natgillin/translations-raw huggingface dataset:
Uncommon side effects: thrush (abnormal) decrease in white blood cells (leukopenia, neutropenia) and platelets (thrombocytopenia) allergic reaction headache, sleeplessness low blood pressure, inflammation of the veins (felt as tenderness or redness in the affected area) jaundice (yellow staining of the skin or whites of the eyes), inflammation of the mucous lining of the mouth, constipation, indigestion, stomach upset increase of certain enzymes in the blood (alanine aminotransferase increased, aspartate aminotransferase increased) itching, nettle rash increase of muscle metabolism product in the blood (blood creatinine increased) fever, injection site reaction yeast infection (candidal superinfection) 
(trombocitopenija), - alergijska reakcija, - glavobol, nespečnost, - nizek krvni tlak, vnetje ven (občutek občutljivosti ali rdečina na prizadetem področju), - zlatenica (rumeno obarvanje kože ali očesnih beločnic), vnetje ustne sluznice, zaprtost, slaba prebava, težave z želodcem, - zvišane vrednosti nekaterih encimov v krvi (zvišanje vrednosti alanin-aminotransferaze, zvišanje vrednosti aspartat-aminotransferaze), - srbenje, koprivnica, - zvišanje vrednosti produkta mišične presnove v krvi (zvišana vrednost kreatinina), - zvišana telesna temperatura, reakcija na mestu injiciranja, - glivična okužba (superinfekcija s kandido).
Tell the doctor or laboratory staff that you are taking TAZOCIN if you have to provide a blood or urine sample. 
Če morate opraviti laboratorijske preiskave krvi ali urina, zdravniku ali laboratorijskemu osebju povejte, da se zdravite z zdravilom TAZOCIN.
Each vial of Tazocin 4 g / 0.5 g contains 11.16 mmol (256 mg) of sodium. 
Ena viala zdravila Tazocin 4 g / 0,5 g vsebuje 11,16 mmol (256 mg) natrija.
The protein binding of either piperacillin or tazobactam is unaffected by the presence of the other compound. 
Piperacilin in tazobaktam pri vezavi na proteine ne vplivata drug na drugega.
A fertility and general reproduction study in rats using intraperitoneal administration of tazobactam or the combination piperacillin / tazobactam reported a decrease in litter size and an increase in fetuses with ossification delays and variations of ribs, concurrent with maternal toxicity. 
Študije vplivov piperacilina/tazobaktama na plodnost so pokazale, da se je po intraperitonealni aplikaciji pri podganah zmanjšalo število skotenih mladičev in povečalo število plodov z zakasnelo osifikacijo ter nepravilnostmi reber.
Leukopenia and neutropenia may occur, especially during prolonged therapy; therefore, periodic assessment of haematopoietic function should be performed. 
Pojavita se lahko levkopenija in trombocitopenija, še posebej pri dolgotrajnem zdravljenju.
Protein measurement with dip sticks is not affected. 
Uporaba zdravila ne vpliva na določanje proteinov s testnimi lističi.
The half-life of piperacillin and tazobactam increases with decreasing creatinine clearance. 
Z manjšanjem kreatininskega očistka se razpolovni čas piperacilina in tazobaktama daljša.
In the following table, adverse reactions are listed by system organ class and MedDRA-preferred term. 
V spodnji tabeli so neželeni učinki navedeni v skladu z MedDRA podatkovno bazo glede na organske sisteme.
TAZOCIN is compatible with lactated Ringer's solution and for co-administration via a Y-site. 
Zdravilo TAZOCIN je kompatibilno z raztopino Ringerjevega laktata in za sočasno aplikacijo preko Ymesta na infuzijskem setu.
Simultaneous co-administration via Y-site in any manner other than listed above may result in inactivation of the aminoglycoside by Tazocin. 
Pri sočasni uporabi aminoglikozida in zdravila Tazocin preko Y-mesta na infuzijskem setu na kakršenkoli drugačen način, ki ni naveden zgoraj, lahko zdravilo Tazocin povzroči inaktivacijo aminoglikozidnega antibiotika.
Simultaneous co-administration via Y-site in any manner other than listed above may result in inactivation of the aminoglycoside by TAZOCIN. 
Pri sočasni uporabi aminoglikozida in zdravila TAZOCIN preko Y-mesta na infuzijskem setu na kakršenkoli drugačen način, ki ni naveden zgoraj, lahko zdravilo TAZOCIN povzroči inaktivacijo aminoglikozidnega antibiotika.
1 vial with powder for solution for infusion. 
1 viala s praškom za raztopino za infundiranje.
Aminoglycoside TAZOCIN Dose 
Odmerek zdravila TAZOCIN
The elimination half-lives of both piperacillin and tazobactam are increased with decreasing renal clearance. 
Z zmanjšanjem ledvičnega očistka se podaljša razpolovni čas izločanja tako piperacilina kot tazobaktama.
12 x 1 vial with powder for solution for infusion. 
12 x 1 viala s praškom za raztopino za infundiranje.
5 x 1 vial with powder for solution for infusion. 
5 x 1 viala s praškom za raztopino za infundiranje.
Common side effects: diarrhoea, vomiting, nausea skin rashes 
Pogosti neželeni učinki: - driska, bruhanje, slabost, - kožni izpuščaj.
The half-life of piperacillin and of tazobactam increases by approximately 25% and 18%, respectively, in patients with hepatic cirrhosis compared to healthy subjects. 
V primerjavi z zdravimi osebami je pri bolnikih z jetrno cirozo razpolovni čas piperacilina daljši za približno 25 %, razpolovni čas tazobaktama pa za približno 18 %.
The inactivation of tobramycin and gentamicin by piperacillin has been demonstrated in patients with severe renal impairment. 
Pri bolnikih s hudo okvaro ledvic piperacilin povzroči inaktivacijo tobramicina in gentamicina.
Co-administration of TAZOCIN with aminoglycosides Due to the in vitro inactivation of the aminoglycoside by beta-lactam antibiotics, TAZOCIN and the aminoglycoside are recommended for separate administration. 
Sočasna uporaba zdravila TAZOCIN z aminoglikozidnimi antibiotiki Ker betalaktamski antibiotiki in vitro inaktivirajo aminoglikozide, je treba zdravilo TAZOCIN in aminoglikozidni antibiotik aplicirati ločeno.
4 g / 0.5 g (4 g piperacillin and 0.5 g tacobactam) 20 ml 
4 g / 0,5 g (4 g piperacilina in 0,5 g tazobaktama)
Piperacillin appears to slightly reduce the clearance of tazobactam. 
Piperacilin lahko zmanjša izločanje metotreksata.
For reconstitution instructions, see section 6.6. 
Za navodila glede rekonstitucije zdravila pred dajanjem, glejte poglavje 6.6.
Due to the in vitro inactivation of the aminoglycoside by beta-lactam antibiotics, Tazocin and the aminoglycoside are recommended for separate administration. 
Ker betalaktamski antibiotiki in vitro inaktivirajo aminoglikozide, je treba zdravilo Tazocin in aminoglikozidni antibiotik aplicirati ločeno.
25 x 1 vial with powder for solution for infusion. 
25 x 1 viala s praškom za raztopino za infundiranje.
Reconstitute each vial with the volume of solvent shown in the table below, using one of the compatible solvents for reconstitution. 
Rekonstitucijo morate opraviti z enim od kompatibilnih vehiklov za rekonstitucijo.
Tazocin (recommended dose) 
Zdravilo Tazocin (priporočeni odmerek) Odmerka ni treba prilagajati.
Neutropenic children with fever suspected to be due to bacterial infections* 
Nevtropenični otroci z zvišano telesno temperaturo, ki je domnevno posledica bakterijske okužbe.
Piperacillin and tazobactam cross the placenta. 
Piperacilin in tazobaktam prehajata skozi placento.
Each vial contains: 4 g piperacillin (as sodium salt) and 0.5 g tazobactam (as sodium salt). 
Ena viala vsebuje: 4 g piperacilina (v obliki natrijeve soli) in 0,5 g tazobaktama (v obliki natrijeve soli).
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription. 
NAČIN IZDAJANJA ZDRAVILA Predpisovanje in izdaja zdravila je le na recept, zdravilo pa se uporablja samo v bolnišnicah.
10 x 1 vial with powder for solution for infusion. 
10 x 1 viala s praškom za raztopino za infundiranje.
HOW TO STORE TAZOCIN 
SHRANJEVANJE ZDRAVILA TAZOCIN
Each vial contains 2 g piperacillin (as sodium salt) and 0.25 g tazobactam (as sodium salt). 
Ena viala vsebuje 2 g piperacilina (v obliki natrijeve soli) in 0,25 g tazobaktama (v obliki natrijeve soli).
Each vial contains 4 g piperacillin (as sodium salt) and 0.5 g tazobactam (as sodium salt). 
Ena viala vsebuje 4 g piperacilina (v obliki natrijeve soli) in 0,5 g tazobaktama (v obliki natrijeve soli).
Citrobacter freundii 
Burkholderia cepacia Citrobacter freundii Enterobacter spp.
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.