natgillin/translations-raw huggingface dataset:
The use of ultrasound or other imaging techniques to assist with intrathecal administration of Spinraza, can be considered at the physician's discretion. 
Po presoji zdravnika lahko pride v poštev uporaba ultrazvoka ali drugih tehnik slikanja kot pomoč pri intratekalnem dajanju zdravila
Statistically significant effects on event-free survival, overall survival, the proportion of patients achieving the definition of a motor milestone responder, and the percentage of patients with at least a 4-point improvement from baseline in Children's Hospital of Philadelphia 
Statistično značilne učinke na preživetje brez dogodkov, stopnjo preživetja, delež bolnikov, ki so dosegli odzivnost, opredeljeno z motoričnimi mejniki in delež bolnikov z izboljšanjem za najmanj 4 točk od izhodišča v rezultatu testa za dojenčke za živčnomišične bolezni bolnišnice Children's Hospital of Philadelphia (Children's Hospital of Philadelphia Infant Test for Neuromuscular DiseaseCHOP INTEND) so ugotovili pri bolnikih v skupini z zdravilom Spinraza v primerjavi z rezultati kontrolne skupine na placebu (preglednica 2).
Calcium chloride dihydrate Magnesium chloride hexahydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev dihidrogenfosfat dihidrat natrijev hidrogenfosfat natrijev klorid kalijev klorid kalcijev klorid dihidrat magnezijev klorid heksahidrat natrijev hidroksid (za uravnavanje pH) klorovodikova kislina (za uravnavanje pH) voda za injekcije
If you are not sure, talk to your doctor or nurse before you or your child are given Spinraza. 
Če ste negotovi, se posvetujte z zdravnikom ali medicinsko sestro, preden prejmete ali preden vaš otrok prejme zdravilo Spinraza.
Spinraza treated Patients 
Bolniki, zdravljeni z zdravilom Spinraza
There have been reports of communicating hydrocephalus not related to meningitis or bleeding in patients treated with nusinersen in the post-marketing setting. 
Pri bolnikih, zdravljenih z nusinersenom v obdobju trženja, so poročali o komunikantnem hidrocefalusu, ki ni bil povezan z meningitisom ali krvavitvijo.
The median time to death or permanent ventilation was 50.9 weeks after initiation of Spinraza treatment in Study CS11. 
Po uvedbi zdravljenja z zdravilom Spinraza v študiji CS11 je vrednost mediane časa do smrti ali trajne ventilacije znašala 50,9 tedna.
A sustained improvement was seen in patients with Type II SMA who experienced a mean improvement from baseline HFMSE score of 5.1 (SD 4.05, n=11) at Day 253, and 9.1(SD 6.61, n=9) at Day 1050. 
Trajno izboljšanje so ugotovili pri bolnikih s SMA tipa II, ki so se povprečno izboljšali z izhodiščnega rezultata 5,1 (SD 4,05, n=11) po 253 dneh,
Thrombocytopenia and coagulation abnormalities, including acute severe thrombocytopenia, have been observed after administration of other subcutaneously or intravenously administered antisense oligonucleotides. 
Po dajanju drugih subkutano ali intravensko apliciranih protismiselnih oligonukleotidov so opazili trombocitopenijo in abnormalnosti koagulacije krvi, vključno z akutno hudo trombocitopenijo.
Sham-control Patients 
Kontrolni bolniki na placebu
Sedation may be required to administer Spinraza, as indicated by the clinical condition of the patient. 
Glede na klinično stanje bolnika bo za dajanje zdravila Spinraza mogoče potrebna sedacija.
Pharma MT limited Tel: +356 213 37008/9 
Tel: +356 213 37008/9
Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena 5 ml viala vsebuje natrijev nusinersenat, ki ustreza 12 mg nusinersena.
Icepharma hf Sími: +354 540 8000 
Sími: +354 540 8000
Adverse reactions associated with the administration of Spinraza by lumbar puncture have been observed. 
Opazili so neželene učinke, povezane z lumbalno punkcijo ob uporabi zdravila Spinraza.
At the interim analysis, all 25 (100%) patients had achieved the WHO motor milestone of sitting without support, 22 (88%) patients were walking with assistance. 
sedenja brez opore, 22 (88 %) bolnikov pa je hodilo s podporo.
The median age when patients received their first dose was 164.5 days for treated patients, and 205 days for sham-control. 
99 % bolnikov je imelo po 2 kopiji gena SMN2 in je bilo zato zanje najverjetneje, da se bo razvila SMA tipa I. Mediana starost, pri kateri so bolniki prejeli prvi odmerek, je bila pri zdravljenih bolnikih 164,5 dni, pri kontrolnih bolnikih na placebu pa 205 dni.
Change from baseline in total HFMSE score at 15 months1,2,3 
Spremembe povprečja najmanjših kvadratov HFMSE od izhodišča meseci
Potassium chloride 
Toksičnost za ledvice
April 2023. 
265. dne.
Spinraza has not been studied in patients with hepatic impairment. 
Pri bolnikih z okvaro jeter zdravila Spinraza niso proučevali.
How to store Spinraza 
Shranjevanje zdravila Spinraza
3At the final analysis, CHOP INTEND and motor milestone analyses were conducted using the Efficacy Set (Spinraza n=73; Sham-control n=37). 
3V končni analizi so opravili analize CHOP INTEND in motoričnih mejnikov z uporabo nabora za oceno učinkovitosti
It is essentially ‘sodium-free' and can be used by people on a sodium-restricted diet. 
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija' in ga lahko uporabljajo ljudje, ki so na dieti z nadzorovanim vnosom natrija.
19.7% (95% CI: 10.9, p=0.0811 
19,7% (95-% IZ: 10,9,
Side effects related to the lumbar puncture may occur while Spinraza is being given or afterwards. 
Med dajanjem ali po dajanju zdravila Spinraza se lahko pojavijo neželeni učinki, povezani z lumbalno punkcijo.
Clinical efficacy and safety 
Klinična učinkovitost in varnost Simptomatični bolniki Začetek bolezni pri dojenčkih
• Back pain 
• bolečina v hrbtu
Talk to your doctor before you or your child are given Spinraza. 
Preden vam ali vašemu otroku dajo zdravilo Spinraza, se posvetujte z zdravnikom.
Renal toxicity has been observed after administration of other subcutaneously and intravenously administered antisense oligonucleotides. 
Po dajanju drugih subkutano ali intravensko apliciranih protismiselnih oligonukleotidov so opazili toksičnost za ledvice.
The analysis was conducted in the ITT population (Spinraza: n=84; sham-control: n=42), and post-baseline HFMSE data for patients without a Month 15 visit were imputed using the multiple imputation method. 
placebo: n=42), poizhodiščne podatke HFMSE pa so bolnikom brez pregleda v 15. mesecu pripisali z metodo večkratne imputacije.
Mean change from baseline to month 15 in total RULM score2,3 
Povprečna sprememba celotnega rezultata RULM od izhodišča do
WHO motor milestones 
odzivnega z motoričnimi mejniki
Adverse reactions have been identified during post-approval use of Spinraza. 
Med uporabo zdravila Spinraza po pridobitvi dovoljenja za promet so ugotovili neželene učinke.
MedDRA System Organ Class 
Organski sistemi po MedDRA Priporočeni izraz po MedDRA
Package leaflet: Information for the user Spinraza 12 mg solution for injection nusinersen 
Navodilo za uporabo Spinraza 12 mg raztopina za injiciranje nusinersen
Breast-feeding 
Hidrocefalus
Study CS4 (CHERISH) was a Phase 3, randomised, double-blind, sham-procedure controlled study conducted in 126 symptomatic patients with later-onset SMA (symptom onset after 6 months of age). 
Študija CS4 (CHERISH) je bila randomizirana, dvojno slepa, s placebom kontrolirana študija 3. faze,
Patients with Type III SMA demonstrated a mean improvement from baseline HFMSE score of 1.3 (SD 1.87, n=16) at Day 253 and 1.2 (SD 4.64, n=11) at Day 1050. 
(SD 1,87, n=16) po 253 dneh in 1,2 (SD 4,64, n=11) po 1050 dneh zdravljenja.
The median age of onset of clinical signs and symptoms of SMA was 6.5 weeks and 8 weeks for Spinraza treated versus sham-control patients respectively, with 99% of patients having 2 copies of the SMN2 gene and therefore deemed most likely to develop Type I SMA. 
Mediana starost ob začetku kliničnih znakov in simptomov SMA je bila pri bolnikih, zdravljenih z zdravilom Spinraza, 6,5 tedna, pri kontrolnih bolnikih na placebu pa 8 tednov.
If removed from the original carton, the total time out of refrigeration should not exceed 30 hours, at a temperature that does not exceed 25°C. 
30 ur pri temperaturi, ki ni višja od 25 °C.
4.2(95% CI: 3.4, 5.0) p=0.00000016 
4,2 (95-% IZ: 3,4, 5,0)
OTHER 
Od
The median age at first dose was 162 days. 
Smatrali so, da je najbolj verjetno, da se bo pri bolnikih v tej študiji razvila SMA tipa I. Mediana starost pri prvem odmerku je bila 162 dni.
Interactions 
Odmerjanje
Spinraza is given; 
Spinraza.
out of 20 patients (55%) met the endpoint of an increase in total CHOP INTEND score of ≥4 points as of the last study visit. 
doseglo končni opazovani dogodek zvečanja rezultata CHOP INTEND za ≥ 4 točke do zadnjega pregleda v študiji pred zaključkom zbiranja podatkov.
Further information on Gefitinib Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije o zdravilu Gefitinib Mylan so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Gefitinib Mylan? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Gefitinib Mylan?
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Iressa, and do not need to be repeated for Gefitinib Mylan. 
Študije o koristih in tveganjih učinkovine pri odobrenem načinu uporabe so že bile izvedene z referenčnim zdravilom Iressa, zato jih ni treba ponoviti za zdravilo Gefitinib Mylan.
EGFR is involved in the growth and spread of cancer cells. 
EGFR je vpleten v rast in širjenje rakavih celic.
It is used in patients whose cancer cells have a mutation in the genes that make a protein called epidermal growth factor receptor (EGFR). 
Uporablja se pri bolnikih, katerih rakave celice imajo mutacijo v genih, ki tvorijo beljakovino, imenovano receptor epidermalnega rastnega dejavnika (EGFR).
Because Gefitinib Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Gefitinib Mylan generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
An overview of Gefitinib Mylan and why it is authorised in the EU 
Pregled zdravila Gefitinib Mylan in zakaj je odobreno v EU
This means that it blocks specific enzymes known as tyrosine kinases. 
To pomeni, da zavira delovanje določenih encimov, imenovanih tirozin-kinaze.
As for every medicine, the company provided studies on the quality of Gefitinib Mylan. 
Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Gefitinib Mylan.
The European Medicines Agency concluded that, in accordance with EU requirements, Gefitinib Mylan has been shown to have comparable quality and to be bioequivalent to Iressa. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Gefitinib Mylan primerljivo raven kakovosti in je bioekvivalentno referenčnemu zdravilu Iressa.
Side effects reported with Gefitinib Mylan are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Gefitinib Mylan, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Gefitinib Mylan have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Gefitinib Mylan upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What are the benefits and risks of Gefitinib Mylan? 
Kakšne so koristi in tveganja zdravila Gefitinib Mylan?
These enzymes can be found on the surface of cancer cells, such as EGFR on the surface of non-small cell lung cancer cells. 
Te encime je mogoče najti na površini rakavih celic, denimo EGFR na površini celic nedrobnoceličnega raka pljuč.
Gefitinib Mylan is used to treat adults who have non-small cell lung cancer that is locally advanced or metastatic (when cancer cells have spread from the original site to other parts of the body). 
Gefitinib Mylan je zdravilo proti raku, ki se uporablja za zdravljenje odraslih bolnikov z lokalno napredovalim ali metastatskim (kadar so se rakave celice s prvotnega mesta razsejale v druge dele telesa) nedrobnoceličnim rakom pljuč.
For more information about using Gefitinib Mylan, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Gefitinib Mylan glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Gefitinib Mylan can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience with anticancer treatments. 
Predpisovanje in izdaja zdravila Gefitinib Mylan je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
As for all medicines, data on the use of Gefitinib Mylan are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Gefitinib Mylan stalno spremljajo.
Other information about Gefitinib Mylan 
Druge informacije o zdravilu Gefitinib Mylan
Why is Gefitinib Mylan authorised in the EU? 
Zakaj je bilo zdravilo Gefitinib Mylan odobreno v EU?
This means that Gefitinib Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Iressa. 
To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Iressa.
What is Gefitinib Mylan and what is it used for? 
Kaj je zdravilo Gefitinib Mylan in za kaj se uporablja?
The active substance in Gefitinib Mylan, gefitinib, is a protein tyrosine kinase inhibitor. 
Učinkovina v zdravilu Gefitinib Mylan, gefitinib, je „zaviralec protein-tirozin kinaze“.
The tablet can be dispersed in water for patients who have difficulty swallowing. 
Pri bolnikih, ki težko požirajo, se tableta lahko raztopi v vodi.
Gefitinib Mylan contains the active substance gefitinib and is a ‘generic medicine'. 
Zdravilo Gefitinib Mylan vsebuje učinkovino gefitinib in je „generično zdravilo“.
Gefitinib Mylan is available as 250 mg tablets to be taken by mouth. 
Na voljo je v obliki 250-miligramskih tablet, ki se jemljejo peroralno.
By blocking EGFR, Gefitinib Mylan helps to slow down the growth and spread of the cancer. 
Zdravilo Gefitinib Mylan z zaviranjem EGFR pripomore k manjši rasti in širjenju raka.
Gefitinib Mylan works only in non-small cell lung cancer cells that have a mutation in their EGFR. 
Tako deluje samo v celicah nedrobnoceličnega raka pljuč, ki imajo mutacijo EGFR.
Therefore, the Agency's view was that, as for Iressa, the benefit of Gefitinib Mylan outweighs the identified risk and it can be authorised for use in the EU. 
Zato je agencija menila, da koristi zdravila Gefitinib Mylan enako kot pri zdravilu Iressa odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
How is Gefitinib Mylan used? 
Kako se zdravilo Gefitinib Mylan uporablja?
How has Gefitinib Mylan been studied? 
Kako je bilo zdravilo Gefitinib Mylan raziskano?
How does Gefitinib Mylan work? 
Kako zdravilo Gefitinib Mylan deluje?
* Equivalent to titre prior to inactivation (log10) 
(*) Ekvivalent titru pred inaktivacijo (log 10)
Subcutaneous use Type I glass bottle with a chlorobutyl rubber stopper and aluminium cap 
Govedo, ovce Subkutano Steklenička tipa I s klorobutilno gumijasto zaporko
EMEA Number Invented name 
EU številka Izmišljeno ime
Withdrawal period 
Suspenzija za injiciranje
Adopted at the 6-9 June 2016 PRAC 
Sprejeto na seji odbora PRAC med 6. in 9. junijem 2016
Page 2/2 
Vmesni rezultati so pokazali stran 2/2
The available data do not indicate a clinically significant benefit from riociguat treatment in these patients. 
Razpoložljivi podatki ne kažejo klinično pomembne koristi zdravljenja z riociguatom pri teh bolnikih.
Section 2 - What you need to know before you take Adempas Do NOT take Adempas: - If you have increased pressure in your pulmonary circulation associated with scarring of the lungs, of unknown cause (idiopathic pulmonary pneumonia). 
Poglavje 2 - Kaj morate vedeti, preden boste vzeli zdravilo Adempas NE jemljite zdravila Adempas: - če imate zvišan tlak v pljučnem krvnem obtoku, povezan z brazgotinjenjem pljuč neznanega vzroka (idiopatsko pljučnico).
Riociguat - Increased mortality and serious adverse events (SAEs) in patients with pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) in a single clinical trial (EPITT no 18681) 
Riociguat - povečana umrljivost in pojavnost resnih neželenih učinkov pri bolnikih s pljučno hipertenzijo (PH), povezano z idiopatsko intersticijsko pljučnico (IIP), v kliničnem preskušanju (št. EPITT 18681)
Interim results showed an increased risk of mortality and serious adverse events in subjects receiving riociguat compared to those receiving 
povečano tveganje za umrljivost in resne neželene učinke pri preiskovancih, ki so prejemali riociguat, v primerjavi s preiskovanci, ki so prejemali placebo.
A randomised, double blind, placebo-controlled phase II study (RISE-IIP) to evaluate the efficacy and safety of riociguat in patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) was terminated early. 
faze (RISE-IIP), ki je vrednotila učinkovitost in varnost riociguata pri bolnikih s simptomatsko pljučno hipertenzijo, povezano z idiopatsko intersticijsko pljučnico (PH-IIP), je bila predčasno zaključena.
Section 4.3 - Contraindications - Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) (see Section 5.1) 
Poglavje 4.3 - Kontraindikacije - bolniki s pljučno hipertenzijo, povezano z idiopatsko intersticijsko pljučnico (PH-IIP) (glejte poglavje
Riociguat is therefore contraindicated in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (see section 4.3). 
Riociguat je zato pri bolnikih s pljučno hipertenzijo, povezano z idiopatsko intersticijsko pljučnico, kontraindiciran (glejte poglavje 4.3).
Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) 
Bolniki s pljučno hipertenzijo, povezano z idiopatsko intersticijsko pljučnico (PH-IIP) Randomizirana, dvojno slepa, s placebom nadzorovana študija II.
When using the individual correction formulae, none of the values were out of the limit. 
Ob uporabi korekcijske formule nobena od vrednosti ni bila zunaj meje.
Do not take Levitra more than once a day. 
Ne vzemite zdravila Levitra več kot enkrat na dan.
(cannot be estimated from the available data) 
Neznana (ni mogoče oceniti iz razpoložljivih podatkov)
There may be physical or psychological causes, or a mixture of both. 
Vzroki so lahko telesni ali duševni, ali kombinacija obeh.
Use in adult men 
Uporaba pri odraslih moških
The mean absolute oral bioavailability is 15%. 
Povprečna absolutna biološka uporabnost je 15-odstotna.
The combination should be avoided (see section 4.5). 
Tej kombinaciji se je treba izogibati (glejte poglavje 4.5).
This was not associated with any muscle or neurological toxicity. 
To pa ni bilo povezano z mišično ali nevrološko toksičnostjo.
Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. 
Večina bolnikov, pri katerih so poročali o teh dogodkih, je imela že prisotne dejavnike tveganja za kardiovaskularne bolezni.
Of these, 900 patients have been treated for one year or longer. 
Med njimi je 900 bolnikov prejemalo zdravilo eno leto ali dlje.
- Swallow one tablet with a glass of water. 
- Tableto pogoltnite s kozarcem vode.
At least one in ten men has trouble getting or keeping an erection at some time. 
Najmanj eden od desetih moških ima v določenem obdobju težave z doseganjem ali ohranjanjem erekcije.
The chance of having a side effect is described by the following categories: 
Verjetnost, da se bo pri vas pojavil neželeni učinek, je opisana s sledečimi kategorijami:
This leaflet was last revised in {month YYYY}. 
Navodilo je bilo nazadnje revidirano dne {mesec LLLL}
The actual clinical impact of these QT changes is unknown. 
Dejanski klinični pomen QT sprememb ni znan.
- Alcoholic drink can make erection difficulties worse. 
- Uživanje alkohola lahko težave z erekcijo še poslabša.
Effect on bleeding 
Učinek na krvavitve
- The other ingredients of the tablets are: 
- Druge sestavine zdravila so:
What Levitra is and what it is used for 
Kaj je zdravilo Levitra in za kaj ga uporabljamo
Most of the men who experienced these side effects had heart problems before taking this medicine. 
Večina moških, ki so imeli te neželene učinke, je imela težave s srcem že pred jemanjem tega zdravila.
Effect on QTc interval 
Učinek na dobo QTc
Therefore the use of such combinations is not recommended. 
Tovrstne kombinacije zato niso priporočljive.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake “EXP”.
Treatment of erectile dysfunction in adult men. 
Zdravljenje erektilne disfunkcije pri odraslih moških.
Allergic reaction 
- alergijske reakcije
The most commonly reported adverse drug reaction occurring in ≥ 10% of patients is headache. 
Neželeni učinek, o katerem so najpogosteje poročali in se je pojavil pri ≥ 10 % bolnikov je glavobol.
It is not possible to determine whether these events were directly related to vardenafil. 
Ni mogoče ugotoviti ali so bili ti dogodki neposredno povezani z jemanjem vardenafila.
Penile erection is a haemodynamic process. 
Erekcija penisa je hemodinamični proces.
In addition, in line with the product information of other PDE5s, a warning should also be included in section 4.4 to highlight these events, and reflect that it is not possible to definitively determine whether these events are related directly to any risk factors, to vardenafil, to sexual activity, or to a combination of these or other factors. 
Dodatno je treba, v skladu z informacijami za druge PDE5, v poglavje 4.4 vključiti tudi opozorilo glede teh dogodkov in dejstvo, da ni mogoče ugotoviti, ali so ti dogodki neposredno povezani z dejavniki tveganja, z vardenafilom, s spolno aktivnostjo ali s kombinacijo teh ali drugih dejavnikov.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnih sprejetih posodobitvah RMP.
The clinical impact of these QT changes is unknown (see section 5.1). 
Klinični pomen spremembe QT ni znan (glejte poglavje 5.1).
Dissolve in the mouth 
Raztopite v ustih.
However, it is not possible to definitively determine whether these events are related directly to these risk factors, to vardenafil, to sexual activity, or to a combination of these or other factors. 
Ni mogoče ugotoviti ali so ti dogodki, o katerih so poročali, neposredno povezani s temi dejavniki tveganja, z uporabo vardenafila, s spolno aktivostjo ali s kombinacijo teh ali drugih dejavnikov.
Effect on vision 
Učinek na vid
Elderly (≥65 years old) 
Starostniki (≥ 65 let)
Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. 
Erektilna disfunkcija je nezmožnost doseganja ali ohranjanja erekcije penisa, ki omogoča zadovoljivo spolno aktivnost.