natgillin/translations-raw huggingface dataset:
Although no reports had been received for Numeta G16%E, the PRAC decided at its June 2013 meeting that this product would also be included in the scope of the referral because of its magnesium content and because of its use in neonates and infants/toddlers up to the age of 2 years, who may also be at risk of developing hypermagnesaemia. 
Čeprav poročil glede zdravila Numeta G16%E ni bilo, se je odbor PRAC na svojem sestanku, ki je potekal junija 2013, odločil, da bo to zdravilo prav tako vključeno v sklop napotitvenega postopka,
No clinical symptoms relative to hypermagnesaemia have been reported with the use of Numeta G13%E or Numeta G16%E. 
Pri uporabi zdravil Numeta G13%E in Numeta G16%E niso poročali o nobenih kliničnih simptomih, povezanih s hipermagneziemijo.
Numeta G13%E is indicated for PN in preterm newborn infants when oral or enteral nutrition is not possible, insufficient or contraindicated. 
Zdravilo Numeta G13%E je indicirano za parenteralno prehrano nedonošenčkov, pri katerih je peroralna ali enteralna prehrana nemogoča, nezadostna ali kontraindicirana.
Information for healthcare professionals 
Informacije za zdravstveno osebje
“For subcutaneous use only. 
„Samo za subkutano uporabo.
Open wound 
Odprta rana
Do not spray closer than the recommended distances. 
Ne pršite bližje od priporočene razdalje.
Laparoscopic / minimally invasive procedures 
Laparoskopski / minimalno invazivni posegi
Excessive clot thickness may negatively interfere with the product's efficacy and the wound healing process. 
Predebel strdek lahko negativno vpliva na učinkovitost zdravila ter proces celjenja rane.
For spray application, see sections 4.4 and 6.6 for specific recommendations on the required pressure and distance from tissue per surgical procedure and length of applicator tips.” 
Za nanos s pršenjem glejte poglavji 4.4 in 6.6 za posebna priporočila glede potrebnega tlaka in razdalje od tkiva pri posameznem kirurškem posegu ter dolžini nastavka aplikatorja.“
“In order to ensure optimal safe use of [PRODUCT NAME] by spray application the following recommendations should be followed: 
„Da zagotovite optimalno varno uporabo zdravila [IME ZDRAVILA] s pršenjem upoštevajte naslednja priporočila:
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet 
PRILOGA III SPREMEMBE ZADEVNIH POGLAVIJ POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILO ZA UPORABO
How to use [PRODUCT NAME] 
Kako uporabljati zdravilo [IME ZDRAVILA]
In minimally invasive/laparoscopic procedures - a pressure regulator device that delivers a maximum pressure of no more than 1.5 bar (22 psi) and uses carbon dioxide gas only should be used. 
Pri minimalno invazivnih/laparoskopskih posegih - uporabite pripomoček z regulatorjem tlaka, katerega največji tlak ne presega 1,5 bar (22 psi) in uporablja izključno plin ogljikov dioksid.
[PRODUCT NAME] is not recommended for laparoscopic surgery. 
Zdravilo [IME ZDRAVILA] ni priporočljivo za laparoskopske kirurške posege.
• Spray devices and the accessory tip provide instructions for use with recommendations for pressure ranges and to the spraying distance from the tissue surface. 
• Pršilnim pripomočkom in ustreznemu nastavku je priloženo navodilo za uporabo s priporočenim razponom tlakov in priporočeno razdaljajo od površine tkiva.
Replaceable tip 
Zamenljiv nastavek
[PRODUCT NAME] should only be reconstituted and administered according to the instructions and with the devices recommended for this product (see section 6.6). 
Zdravilo [IME ZDRAVILA] lahko rekonstituirate in uporabite le v skladu z navodili in s pomočjo pripomočkov, ki so priporočeni za to zdravilo (glejte poglavje 6.6).
Beriplast P and associated names 
Beriplast P (in povezana imena)
4.2.2 Method and route of administration 
4.2.2 Postopek in pot uporabe zdravila
Take special care with [PRODUCT NAME] 
Bodite posebno pozorni pri uporabi zdravila [IME ZDRAVILA]
When applying [PRODUCT NAME] using a spray device, be sure to use a pressure within the pressure range recommended by the spray device manufacturer (see table in section 6.6 for pressures and distances). 
Pri uporabi zdravila [IME ZDRAVILA] s pršilnim pripomočkom izberite nastavitev tlaka znotraj razpona tlakov, ki ga priporoča izdelovalec pršilnega pripomočka (glejte preglednico v poglavju 6.6 za tlake in razdalje).
In order to ensure optimal safe use of [PRODUCT NAME] it should be sprayed using a pressure regulator device that delivers a maximum pressure of up to 2.0 bar (28.5 psi). 
Da zagotovite optimalno varno uporabo zdravila [IME ZDRAVILA], ga pršite s pripomočkom z regulatorjem tlaka, katerega največji tlak ne presega 2,0 bar (28,5 psi).
• “[PRODUCT NAME] should not be used in laparoscopic surgery (keyhole surgery). 
• „Zdravilo [IME ZDRAVILA] se ne sme uporabljati za laparoskopske kirurške posege.
This appears to be related to the use of the spray device at higher than recommended pressures and/or in close proximity to the tissue surface. 
Izgleda, da je to povezano z uporabo pršilnega pripomočka, katerega nastavitev tlaka je višja od priporočenega, in/ali v bližini površine tkiva.
This event appears to be related to the use of the spray device at higher than recommended pressures and/or in close proximity to the tissue surface. 
Izgleda, da je ta dogodek povezan z uporabo pršilnega pripomočka, katerega nastavitev tlaka je višja od priporočenega, in/ali v bližini površine tkiva.
This section of the Package Leaflet should include the following wording, in bold and underlined format where indicated: 
To poglavje navodila za uporabo mora vsebovati naslednje besedilo, ki je tiskano krepko in podčrtano, kjer je to nakazano:
• [PRODUCT NAME] should be administered strictly according to the instructions and only with devices recommended for this product. 
• Zdravilo [IME ZDRAVILA] se mora uporabljati natančno v skladu z navodili in le s pomočjo pripomočkov, ki so priporočeni za to zdravilo.
The risk appears to be higher when fibrin sealants are sprayed with air, as compared to CO2 and therefore cannot be excluded with [Product Name] when sprayed in open wound surgery. 
Zdi se, da je tveganje večje, če so fibrinska lepila za tkiva pršena z zrakom v primerjavi s CO2, zato ga ne moremo izključiti pri pršenju zdravila [ime zdravila] pri operativnih posegih na odprtih ranah.
“Apply [PRODUCT NAME] as a thin layer. 
„Zdravilo nanesite [PRODUCT NAME] v tankem sloju.
Tissucol and associated names 
Tissucol in povezana imena
In open wound surgery - a pressure regulator device that delivers a maximum pressure of no more than 2.0 bar (28.5 psi) should be used. 
Pri operativnih posegih na odprtih ranah - uporabite pripomoček z regulatorjem tlaka, katerega največji tlak ne presega 2,0 bar (28.5 psi).
[PRODUCT NAME] spray application should only be used if it is possible to accurately judge the spray distance as recommended by the manufacturer. 
Za nanos zdravila [IME ZDRAVILA] s pršenjem se odločite samo, če lahko natančno ocenite razdalja pršenja po priporočilih izdelovalca.
Tisseel / Tissucol Spray Set 
Pršilni komplet Tisseel / Tissucol
The product should only be reconstituted and administered according to the instructions and with the devices as provided with this product.” 
Zdravilo se lahko rekonstituira in uporablja le v skladu z navodili in s pomočjo pripomočkov, ki so priloženi zdravilu.“
Tisseel and associated names 
Tisseel in povezana imena
The risk appears to be higher when fibrin sealants are sprayed with air, as compared to CO2 and therefore cannot be excluded with [Product Name]. 
Zdi se, da je tveganje večje, če so fibrinska lepila za tkiva pršena z zrakom v primerjavi s CO2, zato ga ne moremo izključiti pri pršenju zdravila [IME ZDRAVILA] pri operativnih posegih na odprtih ranah.
Recommended pressure, distance and devices for spray application of [product name] Surgery Spray set to be used 
Priporočeni tlak, razdalja in pripomoček za nanos zdravila [ime zdravila] s pršenjem Kirurški poseg Uporabljeni pršilni komplet
When applying [PRODUCT NAME] using a spray device be sure to use a pressure and a distance from the tissue within the range recommended by the manufacturer as follows: 
Pri uporabi zdravila [IME ZDRAVILA] s pršilnim pripomočkom je treba uporabiti tlak in razdalja od tkiva znotraj razpona, ki ga priporoča izdelovalec, in sicer:
“When applying [PRODUCT NAME] using a spray device be sure to use a pressure and a distance from tissue within the ranges recommended by the manufacturer as follows: 
„Pri uporabi zdravila [IME ZDRAVILA] s pršilnim pripomočkom uporabite tlak in razdalja od tkiva znotraj razponov, ki jih priporoča izdelovalec, in sicer:
Recommended pressure, distance and devices for spray application of [product name] 
Priporočeni tlak, razdalja in pripomoček za nanos zdravila [ime zdravila] s pršenjem
The following changes should be made to the SmPC of Artiss: 
V povzetek glavnih značilnosti zdravila Artiss je vnesti naslednje spremembe:
B. Package Leaflet The following changes should be made to the package leaflet of Beriplast P and associated names: 
V navodilu za uporabo zdravila Beriplast P in povezana imena je treba vnesti naslednje spremembe:
Before you use [PRODUCT NAME] 
Kaj morate vedeti, preden boste uporabili zdravilo [IME ZDRAVILA]
Prior to applying [PRODUCT NAME] the surface area of the wound needs to be dried by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices). 
Pred nanosom zdravila [IME ZDRAVILA] morate površino rane osušiti s standardnimi tehnikami (npr. občasno uporabo kompres, tamponov, uporabo aspiracijskih pripomočkov).
Spray application 
B. Navodilo za uporabo
The following text should be inserted in this section: “Prior to applying [PRODUCT NAME] the surface area of the wound needs to be dried by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices). 
V to poglavje je treba dodati naslednje besedilo: „Pred nanosom zdravila [IME ZDRAVILA] morate površino rane osušiti s standardnimi tehnikami (npr. občasno uporabo kompres, tamponov, uporabo aspiracijskih pripomočkov).
“The use of [PRODUCT NAME] is restricted to experienced surgeons who have been trained in the use of [PRODUCT NAME]. 
„Zdravilo [IME ZDRAVILA] lahko uporabljajo le izkušeni kirurgi, ki so usposobljeni za uporabo zdravila [IME ZDRAVILA].“
Open wound surgery of subcutaneou s tissue 
Kirurški poseg na podkožnem tkivu na odprtih ranah
This section of the SmPC should include the following wording: 
V to poglavje povzetka glavnih značilnosti zdravila je treba dodati naslednje besedilo:
This wording: “ARTISS is intended for Hospital Use Only by suitably experienced physicians or surgeons.” Should be replaced by: “The use of [PRODUCT NAME] is restricted to experienced surgeons who have been trained in the use of [PRODUCT NAME].” 
Kako uporabljati zdravilo [IME ZDRAVILA] To poglavje navodila za uporabo mora vsebovati naslednje besedilo, ki je tiskano krepko in podčrtano, kjer je to nakazano: „Zdravilo [IME ZDRAVILA] lahko uporabljajo le izkušeni kirurgi, ki so usposobljeni za uporabo zdravila [IME ZDRAVILA].
Applicator 40cm 
Applicator 40c m
When spraying the [PRODUCT NAME], changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism (see sections 4.2 and 4.4).” 
Pri pršenju zdravila [IME ZDRAVILA] morate spremljati krvni tlak, srčno frekvenco, nasičenost s kisikom in koncentracijo CO2 v izdihanem zraku ob koncu izdiha zaradi možnosti pojava zračne ali plinske embolije (glejte tudi poglavji 4.2 in 4.4).“
Life-threatening air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer fibrin sealants. 
Pri uporabi pršilnih pripomočkov z regulatorjem tlaka za nanos fibrinskih lepil so se pojavili primeri zračne ali plinske embolije, ki so bili smrtno nevarni.
• When spraying [PRODUCT NAME], changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored for possible occurrence of gas embolism. 
• Pri pršenju zdravila [IME ZDRAVILA] je treba spremljati krvni tlak, srčno frekvenco, nasičenost s kisikom in koncentracijo CO2 v izdihanem zraku ob koncu izdiha zaradi možnosti pojava plinske embolije.
Applicator 30cm 
Applicator 30c m
• When spraying [PRODUCT NAME], changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored for possible occurrence of gas embolism.” 
• Pri pršenju zdravila [IME ZDRAVILA] je treba spremljati krvni tlak, srčno frekvenco, nasičenost s kisikom in koncentracijo CO2 v izdihanem zraku ob koncu izdiha zaradi možnosti pojava plinske embolije.“
• “Life-threatening/fatal air or gas embolism (air getting into the blood circulation which can be serious or life-threatening) has occurred very rarely with the use of spray devices employing pressure regulators to administer fibrin sealants. 
• „V zelo redkih primerih se je pri uporabi pršilnih pripomočkov z regulatorjem tlaka za nanos fibrinskih lepil pojavila zračna ali plinska embolija (vstop zraka v krvni obtok, ki je resen ali smrtno nevaren), ki je bila smrtno nevarna ali s smrtnim izidom.
Tisseel / Artiss Spray Set 10 pack 
Pršilni komplet 10 koso v Tisseel / Artiss
[PRODUCT NAME] should only be reconstituted and administered according to the instructions and with the devices as provided with this product.” 
Zdravilo [IME ZDRAVILA] lahko rekonstituirate in uporabite le v skladu z navodili in s pomočjo pripomočkov, ki so priloženi zdravilu.“
Applicator 20cm 
Applicator 20c m
Tisseel / Artiss Spray Set 
Pršilni komplet Tisseel / Artiss
When spraying the [PRODUCT NAME], changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism (see section 2).” 
Pri pršenju zdravila [IME ZDRAVILA] je treba spremljati krvni tlak, srčno frekvenco, nasičenost s kisikom in koncentracijo CO2 v izdihanem zraku ob koncu izdiha zaradi možnosti pojava zračne ali plinske embolije (glejte poglavje 2).“
• Life-threatening/fatal air or gas embolism (air getting into the blood circulation which can be serious or life-threatening) has occurred very rarely with the use of spray devices employing pressure regulators to administer fibrin sealants. 
• V zelo redkih primerih se je pri uporabi pršilnih pripomočkov z regulatorjem tlaka za nanos fibrinskih lepil pojavila zračna ali plinska embolija (vstop zraka v krvni obtok, ki je resen ali smrtno nevaren), ki je bila smrtno nevarna ali s smrtnim izidom.
When spraying [PRODUCT NAME], changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism (also see section 4.2).” 
Pri pršenju zdravila [IME ZDRAVILA] morate spremljati krvni tlak, srčno frekvenco, nasičenost s kisikom in koncentracijo CO2 v izdihanem zraku ob koncu izdiha zaradi možnosti pojava zračne ali plinske embolije (glejte tudi poglavje 4.2).“
The following changes should be made to the package leaflet of Tissucol and associated names: 2. 
V povzetek glavnih značilnosti zdravila Tissucol in povezana imena je treba vnesti naslednje spremembe:
Applicator tips to be used 
Uporabljena konica aplikatorja
The following changes should be made to the package leaflet of Tisseel and associated names: 2. 
V povzetek glavnih značilnosti zdravila Tisseel in povezana imena je treba vnesti naslednje spremembe:
• When [PRODUCT NAME] is applied using a spray device, the pressure and spraying distance have to be within the range recommended by the manufacturer. 
• Pri uporabi zdravila [IME ZDRAVILA] s pršilnim pripomočkom je treba uporabiti tlak in razdalja od tkiva znotraj razpona, ki ga priporoča izdelovalec, in sicer: Zdravilo [IME ZDRAVILA] se mora uporabljati natančno v skladu z navodili in le s pomočjo pripomočkov, ki so priporočeni za to zdravilo.
The following changes should be made to the package leaflet of Artiss and associated names: 
B. Navodilo za uporabo V navodilo za uporabo zdravila Artiss in povezana imena je treba vnesti naslednje spremembe:
Surgery Spray set to be used 
Kirurški poseg Uporabljeni pršilni komplet
Hold this breath for as long as possible (at least 3-4 seconds). 
Dih naj zadrži, kolikor največ lahko (vsaj 3 do 4 sekunde).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 May 2014 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 2. maj 2014
This leaflet was last revised in <{MM/YYYY}> Other sources of information 
Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}> Drugi viri informacij
Do not use Revinty Ellipta if you are allergic to fluticasone furoate, vilanterol or any other ingredients of this medicine (listed in section 6). 
Ne uporabljajte zdravila Revinty Ellipta če ste alergični na flutikazonfuroat, vilanterol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Allergic reactions to Revinty Ellipta are rare (may affect up to 1 in 1,000 people). 
Alergijske reakcije Alergijske reakcije pri zdravilu Revinty Ellipta so redke (pojavijo se lahko pri največ 1 od 1.000 bolnikov).
NAME OF THE MARKETING AUTHORISATION HOLDER GSK Logo 
IME IMETNIKA DOVOLJENJA ZA PROMET GSK logo
Immediate breathing difficulties after using Revinty Ellipta are rare. 
Takojšnje težave z dihanjem po uporabi zdravila Revinty Ellipta so redke.
If you have been told by your doctor that you have an intolerance to some sugars, or to milk protein, contact to your doctor before using this medicine. 
Če vam je vaš zdravnik povedal, da imate intoleranco za nekatere sladkorje ali mlečne beljakovine, se posvetujte z zdravnikom, preden uporabite zdravilo.
Hold this breath for as long as possible (at least 
Dih zadržite, kolikor je mogoče dolgo (vsaj 3 do 4
If you do not have a quick-acting inhaler contact your doctor. 
Če nimate hitrodelujočega inhalatorja se obrnite na svojega zdravnika.
METHOD AND ROUTE(S) OF ADMINISTRATION ONCE DAILY 
POSTOPEK IN POT(I) UPORABE ZDRAVILA ENKRAT NA DAN
Revinty Ellipta should be used every day and not only when you have breathing problems or other symptoms of COPD and asthma. 
Zdravilo Revinty Ellipta morate uporabljati vsak dan in ne samo, kadar imate težave z dihanjem ali druge simptome KOPB in astme.
This is because larger doses of Revinty Ellipta may reduce the amount of steroid hormones produced naturally by your body. 
Večji odmerki zdravila Revinty Ellipta namreč lahko zmanjšajo količino steroidnih hormonov, ki naravno nastajajo v telesu.
Patients with asthma should be given the strength of Revinty Ellipta containing the appropriate fluticasone furoate (FF) dosage for the severity of their disease. 
Bolniki z astmo morajo dobiti tisto jakost zdravila Revinty Ellipta, ki vsebuje odmerek flutikazonfuroata (FF), ustrezen izrazitosti njihove bolezni.
Pneumonia (infection of the lung) (common side effect, may affect up to 1 in 10 people) Tell your doctor if you have any of the following while taking Revinty Ellipta - they could be symptoms of a lung infection: 
Pljučnica (okužba pljuč) (pogost neželeni učinek, pojavi se lahko pri največ 1 od 10 bolnikov ) Svojemu zdravniku morate povedati, če imate med jemanjem zdravila Revinty Ellipta kar koli od naslednjega, ker so to lahko simptomi okužbe pljuč:
Pharmacotherapeutic group: Drugs for obstructive airways diseases, adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics, ATC code: R03AK10. 
Farmakoterapevtska skupina: Zdravila za obstruktivne pljučne bolezni; adrenergiki v kombinaciji s kortikosteroidi ali drugimi učinkovinami razen antiholinergikov, oznaka ATC: R03AK10.
Revinty Ellipta should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. 
Uporabo zdravila Revinty Ellipta je treba takoj prekiniti, bolnika pregledati in uvesti drugo zdravljenje, če je potrebno.
INFORMATION IN BRAILLE revinty ellipta 184:22 
PODATKI V BRAILLOVI PISAVI revinty ellipta 184:22
Your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of Revinty Ellipta. 
Če jemljete katero od teh zdravil, vas bo zdravnik morda skrbno spremljal, kajti ta zdravila lahko povečajo neželene učinke zdravila Revinty Ellipta.
INFORMATION IN BRAILLE revinty ellipta 92:22 
PODATKI V BRAILLOVI PISAVI revinty ellipta 92:22
The safety and efficacy of Revinty Ellipta in children under 12 years of age has not yet been established in the indication for asthma. 
Varnost in učinkovitost zdravila Revinty Ellipta pri otrocih, mlajših od 12 let, za indikacijo astme še nista ugotovljeni.
What Revinty Ellipta is and what it is used for 2. 
Kaj je zdravilo Revinty Ellipta in za kaj ga uporabljamo 2.
if you think the above applies to you, don't use Revinty Ellipta until you have checked with your doctor. 
Če menite, da to velja za vas, ne uporabite zdravila Revinty Ellipta, dokler se ne posvetujte s svojim zdravnikom.
If you accidentally take more Revinty Ellipta than your doctor has instructed, talk to your doctor or pharmacist. 
Če pomotoma uporabite večji odmerek zdravila Revinty Ellipta, kot vam je naročil zdravnik, se posvetujte z zdravnikom ali farmacevtom.
In two replicate 12 month studies in a total of 3,255 patients with COPD the incidence of bone fractures overall was low in all treatment groups, with a higher incidence in all Revinty Ellipta groups (2%) compared with the vilanterol 22 micrograms group (<1%). 
V dveh repliciranih 12-mesečnih študijah pri skupno 3.255 bolnikih s KOPB je bila celotna incidenca zlomov kosti majhna v vseh terapevtskih skupinah, a je bila večja v vseh skupinah z zdravilom Revinty Ellipta (2 %) kot v skupini s 22 mikrogrami vilanterola (< 1 %).
If your symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using your quick-acting inhaler more often contact your doctor as soon as possible. 
Če se vaši simptomi (zasoplost, piskajoče dihanje, kašelj) ne izboljšajo ali se poslabšajo, ali če uporabljate vaš kratkodelujoči inhalator pogosteje:
Revinty Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy. 
Zdravilo Revinty Ellipta je indicirano za simptomatsko zdravljenje odraslih s KOPB, ki imajo FEV1 < 70 % predvidenega normalnega (po bronhodilatatorju), z anamnezo poslabšanj kljub rednemu zdravljenju z bronhodilatatorjem.
Patients usually experience an improvement in lung function within 16-17 minutes of inhaling Revinty Ellipta. 
Bolnikom se pljučna funkcija po navadi izboljša v 16 do 17 minutah po inhaliranju zdravila Revinty Ellipta.
if you have ever been told you have diabetes or high blood sugar. 
če so vam kdaj povedali, da imate sladkorno bolezen ali povišan sladkor v krvi; če imate težave s ščitnico;
If you use more Revinty Ellipta than you should 
Če ste uporabili večji odmerek zdravila Revinty Ellipta, kot bi smeli
*, ** See below ‘Description of selected adverse reactions' *Pneumonia (see section 4.4) 
*, ** Glejte spodaj "Opis izbranih neželenih učinkov" Opis izbranih neželenih učinkov
Neither fluticasone furoate nor vilanterol trifenatate had any adverse effects on fertility or pre- and post-natal development in rats. 
Niti flutikazonfuroat niti vilanterolijev trifenatat pri podganah nista imela neželenih učinkov na plodnost, prenatalni ali postnatalni razvoj.
Although there were more fractures in the Revinty Ellipta groups compared with the vilanterol 22 micrograms group, fractures typically associated with corticosteroid use (e.g., spinal compression/thoracolumbar vertebral fractures, hip and acetabular fractures) occurred in <1% of the Revinty Ellipta and vilanterol treatment arms. 
Čeprav je bilo v skupinah z zdravilom Revinty Ellipta več zlomov kot v skupini z 22 mikrogrami vilanterola, so se zlomi, ki so tipično povezani z uporabo kortikosteroidov (npr. spinalna kompresija/torakolumbalni zlomi vretenc, zlomi kolka in acetabula), tako v krakih z zdravilom Revinty Ellipta kot z vilanterolom pojavili pri < 1 %.