natgillin/translations-raw huggingface dataset:
HyQvia 100 mg/ml infusion for subcutaneous use human normal immunoglobulin 
HyQvia 100 mg/ml infuzija za subkutano uporabo humani polispecifični imunoglobulin
Treatment with HyQvia will be started by your doctor or nurse, but you may be allowed to use the medicine at home once you have received the first few infusions under medical supervision and you (and/or your guardian) have been adequately trained. 
Ko boste prvih nekaj infuzij prejeli pod zdravniškim nadzorom in boste vi (in/ali vaš skrbnik) ustrezno usposobljena, vam bo zdravnik lahko dovolil, da se začnete zdraviti sami doma.
If you get any side effects, talk to your doctor, pharmacist or nurse. 
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
Frequency of Adverse Reactions (ADRs) with HyQvia 
Pogostnost neželenih učinkov zdravila HyQvia
There is reassuring clinical evidence regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety. 
Obstajajo spodbudne klinične izkušnje o tem, da se virusi hepatitisa A in parvovirusa B19 ne prenašajo z imunoglobulini.
Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, and deep vein thrombosis have been rarely observed with IV and SC administration of immunoglobulin products. 
Pri intravenski in subkutani uporabi imunoglobulinskih zdravil so v redkih primerih ugotovili tromboembolične reakcije, kot so miokardni infarkt, možganska kap, pljučna embolija in globoka venska tromboza.
Immunogenicity of recombinant human hyaluronidase 
Preobčutljivost na rekombinantno humano hialuronidazo
A 24 gauge needle may be required to allow patients to infuse at flow rates of 300 mL/hr/infusion site. 
Bolniki bodo za infundiranje s hitrostjo 300 ml/uro/mesto infundiranja morda potrebovali iglo velikosti 24.
Always use this medicine exactly as your doctor has told you. 
Pri uporabi tega zdravila HyQvia natančno upoštevajte navodila svojega zdravnika.
Solution for infusion for subcutaneous use 
Raztopina za infundiranje za subkutano uporabo
What HyQvia is used for 
Za kaj uporabljamo zdravilo HyQvia
The ability to drive and operate machines may be impaired by some adverse reactions associated with HyQvia. 
Nekateri neželeni učinki, povezani z zdravilom HyQvia, lahko poslabšajo sposobnost vožnje in upravljanja strojev.
Immunoglobulin products contain antibodies to blood groups (e.g A, B, D) which may act as haemolysins. 
A, B, D), ki lahko delujejo kot hemolizini.
• Tell your doctor or nurse immediately if you notice any of these signs during the infusion. 
• Če med infuzijo opazite katerega koli od navedenih znakov, morate nemudoma obvestiti zdravnika ali medicinsko sestro.
Infuse 2 
Infundirajte kot 2. komponento.
What HyQvia contains 
Kaj vsebuje zdravilo HyQvia
Open HyQvia dual vial unit(s): 
Odprite enoto(e) z dvema vialama zdravila HyQvia:
Reversible infertility has been observed in male and female guinea pigs immunized to produce antibodies to hyaluronidase. 
Pri budrah moškega in ženskega spola, ki so bile cepljene, da so se tvorila protitelesa proti hialuronidazi, so opazili reverzibilno neplodnost.
Paresthesia 
Odmerjanje
• Follow up with physician as directed. 
• Po zdravnikovih navodilih se dogovorite za kontrolne obiske.
There was no increase in incidence or severity of adverse reactions in patients who developed antibodies to recombinant human hyaluronidase. 
Pri bolnikih s protitelesi proti rekombinantni humani hialuronidazi ni bilo povečane pojavnosti ali resnosti neželenih učinkov.
Infuse 1 
Infundirajte kot 1. komponento.
Infusion speed 
Hitrost infundiranja
How to store HyQvia 
Shranjevanje zdravila HyQvia
- there has been a long interval (e.g., more than 2 or 3 infusion intervals) since you last received 
Določeni neželeni učinki so pogostejši, če: - zdravilo HyQvia uporabljate prvič, - ste prej prejemali drug imunoglobulin, ki ste ga sedaj zamenjali z zdravilom HyQvia, - je od zadnjega prejema zdravila HyQvia preteklo več časa (npr. več kot 2 ali 3 presledki med infuzijami).
Insert the needle: 
Vbodite injekcijsko iglo:
Recommended distance from target tissue 
Priporočena razdalja od ciljnega tkiva
Do not refreeze. 
Ne zamrzujte ponovno.
Do not use solutions that are cloudy or have deposits.” 
Ne uporabite raztopin, ki so motne ali imajo usedline.«
The text of this section should be read as follows: “For epilesional use. 
Besedilo tega poglavja se mora glasiti: »Za epilezijsko uporabo.
The product should only be reconstituted and administered according to the instructions and with the devices recommended for this product (see section 6.6). 
Zdravilo se mora rekonstituirati in nanašati samo po navodilih in s pripomočki, priporočenimi za to zdravilo (glejte poglavje 6.6).
When BAC and Thrombin have been drawn up into the administration device they must be used immediately.” 
Po vnosu BAC in trombina v aplikator ju morate porabiti nemudoma.«
6 cm Yellow Flexible Tip 
Rumeni prožni nastavek dolžine 6 cm
The following text should be added at the end of the section: 
Na konec poglavja je treba dodati naslednje besedilo:
The solution should be clear or slightly opalescent. 
Raztopina mora biti bistra ali rahlo motna.
After thawing, unopened vials can be stored at 2 - 8C and protected from light, for up to 30 days. 
Po odtalitvi lahko neodprte viale shranjujemo zaščitene pred svetlobo pri temperaturi 2C-8C do 30 dni.
Prior to applying Quixil 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 Quixil je treba površino rane osušiti s standardnimi tehnikami (npr. z večkratno aplikacijo kompres, blazinic, z uporabo sesalnih pripomočkov).
The entire section should read as follows, in bold and underlined format where indicated: “To avoid the risk of life threatening gas or air embolism, Quixil should only be sprayed using pressurised CO2 
Celotno poglavje se mora glasiti, kot sledi, v krepkem tisku in podčrtano, kjer je tako označeno: »Da bi se izognili tveganju za življenjsko nevarno plinsko ali zračno embolijo, pršite zdravilo Quixil samo s plinom CO2 pod tlakom.
The product should then be sprayed onto the surface of the tissue in short bursts (0.1-0.2 ml) to form a thin, even layer. 
Zdravilo nato pršite na površino tkiva v kratkih razprških (0,1 ml-0,2 ml), da nastane tanek, enakomeren sloj.
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet 
Priloga III Dopolnitve, ki jih je treba vključiti v ustrezna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo
The following contra-indication should be added at the end of the section: 
Na konec poglavja je treba dodati naslednjo kontraindikacijo:
BEFORE YOU ARE TREATED WITH QUIXIL You must not be treated with Quixil: 
KAJ MORATE VEDETI, PREDEN BOSTE PREJELI ZDRAVILO QUIXIL Ne smete se zdraviti z zdravilom Quixil:
In open wound surgery - for spray application of Quixil, a pressure regulator device that delivers a maximum pressure of no more than 2.5 bar and uses carbon dioxide gas only should be used. 
Pri odprtem kirurškem posegu - za nanos zdravila Quixil s pršenjem se lahko uporablja samo regulator tlaka, ki dovaja najvišji tlak 2,5 bar in uporablja plinski ogljikov dioksid.
Should be replaced with the following text, in bold and underlined format: 
je treba zamenjati z naslednjim besedilom, v krepkem tisku in podčrtano:
Connect the short tube on the application device to the male luer-lock end of the long gas tube. 
Priključite kratko cevko na aplikatorju na moški priključek luer-lock dolge plinske cevke.
Spray devices and the accessory tip provide instructions for use with recommendations for pressure ranges and to the spraying distance from the tissue surface. 
Pršilnikom in nastavkom so priložena navodila za uporabo, kjer so navedena priporočila za razpon tlakov in razdaljo pršenja od tkivne površine.
Quixil spray application should only be used if it is possible to accurately judge the spray distance as recommended by the manufacturer - do not spray closer than the recommended distance. 
Zdravilo Quixil se s pršenjem lahko nanaša le, kadar je mogoče natančno presoditi razdaljo od pršilnika, kot priporoča izdelovalec - ne pršite bližje kot s priporočene razdalje.
“Quixil should only be used by experienced surgeons. 
»Zdravilo Quixil lahko uporabljajo le izkušeni kirurgi.
Recommended spray pressure 
Priporočeni tlak pršenja
4.2 Posology and method of administration The following text should be added to this section: “The use of Quixil is restricted to experienced surgeons who have been trained in the use of QUIXIL.“ 4.2.2 Method and Route of Administration 
Besedilo tega poglavja se mora glasiti: »Zdravilo Quixil lahko uporabljajo le izkušeni kirurgi, usposobljeni za uporabo zdravila QUIXIL.« 4.2.2 Postopek in pot uporabe zdravila
Should be replaced with the following text, in bold and underlined format where indicated 
je treba zamenjati z naslednjim besedilom, v krepkem tisku in podčrtano, kjer je tako označeno:
In the absence of a specific recommendation the pressure should not exceed 2.0-2.5 bars. 
Če ni posebnega priporočila, tlak ne sme presegati 2,0 bara-2,5 bara.
Note: These amendments to the summary of product characteristics and package leaflet are valid at the time of the Commission Decision. 
Opomba: Te spremembe povzetka glavnih značilnosti zdravila in navodila za uporabo so veljavne ob izdaji odločbe Komisije Pristojni nacionalni organi bodo po odločbi Komisije posodobili informacije o zdravilu v skladu z zahtevami.
The text should read as follows: “Store at  -18C. 
»Shranjujte pri temperaturi  -18C.
Quixil Applicator Device 
Aplikator Quixil
• “Spray application of Quixil should not be used in endoscopic procedures.” 
• »Zdravila Quixil s pršenjem ne smete uporabiti pri endoskopskih posegih.«
HOW QUIXIL IS USED 
KAKO UPORABLJAMO ZDRAVILO QUIXIL
When special care should be taken with Quixil: 
Kdaj je treba biti pri zdravilu Quixil posebno pozoren:
Do not spray at a distance closer than the recommended by the spray device manufacturer. 
Ne pršite s krajše razdalje, kot jo priporoča izdelovalec pršilnika.
To avoid the risk of potentially life threatening air embolism your surgeon is recommended to spray Quixil using pressurised CO2 only. 
Da bi se izognili tveganju za potencialno življenjsko nevarno zračno embolijo, vašemu kirurgu priporočamo, da prši zdravilo Quixil samo s plinom CO2 pod tlakom.
• Handling 
• Ravnanje z zdravilom
4.8 Undesirable effects The following text should be added at the end of the section, before the last sentence, as shown below: 
Na konec poglavja, pred zadnjim stavkom, je treba dodati naslednje besedilo, kot je prikazano spodaj:
In the absence of a specific recommendation avoid using pressure above 2.0-2.5 bars. 
Če ni posebnega priporočila, se izogibajte uporabi tlaka nad 2,0 bara-2,5 bara.
“The use of Quixil is restricted to experienced surgeons who have been trained in the use of QUIXIL. 
»Zdravilo Quixil lahko uporabljajo le izkušeni kirurgi, usposobljeni za uporabo zdravila QUIXIL.«
Quixil forms a clear film over the area of application. 
Zdravilo Quixil na področju nanosa napravi prozoren film.
In the absence of a specific recommendation Quixil should not be sprayed closer than 10-15 cm from the tissue surface. 
Če ni posebnega priporočila, zdravila Quixil ne pršite bližje kot 10 cm-15 cm od površine tkiva.
In the absence of a specific recommendation avoid spraying closer than 10-15 cm from the tissue surface. 
Če ni posebnega priporočila, se izogibajte pršenju bližje kot 10 cm-15 cm od površine tkiva.
• „Quixil should not be used in endoscopic surgery or for keyhole surgery.“ 
• »Zdravila Quixil ne smete uporabljati pri endoskopskih ali laparoskopskih kirurških posegih.«
Connect the female luer lock of the gas tube (with the bacteriostatic filter) to a pressure regulator The pressure regulator should be used in accordance with the manufacturer's instructions. 
Ženski priključek luer lock na cevi za plin (z bakteriostatskim filtrom) priključite na regulator tlaka.
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. 
Zdi se, da je ta pojav povezan z uporabo pršilnika s tlaki, ki so višji od priporočenih, in/ali z uporabo v neposredni bližini tkivne površine.
Pressure regulator to be used 
Uporabljeni regulator tlaka
Surgery 
Kirurški poseg
When using an accessory tip with this product, be sure to follow carefully the instructions for use.” 
Če uporabljate dodaten nastavek, se prepričajte, da natančno upoštevate navodila za uporabo.«
The following changes should be made to the SmPC of Quixil: 
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA (SmPC) V SmPC zdravila Quixil je treba narediti naslednje spremembe:
When using accessory tips with this product, be sure to follow carefully the instructions for use.” 
Če uporabljate dodatne nastavke, se prepričajte, da natančno upoštevate navodila za uporabo.«
To avoid the risk of potentially life threatening air embolism Quixil should be sprayed using pressurised CO2 gas only. 
Da bi se izognili tveganju za potencialno življenjsko nevarno zračno embolijo, pršite zdravilo Quixil samo s plinom CO2 pod tlakom.
When applying Quixil 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 distance). 
Pri nanašanju zdravila Quixil s pršilnikom se prepričajte, da uporabljate tlak v tlačnem razponu, ki ga priporoča izdelovalec pršilnika (za tlake in razdaljo glejte tabelo v poglavju 6.6) .
Quixil should not be sprayed at a distance closer than the recommended by the spray device manufacturer. 
Zdravila Quixil ne smete pršiti s krajše razdalje, kot jo priporoča izdelovalec pršilnika.
The following changes should be made to the package leaflet of Quixil: 
V navodilu za uporabo zdravila Quixil je treba narediti naslednje spremembe:
For spray application see sections 4.4 and 6.6 for specific recommendations on the required pressure and distance from tissue.” 
Za posebna priporočila v zvezi s potrebnim tlakom in razdaljo od tkiva pri nanosu s pršenjem glejte poglavji 4.4 in 6.6.«
Open surgery 
Odprt kirurški poseg
• “Life threatening air or gas embolism (air getting into the blood circulation which can be serious or life-threatening) has occurred with the use of spray devices employing pressure regulator to administer Quixil. 
• »Opisani so pojavi življenjsko nevarne zračne ali plinske embolije (zrak, ki pride v krvni obtok, kar je lahko resno ali življenjsko nevarno) ob uporabi pršilnikov z regulatorjem tlaka za uporabo zdravila Quixil.
When applying Quixil using a spray device, be sure to use a pressure and a distance from tissue within the ranges recommended by the manufacturer (see section 4.4) 
Pri nanašanju zdravila Quixil s pršilnikom se prepričajte, da uporabljate tlak in razdaljo od tkiva v razponih, ki ju priporoča izdelovalec (glejte poglavje 4.4).
When using accessory tips with this product, the instructions for use of the tips should be followed.” 
Če uporabljate dodatne nastavke, upoštevajte navodila za njihovo uporabo.«
When spraying Quixil, 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). 
Med pršenjem zdravila Quixil je treba spremljati spremembe krvnega tlaka, srčnega utripa, nasičenosti s kisikom in izdihanega CO2 zaradi možnosti pojava zračne ali plinske embolije (glejte poglavji 4.2 in 4.4).
When applying Quixil using a spray device, the pressure should be within the range recommended by the spray device manufacturer. 
Pri nanašanju zdravila Quixil s pršilnikom mora biti tlak v razponu, ki ga priporoča izdelovalec pršilnika.
When applying Quixil 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 nanašanju zdravila Quixil s pršilnikom se prepričajte, da uporabljate tlak in razdaljo od tkiva v razponih, ki ju priporoča izdelovalec, kot sledi:
When applying Quixil using a spray device, be sure to use only the pressure within the range recommended by the spray device manufacturer. 
Pri nanašanju zdravila Quixil s pršilnikom se prepričajte, da uporabljate le tlak v razponu, ki ga priporoča izdelovalec pršilnika.
Spray Application 
NAVODILO ZA UPORABO
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.” For safety with respect to transmissible agents, see 4.4. 
Zdi se, da je ta pojav povezan z uporabo pršilnika s tlaki, ki so višji od priporočenih, in/ali z uporabo v neposredni bližini tkivne površine.«
When spraying Quixil, 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). 
Med pršenjem zdravila Quixil je treba spremljati spremembe krvnega tlaka, srčnega utripa, nasičenosti s kisikom in izdihanega CO2 zaradi možnosti pojava zračne ali plinske embolije (glejte tudi poglavje 4.2).«
• “Air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer Quixil. 
• »Opisani so pojavi zračne ali plinske embolije ob uporabi pršilnikov z regulatorjem tlaka za uporabo zdravila Quixil.
When applying Quixil using a spray device, be sure to use the pressure within the pressure range recommended by the spray device manufacturer. 
Pri nanašanju zdravila Quixil s pršilnikom se prepričajte, da uporabljate tlak v tlačnem razponu, ki ga priporoča izdelovalec pršilnika.
When spraying Quixil, 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.” 
Med pršenjem zdravila Quixil je treba spremljati spremembe krvnega tlaka, srčnega utripa, nasičenosti s kisikom in izdihanega CO2 zaradi možnosti pojava zračne ali plinske embolije.«
When applying Quixil using a spray device, be sure to use a pressure and a distance from tissue within the range recommended by the manufacturer as follows:. 
Pri nanašanju zdravila Quixil s pršilnikom se prepričajte, da uporabljate tlak in razdaljo od tkiva v razponu, ki ga priporoča izdelovalec, kot sledi: Kirurški poseg
When spraying Quixil, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 will be monitored because of the possibility of occurrence of air or gas embolism. 
Med pršenjem zdravila Quixil se bodo spremljale spremembe krvnega tlaka, srčnega utripa, nasičenosti s kisikom in izdihanega CO2 zaradi možnosti pojava zračne ali plinske embolije.
Applicator tips to be used 
Uporabljeni nastavki aplikatorja
“Life threatening air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer Quixil. 
»Opisani so pojavi življenjsko nevarne zračne ali plinske embolije ob uporabi pršilnikov z regulatorjem tlaka za uporabo zdravila Quixil.
When spraying Quixil, 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. 
Med pršenjem zdravila Quixil je treba spremljati spremembe krvnega tlaka, srčnega utripa, nasičenosti s kisikom in izdihanega CO2 zaradi možnosti pojava zračne ali plinske embolije.
• “Life threatening air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer Quixil. 
• »Opisani so pojavi življenjsko nevarne zračne ali plinske embolije ob uporabi pršilnikov z regulatorjem tlaka za uporabo zdravila Quixil.
PACKAGE LEAFLET 
Nanašanje s pršenjem
Two types of profiles were seen. 
Opazili so dve vrsti profila.
Grounds for positive opinion 
Razlogi za pozitivno mnenje
Scientific conclusions and grounds for positive opinion presented by the European Medicines Agency 
Znanstveni zaključki in podlaga za pozitivno mnenje, ki jih je predstavila Evropska agencija za zdravila
Whereas 
e i
The Netherlands and Germany considered that the granting of the marketing authorisation constitutes a potential serious risk to public health. 
Nizozemska in Nemčija sta menili, da odobritev dovoljenja za promet z zdravilom predstavlja morebitno resno tveganje za javno zdravje;
The 90% CI for these measures were within the acceptance interval of 80%-125%. 
Devetdesetodstotni IZ za ta merila je bil znotraj sprejemljivega intervala od 80 do 125 %.
• all strengths have the same qualitative composition 
• vse jakosti imajo enako kakovostno sestavo;
The major concern raised by Germany and the Netherlands could not be solved during the CMD(h) referral, and the issue was therefore referred to the CHMP. 
Glavnega pomisleka, ki sta ga izpostavili Nemčija in Nizozemska, med napotitvenim postopkom skupine CMD(h) ni bilo mogoče odpraviti, zato je bila zadeva posredovana odboru CHMP.
in FeSSIF and FeSSGF 
6,8 ter v FeSSIF in FeSSGF;
• The Committed considered the notification of the referral triggered by Denmark under Article 29(4) of Directive 2001/83/EC. 
• odbor je obravnaval uradno obvestilo o napotitvenem postopku, ki ga je v skladu s členom 29(4) Direktive 2001/83/ES sprožila Danska.
Pharmacokinetic data 
Farmakokinetični podatki
These ratios are considered as key element responsible for the controlled release of the drug from the tablet core. 
Ta razmerja so ključni elementi, odgovorni za nadzorovano sproščanje zdravila iz jedra tablete.
Overall summary of the scientific evaluation of Methylphenidate Sandoz and associated names (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Methylphenidate Sandoz in povezanih imen (glejte Prilogo I)
Pharmaceutical data 
Farmacevtski podatki
• all strengths are manufactured by the same manufacturer and process 
• vse jakosti izdeluje isti izdelovalec po istem postopku;
The use of partial metrics under fed condition was considered necessary as the reference product can also be taken with food. 
Uporaba delne metrike pri pogojih na poln želodec je nujna, saj se lahko referenčno zdravilo jemlje skupaj s hrano.
The waiver of studies under fed conditions for the lower strengths are considered justified for the following reasons: 
Opustitev študij pri pogojih na poln želodec za manjši jakosti je upravičena zaradi naslednjih razlogov:
• all strengths shows comparable dissolution profiles in various media in the pH range 1 to 6.8, 
• vse jakosti so pokazale primerljive profile raztopitve v različnih medijih z razponom pH od 1 do
• The outer drug coat is proportional in composition among all strengths and the ratio between the amount of the semipermeable membrane and the surface area are comparable amongst all strengths for the applied product. 
• sestava zunanje obloge zdravila je sorazmerna pri vseh jakostih, razmerje med količino polprepustne membrane in površino pa je primerljivo pri vseh jakostih uporabljenega zdravila.
The repeat-use MRP was closed on day 210, with most of the CMS agreeing with the conclusions of the RMS's assessment report except Germany and the Netherlands which raised a potential serious risk to public health (PSRPH). 
Postopek z medsebojnim priznavanjem za večkratno uporabo se je končal 210. dan, pri čemer se je večina zadevnih držav članic strinjala z zaključki poročila o oceni referenčne države članice, z izjemo Nemčije in Nizozemske, ki sta izpostavili morebitno resno tveganje za javno zdravje.
The first pharmacokinetic studies were performed by the applicant/MAH in 2009-2010 and submitted in the first DCP starting in January 2011. 
Prve farmakokinetične študije je predlagatelj/imetnik dovoljenja za promet z zdravilom izvedel med letoma 2009 in 2010 ter jih predložil za namene prvega decentraliziranega postopka, ki se je začel januarja 2011.