FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 32 paediatric patients (8 children aged 2 to 11 years and 24 adolescents aged 12 to 17 years) with HAE were exposed to treatment with icatibant during clinical studies.
Slovenian: V kliničnih študijah so zdravljenju z ikatibantom izpostavili skupno 32 pediatričnih bolnikov (8 otrok, starih od 2 do 11 let in 24 mladostnikov, starih od 12 do 17 let) s HAE.
English: For icatibant, no clinical data on exposed pregnancies are available.
Slovenian: Kliničnih podatkov za nosečnice, ki so bile izpostavljene ikatibantu, ni na voljo .
English: 2) If the icatibant solution does not begin to transfer to the graduated syringe, pull slightly on the graduated syringe plunger until the icatibant solution starts to flow into the graduated syringe (see below image).
Slovenian: 2) Če se raztopina ikatibanta ne začne prenašati v brizgo z oznakami prostornine, rahlo povlecite bat brizge z oznakami prostornine, da začne raztopina ikatibanta pritekati vanjo (glejte spodnjo sliko).
English: Dizziness Headache
Slovenian: omotica glavobol
English: Repeated-dose studies of up to 6-months duration in rats and 9-months duration in dogs have been conducted.
Slovenian: Opravili so študije ponavljajočih se odmerkov, ki so trajale do 6 mesecev pri podganah in do
English: Maximum daily exposures defined by area under the curve (AUC) at the No Observed Adverse Effect Levels (NOAEL) in the 9-month study in dog were 2.3 times the AUC in adult humans after a subcutaneous dose of 30 mg. A NOAEL was not measurable in the rat study, however, all of the findings from that study showed either completely or partially reversible effects in treated rats.
Slovenian: Maksimalna dnevna izpostavljenost, opredeljena kot območje pod krivuljo (AUC) pri stopnji brez opaženih neželenih učinkov (NOAEL), je bila v 9-mesečni študiji na psih 2,3-krat večja od AUC pri odraslih ljudeh po subkutanem odmerku 30 mg.
English: The other ingredients are sodium chloride, acetic acid glacial, sodium hydroxide and water for injection.
Slovenian: Pomožne snovi so natrijev klorid, koncentrirana ocetna kislina, natrijev hidroksid in voda za injekcije.
English: The primary efficacy endpoint was the time to onset of symptom relief using a visual analogue scale (VAS).
Slovenian: V študijah faze III je bil primarni pokazatelj učinkovitosti čas do nastopa olajšanja simptomov, določen z uporabo vizualne analogne lestvice (VAS - visual analogue scale).
English: HAE manifests as intermittent attacks of subcutaneous and/or sub mucosal oedema involving the upper respiratory tract, the skin and the gastrointestinal tract.
Slovenian: HAE se kaže v obliki občasnih napadov subkutanih in/ali submukoznih edemov, ki prizadenejo zgornja dihala, kožo in prebavila.
English: Firazyr is presented as a clear, colourless solution for injection in a pre-filled glass syringe of 3 ml.
Slovenian: Zdravilo Firazyr je bistra, brezbarvna raztopina za injiciranje v napolnjeni injekcijski stekleni brizgi (3 ml).
English: In case of insufficient relief or recurrence of symptoms after self-treatment or administration by a caregiver, it is recommended that the patient or caregiver should seek medical advice.
Slovenian: Če lajšanje simptomov po samoinjiciranju ali injiciranju, ki ga izvede negovalec ni zadostno ali se ti simptomi ponavljajo, se priporoča, da se bolnik ali negovalec obrneta na zdravnika.
English: - If you are not sure which dose to inject, ask your doctor, pharmacist or nurse.
Slovenian: - Če niste prepričani, kateri odmerek je treba injicirati, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: In case of insufficient relief or recurrence of symptoms, a second injection of Firazyr can be administered after 6 hours.
Slovenian: V primeru nezadostnega olajšanja ali ponovitve simptomov se lahko bolniku po 6 urah da druga injekcija zdravila Firazyr.
English: If you are breast-feeding you should not breast-feed for 12 hours after you have last received Firazyr.
Slovenian: Če dojite, ne smete dojiti še 12 ur po zadnji uporabi zdravila Firazyr.
English: Accordingly, caution should be observed in the administration of icatibant to patients in the weeks following a stroke.
Slovenian: Zato je pri dajanju ikatibanta bolnikom v tednih po možganski kapi potrebna previdnost.
English: Hepatic and Renal Impairment Limited data suggest that icatibant exposure is not influenced by hepatic or renal impairment.
Slovenian: Jetrna in ledvična okvara Sicer pomanjkljivi podatki kažejo na to, da okvara jeter ali ledvic ne vpliva na izpostavljenost ikatibantu.
English: There are no observed differences in the exposure to icatibant between HAE patients with and without an attack.
Slovenian: Pri bolnikih s HAE niso opazili razlik pri izpostavljenosti ikatibantu med bolnikih, ki so imeli napad in bolniki, ki napada niso imeli.
English: • Clean the work area (surface) to be used before beginning the process.
Slovenian: 1) Splošne informacije • Preden začnete postopek, očistite delovno površino.
English: Ischemic heart disease
Slovenian: Ishemična bolezen srca
English: • Clean the injection site with a rubbing alcohol pad and allow it to dry.
Slovenian: • Mesto injiciranja očistite s kosmom vate prepojenim z medicinskim alkoholom, potem pa počakajte, da se posuši.
English: Tell your doctor immediately if you notice that the symptoms of your attack get worse after you received Firazyr.
Slovenian: Nemudoma obvestite svojega zdravnika, če opazite, da so se simptomi napada po uporabi zdravila
English: Firazyr is injected with a short needle into the fatty tissue under the skin in the abdomen (tummy).
Slovenian: Zdravilo Firazyr se injicira s kratko iglo v maščobno tkivo pod kožo v predelu trebuha.
English: Do not use this medicine after the expiry date stated on the label after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: For patients who have never received Firazyr previously, the first treatment should be given in a medical institution or under the guidance of a physician.
Slovenian: Injiciranje, ki ga izvede negovalec/samoinjiciranje Pri bolnikih, ki še nikoli niso prejeli zdravila Firazyr, je treba prvo injiciranje opraviti v zdravstveni ustanovi ali pod zdravnikovim nadzorom.
English: The following step-by step instructions are intended for: - self-administration (adults) - administration by a caregiver or healthcare professional to adults, adolescents or children aged over 2 years (weighing at least 12 kg).
Slovenian: Naslednja navodila za uporabo zdravila po korakih so namenjena: - samoinjiciranju (odrasli), - injiciranju pri odraslih, mladostnikih ali otrocih, starejših od 2 let (ki tehtajo najmanj
English: Adrenal gland hypertrophy was seen to reverse after cessation of icatibant treatment.
Slovenian: Opazili so, da je hipertrofija nadledvične žleze po prenehanju zdravljenja z ikatibantom reverzibilna.
English: Almost all patients receiving Firazyr will experience a reaction at the site of the injection (such as skin irritation, swelling, pain, itchiness, redness of the skin and burning sensation).
Slovenian: Skoraj vsi bolniki, ki prejemajo zdravilo Firazyr, občutijo reakcijo na mestu injiciranja (kot so draženje kože, otekanje, bolečina, srbenje, rdečina in pekoč občutek).
English: Pack size of one pre-filled syringe with one needle or a multipack containing three pre-filled syringes with three needles.
Slovenian: Posamično pakiranje z eno napolnjeno injekcijsko brizgo in eno iglo ali skupno pakiranje, ki vsebuje tri napolnjene injekcijske brizge in tri igle.
English: • Keeping the syringe in one hand, use your other hand to gently hold a fold of skin between your thumb and fingers at the previously disinfected injection site.
Slovenian: • Brizgo držite v eni roki, z drugo pa kožno gubo na predhodno razkuženem mestu nežno primitemed palcem in preostalimi prsti.
English: Each pre-filled syringe contains 30 milligrams of icatibant (as acetate).
Slovenian: Vsaka napolnjena brizga vsebuje 30 miligramov ikatibanta (v obliki acetata).
English: All adverse reactions from post-marketing experience are italicised.
Slovenian: Vsi neželeni učinki iz obdobja trženja zdravila so napisani v poševnem tisku.
English: Thirty-one patients received a single dose of icatibant and 1 patient (an adolescent) received icatibant for two HAE attacks (in total, two doses).
Slovenian: Enaintrideset bolnikov je prejelo enkraten odmerek ikatibanta, 1 bolnik (mladostnik), pa je prejel ikatibant za dva napada HAE
English: At 1 and 2 hours post treatment, approximately 50% and 90% of patients experienced onset of symptom relief, respectively.
Slovenian: Po 1 uri po odmerjanju zdravila se je izboljšanje simptomov pojavilo pri 50 %, po 2 urah pa pri 90 % bolnikov.
English: All patients received at least one dose of icatibant (0.4mg/kg body weight up to a maximum dose of 30 mg) and the majority of patients were followed up for a minimum of 6 months.
Slovenian: Vsi bolniki so prejeli vsaj en odmerek ikatibanta (0,4mg/kg telesne mase do največjega odmerka 30 mg),
English: The solution should be clear and colourless and free from visible particles.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Raztopina mora biti bistra in brezbarvna ter brez vidnih delcev.
English: 3 ml of solution in a 3 ml pre-filled syringe (type I glass) with plunger stopper (bromobutyl coated with fluorocarbon polymer).
Slovenian: 3 ml raztopine v 3 ml napolnjeni injekcijski brizgi (steklo tipa I) z batno zaporko (bromobutil,
English: Almost all subjects who were treated with subcutaneous icatibant in clinical trials developed reactions at the site of injection (characterised by skin irritation, swelling, pain, itchiness, erythema, burning sensation).
Slovenian: Skoraj pri vseh bolnikih, ki so subkutano prejemali ikatibant v kliničnih preskušanjih, so se pojavile reakcije na mestu injiciranja (za katere so značilni draženje kože, otekanje, bolečina, srbenje, eritem, pekoč občutek).
English: If you are not sure which volume of solution to extract, ask your doctor, pharmacist or nurse
Slovenian: Če niste prepričani, kakšno prostornino raztopine morate izvleči, vprašajte zdravnika, farmacevta ali medicinsko sestro.
English: Remove the seal from the needle cap (the needle should be still in the needle cap).
Slovenian: • S pokrovčka za iglo odstranite tesnilo (pri tem mora igla ostati v pokrovčku).
English: Efficacy results for FAST-3 Efficacy Results: FAST-3; Controlled Phase -- ITT population
Slovenian: (N = 56) Tabela 4: Rezultati študije FAST-3 za učinkovitost Rezultati za učinkovitost: FAST-3; nadzorovana faza - populacija, ki so jo nameravali zdraviti (ITT)
English: Solution for injection One pre-filled syringe One 25G needle
Slovenian: Raztopina za injiciranje Ena napolnjena injekcijska brizga in ena igla 25 G.
English: The primary endpoint was time to onset of symptom relief assessed using a 3-item composite visual analog score (VAS-3) consisting of assessments of skin swelling, skin pain, and abdominal pain.
Slovenian: Ocenili so ga s sestavljeno vizualno analogno lestvico s tremi postavkami (VAS-3), ki je vključevala oceno otekanja na koži, bolečine na koži in bolečine v trebuhu.
English: Your doctor will tell you when it is safe for you to go home. After discussion with your doctor or nurse and after training in subcutaneous (under the skin) injection technique, you may be able to inject yourself with Firazyr or your caregiver may inject Firazyr for you when you have an HAE attack.
Slovenian: Po pogovoru z zdravnikom ali medicinsko sestro in po usposabljanju o tehniki subkutanega (podkožnega) injiciranja si boste ob napadu hereditarnega angioedema zdravilo Firazyr injicirali sami ali vam ga bo injiciral vaš negovalec.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTI-PACK (INCLUDING BLUE BOX)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (VKLJUČNO Z »BLUE BOX« PODATKI)
English: - If your symptoms are not resolved following one self- or caregiver administered injection of Firazyr, you should seek medical advice regarding additional injections of Firazyr.
Slovenian: - Če simptomi po enem samoinjiciranju zdravila Firazyr ne izginejo, se obrnite na zdravnika, ki vam bo svetoval glede nadaljnjega injiciranja zdravila Firazyr.
English: Refer to table 1 for dosage information.
Slovenian: Informacije o odmerjanju so v preglednici 1.
English: 2) Screw the connector onto the pre-filled syringe.
Slovenian: 2) Privijte vmesnik na napolnjeno injekcijsko brizgo.
English: Acetic acid, glacial (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Slovenian: natrijev hidroksid (za uravnavanje pH)
English: No dose adjustment is required in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter prilagoditev odmerka ni potrebna.
English: Population pharmacokinetic modelling using both adult and paediatric data showed that clearance of icatibant is related to body weight with lower clearance values noted for lower body weights in the paediatric HAE population.
Slovenian: Populacijsko farmakokinetično modeliranje, pri katerem so uporabili podatke, zbrane pri odraslih in pediatričnih bolnikih, je pokazalo, da je očistek ikatibanta povezan s telesno maso.
English: 1) To start transfer of icatibant solution, push the pre-filled syringe plunger (on far left of below image).
Slovenian: 1) Prenos raztopine ikatibanta sprožite tako, da potisnete bat napolnjene injekcijske brizge (čisto levo na spodnji sliki).
English: Median time to regression of symptoms, by patient (hours)
Slovenian: Mediana časa do zmanjšanja simptomov, po oceni bolnika (v urah)
English: - This medicine has been prescribed for you only.
Slovenian: - Zdravilo je predpisano vam osebno in ga ne smete dajati drugim.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA POSAMIČNO PAKIRANJE
English: Contains: acetic acid glacial, sodium hydroxide, sodium chloride, water for injections.
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožne snovi: koncentrirana ocetna kislina, natrijev hidroksid, natrijev klorid, voda za injekcije.
English: There is limited experience with treatment of more than one HAE attack with Firazyr in the paediatric population.
Slovenian: Pri pediatrični populaciji je malo izkušenj z zdravljenjem več kot enega napada HAE z zdravilom
English: Firazyr may be self-administered or administered by a caregiver only after training in subcutaneous injection technique by a healthcare professional.
Slovenian: Zdravilo Firazyr lahko bolnik sam ali njegov negovalec uporabi, šele ko ga je zdravstveni delavec poučil o tehniki subkutanega injiciranja.
English: In addition: - You or your caregiver must be trained on subcutaneous (under the skin) injection technique before you self-inject or your caregiver injects you with Firazyr.
Slovenian: Poleg tega: - Preden si sami injicirate zdravilo Firazyr ali vam ga injicira negovalec, se morate vi ali vaš negovalec poučiti o tehniki subkutanega (podkožnega) injiciranja.
English: 5) Discard the pre-filled syringe and connector into the sharps container.
Slovenian: 5) Zavrzite napolnjeno injekcijsko brizgo in vmesnik v posodo za ostre predmete.
English: An open label, non-randomised single-arm study (HGT-FIR-086) was performed with a total of 32 patients.
Slovenian: Pediatrična populacija Pri skupno 32 bolnikih so izvedli odprto, nerandomizirano študijo z eno skupino (HGT-FIR-086).
English: - Immediately after you self-inject Firazyr or your caregiver injects you with Firazyr while you are experiencing a laryngeal attack (obstruction of the upper airway), you must seek medical care in a medical institution.
Slovenian: - Če si zdravilo Firazyr injicirate med laringealnim napadom (neprehodnost zgornjih dihal) ali vam ga injicira negovalec, se morate takoj po tem obrniti na zdravniško pomoč v zdravstveni ustanovi.
English: Dose (Injection Volume)
Slovenian: Odmerek (prostornina injiciranega zdravila)
English: - The recommended dose of Firazyr is one injection of 1 ml up to a maximum of 3 ml based on body weight injected subcutaneously (under the skin) as soon as you develop symptoms of an angioedema attack (for example increased skin swelling, particularly affecting the face and neck, increasing tummy pain).
Slovenian: Otroci in mladostniki, stari od 2 do 17 let - Priporočeni odmerek zdravila Firazyr je ena injekcija z odmerkom od 1 ml do največ 3 ml glede na telesno maso, injicirana subkutano (pod kožo) takoj, ko se pojavijo simptomi napada angioedema (npr. povečano otekanje kože, ki delno zajame obraz in vrat, okrepljene bolečine v trebuhu).
English: Patients experiencing a laryngeal attack should always seek medical advice and be observed in a medical institution also after having taken the injection at home.
Slovenian: Podatkov o dajanju nadaljnjih odmerkov pri istem napadu pri mladostnikih ali otrocih ni. Bolnik z laringealnim napadom se mora vedno obrniti na zdravnika in ga je treba opazovati v zdravstveni ustanovi, tudi če si je zdravilo injiciral že doma.
English: Firazyr is not recommended for use in children under 2 years of age or weighing less than 12 kg because it has not been studied in these patients.
Slovenian: manjšo od 12 kg, ker pri teh bolnikih študije niso bile izvedene.
English: All episodes (N = 74)
Slovenian: (N = 74)
English: Each ml of the solution contains 10 mg of icatibant.
Slovenian: En mililiter raztopine vsebuje 10 mg ikatibanta.
English: Median time to almost complete symptom relief (hours)
Slovenian: Čas do skoraj popolnega lajšanja simptomov (ure)
English: Firazyr is intended for subcutaneous administration preferably in the abdominal area.
Slovenian: Zdravilo Firazyr je namenjeno subkutani uporabi, najbolje v predelu trebuha.
English: Special populations
Slovenian: populaciji
English: If you get any side effects talk to your doctor.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom.
English: Refer to the patient information leaflet for instructions for use.
Slovenian: Glejte navodilo za uporabo glede navodil za uporabo zdravila.
English: - See section on instructions for use for the dose to inject.
Slovenian: - Za odmerek, ki ga je treba injicirati, glejte navodilo za uporabo zdravila.
English: 12.0 All episodes (N = 56)
Slovenian: 12,0 Vse epizode
English: 1) Remove the caps on each end of the connector.
Slovenian: 1) Odstranite pokrovčka z obeh strani vmesnika.
English: 4) Remove the pre-filled syringe and connector from the graduated syringe.
Slovenian: 4) Odstranite napolnjeno injekcijsko brizgo in vmesnik z brizge z oznakami za prostornino.
English: A total of 66 patients with attacks of HAE affecting the larynx were treated in these controlled Phase III clinical trials.
Slovenian: V teh nadzorovanih kliničnih preskušanjih 3. faze je bilo zdravljenih skupno 66 bolnikov s HAE, ki so prizadeli grlo.
English: • Open the tray by peeling back the seal.
Slovenian: • Odprite podstavek, tako da tesnilo povlečete nazaj.
English: 3) Preparing the injection site
Slovenian: Priprava mesta injiciranja
English: 51 kg to 65 kg
Slovenian: Od 51 kg do 65 kg
English: Firazyr 30 mg solution for injection in pre-filled syringe Icatibant
Slovenian: Firazyr 30 mg raztopina za injiciranje v napolnjeni injekcijski brizgi ikatibant
English: No dose adjustment is required in patients with renal impairment.
Slovenian: Pri bolnikih z okvaro ledvic prilagoditev odmerka ni potrebna.
English: If you are taking a medicine known as an Angiotensin Converting Enzyme (ACE) inhibitor (for example: captopril, enalapril, ramipril, quinapril, lisinopril) which is used to lower your blood pressure or for any other reason, you should inform your doctor before receiving Firazyr.
Slovenian: Če jemljete zdravilo, znano kot zaviralec angiotenzin konvertaze (zaviralec ACE) (na primer: kaptopril, enalapril, ramipril,
English: Firazyr 30 mg solution for injection in pre-filled syringe
Slovenian: Firazyr 30 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Rash Erythema Pruritus
Slovenian: izpuščaj eritem pruritus urtikarija
English: Remove the needle cap from the blister.
Slovenian: • Iz pretisnega omota odstranite pokrovček za iglo.
English: The active substance is icatibant.
Slovenian: Zdravila učinkovina je ikatibant.
English: • Remove the pre-filled syringe from the tray.
Slovenian: • Napolnjeno injekcijsko brizgo odstranite iz podstavka.
English: • 3 ml (recommended) graduated syringe
Slovenian: • brizga z oznakami prostornine velikosti 3 ml (priporočena).
English: The recommended dose of Firazyr based on body weight in children and adolescents (aged 2 to 17 years) is provided in table 1 below.
Slovenian: Priporočeni odmerek zdravila Firazyr na podlagi telesne mase pri otrocih in mladostnikih (starih od 2
English: Other Endpoints Time to Onset of Primary Symptom Relief (hrs)
Slovenian: Čas do pojava lajšanja primarnega simptoma (ure)
English: FAST-3 was a randomized, placebo-controlled, parallel-group study of 98 adult patients with a median age of 36 years.
Slovenian: 98 odraslih bolnikih z mediano starostjo 36 let.
English: Change in Composite Investigator-Assessed Symptom Score at 2 hours
Slovenian: Sprememba sestavljenega rezultata simptomov, ki jih je ocenjeval raziskovalec, po
English: Number of subjects in ITT Population 36
Slovenian: Število oseb v populaciji, ki so jih nameravali zdraviti
English: Hypodermic needle is included in the pack.
Slovenian: Igla za subkutano aplikacijo je priložena pakiranju.
English: 2a) Preparing the syringe for children and adolescents (2-17 years) weighing 65 kg or less 2b) Preparing the syringe and needle for injection (all patients) 3) Preparing the injection site
Slovenian: 2b) Priprava brizge in igle za injiciranje (za vse bolnike) 3) Priprava mesta injiciranja 4) Injiciranje raztopine
English: 26 kg to 40 kg
Slovenian: Od 26 kg do 40 kg
English: 12 kg to 25 kg
Slovenian: Od 12 kg do 25 kg
English: One pre-filled syringe and one 25G needle.
Slovenian: Ena igla 25G
English: All episodes (N = 56)
Slovenian: (N = 56)
English: Firazyr is available as a single pack containing one pre-filled syringe with one needle or as a multipack containing three pre-filled syringes with three needles.
Slovenian: Firazyr je na voljo v posamičnem pakiranju, ki vsebuje eno napolnjeno injekcijsko brizgo in eno iglo,
English: Children and adolescents aged 2-17 years
Slovenian: 2a) Priprava brizge za otroke in mladostnike (stare 2-17 let)
English: Median time to onset of symptom relief (hours)
Slovenian: Mediana časa do nastopa olajšanja simptomov (v urah)
English: Additional injection site reactions (pressure sensation, bruising, reduced sensation and/or numbness, raised itchy skin rash and warmth).
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov): dodatne reakcije na mestu injiciranja (občutek pritiska, podplutbe, zmanjšan čut in/ali otopelost, izbočen srbeč kožni izpuščaj ter občutek toplote)
English: Step-by-Step Instructions for Injection 1) General Information
Slovenian: Navodila za injiciranje po korakih
English: Baseline VAS(mm)
Slovenian: koprivnica (urtikarija)
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu, kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: 51.0 All episodes (N = 56)
Slovenian: 51,0 Vse epizode
English: • Screw the syringe on the needle still fixed in the needle cap.
Slovenian: • Napolnjeno injekcijsko brizgo privijte na iglo, ki je še vedno zaščitena s pokrovčkom.
English: Other medicines and Firazyr
Slovenian: 3 injekcije zdravila Firazyr.
English: 41 kg to 50 kg
Slovenian: Od 41 kg do 50 kg
English: Each 3 ml pre-filled syringe contains icatibant acetate equivalent to 30 mg icatibant.
Slovenian: Ena 3 ml napolnjena injekcijska brizga vsebuje 30 mg ikatibanta v obliki ikatibant acetata.
English: Subcutaneous use Read the package leaflet before use For single use only
Slovenian: Pred uporabo preberite priloženo navodilo.