natgillin/translations-raw huggingface dataset:
This compared to 36% of dogs receiving a dummy treatment (82 of 231).
Pri psih, ki so prejemali zdravilo brez zdravilne učinkovine, je bilo zdravljenje uspešno v 36 % primerov (82 od 231).
It is used in dogs to treat pain associated with mild to moderate osteoarthritis, a condition causing swelling and pain in the joints.
Uporablja se pri psih za zdravljenje bolečine, povezane z blagim do zmernim osteoartritisom, tj. boleznijo, ki povzroča otekanje in bolečine v sklepih.
For more information about treatment with Galliprant, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Galliprant naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For practical information about using Galliprant, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Galliprant naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Other information about Galliprant?
Druge informacije o zdravilu Galliprant
How is Galliprant used?
Kako se zdravilo Galliprant uporablja?
Galliprant must not be given to pregnant, lactating or breeding dogs.
Zdravilo Galliprant se ne sme uporabljati pri brejih psicah, psicah v obdobju laktacije in psicah za razplod.
How does Galliprant work?
Kako zdravilo Galliprant deluje?
Strength Pharmaceutical Form Route of Administration
Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
You can do this by holding them in your hands until they feel as warm as your hands.
To lahko storite tako, da ju držite v dlaneh, dokler ne postaneta enako topli kot dlani.
• Inject slowly over 1 to 3 minutes.
• Injicirajte počasi, v času od 1 do 3 minut.
All evaluated minor surgeries were performed successfully.
Vsi ovrednoteni manjši kirurški posegi so bili izvedeni uspešno.
Always use an aseptic technique.
Vedno uporabljajte aseptično tehniko.
• you have recently had surgery
• ste pred kratkim imeli kirurški poseg,
General recommendations are provided in Table 2.
Splošna priporočila so navedena v preglednici 2.
A double dose should be avoided.
Uporabi dvojnega odmerka se je treba izogibati.
CV = coefficient of variation.
KV = koeficient variacije.
Osmolality: 272 mOsmol/kg.
Osmolalnost: 272 mOsmol/kg.
Additional doses can be given if needed.
Po potrebi se lahko aplicira dodatne odmerke.
This new expiry date should never exceed the one initially mentioned on the outer carton.
Ta nov datum izteka roka uporabnosti ne sme nikoli preseči tistega, ki je prvotno naveden na škatli.
Therefore, silica based reagents should be avoided.
Zato se je treba uporabi reagentov na osnovi silicijevega dioksida izogibati.
• Wash your hands and dry them properly using a clean towel or air dry.
• Umijte si roke in jih popolnoma osušite s čisto brisačo ali na zraku.
In case of shock, standard medical treatment for shock should be implemented.
V primeru šoka je treba uvesti standardno zdravljenje šoka.
Minor surgery including tooth extraction.
Manjši kirurški posegi, vključno z ekstrakcijo zoba
Do not open the equipment until you are ready to use it.
Pripomočkov ne odpirajte dokler niste pripravljeni na njihovo uporabo.
In each of these situations, the benefit of treatment with Refixia should be weighed against the risk of these complications.
V vsakem od teh primerov je treba korist zdravljenja z zdravilom Refixia presojati v primerjavi s tveganjem za te zaplete.
Submission of study results: Q2-2028
Predložitev rezultatov študije: drugo četrtletje 2028
(anaphylactic reactions)
(anafilaktične reakcije)
Thrombin then converts fibrinogen into fibrin and a clot is formed.
Trombin nato pretvori fibrinogen v fibrin in nastane strdek.
common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
< 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
V primeru pojava takšnih zaviralcev se stanje lahko kaže kot nezadosten klinični odziv.
For further information, see section 2 “Allergic reactions and development of inhibitors”.
Za nadaljnje informacije glejte poglavje 2 “Alergijske reakcije in razvoj zaviralcev”.
• Take out the number of Refixia packages you need.
• Vzemite potrebno število pakiranj zdravila Refixia.
If your dose requires more than one vial, repeat steps A to J with additional vials, vial adapters and pre-filled syringes until you have reached your required dose.
Če za odmerek potrebujete več kot eno vialo, ponovite korake od A do J z dodatnimi vialami, nastavki za vialo in napolnjenimi injekcijskimi brizgami, dokler ne dosežete potrebnega odmerka.
This finding was not associated with tissue damage or abnormal clinical signs.
Ta ugotovitev ni bila povezana z okvaro tkiva ali nenormalnimi kliničnimi znaki.
Previously untreated patients The safety and efficacy of Refixia in previously untreated patients have not yet been established.
Predhodno nezdravljeni bolniki Varnost in učinkovitost zdravila Refixia pri predhodno nezdravljenih bolnikih še nista bili dokazani.
Caution: The pre-filled syringe is made of glass and is designed to be compatible with standard luerlock connections.
Opozorilo: Napolnjena injekcijska brizga je izdelana iz stekla in zasnovana tako, da je združljiva s standardnimi luer-lock nastavki.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using Refixia.
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite zdravilo Refixia.
Side effects with unknown frequency (frequency cannot be estimated from the available data) • neutralising antibodies (inhibitors).
Neželeni učinki neznane pogostnosti (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) • nevtralizirajoča protitelesa (zaviralci)
• skin reactions at the site of injection
• kožne reakcije na mestu injiciranja zdravila
40 IU/kg body weight once weekly.
40 i.e./kg telesne mase enkrat na teden.
When you prepare and inject medicine directly into the veins, it is important to use a clean and germ free (aseptic) technique.
Pri pripravi in injiciranju zdravila neposredno v veno je pomembno, da uporabite čisto in sterilno (aseptično) tehniko.
Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breastfeeding is not available.
Zaradi redke pojavnosti hemofilije B pri ženskah, izkušnje z uporabo faktorja IX med nosečnostjo in dojenjem niso na voljo.
Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor IX, ATC code: B02BD04.
Farmakoterapevtska skupina: antihemoragiki, krvni koagulacijski faktor IX; oznaka ATC: B02BD04.
The specific activity of Refixia is approximately 152 IU/mg protein.
Specifična aktivnost zdravila Refixia je približno 152 i.e./mg beljakovine.
Factor IX is activated by factor XIa and by factor VII/tissue factor complex.
Faktor IX se aktivira s faktorjem XIa in kompleksom faktor VII/tkivni faktor.
If you stop using Refixia you may no longer be protected against bleeding or a current bleed may not stop.
Če ste prenehali uporabljati zdravilo Refixia Če prenehate z uporabo zdravila Refixia, morda ne boste več zaščiteni pred pojavom krvavitve ali pa se trenutna krvavitev morda ne bo ustavila.
The procedures included 9 orthopaedic, 1 gastrointestinal, and 3 surgeries in the oral cavity.
Posegi so vključevali 9 ortopedskih, 1 gastrointestinalen in 3 kirurške posege v ustni votlini.
Due to the long half-life of Refixia, the frequency of dosing in the post-surgical period may be extended to once weekly after the first week until bleeding stops and healing is achieved.
Zaradi dolgega razpolovnega časa zdravila Refixia se pogostnost odmerjanja po prvem tednu po kirurškem posegu lahko podaljša na enkrat na teden dokler se krvavitev ne ustavi in rana ustrezno zaceli.
Depending on the location and the severity of bleeding you may need a higher dose (80 IU per kg) or extra injections.
Odvisno od mesta in stopnje krvavitve bo morda treba uporabiti večji odmerek (80 i.e. na kg) ali dodatne injekcije.
In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.
Pri bolnikih z obstoječimi dejavniki tveganja za kardiovaskularne dogodke lahko nadomestno zdravljenje s FIX poveča kardiovaskularno tveganje.
A pre-operative dose of 80 IU/kg Refixia was effective and no patients required additional doses on the day of surgery.
Predoperativni odmerek 80 i.e./kg zdravila Refixia je bil učinkovit in nobeden od bolnikov na dan operacije ni potreboval dodatnih odmerkov.
This incompatibility may prevent administration of the drug and/or result in damage to the needleless connector.
Ta nezdružljivost lahko onemogoči aplikacijo zdravila in/ali povzroči poškodbo brezigelnega nastavka.
The dose recommendations in adolescents (12-18 years) are the same as for adults: 40 IU/kg body weight.
Priporočeni odmerki pri mladostnikih (12-18 let) so enaki kot pri odraslih: 40 i.e./kg telesne mase.
In such cases, it is recommended that a specialised haemophilia centre is contacted.
V teh primerih je priporočljivo, da se obrnete na specializiran center za hemofilijo.
• feeling very tired.
• huda utrujenost
Long-term studies in animals to evaluate the carcinogenic potential of Refixia, or studies to determine the effects of Refixia on genotoxicity, fertility, development, or reproduction have not been performed.
Dolgotrajne študije na živalih, ki bi ovrednotile kancerogeni potencial zdravila Refixia, ali študije, ki bi ovrednotile genotoksičnost, vpliv na plodnost, razvoj ali sposobnost razmnoževanja zdravila Refixia niso bile izvedene.
Therefore, factor IX should be used during pregnancy and lactation only if clearly indicated.
Faktor IX se lahko med nosečnostjo in dojenjem uporablja le, če je to nujno potrebno.
The dose in adolescents is also calculated according to body weight and is the same dose as for adults.
Tudi pri mladostnikih se odmerek izračuna na osnovi telesne mase in je enak kot pri odraslih.
An overall assessment of haemostatic efficacy was performed by the patient or caretaker (for home treatment) or study site investigator (for treatment under health care professional supervision) using a 4-point scale of excellent, good, moderate, or poor.
Vrednotenje celokupne učinkovitosti hemostaze je izvedel bolnik oziroma skrbnik (pri zdravljenju na domu) ali raziskovalec v študiji (pri zdravljenju pod nadzorom zdravstvenega osebja) s pomočjo 4-točkovne lestvice kot odličen, dober, zmeren ali slab.
Allergic reactions are possible with this medicine.
Pri uporabi tega zdravila se lahko pojavijo alergijske reakcije.
Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
Zdravljenje mora potekati pod nadzorom zdravnika z izkušnjami pri zdravljenju hemofilije.
If you forget a dose, inject the missed dose as soon as you remember.
Če ste pozabili uporabiti odmerek, pozabljeni odmerek injicirajte takoj, ko se spomnite.
The listed warnings and precautions apply both to adults and adolescents (12-18 years).
Navedena opozorila in previdnostni ukrepi veljajo tako za odrasle kot mladostnike (12-18 let).
For storage at room temperature and storage conditions after reconstitution of the medicinal product, see section 6.3.
Za pogoje shranjevanja pri sobni temperaturi in pogoje shranjevanja po rekonstituciji zdravila glejte poglavje 6.3.
Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor IX in plasma).
Aktivnost faktorja IX v plazmi se izraža bodisi v odstotkih (glede na normalno človeško plazmo) ali v mednarodnih enotah (glede na mednarodni standard za faktor IX v plazmi).
Factor IX is a protein naturally found in the blood that helps to stop bleeding.
Faktor IX je beljakovina, ki je naravno prisotna v krvi in sodeluje pri zaustavljanju krvavitve.
Non-interventional post-authorisation safety study (PASS): In order to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues/organs, the MAH should conduct and submit the results of a noninterventional post-authorisation safety study deriving from a registry of Haemophilia patients according to an agreed protocol.
Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): Da bi raziskali morebitne učinke kopičenja PEG v horoidnem pletežu možganov in drugih tkivih/organih, mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate neintervencijske študije o varnosti zdravila po pridobitvi dovoljenja za promet iz registra bolnikov s hemofilijo v skladu z dogovorjenim protokolom.
In patients with haemophilia B, factor IX is missing or does not work properly.
Pri bolnikih s hemofilijo B faktor IX manjka ali pa ne deluje pravilno.
• you suffer from other serious illness e.g. liver disease, heart disease, or cancer
• imate kakšno drugo resno bolezen, npr. bolezen jeter, bolezen srca ali raka,
If you are not sure if either of the above applies to you, talk to your doctor before using this medicine.
Če ste negotovi, ali katera koli od zgornjih navedb velja za vas, se pred začetkom uporabe tega zdravila posvetujte z zdravnikom.
Cardiovascular event
Kardiovaskularni dogodki
A single dose is recommended.
Priporočamo uporabo enkratnega odmerka.
Three trials of which one trial was a dedicated surgery trial included in total 15 major and 26 minor surgery procedures (patients aged 13 to 56 years).
Tri preskušanja, od katerih je bilo eno preskušanje namenjeno kirurškemu poskušanju, so vključevala skupno 15 večjih in 26 manjših kirurških posegov (pri bolnikih, starih od 13 do 56 let).
Frequencies have been evaluated according to the following convention: very common (≥ 1/10);
Pogostnost je navedena v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do
Routine monitoring of factor IX activity levels for the purpose of dose adjustment is not necessary.
Spremljanje zdravljenja Rutinsko spremljanje ravni aktivnosti faktorja IX zaradi prilagajanja odmerka ni potrebno.
In some cases, these reactions have progressed to severe anaphylaxis, and they have occurred in close temporal association with development of factor IX inhibitors (see also section 4.4).
V nekaterih primerih so te reakcije napredovale v hudo anafilaksijo, pojavile pa so se v tesni časovni povezavi z razvojem zaviralcev faktorja IX (glejte tudi poglavje 4.4).
The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products.
Število uporabljenih enot faktorja IX se izraža v mednarodnih enotah (i.e.), ki so prilagojene trenutnim standardom SZO za proizvode faktorja IX.
• pale and cold skin, fast heartbeat, and/or dizziness (low blood pressure).
• bleda in hladna koža, hiter srčni utrip in/ali omotica (nizek krvni tlak)
• In case you only need part of the entire vial, use the scale on the syringe to see how much reconstituted solution you withdraw, as instructed by your doctor or nurse.
• Če potrebujete le del celotne vsebine viale, s pomočjo skale na injekcijski brizgi preverite koliko rekonstituirane raztopine ste izvlekli, kot vam je to pokazal zdravnik ali medicinska sestra.
If you forget to use Refixia
Če ste pozabili uporabiti zdravilo Refixia
For Refixia some reagents will cause underestimation (30-50%), while most silica containing reagents will cause severe overestimation of the factor IX activity (more than 400%).
Pri zdravilu Refixia nekateri reagenti podcenijo (30-50 %), večina reagentov s silicijevim dioksidom pa močno preceni aktivnost faktorja IX (več kot 400 %).
In case of residual FIX activity levels, there is a risk of interference when performing the Nijmegen modified Bethesda assay for inhibitor testing.
V primeru rezidualne aktivnosti FIX obstaja tveganje interference pri izvedbi po Nijmegenu modificiranega Bethesda testa za testiranje zaviralca.
• Use a clean and germ free (aseptic) technique.
• Uporabite čisto in aseptično (brezkužno) tehniko.
The European Medicines Agency has deferred the completion of the study with Refixia in previously untreated patients (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila dokončanje študije z zdravilom Refixia pri predhodno nezdravljenih bolnikih (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Known allergic reaction to hamster protein.
Znana alergijska reakcija na hrčkove beljakovine.
Injecting the solution via a central venous access device (CVAD) such as a central venous catheter or a subcutaneous port:
Injiciranje raztopine preko naprave za centralni venski dostop (CVAD - Central Venous Access Device), kot sta centralni venski kateter ali podkožni port:
• Inject the reconstituted solution as instructed by your doctor or nurse.
• Rekonstituirano raztopino injicirajte v skladu z navodili zdravnika ali medicinske sestre.
• redness and/or swelling of the lips, tongue, face or hands
• stiskanje v prsnem košu • rdečina in/ali otekanje ustnic, jezika, obraza ali rok
The long-term safety of Refixia in children below 12 years has not yet been established.
Dolgoročna varnost zdravila Refixia pri otrocih, mlajših od 12 let, še ni bila dokazana.
There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
V literaturi obstajajo poročila, ki kažejo soodvisnost med pojavom zaviralca faktorja IX in alergijskimi reakcijami.
You must contact your doctor or an emergency unit immediately if you have early signs of an allergic reaction such as:
Nemudoma se posvetujte z zdravnikom ali poiščite zdravniško pomoč v najbližjem urgentnem centru, če opazite zgodnje znake alergijske reakcije, kot so:
The dose level and dosing intervals for surgery depend on the procedure and local practice.
Odmerek in odmerni intervali pri kirurških posegih so odvisni od vrste posega in lokalne prakse.
In the absence of compatibility studies, this medicine must not be mixed with other medicinal products or reconstituted with infusion solutions other than the provided histidine solvent.
Zaradi pomanjkanja študij kompatibilnosti, zdravila ne smemo mešati z drugimi zdravili ali rekonstituirati z drugimi raztopinami za infundiranje razen s priloženim vehiklom s histidinom.
Volume of distribution (Vss) (ml/kg)
Volumen porazdelitve (Vss) (ml/kg)
In distribution and excretion studies in mice and rats, the 40 kDa polyethylene-glycol (PEG) moiety of Refixia was shown to be widely distributed to and eliminated from organs, and excreted via plasma in urine (44-56%) and faeces (28-50%).
Študije porazdelitve in izločanja pri miših in podganah so pokazale, da se 40 kDa polietilen glikola (PEG) zdravila Refixia obsežno porazdeli in odstranjuje iz organov ter preko plazme izloči v urin (4456 %) in blato (28-50 %).
The success rate for treatment of bleeding episodes was also independent of whether the bleed was traumatic or spontaneous of nature.
Delež uspešnosti zdravljenja epizod krvavitve tudi ni bil odvisen od travmatske ali spontane narave krvavitve.
Do not throw it out with the ordinary household waste.
Nič od navedenega ne smete zavreči med običajne gospodinjske odpadke.
It is strongly recommended that every time that Refixia is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Zelo priporočljivo je, da se po vsaki aplikaciji zdravila Refixia zabeleži ime in številka serije uporabljenega zdravila, da se zagotovi povezava med bolnikom in serijo uporabljenega zdravila.
If the medicine has not been used before the new expiry date, it should be disposed of.
Če zdravila ne uporabite pred novim iztekom roka uporabnosti, ga morate zavreči.
It is a vitamin-K dependent coagulation factor and it is synthesised in the liver.
Je od vitamina K odvisen koagulacijski faktor, ki se sintetizira v jetrih.
The primary amino acid sequence of the rFIX in Refixia is identical to the Ala148 allelic form of human plasma-derived factor IX.
Primarno aminokislinsko zaporedje rFIX v zdravilu Refixia je identično alelni obliki Ala148 iz humane plazme pridobljenega faktorja IX.
The overall success rate for treatment of breakthrough bleeds was 97.1% (67 out of 69 evaluated bleeds).
Delež celokupne uspešnosti zdravljenja krvavitev med uporabo zdravila je znašal 97,1 % (67 od 69 ovrednotenih krvavitev).
A total of 69 (98.6%) of the 70 bleeding episodes were treated with one injection.
Skupno 69 (98,6 %) od 70 krvavitev so zdravili z eno injekcijo.
Additional doses of 40 IU/kg can be given.
Aplicira se lahko dodatne odmerke po 40 i.e./kg
What Refixia is and what it is used for What you need to know before you use Refixia How to use Refixia
Kaj je zdravilo Refixia in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Refixia Kako uporabljati zdravilo Refixia
Other medicines and Refixia Tell your doctor if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
All pharmacokinetic studies with Refixia were conducted in previously treated patients with haemophilia B (factor IX ≤2%).
Vse farmakokinetične študije zdravila Refixia so bile izvedene pri predhodno zdravljenih bolnikih s hemofilijo B (faktor IX ≤ 2 %).
Half-life (t1/2) (hours)
Razpolovni čas (t1/2) (ure)
In a repeat dose toxicity study in monkeys, mild and transient body tremors were seen 3 hours post dosing and abated within 1 hour.
V študiji toksičnosti pri ponavljajočih se odmerkih so pri opicah 3 ure po odmerjanju opazili blag in prehoden tremor telesa, ki je popustil v 1 uri.
Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Zato je treba pri bolnikih, pri katerih se pojavi alergijska reakcija, določiti prisotnost zaviralca.
Of the 597 treated bleeds observed in 79 (75%) of the 105 patients, 521 (87%) of the bleeds were resolved with 1 injection and 60 (10%) of the bleeds were resolved with 2 injections of Refixia.
Od 597 zdravljenih krvavitev, opaženih pri 79 od 105 bolnikov (75 %), se je 521 krvavitev (87 %) ustavilo z 1 injekcijo, 60 krvavitev (10 %) pa z 2 injekcijama zdravila Refixia.
• Do not touch the rubber stopper with your fingers as this can transfer germs.
• Gumijastega zamaška se ne dotikajte s prsti, saj ga lahko tako kontaminirate z mikrobi.
• you have risk factors for heart disease e.g high blood pressure, obesity, or smoking.
• imate dejavnike tveganja za razvoj bolezni srca, npr. visok krvni tlak, debelost ali ste kadilec.
The use of Refixia in children below 12 years is not indicated (see section 4.2 for information on paediatric use).
Uporaba zdravila Refixia pri otrocih, mlajših od 12 let, ni indicirana (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
For modified long-acting factor products it is known that the one-stage clotting assay results are highly dependent on the aPTT reagent and reference standard used.
Znano je, da so rezultati enostopenjskega testa strjevanja krvi pri modificiranih dolgodelujočih proizvodih faktorja močno odvisni od uporabljenega aPTT reagenta in referenčnega standarda.
Haemostatic effect of Refixia during surgery was confirmed with a success rate of 100% in the 15 major surgeries in the trials.
Hemostatski učinek zdravila Refixia med kirurškim posegom potrjuje delež uspešnosti, ki je pri 15 večjih posegih v preskušanjih znašal 100 %.