FrancophonIA/ELRC3.0 huggingface dataset:
English: Unusual tiredness or weakness (anaemia), nausea, oozing of fluid from wounds, low blood pressure, fever, inflammation of veins sometimes accompanied by a clot, lumps at injection sites, bruising, swelling of the legs caused by fluid retention, non-fatal allergic reactions.
Slovenian: Nenavadna utrujenost ali šibkost (anemija), slabost v želodcu, mezenje tekočine iz rane, nizek krvni tlak, zvišana telesna temperatura, vnetje ven, ki ga včasih spremlja strdek, oteklina na mestu injiciranja, podplutbe, otekanje spodnjih udov, ki jih povzroča zastajanje tekočine, alergijske reakcije, ki se ne končajo z bolnikovo smrtjo.
English: When desirudin is administered in patients with increased risk of bleeding complications, mild to moderate hepatic dysfunction and/or mild to moderate renal impairment, aPTT should be monitored and peak aPTT should not exceed twice the control value.
Slovenian: Med uporabo desirudina pri bolnikih z zvečanim tveganjem za krvavitvene zaplete, blago do zmerno disfunkcijo jeter in/ali blago do zmerno okvaro ledvic je treba nadzirati aPTČ; najvišji aPTČ ne sme preseči dvakratne kontrolne vrednosti.
English: Increase in liver enzymes, dizziness, sleeplessness, confusion, feeling breathless, vomiting (with or without blood), constipation, blood in your urine, difficulty in urinating, rash, itching (urticaria), low levels of potassium in the blood, burning feeling when passing urine with also an increased frequency of urination, slow healing of wounds, nose bleeds, high blood pressure, pain (including pain in legs,
Slovenian: Zvišanje jetrnih encimov, omotica, nespečnost, zmedenost, občutek težke sape, bruhanje (krvavo ali brez krvi), zaprtje, kri v urinu, oteženo uriniranje, izpuščaj, srbenje (koprivnica), nizka koncentracija kalija v krvi, občutek pečenja pri odvajanju vode skupaj z večjo pogostnostjo uriniranja, upočasnjeno celjenje ran, krvavitev iz nosu, zvišan krvni tlak, bolečine (tudi v spodnjih udih, želodcu in/ali prsih).
English: If necessary, therapy with desirudin should be interrupted until aPTT falls to less than twice the control at which time treatment with desirudin can be resumed at a reduced dose (see also section 4.5).
Slovenian: Če je potrebno, je treba zdravljenje z desirudinom prekiniti, dokler se aPTČ ne zniža na manj kot dvakratno normalno vrednost; ko se to zgodi, je zdravljenje z desirudinom mogoče znova začeti z manjšim odmerkom (glejte tudi poglavje 4.5).
English: The disappearance of desirudin from plasma is rapid in the first phase with approximately 90% of an intravenous (IV) bolus dose disappearing from the circulation within 2 hours of the injection.
Slovenian: V prvi fazi je izginjanje desirudina iz plazme hitro: približno 90% intravenskega (i.v.)
English: If you need treatment for longer than 12 days, the doctor may switch you to another similar medicine.
Slovenian: Če potrebujete več kot 12-dnevno zdravljenje,
English: If a dose is missed
Slovenian: Če je bil odmerek zdravila Revasc izpuščen
English: As with other anticoagulants, bleeding is the most common adverse reaction.
Slovenian: Najpogostejši neželeni učinek je krvavitev, tako kot pri drugih antikoagulantih.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Revasc 15 mg/0.5 ml
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Revasc 15 mg/0,5 ml
English: 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000).
Slovenian: Opisani so bile naslednji povezani neželeni učinki, našteti spodaj po organskih sistemih, znotraj posameznih skupin pogostnosti pa so neželeni učinki navedeni po padajoči resnosti: pogosto (≥ 1/100 do <1/10); občasno (≥ 1/1.000 do <1/100); redko (≥ 1/10.000 do <1/1.000).
English: In post-marketing surveillance, rare reports of major haemorrhages, some of which were fatal; and rare reports of non-fatal anaphylactic or anaphylactoid reactions leading to shock have been received.
Slovenian: Pri spremljanju neželenih učinkov zdravila po pridobitvi dovoljenja za promet so bili opisani redki primeri hudih krvavitev, od katerih so bile nekatere usodne, in redki primeri anafilaktičnih ali anafilaktoidnih reakcij, ki so povzročile šok, ne pa bolnikove smrti.
English: - if you are hypersensitive (allergic) to natural or synthetic hirudin, including desirudin or any of the - if you are bleeding a lot or have any serious bleeding disorder (e.g. haemophilia) - if you have serious kidney or liver disease
Slovenian: - če ste alergični na ( preobčutljivi za) naravni ali sintetični hirudin, vključno z desirudinom, ali katerokoli sestavino zdravila Revasc
English: Currently, there is no clinical experience to support the use of Revasc
Slovenian: Trenutno ni kliničnih izkušenj, ki bi govorile v prid več kot 12-dnevni uporabi Revasca.
English: White powder and clear, colourless solvent for solution for injection
Slovenian: FARMACEVTSKA OBLIKA Bel prašek in bister, brezbarven vehikel za raztopino za injiciranje
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih pogosto:
English: Administration is by subcutaneous injection, preferably at an abdominal site.
Slovenian: Revasc se daje s podkožno injekcijo, najbolje v predelu trebuha.
English: What Revasc looks like and contents of the pack Revasc consists of a vial containing a white powder and an ampoule containing clear, colourless
Slovenian: Revasc sestavljata viala, ki vsebuje bel prašek, in ampula, ki vsebuje bister, brezbarven vehikel za raztopino za injiciranje.
English: To date clinical data are available on hip surgery
Slovenian: Doslej so klinični podatki na voljo le za operacijo kolka.
English: There are no adequate data from the use of desirudin in pregnant women.
Slovenian: 4.6 Nosečnost in dojenje Ni zadostnih podatkov o uporabi desirudina pri nosečnicah.
English: NAME OF THE MEDICINAL PRODUCT Revasc 15mg/0.5ml powder and solvent for solution for injection
Slovenian: IME ZDRAVILA Revasc 15 mg/0,5 ml prašek in vehikel za raztopino za injiciranje
English: Important information about some of the ingredients of Revasc This medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 ml, i.e. essentially ‘sodium
Slovenian: To zdravilo vsebuje manj od 1 mmola (23 mg) natrija na 0,5 ml, kar pomeni, da praktično ‘ne vsebuje natrija'.
English: - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
Slovenian: - Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali medicinsko sestro.
English: If you are given more than you should
Slovenian: Če ste prejeli večji odmerek zdravila Revasc, kot bi smeli
English: The dose
Slovenian: IME ZDRAVILA
English: Always take Revasc exactly as your doctor has instructed you.
Slovenian: Natančno upoštevajte zdravnikova navodila.
English: (N=370) was half that in patients treated with a standard dose of unfractionated heparin (N=396) (p<0.0001); the rate of proximal deep venous thrombosis was only one fifth that observed with the heparin (p<0.0001).
Slovenian: V dveh kontroliranih dvojno slepih kliničnih preskušanjih je bil celotni delež trombemboličnih dogodkov pri bolnikih, zdravljenih s 15 mg desirudina subkutano dvakrat na dan (n = 370), polovico manjši kot pri bolnikih, zdravljenih s standardnim odmerkom nefrakcioniranega heparina (n = 396) (p< 0,0001); delež proksimalne globoke venske tromboze je bil le petino tistega pri heparinu
English: What Revasc contains
Slovenian: DODATNE INFORMACIJE Kaj vsebuje zdravilo Revasc
English: injection of 15mg desirudin.
Slovenian: Ena viala vsebuje 15 mg desirudina.
English: Investigations Uncommon:
Slovenian: redko:
English: As with other anticoagulants desirudin should be used with caution in conjunction with medicinal products which affect platelet function these medicinal products include: acetylsalicylic acid and NSAIDs, ticlopidine and clopidogrel, glycoprotein IIb/IIIa antagonists (abciximab, eptifibatide,
Slovenian: Med takšna zdravila spadajo acetilsalicilna kislina in nesteroidni antirevmatiki, tiklopidin in klopidogrel, antagonisti glikoproteina IIb/IIIa (abciksimab, eptifibatid, tirofiban) in iloprost.
English: Make sure you tell your doctor if you are likely to have an increased risk of bleeding, which may be the case if you have, or have had: - bleeding disorders or a family history of bleeding disorder - stomach ulcers or any other bleeding disease of the gut - history of a stroke, or bleeding within the brain or eye - a recent operation (including dental surgery) or biopsy or pricking of a blood vessel within the last month - recently a brief shortage of blood supply to a part of the brain within the last six months
Slovenian: - anamnezo možganske kapi, krvavitve v možgane ali oko - nedavno operacijo (vključno z zobozdravstvenimi operacijami) ali biopsijo ali punktiranje žile v zadnjem mesecu - nedavno kratko poslabšanje pretoka krvi skozi del možganov v zadnjih šestih mesecih
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: FOR 10 VIALS (15mg/vial) AND 10 AMPOULES
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA: ZA 10 VIAL (15 mg/vialo) IN 10 AMPUL
English: A slower terminal elimination phase follows with a dose-independent mean terminal elimination half life of 2 to 3 h. The mean residence times are 1.7-2 h and 6-7 h after IV and SC administration, respectively.
Slovenian: Povprečni rezidenčni čas po intravenski uporabi je od 1,7 do 2 uri in po subkutani uporabi od 6 do 7 ur.
English: Powder and solvent for solution for injection 15mg of powder in a vial and 0.5ml of solvent in an ampoule
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Prašek in vehikel za raztopino za injiciranje 15 mg praška v viali in 0,5 ml vehikla v ampuli
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product
Slovenian: Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Desirudin is contraindicated in patients with severe renal impairment (creatinine clearance of less than 30ml/min corresponding to a serum creatinine > 2.5mg/dl or 221μmol/l; see section 4.3).
Slovenian: kar ustreza kreatininu v serumu >2,5 mg/dl ali 221 µmol/l; glejte poglavje 4.3).
English: SUBSTANCE AND MANUFACTURING AUTHORISATION
Slovenian: OZNAČEVANJE IN NAVODILO ZA UPORABO
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: FOR 1 VIAL (15mg/vial) AND 1 AMPOULE
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA: ZA 1 VIALO (15 mg/vialo) IN 1 AMPULO
English: Patients with renal impairment
Slovenian: Izkušenj pri otrocih ni. Bolniki z okvaro ledvic
English: Desirudin is contraindicated in severe hepatic impairment (see section 4.3).
Slovenian: Bolniki z okvaro jeter Pri hudi okvari jeter je desirudin kontraindiciran (glejte poglavje 4.3).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: FOR 2 VIALS (15mg/vial) AND 2 AMPOULES
Slovenian: ZUNANJA OVOJNINA: ZA 2 VIALI (15 mg/vialo) IN 2 AMPULI
English: Nervous system disorders Uncommon:
Slovenian: Bolezni imunskega sistema pogosto:
English: Dizziness, insomnia, confusion Respiratory, thoracic and mediastinal disorders Uncommon:
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora občasno:
English: Anti-hirudin antibodies have been detected upon re-exposure to desirudin in
Slovenian: V kliničnih preskušanjih so po ponovni izpostavitvi desirudinu ugotovili antihirudinska protitelesa.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Slovenian: SHRANJEVANJE ZDRAVILA REVASC
English: Desirudin should not be administered by intramuscular injection owing to the risk of local
Slovenian: Zaradi tveganja za lokalni hematom se desirudin ne sme aplicirati v intramuskularni injekciji.
English: A mean peak aPTT prolongation of around 1.4 times baseline value is observed following a subcutaneous (SC) b.i.d.
Slovenian: Povprečno največje podaljšanje aPTČ, opaženo po subkutanem (s.c.) injiciranju 15 mg desirudina dvakrat na dan, je bilo okrog 1,4-kratnik izhodiščne vrednosti.
English: EXP
Slovenian: dispneja
English: Tell the doctor or nurse as soon as possible if any of the following side effects occur, some of which may be confused with side effects of surgery:
Slovenian: Če se pojavi kateri od naslednjih neželenih učinkov (nekatere od njih je mogoče zamenjati z neželenimi učinki operacije), to čim prej povejte zdravniku ali medicinski sestri:
English: After reconstitution one vial contains 15 mg** desirudin* per 0.5 ml Desirudin consists in a single chain polypeptide of 65 amino acid residues and 3 disulphide bridges.
Slovenian: Po rekonstituciji ena viala vsebuje 15 mg** desirudina* na 0,5 ml.
English: General disorders and administration site conditions Fever, injection site mass, haematomas, oedema in legs Pain in legs, pain, abdominal and chest pain
Slovenian: bolečine v spodnjih udih, bolečine, bolečine v trebuhu in prsih
English: Desirudin should be used with caution in conditions with increased risks of haemorrhage such as major surgery, biopsy or puncture of a non-compressible vessel within the last month; a history of haemorrhagic stroke, intracranial or intraocular bleeding including diabetic (haemorrhagic) retinopathy; a cerebral ischaemic attack within the last 6 months, a known haemostatic disorder (congenital or acquired, e.g. haemophilia, liver disease) or a history of gastrointestinal or pulmonary
Slovenian: Desirudin je treba previdno uporabljati pri stanjih, ki zvečujejo tveganje za krvavitve, npr. večjih operacijah, biopsiji ali punkciji nestisljive žile v zadnjem mesecu, anamnezi hemoragičnega inzulta,
English: Absorption is complete based on mean area under
Slovenian: Ugotovljeno je, da je celotni očistek desirudina po subkutani in intravenski uporabi v istem območju
English: FURTHER INFORMATION
Slovenian: KLINIČNI PODATKI
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 15 mg desirudin.
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 15 mg desirudina
English: SPECIAL STORAGE CONDITIONS
Slovenian: Previdnostni ukrepi
English: Any agent which may enhance the risk of haemorrhage should be discontinued prior to initiation of desirudin therapy.
Slovenian: Pred začetkom zdravljenja z desirudinom je treba opustiti vsa sredstva, ki lahko zvečajo tveganje za krvavitev.
English: - medicines used to prevent blood-clotting (warfarin, heparin and dicoumarol) - medicines which affect the function of platelets (particles in the blood involved in bloodclotting), e.g. acetylsalicylic acid, a substance present in many medicinal products used to relieve pain and lower fever, and other non-steroidal anti-inflammatory agents.
Slovenian: - zdravila, ki se uporabljajo za preprečevanje strjevanja krvi (varfarin, heparin in dikumarol)
English: Desirudin is contraindicated in patients: - with hypersensitivity to the active substance or to any of the excipients - with active bleeding and/or irreversible coagulation disorders - with severe renal and hepatic impairment
Slovenian: - z aktivno krvavitvijo in/ali ireverzibilnimi motnjami koagulacije, - s hudo okvaro ledvic ali jeter,
English: Dyspnoea Gastrointestinal disorders
Slovenian: magnezijev klorid natrijev hidroksid
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE LABEL: 0.5ml SOLVENT
Slovenian: NALEPKA NA AMPULI: 0,5 ml VEHIKLA
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Revasc 15mg/0.5ml powder and solvent for solution for injection Desirudin Read all of this leaflet carefully before you start using this medicine.
Slovenian: NAVODILO ZA UPORABO Revasc 15 mg/0.5 ml prašek in vehikel za raztopino za injiciranje desirudin
English: EU/1/19/1382/001 Azacitidine Celgene 25 mg/ml
Slovenian: EU/1/19/1382/001
English: Subcutaneous use vial (glass) 100 mg
Slovenian: Azacitidine Celgene 25 mg/ml prašek za suspenzijo za injiciranje subkutana uporaba viala (steklo) 100 mg
English: 24 July 2013
Slovenian: 24. julij 2013
English: 01 October 2013
Slovenian: 1. oktober 2013
English: June 2013 CMDh meeting
Slovenian: Zasedanje skupine CMDh junija 2013
English: 20 January 2012
Slovenian: 20.januar2012
English: The company wanted the authorisation to be recognised in Belgium, Bulgaria, Cyprus, Czech, Denmark, Estonia, Greece, France, Hungary, Ireland, Iceland, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Romania, Slovenia, Slovakia and the United Kingdom (the ‘concerned Member States').
Slovenian: Družba je želela, da bi bilo dovoljenje priznano v naslednjih državah: Belgija, Bolgarija, Ciper, Češka, Danska, Estonija, Grčija, Francija, Madžarska, Irska, Islandija, Litva, Luksemburg, Latvija, Malta, Nizozemska, Norveška, Poljska, Romunija, Slovenija, Slovaška in Združeno kraljestvo ("zadevne države članice").
English: The CHMP also concluded that the potential increased risk for syncope has been proven to be manageable.
Slovenian: CHMP je prav tako zaključil, da se je morebitno povečano tveganje za sinkopo izkazalo za obvladljivo.
English: Priligy is a medicine used to treat premature ejaculation in men aged 18 to 64 years old.
Slovenian: Priligy je zdravilo za zdravljenje prezgodnje ejakulacije pri moških med 18. in 64. letom starosti.
English: However, the Member States were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 24 February 2011.
Slovenian: Vendar države članice niso mogle doseči soglasja, zato je švedska regulatorna agencija za zdravila 24. februarja 2011 zadevo napotila na CHMP v arbitražo.
English: 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.
Slovenian: Evropska agencija za zdravila je zaključila arbitražni postopek po nesoglasju med državami članicami Evropske unije (EU) glede odobritve tablet Priligy.
English: Why was Priligy reviewed?
Slovenian: Zakaj je bilo zdravilo Priligy pregledano?
English: 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.
Slovenian: 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.
English: Priligy is believed to increase the time it takes to ejaculate by increasing the amount of a neurotransmitter between the nerve cells.
Slovenian: Zdravilo Priligy naj bi podaljšalo čas do ejakulacije, tako da poveča količino živčnega prenašalca med živčnimi celicami.
English: 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.
Slovenian: 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.
English: Questions and answers on Priligy (dapoxetine, 30 mg and 60 mg tablets)
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Priligy (dapoksetin, 30 mg in 60 mg tablete)
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Questions and answers on Priligy (dapoxetine, 30 mg and 60 mg tablets) EMA/59013/2012
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Priligy (dapoksetin, 30 mg in 60 mg tablete) EMA/106784/2012
English: What is Priligy?
Slovenian: Kaj je zdravilo Priligy?
English: Content (concentration)
Slovenian: Pot uporabe Stična ovojnina Vsebina(koncen tracija)
English: The marketing authorisation was renewed on 3 May 2001 and on 3 May 2006.
Slovenian: Dovoljenje za promet z zdravilom je bilo podaljšano dne 3. maja 2001 in 3. maja 2006.
English: Other information about Puregon:
Slovenian: Druge informacije o zdravilu Puregon:
English: It is made by a cell that has received a gene (DNA), which makes it able to produce human FSH.
Slovenian: Izdela ga celica, ki je prejela gen (DNK), s katerim lahko tvori človeški FSH.
English: The most common side effects reported are a reaction and pain at the injection site.
Slovenian: Najpogostejši neželeni učinki, o katerih so poročali, so reakcija ali bolečina na mestu injiciranja.
English: The dose and frequency of administration of Puregon depend on its use (see above) and the patient's response to treatment.
Slovenian: Odmerjanje in pogostnost dajanja zdravila Puregon sta odvisna od načina njegove uporabe (glejte zgoraj) in od bolnikovega odziva na zdravljenje.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Puregon on 3 May 1996.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Puregon, veljavno po vsej Evropski uniji, odobrila dne 3. maja 1996.
English: What benefit has Puregon shown during the studies?
Slovenian: Kakšne koristi je zdravilo Puregon izkazalo med študijami?
English: Treatment with Puregon should be carried out by a doctor who has experience in the treatment of fertility problems.
Slovenian: Zdravljenje z zdravilom Puregon mora izvajati zdravnik, ki ima izkušnje z zdravljenjem težav s plodnostjo.
English: The marketing authorisation holder is N.V. Organon.
Slovenian: Imetnik dovoljenja za promet z zdravilom je družba N.V.