natgillin/translations-raw huggingface dataset:
That activity should be taken into account in the evaluation of the overall coagulation status of the patient during the switch (see section 4.2). 
Ta učinek je treba upoštevati pri oceni celotnega koagulacijskega statusa bolnika med prehodom
PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Anticoagulant, ATC code: B01AE01 
Farmakoterapevtska skupina: antitrombotik, oznaka ATC: B01AE01.
Overdosage of desirudin could lead to bleeding complications. 
Preveliko odmerjanje desirudina lahko povzroči krvavitvene zaplete.
Your risk of bleeding may also be increased: - if you have recently given birth, fallen, or suffered a blow to the body or head - if you are already taking medicines, especially blood-thinners (see below). 
- če ste nedavno rodili, padli ali doživeli udarec v telo ali glavo - če že jemljete zdravila, zlasti za redčenje krvi (glejte spodaj)
- if you have an uncontrolled high blood pressure 
- če imate okužbo na srcu - če imate neobvladan visok krvni tlak - če ste noseči
After reconstitution, immediate use is recommended. 
Zdravilo je priporočljivo uporabiti takoj po pripravi.
Rare side effects (likely to affect between 1 in 1,000 and 1 in 10,000 patients): Anti-hirudin antibodies have been detected upon re-exposure Isolated cases of fatal bleeding have been reported. 
Redki neželeni učinki (verjetno se bodo pojavljali pri 1 od 1.000 do 1 od 10.000 bolnikov): Po ponovni izpostavitvi so odkrili antihirudinska protitelesa.
If you have a kidney or liver disease, the doctor or nurse will monitor your blood for clotting activity and may change your dose or dosing schedule accordingly. 
Če imate kakšno bolezen ledvic ali jeter, bosta zdravnik ali medicinska sestra kontrolirala vašo kri glede strjevanja in lahko ustrezno spremenita odmerek ali urnik jemanja zdravila.
In controlled clinical trials investigating desirudin 15 mg twice daily and a standard dose of unfractionated heparin, the nature of the hip surgery operation and the mode of action of the two drugs studied account for most of the adverse experiences reported. 
V kontroliranih kliničnih preskušanjih, v katerih so proučevali desirudin v odmerku 15 mg dvakrat na dan in standardni odmerek nefrakcioniranega heparina, je bila večina opisanih neželenih učinkov posledica narave operacije kolka in načina delovanja obeh proučevanih zdravil.
In vitro and in vivo animal data indicate that desirudin is for the most part eliminated and metabolised by the kidney. 
Živalski podatki in vitro in in vivo kažejo, da se desirudin v glavnem presnavlja in eliminira v ledvicah.
During prophylaxis, concomitant use of medicinal products containing heparins (unfractionated and low-molecular weight heparins) and dextrans is not recommended. 
Med profilakso ni priporočljivo sočasno uporabljati zdravil, ki vsebujejo heparine (nefrakcionirane in nizkomolekularne heparine) in dekstrane.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.5ml of water for injections with 3% (w/v) of mannitol 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 0,5 ml vode za injekcije s 3-odstotnim (m/v) manitolom
At therapeutic serum concentrations it has no effect on other enzymes of the haemostatic system such as factors IXa, Xa, kallikrein, plasmin, tPA, or activated protein C. In addition, it does not display any effect on other serine proteases, such as the digestive enzymes trypsin or chymotrypsin, or on complement activation by the classical or 
V terapevtskih serumskih koncentracijah ne vpliva na druge encime hemostatskega sistema, npr. faktorje IXa, Xa, kalikrein, plazmin, tPA ali aktivirani protein C. Poleg tega ne kaže nobenih učinkov na druge serinske proteaze,
15mg of powder in a vial (Type I glass) with stopper (butyl rubber) covered with a film (fluoropolymer) in the product side and 0.5ml of solvent in an ampoule (Type I glass). 
15 mg praška v viali (steklo tipa I) z zamaškom (butilna guma), prekritim s filmom (fluoropolimer) na strani zdravila, in 0,5 ml vehikla v ampuli (steklo tipa I).
As these reactions are immune-mediated, patients with previous exposure to hirudin or hirudin analogue may be at an increased risk. 
Ker gre za imunsko posredovane reakcije, utegnejo biti bolj ogroženi bolniki, ki so že dobivali hirudin ali hirudinske analoge.
Desirudin should be used with care in patients receiving anticoagulants, and/or platelet inhibitors, and/or non-steroidal anti-inflammatory medicinal products. 
Desirudin je treba previdno uporabljati pri bolnikih, ki dobivajo antikoagulante in/ali zaviralce agregacije trombocitov in/ali nesteroidne antirevmatike.
The active substance is desirudin (15mg/0.5ml powder). 
Zdravilna učinkovina je desirudin (15 mg/0,5 ml).
Uncommon side effects (likely to affect between 1 in 100 and 1 in 1,000 patients): 
Občasni neželeni učinki (verjetno se bodo pojavljali pri 1 od 100 do 1 od 1.000 bolnikov):
Following administration of single SC doses of 0.1-0.75 mg/kg, plasma concentrations of desirudin increased rapidly to maximum levels (Cmax) between 1 and 3 h. Both Cmax and AUC values are dose 
Po uporabi posamičnih subkutanih odmerkov od 0,1 do 0,75 mg/kg se koncentracija desirudina v plazmi hitro zviša do najvišje ravni (Cmax) v času od 1 do 3 ur.
If any of the above apply to you, the doctor or nurse will monitor your blood for clotting activity and may change your dose or dosing schedule accordingly. 
Če za vas velja kaj od zgoraj naštetega, bosta zdravnik ali medicinska sestra kontrolirala vašo kri glede strjevanja in lahko ustrezno spremenita odmerek ali urnik jemanja zdravila.
Adverse reactions irrespective of trial drug relationship reported during clinical trials were bleeding episodes, oliguria, hyperpyrexia and joint dislocation. 
Neželeni učinki, ki so bili ne glede na povezanost s proučevanim zdravilom opisani v kliničnih preskušanjih, so bili krvavitve, oligurija, hiperpireksija in izpah sklepa.
Fatal anaphylactic reactions have been reported in patients re-exposed to hirudin product therapy in a second or subsequent treatment course. 
Usodne anafilaktične reakcije so bile opisane pri bolnikih, ki so bili v naslednjem ali nadaljnjih ciklusih zdravljenja ponovno izpostavljeni zdravljenju s hirudinskimi zdravili.
Usual dosage 
Običajno odmerjanje
4.3 Contraindications 
4.1 Terapevtske indikacije
Keep the vial and ampoule in the outer carton. 
Vialo in ampulo shranjujte v zunanji ovojnini.
In patients with mild to moderate liver impairment (see section 4.4) aPTT monitoring is recommended. 
Pri bolnikih z blago do zmerno okvaro jeter (glejte poglavje 4.4) je priporočljivo kontrolirati aPTČ.
Prevention of deep venous thrombosis in patients undergoing elective hip or knee replacement 
Preprečevanje globoke venske tromboze pri bolnikih z elektivno operacijo za zamenjavo kolka ali kolena.
Common reported side effects (likely to affect between 1 in 10 and 1 in 100 patients): 
Pogosti neželeni učinki, o katerih poročajo (verjetno se bodo pojavljali pri 1 od 10 do 1 od 100 bolnikov):
You should not be given Revasc if you are pregnant. 
Če ste noseči, ne smete dobiti Revasca.
Each vial contains 15mg desirudin with 18,000 ATU/mg corresponding to approximately 270,000 
Ena viala vsebuje 15 mg desirudina z 18.000 ATE/mg, kar ustreza približno 270.000 ATE na vialo.
The active substance is rapidly redispersed by shaking gently producing a clear solution. 
Učinkovina se z rahlim stresanjem hitro redispergira, tako da nastane bistra raztopina.
If necessary, therapy with desirudin should be interrupted until aPTT returns to less than twice the control value at which time treatment with desirudin can be resumed at a reduced dose. 
Če je potrebno, je treba zdravljenje z desirudinom prekiniti, dokler se aPTČ ne zniža na manj kot dvakratno kontrolno vrednost; ko se to zgodi, je zdravljenje z desirudinom mogoče znova začeti z manjšim odmerkom.
The common name of the active substance in Revasc is desirudin. 
Običajno ime zdravilne učinkovine v zdravilu Revasc je desirudin.
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. 
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.
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. 
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.
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, 
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).
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). 
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).
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. 
V prvi fazi je izginjanje desirudina iz plazme hitro: približno 90% intravenskega (i.v.)
If you need treatment for longer than 12 days, the doctor may switch you to another similar medicine. 
Če potrebujete več kot 12-dnevno zdravljenje,
If a dose is missed 
Če je bil odmerek zdravila Revasc izpuščen
As with other anticoagulants, bleeding is the most common adverse reaction. 
Najpogostejši neželeni učinek je krvavitev, tako kot pri drugih antikoagulantih.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Revasc 15 mg/0.5 ml 
IME ZDRAVILA IN POT(I) UPORABE Revasc 15 mg/0,5 ml
1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000). 
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).
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. 
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.
- 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 
- če ste alergični na ( preobčutljivi za) naravni ali sintetični hirudin, vključno z desirudinom, ali katerokoli sestavino zdravila Revasc
Currently, there is no clinical experience to support the use of Revasc 
Trenutno ni kliničnih izkušenj, ki bi govorile v prid več kot 12-dnevni uporabi Revasca.
White powder and clear, colourless solvent for solution for injection 
FARMACEVTSKA OBLIKA Bel prašek in bister, brezbarven vehikel za raztopino za injiciranje
Injury, poisoning and procedural complications 
Poškodbe in zastrupitve in zapleti pri posegih pogosto:
Administration is by subcutaneous injection, preferably at an abdominal site. 
Revasc se daje s podkožno injekcijo, najbolje v predelu trebuha.
What Revasc looks like and contents of the pack Revasc consists of a vial containing a white powder and an ampoule containing clear, colourless 
Revasc sestavljata viala, ki vsebuje bel prašek, in ampula, ki vsebuje bister, brezbarven vehikel za raztopino za injiciranje.
To date clinical data are available on hip surgery 
Doslej so klinični podatki na voljo le za operacijo kolka.
There are no adequate data from the use of desirudin in pregnant women. 
4.6 Nosečnost in dojenje Ni zadostnih podatkov o uporabi desirudina pri nosečnicah.
NAME OF THE MEDICINAL PRODUCT Revasc 15mg/0.5ml powder and solvent for solution for injection 
IME ZDRAVILA Revasc 15 mg/0,5 ml prašek in vehikel za raztopino za injiciranje
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 
To zdravilo vsebuje manj od 1 mmola (23 mg) natrija na 0,5 ml, kar pomeni, da praktično ‘ne vsebuje natrija'.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, 
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali medicinsko sestro.
If you are given more than you should 
Če ste prejeli večji odmerek zdravila Revasc, kot bi smeli
The dose 
IME ZDRAVILA
Always take Revasc exactly as your doctor has instructed you. 
Natančno upoštevajte zdravnikova navodila.
(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). 
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
What Revasc contains 
DODATNE INFORMACIJE Kaj vsebuje zdravilo Revasc
injection of 15mg desirudin. 
Ena viala vsebuje 15 mg desirudina.
Investigations Uncommon: 
redko:
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, 
Med takšna zdravila spadajo acetilsalicilna kislina in nesteroidni antirevmatiki, tiklopidin in klopidogrel, antagonisti glikoproteina IIb/IIIa (abciksimab, eptifibatid, tirofiban) in iloprost.
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 
- 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
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: FOR 10 VIALS (15mg/vial) AND 10 AMPOULES 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA: ZA 10 VIAL (15 mg/vialo) IN 10 AMPUL
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. 
Povprečni rezidenčni čas po intravenski uporabi je od 1,7 do 2 uri in po subkutani uporabi od 6 do 7 ur.
Powder and solvent for solution for injection 15mg of powder in a vial and 0.5ml of solvent in an ampoule 
FARMACEVTSKA OBLIKA IN VSEBINA Prašek in vehikel za raztopino za injiciranje 15 mg praška v viali in 0,5 ml vehikla v ampuli
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product 
Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
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). 
kar ustreza kreatininu v serumu >2,5 mg/dl ali 221 µmol/l; glejte poglavje 4.3).
SUBSTANCE AND MANUFACTURING AUTHORISATION 
OZNAČEVANJE IN NAVODILO ZA UPORABO
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: FOR 1 VIAL (15mg/vial) AND 1 AMPOULE 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA: ZA 1 VIALO (15 mg/vialo) IN 1 AMPULO
Patients with renal impairment 
Izkušenj pri otrocih ni. Bolniki z okvaro ledvic
Desirudin is contraindicated in severe hepatic impairment (see section 4.3). 
Bolniki z okvaro jeter Pri hudi okvari jeter je desirudin kontraindiciran (glejte poglavje 4.3).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: FOR 2 VIALS (15mg/vial) AND 2 AMPOULES 
ZUNANJA OVOJNINA: ZA 2 VIALI (15 mg/vialo) IN 2 AMPULI
Nervous system disorders Uncommon: 
Bolezni imunskega sistema pogosto:
Dizziness, insomnia, confusion Respiratory, thoracic and mediastinal disorders Uncommon: 
Bolezni dihal, prsnega koša in mediastinalnega prostora občasno:
Anti-hirudin antibodies have been detected upon re-exposure to desirudin in 
V kliničnih preskušanjih so po ponovni izpostavitvi desirudinu ugotovili antihirudinska protitelesa.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
SHRANJEVANJE ZDRAVILA REVASC
Desirudin should not be administered by intramuscular injection owing to the risk of local 
Zaradi tveganja za lokalni hematom se desirudin ne sme aplicirati v intramuskularni injekciji.
A mean peak aPTT prolongation of around 1.4 times baseline value is observed following a subcutaneous (SC) b.i.d. 
Povprečno največje podaljšanje aPTČ, opaženo po subkutanem (s.c.) injiciranju 15 mg desirudina dvakrat na dan, je bilo okrog 1,4-kratnik izhodiščne vrednosti.
EXP 
dispneja
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: 
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:
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. 
Po rekonstituciji ena viala vsebuje 15 mg** desirudina* na 0,5 ml.
General disorders and administration site conditions Fever, injection site mass, haematomas, oedema in legs Pain in legs, pain, abdominal and chest pain 
bolečine v spodnjih udih, bolečine, bolečine v trebuhu in prsih
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 
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,
Absorption is complete based on mean area under 
Ugotovljeno je, da je celotni očistek desirudina po subkutani in intravenski uporabi v istem območju
FURTHER INFORMATION 
KLINIČNI PODATKI
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 15 mg desirudin. 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 15 mg desirudina
SPECIAL STORAGE CONDITIONS 
Previdnostni ukrepi
Any agent which may enhance the risk of haemorrhage should be discontinued prior to initiation of desirudin therapy. 
Pred začetkom zdravljenja z desirudinom je treba opustiti vsa sredstva, ki lahko zvečajo tveganje za krvavitev.
- 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. 
- zdravila, ki se uporabljajo za preprečevanje strjevanja krvi (varfarin, heparin in dikumarol)
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 
- z aktivno krvavitvijo in/ali ireverzibilnimi motnjami koagulacije, - s hudo okvaro ledvic ali jeter,
Dyspnoea Gastrointestinal disorders 
magnezijev klorid natrijev hidroksid
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE LABEL: 0.5ml SOLVENT 
NALEPKA NA AMPULI: 0,5 ml VEHIKLA
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. 
NAVODILO ZA UPORABO Revasc 15 mg/0.5 ml prašek in vehikel za raztopino za injiciranje desirudin
Subcutaneous use vial (glass) 100 mg 
Azacitidine Celgene 25 mg/ml prašek za suspenzijo za injiciranje subkutana uporaba viala (steklo) 100 mg
24 July 2013 
24. julij 2013
01 October 2013 
1. oktober 2013
June 2013 CMDh meeting 
Zasedanje skupine CMDh junija 2013
20 January 2012 
20.januar2012
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'). 
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").
The CHMP also concluded that the potential increased risk for syncope has been proven to be manageable. 
CHMP je prav tako zaključil, da se je morebitno povečano tveganje za sinkopo izkazalo za obvladljivo.
Priligy is a medicine used to treat premature ejaculation in men aged 18 to 64 years old. 
Priligy je zdravilo za zdravljenje prezgodnje ejakulacije pri moških med 18. in 64. letom starosti.
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. 
Vendar države članice niso mogle doseči soglasja, zato je švedska regulatorna agencija za zdravila 24. februarja 2011 zadevo napotila na CHMP v arbitražo.