natgillin/translations-raw huggingface dataset:
In Study S6 (340), intensive romiplostim concentrations were available from 4 subjects (2 at 7 mcg/kg and 2 at 9 mcg/kg).
V študiji S6 (340) so bile intenzivne koncentracije romiplostima pridobljene od 4 bolnikov (2 pri 7 µg/kg in 2 pri 9 µg/kg).
Patients eligible for self-administration of Nplate should be trained in these procedures.
Bolnike, ki izpolnjujejo pogoje za samoinjiciranje zdravila Nplate, morate usposobiti za te postopke.
Nplate is not recommended for use in children below age 18.
Zdravila Nplate ni priporočljivo uporabljati pri otrocih, mlajših od 18 let.
A total of 3.2% (9/282) subjects had binding antibodies to TPO at any time during romiplostim treatment.
Celokupno je 3,2 % (9/282) bolnikov imelo vezavna protitelesa na TPO kadar koli med zdravljenjem z romiplostimom.
• painful swollen joints caused by uric acid (food breakdown product) (gout);
• boleča oteklost sklepov zaradi sečne kisline (razgradnega produkta hrane) (protin),
Due to the formation of neutralising antibodies pharmacodynamic effects of romiplostim in rats were often decreasing at prolonged duration of administration.
Zaradi nastajanja nevtralizirajočih protiteles so se farmakodinamičnimi učinki romiplostima pri podganah med dolgotrajno uporabo pogosto zmanjševali.
The vial should not be shaken or vigorously agitated.
Viale ne smete tresti ali močno stresati.
In 6 additional patients reticulin was observed upon bone marrow biopsy (see section 4.4).
Pri 6 nadaljnjih bolnikih so retikulin ugotovili z biopsijo kostnega mozga (glejte poglavje 4.4).
If available, comparison to a prior bone marrow biopsy should be made.
Narediti je treba primerjavo s predhodno biopsijo kostnega mozga, če je na voljo.
Possible side effects in adults with ITP
Možni neželeni učinki pri odraslih bolnikih z ITP
• Pull back on the pink safety cover (toward the syringe and away from the needle).
• Potegnite nazaj rožnati varnostni pokrovček (proti brizgi in proč od igle).
Pharmacokinetic data of romiplostim were collected from two studies in 21 paediatric subjects with ITP.
Podatki o farmakokinetiki romiplostima so bili pridobljeni v dveh preskušanjih 21 pediatričnih bolnikov z ITP.
Dose in mcg x
Odmerek v µg x
The elimination of serum romiplostim is in part dependent on the TPO receptor on platelets.
Odstranjevanje romiplostima v serumu je deloma odvisno od receptorjev TPO na trombocitih.
Among the 154 subjects who received romiplostim, the total median exposure to romiplostim was 52.0 weeks and ranged from 2 to 53 weeks.
Med 154 bolniki, ki so prejeli romiplostim, je bila celotna mediana izpostavljenosti romiplostimu 52,0 tednov in je segala od 2 do 53 tednov.
The most common adverse reactions observed include hypersensitivity reactions (including cases of rash, urticaria and angioedema) and headache.
Najpogosteje opaženi neželeni učinki vključujejo preobčutljivostne reakcije (vključno s primeri izpuščaja, urtikarije in angioedema) in glavobol.
If your doctor has allowed you to self-inject, you should follow up with your doctor every month to have the doctor determine if Nplate is working for you or if another treatment needs to be considered.
Če vam je zdravnik dovolil, da si zdravilo injicirate sami, ga morate vsak mesec obiskati, da bo preveril, ali je zdravilo Nplate pri vas učinkovito ali pa je treba razmisliti o kakšnem drugem zdravljenju.
GENTLY swirl the vial until all of the powder has dissolved and the liquid in the vial is clear and colourless.
PREVIDNO vrtite vialo, dokler se ves prašek ne raztopi ter je tekočina v viali bistra in brezbarvna.
In study S5 (195), romiplostim concentrations were available from 17 subjects at doses ranging from 1 to 10 mcg/kg.
V študiji S5 (195) so bile koncentracije romiplostima pridobljene od 17 bolnikov v odmerkih od 1 do 10 µg/kg.
The volume of romiplostim to administer is calculated based on body weight, dose required, and concentration of product.
Količina za apliciranje se izračuna na podlagi telesne tesne mase, zahtevanega odmerka in koncentracije zdravila.
Reinitiate treatment with Nplate in accordance with dosing and administration recommendations.
Zdravljenje z zdravilom Nplate znova začnite v skladu s priporočili za odmerjanje in dajanje.
• Make sure the top of the plunger head lines up with the syringe marking that matches your prescribed dose.
• Preverite, da je vrh glave bata v isti liniji kot tista oznaka na brizgi, ki ustreza vašemu predpisanemu odmerku.
• Do not inject into areas where the skin is tender, bruised and hard.
• Ne injicirajte v predele, kjer je koža občutljiva, podpluta ali zatrdela.
The European Medicines Agency has deferred the obligation to submit the results of studies with Nplate in one or more subsets of the paediatric population in the treatment of immune thrombocytopenia (idiopathic thrombocytopenic purpura) (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Nplate za eno ali več podskupin pediatrične populacije za zdravljenje imunske trombocitopenije (idiopatične trombocitopenične purpure) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
If you have MDS and receive Nplate you may have an increase in your blast cell counts and your MDS condition may worsen to become an acute myeloid leukaemia, which is a type of cancer of the blood.
Če imate bolezen MDS in prejemate zdravilo Nplate, se vam število blastnih celic lahko poveča in stanje bolezni MDS se lahko poslabša, tako da preide v akutno mieloično levkemijo, ki je vrsta raka krvi.
• Do remove the clear needle shield before injecting.
• Prozorni ščitnik igle odstranite pred injiciranjem.
The median (Q1, Q3) duration of treatment was 138.0 weeks (91.1 weeks, 186.0 weeks).
Mediana (Q1, Q3) trajanja zdravljenja je bila 138,0 tednov (91,1 tednov, 186,0 tednov).
Very slowly and gently expel all water into powder vial.
Zelo počasi in previdno iztisnite vodo v vialo s praškom.
• pain in the mouth and throat (oropharyngeal pain);
• bolečina v ustih in grlu (orofaringealna bolečina),
Do not re-use Nplate!
Zdravila Nplate ne uporabite ponovno!
What Nplate is and what it is used for What you need to know before you use Nplate How to use Nplate
Kaj je zdravilo Nplate in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Nplate Kako uporabljati zdravilo Nplate Možni neželeni učinki
Reoccurrence of thrombocytopenia and bleeding after cessation of treatment
Ponoven pojav trombocitopenije in krvavitev po prenehanju zdravljenja
You can press a cotton ball or gauze over the injection site for 10 seconds.
S kosmom vate ali z gazo lahko 10 sekund pritiskate na mesto injiciranja.
Platelet counts should be monitored in patients receiving Nplate (see sections 4.2, 4.4 and 4.9).
Bolnikom, ki prejemajo zdravilo Nplate, je treba kontrolirati število trombocitov (glejte poglavja 4.2, 4.4 in 4.9).
The paediatric adverse reactions are derived from each of the paediatric ITP randomised safety set (2 controlled clinical trials) and paediatric ITP safety set (2 controlled and 3 uncontrolled clinical trials) where the subject incidence was at least 5% higher in the romiplostim arm compared to placebo and at least a 5% subject incidence in romiplostim-treated subjects.
Neželeni učinki pri pediatrični populaciji so pridobljeni iz vsakega pediatričnega ITP randomiziranega varnostnega sklopa (2 kontrolirani klinični preskušanji) in pediatričnega ITP varnostnega sklopa (2 kontrolirani klinični preskušanji in 3 nekontrolirana klinična preskušanja), v katerih je bila incidenca v skupini, zdravljeni z romiplostimom, vsaj 5 % višja v primerjavi s placebom in incidenca bolnikov, zdravljenih z romiplostimom, vsaj 5 %.
Study S4 (279) was a phase 3 study with 24 weeks of romiplostim treatment and study S5 (195) was a phase 1/2 study with 12 weeks of romiplostim treatment (up to 16 weeks for eligible responders who enter a 4-week pharmacokinetic assessment period).
Študija S4 (279) je bilo klinično preskušanje faze 3, v katerem je zdravljenje z romiplostimom trajalo 24 tednov, v študiji S5 (195), preskušanju faze 1/2, pa 12 tednov (do 16 tednov za izbrane osebe, ki so dosegle odziv na zdravljenje, in so bile vključene v nadaljnjo 4 tedne trajajočo oceno farmakokinetike).
In the placebo group, 0% to 7% of patients were able achieve a platelet count response during the 6 months of treatment.
V skupini s placebom je med 6-mesečno uporabo doseglo odziv števila trombocitov od 0 % do 7 % bolnikov.
Guidelines for calculating individual patient dose and volume of romiplostim to administer
Tabela 1: Smernice za izračun odmerka za posameznega bolnika in količine romiplostima za apliciranje
The most frequently used weekly dose was 3-10 mcg/kg and the maximum allowed dose on study was 10 mcg/kg.
Najpogosteje uporabljen tedenski odmerek je znašal 3-10 µg/kg, najvišji dovoljen odmerek v preskušanju pa je znašal 10 µg/kg.
184 confirmed adult patients were included in this study; for these patients, the incidence of binding antibody post treatment was 3.8% (7/184) to romiplostim, of which 0.5% (1/184) was positive for neutralising antibodies to romiplostim.
184 potrjenih odraslih bolnikov je bilo vključenih v to študijo; za te bolnike je bila incidenca vezavnih protiteles po zdravljenju 3,8 % (7/184) proti romiplostimu, od katerih je bilo 0,5 % (1/184) pozitivnih za nevtralizirajoča protitelesa proti romiplostimu.
• Physicians who express an interest in initiating self-administration for specific patients are provided with a HAT pack for those patients.
• Zdravnikom, ki imajo interes, da bi pri določenih bolnikih uvedli samoinjiciranje zdravila, je za takšne bolnike na voljo paket za usposabljanje za samoinjiciranje doma.
In an ongoing paediatric clinical trial, of the subjects with an evaluable on-study bone marrow biopsy, 5 out of 27 subjects (18.5%) developed increased reticulin in cohort 1 and 2 out of 4 subjects (50.0%) developed increased reticulin in cohort 2.
V kliničnem preskušanju pediatričnih bolnikov, ki še poteka, je od 27 bolnikov z ocenljivo biopsijo kostnega mozga, izvedeno med študijo, 5 bolnikov (18,5 %) razvilo zvišan retikulin v kohorti 1 in 2 bolnika od 4 (50,0 %) sta razvila zvišan retikulin v kohorti 2.
This study evaluated non-splenectomised patients with ITP and platelet counts < 50 x 10
Ta študija je ocenjevala nesplenektomirane bolnike z ITP in s številom trombocitov < 50 x 10
• a rare type of anaemia in which the red blood cells, white blood cells and platelets are all reduced in number (aplastic anaemia);
• redka vrsta anemije, pri kateri je zmanjšano število rdečih in belih krvnih celic ter krvnih ploščic (aplastična anemija),
Romiplostim should not be used in patients with moderate to severe hepatic impairment (Child-Pugh score ≥ 7) unless the expected benefit outweighs the identified risk of portal venous thrombosis in patients with thrombocytopenia associated to hepatic insufficiency treated with thrombopoietin (TPO) agonists (see section 4.4).
Romiplostima se ne sme uporabljati pri bolnikih z zmerno ali hudo okvaro jeter (stopnja ≥ 7 po Child-Pughu), razen če pričakovana korist odtehta ugotovljeno tveganje za portalno vensko trombozo pri bolnikih s trombocitopenijo, povezano z insuficienco jeter in zdravljeno s trombopoetinskimi (TPO) agonisti (glejte poglavje 4.4).
The incidence of pre-existing antibodies to romiplostim and TPO was 8.0% and 5.4%, respectively.
Incidenca že obstoječih protiteles proti romiplostimu je bila 8,0 % in proti TPO 5,4 %.
The incidence of thrombotic/thromboembolic events observed in clinical trials was 6.0% with romiplostim and 3.6% with placebo.
V kliničnih preskušanjih je bila incidenca trombotičnih/tromboemboličnih dogodkov med uporabo romiplostima 6,0 % in med uporabo placeba 3,6 %.
However, no subject showed any bone marrow abnormalities that were inconsistent with an underlying diagnosis of ITP at baseline or on-treatment.
Vendar pa noben od bolnikov ni kazal kakršnih koli nepravilnosti kostnega mozga, ki bi bile neskladne z osnovno diagnozo ITP na začetku ali med zdravljenjem.
• weight decreased; weight increased; intolerance of alcohol; loss of appetite (anorexia or decreased appetite); dehydration;
• zmanjšanje telesne mase, povečanje telesne mase, neprenašanje alkohola, izguba apetita (neješčnost ali zmanjšan apetit), dehidracija,
Medicinal products used in the treatment of ITP in combination with romiplostim in clinical trials included corticosteroids, danazol, and/or azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin.
Med zdravili, ki so jih v kliničnih preskušanjih uporabljali za zdravljenje ITP v kombinaciji z romiplostimom, so bili kortikosteroidi, danazol in/ali azatioprin, intravenski imunoglobulin (IVIG) in anti-D imunoglobulin.
Instructions for preparing and giving an injection of Nplate
Navodila za pripravo in injiciranje zdravila Nplate
As a result for a given dose, patients with high platelet counts are associated with low serum concentrations and vice versa.
Zato je pri določenem odmerku koncentracija v serumu pri bolnikih z velikim številom trombocitov nizka in obratno.
Concurrent anaemia and leucocytosis (within a 4-week window) may occur in patients regardless of splenectomy status, but have been seen more often in patients who have had a prior splenectomy.
Ne glede na status splenektomije se pri bolnikih lahko (v obdobju 4 tednov) sočasno pojavita anemija in levkocitoza, vendar sta bili pogosteje opaženi pri bolnikih, ki so pred tem imeli splenektomijo.
Using: A new 1 mL syringe package and the vial of dissolved, clear Nplate.
Uporabite: Novo pakiranje z 1 ml brizgo ter vialo raztopljenega, bistrega zdravila Nplate.
• In paediatric patients, future dose adjustments are based on changes in platelet counts and changes in body weight.
• Pri pediatričnih bolnikih nadaljnje prilagoditve odmerka temeljijo na spremembi števila trombocitov in spremembah telesne mase.
• Very slowly and gently push down on plunger rod to inject all water in the syringe into the vial.
• Zelo počasi in previdno pritisnite na držalo bata, da boste vso vodo iz brizge injicirali v vialo.
Doses were increased in increments of 2 mcg/kg every 2 weeks and the target platelet count was ≥ 50 x 10
Odmerki so bili postopoma povečani za 2 µg/kg vsaka 2 tedna, ciljno število trombocitov je znašalo ≥ 50 x 10
Your initial dose is 1 microgram of Nplate per kilogram of your body weight once a week.
Začetni odmerek bo 1 mikrogram zdravila Nplate na kilogram telesne mase enkrat na teden.
Self-administration of romiplostim is not allowed for paediatric patients.
Samoinjiciranje romiplostima pri pediatričnih bolnikih ni dovoljeno.
Additionally, 2.5% (7/282) developed neutralising antibodies to romiplostim.
Dodatno je 2,5 % (7/282) bolnikov razvilo nevtralizirajoča protitelesa proti romiplostimu.
Note: Remove all air bubbles from syringe to ensure precise solution amount is in syringe.
Opomba: Iz brizge odstranite vse zračne mehurčke, da boste zagotovili natančno količino raztopine v brizgi.
A clinically significant bleeding event was defined as a Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade ≥ 2 bleeding event.
Klinično pomembna krvavitev je bila definirana kot krvavitev 2. stopnje ali več po terminološko poenotenih kriterijih za neželene učinke (CTCAE - Common Terminology Criteria for Adverse Events), verzija 3.0.
Total vial content of romiplostim
Celokupna vsebina romiplostima v viali
The corresponding amount of Nplate solution to inject =
Ustrezna količina raztopine Nplate za injiciranje =
Platelet counts should be assessed monthly thereafter and appropriate dose adjustments made as per the dose adjustment table (table 2) in order to maintain platelet counts within the recommended range.
Potem je treba število trombocitov kontrolirati vsak mesec in ustrezno prilagoditi odmerek, kot navaja tabela prilagajanja odmerkov (Tabela 2), da se ohrani število trombocitov znotraj priporočenih mej.
If individual patient dose is ≥ 23 mcg
Če je odmerek za posameznega bolnika ≥ 23 µg
Uncommon: may affect up to 1 in 100 people • higher than normal platelet counts (thrombocytosis).
Občasni: lahko se pojavijo pri največ 1 od 100 bolnikov • število trombocitov, večje od normalnega (trombocitoza).
• Clean the flat work surface with a new alcohol swab.
• Delovno površino očistite z novim alkoholnim zložencem.
Patients had been diagnosed with ITP for approximately 8 years at the time of study entry.
Ob vključitvi v študijo so imeli ITP diagnosticirano približno 8 let.
There are no or limited amount of data from the use of romiplostim in pregnant women.
Podatkov o uporabi romiplostima pri nosečnicah ni oziroma so omejeni.
Your doctor may decide that it is best for you to inject Nplate.
Vaš zdravnik bo morda presodil, da je najbolje, če si zdravilo Nplate injicirate sami.
After subcutaneous administration of 3 to 15 mcg/kg romiplostim, maximum romiplostim serum levels in ITP patients were obtained after 7-50 hours (median 14 hours).
Po subkutani uporabi od 3 do 15 µg/kg romiplostima je bila največja koncentracija romiplostima v serumu pri bolnikih z ITP dosežena po 7 do 50 urah (mediano po 14 urah).
• muscles pain or weakness (myalgia);
• bolečine v mišicah ali šibkost mišic (mialgija),
• bone marrow disorder, including increased bone marrow fibres (reticulin);
• motnja kostnega mozga, vključno s povečanim nastajanjem vlaken kostnega mozga (retikulin),
Using: Filled syringe with measured Nplate dose and safety needle.
Uporabite: Napolnjeno brizgo z odmerjenim odmerkom zdravila Nplate in varnostno iglo.
If someone else is giving you the injection, they can also use the outer area of the upper arms
Če vam injekcijo da kdo drug, lahko zdravilo injicira tudi v zunanji del nadlaktov
(95% CI) (9%, 35%) (38%, 82%) (14%, 42%) (34%, 78%) (14%, 33%) (43%, 74%) p-value
(95 % IZ) (9 %, 35 %) (38 %, 82 %) (14 %, 42 %)
• Do not set filled syringe down after removing from vial.
• Ne odlagajte napolnjene brizge, potem ko ste jo odstranili z viale.
• bleeding under the skin (ecchymosis);
• krvavitve pod kožo (ekhimoze),
Nplate is not recommended for use in children aged under 1 year.
Zdravila Nplate ni priporočljivo uporabljati pri otrocih, mlajših od 1 leta.
The incidence of binding antibody post treatment was 16% (3/19) to romiplostim, of which 5.3% (1/19) were positive for neutralising antibodies to romiplostim.
Incidenca vezavnih protiteles po zdravljenju je bila 16 % (3/19) proti romiplostimu, od katerih je bilo 5,3 % (1/19) pozitivnih za nevtralizirajoča protitelesa proti romiplostimu.
Reinitiate treatment with Nplate in accordance with dosing and administration recommendations (see sections 4.2 and 4.4).
Ponoven začetek zdravljenja z zdravilom Nplate mora biti v skladu s priporočili za odmerjanje in dajanje (glejte poglavji 4.2 in 4.4).
Oropharyngeal pain, upper abdominal pain, rhinitis, pharyngitis, conjunctivitis, ear infection, sinusitis and peripheral swelling were additional adverse reactions observed in paediatric studies compared to those seen in adult studies.
Orofaringealna bolečina, bolečina v zgornjem delu trebuha, rinitis, faringitis, konjuktivitis, vnetje ušesa, sinusitis in periferno zatekanje so bili dodatni neželeni učinki, ki so jih opazili v preskušanjih pri pediatričnih bolnikih v primerjavi z neželenimi učinki, opaženimi v preskušanjih pri odraslih bolnikih.
• With a short, sharp motion, push the needle into the skin.
• S kratkim, odločnim gibom iglo zabodite v kožo.
It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse or pharmacist.
Pomembno je, da si zdravila ne poskušate injicirati sami, dokler vas tega ne nauči vaš zdravnik, medicinska sestra ali farmacevt.
Your doctor will adjust your dose of Nplate to ensure that your platelet count does not become too high.
Zdravnik bo odmerek zdravila Nplate prilagodil tako, da se vam število trombocitov ne bo preveč povečalo.
The most frequently used weekly dose was between 3-5 mcg/kg (25th-75th percentile respectively; median 3 mcg/kg).
Najpogosteje uporabljeni tedenski odmerek je bil 3-5 µg/kg (vrednosti sta 25. in 75. percentil; mediana 3 µg/kg).
Nplate is administered once a week as an injection under the skin (subcutaneous).
Zdravilo Nplate uporabljamo enkrat tedensko z injiciranjem pod kožo (subkutano injiciranje).
Check the expiry date on the self injection kit.
Preverite datum izteka roka uporabnosti na kompletu za samoinjiciranje.
A decision on whether to discontinue breast-feeding or discontinue therapy with romiplostim should be made taking into account the benefit of breast-feeding to your child and the benefit of romiplostim therapy to you.
Pri odločitvi o prekinitvi dojenja ali prekinitvi zdravljenja z romiplostimom je treba upoštevati korist dojenja za otroka in korist zdravljenja z romiplostimom za vas.
1 sterile safety needle.
1 sterilno varnostno iglo.
• The clear plastic plunger rod MUST always be attached first before breaking the white tip off of the pre-filled water syringe.
• Prozorno plastično držalo bata MORATE vedno namestiti prej, preden odlomite belo konico z napolnjene injekcijske brizge z vodo.
9/L, resume dosing with once weekly dose reduced by 1 mcg/kg
9/l, znova začnite uporabljati zdravilo enkrat na teden v odmerku, zmanjšanem za 1 µg/kg.
If you experience a loss of response or failure to maintain a platelet response with romiplostim treatment, your doctor will investigate the reasons why including whether you are experiencing increased bone marrow fibres (reticulin) or have developed antibodies which neutralise romiplostim's activity.
Če izgubite odziv na zdravljenje z romiplostimom ali vam z njim ni mogoče vzdrževati odziva trombocitov, bo zdravnik proučil razloge za to; med drugim bo raziskal, ali se vam je pojavilo zvišanje vlaken (retikulina) v kostnem mozgu in ali so se vam pojavila protitelesa, ki nevtralizirajo delovanje romiplostima.
Reconstitute lyophilised product and then dilute the product as described in section 6.6.
Pripravite liofilizirano zdravilo in ga nato razredčite, kot je opisano v poglavju 6.6.
Serum concentrations of romiplostim in paediatrics with ITP were within the range observed in adult ITP subjects receiving the same dose range of romiplostim.
Serumske koncentracije romiplostima pri pediatričnih bolnikih z ITP so bile znotraj mej, opaženih pri odraslih bolnikih z ITP, ki so prejemali enak razpon odmerka romiplostima.
Some of the adverse reactions seen in adults were reported more frequently in paediatric subjects such as cough, diarrhoea, rash, pyrexia and contusion reported very commonly (≥ 1/10) in paediatric subjects and purpura and urticaria were reported commonly (≥ 1/100 to < 1/10) in paediatric subjects.
O nekaterih neželenih učinkih, opaženih pri odraslih bolnikih, so bolj pogosto poročali pri pediatričnih bolnikih, kot npr. kašelj, driska, pireksija in zmedenost so bili poročani zelo pogosto (≥ 1/10) pri pediatričnih bolnikih, ter purpura in urtikarija sta bili poročani pogosto (≥ 1/100 do < 1/10)) pri pediatričnih bolnikih.
The HAT pack includes materials for HCPs on how to select and train patients for self-administration of romiplostim; and for patients, in order to help them with the process of preparation and self-administration of the correct dose of romiplostim.
Paket za usposabljanje za samoinjiciranje doma obsega gradiva za zdravnike o tem, kako izbrati in usposobiti bolnike za samoinjiciranje romiplostima, in gradiva za bolnike kot pomoč v postopku priprave in samoinjiciranja pravilnega odmerka romiplostima.
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema);
• otekanje obraza, ustnic, ust, jezika ali grla, ki lahko povzroči težave pri požiranju ali dihanju
• Remove 1 mL syringe from package.
• Vzemite 1 ml brizgo iz pakiranja.
Rescue therapies defined as any therapy administered to raise platelet counts.
Za rešilno terapijo velja vsaka terapija, uvedena z namenom povečanja števila trombocitov.
In mice there was evidence of increased post-implantation loss.
Pri miših so ugotavljali večje poimplantacijske izgube plodov.