natgillin/translations-raw huggingface dataset:
In the clinical trial, not more than 1 injection of Firazyr per HAE attack has been administered.
V kliničnem preskušanju niso dajali več kot 1 injekcije zdravila Firazyr na napad HAE.
Laryngeal attacks
Laringealni napadi
These reactions were generally mild to moderate in severity, transient, and resolved without further intervention.
Te reakcije so bile navadno blage do zmerne, prehodne in so samodejno prenehale.
The injection site should be a skin fold on your abdomen approximately 5-10 cm (2-4 inches) below your navel on either side.
Mesto injiciranja mora biti kožna guba na kateri koli strani trebuha, približno 5-10 cm pod popkom.
Time to symptom relief was defined as the duration of time (in hours) taken for improvement of symptoms to occur by a magnitude of 20%.
Čas do izboljšanja simptomov je bil opredeljen kot čas (v urah), potreben za 20
A total of 130 patients were randomized to receive either a 30 mg dose of icatibant (63 patients) or comparator (either tranexamic acid, - 38 or placebo - 29 patients).
Prejemali so ikatibant v odmerku 30 mg (63 bolnikov) ali komparator (38 bolnikov je prejemalo traneksamično kislino, 29 pa placebo).
Efficacy Results: FAST-3; Controlled Phase -- ITT population
Rezultati za učinkovitost: FAST-3; nadzorovana faza - populacija, ki so jo nameravali zdraviti (ITT)
Carefully attach the needle to the syringe containing the colourless solution.
Iglo previdno pritrdite na napolnjeno injekcijsko brizgo, ki vsebuje brezbarvno raztopino.
Icatibant had no effect on the fertility of male mice (top dose 80.8 mg/kg/day) and rats (top dose 10 mg/kg/day).
Ikatibant ni imel nobenega vpliva na plodnost mišjih (največji odmerek 80,8 mg/kg/dan) in podganjih (največji odmerek 10 mg/kg/dan) samcev.
- The recommended dose of Firazyr is one injection (3 ml, 30 mg) injected subcutaneously (under the skin) as soon as you notice the attack of angioedema (for example increased skin swelling, particularly affecting the face and neck, or increasing tummy pain).
- Priporočeni odmerek zdravila Firazyr je ena injekcija (3 ml, 30 mg), injicirana subkutano (pod kožo), kakor hitro opazite napad angioedema (na primer povečano otekanje kože, zlasti na obrazu in vratu, ali močnejše bolečine v trebuhu)
Response rate (%, CI) at 4 hours after start of treatment
CI) po 4 urah po začetku zdravljenja
The primary efficacy endpoint was the time to onset of symptom relief (TOSR) measured using a composite investigator-reported symptom score.
Primarni cilj študije pri ugotavljanju učinkovitosti je bil čas do nastopa izboljšanja simptomov (TOSR - time to onset of symptom relief), ki so ga izmerili s sestavljenim rezultatom simptomov, ki jih poročajo raziskovalci.
Patients with symptoms of laryngeal angioedema received open label treatment with icatibant.
Bolniki s simptomi laringealnega angioedema so prejemali zdravljenje z ikatibantom v odprti fazi.
Table 4 shows the efficacy results for FAST-3.
Tabela 4 vsebuje rezultate študije FAST-3 za učinkovitost.
No effects were detected in the post-natal development of rat pups.
Učinkov na postnatalni razvoj podganjih mladičev niso ugotovili.
Firazyr was administered by subcutaneous injection at a dose of 0.4 mg/kg based on body weight to a maximum dose of 30 mg.
Zdravilo Firazyr so injicirali subkutano pri odmerku 0,4 mg/kg na podlagi telesne mase do največjega odmerka 30 mg.
The pharmacokinetics of icatibant were characterized in paediatric HAE patients in study HGT-FIR086 (see section 5.1).
V študiji HGT-FIR-086 so raziskovali farmakokinetiko ikatibanta pri pediatričnih bolnikih s HAE (glejte poglavje 5.1).
The clinical relevance of the adrenal gland findings is unknown.
Klinična pomembnost ugotovitev pri nadledvični žlezi ni znana.
Icatibant was not teratogenic when administered by SC injection during early embryonic and fetal development in rat (top dose 25 mg/kg/day) and rabbit (top dose 10 mg/kg/day).
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).
Co-administration of Firazyr with angiotensin-converting-enzyme (ACE) inhibitors has not been studied.
Sočasno dajanje zdravila Firazyr in zaviralcev angiotenzinske konvertaze (ACE) ni bilo raziskano.
In an integrated analysis of these controlled Phase III studies, the time to onset of symptom relief and time to onset of primary symptom relief were similar regardless of age group, sex, race, weight or whether or not the patient used androgens or antifibrinolytic agents.
V integrirani analizi teh nadzorovanih študij 3. faze sta bila čas do pojava lajšanja simptomov in čas do pojava lajšanja primarnega simptoma podobna ne glede na starostno skupino, spol, raso, telesno maso in ne glede na to, ali je bolnik uporabljal androgene ali antifibrinolitične učinkovine ali ne. Tudi odziv v nadzorovanih preskušanjih 3. faze je bil podoben pri vseh ponavljajočih se napadih.
No clinical information on overdose is available.
Na voljo ni kliničnih poročil o primerih prevelikega odmerjanja.
All needles and syringes should be disposed of in a sharps container.
Vse igle in brizge morate zavreči v zbiralnik za ostre predmete.
The injection solution contains less than 1 mmol (23 milligrams) of sodium, so it is essentially ‘sodium-free'.
Firazyr vsebuje majhno količino natrija Raztopina za injiciranje vsebuje manj kot 1 mmol (23 miligramov) natrija, zato je pravzaprav »brez natrija«.
The decision on initiating caregiver or self-administration of Firazyr should only be taken by a physician experienced in the diagnosis and treatment of hereditary angioedema (see section 4.4).
Injiciranje, ki ga izvede negovalec/samoinjiciranje Odločitev o tem, ali bo injiciranje zdravila Firazyr izvedel negovalec ali bolnik lahko sprejme samo zdravnik z izkušnjami pri diagnosticiranju in zdravljenju dednega angioedema (glejte poglavje 4.4).
A 2-week subcutaneous dose range finding study in juvenile rats identified 25 mg/kg/day as a maximally tolerated dose.
V 2-tedenski študiji za ugotavljanje razpona subkutanega odmerka pri mladičih podgan so ugotovili, da je 25 mg/kg/dan največji odmerek, ki ga živali še prenašajo.
Median time to overall patient improvement, by physician (hours)
Mediana časa do celokupnega izboljšanja stanja bolnika, po oceni zdravnika (v urah)
Table 2: Adverse reactions reported with icatibant
Preglednica 2: Neželeni učinki, o katerih so poročali pri uporabi ikatibanta
Talk to your doctor before taking Firazyr: - if you are suffering from angina (reduced blood flow to the heart muscle) - if you have recently suffered a stroke
Pred začetkom jemanja zdravila Firazyr se posvetujte s svojim zdravnikom: - če imate angino pektoris (zmanjšan dovod krvi v srčno mišico)
3) Continue to push on the pre-filled syringe plunger until the required injection volume (dose) is transferred to the graduated syringe.
3) Še naprej potiskajte bat napolnjene injekcijske brizge, dokler se potrebna prostornina za injiciranje (odmerek) ne prenese v brizgo z oznakami za prostornino.
In HAE levels of a substance in your bloodstream called bradykinin are increased and this leads to symptoms like swelling, pain, nausea, and diarrhoea.
Pri HAE je v krvnem obtoku povečana raven snovi, imenovane bradikinin, ki povzroča simptome, kot so oteklina, bolečina, navzea (slabost) in driska.
In both rats and dogs, there was a dose-related reduction in circulating sex hormone levels and the repeated use of icatibant reversibly delayed sexual maturation.
Pri podganah in psih so pokazali znižanje ravni cirkulirajočih spolnih hormonov, ki je bilo odvisno od odmerka, pri ponavljajoči se uporabi ikatibanta pa reverzibilno upočasnjeno spolno zorenje.
The pre-filled icatibant syringe and all other components are for single use only.
Napolnjena injekcijska brizga z ikatibantom in vsi drugi deli so namenjeni enkratni uporabi.
Firazyr is used for treating the symptoms of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older.
Zdravilo Firazyr je namenjeno za zdravljenje simptomov hereditarnega (prirojenega) angioedema (HAE) pri odraslih, mladostnikih in otrocih, starih 2 leti ali več.
No hypersensitivity or anaphylactic reactions were reported with Firazyr.
Pri zdravilu Firazyr niso poročali o nobenih preobčutljivostnih ali anafilaktičnih reakcijah.
What Firazyr looks like and contents of the pack
Izgled zdravila Firazyr in vsebina pakiranja
If the second injection produces insufficient relief or a recurrence of symptoms is observed, a third injection of Firazyr can be administered after a further 6 hours.
Če po drugi injekciji ni zadostnega olajšanja ali se simptomi ponovijo, se lahko bolniku po nadaljnjih 6 urah aplicira še tretja injekcija zdravila Firazyr.
Patients were randomized to receive either icatibant 30 mg or placebo by subcutaneous injection.
Bolnike so naključno razporedili tako, da so s subkutanim injiciranjem prejeli ikatibant 30 mg ali placebo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTI-PACK (WITHOUT BLUE BOX)
PODATKI NA ZUNANJI OVOJNINI VMESNA ŠKATLA PRI SKUPNEM PAKIRANJU (BREZ »BLUE BOX« PODATKOV)
Solution for injection Multipack containing three pre-filled syringes and three 25G needles
Skupno pakiranje, ki vsebuje tri napolnjene injekcijske brizge in tri igle 25G
Efficacy results for FAST-1 and FAST-2
Tabela 3: Rezultati študij FAST-1 in FAST-2 za učinkovitost
- If you experience no relief of symptoms after 6 hours, you should seek medical advice regarding additional injections of Firazyr.
- Če po 6 urah ne občutite olajšanja simptomov, se morate posvetovati z zdravnikom o dodatnih injekcijah zdravila Firazyr.
Change in Composite VAS Score at 2 hrs after treatment
Sprememba rezultata sestavljenega VAS 2 uri po zdravljenju
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.
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.
For icatibant, no clinical data on exposed pregnancies are available.
Kliničnih podatkov za nosečnice, ki so bile izpostavljene ikatibantu, ni na voljo .
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).
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).
Dizziness Headache
omotica glavobol
Repeated-dose studies of up to 6-months duration in rats and 9-months duration in dogs have been conducted.
Opravili so študije ponavljajočih se odmerkov, ki so trajale do 6 mesecev pri podganah in do
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.
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.
The other ingredients are sodium chloride, acetic acid glacial, sodium hydroxide and water for injection.
Pomožne snovi so natrijev klorid, koncentrirana ocetna kislina, natrijev hidroksid in voda za injekcije.
The primary efficacy endpoint was the 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).
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.
Firazyr is presented as a clear, colourless solution for injection in a pre-filled glass syringe of 3 ml.
Zdravilo Firazyr je bistra, brezbarvna raztopina za injiciranje v napolnjeni injekcijski stekleni brizgi (3 ml).
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.
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.
- If you are not sure which dose to inject, ask your doctor, pharmacist or nurse.
- Če niste prepričani, kateri odmerek je treba injicirati, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
In case of insufficient relief or recurrence of symptoms, a second injection of Firazyr can be administered after 6 hours.
V primeru nezadostnega olajšanja ali ponovitve simptomov se lahko bolniku po 6 urah da druga injekcija zdravila Firazyr.
If you are breast-feeding you should not breast-feed for 12 hours after you have last received Firazyr.
Če dojite, ne smete dojiti še 12 ur po zadnji uporabi zdravila Firazyr.
Accordingly, caution should be observed in the administration of icatibant to patients in the weeks following a stroke.
Zato je pri dajanju ikatibanta bolnikom v tednih po možganski kapi potrebna previdnost.
Hepatic and Renal Impairment Limited data suggest that icatibant exposure is not influenced by hepatic or renal impairment.
Jetrna in ledvična okvara Sicer pomanjkljivi podatki kažejo na to, da okvara jeter ali ledvic ne vpliva na izpostavljenost ikatibantu.
There are no observed differences in the exposure to icatibant between HAE patients with and without an attack.
Pri bolnikih s HAE niso opazili razlik pri izpostavljenosti ikatibantu med bolnikih, ki so imeli napad in bolniki, ki napada niso imeli.
• Clean the work area (surface) to be used before beginning the process.
1) Splošne informacije • Preden začnete postopek, očistite delovno površino.
Ischemic heart disease
Ishemična bolezen srca
• Clean the injection site with a rubbing alcohol pad and allow it to dry.
• Mesto injiciranja očistite s kosmom vate prepojenim z medicinskim alkoholom, potem pa počakajte, da se posuši.
Tell your doctor immediately if you notice that the symptoms of your attack get worse after you received Firazyr.
Nemudoma obvestite svojega zdravnika, če opazite, da so se simptomi napada po uporabi zdravila
Firazyr is injected with a short needle into the fatty tissue under the skin in the abdomen (tummy).
Zdravilo Firazyr se injicira s kratko iglo v maščobno tkivo pod kožo v predelu trebuha.
Do not use this medicine after the expiry date stated on the label after ‘EXP'.
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.
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.
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.
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).
Naslednja navodila za uporabo zdravila po korakih so namenjena: - samoinjiciranju (odrasli), - injiciranju pri odraslih, mladostnikih ali otrocih, starejših od 2 let (ki tehtajo najmanj
Adrenal gland hypertrophy was seen to reverse after cessation of icatibant treatment.
Opazili so, da je hipertrofija nadledvične žleze po prenehanju zdravljenja z ikatibantom reverzibilna.
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).
Skoraj vsi bolniki, ki prejemajo zdravilo Firazyr, občutijo reakcijo na mestu injiciranja (kot so draženje kože, otekanje, bolečina, srbenje, rdečina in pekoč občutek).
Pack size of one pre-filled syringe with one needle or a multipack containing three pre-filled syringes with three needles.
Posamično pakiranje z eno napolnjeno injekcijsko brizgo in eno iglo ali skupno pakiranje, ki vsebuje tri napolnjene injekcijske brizge in tri igle.
• 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.
• Brizgo držite v eni roki, z drugo pa kožno gubo na predhodno razkuženem mestu nežno primitemed palcem in preostalimi prsti.
Each pre-filled syringe contains 30 milligrams of icatibant (as acetate).
Vsaka napolnjena brizga vsebuje 30 miligramov ikatibanta (v obliki acetata).
All adverse reactions from post-marketing experience are italicised.
Vsi neželeni učinki iz obdobja trženja zdravila so napisani v poševnem tisku.
Thirty-one patients received a single dose of icatibant and 1 patient (an adolescent) received icatibant for two HAE attacks (in total, two doses).
Enaintrideset bolnikov je prejelo enkraten odmerek ikatibanta, 1 bolnik (mladostnik), pa je prejel ikatibant za dva napada HAE
At 1 and 2 hours post treatment, approximately 50% and 90% of patients experienced onset of symptom relief, respectively.
Po 1 uri po odmerjanju zdravila se je izboljšanje simptomov pojavilo pri 50 %, po 2 urah pa pri 90 % bolnikov.
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.
Vsi bolniki so prejeli vsaj en odmerek ikatibanta (0,4mg/kg telesne mase do največjega odmerka 30 mg),
The solution should be clear and colourless and free from visible particles.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Raztopina mora biti bistra in brezbarvna ter brez vidnih delcev.
3 ml of solution in a 3 ml pre-filled syringe (type I glass) with plunger stopper (bromobutyl coated with fluorocarbon polymer).
3 ml raztopine v 3 ml napolnjeni injekcijski brizgi (steklo tipa I) z batno zaporko (bromobutil,
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).
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).
If you are not sure which volume of solution to extract, ask your doctor, pharmacist or nurse
Če niste prepričani, kakšno prostornino raztopine morate izvleči, vprašajte zdravnika, farmacevta ali medicinsko sestro.
Remove the seal from the needle cap (the needle should be still in the needle cap).
• S pokrovčka za iglo odstranite tesnilo (pri tem mora igla ostati v pokrovčku).
Efficacy results for FAST-3 Efficacy Results: FAST-3; Controlled Phase -- ITT population
(N = 56) Tabela 4: Rezultati študije FAST-3 za učinkovitost Rezultati za učinkovitost: FAST-3; nadzorovana faza - populacija, ki so jo nameravali zdraviti (ITT)
Solution for injection One pre-filled syringe One 25G needle
Raztopina za injiciranje Ena napolnjena injekcijska brizga in ena igla 25 G.
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.
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.
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.
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.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTI-PACK (INCLUDING BLUE BOX)
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (VKLJUČNO Z »BLUE BOX« PODATKI)
- 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.
- Če simptomi po enem samoinjiciranju zdravila Firazyr ne izginejo, se obrnite na zdravnika, ki vam bo svetoval glede nadaljnjega injiciranja zdravila Firazyr.
Refer to table 1 for dosage information.
Informacije o odmerjanju so v preglednici 1.
2) Screw the connector onto the pre-filled syringe.
2) Privijte vmesnik na napolnjeno injekcijsko brizgo.
Acetic acid, glacial (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
natrijev hidroksid (za uravnavanje pH)
No dose adjustment is required in patients with hepatic impairment.
Pri bolnikih z okvaro jeter prilagoditev odmerka ni potrebna.
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.
Populacijsko farmakokinetično modeliranje, pri katerem so uporabili podatke, zbrane pri odraslih in pediatričnih bolnikih, je pokazalo, da je očistek ikatibanta povezan s telesno maso.
1) To start transfer of icatibant solution, push the pre-filled syringe plunger (on far left of below image).
1) Prenos raztopine ikatibanta sprožite tako, da potisnete bat napolnjene injekcijske brizge (čisto levo na spodnji sliki).
Median time to regression of symptoms, by patient (hours)
Mediana časa do zmanjšanja simptomov, po oceni bolnika (v urah)
- This medicine has been prescribed for you only.
- Zdravilo je predpisano vam osebno in ga ne smete dajati drugim.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA POSAMIČNO PAKIRANJE
Contains: acetic acid glacial, sodium hydroxide, sodium chloride, water for injections.
SEZNAM POMOŽNIH SNOVI Pomožne snovi: koncentrirana ocetna kislina, natrijev hidroksid, natrijev klorid, voda za injekcije.
There is limited experience with treatment of more than one HAE attack with Firazyr in the paediatric population.
Pri pediatrični populaciji je malo izkušenj z zdravljenjem več kot enega napada HAE z zdravilom
Firazyr may be self-administered or administered by a caregiver only after training in subcutaneous injection technique by a healthcare professional.
Zdravilo Firazyr lahko bolnik sam ali njegov negovalec uporabi, šele ko ga je zdravstveni delavec poučil o tehniki subkutanega injiciranja.
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.
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.
5) Discard the pre-filled syringe and connector into the sharps container.
5) Zavrzite napolnjeno injekcijsko brizgo in vmesnik v posodo za ostre predmete.
An open label, non-randomised single-arm study (HGT-FIR-086) was performed with a total of 32 patients.
Pediatrična populacija Pri skupno 32 bolnikih so izvedli odprto, nerandomizirano študijo z eno skupino (HGT-FIR-086).