejši neželeni učinki pri otrocih so okužbe nosu in žrela, izcedek iz nosu, kašelj, vročina, bolečina v ustih in žrelu, abdominalna (trebušna) bolečina, driska, izpuščaj in podplutbe.
The full EPAR for Nplate can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Nplate je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The company that markets Nplate will provide doctors a ‘dosing calculator' to help them calculate the sometimes very small volumes of Nplate that need to be injected.
Družba, ki trži zdravilo Nplate, bo zdravnikom priskrbela računalo za odmerjanje, ki jim bo pomagalo izračunati prostornino zdravila Nplate, ki jo je treba injicirati in ki je včasih zelo majhna.
All studies compared Nplate with placebo (a dummy treatment).
V vseh študijah so zdravilo Nplate primerjali s placebom (zdravilom brez učinkovine).
The starting dose depends on the patient's weight, and is then adjusted to maintain platelet counts at the target levels.
Začetni odmerek je odvisen od telesne mase bolnika, nato pa ga je treba za ohranjanje števila trombocitov na ciljni ravni prilagoditi.
Nplate is a powder that is made up into a solution for injection.
Zdravilo Nplate je prašek za pripravo raztopine za injiciranje.
The most common side effects with Nplate in adults (seen in more than 1 patient in 10) include headache, infections of the nose and throat and allergic (hypersensitivity) reactions such as rash, itching and rapid swelling under the skin.
Najpogostejši neželeni učinki zdravila Nplate pri odraslih (opaženi pri več kot 1 bolniku od 10) so glavobol, okužbe nosu in žrela ter alergijske (preobčutljivostne) reakcije, npr. izpuščaj, srbenje in hitro podkožno otekanje.
The spleen, an organ behind the stomach, is involved in the removal of platelets from the blood.
Vranica, organ za želodcem, sodeluje pri odstranjevanju trombocitov iz krvi.
For practical information about using Nplate, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Nplate naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Two main studies in adults and a third one in children found Nplate effective for the treatment of longstanding ITP.
Dve glavni študiji pri odraslih in tretja pri otrocih so pokazale, da je zdravilo Nplate učinkovito pri zdravljenju kronične imunske trombocitopenične purpure.
Nplate contains the active substance romiplostim.
Zdravilo Nplate vsebuje učinkovino romiplostim.
Nplate is used in patients from 1 year of age with long-term immune thrombocytopenic purpura (ITP), a disease in which the patient's immune system destroys platelets (components in the blood that help it to clot).
Zdravilo Nplate se uporablja pri bolnikih, starejših od enega leta, s kronično imunsko trombocitopenično purpuro (ITP), tj. boleznijo, pri kateri bolnikov imunski sistem uničuje trombocite (sestavino krvi, ki sodeluje pri njenem strjevanju).
By mimicking the action of thrombopoietin, romiplostim stimulates the production of platelets, thereby increasing blood platelet counts and reducing the risk of bleeding.
S posnemanjem delovanja trombopoetina ta spodbuja nastajanje trombocitov ter tako poveča njihovo število v krvi in zmanjša tveganje za krvavitev.
For the full list of side effects reported with Nplate, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Nplate, glejte navodilo za uporabo.
Nplate can be used in patients whose spleen has been removed to control the disease and in those who still have a spleen.
Uporablja se lahko pri bolnikih z odstranjeno vranico, da bi se bolezen nadzorovala, in pri tistih, ki jo še imajo.
The Agency noted that Nplate was effective in patients who had had their spleen removed, as well as in patients who had not had their spleen removed.
Menila je, da je bilo zdravilo Nplate učinkovito pri bolnikih, ki so jim vranico odstranili, pa tudi pri bolnikih, ki jim vranice niso odstranili.