FrancophonIA/ELRC3.0 huggingface dataset:
English: • In case of a severe bleed you should contact your doctor.
Slovenian: • V primeru hude krvavitve se morate posvetovati z zdravnikom.
English: Safety and efficacy of NovoSeven have not been established outside the approved indications and therefore NovoSeven should not be used.
Slovenian: Ker varnost in učinkovitost zdravila NovoSeven izven odobrenih indikacij nista bili dokazani, se ga izven indikacij naj ne uporablja.
English: The following dose varies according to the type and severity of the haemorrhage.
Slovenian: Naslednji odmerek se razlikuje glede na vrsto in resnost krvavitve.
English: An observational registry (F7HAEM-3521) covered 133 subjects with Glanzmann's thrombasthenia treated with NovoSeven.
Slovenian: Opazovalni register (F7HAEM-3521) je zajel 133 oseb z Glanzmannovo trombastenijo, ki so se zdravili z zdravilom NovoSeven.
English: Some needleless connectors with an internal spike are incompatible with the pre-filled syringe.
Slovenian: Nekateri brezigelni konektorji, ki imajo notranjo konico, niso združljivi z napolnjeno injekcijsko brizgo.
English: • Allergic, hypersensitivity or anaphylactic reactions.
Slovenian: • Alergijske, preobčutljivostne ali anafilaktične reakcije.
English: Contents of the pack and other information What NovoSeven contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo NovoSeven
English: If your dose requires more than one vial, repeat steps A to J with additional vials, vial adapters and pre-filled syringes until you have reached your required dose.
Slovenian: Če za svoj odmerek potrebujete več kot eno vialo, ponovite korake od A do J z dodatnimi vialami, nastavki za vialo in napolnjenimi injekcijskimi brizgami, dokler ne dosežete potrebnega odmerka.
English: If you have Glanzmann's thrombasthenia:
Slovenian: Če imate Glanzmannovo trombastenijo:
English: • If you recently had a crush injury
Slovenian: • če ste nedavno imeli poškodbo z zmečkanino,
English: - Disseminated intravascular coagulation (see section 4.4)
Slovenian: - diseminirana intravaskularna koagulacija (glejte poglavje 4.4)
English: • If, at any point, there is too much air in the syringe, inject the air back into the vial.
Slovenian: • Če je kadar koli v injekcijski brizgi preveč zraka, potisnite zrak nazaj v vialo.
English: If you cannot use it at once, see section 5 How to store NovoSeven on the other side of this leaflet.
Slovenian: Če ga ne morete uporabiti takoj, glejte poglavje 5, Shranjevanje zdravila NovoSeven, na drugi strani tega navodila.
English: There are no clinical data available on interaction between rFVIIa and rFXIII.
Slovenian: Kliničnih podatkov o medsebojnem delovanju rFVIIa in rFXIII ni na voljo.
English: Dose and frequency of injections for prophylaxis should be based on clinical response and adapted to each individual.
Slovenian: Odmerek in pogostnost injiciranja za profilakso morata temeljiti na kliničnem odzivu in morata biti prilagojena posamezniku.
English: - Coagulopathy
Slovenian: - koagulopatija
English: A potential synergistic effect of combined treatment with rFXIII and rFVIIa in an advanced cardiovascular model in cynomolgus monkey resulted in exaggerated pharmacology (thrombosis and death) at a lower dose level than when administering the individual compounds.
Slovenian: Možni sinergistični učinek kombiniranega zdravljenja z rFXIII in rFVIIa v naprednem srčno-žilnem modelu pri opicah cynomolgus je povzročil čezmeren farmakološki učinek (trombozo in smrt) pri manjših odmerkih kot v primeru uporabe vsake od učinkovin same zase.
English: Patients should be informed of the early signs of hypersensitivity reactions.
Slovenian: Bolnika morate seznaniti z zgodnimi znaki preobčutljivostnih reakcij.
English: It is used in certain groups of people:
Slovenian: Uporablja se pri ljudeh, ki imajo:
English: Caution: The pre-filled syringe is made of glass and is designed to be compatible with standard luer-lock connections.
Slovenian: Opozorilo: Napolnjena injekcijska brizga je izdelana iz stekla in pripravljena tako, da je združljiva s povezavami, ki imajo nastavek luer.
English: Use a disposable syringe of an appropriate size and a vial adapter, transfer needle (20 - 26G) or other suitable device.
Slovenian: Uporabite primerno veliko brizgo za enkratno uporabo ter nastavek za vialo, iglo za prenos (20-26 G) ali drug ustrezen pripomoček.
English: Four cases of overdose have been reported in patients with haemophilia in 16 years.
Slovenian: Pri bolnikih s hemofilijo so bili v 16. letih opisani štirje primeri prevelikega odmerjanja.
English: In case the factor VIIa activity fails to reach the expected level or bleeding is not controlled after treatment with the recommended doses, antibody formation may be suspected and analysis for antibodies should be performed.
Slovenian: Če aktivnost faktorja VIIa ne uspe doseči pričakovane ravni ali krvavitev po zdravljenju s priporočenimi odmerki ni obvladana, obstaja sum na tvorbo protiteles in opraviti je treba preiskavo nanje.
English: The usual dose is 90 micrograms for every 1 kilogram you weigh; you can repeat the injection every 2-3 hours until bleeding is controlled.
Slovenian: Običajni odmerek je 90 mikrogramov na vsak kilogram telesne mase; injekcijo lahko ponovite na 2 do 3 ure, dokler krvavitev ni obvladana.
English: • Do not throw it out with the ordinary household waste.
Slovenian: • Ničesar od tega ne smete odvreči med običajne gospodinjske odpadke.
English: Therefore, higher doses of rFVIIa may be needed in paediatric patients to achieve similar plasma concentrations as in adult patients (see section
Slovenian: Pediatrični bolniki utegnejo zato potrebovati večje odmerke rFVIIa za doseganje podobne koncentracije v plazmi, kot je dosežena pri odraslih bolnikih (glejte poglavje 5.2).
English: It works in all types of bleeds, including joint bleeds.
Slovenian: Deluje pri vseh vrstah krvavitev, vključno s krvavitvami v sklepe.
English: Pooling of vials (hospital use only):
Slovenian: Združevanje vsebine vial (le za bolnišnično uporabo):
English: - Pruritus and urticaria
Slovenian: - srbenje in urtikarija
English: • The active substance is recombinant coagulation factor VIIa (activated eptacog alfa).
Slovenian: • Učinkovina je rekombinantni koagulacijski faktor VIIa (aktivirani eptakog alfa).
English: • Do not touch the rubber stopper with your fingers as this can transfer germs.
Slovenian: • Ne dotikajte se gumijastega zamaška s prsti, ker lahko tako prenesete klice.
English: • Repeat the above procedure with the remaining vials with reconstituted product, to obtain the desired volume in the syringe.
Slovenian: • Zgoraj navedeni postopek ponovite s preostalimi vialami pripravljenega zdravila, da boste v brizgo dobili želeno količino.
English: The initial dose interval should be 2 - 3 hours.
Slovenian: Začetni odmerni interval mora biti od 2 do 3 ure.
English: Patients/carers should inform the physician/supervising hospital at the earliest possible opportunity about all usages of NovoSeven.
Slovenian: Bolniki oz. tisti, ki zanje skrbijo, morajo zdravnika oz. nadzorno bolnišnico obvestiti o vseh uporabah zdravila NovoSeven, čim prej je mogoče.
English: The shelf life for the product packed for sale is 3 years when the product is stored below 25°C.
Slovenian: Rok uporabnosti zdravila, pakiranega za prodajo, je 3 leta, če je zdravilo shranjeno pri temperaturi do 25 °C.
English: NovoSeven is used to treat bleeding, and to prevent excessive bleeding after surgery or other important treatments.
Slovenian: Zdravilo NovoSeven se uporablja za zdravljenje krvavitev in preprečevanje čezmernih krvavitev po operaciji ali drugih pomembnih zdravljenjih.
English: • All steps should be completed under controlled and validated aseptic conditions by adequately trained staff.
Slovenian: • Vse korake mora izvesti ustrezno usposobljeno osebje v nadzorovanih in preverjenih aseptičnih pogojih.
English: Simultaneous use of prothrombin complex concentrates, activated or not, should be avoided.
Slovenian: Izogibati se je treba sočasni uporabi koncentratov protrombinskega kompleksa, tako aktiviranih kot neaktiviranih.
English: In some cases, the antibodies showed inhibitory effect in vitro.
Slovenian: V nekaterih primerih so imela ta protitelesa zaviralen učinek in vitro.
English: • If you have an increased risk of blood clots (thrombosis)
Slovenian: • če imate večje tveganje za krvne strdke (tromboza),
English: If the entire dose is not required, use the scale on the syringe to see how much mixed solution is withdrawn.
Slovenian: Če ni potreben celotni odmerek, uporabite merilo na brizgi, da boste videli, koliko pripravljene raztopine ste izvlekli.
English: See overleaf for detailed instructions.
Slovenian: Glejte na drugo stran lista za podrobna navodila.
English: Such situations may include patients with advanced atherosclerotic disease, crush injury, septicaemia or DIC.
Slovenian: Takšne okoliščine lahko vključujejo bolnike z napredovano aterosklerotično boleznijo, zmečkaninami, septikemijo ali DIK.
English: Based on a non-clinical study (see section 5.3) it is not recommended to combine rFVIIa and rFXIII.
Slovenian: Na podlagi predklinične študije (glejte poglavje 5.3) rFVIIa in rFXIII ni priporočljivo uporabljati v kombinaciji.
English: You will also need an administration set (tubing and butterfly needle, sterile alcohol swabs, gauze pads and plasters).
Slovenian: Potrebovali boste tudi komplet za injiciranje (cevko in iglo z metuljčkom, sterilne alkoholne zložence, vpojno gazo in obliže).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu/.
English: The recommended route of administration is bolus injection as lack of efficacy may appear in connection with continuous infusion.
Slovenian: Priporočeni način uporabe je bolusna injekcija, ker se ob stalni infuziji lahko pojavi neučinkovitost.
English: Glanzmann's thrombasthenia
Slovenian: Glanzmannova trombastenija
English: Plunger rod: made of polypropylene.
Slovenian: Nosilec bata: izdelan iz polipropilena.
English: Injecting the solution via a central venous access device (CVAD) such as a central venous catheter or a subcutaneous port:
Slovenian: Injiciranje raztopine skozi centralni venski dostop (CVD), na primer skozi centralni venski kateter ali subkutani nastavek:
English: Although NovoSeven will be stable for 24 hours after it has been mixed, you should use it at once to avoid infection.
Slovenian: Čeprav je zdravilo NovoSeven stabilno 24 ur po pripravi, ga uporabite takoj, da boste preprečili možnost okužbe.
English: Initially 2 - 3 hours to obtain haemostasis.
Slovenian: Uvodoma na 2 do 3 ure, da se zagotovi hemostaza.
English: Experience with concomitant administration of anti-fibrinolytics and rFVIIa treatment is however limited.
Slovenian: Vendar so izkušnje s sočasno uporabo antifibrinolitikov in rFVIIa omejene.
English: • If you have just had surgery
Slovenian: • če ste bili pred kratkim operirani,
English: In the same registry 3 out of 91 surgical patients experienced thromboembolic events.
Slovenian: V istem registru so se trombembolični dogodki pojavili pri 3 od 91 bolnikov, ki so potrebovali kirurško zdravljenje.
English: NovoSeven was used in 157 surgical procedures, at a median dose of 92 µg/kg (up to 270 µg/kg).
Slovenian: Zdravilo NovoSeven so uporabili pri 157 kirurških posegih v medianem odmerku 92 µg/kg (do 270 µg/kg).
English: If allergic or anaphylactic-type reactions occur, the administration should be discontinued immediately.
Slovenian: Če se pojavi alergijska ali anafilaktična reakcija, morate uporabo zdravila nemudoma prekiniti.
English: Eptacog alfa (activated) is recombinant coagulation factor VIIa (rFVIIa) with a molecular mass of approximately 50,000 Daltons produced in baby hamster kidney cells (BHK Cells) by recombinant DNA technology.
Slovenian: Aktivirani eptakog alfa je rekombinantni koagulacijski faktor VIIa (rFVIIa) z molekulsko maso približno 50.000 daltonov, pridobljen z rekombinantno DNA tehnologijo iz ledvičnih celic hrčkovega mladiča (celice BHK - baby hamster kidney cells).
English: The pharmacodynamic effect of factor VIIa gives rise to an increased local formation of factor Xa, thrombin and fibrin.
Slovenian: Farmakodinamični učinki Farmakodinamični učinek faktorja VIIa povzroči zvečano lokalno nastajanje faktorja Xa, trombina in fibrina.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you use NovoSeven.
Slovenian: Nosečnost, dojenje in plodnost Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden boste uporabili to zdravilo.
English: The dose interval may then be increased to 6 - 8 hours for another 2 weeks of treatment.
Slovenian: Odmerni interval je potem mogoče podaljšati na 6 do 8 ur za nadaljnja 2 tedna zdravljenja.
English: If further treatment is required, one additional dose of 90 µg per kg body weight can be administered.
Slovenian: Če je potrebno nadaljnje zdravljenje, se lahko aplicira dodatni odmerek 90 µg na kg telesne mase.
English: Patients with factor VII deficiency treated with NovoSeven should be monitored for factor VII antibodies (see section 4.4).
Slovenian: Bolnike s pomanjkanjem faktorja VII, ki se zdravijo z zdravilom NovoSeven, je treba spremljati glede protiteles (glejte poglavje 4.4).
English: • Injecting into a CVAD may require using a sterile 10 ml plastic syringe for withdrawal of the reconstituted solution.
Slovenian: • Injiciranje v CVD lahko zahteva uporabo sterilne 10-ml plastične brizge za izvlek pripravljene raztopine.
English: • in patients with congenital FVII deficiency
Slovenian: • pri bolnikih s prirojenim pomanjkanjem FVII,
English: ► If any of these conditions apply to you, talk to your doctor before using the injection.
Slovenian: ► Če kaj od naštetega velja za vas, se posvetujte s svojim zdravnikom, preden uporabite to zdravilo.
English: 1) Two to three injections of 90 µg per kg body weight administered at three-hour intervals.
Slovenian: 1) Dve do tri injekcije 90 µg na kg telesne mase, aplicirane v triurnih presledkih.
English: After administration of rFVIIa, prothrombin time (PT) and activated partial thromboplastin time (aPTT) have been shown to shorten, however no correlation has been demonstrated between PT and aPTT and clinical efficacy of rFVIIa.
Slovenian: Dokazano je, da se po uporabi rFVIIa protrombinski čas (PČ) in aktivirani parcialni tromboplastinski čas (aPTČ) skrajšata, vendar ni ugotovljeno, da bi PČ in aPTČ korelirala s klinično učinkovitostjo rFVIIa.
English: Using the FVIIa assay, the pharmacokinetic properties of rFVIIa were studied in 12 paediatric (212 years) and 5 adult patients in non-bleeding state.
Slovenian: Farmakokinetične lastnosti rFVIIa so s preizkusom z FVIIa raziskali pri 12 pediatričnih (2-12 let) in 5 odraslih bolnikih, ki niso krvaveli.
English: Risk factors that may have contributed to antibody development including previous treatment with human plasma and/or plasma-derived factor VII, severe mutation of FVII gene, and overdose of NovoSeven, were present.
Slovenian: Prisotni so bili dejavniki tveganja, ki bi lahko pripomogli k razvoju protiteles, med njimi predhodno zdravljenje s človeško plazmo in/ali faktorjem VII, pridobljenim iz plazme, huda mutacija gena FVII in preveliko odmerjanje zdravila NovoSeven.
English: Uncommon (≥1/1,000 to
Slovenian: Občasno (≥1/1.000 do
English: The frequencies of both serious and non-serious adverse drug reactions are listed by system organ classes in the table below
Slovenian: Pogostnosti resnih in neresnih neželenih učinkov zdravila so navedene v spodnji preglednici po organskih sistemih.
English: Adverse drug reactions reported post-marketing only (i.e. not in clinical trials) are presented with a frequency of ‘not known'.
Slovenian: Neželeni učinki, ki so bili spontano poročani po začetku trženja (torej ne v kliničnih preskušanjih) so navedeni s "pogostnost ni znana".
English: In case of severe bleeds the product should be administered in hospitals preferably specialised in treatment of haemophilia patients with coagulation factor VIII or IX inhibitors, or if not possible, in close collaboration with a physician specialised in haemophilia treatment.
Slovenian: V primeru hudih krvavitev je treba zdravilo aplicirati v bolnišnici, po možnosti tam, kjer so specializirani za zdravljenje bolnikov s hemofilijo z zaviralci koagulacijskih faktorjev VIII in IX - če to ni mogoče, pa v tesnem sodelovanju z zdravnikom, specializiranim za zdravljenje hemofilije.
English: In major surgery, the dose should be continued at 2 - 4 hour intervals for 6 - 7 days.
Slovenian: Po večjih operacijah je treba z odmerkom nadaljevati v 2- do 4-urnih presledkih 6 do 7 dni.
English: - Injection site reaction including injection site pain
Slovenian: - reakcija na mestu injiciranja, vključno s bolečino na mestu injiciranja
English: - Anaphylactic reaction
Slovenian: - anafilaktična reakcija
English: The reconstituted solution should be stored in the vial.
Slovenian: Pripravljeno raztopino je treba shranjevati v viali.
English: • Inject the reconstituted solution as instructed by your doctor or nurse.
Slovenian: • Pripravljeno raztopino injicirajte, kot vam je naročil vaš zdravnik ali medicinska sestra.
English: Clinical trials conducted in 61 patients with acquired haemophilia with a total of 100 treatment episodes, showed that certain adverse drug reactions were reported more frequently (1% based on treatment episodes): Arterial thromboembolic events (cerebral artery occlusion, cerebrovascular accident), venous thromboembolic events (pulmonary embolism and deep vein thrombosis), angina pectoris, nausea, pyrexia, erythematous rash and investigation of increased levels of fibrin degradation products.
Slovenian: V kliničnih preskušanjih z 61 bolniki s pridobljeno hemofilijo v skupno 100 epizodah zdravljenja je bilo ugotovljeno, da se določeni neželeni učinki pojavljajo pogosteje (1 % epizod zdravljenja): arterijski trombembolični dogodki (zapora možganske arterije, cerebrovaskularni incident), venski trombembolični dogodki (pljučna embolija in globoka venska tromboza), angina pektoris, siljenje na bruhanje, pireksija, eritematozni izpuščaj in zvišanje razgradnih produktov fibrina.
English: MARKETING AUTHORISATION NUMBERS
Slovenian: ŠTEVILKI DOVOLJENJA ZA PROMET
English: Thrombin leads to the activation of platelets and factors V and VIII at the site of injury and to the formation of the haemostatic plug by converting fibrinogen into fibrin.
Slovenian: Trombin povzroči aktivacijo trombocitov in faktorjev V in VIII na mestu poškodbe ter nastanek hemostatskega čepa s spremembo fibrinogena v fibrin.
English: 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:
Slovenian: Zdravilo NovoSeven je indicirano za zdravljenje krvavitev in za preprečevanje krvavitev pri operacijah ali invazivnih postopkih v naslednjih skupinah bolnikov:
English: Early treatment with NovoSeven reduces how much you bleed and for how long.
Slovenian: Zgodnje zdravljenje z zdravilom NovoSeven zmanjša obseg krvavitve in skrajša njeno trajanje.
English: If you have haemophilia:
Slovenian: Če imate hemofilijo:
English: If bleeding is not kept under control hospital care is mandatory.
Slovenian: Če krvavitve ni moč obvladati, je obvezno zdravljenje v bolnišnici.
English: The mean steady state volume of distribution ranged from 130 to 165 ml/kg, the mean values of clearance ranged from 33.3 to 37.2 ml/h×kg.
Slovenian: Povprečen volumen porazdelitve v stanju dinamičnega ravnovesja je bil od 130 do 165 ml/kg, povprečna vrednost očistka je segala od 33,3 do 37,2 ml/h×kg.
English: - Rash (including allergic dermatitis and rash erythematous)
Slovenian: - izpuščaj (vključno z alergijskim dermatitisom in eritematoznim izpuščajem)
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to mouse, hamster or bovine protein.
Slovenian: Preobčutljivost na učinkovino, katero koli pomožno snov, ki je navedena v poglavju 6.1, ali mišje,
English: Factor VII deficiency
Slovenian: Pomanjkanje faktorja VII
English: Limited clinical experience in long term prophylaxis has been gathered in the paediatric population below 12 years of age, with a severe clinical phenotype (see section 5.1).
Slovenian: Pediatrična populacija Pridobljene klinične izkušnje v dolgotrajni profilaksi v pediatrični populaciji, mlajši od 12 let in s hudim kliničnim fenotipom, so omejene (glejte poglavje 5.1).
English: • Repeat the procedure with the appropriate number of additional vials, solvent vials/pre-filled syringes and vial adapters.
Slovenian: • Postopek ponovite z ustreznim številom dodatnih vial, vial/napolnjenih injekcijskih brizg topila in nastavkov za vialo.
English: - Pyrexia
Slovenian: - pireksija
English: Data from non-clinical studies as well as post-marketing data show no indication that rFVIIa has a harmful effect on male or female fertility.
Slovenian: Podatki predkliničnih študij kot tudi izkušnje po prihodu zdravila na trg ne kažejo, da bi rFVIIa škodljivo vplival na plodnost moških ali žensk.
English: Ensure that the syringe, the infusion tube and the in-line filter are primed and free of air before administration.
Slovenian: Poskrbite, da so brizga, infuzijska cevka in linijski filter pred uporabo ustrezno pripravljeni in ne vsebujejo zraka.
English: Mean clearance was approximately 50% higher in paediatric patients relative to adults (78 versus 53 ml/h×kg), whereas the mean terminal half-life was determined to 2.3 hours in both groups.
Slovenian: Povprečni očistek je bil pri pediatričnih bolnikih približno 50 % večji kot pri odraslih (78 v primerjavi s 53 ml/h×kg), ugotovljeni povprečni terminalni razpolovni čas pa je bil v obeh skupinah 2,3 ure.
English: • Use NovoSeven at once after mixing the powder with the solvent to avoid infection.
Slovenian: • Zdravilo NovoSeven uporabite takoj potem, ko prašek zmešate s topilom, da boste preprečili okužbo.
English: After reconstitution, chemical and physical stability has been demonstrated for 6 hours at 25°C and 24 hours at 5°C.
Slovenian: Po pripravi je kemična in fizikalna stabilnost dokazana za 6 ur pri temperaturi 25 °C in 24 ur pri temperaturi 5 °C.
English: If not used immediately, storage time and storage conditions prior to use are the responsibility of the user, and should not be longer than 24 hours at 2°C - 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Slovenian: Če ni uporabljeno takoj, je za čas shranjevanja in pogoje pred uporabo odgovoren uporabnik; čas ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C, razen če je bila priprava opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
English: Do not disassemble the equipment before disposal.
Slovenian: Ne razstavljajte opreme, preden jo zavržete.
English: However, there is no medical reason to think that it would affect your ability.
Slovenian: Vendar ni zdravstvenih razlogov, zaradi katerih bi lahko pričakovali, da bo to zdravilo vplivalo na vašo sposobnost upravljanja vozil in strojev.
English: Locate a suitable site, and slowly inject NovoSeven into a vein over a period of 2 - 5 minutes without removing the needle from the injection site.
Slovenian: Poiščite primerno mesto in počasi, od 2 do 5 minut, injicirajte zdravilo NovoSeven v veno, ne da bi iglo odstranili z mesta injiciranja.
English: Haemophilia A or B with inhibitors or expected to have a high anamnestic response
Slovenian: Hemofilija A ali B z zaviralci ali pričakovanim velikim anamnestičnim odzivom
English: 2) One single injection of 270 µg per kg body weight.
Slovenian: 2) Ena posamična injekcija 270 µg na kg telesne mase.
English: - Flushing - Angioedema
Slovenian: - zardevanje - angioedem
English: There is no clinical experience in people over 65 using this single dose.
Slovenian: Kliničnih izkušenj z uporabo tega posamičnega odmerka pri bolnikih, starejših od 65 let, ni.