natgillin/translations-raw huggingface dataset:
Like all medicines, Refludan can have side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi zdravilo Refludan neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Additionally, individual case reports and in-vitro data suggest that either haemofiltration or haemodialysis (using high flux dialysis membranes with a cut-off point of 50,000 Dalton) may be useful in this situation. 
Nadalje je iz posameznih prikazov primerov in in vitro podatkov razvidno, da je lahko v tem primeru koristna hemofiltracija ali hemodializa (ob uporabi visokopretočnih membran z mejno vrednostjo 50.000 daltonov).
VIAL LABEL: 50 mg 
OZNAKA NA VIALI: 50 mg
It may be necessary to exclude patients with renal impairment from treatment with lepirudin regimen. 
Bolnike z okvaro ledvic bo morda potrebno izključiti iz zdravljenja z lepirudinom.
Do not use Refludan after the expiry date which is stated on the carton and the vial after EXP. 
Zdravila Refludan ne smete uporabljati po datumu izteka uporabnosti, ki je naveden na ovojnini in na viali po oznaki EXP.
Creatinine clearance [ml/min] 
Očistek kreatinina [ml/min]
- For rapid, complete reconstitution, inject 1 ml of diluent into the vacuum vial and shake it gently. 
- Za hitro in popolno rekonstitucijo vbrizgajte 1 mL vehikla v vakuumsko vialo in rahlo pretresite.
Refludan should therefore not be administered to pregnant women or nursing mothers. 
Refludana se zato ne sme dajati nosečnicam in doječim materam.
Do not use Refludan - if you are allergic (hypersensitive) to lepirudin, to hirudins or any of the other ingredients of 
Ne uporabljajte zdravila Refludan: - če ste alergični na (preobčutljivi za) na lepirudin, hirudine ali katerokoli sestavino zdravila
- In case of renal impairment relative overdose may occur even under a standard dosage regimen. 
- V primeru ledvične okvare lahko pride do relativnega prevelikega odmerka tudi ob standardni shemi odmerjanja.
On reconstitution a clear, colourless solution is usually obtained within less than 
Ob rekonstituciji dobite prozorno, brezbarvno raztopino običajno v manj kot 3
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 
Če katerikoli stranski učinek postane resen ali če opazite kakršenkoli neželen učinek, ki ni omenjen v tem navodilu, vas prosimo, da o tem obvestite svojega zdravnika ali farmacevta.
Celgene Europe Ltd., 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom 
Celgene Europe Ltd., 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, Velika Britanija
Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koţa in mediastinalnega prostora
• CONDITIONS OR RESTRICTIONS WITH REGARD TO SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
• POGOJI IN OMEJITVE ZA VARNO IN UČINKOVITO UPORABO ZDRAVILA Navedba smiselno ni potrebna.
This particularly includes the following situations with increased bleeding risk: - Recent puncture of large vessels or organ biopsy - Anomaly of vessels or organs - Recent cerebrovascular accident, stroke, or intracerebral surgery - Severe uncontrolled hypertension - Bacterial endocarditis - Advanced renal impairment - Haemorrhagic diathesis - Recent major surgery - Recent bleeding (e.g. intracranial, gastrointestinal, intraocular, pulmonary) - Overt signs of bleeding - Recent active peptic ulcer - Age > 65 years. 
To velja še zlasti za naslednja stanja s povečanim tveganjem krvavitve: - nedavna punkcija večjih žil ali biopsija organov - nepravilnosti ožilja ali organov - nedavni cerebrovaskularni insult, kap ali možganska operacija - huda neobvladana hipertenzija - bakterijski enodkarditis - napredovala okvara ledvic - hemoragična diateza - nedavni večji operativni poseg - nedavna krvavitev (npr. intrakranialna, gastrointestinalna, intraokularna, pljučna) - prikriti znaki krvavitve - nedavno aktivna želodčna razjeda - starost > 65 let.
- 0.4 mg / kg body weight intravenously as a bolus dose - followed by 0.15 mg / kg body weight / hour as a continuous intravenous infusion for 2 - 10 
- 0,4 mg / kg telesne mase intravensko v obliki bolusa - temu sledi 0,15 mg / kg telesne mase / uro v obliki neprekinjene intravenske infuzije, ki traja 2
Refludan should not be administered to pregnant women or nursing mothers. 
Refludana se ne sme dajati nosečnicam in doječim materam.
- For rapid, complete reconstitution, inject 0.4 ml of diluent into the vacuum vial and shake it gently. 
- Za hitro in popolno rekonstitucijo vbrizgajte 0,4 mL vehikla v vakuumsko vialo in rahlo pretresite.
EU/1/97/035/003 REFLUDAN - 20 mg - Powder for solution for injection or infusion - 1 vial EU/1/97/035/004 REFLUDAN - 20 mg - Powder for solution for injection or infusion - 10 vials 
EU/1/97/035/003 REFLUDAN - 20 mg - prašek za raztopino za injiciranje ali infundiranje - 1 viala EU/1/97/035/004 REFLUDAN - 20 mg - prašek za raztopino za injiciranje ali infundiranje - 10 vial
Any unused solution must be discarded appropriately. 
Vso neuporabljeno raztopino je treba ustrezno zavreči.
Injection site reactions including pain. 
Reakcije na mestu injiciranja, vključno z bolečino.
Manufacturer CSL Behring GmbH, Emil-von-Behring-Straße 76, 35041 Marburg, Germany. 
Izdelovalec CSL Behring GmbH, Emil-von-Behring-Straße 76, 35041 Marburg, Nemčija.
If you have a bleeding tendency, your doctor will weigh the risk of Refludan administration against its benefit. 
Bodite posebej pozorni pri uporabi zdravila Refludan Če ste nagnjeni h krvavitvam, bo vaš zdravnik pretehtal tveganje, povezano z uporabo Refludana, v primerjavi z njegovimi koristmi.
EU/1/97/035/001 REFLUDAN - 50 mg - Powder for solution for injection or infusion - 1 vial EU/1/97/035/002 REFLUDAN - 50 mg - Powder for solution for injection or infusion - 10 vials 
EU/1/97/035/003 REFLUDAN - 50 mg - prašek za raztopino za injiciranje ali infundiranje - 1 viala EU/1/97/035/004 REFLUDAN - 50 mg - prašek za raztopino za injiciranje ali infundiranje - 10 vial
For continuous intravenous infusion, a solution with a concentration of 2 mg/ml is needed. 
Za neprekinjeno intravensko infuzijo potrebujemo raztopino v koncentraciji 2 mg/ml.
Anaphylactic/oid reactions 
Anafilaktične/anafilaktoidne reakcije
The other ingredients are mannitol (E421) and sodium hydroxide for pH adjustment. 
Ostale snovi so manitol (E421) in natrijev hidroksid za uravnavanje PH.
In case of renal impairment relative overdose might occur even under standard dosage regimen. 
V primeru ledvične okvare lahko pride do prevelikega odmerka tudi ob standardni shemi odmerjanja.
VIAL LABEL: 20 mg 
NALEPKA NA VIALI: 20 mg
Also contains: mannitol, sodium hydroxide. 
Ostale sestavine: manitol, natrijev hidroksid
- Any unused solution must be discarded appropriately. 
- Vso neuporabljeno raztopino je treba ustrezno zavreči.
The speed of the perfusor automate [ml per hour] is to be set in a body weight dependent fashion. 
Hitrost perfuzorja [mL na uro] je treba nastaviti glede na telesno maso.
Once reconstituted Refludan is to be used immediately. 
Rekonstituirano raztopino je treba takoj uporabiti.
4.7 Effects on ability to drive and use machines 
4.7 Vpliv na sposobnost voţnje in upravljanja s stroji Navedba smiselno ni potrebna.
Refludan is used for anticoagulation in adult patients with heparin-induced thrombocytopenia (HIT) type II and thromboembolic disease requiring injected antithrombotic medicines. 
Refludan se uporablja za antikoagulacijo pri odraslih bolnikih, ki imajo s heparinom izzvano trombocitopenijo (HIT) tipa II in tromboembolijo, ki zahteva zdravljenje z injekcijami antitrombotikov.
Angio-oedema (including: face oedema, tongue oedema, larynx oedema) 
Angioedem (vključno z: edemom obraza, edemom jezika, edemom grla)
Gastrointestinal bleeding 
Gastrointestinalna krvavitev Vaginalna krvavitev Rektalna krvavitev Pljučna hemoragija
Dosing adjustments are based on renal function, weight, and aPTT (see section 4.2). 
Specifičnih prilagoditev odmerjanja za starejše bolnike ni. Odmerjanje se prilagaja glede na delovanje ledvic, telesno maso in aPTT (glejte poglavje 4.2).
Thus, please tell your doctor if you have or have had: - Recent puncture of large vessels or organs - Anomaly of vessels or organs - Recent stroke, accident or surgery involving the brain - High blood pressure - Inflammation of the inner membrane of the heart - Advanced kidney disease - Advanced bleeding tendency - Recent major surgery 
Prosimo, povejte svojemu zdravniku, če imate ali ste imeli kaj od spodaj naštetega: - pred kratkim punkcijo večjih žil ali organov - nepravilnosti ožilja ali organov - pred nedavnim kap, nesrečo ali operacijo možganov - visok krvni tlak - vnetje osrčnika (notranje srčeve ovojnice) - napredovalo bolezen ledvic - večjo nagnjenost h krvavitvam - pred kratkim večji operativni poseg - pred kratkim krvavitev (npr. v možganih, želodcu, črevesu, očeh, pljučih)
Marketing Authorisation Holder Celgene Europe Ltd., 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom. 
Imetnik dovoljenja za promet z zdravilom in izdelovalec Celgene Europe Ltd., 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, Združeno kraljestvo
In clinical trials, Refludan was not therapeutically administered to HIT type II patients with significant renal impairment. 
V kliničnih preskušanjih bolniki z HIT tipa II in pomembno okvaro ledvic niso bili zdravljeni z Refludanom.
Anticoagulation in adult patients with HIT type II and thromboembolic disease: 
Začetni odmerek Antikoagulacija pri odraslih bolnikih s HIT tipa II in tromboembolijo:
Its mode of action is independent of antithrombin III. 
Njegov način delovanja je neodvisen od antitrombina III. Trombocitni faktor 4 ne zavira lepirudina.
- Do not use solutions which are cloudy or contain particles. 
- Ne uporabljajte raztopine, če je kalna ali če vsebuje delce.
In intensified post-marketing surveillance in HIT type II, fatal bleeding was reported in 1 % and intracranial bleeding in 0.2 % of patients. 
V intenzivnem postmarketinškem spremljanju bolnikov s HIT tipa II so poročali o pojavu usodnih krvavitev pri 1 % in o pojavu intrakranialnih krvavitev pri 0,2 % bolnikov.
What Refludan contains The active substance is lepirudin, a recombinant DNA product derived from yeast cells. 
Aktivna učinkovina je lepirudin, rekombinantni produkt DNA, pridobljen iz celic kvasovk.
Therefore, the bolus dose and infusion rate must be reduced in case of known or suspected renal insufficiency (creatinine clearance below 60 ml/min or creatinine value above 15 mg/l [133 mol/l]). 
Zato je treba v primeru potrjene ledvične insuficience ali suma na okvaro ledvic (očistek kreatinina < 60 ml/min ali vrednost kreatinina > 15 mg/l [133 mol/l]) bolusni odmerek in hitrost infundiranja ustrezno zmanjšati.
Do not use Refludan - if you are allergic (hypersensitive ) to lepirudin, to hirudins or any of the other ingredients of 
Ne uporabljajte zdravila Refludan: - če ste alergični na (preobčutljivi za) lepirudin, hirudine ali katerokoli sestavino zdravila Refludan - če ste noseči ali dojite.
MARKETING AUTHORISATION NUMBER(S) 
ŠTEVILKE DOVOLJENJA (DOVOLJENJ) ZA PROMET
For intravenous bolus injection, a solution with a concentration of 5 mg/ml is needed. 
Za injekcijo intravenskega bolusa potrebujemo raztopino v koncentraciji 5 mg/ml.
- Recent bleeding (e.g. in brain, stomach/intestine, eye, lung) - Obvious signs of bleeding - Recent active peptic ulcer - Age > 65 years 
- očitne znake krvavitve - pred kratkim aktivno želodčno razjedo - starost nad 65 let.
- Mannitol - Sodium hydroxide for adjustment to pH 7 
6.1 Seznam pomoţnih snovi - manitol - natrijev hidroksid za prilagoditev vrednosti pH na 7 6.2 Inkompatibilnosti
Liver cirrhosis may also affect the renal excretion of lepirudin. 
Jetrna ciroza lahko vpliva tudi na izločanje lepirudina preko ledvic.
Anticoagulation in adult patients with heparin-induced thrombocytopenia (HIT) type II and thromboembolic disease mandating parenteral antithrombotic therapy. 
Antikoagulacija pri odraslih bolnikih, ki imajo s heparinom inducirano trombocitopenijo (HIT) tipa II in tromboembolijo, ki zahteva parenteralno antitrombotično zdravljenje.
Do not use solutions which are cloudy or contain particles. 
Ne uporabljajte raztopine, če je kalna ali če vsebuje delce.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
DATUM PRVE PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve: 13-03-1997
Urticaria 
Serija
Powder for solution for injection or infusion. 
Prašek za raztopino za injiciranje ali infundiranje.
1 vial contains 50 mg lepirudin. 
1 viala vsebuje 50 mg lepirudina.
1 vial contains 20 mg lepirudin. 
1 viala vsebuje 20 mg lepirudina.
Refludan. 
bolusa).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING 
Izgled zdravila Refludan in vsebina pakiranja
General Disorders and Administration Site Conditions 
Splošne teţave in spremembe na mestu aplikacije
Presentations: - Pack with 1 vial - Pack with 10 vials Not all pack sizes may be marketed. 
Oprema: - škatla z 1 vialo - škatla z 10 vialami
Dosage 0.2 mg / kg body weight 
Odmerek 0,1 mg/kg telesne mase /h
What Refludan looks like and contents of the pack Refludan is a white powder for solution for injection or infusion supplied in a vial containing 50 mg lepirudin. 
Refludan je bel prašek za raztopino za injiciranje ali infundiranje v viali, ki vsebuje 50 mg lepirudina.
What Refludan looks like and contents of the pack Refludan is a white powder for solution for injection or infusion supplied in a vial containing 20 mg lepirudin. 
Refludan je bel prašek za raztopino za injiciranje ali infundiranje v viali, ki vsebuje 20 mg lepirudina.
OUTER CARTON: 50 mg x 1 VIAL 
ZUNANJA ZLOŢENKA: 50 mg x 1 viala
10 x 1 vial of powder for solution for injection or infusion. 
10 x 1 viala s praškom za raztopino za injiciranje ali infundiranje
Dosage 0.15 mg / kg body weight / h Dosage 0.1 mg / kg body weight / h 
Odmerek 0,15 mg/kg telesne mase /h
Reconstitute one vial (20 mg of lepirudin) with 0.4 ml of either water for injections or sodium chloride 9 mg/ml (0.9 %) solution. 
Eno vialo (20 mg lepirudina) rekonstituirajte z 0,4 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/mL (0,9 %).
OUTER CARTON: 20 mg x 1 VIAL 
ZUNANJA ZLOŢENKA: 20 mg x 1 viala
- For reconstitution water for injections or sodium chloride 9 mg/ml (0.9 %) solution are to be used. 
- Za rekonstitucijo se uporablja voda za injekcije ali raztopina natrijevega klorida 9 mg/mL (0,9
BEFORE YOU USE REFLUDAN 
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO REFLUDAN
- For further dilution sodium chloride 9 mg/ml (0.9 %) or glucose 5 % solutions are suitable. 
- Za nadaljnje redčenje je primerna raztopina natrijevega klorida 9 mg/mL (0,9 %) ali raztopina 5
CLINICAL PARTICULARS 
Ţilne bolezni
Chills 
Hematurija
Do not use Refludan if the reconstituted solution is cloudy or contains particles. 
Če je rekonstituirana raztopina Refludana motna ali če vsebuje delce, je ne uporabite.
Reconstitute one vial (50 mg of lepirudin) with 1 ml of either water for injections or sodium chloride 9 mg/ml (0.9 %) solution. 
Eno vialo (50 mg lepirudina) rekonstituirajte z 1 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/mL (0,9 %).
Fever 
Navali vročine
Refludan 50 mg powder for solution for injection or infusion 
Refludan 50 mg prašek za raztopino za injiciranje ali infundiranje
Refludan 20 mg powder for solution for injection or infusion 
Refludan 20 mg prašek za raztopino za injiciranje ali infundiranje
- If any of the side effects gets serious, or if you notice 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 farmacevta.
1 vial of powder for solution for injection or infusion. 
1 viala s praškom za raztopino za injiciranje ali infundiranje.
Epistaxis 
Urtikarija
HOW TO STORE REFLUDAN 
SHRANJEVANJE ZDRAVILA REFLUDAN
Preparation of a Refludan solution with a concentration of 2 mg/ml For continuous intravenous infusion, a solution with a concentration of 2 mg/ml is needed: - Reconstitute two vials (each containing 20 mg of lepirudin) with 0.4 ml each using either water for injections or sodium chloride 9 mg/ml (0.9 %) solution. 
Priprava raztopine Refludana v koncentraciji 2 mg/ml Za neprekinjeno intravensko infuzijo potrebujemo raztopino v koncentraciji 2 mg/ml: - Uporabite dve viali s po 20 mg lepirudina; vsako od njih rekonstituirajte z 0,4 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/mL (0,9 %).
Preparation of a Refludan solution with a concentration of 5 mg/ml For intravenous bolus injection a solution with a concentration of 5 mg/ml is needed: - Reconstitute one vial (20 mg of lepirudin) with 0.4 ml of either water for injections or sodium chloride 9 mg/ml (0.9 %) solution. 
Priprava raztopine Refludana v koncentraciji 5 mg/ml Za intravensko bolusno injekcijo potrebujemo raztopino v koncentraciji 5 mg/ml: - Eno vialo (20 mg lepirudina) rekonstituirajte z 0,4 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/mL (0,9 %).
- The final concentration of 5 mg/ml is obtained by transfer into a sterile, single-use syringe (of at least 10 ml capacity) and further dilution to a total volume of 10 ml using sodium chloride 9 
- Končno koncentracijo 5 mg/mL dobimo s prenosom v sterilno brizgo za enkratno uporabo (s prostornino najmanj 10 mL) in nadaljnjim redčenjem z raztopino natrijevega klorida 9 mg/mL
Preparation of a Refludan solution with a concentration of 2 mg/ml For continuous intravenous infusion, a solution with a concentration of 2 mg/ml is needed: - Reconstitute two vials (each containing 50 mg of lepirudin) with 1 ml each using either water for injections or sodium chloride 9 mg/ml (0.9 %) solution. 
Priprava raztopine Refludana v koncentraciji 2 mg/mL Za neprekinjeno intravensko infuzijo potrebujemo raztopino v koncentraciji 2 mg/mL: - Uporabite dve viali s po 50 mg lepirudina; vsako od njih rekonstituirajte z 1 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/mL (0,9 %).
Preparation of a Refludan solution with a concentration of 5 mg/ml For intravenous bolus injection a solution with a concentration of 5 mg/ml is needed: - Reconstitute one vial (50 mg of lepirudin) with 1 ml of either water for injections or sodium chloride 9 mg/ml (0.9 %) solution. 
Priprava raztopine Refludana v koncentraciji 5 mg/mL Za intravensko bolusno injekcijo potrebujemo raztopino v koncentraciji 5 mg/mL: - Eno vialo (50 mg lepirudina) rekonstituirajte z 1 mL vode za injekcije ali z raztopino natrijevega klorida 9 mg/mL (0,9 %).
- The final concentration of 5 mg/ml is obtained by transfer into a sterile, single-use syringe (of at least 5 ml capacity) and further dilution to a total volume of 4 ml using sodium chloride 9 
- Končno koncentracijo 5 mg/mL dobimo s prenosom v sterilno brizgo za enkratno uporabo (s prostornino najmanj 5 ml) in nadaljnjim redčenjem z raztopino natrijevega klorida 9 mg/mL
Refludan 20 mg powder for solution for injection or infusion lepirudin 
Refludan 20 mg prašek za raztopino za injiciranje ali infundiranje Lepirudin
Discard unused solution appropriately. 
Neuporabljeno raztopino ustrezno zavrzite.
Refludan 50 mg powder for solution for injection or infusion Lepirudin 
Refludan 50 mg prašek za raztopino za injiciranje ali infundiranje Lepirudin
single-use perfusor syringe (50 ml capacity) and further dilution to a total volume of 20 ml using sodium chloride 9 mg/ml (0.9 %) or glucose 5 % solution. 
- Končno koncentracijo 2 mg/mL dobimo s prenosom obeh raztopin v eno sterilno perfuzijsko brizgo za enkratno uporabo (s prostornino 50 ml) in nadaljnjim redčenjem z raztopino natrijevega klorida 9 mg/mL (0,9 %) ali z raztopino 5 % glukoze do skupnega volumna 20 ml. - Infuzijsko hitrost avtomatskega perfuzorja naravnamo v skladu s telesno maso bolnika.
single-use perfusor syringe (50 ml capacity) and further dilution to a total volume of 50 ml using sodium chloride 9 mg/ml (0.9 %) or glucose 5 % solution. 
- Končno koncentracijo 2 mg/mL dobimo s prenosom obeh raztopin v eno sterilno perfuzijsko brizgo za enkratno uporabo (s prostornino 50 mL) in nadaljnjim redčenjem z raztopino natrijevega klorida 9 mg/mL (0,9 %) ali z raztopino 5 % glukoze do skupnega volumna 50 mL. - Infuzijsko hitrost avtomatskega perfuzorja naravnamo v skladu s telesno maso bolnika.
Skin and Subcutaneous Tissue Disorders 
Bolezni koţe in podkoţja
Each vial contains 20 mg lepirudin. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka viala vsebuje 20 mg lepirudina.
Each vial contains 50 mg lepirudin. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka viala vsebuje 50 mg lepirudina.
Main initiatives of this new framework: 
Glavne pobude tega novega okvira:
Other 1% Netherlands 
Drugo 1% Nizozemska
This success has been recognised by all of the Agency's stakeholders. 
Ta uspeh priznavajo vse interesne skupine Agencije.
Special financial support from the EU budget 
Posebna finančna podpora iz proračuna EU
The base system is in place. 
Temeljni sistem je vzpostavljen.
Testing results showed that the majority of the products were of high quality. 
Rezultati preizkušanja so pokazali, da je bila večina izdelkov visoke kakovosti.
6.3 Personnel 
6.3 Osebje
Total Recalls Class 1 Class 2 Class 3 
Skupaj Umiki Razred 1 Razred 2 Razred 3
These products potentially benefit some 1.6 million European patients suffering from 24 different rare conditions. 
Od teh proizvodov ima potencialne koristi okoli 1,6 milijona evropskih bolnikov, ki bolehajo za 24 redkimi boleznimi.
A new system of revenue (invoicing) was introduced and implemented successfully. 
Uveden in uspešno izveden je bil nov sistem prihodkov (fakturiranja).
2.8 Parallel distribution 
2.8 Vzporedna distribucija
It is once again my pleasure to introduce to you our report on the activities and achievements of the European Medicines Agency in the past year. 
Z veseljem vam ponovno predstavljam poročilo o dejavnostih in dosežkih Evropske agencije za zdravila v lanskem letu.
To pick out just a few notable achievements in core business areas: 
Navedimo samo nekatere pomembne dosežke na ključnih področjih poslovanja:
Results requiring further investigation were found in 18 products. 
Rezultati, ki so zahtevali nadaljnje preiskave, so bili ugotovljeni pri 18 izdelkih.
These included the first ‘opinions on any scientific matter', under Article 5(3) of Regulation (EC) No 726/2004. 
Ta so vključevala prva „mnenja o katerikoli znanstveni zadevi“ na podlagi člena 5(3) Uredbe (ES) št. 726/2004.
Regulation (EC) No 1901/2006 on medicinal products for paediatric use. 
Uredba (ES) št. 1901/2006 o zdravilih za pediatrično uporabo.
The European Commission adopts its decisions with the assistance of a standing committee composed of representatives of the Member States. 
Evropska komisija sprejme odločitev s pomočjo stalnega odbora, ki ga sestavljajo predstavniki držav članic.
Other initiatives for improving the safety of veterinary medicines included: 
Druge pobude za izboljšanje varnosti veterinarskih zdravil vključujejo:
In December 2006, the HMPC presented to the European Commission a comprehensive overview of its activities and achievements since its establishment in September 2004. 
Decembra 2006 je HMPC Evropski komisiji predstavil celovit pregled svojih dejavnosti in dosežkov od njegove ustanovitve septembra 2004.
I would like to begin by congratulating the Executive Director, his staff, the scientific committees and all working parties for their outstanding performance in 2006. 
Dovolite mi, da na začetku čestitam izvršnemu direktorju, njegovemu osebju, znanstvenim odborom in vsem delovnim skupinam za njihovo izjemno uspešnost v letu 2006.
An annual management review was conducted, aimed at ensuring that management tools are effective and suitable. 
Opravil se je letni pregled upravljanja, katerega cilj je zagotoviti, da so orodja upravljanja učinkovita in primerna.
6.2 Integrated quality-management at the Agency 
6.2 Integrirano upravljanje kakovosti v Agenciji
Implementation and further development of risk-management plans 
Izvajanje in nadaljnji razvoj načrtov za obvladovanje tveganja
More procedures finalised, in shorter time 
Več dokončanih postopkov v krajšem času