natgillin/translations-raw huggingface dataset:
Caution is advisable when administering the product to patients with: acute endocarditis, prosthetic valves, acute systemic inflammation and/or sepsis, hyperactive coagulation states and/or recent thromboembolism, and end-stage renal or hepatic disease, as the numbers of patients with those conditions who were exposed to SonoVue in the clinical trials were limited.
Svetujemo previdnost pri dajanju zdravila SonoVue bolnikom z: akutnim endokarditisom, umetnimi zaklopkami, akutnim sistemskim vnetjem in/ali sepso, s hiperaktivnimi motnjami koagulacije in/ali nedavno tromboembolijo in odpovedjo jeter ali ledvic, ker je število bolnikov s temi stanji, ki so v kliničnih preskušanjih prejeli zdravilo SonoVue omejeno.
Slide the vial into the transparent sleeve of the transfer system and press firmly to lock the vial in place.
Potisnite vialo v prozorno cev sistema za prenos in čvrsto pritisnite, da se viala usede na svoje mesto.
SonoVue is a transpulmonary echocardiographic contrast agent for use in adult patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation.
Zdravilo SonoVue je transpulmonalno ehokardiografsko kontrastno sredstvo, ki se uporablja pri odraslih bolnikih s sumom na ali z dokazanim kardiovaskularnim obolenjem, da zagotovi opacifikacijo srčnih votlin in izboljša razmejitev konture endokardija levega ventrikla.
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja osip pruritus
Adult population-Intravenous use
Odrasla populacija - intravenska uporaba
If SonoVue is not used immediately after reconstitution the dispersion will be shaken again before being drawn up into a syringe.
Če zdravila SonoVue ne uporabite takoj po rekonstituciji, je treba disperzijo ponovno pretresti, preden jo povlečete v brizgo.
Doppler of macrovasculature
Doppler velikih žil
The following side effects have been reported with SonoVue:
Pri zdravilu SonoVue so poročali o naslednjih neželenih učinkih:
PHARMACEUTICAL FORM Powder and solvent for dispersion for injection.
FARMACEVTSKA OBLIKA Prašek in vehikel za disperzijo za injiciranje Beli prašek
SonoVue should be administered immediately by injection into a peripheral vein for use in echocardiography and in vascular Doppler imaging in adults or by intravesical administration for use in ultrasonography of the excretory urinary tract in paediatric patients.
Zdravilo SonoVue morate aplicirati takoj z injiciranjem v periferno veno za uporabo pri ehokardiografskem in vaskularnem dopplerskem slikanju pri odraslih ali z intravezikalnim injiciranjem za uporabo pri ultrazvoku sečnih zvodil pri pediatričnih bolnikih.
False negative cases can occur with voiding ultrasonography with SonoVue and have not been clarified (see section 5.1).
Interpretacija ultrazvočne cistografije z zdravilom SonoVue in omejitve uporabe Pri uporabi zdravila SonoVue za ultrazvočno cistografijo za odkrivanje vezikoureternega refluksa lahko pride do lažno negativnih primerov za katere vzroki niso razjasnjeni (glejte poglavje 5.1).
It was therefore concluded that SonoVue is well tolerated in the urinary tract in the rat.
Zato je bilo zaključeno, da se zdravilo SonoVue dobro prenaša v sečilih pri podganah.
BATCH NUMBER Lot:
ŠTEVILKA SERIJE Številka serije:
Administration of SonoVue is followed by completion of bladder filling with saline until patient has the urge to micturate or there is the first slight sign of back pressure to the infusion.
Apliciranju zdravila SonoVue sledi aplikacija fiziološke raztopine do napolnitve mehurja, dokler bolnik ne začuti potrebo po uriniranju ali dokler se ne pojavi prvi rahel znak protitlaka na infuzijo.
Headache, paraesthesia, dizziness, dysgeusia
Bolezni živčevja glavobol, parestezija, omotica, disgevzija vazovagalna reakcija
If SonoVue is not used immediately after reconstitution the microbubble dispersion should be shaken again before being drawn up into a syringe.
Če se zdravila SonoVue ne porabi takoj po rekonstituiranju, se mora disperzijo ponovno pretresti, predno se jo potegne v injekcijsko brizgo.
SonoVue improves display of the vascularity of liver and breast lesions during Doppler sonography in adult patients leading to more specific lesion characterisation.
Zdravilo SonoVue izboljša prikaz vaskularnosti lezij v jetrih in dojkah pri dopplerski sonografiji, kar pri odraslih bolnikih daje bolj specifične podatke o lezijah.
How to store SonoVue
Kako uporabljati zdravilo SonoVue
Intravesical use
Intravezikalna uporaba
SonoVue contains sodium
Zdravilo SonoVue vsebuje natrij
Unscrew the syringe from the transfer system.
Odvijte injekcijsko brizgo s sistema za prenos.
STATEMENT OF ACTIVE SUBSTANCE(S) Each mL of the dispersion contains 8 µLsulphur hexafluoride microbubbles, equivalent to 45 micrograms.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsak ml disperzije vsebuje 8 µl mikromehurčkov žveplovega heksafluorida, kar ustreza 45 mikrogramom.
The intensity of the reflected signal is dependent on concentration of the microbubbles and frequency of the ultrasound beam .The interface between the sulphur hexafluoride bubble and the aqueous medium acts as a reflector of the ultrasound beam thus enhancing blood echogenicity and increasing contrast between the blood and the surrounding tissues .
Mejna ploskev med mehurčkom žveplovega heksafluorida in vodnim medijem deluje kot odbojnik ultrazvočnih valov in tako poveča ehogenost krvi in poveča kontrast med krvjo in okoliškimi tkivi.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and toxicity to reproduction.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, genotoksičnosti in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
Moreover, ECG and blood pressure monitoring should be performed during SonoVue-enhanced echocardiography with a pharmacological stress (e.g. with dobutamine).
Poleg tega, kadar se zdravilo SonoVue uporablja za ehokardiografijo s farmakološko obremenitvijo (npr. z dobutaminom), se mora spremljati EKG in krvni tlak.
This product should only be used by physicians experienced in diagnostic ultrasound imaging.
Zdravilo SonoVue lahko daje samo zdravnik z izkušnjami v diagnostiki z ultrazvokom.
Distearoylphosphatidylcholine Dipalmitoylphosphatidylglycerol Sodium Palmitic acid
Makrogol 4000 distearilfosfatidilholin natrijev fosfatidilglicerildipalmitat palmitinska kislina
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Sodium chloride 9 mg/mL solution for injection Solvent for SonoVue
IME ZDRAVILA IN POT(I) UPORABE Raztopina natrijevega klorida 9 mg/ml za injiciranje Vehikel za zdravilo SonoVue
ECG monitoring should be performed in high-risk patients as clinically indicated.
Bolniki z nestabilnim kardiopulmonalnim statusom Opazovanje z EKG mora biti izvajano pri bolnikih z visoko stopnjo tveganja.
What SonoVue contains
Kaj vsebuje zdravilo SonoVue
A low mechanical index (≤ 0.4) is recommended for imaging the bladder, ureters, and kidney during ultrasonography of the urinary tract with contrast.
Za slikanje mehurja, sečevodov in ledvic pri ultrazvoku sečil s kontrastnim sredstvom se priporoča nizek mehanski indeks (≤ 0,4).
Open the MiniSpike transfer system blister and remove syringe tip cap. Open the transfer system cap and connect the syringe to the transfer system by screwing it in clockwise.
Odprite pretisni omot MiniSpike sistema za prenos in odstranite pokrovček injekcijske brizge.
SonoVue should be administered immediately after drawing into the syringe by injection into a peripheral vein.
Zdravilo SonoVue se mora injicirati bolniku v periferno veno takoj, ko se potegne disperzijo v brizgo.
SonoVue 8 microlitres/mL powder and solvent for dispersion for injection sulphur hexafluoride
SonoVue 8 mikrolitrov/ml prašek in vehikel za disperzijo za injiciranje žveplov heksafluorid
Musculoskeletal, connective tissue and bone disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v hrbtu
Overdose is not likely to happen since SonoVue is given by a doctor.
Če prejmete večji odmerek zdravila SonoVue, kot bi smeli Preveliko odmerjanje ni verjetno, saj vam zdravilo SonoVue da zdravnik.
- The other ingredients are: macrogol 4000, distearoylphosphatidylcholine,
- Pomožne snovi: makrogol 4000, distearilfosfatidilholin, natrijev fosfatidilglicerildipalmitat,
Solvent: Sodium chloride 9 mg/mL (0.9%) solution for injection.
Vehikel: 9 mg/ml (0,9%) raztopina natrijevega klorida za injiciranje.
SonoVue is for use with ultrasound imaging to enhance the echogenicity of the blood, or of fluids in the urinary tract which results in an improved signal to noise ratio.
Zdravilo SonoVue uporabljamo pri ultrazvočnih preiskavah, kjer poveča ehogenost krvi ali tekočine v sečilih, kar se pokaže z izboljšanim razmerjem med signalom in šumom.
SonoVue will then be administered through the thin tube and will be followed by administration of saline to continue filling the bladder.
Nato se skozi cevko vnese zdravilo SonoVue, čemur sledi vnašanje fiziološke raztopine za nadaljnje polnjenje mehurja.
Every injection should be followed by a flush with 5 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Vsakemu injiciranju sledi izpiranje s 5 ml 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje.
NAME OF THE MEDICINAL PRODUCT SonoVue 8 microlitres/mL powder and solvent for dispersion for injection
IME ZDRAVILA SonoVue 8 mikrolitrov/ml prašek in vehikel za disperzijo za injiciranje
There are literature reports of the use of the gas in the study of respiratory physiology and in pneumatic retinopexy.The addition of sodium chloride 9 mg/mL (0.9%) solution for injection to the lyophilised powder followed by vigorous shaking results in the production of the microbubbles of sulphur hexafluoride.
Dodatek 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje k liofiliziranemu prašku ob močnem stresanju ustvari mikromehurčke žveplovega heksafluorida.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SonoVue 8 microlitres/mL powder for dispersion for injection sulphur hexafluoride
IME ZDRAVILA IN POT(I) UPORABE SonoVue 8 mikrolitrov/ml prašek za disperzijo za injiciranje žveplov heksafluorid
The glass syringe contains sodium chloride 9 mg/mL (0.9%) solution for injection.
Steklena injekcijska brizga vsebuje 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje.
For ultrasound scan of urinary tract in children the recommended dose is 1 mL per patient to be administered into the bladder as follows:
Ultrazvok sečil pri otrocih: priporočeni odmerek, ki se ga daje v mehur je 1 ml na bolnika, po naslednjem postopku: po izpraznjenju mehurja, se vanj skozi tanko cevko vnese fiziološko raztopino.
Type I clear glass pre-filled syringe containing 5 mL sodium chloride 9 mg/mL (0.9%) solution for injection.
Napolnjena, prozorna injekcijska brizga iz stekla tipa I s 5 ml 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje.
It did not reveal any test item-related lesions in any of the examined organs, in particular in the urinary bladder, in both the single-dose and the repeat-dose studies.
Tako pri študiji z enkratnim odmerkom kot pri študiji s ponavljajočimi se odmerki, poškodbe povezane s testnimi vzorci pri pregledanih organih, še zlasti v sečnem mehurju, niso bile odkrite.
Nervous system disorders
Žilne bolezni zardevanje hipotenzija
SonoVue must be prepared before use by injecting through the septum 5 mL of sodium chloride 9 mg/mL (0.9%) solution for injection to the contents of the vial.
Skozi zamašek k vsebini viale vbrizgajte 5 ml 9 mg/ml (0,9%) raztopine natrijevega klorida za injiciranje.
Chest discomfort, injection site reaction, feeling hot
Splošne težave in spremembe na mestu aplikacije nelagodje v prsnem košu, reakcija na mestu injiciranja, občutek vročine bolečine v prsnem košu, bolečina, utrujenost
Outer packaging
Ultrazvok sečnih izvodil
Vomiting
Odmerjanje
dipalmitoylphosphatidylglycerol sodium, palmitic acid.
palmitinska kislina.
Rash
Rok
Empty the contents of the syringe into the vial by pushing on the plunger rod.
S pritiskom na bat izpraznite vsebino injekcijske brizge v vialo.
Interpretation of voiding urosonography with SonoVue and limitations of use
Shranjevanje zdravila SonoVue Vsebina pakiranja in dodatne informacije
METHOD OF ADMINISTRATION
NAČIN UPORABE ZDRAVILA
For single use only
Zdravilo je za enkratno uporabo
Vision blurred,
Očesne bolezni zamegljen vid
If you are taking any of the following:
Če jemljete katero koli od naslednjih zdravil:
Adopted at the 14-17 May 2018 PRAC
Sprejeto na seji odbora PRAC od 14. do 17. maja 2018
Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Bolnikom je treba tudi priporočiti, naj svojega partnerja ali skrbnike obvestijo o svojem zdravljenju, ker lahko opazijo simptome, ki se jih bolnik ne zaveda.
Summary of product characteristics 4.4.
Povzetek glavnih značilnosti zdravila 4.4.
If you had these symptoms prior to treatment with lenalidomide, tell your doctor about any change in these symptoms.
Če ste imeli te simptome že pred začetkom zdravljenja z lenalidomidom, o kakršni koli njihovi spremembi obvestite zdravnika.
The following medicines may increase the effects of Eliquis and increase the chance for unwanted bleeding:
Naslednja zdravila lahko okrepijo učinek zdravila Eliquis in s tem povečajo tveganje za pojav neželene krvavitve:
Pembrolizumab - Aseptic meningitis (EPITT no 19115)
Pembrolizumab - Aseptični meningitis (EPITT št. 19115)
PML was reported several months to several years after starting the treatment with lenalidomide.
O nastopu PML so poročali od več mesecev do več let po začetku zdravljenja z lenalidomidom.
Concomitant use of medicines affecting haemostasis may increase the risk of bleeding.
Sočasna uporaba zdravil, ki vplivajo na hemostazo, lahko zveča nevarnost krvavitve.
If PML is confirmed, lenalidomide must be permanently discontinued.
Če se PML potrdi, je treba zdravljenje z lenalidomidom trajno ukiniti.
Cases have generally been reported in patients taking concomitant dexamethasone or prior treatment with other immunosuppressive chemotherapy.
O primerih so na splošno poročali pri bolnikih, ki so sočasno jemali deksametazon ali so se predhodno zdravili z drugo imunosupresivno kemoterapijo.
What you need to know before you take Eliquis Other medicines and Eliquis
Kaj morate vedeti, preden boste vzeli zdravilo Eliquis Druga zdravila in zdravilo Eliquis
Physicians should monitor patients at regular intervals and should consider PML in the differential diagnosis in patients with new or worsening neurological symptoms, cognitive or behavioural signs or symptoms.
Zdravniki morajo redno spremljati bolnike in pri diferencialni diagnozi pri bolnikih z novimi ali napredujočimi nevrološkimi, kognitivnimi ali vedenjskimi znaki ali simptomi upoštevati možnost PML.
What you need to know before you take Lixiana/Roteas Other medicines and Lixiana/Roteas
Kaj morate vedeti, preden boste vzeli zdravilo Lixiana/Roteas Druga zdravila in zdravilo Lixiana/Roteas
*Note: Stated frequencies are applicable for pegfilgrastim; for lipegfilgrastim and lenograstim the frequency is to be calculated by the MAHs.
* Opomba: Navedene pogostnosti veljajo za pegfilgrastim; pogostnost za lipegfilgrastim in lenograstim izračunajo imetniki dovoljenja za promet z zdravilom.
The evaluation for PML should be based on neurological examination, magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JC virus (JCV) DNA by polymerase chain reaction (PCR) or a brain biopsy with testing for JCV.
Diagnostika za PML mora temeljiti na nevrološkem pregledu, magnetnoresonančnem slikanju možganov in analizi cerebrospinalnega likvorja za DNK virusa JC (JCV) z verižno reakcijo s polimerazo (PCR) ali na biopsiji možganov s preiskavo za JCV.
Additional follow-up and evaluation may be warranted if no alternative diagnosis can be established.
Če ni mogoče postaviti druge diagnoze, sta lahko potrebna dodatno spremljanje in diagnostika.
Lenalidomide - Progressive multifocal leukoencephalopathy (PML) (EPITT no 19130)
Lenalidomid - Progresivna multifokalna levkoencefalopatija (PML) (EPITT št. 19130)
Lenograstim; lipegfilgrastim; pegfilgrastim - Pulmonary haemorrhage (EPITT no 19181)
Lenograstim; lipegfilgrastim; pegfilgrastim - Krvavitev v pljučih (EPITT št. 19181)
If PML is suspected, further dosing must be suspended until PML has been excluded.
Pri sumu na PML je treba nadaljnje odmerke začasno ustaviti do izključitve PML.
Special warnings and precautions for use Interaction with other medicinal products affecting haemostasis
Posebna opozorila in previdnostni ukrepi Medsebojno delovanje z drugimi zdravili, ki vplivajo na hemostazo
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid (aspirin))
• protivnetna zdravila in zdravila za lajšanje bolečin (npr. naproksen ali acetilsalicilno kislino (aspirin))
What you need to know before you use REVLIMID [...]
Kaj morate vedeti, preden boste uporabili zdravilo REVLIMID [...] Opozorila in previdnostni ukrepi
Despite these findings, there may be individuals with a more pronounced pharmacodynamic response when antiplatelet agents are coadministered with apixaban.
Kljub tem ugotovitvam pa je pri posameznih bolnikih lahko farmakodinamični odziv pri sočasni uporabi antitrombocitnih učinkovin in apiksabana izrazitejši.
Anticoagulants, antiplatelets, and thrombolytics Interaction with other medicinal products affecting haemostasis
Antikoagulanti, antiagregacijska zdravila in trombolitiki Medsebojno delovanje z drugimi zdravili, ki vplivajo na hemostazo
Undesirable effects Nervous system disorders Frequency ‘rare': meningitis (aseptic)
Pogostnost „redki“: meningitis (aseptični)
Cases of progressive multifocal leukoencephalopathy (PML), including fatal cases, have been reported with lenalidomide.
Pri zdravljenju z lenalidomidom so poročali o primerih progresivne multifokalne levkoencefalopatije (PML), tudi s smrtnim izidom.
Inflammation of the membrane around the spinal cord and brain, which may present as neck stiffness, headache, fever, eye sensitivity to light, nausea and vomiting (meningitis)
Redki (pojavijo se lahko pri največ 1 od 1 000 bolnikov) Vnetje ovojnice hrbtenjače in možganov, ki se lahko kaže kot otrdelost vratu, glavobol, vročina, preobčutljivost oči na svetlobo, slabost in bruhanje (meningitis).
Apixaban; edoxaban - Drug interaction between apixaban or edoxaban and selective serotonin reuptake inhibitors (SSRI) and/or serotonin and noradrenaline reuptake inhibitors (SNRI) leading to increased risk of bleeding (EPITT no 19139)
Apiksaban; edoksaban - Medsebojno delovanje med apiksabanom ali edoksabanom ter selektivnimi zaviralci privzema serotonina (SSRI) in/ali zaviralci privzema serotonina in noradrenalina (SNRI), ki povzroči povečano tveganje za pojav krvavitve (EPITT št. 19139)
- medicines for high blood pressure or heart problems (e.g., diltiazem) - antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin
- zdravila za zdravljenje visokega krvnega tlaka ali težav s srcem (npr. diltiazem) - antidepresivi, imenovani selektivni zaviralci privzema serotonina ali zaviralci privzema serotonina in noradrenalina
At any time during or after your treatment, tell your doctor or nurse immediately if you: experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion.
Če se kadar koli med zdravljenjem ali po njem pojavi kaj od naslednjega, o tem takoj obvestite zdravnika ali medicinsko sestro: zamegljen vid, izguba vida ali dvojni vid, težave pri govorjenju,
Eliquis should be used with caution when coadministered with SSRIs/SNRIs or NSAIDs (including acetylsalicylic acid) because these medicinal products typically increase the bleeding risk.
Pri sočasni uporabi zdravila Eliquis in SSRI/SNRI ali NSAID nesteroidnih protivnetnih zdravil (vključno z acetilsalicilno kislino) je potrebna previdnost, saj je za ta zdravila značilno, da povečajo tveganje za krvavitve.
These include acetylsalicylic acid (ASA), P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), and chronic nonsteroidal anti-inflammatory drugs (NSAIDs) (see section 4.5).
Ta zdravila vključujejo acetilsalicilno kislino (ASA), inhibitorje trombocitov P2Y12, druge antitrombotike, fibrinolitično terapijo, selektivne zaviralce privzema serotonina (SSRI) ali zaviralce privzema serotonina in noradrenalina (SNRI) in kronična nesteroidna protivnetna zdravila (NSAID)(glejte poglavje 4.5).
Care is to be taken if patients are treated concomitantly with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), or non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid.
Previdnost je potrebna, kadar se bolniki sočasno zdravijo s selektivnimi zaviralci privzema serotonina (SSRI) ali zaviralci privzema serotonina in noradrenalina (SNRI) ali z nesteroidnimi protivnetnimi zdravili (NSAID), vključno z acetilsalicilno kislino.
• antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin
• antidepresive, imenovane selektivni zaviralci privzema serotonina ali zaviralci privzema serotonina in noradrenalina
A significant increase in bleeding risk was reported with the triple combination of apixaban, ASA and clopidogrel in a clinical study in patients with acute coronary syndrome (see section 4.4).
V klinični študiji so pri bolnikihz akutnim koronarnim sindromom pri sočasni uporabi apiksabana, acetilsalicilne kisline in klopidogrela poročali o pomembnem povečanju tveganja za pojav krvavitev (glejte poglavje 4.4).
Coughing up blood (haemoptysis) - uncommon* Bleeding from the lung (pulmonary haemorrhage) - rare*
Možni neželeni učinki (na podlagi ustrezajoče pogostnosti): izkašljevanje krvi (hemoptiza) - občasni* krvavitev iz pljuč (pljučna hemoragija) - redki*
Undesirable effects Respiratory, thoracic and mediastinal disorders Haemoptysis (uncommon*) Pulmonary haemorrhage (rare*)
Bolezni dihal, prsnega koša in mediastinalnega prostora Hemoptiza (občasni*)
Interaction with other medicinal products and other forms of interaction Anticoagulants, platelet aggregation inhibitors, SSRIs/SNRIs and NSAIDs
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Antikoagulanti, zaviralci agregacije trombocitov, selektivni zaviralci privzema serotonina (SSRI)/zaviralci privzema serotonina in noradrenalina (SNRI) in nesteroidna protivnetna zdravila (NSAID)
Interaction with other medicinal products and other forms of interaction Anticoagulants, antiplatelets, and NSAIDs and SSRIs/SNRIs
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Antikoagulanti, antitrombotiki,in nesteroidna protivnetna zdravila (NSAID) ter selektivni zaviralci privzema serotonina (SSRI)/zaviralci privzema serotonina in noradrenalina (SNRI)
Warnings and precautions
Bolezni živčevja
The current fee system consists of around 130 different fees.
Sedanji sistem pristojbin vključuje približno 130 različnih pristojbin.
Transparency is the key aspects of the new proposals.
Preglednost je ključni vidik novih predlogov.
A separate discussion with the ECDC will be organised.
Organizirana bo ločena razprava s centrom ECDC.
As a consequence, resources needed to respond to a single request are currently disproportionate.
Zato so viri, ki so potrebni za odgovor na posamezen zahtevek, zdaj nesorazmerni.
The European Commission study estimates that 5-7 full time equivalents will be needed for this task.
V študiji Evropske komisije je bilo ocenjeno, da bo za to nalogo potrebnih 5-7 ekvivalentov polnega delovnega časa.
The second meeting of the chairs took place on 31 May 2010.
Drugi sestanek predsednikov je potekal 31. maja 2010.
The first report is expected at the beginning of 2011.
Pričakuje se, da bo prvo poročilo pripravljeno na začetku leta 2011.