natgillin/translations-raw huggingface dataset:
When diluted in glucose 50 mg/ ml (5%) solution for infusion, Filgrastim ratiopharm is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Če je razredčeno v glukozi 50 mg/ ml (5%) raztopini za infundiranje, je zdravilo Filgrastim ratiopharm kompatibilno s steklom in vrsto plastičnih snovi, med katerimi so PVC, poliolefin (kopolimer polipropilena in polietilena) in polipropilen.
16 Accidental exposure to freezing temperatures does not adversely affect the stability of Filgrastim ratiopharm.
Če je zdravilo Filgrastim ratiopharm pomotoma izpostavljeno temperaturam pod lediščem, to ne škoduje njegovi stabilnosti.
ratiopharm GmbH Graf-Arco-Straße 3 D-89079 Ulm Germany info@ratiopharm. de
ratiopharm GmbH Graf- Arco- Straße 3 D- 89079 Ulm Nemčija info@ ratiopharm. de
Filgrastim ratiopharm 48 MIU/ 0.8 ml solution for injection or infusion
Filgrastim ratiopharm 48 000 k. i. e. / 0, 8 ml raztopina za injiciranje ali infundiranje
Filgrastim ratiopharm contains sorbitol.
25 Zdravilo Filgrastim ratiopharm vsebuje sorbitol.
The efficacy and safety of Filgrastim ratiopharm has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
30 Učinkovitost in varnost Filgrastim ratiopharma sta bili ocenjeni v randomiziranih in nadzorovanih študijah faze III pri bolnikih z rakom dojk, rakom na pljučih in Ne- Hodkinovim limfomom.
31 Filgrastim ratiopharm should not be diluted with sodium chloride solution.
Zdravila Filgrastim ratiopharm ne smemo mešati z raztopino natrijevega klorida.
Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned in section 6.6.
31 Če ni razredčeno v skladu z navodili v poglavju 6. 6, se razredčen filgrastim lahko adsorbira na steklene in plastične materiale.
32 Accidental exposure to freezing temperatures does not adversely affect the stability of Filgrastim ratiopharm.
Če je zdravilo Filgrastim ratiopharm pomotoma izpostavljeno temperaturam pod lediščem, to ne škoduje njegovi stabilnosti.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2.1 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.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora poskrbeti za vzpostavitev sistema farmakovigilance, kot je opisan v različici 2. 1 in predstavljen v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, ki mora biti v veljavi tako preden gre zdravilo na trg kot tudi takrat, ko je zdravilo že na trgu.
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
Glede na Smernico CHMP o sistemih za upravljanje s tveganji za zdravila v humani medicini, je potrebno posodobljen Načrt za upravljanje s tveganji oddati istočasno kot periodično poročilo o varnosti zdravila (PSUR).
35 • At the request of the EMEA
Posodobljen načrt za upravljanje s tveganji je potrebno predložiti tudi • ko so na voljo nove informacije, ki bi lahko vplivale na trenutna določila o varnosti, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganj 35 • v 60- ih dneh od pomembnega (farmakovigilanca ali zmanjšanje tveganja) dogodka • na zahtevo organizacije EMEA
Filgrastim ratiopharm 30 MIU/ 0.5 ml
Filgrastim ratiopharm 30 000 k. i. e. / 0, 5 ml
Filgrastim ratiopharm 48 MIU/ 0.8 ml
Filgrastim ratiopharm 48 000 k. i. e. / 0, 8 ml
Filgrastim ratiopharm 30 MIU/ 0.5 ml
Filgrastim ratiopharm 30 000 k. i. e. / 0. 5 ml
Filgrastim ratiopharm 30 MIU/ 0.5 ml solution for injection or infusion Filgrastim ratiopharm 48 MIU/ 0.8 ml solution for injection or infusion
Filgrastim ratiopharm 30 000 k. i. e. / 0, 5 ml raztopina za injiciranje ali infundiranje Filgrastim ratiopharm 48 000 k. i. e. / 0, 8 ml raztopina za injiciranje ali infundiranje
What Filgrastim ratiopharm is and what it is used for 2.
Kaj je zdravilo Filgrastim ratiopharm in za kaj ga uporabljamo 2.
Before you use Filgrastim ratiopharm 3.
Kaj morate vedeti, preden boste uporabili zdravilo Filgrastim ratiopharm 3.
How to use Filgrastim ratiopharm 4.
Kako uporabljati zdravilo Filgrastim ratiopharm 4.
How to store Filgrastim ratiopharm 6.
Shranjevanje zdravila Filgrastim ratiopharm 6.
WHAT Filgrastim ratiopharm IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO Filgrastim ratiopharm IN ZA KAJ GA UPORABLJAMO
What Filgrastim ratiopharm is Filgrastim ratiopharm contains the active substance filgrastim.
Kaj je zdravilo Filgrastim ratiopharm Filgrastim ratiopharm vsebuje zdravilno učinkovino filgrastim.
What Filgrastim ratiopharm is used for Your doctor has prescribed Filgrastim ratiopharm for you to help your body make more white blood cells.
Za kaj se uporablja zdravilo Filgrastim ratiopharm Zdravnik vam je predpisal zdravilo Filgrastim ratiopharm zato, da bi vaše telo lahko proizvajalo več belih krvničk.
BEFORE YOU USE Filgrastim ratiopharm
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO Filgrastim ratiopharm
Do not use Filgrastim ratiopharm
Ne uporabljajte zdravila Filgrastim ratiopharm
- if you are allergic (hypersensitive) to filgrastim or to any of the other ingredients of Filgrastim
- če ste alergični (preobčutljivi) na filgrastim ali katerokoli sestavino zdravila Filgrastim
ratiopharm.
ratiopharm.
Take special care with Filgrastim ratiopharm
Bodite posebno pozorni pri uporabi zdravila Filgrastim ratiopharm
POSSIBLE SIDE EFFECTS”).
MOŽNI NEŽELENI UČINKI «).
HOW TO USE Filgrastim ratiopharm
KAKO UPORABLJATI ZDRAVILO Filgrastim ratiopharm
The amount of Filgrastim ratiopharm you need will depend on the condition you are taking Filgrastim ratiopharm for and on your bodyweight.
Količina zdravila Filgrastim ratiopharm, ki jo potrebujete, je odvisna od stanja, zaradi katerega morate jemati zdravilo, in od vaše telesne teže.
Filgrastim ratiopharm and chemotherapy The usual dose is 0.5 million international units (MIU) per kilogram of bodyweight each day.
Zdravilo Filgrastim ratiopharm in kemoterapija Običajni odmerek na kilogram telesne teže je 0, 5 milijonov mednarodnih enot (i. e.) dnevno.
Filgrastim ratiopharm and bone marrow transplantation The usual starting dose is 1 million international units (MIU) per kilogram of bodyweight each day.
Zdravilo Filgrastim ratiopharm in presaditev kostnega mozga Običajni odmerek na kilogram telesne teže je 1 milijon mednarodnih enot (i. e.) dnevno.
You will normally receive your first dose of Filgrastim ratiopharm at least 24 hours after your chemotherapy but within 24 hours of receiving your bone marrow transfusion.
Običajno boste prvi odmerek zdravila Filgrastim ratiopharm prejeli šele 24 ur po kemoterapiji, v primeru presaditve kostnega mozga pa boste zdravili prejeli v roku 24- ih ur.
Filgrastim ratiopharm and severe chronic neutropenia The usual starting dose is between 0.5 million and 1.2 million international units (MIU) per kilogram bodyweight each day in a single or divided dose.
Zdravilo Filgrastim ratiopharm in huda kronična nevtropenija Običajni odmerek na kilogram telesne teže je od 0, 5 do 1, 2 milijona mednarodnih enot (i. e.) dnevno, bodisi v enkratnem ali večkratnih odmerkih.
Your doctor will then test your blood to see how well your treatment is working and to find the dose that is best for you.
55 kakšen odmerek je najbolj primeren za vas, bo vaš zdravnik vsak dan analiziral vašo kri.
54 Filgrastim ratiopharm and neutropenia in patients with HIV infection The usual starting dose is between 0.1 and 0.4 million international units (MIU) per kilogram bodyweight each day.
Zdravilo Filgrastim ratiopharm in nevtropenija pri bolnikih, okuženih s HIV Običajni odmerek na kilogram telesne teže je od 0, 1 do 0, 4 milijona mednarodnih enot (i. e.) dnevno.
Filgrastim ratiopharm and peripheral blood stem cell mobilisation If you are donating stem cells for yourself, the usual dose is 0.5 million to 1 million international units (MIU) per kilogram bodyweight each day.
Zdravilo Filgrastim ratiopharm in zbiranje matičnih celic iz periferne krvi Če darujete izvorne celice zase, potem je običajni odmerek na kilogram telesne teže 0, 5 milijonov mednarodnih enot (i. e.) dnevno.
If you use more Filgrastim ratiopharm than you should If you use more Filgrastim ratiopharm than you should, contact your doctor or pharmacist as soon as possible.
Če ste uporabili večji odmerek zdravila Filgrastim ratiopharm, kot bi smeli Če ste uporabili večji odmerek zdravila Filgrastim ratiopharm, kot bi smeli, se čimprej posvetujte z zdravnikom ali farmacevtom.
Allergic-type reactions to filgrastim, including skin rash, raised areas of the skin that itch and anaphylaxis (weakness, drop in blood pressure, difficulty breathing and swelling of the face) have been reported.
56 Poročali so tudi o alergijskih reakcijah na filgrastim, vključno z izpuščajem na koži, dvignjenimi in srbečimi predeli kože in anafilaksijo (oslabelost, padec krvnega tlaka, težave z dihanjem in otekanje obraza).
Some cases of splenic rupture were fatal.
Poročali so tudi o redkih primerih zvečanja vranice in rupturah (pretrganje) vranice, ki pa so bile pri nekaterih posameznikih usodne.
HOW TO STORE Filgrastim ratiopharm
SHRANJEVANJE ZDRAVILA Filgrastim ratiopharm
Do not use Filgrastim ratiopharm after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP.
57 Zdravila Filgrastim ratiopharm ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini in na napolnjeni injekcijski brizgi poleg oznake 'uporabno do'.
56 Medicines should not be disposed of via wastewater or household waste.
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
What Filgrastim ratiopharm contains
Kaj vsebuje zdravilo Filgrastim ratiopharm
Filgrastim ratiopharm 30 MIU/ 0.5 ml:
milijonov mednarodnih enot [i. e.] (600 mikrogramov) zdravila filigrastim Filgrastim ratiopharm 30 000 k. i. e. / 0, 5 ml: ena napolnjena injekcijska brizga vsebuje 30 milijonov mednarodnih enot [i. e.] (300 mikrogramov) zdravila filgrastim v 0, 5 ml raztopine.
Filgrastim ratiopharm 48 MIU/ 0.8 ml:
Filgrastim ratiopharm 48 000 k. i. e. / 0, 8 ml: ena napolnjena injekcijska brizga vsebuje 48 milijonov mednarodnih enot [i. e.] (480 mikrogramov) zdravila filgrastim v 0, 8 ml raztopine.
You will find detailed information about the ingredient sorbitol (a sugar) in section 2. under the heading “ Important information about some of the ingredients of Filgrastim ratiopharm”.
Podrobne podatke o sorbitolu (vrsta sladkorja) boste našli v poglavju 2 pod “ Pomembne informacije o nekaterih sestavinah zdravila ratiogratsim ”.
Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3 D-89079 Ulm Germany info@ratiopharm. de
Imetnik dovoljenja za promet z zdravilom ratiopharm GmbH Graf- Arco- Straße 3 D- 89079 Ulm Nemčija info@ ratiopharm. de
България ratiopharm GmbH, Германия Teл: +49 731 402 02
ratiopharm GmbH, Германия Teл: +49 731 402 02
Magyarország ratiopharm Hungária Kft.
ratiopharm Hungária Kft.
United Kingdom ratiopharm UK Ltd Tel: +44 239 238 6330
United Kingdom Latvija ratiopharm UK Ltd ratiopharm Latvijas pārstāvniecība Tel: +44 239 238 6330 Tel: +371 67499110
This leaflet was last approved in {MM/ YYYY}
59 Navodilo je bilo odobreno {MM/ LLLL}
It is important that you do not try to give yourself the injection unless you have received special training
Pomembno je, da si injekcije ne poskušate dati sami, če vas nista zdravnik ali medicinska sestra tega posebej naučila.
Equipment that you need To give yourself a subcutaneous injection you will need:
Oprema, ki jo boste potrebovali Za subkutano samoinjiciranje boste potrebovali:
- a pre-filled syringe of Filgrastim ratiopharm,
- napolnjeno injekcijsko brizgo z zdravilom Filgrastim ratiopharm,
59 2.
60 2 2.
Dilution to a final concentration less than 0.2 MIU (2 μ g) per ml is not recommended at any time.
Zdravila nikoli ne smete razredčiti v tolikšni meri, da bi končna koncentracija padla pod
Firazyr is used to treat the symptoms of attacks of hereditary angioedema in adults.
Zdravilo Firazyr se uporablja za zdravljenje simptomov napadov hereditarnega angioedema pri odraslih.
Patients with angioedema have attacks of swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain. ‘ Hereditary ’ means that the disease is caused by the patient ’ s genes.
„ Hereditarni “ pomeni, da bolezen povzročajo bolnikovi geni.
Firazyr is used in patients whose angioedema is linked to naturally low levels of a protein called ‘ C1 esterase inhibitor’.
Zdravilo Firazyr se uporablja pri bolnikih, katerih angioedem je povezan z naravno nizkimi ravnmi beljakovine, imenovane „ inhibitorji C1- esteraze “.
Because the number of patients who have hereditary angioedema is low, the disease is considered ‘ rare’, and Firazyr was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 17 February 2003.
Ker je število bolnikov z dednim angioedemom majhno, velja ta bolezen za redko, zato je bilo zdravilo Firazyr dne 17. februarja 2003 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja pri redkih boleznih).
Firazyr is given as a slow injection under the skin by a doctor or nurse, preferably in the abdomen (tummy).
Zdravilo Firazyr se uporablja kot počasna injekcija v podkožje, ki jo daje zdravnik ali medicinska sestra, zaželeno v trebuh.
If symptoms continue or come back, a second injection can be given after six hours.
Če se simptomi nadaljujejo ali se ponovijo, se lahko po šestih urah vbrizga druga injekcija.
No more than three injections should be given in any 24-hour period.
V 24- urnem obdobju se smejo dati največ tri injekcije.
Firazyr has not been tested in children.
Zdravila Firazyr niso preučevali pri otrocih.
Patients with hereditary angioedema have high levels of a substance called ‘ bradykinin’, which is involved in causing inflammation and swelling.
Bolniki s hereditarnim angioedemom imajo visoke koncentracije snovi, imenovane „ bradikinin “, ki je vključena v povzročanje vnetja in otekanja.
Firazyr has been studied in two main studies in patients with angioedema of the skin or the abdomen.
Učinki zdravila Firazyr so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Reproduction is authorised provided the source is acknowledged. patients, and the second study compared Firazyr with placebo (a dummy treatment) in 56 patients.
Zdravilo Firazyr so preučevali v dveh glavnih študijah pri bolnikih z angioedemom kože ali trebuha.
The main measure of effectiveness was how long it took until the patient’ s symptoms were relieved.
Glavno merilo učinkovitosti je bil čas do olajšanja bolnikovih simptomov.
Firazyr was more effective than tranexamic acid and placebo in controlling the symptoms of the disease.
Zdravilo Firazyr je bilo učinkovitejše od traneksamične kisline in placeba pri nadzorovanju simptomov bolezni.
In both studies, the time it took for the patient ’ s symptoms to improve was shorter for patients taking Firazyr than for those taking tranexamic acid or placebo.
V obeh študijah je bil čas do izboljšanja bolnikovih simptomov krajši pri bolnikih, ki so jemali zdravilo Firazyr, kot pri tistih, ki so jemali traneksamično kislino ali placebo.
Patients experienced relief an average of 2.0 to 2.5 hours after receiving Firazyr, compared with 12.0 hours after receiving tranexamic acid and 4.6 hours after receiving placebo.
Bolniki so olajšanje občutili v povprečju 2, 0 do 2, 5 ure po prejetju zdravila Firazyr v primerjavi z 12, 0 ure po prejetju traneksamične kisline in 4, 6 ure po prejetju placeba.
The most common side effects with Firazyr (seen in more than 1 patient in 10) are erythema (redness), swelling, a warm sensation, burning, itching and pain.
Najpogostejši neželeni učinki zdravila Firazyr (opaženi pri več kot 1 bolniku od 10) so eritem (pordelost), otekanje, občutek toplote, pekoč občutek, srbenje in bolečina.
For the full list of all side effects reported with Firazyr, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Firazyr, glejte navodilo za uporabo.
The Committee for Medicinal Products for Human Use (CHMP) decided that Firazyr’ s benefits are greater than its risks for the symptomatic treatment of acute attacks of hereditary angioedema in adults.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Firazyr pri simptomatskem zdravljenju akutnih napadov hereditarnega angioedema pri odraslih večje od z njim povezanih tveganj.
The Committee recommended that Firazyr be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Firazyr odobri dovoljenje za promet.
Other information about Firazyr:
Druge informacije o zdravilu Firazyr:
The European Commission granted a marketing authorisation valid throughout the European Union for Firazyr to Jerini AG on 11 July 2008.
Evropska komisija je dovoljenje za promet z zdravilom Firazyr, veljavno po vsej Evropski uniji, odobrila družbi Jerini AG dne 11. julija 2008.
The summary of opinion of the Committee for Orphan Medicinal Products for Firazyr is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Firazyr je na voljo tukaj.
The full EPAR for Firazyr can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Firazyr je na voljo tukaj.
1 pre-filled syringe + 1 needle
1 napolnjena brizga + igla
Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults (with C1-esterase-inhibitor deficiency).
Zdravilo Firazyr je indicirano za simptomatsko zdravljenje akutnih napadov hereditarnega (prirojenega) angioedema (HAE) pri odraslih (s pomanjkanjem zaviralca C1- esteraze).
The recommended dose of Firazyr is one subcutaneous injection of 30 mg administered by a health care professional, preferably in the abdominal area, for the treatment of a hereditary angioedema attack.
Priporočeni odmerek zdravila Firazyr je 30 mg v obliki subkutane injekcije, ki jo aplicira zdravstveni delavec, po možnosti v predel trebuha, za zdravljenje napada hereditarnega angioedema.
Firazyr is not for self-administration.
Zdravilo Firazyr ni namenjeno za samoinjiciranje.
For single use only.
Zdravilo Firazyr je namenjeno subkutani uporabi in samo za enkratno uporabo.
Patients with laryngeal attacks need to be carefully managed in an appropriate medical institution after injection until the physician considers discharge to be safe.
Bolnike z laringealnimi napadi je treba po injiciranju skrbno spremljati v ustrezni zdravstveni ustanovi, dokler zdravnik ne oceni, da je bolnika varno odpustiti.
Injection should be given slowly due to the large volume to be administered (3 ml).
Zaradi velike injicirane količine (3 ml) je treba injiciranje izvesti počasi.
No more than 3 injections of Firazyr should be administered in a 24 hour period.
V 24- urnem obdobju se smejo dati največ 3 injekcije zdravila Firazyr.
Children and adolescents There is no experience in children.
Otroci in mladostniki Izkušenj pri otrocih ni.
Elderly patients Limited information is available on patients older than 65 years of age.
Starostniki O uporabi pri bolnikih, starejših od 65 let, ni na voljo zadostnih informacij.
Elderly patients have been shown to have increased systemic exposure to icatibant.
Pri starejših bolnikih je bila dokazana večja sistemska izpostavljenost ikatibantu.
The relevance of this to the safety of Firazyr is unknown (see section 5.2).
Pomen tega dejstva za varnost zdravila Firazyr ni znan (glejte poglavje 5. 2).
2 Hepatic impairment No dosage adjustment is required in patients with hepatic impairment.
2 Okvara jeter Pri bolnikih z okvaro jeter prilagoditev odmerka ni potrebna.
Renal impairment No dosage adjustment is required in patients with renal impairment.
Okvara ledvic Pri bolnikih z okvaro ledvic prilagoditev odmerka ni potrebna.
Ischemic heart disease Under ischemic conditions, a deterioration of cardiac function and a decrease in coronary blood flow could theoretically arise from antagonism of bradykinin receptor type 2.
Ishemična bolezen srca Pri ishemičnih stanjih je poslabšanje srčne funkcije in zmanjšanja koronarnega pretoka teoretično lahko posledica antagonizma na receptorju za bradikinin tipa 2.
Caution should therefore be observed in the administration of Firazyr to patients with acute ischemic heart disease or unstable angina pectoris (see section 5.3).
Zaradi tega je pri dajanju zdravila Firazyr bolnikom z akutno ishemično boleznijo srca ali nestabilno angino pektoris potrebna previdnost (glejte poglavje 5. 3).
Stroke Although there is evidence to support a beneficial effect of B2 receptor blockade immediately following a stroke, there is a theoretical possibility that icatibant may attenuate the positive late phase neuroprotective effects of bradykinin.
Kap Kljub dokazanemu ugodnemu učinku blokade receptorja B2 neposredno po kapi je teoretično mogoče, da ikatibant oslabi pozitivne zaščitne učinke bradikinina na živčne celice v pozni fazi.
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 kapi potrebna previdnost.
Pharmacokinetic drug interactions involving CYP450 are not expected (see section 5.2)
Farmakokinetične interakcije, povezane s CYP450, niso pričakovane (glejte poglavje 5. 2).
Co-administration of Firazyr with ACE inhibitors has not been studied.
Sočasno dajanje zdravila Firazyr in zaviralcev ACE ni bilo raziskano.
For icatibant, no clinical data on exposed pregnancies are available.
Kliničnih podatkov za nosečnice, ki so bile izpostavljene ikatibantu, ni na voljo.
Animal studies showed effects on uterine implantation and parturition (see section 5.3), but the potential risk for humans is unknown.
Študije na živalih so pokazale učinke na ugnezdenje v maternico in kotenje (glejte poglavje 5. 3), vendar pa možno tveganje za ljudi ni znano.
Firazyr should be used during pregnancy only, if the potential benefit justifies the potential risk for the foetus, (e. g for treatment of potentially life threatening laryngeal attacks).
Zdravilo Firazyr se sme uporabljati med nosečnostjo samo, če možna korist odtehta možno tveganje za plod (npr. pri zdravljenju morebitnih življenjsko ogrožajočih laringealnih napadov).
5.3).
Pri mladih živalih je ponavljajoča uporaba ikatibanta reverzibilno upočasnila spolno dozorevanje (glejte poglavje 5. 3).
Firazyr has minor or moderate influence on the ability to drive and use machines.
Zdravilo Firazyr ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
Fatigue, lethargy, tiredeness, somnolence, and dizziness have been reported uncommonly following the use of Firazyr.
Po uporabi zdravila Firazyr so občasno poročali o primerih utrujenosti, letargije, somnolence in omotice.
However, a causal relationship to the use of Firazyr cannot be excluded.
Vseeno pa vzročne povezave z uporabo zdravila Firazyr ni mogoče izključiti.
3 4.8 Undesirable effects
4. 8 Neželeni učinki
The safety of icatibant has been established in 1022 subjects treated with various doses, regimens and routes of administration during Phase I-III studies in various indications.
3 Varnost ikatibanta je bila potrjena pri 1022 osebah, ki so jih zdravili z različnimi odmerki, po različnih shemah odmerjanja in poteh uporabe ter za različne indikacije v študijah faze I- III.
Sixty three (HAE) patients received icatibant in two Phase III trials for treatment of an attack in the controlled phase and 118 patients were treated in the open label phase.
Triinšestdeset bolnikov (s HAE) je prejelo ikatibant v dveh preskušanjih faze III za zdravljenje napada v kontrolirani fazi, 118 bolnikov pa so zdravili v odprti fazi.