natgillin/translations-raw huggingface dataset:
Any unused product should be discarded in accordance with local requirements.
Neuporabljeno zdravilo zavrzite v skladu z lokalnimi predpisi.
- as a glue for the fixation of patches - as a glue for intestines (gastrointestinal anastomoses) - on severe arterial bleeds
- neposredno v krvno žilo - pri endoskopskih posegih (posegih, pri katerih se za ogled notranjih organov uporablja endoskop) ali pri laparoskopskih posegih - kot lepilo za pritrditev obližev - kot lepilo za črevesje (gastrointestinalna anastomoze) - pri hudih krvavitvah iz arterije
The spray device and the accessory nozzle are provided with instructions for use, which should be carefully followed.
Pršilniku in šobi je priloženo navodilo za uporabo s priporočili za razpon tlaka in bližino do površine tkiva, kar je treba natančno upoštevati.
When spraying Raplixa, 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.
Pri pršenju zdravila Raplixa je treba spremljati spremembe krvnega tlaka, utripa, saturacijo s kisikom in CO2 na koncu izdiha, saj se lahko pojavi zračna ali plinska embolija.
• The Summary of Product Characteristics (SmPC)
• povzetek glavnih značilnosti zdravila
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Kljub temu pri uporabi zdravil, pripravljenih iz humane krvi ali plazme, ni možno povsem izključiti možnosti prenosa povzročiteljev nalezljivih bolezni, tudi tistih, ki do danes še niso poznani, porajajočih se virusov
The vial with powder is attached to the RaplixaSpray device by inverting the device over the upright vial and pushing the vial into place.
Vialo s praškom je treba pritrditi na pripomoček RaplixaSpray tako, da se pripomoček obrne na glavo čez vialo, ki stoji navpik, in vstavi v vialo.
The RaplixaSpray device comes with the rigid nozzle attached.
Pripomoček RaplixaSpray ima priključeno togo šobo.
- The third method is application of Raplixa onto the bleeding site using the recommended spray device followed by the application of the gelatin sponge.
Tretja metoda je nanos zdravila Raplixa na mesto krvavitve s priporočenim pršilnikom, ki mu sledi nanos želatinske gobice.
Recommended spray pressure
Priporočeni tlak pršenja odprta metoda operacije
Life-threatening events have occurred with the use of other spray devices employing a pressure regulator to administer other fibrin sealants.
Pri uporabi drugih pršilnikov, ki uporabljajo regulator tlaka, za nanos fibrinskih lepil, je prišlo do življenjsko nevarnih dogodkov.
The Raplixa spray device is connected to the RaplixaReg pressure regulator and thereby to the medical gas supply set to a pressure setting of 1.5 bar (22 psi).
Pripomoček RaplixaSpray se poveže z regulatorjem tlaka RaplixaReg in s tem z dovajanjem medicinskega zraka, nastavljenim na tlak 1,5 bara (22 psi).
Spray application using Raplixa spray device followed by gelatin sponge Use Raplixa with the Raplixa spray device.
Nanos s pršilom z uporabo pripomočka RaplixaSpray, ki mu sledi uporaba želatinske gobice Zdravilo Raplixa se lahko uporablja s pripomočkom RaplixaSpray.
1 vial 0.5 g 1 vial 1 g 1 vial 2 g
1 viala 2 g
Connect the vial to the device by inverting the device over the upright vial and pushing the vial into place.
Vialo pritrdite na pršilo tako, da pripomoček poveznete čez vialo, ki stoji navpik, in vstavite vialo.
Take the vial and device out of their respective pouches maintaining sterility.
Vialo in pršilo RaplixaSpray vzemite iz vrečk in ohranite sterilnost.
There is limited experience of use of Raplixa in vascular surgery when applied with the RaplixaSpray device.
Z uporabo zdravila Raplixa pri posegih na žilju so izkušnje omejene, če se zdravilo Raplixa uporablja s pripomočkom RaplixaSpray.
• Requirement to closely monitor blood pressure, pulse rate, oxygen saturation, and end tidal CO2
• zahtevano je, da je treba natančno spremljati spremembe v krvnem tlaku, pulzu, saturaciji s kisikom ter CO2 v izdihanem zraku ob koncu izdiha zaradi možnosti za pojav plinske embolije
Maximum Surface Area Application Using RaplixaSpray
Največja površina nanosa Nanos z uporabo pripomočka RaplixaSpray
Fertility Fertility studies have not been conducted.
Posledično intravaskularnih farmakokinetičnih študij pri ljudeh niso izvajali.
Powder is applied directly from the vial onto a saline-wetted CE marked gelatin sponge and then applied to the bleeding site.
Prašek se aplicira neposredno iz viale na želatinsko gobico z oznako CE, namočeno v fiziološko raztopino, nato pa se nanese na mesto krvavitve.
When Raplixa is applied directly to the surgical bleeding site, a thin layer should be used to cover the bleeding/oozing area completely.
Pri nanosu zdravila Raplixa neposredno na kirurško mesto, ki krvavi, je treba uporabiti tanek sloj, ki povsem prekrije predel, ki krvavi/iz katerega se izceja.
• Itch
• srbenje
Life threatening thromboembolic complications may occur if the preparation is unintentionally applied intravascularly.
Če se zdravilo nenamerno uporabi intravaskularno, se lahko pojavijo življenjsko nevarni trombembolični zapleti.
Presentation
Odmerjanje
6.6 Instructions for use and handling and special precautions for disposal
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
• Raplixa will be applied as a thin layer.
• Zdravilo Raplixa se nanese v tanki plasti.
sealant powder
Nalepka viale
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na Univerzitetni klinični center Ljubljana, Interna klinika Center za zastrupitve
- Application of Raplixa straight from the vial to the bleeding site followed by the application of the gelatin sponge.
Zdravilo Raplixa se lahko nanese na mesto krvavitve neposredno iz viale, nato pa sledi nanos želatinske gobice.
Life threatening air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer fibrin sealant/haemostatic products.
Pri uporabi drugih pršil, ki uporabljajo regulator tlaka, za nanos fibrinskih lepil/hemostatskih zdravil, je prišlo do življenjsko nevarne zračne ali plinske embolije.
Method and route of administration
Odmerjanje in način uporabe
Do not use Raplixa if the seal on the vial has been tampered with.
Zdravila Raplixa ne uporabljajte, če opazite poškodbe tesnilnega zamaška ali viale.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING ALUMINIUM-BONDED FOIL SACHET
VREČKA IZ ALUMINIJASTE FOLIJE
You can also report side effects directly via the national reporting system.
O neželenih učinkih lahko poročate tudi neposredno na Univerzitetni klinični center Ljubljana, Interna klinika Center za zastrupitve
Apply first to gelatin sponge
Nanos na želatinsko gobico
PHARMACEUTICAL FORM AND CONTENTS
Izgled zdravila Raplixa in vsebina pakiranja
- Application from the vial onto a wetted gelatin sponge and then applied to the bleeding site.
Drugi način je nanos iz viale na omočeno želatinsko gobico in nato na mesto krvavitve.
Raplixa sealant powder
Raplixa prašek za lepilo za tkiva
Date of first authorisation: 24 April 2012 Date of latest renewal: 18 November 2016
Datum prve odobritve: 24. april 2012 Datum zadnjega podaljšanja: 18. november 2016
Treatment should not be restarted.
Zdravljenja se ne sme ponovno uvesti.
What do I need
Kaj potrebujete
Elderly patients (≥65 years)
Starejši bolniki (≥65 let)
The dose may be decreased either temporarily or permanently.
Odmerek je mogoče znižati bodisi začasno ali trajno.
Linearity and time dependency
Linearnost in časovna odvisnost
(figure B).
(slika B).
Please follow their instructions.
Držite se njunih navodil.
192 patients were treated.
Zdravili so 192 bolnikov.
Normalisation of IGF-1
normalizacija IGF-1
The study enrolled 150 patients.
V študijo so vključili 150 bolnikov.
The safety and efficacy of Signifor in children and adolescents aged 0 to 18 years have not been established.
Varnost in učinkovitost zdravila Signifor pri otrocih in mladostnikih, starih od 0 do 18 let, nista bili dokazani.
- If you are a sexually active woman, you should use an effective method of contraception during treatment.
- Če ste spolno aktivna ženska, morate med zdravljenjem uporabljati učinkovito metodo kontracepcije.
If this happens, tell your doctor immediately.
Če pride do navedenega, takoj obvestite zdravnika.
The clinical significance of this prolongation is unknown.
Klinični pomen tega podaljšanja ni znan.
Cushing's disease
Cushingova bolezen
Based on the local clinical practice, your doctor or nurse will tell you which method to use.
Glede na lokalno klinično prakso vam bosta vaš zdravnik ali medicinska sestra povedala, katero metodo boste uporabljali.
- Take the ampoule out of the box.
- Ampulo vzemite iz škatle.
Similar results were also seen at month 12.
Podobne rezultate so opažali tudi po 12 mesecih.
You should also read the instructions at the end of this leaflet.
Prebrati morate tudi navodila na koncu tega navodila za uporabo.
Pasireotide did not affect insulin sensitivity.
Pasireotid ni vplival na občutljivost za insulin.
Do not give this medicine to children and adolescents below 18 years old because no data are available in this age group.
Zdravila ne smete dajati otrokom in mladostnikom pred 18 letom starosti, ker za to starostno skupino ni na voljo nobenih podatkov.
Table 3 Key results at week 24 (Study C2402)
Preglednica 3 Glavni rezultati po 24 tednih (študija C2402)
Do not let the needle touch anything.
Pazite, da se z iglo ničesar ne dotaknete.
- You should not use Signifor during pregnancy unless clearly necessary.
- Med nosečnostjo ne smete uporabljati zdravila Signifor, razen če je to nedvomno potrebno.
Signifor may affect the way some other medicines work.
Zdravilo Signifor lahko vpliva na delovanje nekaterih drugih zdravil.
The incidence of such events was highest in the first 3 months of treatment.
Pogostnost takih dogodkov je bila največja v prvih 3 mesecih zdravljenja.
Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Zdravnik bo redno spremljal vaše stanje in preverjal, ali zdravljenje dosega želene učinke.
Do not use Signifor - if you are allergic to pasireotide or any of the other ingredients of this medicine (listed in section 6).
Ne uporabljajte zdravila Signifor - če ste alergični na pasireotid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Long-term follow-up data are not available.
Podatki dolgoročnega spremljanja bolnikov niso na voljo.
After the initial 6 months in the study, patients entered an additional 6-month open-label treatment period.
Po prvih 6 mesecih študije so bolniki vstopili v dodatno 6-mesečno obdobje odprtega zdravljenja.
Other side effects of Signifor may include:
Drugi neželeni učinki zdravila Signifor lahko vključujejo:
The clinical relevance of these effects in humans is unknown.
Klinična pomembnost teh učinkov pri ljudeh ni znana.
ULN = upper limit of normal
ZMN = zgornja meja normalnih vrednosti
A total of 358 patients were randomised and treated.
Skupno so randomizirali in zdravili 358 bolnikov.
- Inspect the ampoule.
- Ampulo preglejte.
Gallbladder and related events
Žolčnik in z njim povezani dogodki
In both these cases, return the entire pack to the pharmacy.
V obeh primerih vrnite celotno pakiranje v lekarno.
When you are ready to give yourself the injection, carefully follow the steps below: - Wash your hands thoroughly with soap and water.
Ko boste pripravljeni, da si injicirate zdravilo, previdno postopajte po naslednjih korakih: - Temeljito si umijte roke z milom in vodo.
Frequencies were defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100).
Kategorije pogostnosti so opredeljene takole: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100).
The improvement observed up to week 24 between the treatment groups was also not statistically significant.
Tudi razlika v obsegu izboljšanja do konca 24. tedna med študijskimi skupinami ni dosegla statistične značilnosti.
It is used to treat acromegaly in adult patients.
Uporabljamo ga za zdravljenje akromegalije pri odraslih bolnikih.
N=65 n (%), p value
N=65 n (%), vrednost p
Cushing's disease study G2304
Študija Cushingove bolezni z oznako G2304
Extension phase
Faza podaljšanja
Plasma protein binding is moderate (88%) and independent of concentration.
Vezava na proteine v plazmi je zmerna (88 %) in ni odvisna od koncentracije.
All QT-related events were transient and resolved without therapeutic intervention.
Vsi z intervalom QT povezani dogodki so bili prehodni in so izzveneli brez terapevtskih ukrepov.
Multipack containing 3 intermediate cartons
skupno pakiranje, ki vsebuje 3 vmesne škatle
Once the ampoule is open, put it upright on a clean, flat surface.
Ko je ampula odprta, jo postavite pokončno na čisto, ravno površino.
In all these cases, return the entire pack to the pharmacy.
V vseh navedenih primerih vrnite celotno pakiranje v lekarno.
Similar trends were observed at month 12.
Podoben trend so opažali tudi po 12 mesecih.
Five human somatostatin receptor subtypes are known: hsst1, 2, 3, 4, and 5.
Pri človeku je znanih pet podvrst receptorjev za somatostatin: hsst1, 2, 3, 4 in 5.
Distribution between blood cells and plasma is concentration independent and shows that pasireotide is primarily located in the plasma (91%).
Porazdelitev med krvnimi celicami in plazmo ni odvisna od koncentracije zdravila in kaže, da se pasireotid porazdeli predvsem v plazmi (91 %).
- if you have severe liver problems.
- če imate hudo okvaro jeter.
Patients uncontrolled at both month 1 and month 2 are likely (90%) to remain uncontrolled at months 6 and 12.
Bolniki, ki so bili tako po 1. kot po 2. mesecu neurejeni, so z veliko verjetnostjo (v 90 %) ostali neurejeni tudi po 6 in 12 mesecih.
If you see blood in the syringe, first remove the needle from the skin, then replace the short needle with a new one and insert it into a different injection site.
Če pri tem opazite kri v brizgi, najprej izvlecite iglo iz kože, nato zamenjajte kratko iglo z novo in jo zabodite na drugem mestu injiciranja.
This may involve measuring the levels of growth hormone or other hormones in your blood.
To lahko vključuje merjenje ravni rastnega hormona ali drugih hormonov v krvi.
* Grouped terms: Adrenal insufficiency includes adrenal insufficiency and blood cortisol decreased.
* Skupni izrazi: Adrenalna insuficienca vključuje adrenalno insuficienco in znižano vrednost kortizola v krvi.
Your doctor will check regularly how you respond to the treatment with Signifor and determine which dose is best for you.
Zdravnik bo redno preverjal vaš odziv na zdravljenje z zdravilom Signifor in določal, kateri odmerek je za vas najbolj primeren.
Additional dose adjustments (up to a maximum of 40 mg) were allowed at months 7 and 9 of the core phase.
Nadaljnje prilagajanje odmerka (do največ 40 mg) je bilo dovoljeno po 7 in 9 mesecih osnovne faze študije.
What you need to know before you use Signifor
Kaj morate vedeti, preden boste uporabili zdravilo Signifor
Therefore, do not stop using Signifor unless your doctor tells you to.
Iz tega razloga ne prenehajte uporabljati zdravila Signifor, razen če vam tako naroči zdravnik.
At the end of the core phase, patients not adequately responding to their initial therapy were allowed to switch treatment.
Po zaključku osnovne faze so bolnikom, pri katerih ni prišlo do ustreznega odziva na začetno zdravljenje, omogočili, da so zamenjali zdravilo.
Signifor reduces the production of these hormones and possibly also the size of the adenoma.
Zdravilo Signifor zmanjšuje tvorbo teh hormonov in lahko zmanjša tudi obseg adenoma.
Grade 1 and 2 adverse reactions were reported in 57.4% of patients.
O neželenih učinkih 1. in 2. stopnje so poročali pri 57,4 % bolnikov.
Other medicines and Signifor
Druga zdravila in zdravilo Signifor
The injection site is the place on your body where you are going to give yourself the injection.
Mesto injiciranja je mesto na vašem telesu, kamor si boste injicirali zdravilo.
Octreotide intramuscular use n (%) N=182
oktreotid intramuskularna uporaba n (%) N=182
Each ampoule is packed in a cardboard tray which is placed in an outer box.
Vsaka ampula leži na kartonskem podstavku, ki je pakiran v zunanjo škatlo.
If you are using other medicines at the same time as Signifor (including medicines obtained without a prescription), your doctor may need to monitor your heart more carefully or change the dose of Signifor or the other medicines.
Če sočasno z zdravilom Signifor uporabljate še druga zdravila (vključno z zdravili, ki jih lahko dobite brez recepta), vam bo moral morda zdravnik bolj skrbno pregledovati srce ali spremeniti odmerek zdravila Signifor oziroma odmerke drugih zdravil.
Available toxicological data in animals have shown excretion of pasireotide in milk.
Razpoložljivi toksikološki podatki pri živalih kažejo na izločanje pasireotida v mleko.
Carcinogenicity studies conducted in rats and transgenic mice did not identify any carcinogenic potential.
V študijah kancerogenosti, ki so jih izvajali na podganah in transgenskih miših, niso odkrili, da bi imel pasireotid kancerogeni potencial.
This medicine will be given to you by a trained healthcare professional.
To zdravilo vam bo dajal usposobljen zdravstveni delavec.
In the event of overdose, it is recommended that appropriate supportive treatment be initiated, as dictated by the patient's clinical status, until resolution of the symptoms.
V primeru prevelikega odmerjanja je priporočeno začeti z ustreznim podpornim zdravljenjem v skladu z bolnikovim kliničnim stanjem, dokler simptomi niso odpravljeni.
This may involve measuring the levels of cortisol in your blood or urine.
To lahko vključuje merjenje ravni kortizola v krvi in urinu.
If you have been told to use two needles, you should now replace the long needle with the short one.
Če so vam naročili, da uporabljate dve igli, morate zdaj zamenjati dolgo iglo s kratko.
Anticipated pharmacodynamic interactions
Predvidene farmakodinamične interakcije
Tell your doctor straight away if you get any of the following:
Takoj povejte zdravniku, če se pri vas pojavi kateri od naslednjih neželenih učinkov:
- Store in a refrigerator (2°C-8°C).
- Shranjujte v hladilniku (2 °C-8 °C).
Data on Cushing's disease patients older than 65 years are limited but do not suggest any clinically significant differences in safety and efficacy in relation to younger patients.
Podatkov o bolnikih, ki imajo Cushingovo bolezen in so stari več kot 65 let, je malo, vendar ne kažejo klinično pomembnih razlik glede varnosti in učinkovitosti zdravila v primerjavi z mlajšimi bolniki.
The patient should be evaluated for clinical benefit after the first month of treatment and periodically thereafter.
Bolnika je treba oceniti glede kliničnih koristi po prvem mesecu zdravljenja in nato redno tekom zdravljenja.
- your doctor may also wish to check your gallbladder, liver enzymes and pituitary hormones periodically, since these might all be affected by this medicine.
- Zdravnik vam bo morda želel redno pregledovati tudi žolčnik in vrednosti jetrnih encimov ter hipofiznih hormonov, saj to zdravilo lahko vpliva nanje.
There is a limited amount of data from the use of pasireotide in pregnant women.
Podatkov o uporabi pasireotida pri nosečnicah je malo.
Fatigue includes fatigue and asthenia.
Utrujenost vključuje utrujenost in astenijo.
Pasireotide 10 mg N=74
pasireotid 10 mg N=74
Your doctor may wish to monitor your heart rate using a machine that measures electrical activity of the heart (an “ECG”, or electrocardiogram).
Zdravnik bo morda hotel spremljati vaš srčni utrip in vam posneti električno aktivnost srca (preiskava “EKG” oziroma elektrokardiogram).
The mean age of patients was approximately 40 years and the majority of patients (77.8%) were female.
Povprečna starost bolnikov je bila približno 40 let in večina bolnikov (77,8 %) je bila ženskega spola.
Ask your doctor about the need for contraception before taking this medicine.
O potrebi po kontracepciji se posvetujte z zdravnikom, preden začnete uporabljati to zdravilo.
In healthy volunteers, pasireotide is predominantly found in unchanged form in plasma, urine and faeces.
Pri zdravih prostovoljcih je pasireotid mogoče najti v plazmi, urinu in blatu pretežno v nespremenjeni obliki.
Pasireotide 30 mg N=76
pasireotid 30 mg N=76
Before you proceed to step 4, clean the injection site with an alcohol wipe.
Preden nadaljujete s 4. korakom, očistite mesto injiciranja z alkoholno blazinico.
Using Signifor at the same time each day will help you remember when to use your medicine.
Če boste uporabljali zdravilo Signifor vsak dan ob istem času, se boste laže spomnili, kdaj si ga morate odmeriti.
Withdraw the needle from the injection site and activate the safety guard (as shown in Step 8).
Izvlecite iglo z mesta injiciranja in aktivirajte varnostni ščitnik (kot je prikazano pri 8. koraku).
• The injection kit must reach room temperature.
• Komplet za injiciranje se mora ogreti na sobno temperaturo.
Pasireotide works in a very similar way to somatostatin.
Pasireotid deluje zelo podobno kot somatostatin.
No change in the pharmacokinetics (rate or extent of exposure) of pasireotide was observed.
Sprememb v farmakokinetiki pasireotida (v stopnji ali obsegu izpostavljenosti) niso opazili.
Keep the plunger pressed down and hold the syringe in place for 5 seconds.
Bat držite pritisnjen do konca in zadržite brizgo na mestu približno 5 sekund.
Never share needles and syringes.
Igel in brizg nikoli ne posojajte.
Gently pinch the skin at the injection site and, holding the needle at an angle of approximately 45 degrees (as shown in the picture) insert it into the injection site.
Nežno stisnite kožo na mestu za injiciranje in zabodite iglo pod kotom približno 45 stopinj (kot je prikazano na sliki) v kožo na mestu injiciranja.
INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
ŠKATLA ZA VMESNO PAKIRANJE V SKUPNEM PAKIRANJU (BREZ “BLUE BOX” PODATKOV)
Episodes of torsade de pointes were not observed either in those studies or in clinical studies in other patient populations.
Epizod torsade de pointes niso opažali niti v teh študijah niti v kliničnih študijah z drugimi populacijami bolnikov.
The site of repeat intramuscular injections should be alternated between the left and right gluteal muscle.
Nadaljnje intramuskularne injekcije je treba dajati izmenično v levo in desno glutealno mišico.
Patients should be advised to be cautious when driving or using machines if they experience fatigue, dizziness or headache during treatment with Signifor.
Bolnikom je treba svetovati previdnost pri vožnji ali upravljanju s stroji, če so med zdravljenjem z zdravilom Signifor utrujeni, omotični ali imajo glavobol.
Medicinal products that prolong the QT interval
Zdravila, ki podaljšujejo interval QT
Insulin and antidiabetic medicinal products
Insulin in antidiabetiki
- Signifor may lower your heart rate.
- Zdravilo Signifor vam lahko upočasni srčni utrip.
This means that it is injected through a short needle into the fatty tissue just under the skin.
To pomeni, da ga je s kratko iglo treba injicirati v maščobno tkivo tik pod kožo.
Two months after the start of Signifor therapy, patients should be evaluated for clinical benefit.
Dva meseca po začetku zdravljenja z zdravilom Signifor je treba oceniti klinične koristi zdravljenja za bolnika.
Patients who experience a significant reduction in urinary free cortisol (UFC) levels should continue to receive Signifor for as long as benefit is derived.
Bolniki, pri katerih pride do pomembnega znižanja koncentracije prostega kortizola v urinu (angl. urinary free cortisol, UFC), bi morali še naprej prejemati zdravilo Signifor, dokler jim to koristi.
To prepare Signifor for deep intramuscular injection, please adhere to the following instructions:
Pri pripravi zdravila Signifor za globoko intramuskularno injiciranje upoštevajte naslednja navodila: