natgillin/translations-raw huggingface dataset:
Wash your hands thoroughly with soap and water and dry them with a towel.
Temeljito si umijte roke z milom in vodo in jih osušite z brisačo.
Do not inject a double dose to make up for a forgotten dose.
Ne injicirajte si dvojnega odmerka, da bi nadomestili pozabljeni odmerek.
No conclusion can be drawn with regard to clinical efficacy in this uncontrolled study.
Zaključki glede klinične učinkovitosti v tej nekontrolirani študiji niso mogoči.
Sit or lie down in a comfortable position.
Udobno sedite ali lezite.
The median duration of treatment in this study was 3.5 days.
Mediana trajanja zdravljenja v tej študiji je bila 3,5 dneva.
• Take the dose as soon as you remember.
• Odmerek injicirajte takoj, ko se spomnite.
• if you are 75 years old or older.
• če ste stari 75 let ali več.
Two patients had reports of bleeding during the study.
Pri dveh bolnikih so poročali o krvavitvi med študijo.
For additional instructions for use and handling and disposal see section 6.6.
Za dodatna navodila za uporabo in ravnanje z zdravilom ter odstranjevanje glejte poglavje 6.6.
You should inject at about the same time each day.
Zdravilo si morate injicirati vsak dan ob približno istem času.
The distribution volume of fondaparinux is limited (7-11 litres).
Volumen porazdelitve fondaparinuksa je majhen (7-11 litrov).
Do not use this medicine:
Tega zdravila ne smete uporabljati:
Where the instruction for a syringe is different this is clearly stated.
Kjer se navodila za uporabo injekcijske brizge razlikujejo, je to jasno navedeno.
• after the expiry date shown on the label and carton
• po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli;
The syringes are pre-filled with the exact dose you need.
Injekcijske brizge so napolnjene z natančnim odmerkom, ki ga potrebujete.
The majority of patients were Hispanic (67%) and 58% were male.
Večina bolnikov je bila hispanskega porekla (67 %) in 58 % je bilo moških.
10 mg once a day.
10 mg enkrat na dan.
• Do not inject Arixtra into muscle.
• Ne injicirajte zdravila Arixtra v mišico.
TVR - target vessel revascularization
TVR - revaskularizacija ciljne žile ("target vessel revascularization")
Signs include:
Med znaki so:
No studies on the effect on the ability to drive and to use machines have been performed.
Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
The elimination half-life (t½) is about 17 hours in healthy young subjects and about 21 hours in healthy elderly subjects.
Razpolovni čas izločanja (t½) je približno 17 ur pri zdravih mladih osebah in približno 21 ur pri zdravih starejših osebah.
Rare: non-protein-nitrogen (Npn) 2 increased
Redki: zvišanje vrednosti neproteinskega dušika (Npn) 2
Over 4,874 patients were studied in controlled Phase II and III clinical studies.
V kontroliranih kliničnih študijah faze II in III so proučevali več kot 4.874 bolnikov.
The safety and efficacy of 1.5 mg has not been studied.
Varnost in učinkovitost odmerka 1,5 mg nista raziskani.
Treatment should be continued for at least 5 days and until adequate oral anticoagulation is established (International Normalised Ratio 2 to 3).
Zdravljenje se mora nadaljevati vsaj 5 dni in dokler se ne vzpostavi primerna peroralna antikoagulacija (internacionalno normalizirano razmerje 2 do 3).
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Pred uporabo natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
The mortality benefit shown in the fondaparinux group was maintained until the end of follow-up at Day 180.
Korist fondaparinuksa pri zmanjšanju umrljivosti se je ohranila do konca spremljanja na 180. dan.
• fainting or dizziness, low blood pressure
• omedlevica ali omotica, nizek krvni tlak;
After subcutaneous dosing, fondaparinux is completely and rapidly absorbed (absolute bioavailability 100%).
Po subkutani uporabi se fondaparinuks popolno in hitro absorbira (absolutna biološka uporabnost 100 %).
• if you are bleeding excessively
• če prekomerno krvavite,
The majority of patients (88%) achieved target fondaparinux concentrations at 4 hours after the first dose of fondaparinux.
Večina bolnikov (88 %) je dosegla ciljno koncentracijo fondaparinuksa po 4 urah že po prvem odmerku fondaparinuksa.
The average duration of administration in clinical trials was 7 days and the clinical experience from treatment beyond 10 days is limited.
Povprečno trajanje uporabe v kliničnih preskušanjih je bilo 7 dni, klinične izkušnje z zdravljenjem, ki bi trajalo dlje kot 10 dni, so omejene.
Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no evidence for the formation of active metabolites.
Čeprav ni v celoti ovrednotena, ni dokazov za presnovo fondaparinuksa in zlasti ne za tvorbo aktivnih metabolitov.
Odds Ratio1 (95%CI)
Razmerje obetov1 (95 % IZ)
• if you have a risk of uncontrolled bleeding (haemorrhage) including:
• če imate tveganje za pojav nenadzorovane krvavitve, vključno z:
Prevention of VTE following Surgery
Preprečevanje VTE po operaciji
• if you have opened a syringe and you do not use it straightaway.
• če ste odprli injekcijsko brizgo in je niste takoj uporabili.
No clinical data on exposed pregnancies are available.
Klinični podatki o izpostavljenosti med nosečnostjo niso na voljo.
This medicinal product is for single use only.
To zdravilo je namenjeno samo za enkratno uporabo.
If co-administration is essential, close monitoring is necessary.
Če je sočasna uporaba nujna, je potreben skrben nadzor.
The risk of bleeding increases with increasing renal impairment.
Nevarnost krvavitve narašča z naraščajočo ledvično okvaro.
Types of safety syringe
Vrste varnostnih brizg
Oral absorption by the child is however unlikely.
Vendar je peroralna absorpcija pri dojenčku le malo verjetna.
• Patients who are to undergo surgery or other invasive procedures
• Bolniki, ki morajo na operacijo ali drug invaziven poseg
Clinical studies
Klinične študije
Remove the syringe from the carton and check that:
Iz škatle vzemite injekcijsko brizgo in preverite:
The majority of events were asymptomatic distal DVT.
Večina dogodkov so bile asimptomatske distalne DVT.
Release the plunger and the needle will automatically withdraw from the skin and go back into the security sleeve where it will be locked permanently (picture F).
Popustite bat in igla se bo samodejno odstranila iz kože ter se umaknila v zaščitni tulec, kjer bo trajno zaprta (slika F).
However, studies performed in Asian (Japanese) healthy subjects did not reveal a different pharmacokinetic profile compared to Caucasian healthy subjects.
Vendar raziskave z zdravimi osebami v Aziji (Japonci) niso razkrile drugačnega farmakokinetičnega profila, kot ga imajo zdravi Kavkazijci.
Rare: post-operative wound infection
Redki: pooperacijska okužba rane
• Arixtra does not have to be kept in the fridge.
• Zdravila Arixtra ni treba shranjevati v hladilniku.
Sites of administration should alternate between the left and the right anterolateral and left and right posterolateral abdominal wall.
Mesto injiciranja je treba izmenjavati med levo in desno anterolateralno in levo in desno posterolateralno stranjo trebušne stene.
As a result, the concentration of fondaparinux is expressed as milligrams (mg).
Zato koncentracijo fondaparinuksa izražamo v miligramih (mg).
Body weight - Plasma clearance of fondaparinux increases with body weight (9% increase per 10 kg).
Telesna masa - Plazemski očistek fondaparinuksa se povečuje s telesno maso (9 % povečanje na 10 kg).
Fondaparinux is intended for subcutaneous use only.
Fondaparinuks je namenjen samo za subkutano uporabo.
Severe allergic reactions (anaphylaxis): These are very rare in people (up to 1 in 10,000) taking Arixtra.
Hude alergijske reakcije (anafilaksija): Te so pri osebah, ki jemljejo zdravilo Arixtra, zelo redke (do 1 od 10.000).
Fondaparinux is excreted to 64 - 77 % by the kidney as unchanged compound.
Fondaparinuks se izloča preko ledvic, 64 - 77 % v nespremenjeni obliki.
Medical patients who are at high risk for thromboembolic complications based on an individual risk assessment
Internistični bolniki, pri katerih obstaja velika nevarnost trombemboličnih zapletov na podlagi individualne ocene tveganja
There are no data available on the effect of fondaparinux on human fertility.
Na voljo ni podatkov o vplivu fondaparinuksa na plodnost pri človeku.
• increase in the amount of non-protein nitrogen in the blood
• povečanje vrednosti neproteinskega dušika v krvi.
• Do not touch the needle or allow it to touch any surface before the injection.
• Ne dotikajte se igle in pazite, da se igla pred injiciranjem ne dotakne nobene površine.
• anxiety or confusion
• anksioznost ali zmedenost;
Arixtra is used to:
Zdravilo Arixtra se uporablja za:
You should continue Arixtra treatment for as long as your doctor has told you, since Arixtra prevents development of a serious condition.
Zdravilo Arixtra morate uporabljati tako dolgo, kot vam je predpisal zdravnik, ker zdravilo Arixtra preprečuje razvoj resnega zdravstvenega stanja.
Other medicines and Arixtra
Druga zdravila in zdravilo Arixtra
The baseline characteristics and duration of fondaparinux treatment were comparable in both UFH
Izhodiščne značilnosti in trajanje zdravljenja s fondaparinuksom so bili v obeh skupinah UFH primerljivi.
After the injection hold the syringe in one hand by gripping the security sleeve, use the other hand to hold the finger grip and pull firmly back.
Po injiciranju injekcijsko brizgo z eno roko primite za varnostni tulec, z drugo roko pa primite za držalo za prste in močno povlecite nazaj.
These instructions are for both types of syringes (automatic and manual needle protection system).
Ta navodila veljajo za obe vrsti injekcijskih brizg (s samodejnim in ročnim sistemom za zaščito igle).
The risk of these rare events may be higher with postoperative use of indwelling epidural catheters or the concomitant use of other medicinal products affecting haemostasis.
Tveganje za te redke dogodke je lahko večje pri pooperativni uporabi stalnih epiduralnih katetrov ali sočasni uporabi drugih zdravil, ki vplivajo na hemostazo.
Animal studies do not show any effect on fertility.
Raziskave na živalih niso pokazale vpliva na plodnost.
If fondaparinux sodium is added to a 0.9% saline minibag it should ideally be infused immediately, but can be stored at room temperature for up to 24 hours.
Če se fondaparinuks doda v minibag z 0,9 % fiziološko raztopino, je najbolje, da se ga infundira takoj, vendar pa se ga pri sobni temperaturi lahko shranjuje do 24 ur.
Stop taking Arixtra.
Nehajte jemati zdravilo Arixtra.
If administered via a minibag, the infusion should be given over 1 to 2 minutes.
Če zdravilo aplicirate preko minibaga, mora infuzija trajati od 1 do 2 minuti.
• treat some types of heart attack and severe angina (pain caused by narrowing of the arteries in the heart).
• zdravljenje nekaterih oblik srčnega infarkta in hude oblike angine pektoris (bolečine, ki je posledica zoženja arterij v srcu);
Efficacy was maintained up to Day 77 and was consistent across all predefined subgroups including patients with varicose veins and patients with superficial-vein thrombosis located below the knee.
Učinkovitost se je ohranila do 77. dneva in je bila konsistentna po vseh vnaprej opredeljenih podskupinah, vključno z bolniki, ki so imeli varikozne vene, in bolniki s povrhnjo vensko trombozo nižje od kolena.
A randomised, open-label, clinical trial was conducted in patients with acute symptomatic PE.
Randomizirano, odprto klinično preskušanje so opravili pri bolnikih z akutno simptomatsko PE.
Sixty-nine percent of the patients underwent surgery for cancer.
69 % bolnikov je bilo operiranih zaradi tumorja.
There are two types of syringes:
Na voljo sta dve vrsti injekcijskih brizg:
All patients received standard treatments for STEMI, including primary PCI (31%), thrombolytics (45%) or no reperfusion (24%).
Vsi bolnikih so bili standardno zdravljeni za STEMI, vključno s primarno PCI (31 %), trombolitiki (45 %) ali brez reperfuzije (24 %).
Spinal / Epidural anaesthesia
Spinalna / Epiduralna anestezija
Don't stop using Arixtra without advice
Zdravila Arixtra ne prenehajte uporabljati brez zdravnikovega nasveta
Hold the syringe firmly by the finger grip.
Injekcijsko brizgo čvrsto primite za držalo za prste.
The subcutaneous injection is administered in the same way as with a classical syringe.
Subkutano injekcijo se daje na enak način kot s klasično injekcijsko brizgo.
Treatment should be continued for a minimum of 30 days and up to a maximum of 45 days in patients at high risk of thromboembolic complications (see sections 4.4 and 5.1).
Zdravljenje se mora nadaljevati vsaj 30 dni in do največ 45 dni pri bolnikih z velikim tveganjem trombemboličnih zapletov (glejte poglavji 4.4 in 5.1).
Choose a place in the lower abdominal (tummy) area, at least 5 cm below your belly button (picture A).
Izberite mesto na spodnjem predelu trebuha, vsaj 5 cm od popka (slika A).
Treatment of Pulmonary Embolism
Zdravljenje pljučne embolije
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali bi lahko začeli jemati katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta.
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in swallowing or breathing
• oteklost, včasih oteklost obraza ali ust (angioedem), ki povzroči težave pri požiranju ali dihanju;
Elderly patients - Renal function may decrease with age and thus, the elimination capacity for fondaparinux may be reduced in elderly.
Starejši bolniki - Delovanje ledvic lahko s starostjo upada, zato je lahko pri starejših zmanjšana zmogljivost izločanja fondaparinuksa.
The injection should not be given unless haemostasis has been established (see section 4.4).
Injekcije se ne sme dati, če ni bila dosežena hemostaza (glejte poglavje 4.4).
There are no adequate data from the use of fondaparinux in pregnant women.
Ustrezni podatki o uporabi fondaparinuksa pri nosečnicah niso na voljo.
If follow up treatment with a Vitamin K antagonist is required, treatment with fondaparinux should be continued until the target INR value has been reached.
Če je potrebno nadaljevanje zdravljenja z antagonistom vitamina K, moramo zdravljenje s fondaparinuksom nadaljevati, dokler ni dosežena ciljna vrednost INR.
Death, MI or TVR at Day 30
30. dan Smrt, MI ali TVR
Elderly patients - No dosing adjustment is necessary.
Starejši bolniki - Prilagajanje odmerjanja ni potrebno.
The primary efficacy endpoint was the composite of confirmed symptomatic recurrent non-fatal VTE and fatal VTE reported up to Day 97.
Končno stanje primarne učinkovitosti je bilo sestavljeno iz potrjene simptomatske recidivne neletalne VTE in smrtne VTE, o katerih so poročali do 97. dne.
Fondaparinux should not be prescribed to pregnant women unless clearly necessary.
Fondaparinuksa nosečnicam ne smemo predpisovati, razen kadar je nedvoumno potrebno.
If you have kidney disease, the dose may be reduced to 1.5 mg once a day.
Če imate bolezen ledvic, se odmerek lahko zmanjša na 1,5 mg enkrat na dan.
• if you have a bacterial heart infection
• če imate bakterijsko okužbo srca,
The diagnosis was confirmed by objective testing (lung scan, pulmonary angiography or spiral CT scan).
Diagnozo so potrdili z objektivnimi preiskavami (slikanje pljuč, pljučna angiografija ali spiralno slikanje CT).
To treat some types of heart attack, a health professional may give the first dose into a vein (intravenously).
Pri zdravljenju nekaterih oblik srčnega infarkta vam lahko zdravstveno osebje prvi odmerek zdravila aplicira v žilo (intravensko).
If you inject too much Arixtra
Če ste injicirali prevelik odmerek zdravila Arixtra
Associated terminal half-life values were 29 h in moderate and 72 h in patients with severe renal impairment.
Pripadajoče vrednosti končnega razpolovnega časa so 29 h pri zmerni okvari in 72 h pri bolnikih s hudo okvaro ledvic.
Over 8,000 patients (hip fracture - 1,711, hip replacement - 5,829, major knee surgery - 1,367) were studied in controlled Phase II and III clinical studies.
Več kot 8.000 bolnikov (zlom kolka - 1.711, zamenjava kolka - 5.829, velike operacije kolen- 1.367) so proučevali v kontroliranih kliničnih preskušanjih II.
Instructions for use
Navodilo za uporabo
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
Four (0.3%) non-randomised patients experienced thrombus in the diagnostic catheter during coronary angiography.
Štirim (0,3 %) nerandomiziranim bolnikom se je pojavil tromb v diagnostičnem katetru med koronarno angiografijo.
The whole length of the needle should be inserted perpendicularly into a skin fold held between the thumb and the forefinger; the skin fold should be held throughout the injection.
Iglo je treba uvesti po celi dolžini navpično v kožno gubo, ki se jo drži s palcem in kazalcem; kožno gubo se mora držati ves čas injiciranja.
Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human milk.
Fondaparinuks se pri podganah izloča v mleko, ni pa znano, ali se izloča tudi pri človeku.
Arixtra should not be prescribed to pregnant women unless clearly necessary.
Zdravilo Arixtra se ne sme predpisati nosečnicam, razen če je to nujno potrebno.
The repeated dose and reproduction toxicity studies did not reveal any special risk but did not provide adequate documentation of safety margins due to limited exposure in the animal species.
Študije s ponavljajočimi odmerki in študije reproduktivne toksičnosti niso razkrile nikakršnega posebnega tveganja, zaradi omejene izpostavljenosti pri raziskovani živalski vrsti pa niso zadostno dokumentirale varnostnih mej.
Some other medicines may affect the way that Arixtra works or be affected by Arixtra.
Nekatera druga zdravila lahko vplivajo na delovanje zdravila Arixtra ali pa zdravilo Arixtra vpliva na delovanje drugih zdravil.
At higher doses, moderate changes in aPTT can occur.
V večjih odmerkih se lahko pojavijo zmerne spremembe aPTT.
If injecting in the lower abdominal area is not possible, ask your nurse or doctor for advice.
Če injiciranje v spodnjem predelu trebuha ni možno, se posvetujte z medicinsko sestro ali zdravnikom.
The efficacy and safety of fondaparinux have not been formally studied in patients with HIT type II.
Učinkovitosti in varnosti fondaparinuksa pri bolnikih s HIT tipa II niso formalno proučevali.
A similar pattern is observed in DVT and PE treatment patients.
Podoben vzorec opazujejo pri zdravljenih bolnikih z DVT in PE.
However, rare spontaneous reports of HIT in patients treated with fondaparinux have been received.
Vendar pa obstajajo redka spontana poročila o HIT pri bolnikih, zdravljenih s fondaparinuksom.
The mean age of the patients was 67 years, and approximately 60% were at least 65 years old.
Povprečna starost bolnikov je bila 67 let, približno 60 % bolnikov je bilo starih najmanj 65 let.
In a pooled analysis of these studies, the recommended dose regimen of fondaparinux versus enoxaparin was associated with a significant decrease (54% [95% CI, 44 %; 63%]) in the rate of VTE evaluated up to day 11 after surgery, irrespective of the type of surgery performed.
V zbirni analizi teh preskušanj je bila priporočena shema odmerjanja fondaparinuksa v primerjavi z enoksaparinom povezana s pomembnim zmanjšanjem (54 % [95 % IZ, 44 %; 63 %]) deleža VTE proučevano do 11 dni po operaciji, neodvisno od vrste izvedene operacije.
The difference in mortality was statistically significant in stratum 1 (placebo comparator) but not in stratum 2 (UFH comparator).
Razlika v smrtnosti je bila statistično pomembna v skupini 1 (primerjava s placebom), ne pa tudi v skupini 2 (primerjava z UHF).
Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4) in vitro.
Fondaparinuks in vitro ne zavira CYP450 (CYP1A2, CYP2A6, CYP2C9, CYP2C19,
(listed in section 6)
(glejte poglavje 4.4).
The primary outcome was a composite of peri-PCI (defined as time of randomisation up to 48 hours post-PCI) adjudicated major or minor bleeding, or major vascular access site complications.
Primarni opazovani dogodek je bil sestavljen dogodek v času okrog PCI (opredeljenem kot čas od randomizacije do 48 ur po PCI), ki je obsegal večje ali manjše krvavitve ali večje zaplete na mestu žilnega dostopa.
Remove the needle shield, by first twisting it (picture B1), and then pulling it in a straight line away from the body of the syringe (picture B2).
Odstranite ščitnik igle tako, da ga najprej zavrtite (slika B1), nato pa potegnite naravnost stran od telesa injekcijske brizge (slika B2).
The duration of treatment should not exceed that evaluated during clinical trial (mean 7 days) (see sections 4.2, 4.3 and 5.2).
Trajanje zdravljenja ne sme preseči trajanja, ovrednotenega med kliničnim preskušanjem (povprečno 7 dni) (glejte poglavja 4.2, 4.3 in 5.2).
PCI and risk of guiding catheter thrombus
PCI in tveganje za tromb vodilnega katetra
Aspen Notre Dame de Bondeville, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France.
Aspen Notre Dame de Bondeville, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, Francija
This will help to reduce the discomfort at the injection site.
Na ta način boste preprečili pojav neugodja na mestu injiciranja.
Treatment should be continued until the risk of venous thrombo-embolism has diminished, usually until the patient is ambulant, at least 5 to 9 days after surgery.
Zdravljenje se mora nadaljevati, dokler se ne zmanjša tveganje za vensko trombembolijo, ponavadi dokler se bolnik spet ne giblje, najmanj 5 do 9 dni po operaciji.
Arixtra does not contain any animal products.
Zdravilo Arixtra ne vsebuje sestavin živalskega izvora.
There is no known antidote to fondaparinux.
Antidota za fondaparinuks ne poznamo.
Similarly, no plasma clearance differences were observed between black and Caucasian patients undergoing orthopaedic surgery.
Podobno niso opazili razlik v plazemskem očistku med temnopoltimi in kavkaškimi bolniki po ortopedskih operacijah.
Initiation of appropriate therapy such as surgical haemostasis, blood replacements, fresh plasma transfusion, plasmapheresis should be considered.
Presoditi moramo o primerni terapiji, kot je kirurška hemostaza, nadomeščanje krvi, transfuzija sveže plazme in plazmafereza.
In these patients the use of prolonged prophylaxis with fondaparinux should be considered for up to an additional 24 days (see section 5.1).
Pri teh bolnikih se mora upoštevati podaljšano profilakso s fondaparinuksom vse do 24 dodatnih dni (glejte poglavje 5.1).
What Arixtra is and what it is used for
Kaj je zdravilo Arixtra in za kaj ga uporabljamo
Fondaparinux does not inactivate thrombin (activated Factor II) and has no effects on platelets.
Fondaparinuks ne deaktivira trombina (aktivirani faktor II) in nima učinka na trombocite.
The fondaparinux dose (10 mg) in the interaction studies was higher than the dose recommended for the present indications.
V študijah interakcij je bil odmerek fondaparinuksa (10 mg) večji od priporočenega odmerka za predloženo indikacijo.
The most common adverse reactions were bleeding complications (see section 4.4).
Najpogostejši neželeni učinki so bili zapleti s krvavitvami (glejte poglavje 4.4).
Overdose associated with bleeding complications should lead to treatment discontinuation and search for the primary cause.
Preveliko odmerjanje, ki je povezano z zapleti krvavenja, zahteva prekinitev zdravljenja in ugotavljanje osnovnega vzroka.
It is available in packs of 2, 7, 10 and 20 pre-filled syringes (not all pack sizes may be marketed).
Na voljo je v pakiranjih po 2, 7, 10 in 20 napolnjenih injekcijskih brizg (na trgu ni vseh navedenih pakiranj).