natgillin/translations-raw huggingface dataset:
4.7 Effects on ability to drive and use machines Revasc has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Revasc nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
The reconstituted solution should be used as soon as possible (see section 6.3 above).
Pripravljeno raztopino je treba uporabiti čim prej (glejte poglavje 6.3 zgoraj).
It is often given for several days after operations because blood clots are most likely to form when you are resting in bed.
Pogosto se daje več dni po operaciji, kajti verjetnost, da nastanejo krvni strdki, je največja, kadar ležite v postelji.
This decrease can be considered unlikely to be of clinical significance, thus requiring no dose reduction.
Ni verjetno, da bi bilo to zmanjšanje klinično pomembno, zato odmerka ni treba zmanjšati.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 July 1997
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve: 9. julij 1997
Some of these side effects may be similar to the effects of surgery.
Nekateri teh neželenih učinkov so lahko podobni posledicam operacije.
If necessary, plasma expanders and/or blood transfusion may be used.
Če je potrebno, je mogoče uporabiti plazemske ekspanderje in/ali transfuzijo krvi.
In the absence of compatibility studies, this medicinal product must not be mixed with other
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
The first injection should be initiated 5 to 15 minutes before surgery but after induction of regional block anaesthesia, if used.
Prvo injekcijo je treba začeti od 5 do 15 minut pred operacijo, vendar po indukciji regionalne anestezije z blokom, če se ta uporabi.
Powder for injection
voda za injekcije
- bleeding in the gut or lung within the past three months.
- krvavitev v črevo ali pljuča v zadnjih treh mesecih.
Increase in serum transaminases
Preiskave porast serumskih transaminaz
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C when reconstitution has taken place in controlled and validated aseptic conditions.
Če ga ne uporabite takoj, je za trajanje in razmere shranjevanja pred uporabo odgovoren uporabnik, čas shranjevanja naj normalno ne presega 24 ur pri 2 do 8 °C, če je bilo zdravilo rekonstituirano v kontroliranih in validiranih aseptičnih razmerah.
Instructions for the preparation of Revasc are provided in section 6.6.
Navodila za pripravo Revasca so v poglavju 6.6.
If a dose of this medicine is missed, it should be given to you as soon as possible.
Če niste prejeli enega odmerka tega zdravila, ga morate prejeti, čim je mogoče.
Do not use Revasc if you notice that the solution for injection contains visible particles.
Ne uporabljajte Revasca, če ste opazili, da raztopina za injiciranje vsebuje vidne delce.
The recommended dose is 15 mg twice daily.
Priporočeni odmerek je 15 mg dvakrat na dan.
This applies to both prescription and non-prescription medicines, especially:
To velja tako za zdravila na recept kot tista, ki so na voljo brez recepta, še zlasti za:
If you are of a child-bearing age, a pregnancy test may be done by your doctor to make sure you are not
Če ste v rodni dobi, bo zdravnik morda napravil nosečnostni test, da se bo prepričal, da niste noseči.
It is advisable not to breast-feed during treatment.
Priporočljivo je, da med zdravljenjem ne dojite.
You should also inform your doctor if you have ever received Revasc, hirudin or an hirudin analogue.
Zdravniku morate tudi povedati, če ste kdaj v preteklosti dobili Revasc, hirudin ali kakšen hirudinski analog.
- If you have any further questions, ask your doctor, nurse or your pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, medicinsko sestro ali s farmacevtom.
If it is almost time for the next dose you will skip the missed dose and go back to the normal dosage schedule.
Če je že skoraj čas za naslednji odmerek, izpuščenega odmerka ne boste dobili in nadaljevali boste običajni razpored odmerjanja.
The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, in predložen v modulu 1.8.1 za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
It is not known whether desirudin is excreted in human milk.
Ni znano, ali se desirudin izloča v materinem mleku.
4.4 Special warnings and precautions for use
4.4 Posebna opozorila in previdnostni ukrepi Opozorila
Cross-sensitivity to other hirudin products is possible.
Možna je navzkrižna preobčutljivost z drugimi hirudinskimi zdravili.
If co-administration cannot be avoided, close clinical and laboratory monitoring should be conducted (see section 4.4).
Če se sočasni uporabi ni mogoče izogniti, je potrebno natančno klinično in laboratorijsko nadziranje (glejte poglavje 4.4).
WHAT REVASC IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO REVASC IN ZA KAJ GA UPORABLJAMO
** corresponding to approximately 270,000 antithrombin units (ATU) or 18,000 ATU per mg of desirudin with reference to the WHO Second International Standard for alpha-thrombin.
** ustreza približno 270.000 antitrombinskim enotam (ATE) ali 18.000 ATE na mg desirudina po Drugem mednarodnem standardu SZO za alfa-trombin.
- with severe uncontrolled hypertension and subacute bacterial endocarditis.
- pri bolnikih s hudo neobvladano hipertenzijo in subakutnim bakterijskim endokarditisom.
4.2 Posology and method of administration Treatment with Revasc should be initiated under the guidance of a physician with experience in coagulation disorders.
4.2 Odmerjanje in način uporabe Zdravljenje z Revascom je treba začeti pod nadzorstvom zdravnika, izkušenega v zdravljenju koagulacijskih motenj.
Like all medicines, Revasc can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Revasc neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Treatment initiation with Revasc should be undertaken only in a setting where medical assistance is readily available and where there is access to treatment for anaphylactic reactions.
Zdravljenje z Revascom se sme začeti le v okolju, kjer je takoj na voljo zdravniška pomoč in kjer obstaja možnost za zdravljenje anafilaktičnih reakcij.
Anaphylaxis: Revasc may cause allergic reactions including anaphylaxis and shock (see section 4.8).
Anafilaksa: Revasc lahko povzroči alergijske reakcije, vključno z anafilaksijo in šokom (glejte poglavje 4.8).
Metabolites lacking one or two C-terminal amino acids constitute a minor proportion of the material recovered from urine (<7%).
Presnovka brez ene ali dveh C-terminalnih aminokislin predstavljata zelo majhen (<7%) delež snovi, izločenih v urinu.
The anticoagulant effect of desirudin is poorly reversible.
Antikoagulantni učinek desirudina je slabo reverzibilen.
However, the in-use stability has been demonstrated for 24 hours between 2°C and 8°C (in a refrigerator).
24 ur pri temperaturi med 2 °C in 8 °C (v hladilniku).
The usual dosage is 15mg injected twice a day for 9 days to a maximum of 12 days.
Običajni odmerek je 15 mg, injiciran dvakrat na dan od 9 do največ 12 dni.
The anticoagulant properties of desirudin are demonstrated by its ability to prolong the clotting time of human or rat plasma whether induced directly (thrombin time) or via the intrinsic (aPTT) or extrinsic (PT) pathways.
Antikoagulantne lastnosti desirudina se kažejo z njegovo sposobnostjo za podaljšanje časa strjevanja človeške ali podganje plazme, izzvanega neposredno (trombinski čas) ali po intrinzični (aPTČ) ali ekstrinzični (PČ) poti.
* produced by recombinant DNA technology in yeast cells.
* pridobljen s tehnologijo rekombinantne DNA v celicah kvasovk.
Laboratory Tests: Activated partial thromboplastin time (aPTT) should be monitored in patients with increased risk of bleeding and/or renal or hepatic impairment.
Laboratorijske preiskave: Aktivirani parcialni tromboplastinski čas (aPTČ) je treba kontrolirati pri bolnikih z večjim tveganjem za krvavitve in/ali okvaro ledvic ali jeter.
Although fatal reactions have not been reported with desirudin, alternative treatment options must be considered before the decision to re-expose a patient to Revasc.
Čeprav pri desirudinu niso poročali o usodnih reakcijah, je treba pred odločitvijo o ponovni uporabi Revasca pri bolniku pretehtati druge možnosti zdravljenja.
Revasc is contraindicated in pregnancy (see section 4.3).
Revasc je kontraindiciran med nosečnostjo (glejte poglavje 4.3).
Do not use Revasc after the expiry date which is stated on the carton and the pack.
Zdravila Revasc ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in ovojnini.
Keep the vial and ampoule in the outer carton in order to protect from light.
Vialo in ampulo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
In patients with mild or moderate renal impairment (creatinine clearance between 31 and 90 ml/min; see section 4.4) activated partial thromboplastin time (aPTT) should be monitored.
Pri bolnikih z blago ali zmerno okvaro ledvic (očistek kreatinina med 31 in 90 ml/min, glejte poglavje 4.4) je treba kontrolirati aktivirani parcialni tromboplastinski čas (aPTČ).
EU/1/97/043/002 10 vials/10 ampoules of solvent EU/1/97/043/003 1 vial/1 ampoule of solvent
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/97/043/001 2 viali/2 ampuli vehikla EU/1/97/043/002 10 vial/10 ampul vehikla EU/1/97/043/003 1 viala/1 ampula vehikla
Blood and the lymphatic system disorders Common:
Bolezni krvi in limfatičnega sistema pogosto:
The other ingredients in the powder are magnesium chloride and sodium hydroxide.
Pomožni snovi v prašku sta magnezijev klorid in natrijev hidroksid.
If a patient is switched from oral anticoagulants to desirudin therapy or from desirudin to oral anticoagulants, the anticoagulant activity should continue to be closely monitored with appropriate methods.
Če bolnik preide s peroralnih antikoagulantov na desirudin ali z desirudina na peroralne antikoagulante, je treba antikoagulantni učinek še naprej kontrolirati z ustreznimi metodami.
Desirudin is a highly potent and selective inhibitor of free circulating and clot-bound thrombin.
Desirudin je zelo močan in selektiven zaviralec prosto krožečega in v strdkih vezanega trombina.
Solvent for parenteral use
Vehikel za parenteralno uporabo
Do not use reconstituted vials containing visible particles.
Ne uporabite pripravljenih vial, v katerih so vidni delci.
aPTT levels can, however, be reduced by intravenous administration of DDAVP (desmopressin).
aPTČ je mogoče skrajšati z intravensko uporabo DDAVP (dezmopresina).
Monitoring for evidence of bleeding is advised (see section 4.5).
Priporočeno je spremljanje glede morebitnih znakov krvavitve (glejte poglavje 4.5).
You will be given Revasc as an injection under the skin.
KAKO UPORABLJATI ZDRAVILO REVASC Revasc boste dobivali v injekciji pod kožo.
Desirudin has no profibrinolytic activity.
Desirudin ne deluje profibrinolitično.
Desirudin belongs to a group of medicines called anticoagulants, which prevent blood clots from forming in the blood vessels.
Desirudin spada v skupino zdravil, ki jih imenujemo antikoagulanti in preprečujejo nastanek krvnih strdkov v žilah.
Pack sizes: 1 vial and 1 ampoule in one package 2 vials and 2 ampoules in one package 10 vials and 10 ampoules in one package
1 viala in 1 ampula v enem zavitku 2 viali in 2 ampuli v enem zavitku 10 vial in 10 ampul v enem zavitku
There is no experience with Revasc in children.
Otroci Pri otrocih ni izkušenj z Revascom.
The most likely side effect is bleeding.
Najverjetnejši neželeni učinek so krvavitve.
Treatment with desirudin is then continued twice daily post-operatively for 9 to a maximum of 12 days or until the patient is fully mobile, whichever occurs first.
Zdravljenje z desirudinom se po operaciji nadaljuje dvakrat na dan od 9 do največ 12 dni oz. dokler bolnik ni popolnoma pokreten, kar se pač zgodi prej.
There is no antidote for desirudin.
Proti desirudinu ni antidota.
The effects of desirudin and unfractionated heparins on prolongation of aPTT have been shown to be additive (see section 4.4).
Ugotovljeno je, da so učinki desirudina in nefrakcioniranih heparinov na podaljšanje aPTČ aditivni (glejte poglavje 4.4).
The total urinary excretion of unchanged desirudin amounts to 40-50 % of the administered dose.
Skupna količina v urinu izločenega nespremenjenega desirudina predstavlja od 40 do 50%
The total and renal clearances of desirudin are slightly reduced in elderly subjects compared to young volunteers.
V primerjavi z mladimi prostovoljci sta celotni in ledvični očistek desirudina pri starejših osebah rahlo zmanjšana.
Reproductive toxicology studies in animals showed desirudin to be teratogenic with changes comprising spina bifida in rabbits and omphaloceles in rats.
Študije reproduktivne toksičnosti na živalih so pokazale, da je desirudin teratogen; spremembe so obsegale spino bifido pri kuncih in omfalokele pri podganah.
Ask you pharmacist how to dispose of medicines no longer required.
O načinu odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom.
Allergic reactions have been reported in the same proportion (1.6%) of patients treated with desirudin (N=2,367) or with unfractionated heparin (N=1,1 34) in clinical trials, regardless of causality.
(1,6 %) bolnikov, zdravljenih z desirudinom (n = 2.367) ali nefrakcioniranim heparinom (n = 1.134), ne glede na vzrok.
However, lactating mothers should be advised to avoid breast feeding or alternative
Vendar je treba doječim materam svetovati, naj ne dojijo ali naj uporabljajo druga zdravila.
Overdose with Revasc may lead to bleeding.
Prevelik odmerek zdravila Revasc lahko povzroči krvavitev.
Mean absorption time of subcutaneous (SC) desirudin is 4.1, 4.5 and 5.4 h for dose levels of 0.1, 0.3 and 0.5 mg/kg, respectively (overall mean = 4.6 h).
Povprečni čas absorpcije subkutanega (s.c.) desirudina je po odmerku 0,1 mg/kg 4,1 ure, po 0,3 mg/kg 4,5 ure in po 0,5 mg/kg 5,4 ure (celotno povprečje = 4,6 ure).
Powder: magnesium chloride, sodium hydroxide Solvent: mannitol, water for injections
SEZNAM POMOŽNIH SNOVI Prašek: magnezijev klorid, natrijev hidroksid Vehikel: manitol, voda za injekcije
The concomitant use of desirudin with thrombolytics and ticlopidine has not been investigated in this patient population.
Sočasna uporaba desirudina s trombolitiki in tiklopidinom pri tej populaciji bolnikov ni raziskana.
Peak aPTT should not exceed twice the control value.
Najvišji aPTČ ne sme preseči dvakratne normalne vrednosti.
Metabolism and elimination
Presnova in eliminacija
Desirudin is distributed in the extracellular space with a distribution volume at steady state of 0.251/kg independently of the dose.
Desirudin se distribuira v zunajcelični prostor z distribucijskim volumnom v stanju dinamičnega ravnotežja 0,25 l/kg, neodvisno od odmerka.
If this occurs, Revasc will be stopped and treatment given for the bleeding.
V takem primeru vam bodo Revasc ukinili in vas zdravili zaradi krvavitve.
Desirudin is a recombinant DNA product derived from yeast cells.
Desirudin je izdelek rekombinantne DNA, pridobljen iz celic kvasovk.
Revasc is used to prevent blood clotting after elective hip or knee replacement surgery, as harmful blood clots can form in the blood vessels of the legs.
Revasc se uporablja za preprečevanje krvnih strdkov po elektivni operaciji zamenjave kolka ali kolena, ker lahko sicer v žilah nog nastanejo škodljivi krvni strdki.
6.6 Special precautions for disposal and other handling To prepare the reconstituted aqueous solution, 0.5ml of the accompanying mannitol solvent is added under aseptic conditions to the vial containing the powder for solution for injection.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Za pripravo rekonstituirane vodne raztopine je treba 0,5 ml priloženega vehikla z manitolom v aseptičnih pogojih dodati v vialo s praškom za raztopino za injiciranje.
Hepatic elimination of desirudin or the thrombindesirudin complex does not appear to be significant.
Kaže, da jetrna eliminacija desirudina in kompleksa trombin-desirudin ni pomembna.
That activity should be taken into account in the evaluation of the overall coagulation status of the patient during the switch (see section 4.2).
Ta učinek je treba upoštevati pri oceni celotnega koagulacijskega statusa bolnika med prehodom
PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Anticoagulant, ATC code: B01AE01
Farmakoterapevtska skupina: antitrombotik, oznaka ATC: B01AE01.
Overdosage of desirudin could lead to bleeding complications.
Preveliko odmerjanje desirudina lahko povzroči krvavitvene zaplete.
Your risk of bleeding may also be increased: - if you have recently given birth, fallen, or suffered a blow to the body or head - if you are already taking medicines, especially blood-thinners (see below).
- če ste nedavno rodili, padli ali doživeli udarec v telo ali glavo - če že jemljete zdravila, zlasti za redčenje krvi (glejte spodaj)
- if you have an uncontrolled high blood pressure
- če imate okužbo na srcu - če imate neobvladan visok krvni tlak - če ste noseči
After reconstitution, immediate use is recommended.
Zdravilo je priporočljivo uporabiti takoj po pripravi.
Rare side effects (likely to affect between 1 in 1,000 and 1 in 10,000 patients): Anti-hirudin antibodies have been detected upon re-exposure Isolated cases of fatal bleeding have been reported.
Redki neželeni učinki (verjetno se bodo pojavljali pri 1 od 1.000 do 1 od 10.000 bolnikov): Po ponovni izpostavitvi so odkrili antihirudinska protitelesa.
If you have a kidney or liver disease, the doctor or nurse will monitor your blood for clotting activity and may change your dose or dosing schedule accordingly.
Če imate kakšno bolezen ledvic ali jeter, bosta zdravnik ali medicinska sestra kontrolirala vašo kri glede strjevanja in lahko ustrezno spremenita odmerek ali urnik jemanja zdravila.
In controlled clinical trials investigating desirudin 15 mg twice daily and a standard dose of unfractionated heparin, the nature of the hip surgery operation and the mode of action of the two drugs studied account for most of the adverse experiences reported.
V kontroliranih kliničnih preskušanjih, v katerih so proučevali desirudin v odmerku 15 mg dvakrat na dan in standardni odmerek nefrakcioniranega heparina, je bila večina opisanih neželenih učinkov posledica narave operacije kolka in načina delovanja obeh proučevanih zdravil.
In vitro and in vivo animal data indicate that desirudin is for the most part eliminated and metabolised by the kidney.
Živalski podatki in vitro in in vivo kažejo, da se desirudin v glavnem presnavlja in eliminira v ledvicah.
During prophylaxis, concomitant use of medicinal products containing heparins (unfractionated and low-molecular weight heparins) and dextrans is not recommended.
Med profilakso ni priporočljivo sočasno uporabljati zdravil, ki vsebujejo heparine (nefrakcionirane in nizkomolekularne heparine) in dekstrane.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.5ml of water for injections with 3% (w/v) of mannitol
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 0,5 ml vode za injekcije s 3-odstotnim (m/v) manitolom
At therapeutic serum concentrations it has no effect on other enzymes of the haemostatic system such as factors IXa, Xa, kallikrein, plasmin, tPA, or activated protein C. In addition, it does not display any effect on other serine proteases, such as the digestive enzymes trypsin or chymotrypsin, or on complement activation by the classical or
V terapevtskih serumskih koncentracijah ne vpliva na druge encime hemostatskega sistema, npr. faktorje IXa, Xa, kalikrein, plazmin, tPA ali aktivirani protein C. Poleg tega ne kaže nobenih učinkov na druge serinske proteaze,
15mg of powder in a vial (Type I glass) with stopper (butyl rubber) covered with a film (fluoropolymer) in the product side and 0.5ml of solvent in an ampoule (Type I glass).
15 mg praška v viali (steklo tipa I) z zamaškom (butilna guma), prekritim s filmom (fluoropolimer) na strani zdravila, in 0,5 ml vehikla v ampuli (steklo tipa I).
As these reactions are immune-mediated, patients with previous exposure to hirudin or hirudin analogue may be at an increased risk.
Ker gre za imunsko posredovane reakcije, utegnejo biti bolj ogroženi bolniki, ki so že dobivali hirudin ali hirudinske analoge.
Desirudin should be used with care in patients receiving anticoagulants, and/or platelet inhibitors, and/or non-steroidal anti-inflammatory medicinal products.
Desirudin je treba previdno uporabljati pri bolnikih, ki dobivajo antikoagulante in/ali zaviralce agregacije trombocitov in/ali nesteroidne antirevmatike.
The active substance is desirudin (15mg/0.5ml powder).
Zdravilna učinkovina je desirudin (15 mg/0,5 ml).
Uncommon side effects (likely to affect between 1 in 100 and 1 in 1,000 patients):
Občasni neželeni učinki (verjetno se bodo pojavljali pri 1 od 100 do 1 od 1.000 bolnikov):
Following administration of single SC doses of 0.1-0.75 mg/kg, plasma concentrations of desirudin increased rapidly to maximum levels (Cmax) between 1 and 3 h. Both Cmax and AUC values are dose
Po uporabi posamičnih subkutanih odmerkov od 0,1 do 0,75 mg/kg se koncentracija desirudina v plazmi hitro zviša do najvišje ravni (Cmax) v času od 1 do 3 ur.
If any of the above apply to you, the doctor or nurse will monitor your blood for clotting activity and may change your dose or dosing schedule accordingly.
Če za vas velja kaj od zgoraj naštetega, bosta zdravnik ali medicinska sestra kontrolirala vašo kri glede strjevanja in lahko ustrezno spremenita odmerek ali urnik jemanja zdravila.
Adverse reactions irrespective of trial drug relationship reported during clinical trials were bleeding episodes, oliguria, hyperpyrexia and joint dislocation.
Neželeni učinki, ki so bili ne glede na povezanost s proučevanim zdravilom opisani v kliničnih preskušanjih, so bili krvavitve, oligurija, hiperpireksija in izpah sklepa.
Fatal anaphylactic reactions have been reported in patients re-exposed to hirudin product therapy in a second or subsequent treatment course.
Usodne anafilaktične reakcije so bile opisane pri bolnikih, ki so bili v naslednjem ali nadaljnjih ciklusih zdravljenja ponovno izpostavljeni zdravljenju s hirudinskimi zdravili.
Usual dosage
Običajno odmerjanje
4.3 Contraindications
4.1 Terapevtske indikacije
Keep the vial and ampoule in the outer carton.
Vialo in ampulo shranjujte v zunanji ovojnini.
In patients with mild to moderate liver impairment (see section 4.4) aPTT monitoring is recommended.
Pri bolnikih z blago do zmerno okvaro jeter (glejte poglavje 4.4) je priporočljivo kontrolirati aPTČ.
Prevention of deep venous thrombosis in patients undergoing elective hip or knee replacement
Preprečevanje globoke venske tromboze pri bolnikih z elektivno operacijo za zamenjavo kolka ali kolena.
Common reported side effects (likely to affect between 1 in 10 and 1 in 100 patients):
Pogosti neželeni učinki, o katerih poročajo (verjetno se bodo pojavljali pri 1 od 10 do 1 od 100 bolnikov):
You should not be given Revasc if you are pregnant.
Če ste noseči, ne smete dobiti Revasca.
Each vial contains 15mg desirudin with 18,000 ATU/mg corresponding to approximately 270,000
Ena viala vsebuje 15 mg desirudina z 18.000 ATE/mg, kar ustreza približno 270.000 ATE na vialo.
The active substance is rapidly redispersed by shaking gently producing a clear solution.
Učinkovina se z rahlim stresanjem hitro redispergira, tako da nastane bistra raztopina.
If necessary, therapy with desirudin should be interrupted until aPTT returns to less than twice the control value at which time treatment with desirudin can be resumed at a reduced dose.
Če je potrebno, je treba zdravljenje z desirudinom prekiniti, dokler se aPTČ ne zniža na manj kot dvakratno kontrolno vrednost; ko se to zgodi, je zdravljenje z desirudinom mogoče znova začeti z manjšim odmerkom.