natgillin/translations-raw huggingface dataset:
Almost all subjects who were treated with subcutaneous icatibant in clinical trials developed reactions at the site of injection including erythema, swelling, warm sensation, burning, itching and/ or cutaneous pain.
Skoraj pri vseh bolnikih, ki so subkutano prejemali ikatibant v kliničnih preskušanjih, so se pojavile reakcije na mestu injiciranja, vključno z eritemi, oteklino, občutkom toplote, pekočim občutkom, srbečico in/ ali bolečo kožo.
These reactions were generally mild in severity, transient, and resolved without further intervention.
Te reakcije so bile navadno blage, prehodne in so samodejno prenehale.
Very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000).
Zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100, < 1/ 10); občasni (≥ 1/ 1. 000, < 1/ 100); redki (≥ 1/ 10. 000, < 1/ 1. 000); zelo redki (< 1/ 10. 000).
Due to the low number of patients, each of the uncommon events has only been reported in a single patient.
Ker je število bolnikov zelo majhno, se poročila o posameznih občasnih neželenih učinkih nanašajo samo na enega bolnika.
Adverse reactions reported with icatibant in the phase III clinical trials.
Neželeni učinki, o katerih so poročali pri uporabi ikatibanta v kliničnih preskušanjih faze III.
Hereditary angioedema*
hereditarni angioedem *
Nausea, abdominal pain
navzea, bolečine v trebuhu
Erythema, swelling, warm sensation, burning, itching, cutaneous pain
eritemi, oteklina,
Fatigue, pyrexia
utrujenost, zvišana
Infections and infestations
spremembe na mestu aplikacije
Pharyngitis
telesna temperatura
Injury, poisoning and procedural complications
Infekcijske in parazitske bolezni
Contusion
faringitis
Blood creatinine phosphokinase increased, liver function test abnormal
povečanje kreatin fosfokinaze v krvi, neobičajni testi jetrne funkcije
Weight increased, prothrombin time prolonged
mase, podaljšanje protrombinskega časa
Nervous system disorders
Bolezni živčevja Bolezni sečil
Dizziness, headache
omotica, glavobol
Asthma, cough
astma, kašelj
Pruritus, erythema,
pruritus, eritemi
Hot flush
navali vročine
* HAE attacks were reported as adverse reactions, however based on time of occurrence, the majority were recurrent attacks and not related to treatment with Firazyr.
* O napadih HAE so poročali kot o neželenem učinku, vendar je šlo glede na čas pojavitve večinoma za ponovne napade, ki niso povezani z zdravljenjem z zdravilom Firazyr.
4 4.9 Overdose
4. 9 Preveliko odmerjanje
A dose of 3.2 mg/ kg intravenously (approximately 8 times the therapeutic dose) caused transient erythema, itching or hypotension in healthy subjects.
4 Odmerek 3, 2 mg/ kg intravensko (približno 8- kratni terapevtski odmerek) je pri zdravih osebah povzročil prehodne eriteme, srbečico ali hipotenzijo.
[to be decided] ATC code:
[bo določena], oznaka ATC:
[not yet assigned].
[še ni dodeljena].
HAE (an autosomal dominant disease) is caused by an absence or dysfunction of C1-esterase- inhibitor.
Hereditarni angioedem (HAE) (avtosomna dominantna bolezen) se pojavi zaradi odsotnosti ali disfunkcije zaviralca C1- esteraze.
HAE manifests as intermittent attacks of subcutaneous and/ or sub mucosal oedema involving the upper respiratory tract, the skin and the gastrointestinal tract.
HAE se kaže v obliki občasnih napadov subkutanih in/ ali submukoznih edemov, ki prizadenejo zgornja dihala, kožo in prebavila.
In healthy young subjects, icatibant administered in doses of 0.8 mg/ kg over 4 hours; 1.5 mg/ kg/ day or 0.15 mg/ kg/ day for 3 days, development of bradykinin-induced hypotension, vasodilatation and reflex tachycardia was prevented.
Pri zdravih mladih osebah so ikatibant dajali v odmerkih 0, 8 mg/ kg v 4 urah; 1, 5 mg/ kg/ dan ali 0, 15 mg/ kg/ dan 3 dni; pojav hipotenzije, vazodilatacije in refleksne tahikardije zaradi bradikinina je bil preprečen.
Icatibant was shown to be a competitive antagonist when the bradykinin challenge dose was increased 4-fold.
Ikatibant je izkazal lastnosti kompetitivnega antagonista, ko je bil provokacijski odmerek bradikinina povečan 4- kratno.
Efficacy data were obtained from an initial open-label Phase II study and from two randomised, double blind controlled multi centre Phase III studies (one with oral tranexamic acid as the comparator and one placebo controlled).
Podatki o učinkovitosti so bili pridobljeni iz začetne odprte študije faze II in iz dveh randomiziranih, dvojno slepih, kontroliranih multicentričnih študij faze III (v eni je bilo zdravilo primerjano s peroralno traneksamično kislino in v drugi s placebom).
The pivotal Phase III studies were otherwise identical in design.
Osrednji študiji faze III sta bili sicer enako zasnovani.
Patients with symptoms of laryngeal angioedema received open label treatment with icatibant.
Bolniki s simptomi laringalnega angioedema so prejemali zdravljenje z ikatibantom v odprti fazi.
In the Phase III trials, the primary efficacy endpoint was time to onset of symptom relief using a visual analogue scale (VAS).
V študijah faze III je bil primarni pokazatelj učinkovitosti čas do nastopa olajšanja simptomov, določen z uporabo vizualne analogne lestvice (VAS – visual analogue scale).
In both studies, patients on icatibant had a faster median time to onset of symptom relief (2.0 and 2.5 hours, respectively) compared to tranexamic acid (12.0 hours) and placebo (4.6 hours).
V obeh študijah so imeli bolniki, ki so prejemali ikatibant, krajšo mediano časa do nastopa olajšanja simptomov (2, 0 oziroma 2, 5 ure) kot bolniki, ki so prejemali traneksamično kislino (12, 0 ure) ali tisti, ki so prejemali placebo (4, 6 ure).
The following table shows the results for the two pivotal trials
V naslednji tabeli so prikazani rezultati obeh osrednjih preskušanj.
Efficacy Results
5 Kontrolirana klinična študija zdravila FIRAZYR v primerjavi s traneksamično kislino/ placebom: rezultati učinkovitosti
STUDY 1
ŠTUDIJA 1
Tranexamic
traneksamična
STUDY 2
ŠTUDIJA 2
Icatibant
Število oseb v populaciji, ki so jih
acid
ikatibant
Icatibant
kislina
Placebo
Število oseb v ITT
Number of subjects
ikatibant
Number of subjects
placebo
in ITT Population
nameravali zdraviti (ITT – intent- to - treat population) Izhodiščna
in ITT Population
populaciji Izhodiščna vrednost
Tranexamic
po VAS (mm)
STUDY 2
69, 3
acid
67, 7
Icatibant
Sprememba
Baseline
Sprememba
63.7
- 41, 6
61.5
- 14, 6
69.3
- 44, 6
67.7
- 23, 5
baseline to 4 hours Difference
izhodiščne vrednosti na 4 ure Razlika med
-44.6
zdravljenji (95% - 27, 8 (- 39, 4, - 16, 2) p CI, p- vrednost) Sprememba
between treatments -27.8 (-39.4, -16.2) p < 0.001 between treatments -22.3 (-36.1, -9.3) p = 0.002 (95% CI, p-value) Change from
< 0, 001 zdravljenji (95% CI, p- vrednost) Sprememba
(95% CI, p-value) Change from
- 22, 3 (- 36, 1, - 9, 3)
baseline to 12 hours Difference
- 30, 3 izhodiščne vrednosti na 12 ur Razlika med
-54.0
- 53, 9
-30.3
- 41, 0
-53.9
p = 0, 046
-41.0
Vse epizode
between treatments -24.1 (-33.6, -14.6) p < 0.001 between treatments -14.0 (-27.7, -0.3) p = 0.046 (95% CI, p-value) Median time to onset of symptom relief (hours) All episodes
12, 0 (N = 56) Stopnja odziva (%, CI) po 4 urah po začetku zdravljenja
(95% CI, p-value) Median time to onset of symptom relief (hours) All episodes
4, 6
(N = 74) Response rate (%, CI) at 4 hours after start of treatment
Vse epizode 80, 0
2.0
30, 6 Vse epizode
12.0
66, 7
(N = 56) Response rate (%, CI) at 4 hours after start of treatment
46, 4
2.5
(N = 74) Mediana časa do nastopa olajšanja simptomov: vsi simptomi (v urah): bolečina v trebuhu oteklina na koži bolečine v koži Mediana časa do skoraj popolnega olajšanja simptomov (v urah)
All episodes
(63, 1, 91, 6) 1, 6 2, 6 1, 5
80.0
(16, 3, 48, 1) (N = 56) Mediana časa do nastopa olajšanja simptomov: vsi simptomi (v urah): bolečina v trebuhu 3, 5 oteklina na koži 18, 1 bolečine v koži 12, 0 Mediana časa do skoraj popolnega olajšanja simptomov (v urah)
30.6 Al
(46, 0, 83, 5) (27, 5, 2, 0 3, 1 1, 6
All episodes 80.0 30.6 All episodes
66, 1) 3, 3 10, 2 9, 0
66.7
Vse epizode
46.4
Vse epizode
(63.1, 91.6)
(N = 74)
(16.3, 48.1)
10, 0
(N = 56) Median time to onset of symptom relief: all symptoms (hours):
51, 0 (N = 56)
(46.0, 83.5)
8, 5
(27.5, 66.1)
23, 3
Abdominal pain Skin swelling Skin pain Median time to almost complete symptom relief (hours) All episodes
6 Kontrolirana klinična študija zdravila FIRAZYR v primerjavi s traneksamično kislino/ placebom: rezultati učinkovitosti
1.6 2.6 1.5
ŠTUDIJA 1
3.5 18.1 12.0
traneksamična
Abdominal pain Skin swelling Skin pain Median time to almost complete symptom relief (hours) All episodes
ŠTUDIJA 2
2.0 3.1 1.6
ikatibant
3.3 10.2 9.0
kislina
(N = 74) Median time to regression of symptoms, by patient (hours) All episodes
ikatibant
10.0
placebo
51.0
Mediana časa do zmanjšanja simptomov, po oceni bolnika (v urah)
(N = 56) Median time to regression of symptoms, by patient (hours) All episodes
Mediana časa do zmanjšanja simptomov, po oceni bolnika (v urah)
8.5
Vse epizode
23.3
Vse epizode
(N = 74) Median time to overall patient improvement, by physician (hours) All episodes
(N = 74) Mediana časa do celokupnega izboljšanja stanja bolnika, po oceni zdravnika (v urah) Vse epizode
(N = 56) Median time to overall patient improvement, by physician (hours) All episodes
(N = 56) Mediana časa do celokupnega izboljšanja stanja bolnika, po oceni zdravnika (v urah) Vse epizode
6 One hundred and eighteen patients were treated in the open label extension (OLE) phase for a total of 597 separate attacks.
Sto osemnajst bolnikov je bilo zdravljenih v odprti razširjeni (OLE – open label extension) fazi, v kateri je bilo obravnavanih skupaj 597 posameznih napadov.
The efficacy results were similar to those seen in the controlled phase of the studies.
Rezultati učinkovitosti so bili podobni kot v kontrolirani fazi študij.
The majority of attacks (89.3% and 90.9%, respectively) in both studies required only a single dose of icatibant.
90, 9%) v obeh študijah je zadoščal že en odmerek ikatibanta.
A total of 36 patients were treated for a total of 61 attacks of HAE affecting the larynx.
Zdravljenih je bilo skupaj 36 bolnikov s skupaj 61 napadi HAE, ki so prizadeli grlo.
The results were again similar to patients with non-laryngeal attacks of HAE with a median time to start of regression of symptoms of 0.6 - 1.0 hours (controlled phase).
Rezultati so bili ponovno podobni kot pri bolnikih z nelaringealnimi napadi HAE z mediano časa do začetka nazadovanja simptomov 0, 6– 1, 0 ure (kontrolirana faza).
Absorption Following subcutaneous administration, the absolute bioavailability of icatibant is 97%.
Absorpcija Po subkutani aplikaciji je absolutna biološka uporabnost ikatibanta 97%.
The time to maximum concentration is approximately 0.5 hours.
Čas do maksimalne koncentracije je približno 0, 5 ure.
Distribution Icatibant volume of distribution (Vss) is about 20-25 L.
Porazdelitev Volumen porazdelitve (Vss) ikatibanta je približno 20– 25 l.
Plasma protein binding is 44%.
Vezava na plazemske proteine je 44%.
Elimination Icatibant is mainly eliminated by metabolism with less than 10% of the dose eliminated in the urine as unchanged drug.
Izločanje Ikatibant se izloča pretežno presnovljen, manj kot 10% odmerka pa se izloči z urinom v nespremenjeni obliki.
Clearance is about 15-20 l/ h and independent of dose.
Očistek je približno 15– 20 l/ h in je neodvisen od odmerka.
The terminal half-life is about 1-2 hours.
Končna razpolovna doba je približno 1– 2 uri.
Metabolism Icatibant is extensively metabolized by proteolytic enzymes to inactive metabolites that are primarily excreted in the urine.
Presnova Ikatibant obsežno presnavljajo proteolitični encimi v neaktivne presnovke, ki se primarno izločajo z urinom.
Special populations Data suggest an age-related decline in clearance resulting in about 50-60% higher exposure in the elderly (75-80 years) compared to a patient aged 40 years.
7 Podatki nakazujejo, da se očistek s starostjo zmanjšuje, kar pomeni, da je pri starejših (75– 80 let) izpostavljenost 50– 60% večja kot pri bolniku, starem 40 let.
Repeated-dose studies of up to 3-months duration have been conducted in rat and dog.
Študije ponavljajočih odmerkov v trajanju do 3 mesecev so izvajali pri podganah in psih.
Maximum daily exposures (AUC) at the No Observed Adverse Effect Levels in the 3-month study in rat were 3.6 times and in the 4 week study in dog were 9.4 times the AUC in humans after a subcutaneous dose of 30 mg.
Maksimalna dnevna izpostavljenost (AUC), pri kateri ni opaznih neželenih učinkov, je bila v 3- mesečni študiji pri podganah 3, 6- krat, v 4- tedenski študiji pri psih pa 9, 4- krat večja od AUC pri ljudeh po subkutanem odmerku 30 mg.
Long-term studies to determine the carcinogenic potential of icatibant have not been conducted to date.
Dolgotrajne študije za določitev karcinogenega potenciala ikatibanta do sedaj še niso bile izvedene.
Icatibant is a potent
Ikatibant ni bil teratogen, ko so ga dajali s subkutano injekcijo med zgodnjim embrionalnim in fetalnim razvojem pri podganah (maksimalni odmerek 25 mg/ kg/ dan) in zajcih (maksimalni odmerek 10 mg/ kg/ dan).
7 antagonist of bradykinin and therefore, at high dose levels, treatment can have effects on the uterine implantation process and subsequent uterine stability in early pregnancy.
Ikatibant je močan antagonist bradikinina, zato lahko zdravljenje z visokimi odmerki vpliva na proces ugnezdenja v maternico in nadaljnjo stabilnost v maternici v zgodnji nosečnosti.
These uterine effects also manifest in late stage pregnancy where icatibant exhibits a tocolytic effect resulting in delayed parturition in the rat, with increased fetal distress and perinatal death at high doses (10 mg/ kg/ day).
Ti učinki na maternico se kažejo tudi v poznem stadiju nosečnosti, ko ikatibant izkazuje tokolitičen učinek, kar se kaže v zakasneli kotitvi pri podganah, s povečanjem fetalnega distresa in perinatalne smrti pri visokih odmerkih (10 mg/ kg/ dan).
In immature rats and dogs, repeated use of icatibant reversibly delayed sexual maturation.
Pri mladih podganah in psih je ponavljajoča uporaba ikatibanta reverzibilno upočasnila spolno dozorevanje.
The effects appeared to be secondary to icatibant-induced changes in gonadotrophin levels, and were reversible.
Ti učinki so videti sekundarni glede na spremembe v ravneh gonadotropina, pogojene z ikatibantom, in so bili reverzibilni.
Similar effects of icatibant on gonadotrophins also occurred in sexually mature dogs.
Podoben vpliv ikatibanta na gonadotropin se je pojavil tudi pri spolno dozorelih psih.
Icatibant had no effect on the fertility of male mice and rats.
Ikatibant ni imel nikakršnih učinkov na plodnost samcev miši in podgan.
Sodium chloride Acetic acid, glacial (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
natrijev klorid ocetna kislina, koncentrirana (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) voda za injekcije
24 months.
8 24 mesecev
Do not store above 25○ C.
Shranjujte pri temperaturi do 25 °C.
One pre-filled syringe (type I glass) with plunger stopper (bromobutyl coated with fluorocarbon polymer).
Ena napolnjena injekcijska brizga (steklo tipa I) z batno zaporko (bromobutil, prevlečen s fluoroogljikovim polimerom).
3 ml of solution filled in a 3 ml syringe.
3 ml raztopine, napolnjene v 3 ml brizgi.
A hypodermic needle (25 G; 16 mm) is included in the package.
Igla za subkutano aplikacijo (25 G; 16 mm) je priložena pakiranju.
130 D-10115 Berlin
130 D- 10115 Berlin Nemčija
9 DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
9 DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Podrobne informacije o tem zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
A IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
RENTSCHLER Biotechnologie GmbH Erwin-Rentschler-Strasse 21 D-88471 Laupheim Germany
RENTSCHLER Biotechnologie GmbH Erwin- Rentschler- Strasse 21 D- 88471 Laupheim Nemčija
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE ZDRAVILA, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
The MAH must ensure that the system of pharmacovigilance, as described in version 5.0 dated 11 April 2008 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 5. 0 z dne 11. aprila 2008, ki je predstavljena v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v prometu.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.2 dated 15 April 2008 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 1. 2 načrta za obvladovanje tveganja, predstavljeni v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah načrta za obvladovanje tveganja, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skladno z smernico CHMP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljeni načrt za obvladovanje tveganja predložen sočasno z naslednjim periodičnim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega je treba posodobljeni načrt za obvladovanje tveganja predložiti: • kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki bi lahko vplivale na trenutne varnostne zahteve, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja, • v 60 dneh potem, ko je dosežen pomemben mejnik (farmakovigilančni ali glede zmanjševanja tveganja), • na zahtevo EMEA.
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
13 PODATKI NA ZUNANJI OVOJNINI Škatla
Firazyr 30 mg solution for injection pre-filled syringe Icatibant
Firazyr 30 mg raztopina za injiciranje v napolnjeni injekcijski brizgi ikatibant
Each ml of the solution contains 10mg of icatibant.
En mililiter raztopine vsebuje 10 mg ikatibanta.
25G needle
Raztopina za injiciranje 1 napolnjena injekcijska brizga Igla 25G
Subcutaneous use Read the package leaflet before use For single use only
Samo za enkratno uporabo.
130 D-10115 Berlin Germany
Imetnik dovoljenja za promet z zdravilom Jerini AG Invalidenstrasse 130 D- 10115 Berlin Nemčija
OTHER Subcutanous use
DRUGI PODATKI Subkutana uporaba
{Syringe label}
{Nalepka na brizgi}
30 mg/ 3 ml
30mg/ 3 ml
OTHER Jerini
DRUGI PODATKI Jerini
Do not pass it on to others.
- Zdravilo je predpisano vam osebno in ga ne smete dajati drugim.
It may harm them, even
Njim bi lahko celo škodovalo,
if their symptoms are the same as yours.
čeprav imajo znake bolezni, podobne vašim.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Če kateri koli neželeni učinek postane resen ali če opazite kakršen koli neželeni učinek, ki ni
What Firazyr is and what it is used for 2.
Kaj je zdravilo Firazyr in za kaj ga uporabljamo 2.
Before you use Firazyr 3.
Kaj morate vedeti, preden boste uporabili zdravilo Firazyr 3.
How to use Firazyr 4.
Kako uporabljati zdravilo Firazyr 4.
How to store Firazyr 6.
Shranjevanje zdravila Firazyr 6.
WHAT FIRAZYR IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO FIRAZYR IN ZA KAJ GA UPORABLJAMO
Firazyr blocks the activity of bradykinin and therefore ends the further progression of the symptoms of an HAE attack.
Zdravilo Firazyr zavira aktivnost bradikinina ter tako ustavi nadaljnje napredovanje simptomov napada HAE.
BEFORE YOU USE FIRAZYR
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO FIRAZYR
Do not use Firazyr
Ne uporabljajte zdravila Firazyr
- If you know that you are allergic (hypersensitive) to icatibant, or any of the other ingredients of
- če ste alergični na (preobčutljivi za) ikatibant ali katero koli sestavino zdravila Firazyr.
Take special care with Firazyr
Bodite posebno pozorni pri uporabi zdravila Firazyr
Tell your doctor immediately if you notice that your symptoms of the attack get worse after you received Firazyr.
Če opazite, da so se simptomi napada poslabšali po prejemu zdravila Firazyr, morate nemudoma obvestiti svojega zdravnika.
If you are suffering from angina (reduced blood flow to the heart muscle), please consult your doctor before using Firazyr.
Če imate angino pektoris (zmanjšan dovod krvi v srčno mišico), se pred uporabo zdravila Firazyr posvetujte z zdravnikom.
If you have recently suffered a stroke, please consult your doctor before using Firazyr.
Če ste nedavno doživeli kap, se pred uporabo zdravila Firazyr posvetujte z zdravnikom.
Firazyr is not known to interact with other medicines, but please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed by a doctor.
Ni znano, da bi zdravilo Firazyr medsebojno delovalo z drugimi zdravili, vendar obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta.
If you are taking a medicine known as an Angiotensin Converting Enzyme (ACE) inhibitor (for
Če jemljete zdravilo, znano kot zaviralec angiotenzin konvertaze (zaviralec ACE)
19 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.
19 (na primer: kaptopril, enalapril, ramipril, kvinapril, lizinopril), ki se uporablja za zniževanje krvnega tlaka ali v kak drug namen, morate pred začetkom uporabe zdravila Firazyr obvestiti svojega zdravnika.
Taking Firazyr with food and drink
Uporaba zdravila Firazyr skupaj s hrano in pijačo
Food and drink have no effect on the action of Firazyr.
Hrana in pijača ne vplivata na delovanje zdravila Firazyr.
If you are pregnant or plan becoming pregnant, discuss this with your doctor before starting to use Firazyr.
Če ste noseči ali nameravate zanositi, se o tem posvetujte s svojim zdravnikom pred začetkom zdravljenja z zdravilom Firazyr.
If you are breast-feeding you should not breast-feed for 12 hours after you have received Firazyr.
Če dojite, ne smete dojiti 12 ur po uporabi zdravila Firazyr.
Do not drive or use machinery if you feel tired or dizzy as a result of your HAE attack or after using Firazyr.
Ne vozite avtomobila in ne upravljajte s stroji, če ste utrujeni ali omotični zaradi napada HAE ali po uporabi zdravila Firazyr.
Important information about some of the ingredients of Firazyr
Pomembne informacije o nekaterih sestavinah zdravila Firazyr
The injection solution contains less than 1 mmol (23 milligrams) of sodium, so it is essentially ‘ sodium-free’.
Raztopina za injiciranje vsebuje manj kot 1 mmol (23 miligramov) natrija, zato je pravzaprav „ brez natrija “.
HOW TO USE FIRAZYR
KAKO UPORABLJATI ZDRAVILO FIRAZYR
Firazyr will always be injected by your doctor or nurse.
Zdravilo Firazyr vam bo vedno injiciral vaš zdravnik ali medicinska sestra.
Your doctor will tell you when it is safe for you to go home.
Zdravnik vam bo povedal, kdaj boste lahko varno odšli domov.