natgillin/translations-raw huggingface dataset:
NovoSeven is used for the treatment and prevention of bleeding connected with surgery in the following groups of patients: • patients with congenital haemophilia (a bleeding disorder present from birth) who have developed or are expected to develop ‘ inhibitors ’ (antibodies) against factor VIII or IX; • patients with acquired haemophilia (a disease caused by the spontaneous development of inhibitors to factor VIII); • patients with congenital factor VII deficiency; • patients with Glanzmann’ s thrombasthenia (a rare bleeding disorder) who cannot be treated with a transfusion of platelets (components that help the blood to clot).
Zdravilo NovoSeven se uporablja za zdravljenje in preprečevanje krvavitev pri operacijah pri naslednjih skupinah bolnikov: • pri bolnikih s prirojeno hemofilijo (motnja strjevanja krvi od rojstva), pri katerih so se razvili ali je pričakovati, da se bodo razvili, „ zaviralci “ (protitelesa) faktorja VIII ali IX; • pri bolnikih s pridobljeno hemofililjo (bolezen, ki jo sproži spontan razvoj zaviralcev faktorja VIII; • pri bolnikih s prirojenim pomanjkanjem faktorja VII: • pri bolnikih z Glanzmannovo trombastenijo (redko motnjo strjevanja krvi), ki jih ni mogoče zdraviti s transfuzijo trombocitov (sestavina krvi, ki pomaga pri strjevanju krvi).
Treatment with NovoSeven should be started under the supervision of a doctor who has experience in the treatment of haemophilia or bleeding disorders.
Zdravljenje z zdravilom NovoSeven se mora začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem hemofilije ali motenj strjevanja krvi.
NovoSeven is given by injection into a vein. • In haemophilia, the dose is 90 micrograms per kilogram body weight, repeated every two to three hours until the bleeding is controlled.
Zdravilo NovoSeven se daje z injekcijo v veno. • Pri hemofiliji se daje odmerek 90 mikrogramov na kilogram telesne mase, vsake dve do tri ure, dokler se ne vzpostavi nadzor nad krvavitvijo.
A single dose of 270 micrograms/ kg may be used in adults with a mild or moderate bleeding episode. • In factor VII deficiency, the dose is 15 to 30 micrograms/ kg every four to six hours until the bleeding is controlled. • In Glanzmann’ s thrombasthenia, the dose is 90 micrograms/ kg every two hours, for a minimum of three doses.
Pri odraslih z blago do zmerno epizodo krvavitve se sme uporabiti enkraten odmerek 270 mikrogramov na kilogram. • Pri pomanjkanju faktorja VII se daje odmerek 15 do 30 mikrogramov/ kg telesne mase vsakih štiri do šest ur, dokler se ne vzpostavi nadzor nad krvavitvijo. • Pri Glanzmannovi trombasteniji je odmerek 90 mikrogramov na kilogram vsaki dve uri, pri čemer je treba bolniku dati najmanj tri odmerke.
NovoSeven can be administered in the home setting.
Zdravilo NovoSeven se lahko daje tudi na bolnikovem domu.
See the Package Leaflet for the full dosing details in all uses.
Za podrobnejše podatke o odmerjanju za vse vrste uporabe zdravila glejte navodilo za uporabo.
The active substance in NovoSeven, eptacog alfa, is a blood coagulation factor protein that is almost identical to a human protein called factor VII.
Zdravilna učinkovina zdravila NovoSeven, eptakog alfa, je beljakovinski krvni koagulacijski faktor, ki je skoraj popolnoma isti kot človeška beljakovina, imenovana faktor VII.
Eptacog alfa is not extracted from human blood but is produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce eptacog alfa.
Eptakog alfa se ne pridobiva iz človeške krvi, temveč se proizvaja z metodo, znano kot „ tehnologija rekombinantne DNK “, pri kateri celica prejme gen (DNK), s katerim lahko tvori eptakog alfa.
Eptacog alfa works in the same way as factor VII.
Eptakogalfa deluje na enak način kot faktor VII.
In the body, factor VII is involved in blood coagulation (clotting).
Faktor VII v telesu sodeluje pri koagulaciji (strjevanju) krvi.
It activates another factor called factor X, which starts the coagulation process.
Učinkuje na drug faktor, imenovan faktor X, ki sproži proces strjevanja krvi.
Because factor VII acts directly on factor X, independently from factors VIII and IX, NovoSeven can be used in haemophilia patients who have developed inhibitors to factor VIII or IX.
Ker faktor VII učinkuje neposredno na faktor X, to pomeni neodvisno od faktorjev VIII in IX, se lahko zdravilo NovoSeven uporablja pri bolnikih, pri katerih so se razvili zaviralci faktorjev VIII in IX.
NovoSeven can also be used to replace the missing factor VII in patients with factor VII deficiency.
Zdravilo NovoSeven se lahko uporablja tudi za nadomeščanje manjkajočega faktorja VII pri bolnikih s pomanjkanjem faktorja VII.
The main measure of effectiveness was the number of bleeding episodes.
Najpomembnejše merilo učinkovitosti je bilo število epizod krvavitev.
NovoSeven has also been studied in patients with Glanzmann’ s thrombasthenia who could not receive platelets.
Zdravilo NovoSeven so preučevali tudi pri bolnikih z Glanzmannovo trombastenijo, ki niso mogli prejeti transfuzije trombocitov.
Two further studies compared the single 270 microgram/ kg dose of NovoSeven with three 90 microgram/ kg doses in a total of 51 patients with haemophilia.
V dveh nadaljnjih študijah so primerjali enkratni odmerek 270 mikrogramov/ kg zdravila NovoSeven s tremi odmerki 90 mikrogramov/ kg pri skupaj 51 bolnikih s hemofilijo.
These studies assessed the medicine ’ s effectiveness in reducing the symptoms of pain and joint mobility nine hours after treatment.
S temi študijami so ocenili učinkovitost zdravila pri zmanjševanju simptomov bolečine in na gibljivost sklepov devet ur po prejemu zdravila.
The company also carried out a ‘ bioequivalence’ study in 25 healthy volunteers to show that the two formulations of NovoSeven are treated in the same way by the body.
Družba je izvedla tudi študijo biološke enakovrednosti pri 25 zdravih prostovoljcih, da bi dokazali, da telo obe obliki zdravila NovoSeven sprejema na enak način.
In the largest study, which included 61 haemophilia patients with inhibitors, 84% of the 57 serious bleeds and 59% of the 38 surgical bleeds were treated effectively with NovoSeven.
V največji študiji, ki je zajela 61 bolnikov s hemofilijo z zaviralci, je bilo zdravilo NovoSeven učinkovito pri 84% od 57 resnih krvavitev in pri 59% od 38 krvavitev zaradi kirurškega posega.
In the study where NovoSeven was given in the home setting, 90% of the bleeding episodes were stopped.
V študiji, ki je preučevala uporabo zdravila NovoSevn na domu, se je ustavilo 90% krvavitev.
In Glanzmann’ s thrombasthenia, the study showed that treatment with NovoSeven was effective in 74% of the bleeds (42 out of 57).
Pri bolnikih s Glanzmannovo trombastenijo je študija pokazala, da je bilo zdravilo NovoSeven učinkovito v 74% krvavitev (42 od 57).
The additional studies showed that a single 270 microgram/ kg dose was as effective as three 90 microgram/ kg doses in improving symptoms.
Dodatne študije so pokazale, da je bil pri izboljševanju simptomov enkratni odmerek 270 mikrogramov/ kg enako učinkovit kot trije odmerki 90 mikrogramov/ kg.
The side effects of NovoSeven are generally rare: for every 1,000 doses less than one side effect has been reported.
Neželeni učinki zdravila NovoSeven so na splošno redki: na vsakih 1000 odmerkov je bil zabeležen manj kot en neželeni stranski učinek.
Serious but very rare side effects include blood clots in the veins or arteries.
Med resne, vendar zelo redke neželene učinke spada nastanek krvnih strdkov v venah ali arterijah.
For the full list of all side effects reported with NovoSeven, see the Package Leaflet.
Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila NovoSeven, glejte navodilo za uporabo.
NovoSeven should not be used in people who may be hypersensitive (allergic) to human recombinant coagulation factor VII, to mouse, hamster or cow proteins, or to any of the other ingredients.
Zdravila NovoSeven ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) človeški rekombinantni koagulacijski faktor VII, za mišje, hrčkove ali kravje beljakovine ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that NovoSeven’ s benefits are greater than its risks for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in patients with congenital haemophilia, acquired haemophilia, congenital factor VII deficiency or Glanzmann’ s thrombasthenia.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila NovoSeven pri zdravljenju krvavitev ali za preprečevanje krvavitev pri operacijah ali invazivnih postopkih pri bolnikih s prirojeno hemofilijo, pridobljeno hemofilijo, prirojenim pomanjkanjem faktorja VII ali Glanzmannovo trombastenijo, večje od z njim povezanih tveganj.
The Committee recommended that NovoSeven be given marketing authorisation.
Odbor je priporočil, da se za zdravilo NovoSeven odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of NovoSeven?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila NovoSeven?
Before the new formulation that can be stored at room temperature becomes available on the market, the company that makes NovoSeven will provide doctor and patient information packs.
Preden bo oblika, ki se lahko shranjuje na sobni temperaturi, poslana na tržišče, bo družba, ki izdeluje zdravilo NovoSeven, priskrbela informativne pakete za zdravnike in bolnike.
The information packs will explain the differences between the two formulations of NovoSeven, to help avoid errors when calculating doses.
V informativnih paketih bo pojasnjena razlika med obema oblikama zdravila NovoSeven, da bi preprečili napake pri izračunavanju odmerkov.
2/ 3 Other information about NovoSeven:
2/ 3 Druge informacije o zdravilu NovoSeven:
The European Commission granted a marketing authorisation valid throughout the European Union for NovoSeven to Novo Nordisk A/ S on 23 February 1996.
Evropska komisija je dovoljenje za promet z zdravilom NovoSeven, veljavno po vsej Evropski uniji, odobrila družbi Novo Nordisk A/ S dne 23. februarja 1996.
The authorisation was renewed on 23 February 2001 and on 23 February 2006.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 23. februarja 2001 in 23. februarja 2006.
The full EPAR for NovoSeven is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo NovoSeven je na voljo tukaj.
1.2 mg (60 KIU)
1, 2 mg (60 k. i. e.)
powder: vial (glass); solvent: vial (glass)
prašek: viala (steklo) vehikel: viala (steklo)
1.2 mg (60 KIU); 2.2 ml 0.6 mg/ ml (30 KIU/ ml)
2, 2 ml 0, 6 mg / ml (30 k. i. e. / ml)
1 vial + 1 vial + 1 vial adapter for reconstitution + 1 syringe + 1 sterile infusion set + 2 alcohol swabs
1 viala + 1 viala + 1 adapter za vialo za pripravo + 1 brizga + 1 sterilen infuzijski komplet + 2 z alkoholom prepojena zloženca
2.4 mg (120 KIU)
2, 4 mg (120 k. i. e.)
2.4 mg (120 KIU); 4.3 ml 0.6 mg/ ml (30 KIU/ ml)
4, 3 ml 0, 6 mg / ml (30 k. i. e. / ml)
4.8 mg (240 KIU)
4, 8 mg (240 k. i. e.)
4.8 mg (240 KIU); 8.5 ml 0.6 mg/ ml (30 KIU/ ml)
8, 5 ml 0, 6 mg / ml (30 k. i. e. / ml)
1 mg (50 KIU)
1 mg (50
Powder and solvent for solution for injection
prašek in topilo za
Intravenous use
Za intravensko
powder: vial (glass); solvent: vial (glass)
topilo: viala (steklena)
1.1 ml
(50 k. i. e. / ml)
2 mg (100 KIU)
2 mg (100
powder: vial (glass); solvent: vial (glass)
prašek: viala (steklena); topilo: viala (steklena)
2.1 ml
2 mg (100 k. i. e.); (50 k. i. e. / ml)
5 mg (250 KIU)
5 mg (250
5.2 ml
5 mg (250 k. i. e.); (50 k. i. e. / ml)
London, 06 April 2006 Doc.
London, 27. april 2006 CHMP/ 154955/ 2006
EMEA/ 123938/ 2006
Podjetje Novo Nordisk A/ S je 3. aprila 2006 uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za novo indikacijo za zdravilo NovoSeven, in sicer zdravljenje akutne znotrajmožganske krvavitve (ZMK) pri odraslih za omejitev krvavitve in za izboljšanje kliničnega izida.
Press release Novo Nordisk withdraw their application to extend the marketing authorisation for NovoSeven The European Medicines Agency was formally notified by Novo Nordisk A/ S of their decision to withdraw the application for an extension of the marketing authorisation for the medicinal product NovoSeven (Human recombinant coagulation Factor VIIa (rFVIIa)).
Zdravilo NovoSeven je prašek in vehikel za raztopino za injiciranje, ki vsebuje zdravilno učinkovino eptakog alfa (aktivirani humani rekombinantni koagulacijski faktor VII).
NovoSeven was first authorised in the European Union on 23 February 1996 and is currently indicated for the treatment of bleeding episodes and prevention of bleeding during surgery or invasive procedures in specific patients with certain blood-clotting disorders.
Zdravilo NovoSeven se trenutno uporablja za zdravljenje in preprečevanje krvavitev pri operacijah bolnikov s hemofilijo, ki so razvili “ inhibitorje ” (protitelesa) faktorjev VIII ali IX.
On 6 October 2005, Novo Nordisk A/ S submitted an application for the extension of the marketing authorisation to include the treatment of acute intracerebral haemorrhage in adults for limiting haemorrhage growth and improving clinical outcomes.
Uporablja se tudi pri bolnikih s pridobljeno hemofilijo, pri bolnikih s prirojenim pomanjkanjem faktorja VII in pri bolnikih z Glanzmannovo trombastenijo (redko motnjo strjevanja krvi), ki jih ni mogoče zdraviti s transfuzijo trombocitov.
Following review of the data submitted, the Committee for Medicinal Products for Human Use (CHMP) requested the company to submit additional safety and efficacy data.
Zdravilo NovoSeven naj bi se uporabljalo za zdravljenje odraslih bolnikov z intracerebralno krvavitvijo (krvavitev znotraj možganov).
In their official withdrawal letter, the company stated that based on this request they decided to withdraw the current application and re-submit an application upon completion of an ongoing clinical study.
Zdravilo NovoSeven naj bi omejilo krvavitev in tako zmanjšalo posledice znotrajmožganske krvavitve.
More information about NovoSeven and the current state of the scientific assessment at the time of withdrawal will be made available in a question and answer document.
NovoSeven vsebuje eptakog alfa (aktiviran), ki je beljakovinski krvni koagulacijski faktor.
This document, together with the withdrawal letter from the company, will be published on the EMEA website, after the next meeting of the Committee for Medicinal Products for Human Use (CHMP) on 24-27 April 2006.
Poveča proizvodnjo trombina, še enega koagulacijskega faktorja, na površini delcev, ki tvorijo krvne strdke (trombocitov), kar pripomore k nastanku stabilnega “ zamaška ” na mestu krvavitve.
2.
Katero dokumentacijo je podjetje predložilo CHMP v podporo svoji vlogi?
Withdrawal of an application does not prejudice the possibility of a company to make a new application at a later stage.
Podjetje je predložilo rezultate treh raziskav, v katerih je sodelovalo skupaj 486 bolnikov.
4.
V glavno raziskavo je bilo vključenih 399 bolnikov (povprečne starosti 66 let), v njej pa so primerjali učinkovitost treh odmerkov zdravila NovoSeven s placebom (zdravilom brez zdravilne učinkovine).
This press release, together with other information about the work of the EMEA, may be found on the EMEA website: http: / /www. emea. eu. int
Učinkovitost zdravila NovoSeven je bila ocenjena glede na to, kakšen je njegov učinek na volumen krvavitve znotraj možganov, izmerjeno s slikanjem (sprememba volumna v odstotkih po 24 urah zdravljenja z zdravilom NovoSeven ali placebom).
Media enquiries only to:
Kako daleč je bil postopek ocenjevanja vloge ob umiku vloge?
Martin Harvey Allchurch Tel:
Ko je podjetje vlogo umaknilo, je bila le- ta v postopku 157. dan.
(44-20) 74 18 84 27, E-mail: press@emea. eu. int
Ko CHMP poda mnenje, Evropska komisija v približno 6 tednih posodobi dovoljenje.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 09 E-mail: mail@emea. eu. int http: / /www. emea. eu. int
(44- 20) 74 18 84 00 Fax (44- 20) 75 23 71 29 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kakšno je bilo takrat priporočilo CHMP?
The Marketing Authorisation Holder (MAH) shall ensure that, at launch, all physicians who are expected to prescribe/ use NovoSeven are provided with an Educational pack containing the following: • Physician information pack • Patient information pack
Ta komplet vsebuje: • komplet informacij za zdravnike • komplet informacij za bolnike.
The physician information pack should contain the following: • Summary leaflet of the product features and reconstitution guide, including highlighted changes that have been made for the new formulation of NovoSeven. • Educational slide kit • Dosing reference card • Question & Answer booklet • Patient information pack • Letter to healthcare professionals
Komplet informacij za zdravnike mora vsebovati: • Povzetek lastnosti zdravila in navodilo za rekonstitucijo s poudarjenimi spremembami, sprejetimi za novo formulacijo NovoSeven • Izobraževalni komplet prosojnic • Referenčno kartico za odmerjanje • Knjižico z vprašanji in odgovori • Dokumentacijo z informacijami za bolnike • Pismo zdravnikom
The physician information should contain the following key elements: • Clear demarcation of the new formulation of NovoSeven from original NovoSeven, with clear descriptions of any differences in the vial sizes, colour codes and dosing and reconstitution instructions • Clear information about their difference in concentration. • Information about the potential safety risks of errors in dosing calculation resulting from the confusion between the two formulations and its possible clinical consequences (e. g. potential for thrombotic risk if overdose). • Encouragement to report medications errors and their causes and consequences.
Informacije za zdravnike morajo vključevati naslednje ključne elemente: • Jasno razmejitev med novo formulacijo NovoSeven in prvotnim NovoSeven z jasnim opisom vseh razlik v velikosti vial, barvnem kodiranju ter navodilih za odmerjanje in rekonstitucijo. • Jasne informacije o razliki v koncentraciji. • Informacije o možnih varnostnih tveganjih zaradi napak v odmerjanju, ki bi se pojavile zaradi nerazlikovanja med obema formulacijama, in o možnih kliničnih posledicah (npr. o možnem tveganju za trombozo v primeru prevelikega odmerjanja). • Spodbudo za prijavljanje napak pri zdravljenju, njihovih vzrokih in posledicah.
NovoSeven 1.2 mg (60 KIU) - powder and solvent for solution for injection
NovoSeven 1, 2 mg (60 k. i. e.) – prašek in vehikel za raztopino za injiciranje
NovoSeven is presented as powder and solvent for solution for injection containing 1.2 mg eptacog alfa (activated) per vial (corresponds to 60 KIU/ vial).
Zdravilo NovoSeven je na voljo kot prašek in vehikel za raztopino za injiciranje in vsebuje 1, 2 mg aktiviranega eptakoga alfa na vialo (ustreza 60 k. i. e. / vialo).
1 KIU equals 1000 IU (International Units).
(mednarodnih enot).
eptacog alfa (activated) is recombinant coagulation factor VIIa with a molecular mass of approximately 50,000 Dalton produced by genetic engineering from baby hamster kidney cells (BHK Cells).
Aktivirani eptakog alfa je rekombinantni koagulacijski faktor VIIa z molekulsko maso približno 50. 000 daltonov, pridobljen z genetskim inženiringom iz ledvičnih celic hrčkovega mladiča (celice BHK - baby hamster kidney cells).
After reconstitution the product contains 0.6 mg/ ml eptacog alfa (activated) when reconstituted with solvent.
Po pripravi z vehiklom vsebuje zdravilo 0, 6 mg/ ml aktiviranega eptakoga alfa.
NovoSeven is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: • in patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX > 5 Bethesda Units (BU) • in patients with congenital haemophilia who are expected to have a high anamnestic response to factor VIII or factor IX administration • in patients with acquired haemophilia • in patients with congenital FVII deficiency • in patients with Glanzmann ’ s thrombasthenia with antibodies to GP IIb - IIIa and/ or HLA, and with past or present refractoriness to platelet transfusions.
NovoSeven je indiciran za zdravljenje krvavitev in za preprečevanje krvavitev pri operacijah ali invazivnih postopkih v naslednjih skupinah bolnikov: • pri bolnikih s prirojeno hemofilijo z zaviralci koagulacijskih faktorjev VIII ali IX > 5 Bethesda - enot (BU), • pri bolnikih s prirojeno hemofilijo, pri katerih je pričakovan visok anamnestičen odziv na uporabo faktorja VIII ali faktorja IX, • pri bolnikih s pridobljeno hemofilijo, • pri bolnikih s prirojenim pomanjkanjem FVII, • pri bolnikih z Glanzmannovo trombastenijo s protitelesi proti GP IIb- IIIa in/ ali HLA in refraktarnostjo proti transfuzijam trombocitov zdaj ali kdaj v preteklosti.
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/ or bleeding disorders.
Zdravljenje je treba začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem hemofilije in/ ali drugih motenj strjevanja krvi.
Dose NovoSeven should be given as early as possible after the start of a bleeding episode.
Odmerek NovoSeven je treba dati čim prej po začetku krvavitve.
The recommended initial dose, administered by intravenous bolus injection, is 90 μ g per kg body weight.
Aplicira se ga v intravenski bolusni injekciji.
Dosing in children
Odmerjanje pri otrocih
2 Current clinical experience does not warrant a general differentiation in dosing between children and adults, although children have faster clearance than adults.
2 Trenutne klinične izkušnje ne zahtevajo splošno drugačnega odmerjanja pri otrocih in pri odraslih, čeprav je očistek pri otrocih hitrejši kot pri odraslih.
Therefore, higher doses of rFVIIa may be needed in paediatric patients to achieve similar plasma concentrations as in adult patients (see section 5.2).
Pediatrični bolniki utegnejo zato potrebovati večje odmerke rFVIIa za doseganje podobne koncentracije v plazmi, kot je dosežena pri odraslih bolnikih (glejte poglavje 5. 2).
Dose interval Initially 2 - 3 hours to obtain haemostasis.
Odmerni interval Uvodoma na 2 do 3 ure, da se zagotovi hemostaza.
If continued therapy is needed, the dose interval can be increased successively once effective haemostasis is achieved to every 4, 6, 8, or 12 hours for as long as treatment is judged as being indicated.
Če je treba zdravljenje nadaljevati, je mogoče potem, ko je dosežena učinkovita hemostaza, odmerni interval postopoma podaljševati na 4, 6, 8 ali 12 ur, dokler je zdravljenje indicirano.
1) Two to three injections of 90 µg per kg body weight administered at three-hour intervals If further treatment is required, one additional dose of 90 µg per kg body weight can be administered 2) One single injection of 270 µg per kg body weight
2) Ena posamična injekcija 270 µg na kg telesne mase.
The duration of the home therapy should not exceed 24 hours.
Zdravljenje na domu ne sme trajati več kot 24 ur.
Serious bleeding episodes An initial dose of 90 µg per kg body weight is recommended and could be administered on the way to the hospital where the patient is usually treated.
Resne krvavitve Priporočen je začetni odmerek 90 µg na kg telesne mase; aplicirati ga je mogoče na poti v bolnišnico, kjer ponavadi poteka zdravljenje.
Invasive procedure/ surgery An initial dose of 90 µg per kg body weight should be given immediately before the intervention.
Invazivni postopki/ operacija Tik pred posegom je treba dati začetni odmerek 90 µg na kg telesne mase.
The dose should be repeated after 2 hours and then at 2 - 3 hour intervals for the first 24 - 48 hours depending on the intervention performed and the clinical status of the patient.
Odmerek je treba ponoviti čez 2 uri in potem v 2 - do 3- urnih presledkih v prvih 24 do 48 urah, odvisno od opravljenega posega in bolnikovega kliničnega stanja.