natgillin/translations-raw huggingface dataset:
The solution is to be inspected visually for particulate matter and discolouration prior to administration.
Pred aplikacijo morate pripravljeno raztopino vizualno pregledati glede prisotnosti trdnih delcev in spremembe barve.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains: 2 g piperacillin (as sodium salt) and 0.25 g tazobactam (as sodium salt).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje: 2 g piperacilina (v obliki natrijeve soli) in 0,25 g tazobaktama (v obliki natrijeve soli).
The reconstituted solutions should be withdrawn from the vial by syringe.
Rekonstituirano raztopino iz viale izvlecite z injekcijsko brizgo.
Non-species related breakpoints
Vrstno nespecifične mejne vrednosti
Dose in elderly patients
Odmerjanje pri starostnikih
Special populations
Velika Britanija
In these cases Tazocin, should be discontinued.
V primeru pojava simptomov psevdomembranskega kolitisa je treba zdravljenje z zdravilom Tazocin prekiniti.
Rare side effects: (abnormal) decrease of red blood cells or blood pigment / haemoglobin, (abnormal) decrease of red blood cells due to premature breakdown (degradation) (haemolytic anaemia), small spot bruising (purpura), bleeding of the nose (epistaxis) and bleeding time prolonged, (abnormal) increase of a specific type of white blood cells (eosinophilia) severe allergic reaction (anaphylactic/anaphylactoid reaction, including shock) flushed red skin a certain form of infection of the colon (pseudomembranous colitis), abdominal pain inflammation of the liver (hepatitis), increase of a blood pigments breakdown product (bilirubin), increase of certain enzymes in the blood (blood alkaline phosphatase increased, gammaglutamyltransferase increased)
(hemolitična anemija), majhne pikčaste krvavitve (purpura), krvavitev iz nosu (epistaksa), podaljšan čas krvavitve, (nenormalno) zvišanje števila nekaterih belih krvnih celic (eozinofilija), - huda alergijska reakcija (anafilaktična/anafilaktoidna reakcija, vključno s šokom).
TAZOCIN and the aminoglycoside should be reconstituted and diluted separately when concomitant therapy with aminoglycosides is indicated.
Če je indicirano sočasno zdravljenje z aminoglikozidom, je treba zdravilo TAZOCIN in aminoglikozidni antibiotik rekonstituirati in razredčiti ločeno.
skin reactions with redness and formation of skin lesions (exanthema, erythema multiforme), skin reactions with blistering (bullous dermatitis) joint and muscle pain poor kidney functions and kidney problems rigors chill / rigidity
vnetje jeter (hepatitis), zvišanje vrednosti produkta razgradnje krvnega pigmenta (bilirubina), zvišanje vrednosti nekaterih encimov v krvi (zvišanje vrednosti alkalne fosfataze v krvi, zvišanje vrednosti gamaglutamiltransferaze), kožne reakcije z rdečino in nastankom sprememb na koži (eksantem, multiformni eritem), kožne reakcije s pojavom mehurjev na koži (bulozni dermatitis), bolečina v sklepih in mišicah, slabo delovanje ledvic in težave z ledvicami, mrzlica / okorelost.
No dose adjustment needed.
ZdraviloTazocin (priporočeni odmerek) Odmerka ni treba prilagajati.
medicines to thin your blood or to treat blood clots (e.g. heparin, warfarin or aspirin).
(npr. heparin, varfarin ali acetilsalicilna kislina).
Treatment in this group can therefore not be recommended.
Zdravljenja za to skupino zato ni mogoče priporočiti.
Patients should be instructed:
Bolnikom je treba naročiti:
Altogether 30 female partners participated in the study.
V študiji je sodelovalo skupno 30 partnerk.
Date of first authorisation: 28 February 2011 Date of latest renewal: 18 January 2016
Datum prve odobritve: 28. februar 2011 Datum zadnjega podaljšanja: 18. januar 2016
Thus, the carcinogenic risk is unknown.
Zato kancerogeni potencial ni znan.
For each injection, follow steps 4-10.
Za vsako injekcijo sledite korakom 4 - 10.
Long-term efficacy and safety
Dolgoročna učinkovitost in varnost
Emergency medication for treatment of potential allergic reactions should be available.
Na voljo mora biti zdravilo za nujne primere za zdravljenje možnih alergijskih reakcij.
Patients were however followed up to 36 weeks.
Vendar je sledenje bolnikov trajalo do 36 tednov.
• sudden loss of the ability to maintain an erection
• nenadno izgubo zmožnosti ohranjanja erekcije
As this medicine is administered to you by your doctor it is very unlikely that you will be given an incorrect dose.
Ker vam bo to zdravilo dal vaš zdravnik, je malo verjetno, da boste dobili nepravilen odmerek.
The reduction of the curve achieved will vary between individuals.
Dosežena zmanjšanja ukrivljenost se med posamezniki razlikuje.
Follow-up Interval (days)
Interval spremljanja (dni)
Before you are given this medicine, make sure your doctor knows:
Preden boste dobili to zdravilo, se prepričajte, da je vaš zdravnik seznanjen:
Reduced peripheral circulation may be one contributing factor for finger necrosis.
Zmanjšana periferna cirkulacija je lahko dejavnik, ki prispeva k nekrozi prsta.
The two classes of collagenases have similar but complementary substrate specificity.
Oba razreda kolagenaz imata podobne, vendar komplementarne substratne posebnosti.
No formal studies on elimination have been performed.
Izločanje Formalne študije izločanja niso bile izvedene.
No overall differences in safety or effectiveness were observed between elderly and younger patients.
Med starostniki in mlajšimi bolniki na splošno niso opazili razlik v varnosti ali učinkovitosti.
Results showed no cross-reactivity with any of the five MMPs tested.
Rezultati niso pokazali navzkrižne reaktivnosti z nobenim od petih testiranih MMP.
This is particularly important for cords situated at the PIP joint of the fifth finger.
To je zlasti pomembno za vozliče PIP sklepa v petem prstu.
Patients should be instructed to consult a doctor immediately if they experience any of these signs or symptoms.
Bolnikom je treba naročiti, naj se takoj posvetujejo z zdravnikom, če se pojavijo kateri od teh znakov ali simptomov.
The potential risk for humans on parturition and postnatal development is unknown.
Možno tveganje za ljudi glede vpliva na porod in postnatalni razvoj ni znano.
If you notice such symptoms you should inform your doctor.
Če opazite take simptome, morate obvestiti svojega zdravnika.
All plasma levels were below the limits of quantification within 30 minutes following dosing.
Vse ravni v plazmi so bile pod mejo merljivosti v 30 minutah po odmerjanju.
Greater patient satisfaction was correlated with improved range of motion (r=0.51, p<0.001).
Večje zadovoljstvo bolnikov je koreliralo z izboljšanim razponom gibanja (r = 0,51, p < 0,001).
IIEF erectile function**
Erektilna funkcija IIEF**
There were no changes in the international index of erectile function (IIEF) scores.
Sprememb v ocenah mednarodnega indeksa erektilne funkcije (IIEF, international index of erectile function) ni bilo.
Bending your penis should not cause any pain or discomfort.
Upogibanje penisa ne sme povzročati bolečin ali nelagodja.
Improvement was observed regardless of joint type or finger involvement (range: 60.5% to 83.9%).
Izboljšanje so opazili ne glede na vrsto sklepa ali vpletenost prsta (razpon: 60,5 % do 83,9 %).
For plaques that are only a few millimetres in width, the distance of withdrawal of the syringe may be very minimal.
Za plake, ki so široki le nekaj milimetrov, je lahko razdalja do izvleka brizge zelo majhna.
**Note: 22 subjects were excluded from this analysis.
**Opomba: 22 oseb je bilo izključenih iz analize.
c The nominal rate of recurrence was the total number of recurrences occurring prior to the last day of the interval divided by the total number of joints (×100).
c Nominalni delež ponovitve je bil celotno število ponovitev, ki se je pojavile pred zadnjim dnem intervala, deljeno s številom sklepov (×100).
Direct pressure on the injection site should be avoided.
Direktnemu pritisku na mesto injiciranja se je treba izogibati.
Using an aseptic technique, the following procedure for reconstitution must be followed:
Z uporabo aseptične tehnike se je treba držati naslednjih navodil za postopek rekonstitucije:
No systemic toxicity was observed in this study at any dose level.
V tej študiji pri nobenem nivoju odmerka niso opažali sistemske toksičnosti.
Be sure to ask your doctor when you can resume normal activities after treatment with Xiapex.
Ne pozabite vprašati svojega zdravnika, kdaj se lahko vrnete k opravljanju normalnih aktivnosti po zdravljenju z zdravilom Xiapex.
Intralesional use.
Intralezijska uporaba.
• Your doctor will show you how to gently stretch and straighten your penis the right way.
• Zdravnik vam bo pokazal, kako nežno raztezate in ravnate penis na pravilni način.
• if you have had an allergic reaction to a previous Xiapex injection.
• če ste imeli alergijsko reakcijo na prejšnjo injekcijo zdravila Xiapex.
The duration of assessment started at the day of success (visit after the last injection where the 0° to 5° measurement was first recorded).
Trajanje ocenjevanja se je začelo z dnem uspeha (obisk po zadnji injekciji, ko je bilo prvič izmerjenih 0° do 5°).
It is recommended to avoid strenuous activities of your finger until instructed further by your doctor.
Priporočljivo je, da se izogibate napornim aktivnostim s svojim prstom, dokler vam zdravnik ne da nadaljnjih navodil.
The interval between treatment cycles is approximately six weeks.
Interval med cikli zdravljenja je približno šest tednov.
Together, these collagenases work to provide broad hydrolytic activity towards collagen.
Skupaj te kolagenaze delujejo tako, da zagotovijo široko hidrolitično aktivnost proti kolagenu.
Your doctor will tell you when to come back for this.
Zdravnik vam bo povedal, kdaj se boste vrnili za ta postopek.
• unpleasant taste
• neprijeten okus
• difficulty urinating or blood in the urine
• težave z uriniranjem ali kri v urinu
The median duration of disease was 4.9 years (range 2.0 to 27.9 years).
Mediana trajanja bolezni je bila 4,9 leta (razpon od 2,0 do 27,9 leta).
• fractured finger • loss of finger or finger parts
• zlomljen prst; • izguba prsta ali delov prsta.
Percentage of patients who achieved reduction in contracture to 5° or less (Last injection)
Delež bolnikov, ki so dosegli zmanjšanje kontrakture na 5° ali manj (zadnje injiciranje)
For patients who achieved a contracture of the selected joint to 5° or less, the mean number of injections required to achieve this was 1.5 in the 2 studies.
Pri bolnikih, ki so dosegli kontrakturo izbranih sklepov 5° ali manj, je bilo povprečno število injekcij, ki so bile potrebne za doseganje tega stanja, 1,5 v obeh študijah.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
The figures 1 and 2 below are for illustrative purposes only and may not be representative of the precise location of anatomical structures in an individual patient.
Sliki 1 in 2 spodaj služita samo prikazu in ni nujno, da predstavljata natančno mesto anatomskih struktur pri posameznem bolniku.
Preparation - Reconstitution procedure
Priprava - postopek rekonstitucije
These differences account for the ability of the two classes of enzymes to digest collagen in a complementary manner.
Te razlike utemeljujejo sposobnost obeh encimskih razredov, da razgradijo kolagen na komplementaren način.
A treatment course consists of a maximum of 4 treatment cycles.
Postopek zdravljenja sestavljajo največ 4 cikli zdravljenja.
• Let go of the tip of your penis and let your penis return to its normal length.
• Izpustite konico penisa in počakajte, da se penis vrne na normalno dolžino.
In Study AUX-CC-867, most (85%) subjects received local anaesthesia prior to the finger extension procedure.
V študiji AUX-CC-867 je večina (85 %) oseb prejela lokalno anestezijo pred postopkom iztegovanja prsta.
These data support the long-term safety profile of Xiapex confirming that no new safety risks were identified during the 5 year follow-up period.
Ti podatki podpirajo dolgoročni varnostni profil zdravila Xiapex in potrjujejo, da v 5-letnem obdobju spremljanja niso ugotovili novih tveganj, povezanih z varnostjo.
• Your doctor will also tell you when to come back if more treatment cycles are needed.
• Zdravnik vam bo povedal tudi, kdaj se boste vrnili za več ciklov zdravljenja, če bodo potrebni.
• Your doctor will tell you when you can resume sexual activity after each treatment cycle.
• Zdravnik vam bo povedal, kdaj lahko ponovno postanete spolno aktivni po vsakem ciklu zdravljenja.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili ali vehikli za rekonstitucijo, razen s tistimi, ki so omenjena v poglavju 6.6.
Age category (years), n (%)
povprečje starostna kategorija (leta), n (%)
Nominal Change in Recurrence Rate vs Previous Year (%)
Nominalna sprememba deleža ponovitve v primerjavi s prejšnjim letom (%)
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE sight and REACH OF CHILDREN
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
• If you are allergic to collagenase clostridium histolyticum or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na kolagenazo clostridium histolyticum ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Patients must be instructed to avoid potentially hazardous tasks such as driving or using machines until it is safe to do so or as advised by the physician.
Bolnikom je treba naročiti, naj se izogibajo morebitnim nevarnim opravilom, kot je vožnja ali uporaba strojev, dokler to ni varno oziroma dokler jim tega ne svetuje zdravnik.
Cases of finger necrosis have been reported, which in some cases led to amputation of finger parts.
Poročali so o primerih nekroze prstov, zaradi katere je bila v nekaterih primerih potrebna amputacija delov prstov.
Severe allergic reaction has been reported uncommonly (1 case).
Občasno so poročali o hudi alergijski reakciji (1 primer).
In Studies 1 and 2, the co-primary endpoints were:
Sočasni primarni opazovani dogodki v študiji 1 in 2 so bili:
For many people, a contracture causes significant difficulties with performing everyday tasks like driving, shaking hands, playing sports, opening jars, typing or holding objects.
Za mnoge ljudi kontraktura predstavlja pomembno oviro pri izvajanju vsakodnevnih opravil, na primer vožnja, rokovanje, ukvarjanje s športom, odpiranje kozarcev, tipkanje ali držanje predmetov.
The mean age was 63 years (range 33 to 89 years) and 80% of patients were male.
Povprečna starost je bila 63 let (razpon 33 do 89 let) in 80 % bolnikov je bilo moških.
There will be a small amount of reconstituted solution left in the vial.
V viali bo ostala majhna količina rekonstituirane raztopine.
Hold the penis in this more straightened position for 30 seconds, then let go.
Penis 30 sekund držite v tem bolj izravnanem položaju, nato ga izpustite.
You must not be given Xiapex if you know that you have had a serious allergic reaction to collagenase or any of the other ingredients.
Zdravila Xiapex ne smete dobiti, če veste, da ste imeli resno alergijsko reakcijo na kolagenazo ali katerokoli drugo sestavino zdravila.
No new safety signals were identified during the 5 year follow-up period.
V 5-letnem obdobju spremljanja niso ugotovili novih signalov, povezanih z varnostjo.
The duration of assessment ended at the last available measurement or at the day of medical intervention for joints that did not recur and the recurrence day for recurrent joints.
Trajanje ocenjevanja se je končalo z zadnjo razpoložljivo meritvijo ali na dan zdravniškega posega za sklepe, pri katerih ni bilo ponovitve, in dan ponovitve za sklepe, pri katerih je do ponovitve prišlo.
Xiapex is indicated for:
Zdravilo Xiapex je indicirano za:
• avoidance of sex
• izogibanje spolnosti
At study entry, patients must have had penile curvature deformity of at least 30 degrees in the stable phase of Peyronie's disease.
Ob vstopu v študijo so morali imeti bolniki deformacijo ukrivljenosti penisa vsaj 30 stopinj v stabilni fazi Peyroniejeve bolezni.
All p-values < 0.001 for all comparisons between Xiapex and placebo, except for PIP joints in Study CORD II which was not eligible for statistical testing due to a hierarchical testing procedure.
Vse p-vrednosti < 0,001 za vse primerjave med zdravilom Xiapex in placebom, razen za sklepe PIP v študiji CORD II, ki zaradi hierarhičnega testnega postopka ni bil primeren za statistično testiranje.
Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, or embryonal/foetal development, (see section 5.3).
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na plodnost, nosečnost ali razvoj zarodka/plodu (glejte poglavje 5.3).
Penile modelling procedure
Postopek modeliranja penisa
Neutralizing antibodies were assayed for a subset of 70 samples selected to be representative of high and low titer binding antibody responses at week 12 of treatment.
Nevtralizirajoča protitelesa so bila testirana pri podskupini 70 vzorcev, izbranih kot reprezentativnih za visok in nizek titer odgovora vezavnih protiteles v 12. tednu zdravljenja.
The clinical efficacy in study AUX-CC-862 was similar to that reported in studies CORD I and CORD II.
Klinična učinkovitost v študiji AUX-CC-862 je bila podobna tisti, o kateri so poročali v študijah CORD I in CORD II.
If the curvature deformity is less than 15 degrees after the first, second or third treatment cycle, or if the physician determines that further treatment is not clinically indicated, then the subsequent treatment cycles should not be administered.
Če je deformacija ukrivljenosti po prvem, drugem ali tretjem ciklu zdravljenja manjša od 15 stopinj ali če zdravnik določi, da nadaljnje zdravljenje ni klinično indicirano, se naknadnih ciklov zdravljenja ne sme izvršiti.
This is a disease that causes your finger(s) to bend inward.
To je bolezen, ki povzroči upogib vašega prsta (vaših prstov) navznoter v dlan.
• The treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy (see sections 4.2 and 4.4).
• zdravljenje odraslih moških s Peyroniejevo boleznijo z otipljivim plakom in deformacijo ukrivljenosti na začetku zdravljenja vsaj 30 stopinj (glejte poglavji 4.2 in 4.4).
After confirming that the needle is correctly placed in the cord, inject approximately one-third of the dose.
Potem, ko ste preverili, da je igla pravilno nameščena v vozliču, injicirajte približno eno tretjino odmerka.
• Xiapex is given as part of a treatment cycle.
• Zdravilo Xiapex se daje kot del cikla zdravljenja.
Retreatment of recurrent contractures
Ponovno zdravljenje ponovljenih kontraktur
Early diagnosis and prompt evaluation and treatment are important because tendon rupture/ligament injury may potentially affect overall hand function.
Zgodnja diagnoza in hitra ocenitev ter zdravljenje so pomembni, saj lahko ruptura kite/poškodba ligamenta vpliva na splošno funkcijo roke.
The goal is always to deposit the full dose entirely within the plaque.
Cilj je vedno vnos celotnega odmereka znotraj plaka.
Peyronie's disease occurs exclusively in adult male patients and hence there is no relevant information for use in females.
Peyroniejeva bolezen se pojavlja samo pri odraslih moških bolnikih, zato za uporabo pri ženskah ni relevantnih podatkov.
Your doctor must not use Xiapex if the reconstituted solution is discoloured or contains particles.
Vaš zdravnik ne sme uporabiti zdravila Xiapex, če je rekonstituirana raztopina obarvana ali vsebuje delce.
The signs and symptoms of Peyronie's disease are caused by a collagen plaque.
Znaki in simptomi Peyroniejeve bolezni so posledica kolagenskega plaka.
Collagenases are proteinases that hydrolyze collagen under physiological conditions.
Kolagenaze so proteinaze, ki hidrolizirajo kolagen v fizioloških pogojih.
Other minor influences on the ability to drive and use machines include dizziness, paresthesia, hypoesthesia, and headache that have also been reported following injection of Xiapex.
Drugi manjši vplivi na sposobnost vožnje in upravljanja strojev vključujejo omotico, parestezijo, hipestezijo in glavobol, ki so jih prav tako opisovali po injekciji zdravila Xiapex.
The maximal individual plasma concentrations of AUX-I and AUX-II were <29 ng/mL and <71 ng/mL, respectively.
Največji posamični koncentraciji AUX-I oz. AUX-II v plazmi sta bili < 29 ng/ml oz. < 71 ng/ml.
Treatment of two concurrent injections
Zdravljenje z dvema sočasnima injekcijama
This is called a corporal rupture or penile fracture.
Temu se reče ruptura korpusa ali zlom penisa.
The median age of the patients included was 60, ranging between 33 and 77 years.
Mediana starost vključenih bolnikov je bila 60 let, z razponom med 33 in 77 leti.
j) The second injection of each treatment cycle should be made approximately 2 to 3 mm apart from the first injection.
j) Drugo injekcijo vsakega cikla zdravljenja je treba aplicirati približno 2 do 3 mm proč od prve injekcije.
The majority of the skin lacerations occurred on the manipulation day.
Večina raztrganin kože se je pojavila na dan obravnave.
Time of finger extension after injection had no impact on the rate of clinical success for either MP or PIP joints.
Čas iztegovanja prsta po injiciranju ni vplival na stopnjo kliničnega uspeha za MP ali PIP sklepe.
In addition, seropositivity for neutralizing anti-AUX-I and anti-AUX-II antibodies was maintained.
Poleg tega je bila ohranjena seropozitivnost za nevtralizirajoča protitelesa proti AUX-I in proti AUX-II.
• increased white blood cells
• povečano število belih krvnih celic
The safety of more than one treatment course of Xiapex for Peyronie's disease is not known.
Varnost več kot enega postopka zdravljenja z zdravilom Xiapex za Peyroniejevo bolezen ni znana.
Use in patients with coagulation disorders
Uporaba pri bolnikih z motnjami koagulacije
In patients treated for these two indications, there was no apparent correlation of antibody frequency, antibody titers, or neutralizing status to clinical response or adverse reactions.
Pri bolnikih, zdravljenih za ti dve indikaciji, ni bilo očitne povezave med pogostnostjo protiteles, titrov protiteles ali nevtralizirajočega statusa in kliničnim odzivom ali neželenimi učinki.
Xiapex must be used with caution in patients with coagulation disorders or those taking anticoagulants.
Zdravilo Xiapex je treba pri bolnikih z motnjami koagulacije ali pri tistih, ki jemljejo antikoagulante, uporabljati previdno.
Your doctor will take care of storing, handling and disposing of Xiapex.
Zdravnik bo poskrbel za shranjevanje, pripravo in odstranjevanje zdravila Xiapex.
The two polypeptides are purified by chromatographic steps customary for the separation and isolation of biotherapeutic proteins to yield a consistent, well characterized and controlled mixture of two collagenase enzymes.
Oba polipeptida sta očiščena s kromatografskimi koraki, ki so običajni za separacijo in izolacijo bioterapevtskih beljakovin, da nastane konsistentna, jasno opredeljena in nadzorovana mešanica dveh encimov kolagenaz.
• Recognition and treatment of severe immune-mediated reaction, including anaphylaxis.
• prepoznava in zdravljenje hudih imunsko pogojenih reakcij, vključno z anafilaksijo,
• painful erection, painful sex and erectile dysfunction.
• boleča erekcija, boleč spolni odnos in erektilna disfunkcija
N (%) of Joints in Each Intervala
N (%) sklepov za vsak intervala
The median age was 58 years (range 23 to 84 years).
Mediana starost je bila 58 let (razpon od 23 do 84 let).
The plaque may interfere with the ability to get a straight erection because the plaque will not stretch as much as the rest of the penis.
Plak lahko vpliva na sposobnost ravne erekcije, saj se ne raztegne toliko kot preostanek penisa.
If more than one plaque is present, only the plaque causing the curvature deformity should be injected.
Če je prisoten več kot en plak, je treba injicirati samo v plak, ki povzroča ukrivljenost.