natgillin/translations-raw huggingface dataset:
Caution should be exercised in prescribing and infusing IVIg in obese patients and in patients with pre-existing risk factors for thrombotic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilisation, severely hypovolemic patients, and patients with diseases which increase blood viscosity).
Bodite pozorni, ko IVIg predpisujete in infundirate bolnikom s prekomerno težo in bolnikom, pri katerih obstajajo dejavniki tveganja za trombotične dogodke (kot so visoka starost, hipertenzija, sladkorna bolezen in žilna obolenja ali trombotične epizode, bolniki s pridobljenimi ali prirojenimi trombofilnimi boleznimi, bolniki z dolgo dobo imobilizacije, bolnikih z resno hipovolemijo in bolnikih z boleznimi, ki povečujejo viskoznost krvi).
Cases of acute renal failure have been reported in patients receiving IVIg therapy.
Pri bolnikih, ki so bili zdravljeni z IVIg, so poročali o primerih akutne odpovedi ledvic.
In most cases, risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolemia, overweight, concomitant nephrotoxic medicinal products or age over 65.
V večini primerov so ugotovili dejavnike tveganja, kot so predhodno obstoječa ledvična insuficienca, sladkorna bolezen, hipovolemija, prekomerna telesna teža, sočasno zdravljenje z nefrotoksičnimi zdravili ali starost nad 65 let.
In case of renal impairment, IVIg discontinuation should be considered.
V primeru ledvične okvare je potrebno razmisliti o prekinitvi zdravljenja z IVIg.
While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IVIg products, those containing sucrose as a stabiliser accounted for a disproportionate share of the total number.
Čeprav so poročali, da sta zmanjšano delovanje ledvic in akutna odpoved ledvic povezana z uporabo mnogih licenčnih zdravil IVIg, so zdravila s saharozo kot stabilizatorjem odgovorna za nesorazmerno velik delež celotnega števila poročil.
In patients at risk, the use of IVIg products that do not contain sucrose may be considered.
Pri bolnikih s tveganjem premislite o uporabi zdravil IVIg, ki ne vsebujejo saharoze.
In patients at risk for acute renal failure or thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable.
Bolnikom s tveganjem za akutno odpoved ledvic ali tromboembolične neželene učinke infundirajte zdravila IVIg z minimalno hitrostjo in v najmanjšem možnem odmerku.
In all patients, IVIg administration requires:
Pri vseh bolnikih uporaba IVIg zahteva:
- adequate hydration prior to the initiation of the infusion of IVIg
- ustrezno hidracijo pred začetkom infundiranja IVIg
- monitoring of urine output
- nadzor izločanja urina
- monitoring of serum creatinine levels
- nadzor ravni serumskega kreatinina
- avoidance of concomitant use of loop diuretics
- izogibanje sočasni uporabi diuretikov Henlejeve zanke
In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped.
V primeru neželenih učinkov morate ali zmanjšati hitrost infundiranja ali infundiranje prekiniti.
The treatment required depends on the nature and severity of the side effect.
Ustrezno zdravljenje je odvisno od vrste in resnosti neželenih učinkov.
5 In case of shock, standard medical treatment for shock should be implemented.
5 V primeru šoka izvedite standardno medicinsko zdravljenje za šok.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses.
Standardni ukrepi za preprečevanje okužb zaradi uporabe zdravil, ki so bila pripravljena iz človeške krvi ali plazme so med drugim izbor darovalcev, pregled posameznih enot darovane krvi in združene plazme na specifične markerje okužbe in vključitev učinkovitih postopkov za inaktivacijo/ odstranitev virusov.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19.
Ti ukrepi so učinkoviti pri virusih z ovojnico kot so HIV, HBV in HCV in pri virusih brez ovojnice HAV in parvovirusu B19.
It is strongly recommended that every time Flebogammadif is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Zelo priporočljivo je, da vsakič, ko bolniku date Flebogammadif, zabeležite ime in serijsko številko zdravila, da tako ohranite sledljivost med bolnikom in serijo zdravila.
Special warnings about excipients:
Posebna opozorila za pomožne snovi:
This medicinal product contains 50 mg of sorbitol per ml as excipient.
To zdravilo vsebuje 50 mg sorbitola na ml pomožne snovi.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Bolniki z redkimi oblikami dedne intolerance fruktoze ne smejo jemati tega zdravila.
Special precautions should be taken with babies and young children because this fructose intolerance may not yet be diagnosed and may be fatal.
Posebni previdnostni ukrepi so potrebni pri dojenčkih in malih otrocih, ker ta intoleranca fruktoze morda še ni bila diagnosticirana in je lahko smrtna.
Interferences with determination of blood glucose levels are not expected.
Motenj pri določanju ravni krvne glukoze naj ne bi bilo.
Therefore patients receiving measles vaccine should have their antibody status checked.
Zato se mora pri bolnikih, ki bodo prejeli cepivo proti ošpicam, preveriti prisotnost protiteles v krvi.
After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patients blood may result in misleading positive results in serological testing.
Po infundiranju imunoglobulina lahko začasni porast različnih pasivno prenešenih protiteles v krvi bolnika povzroči lažno pozitivne rezultate seroloških preiskav.
Passive transmission of antibodies to erythrocyte antigens, e. g.
Pasivno prenašanje protiteles proti antigenom eritrocitov, npr.
A, B, D, may interfere with some serological tests for red cell antibodies, for example the antiglobulin test (Coomb’ s test).
A, B, D lahko izzove motnje pri nekaterih seroloških preiskavah za protitelesa proti rdečim krvnim telescem, na primer antiglobulinski test (Coombsov test).
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers.
V nadzorovanih kliničnih raziskavah varnosti tega zdravila med uporabo v nosečnosti niso ugotavljali in ga je zato potrebno pri nosečnicah in doječih materah uporabljati previdno.
Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
Klinične izkušnje z imunoglobulini kažejo, da naj ne bi bilo škodljivih učinkov na potek nosečnosti ali plod, ter novorojenčka.
Since Flebogammadif might induce dizziness, patients should be cautioned when driving or operating machines.
6 Ker lahko zdravilo Flebogammadif povzroča omotico, morajo biti bolniki previdni pri vožnji ali upravljanju s stroji.
Adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.
Občasno se lahko pojavijo neželeni učinki kot so mrzlica, glavobol, povišana telesna temperatura, bruhanje, alergijske reakcije, navzea, artralgija, nizek krvni tlak ter zmerna bolečina v ledvenem delu hrbta.
Cases of reversible aseptic meningitis, isolated cases of reversible haemolytic anaemia/ haemolysis and rare cases of transient cutaneous reactions, have been observed with human normal immunoglobulin.
Pri uporabi humanega polispecifičnega imunoglobulina so opažali primere reverzibilnega aseptičnega meningitisa, posamezne primere reverzibilne hemolitične anemije/ hemolize in redke primere prehodnih kožnih reakcij.
Increase in serum creatinine level and/ or acute renal failure have been observed.
Opažali so povečanje ravni serumskega kreatinina in/ ali akutno odpoved ledvic.
Very rarely:
Zelo redko:
Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, deep vein thromboses.
Tromboembolični dogodki kot so miokardni infarkt, možganska kap, pljučna embolija in globoka venska tromboza.
Two multicenter clinical trials were performed, one of them in children and adults with primary immune deficiency and the second one in patients with chronic immune thrombocytopenic purpura in acute phase.
Izvedli so dve multicentrični klinični raziskavi, prvo pri otrocih in odraslih s primarno imunsko pomanjkljivostjo in drugo pri bolnikih s kronično imunsko trombocitopenično purpuro v akutnem stanju.
Forty-six patients were included in the first trial and 41 completed the study.
Pri prvi raziskavi je sodelovalo šestinštirideset bolnikov, 41 pa jo je tudi zaključilo.
They were followed during 1 year of treatment at a dose of 300-600 mg/ kg every 3 to 4 weeks.
Zdravljenje bolnikov z odmerki 300– 600 mg/ kg na vsake 3 do 4 tedne so spremljali 1 leto.
A total of 20 patients were included in the second study.
V drugo študijo je bilo vključenih 20 bolnikov.
Patients received a total dose of 400 mg/ kg body weight for 5 consecutive days and were followed for 3 months.
Bolniki so prejeli skupni odmerek 400 mg/ kg telesne teže 5 dni zaporedoma, spremljali pa so jih 3 mesece.
Therefore, a total of 66 patients have been exposed to Flebogammadif and they have received 806 infusions.
Tako je bilo z zdravilom Flebogammadif zdravljenih skupno 66 bolnikov, ki so prejeli 806 infuzij.
Data from both studies indicate a good tolerability of the product as incidence of adverse events was low and most of them were mild to moderate in intensity.
Podatki obeh študij nakazujejo dobro prenašanje zdravila, saj so bili neželeni učinki redki, večinoma pa so bili neželeni učinki blagi do zmerni.
Of the 806 infusions administered in patients enrolled in both studies 10.8% (1-sided 95% CI upper bound = 12.9%) were associated with an adverse event suspected to be related to the product.
Od 806 infuzij, danih bolnikom, ki so sodelovali pri obeh študijah, se je pri 10, 8% (enostranska 95% zgornja meja intervala zaupanja = 12, 9%) pojavil neželen učinek, za katerega so domnevali, da je povezan z jemanjem zdravila.
No patients died, only 6 patients withdrew from the studies but none of them because of potentially related adverse events.
Noben bolnik ni umrl, zgolj 6 bolnikov je prekinilo študijo, vendar noben izmed njih zaradi možnih neželenih učinkov, povezanih z zdravilom.
Four patients experienced 8 serious adverse events that were considered not related to the study medicinal product.
Pri štirih bolnikih je nastopilo 8 resnih neželenih učinkov, za katere domnevajo, da niso bili povezani s študijo zdravila.
Pyrexia and headache were the most frequently reported adverse events potentially related to the medicinal product in both studies.
Pireksija in glavobol sta bili najpogostejši obliki nezaželenih učinkov, o katerih so bolniki poročali in ki sta bili v obeh študijah potencialno povezani z zdravilom.
The adverse drug reactions reported in the 2 trials by at least the 5% of the patients are summarised and categorised according to the MedDRA system organ class in the table below:
Neželeni učinki, o katerih je pri obeh raziskavah poročalo najmanj 5% bolnikov, so povzeti in kategorizirani v skladu z MedDRA klasifikacijo organskih sistemov v spodnji razpredelnici:
Frequency has been determined using the following criteria:
Pogostnost je določena z naslednjimi kriteriji:
- very common: > 1/ 10
- zelo pogosti: > 1/ 10
- common: > 1/ 100 to < 1/ 10
- pogosti: > 1/ 100 do < 1/ 10
- uncommon: > 1/ 1,000 to < 1/ 100
- občasni: > 1/ 1, 000 do < 1/ 100
- rare: > 1/ 10,000 to < 1/ 1,000
- redki: > 1/ 10, 000 do < 1/ 1, 000
- very rare: < 1/ 10,000, not known (cannot be estimated from the available data.)
- zelo redki: < 1/ 10, 000, neznana (ni mogoče oceniti iz razpoložljivih podatkov)
7 System Organ Class
7 V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Body System Preferred Term
Priporočen izraz po MedDRA
ADR frequency evaluation
neželenih učinkov
Coombs test positive, blood pressure systolic decreased, blood pressure systolic increased, body temperature increased
Pozitivni Coombsov test, znižanje sistoličnega krvnega tlaka, zvišanje sistoličnega krvnega tlaka, povišana telesna temperatura
Uncommon
Občasno
Common Uncommon
Pogosto Občasno
Bronchitis, cough, wheezing
Bronhitis, kašelj, sopenje
Diarrhoea, nausea, vomiting, abdominal pain, abdominal pain upper
Driska, navzea, bruhanje, abdominalna bolečina, bolečina zgornjega abdomna
Urticaria, rash pruritic, dermatitis contact
Urtikarija, srbeč izpuščaj, kontaktni dermatitis
Back pain, arthralgia, myalgia, muscle cramp
Bolečine v hrbtu, artralgija, mialgija, krči v mišicah
Hypotension, hypertension, diastolic hypertension, blood pressure fluctuations
Hipotenzija, hipertenzija, diastolična hipertenzija, fluktuacija krvnega tlaka
General disorders & administration site conditions
Splošne težave in spremembe na mestu aplikacije
Pyrexia, injection site reaction Rigors, asthenia, pain, infusion site inflammation, injection site oedema, injection site pain, injection site pruritus, injection site swelling, migration of implant
Pireksija, reakcije na mestu infuzije Tresavica, astenija, bolečina, vnetje mesta infuzije, edem na mestu infuzije, bolečina na mestu infuzije, srbenje na mestu infuzije, oteklina na mestu infuzije, premik vsadka
For safety with respect to transmissible agents, see section 4.4.
Glede zaščite pred prenosljivimi povzročitelji bolezni, glejte poglavje 4. 4.
Pharmacodynamic properties
Farmakološke lastnosti
Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration, ATC code:
Farmakoterapevtska skupina: imunski serumi in imunoglobulini: humani polispecifični imunoglobulini za intravaskularno uporabo, oznaka ATC:
Human normal immunoglobulin contains the IgG antibodies present in the normal population.
Humani polispecifični imunoglobulin vsebuje protitelesa IgG, ki so prisotna v polispecifični populaciji.
It is usually prepared from pooled plasma from not fewer than 1000 donors.
Običajno ga pripravijo iz združene plazme najmanj 1000 darovalcev.
8 The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
Mehanizem delovanja pri indikacijah, ki niso del nadomestnega zdravljenja, ni v celoti pojasnjen, vendar vključuje učinke imunomodulacije.
A significant increase in median platelet levels was achieved in a clinical trial in chronic ITP patients (64,000/ µl) although it did not reach normal levels.
Znatno zvišanje srednje ravni trombocitov so dosegli v klinični raziskavi pri bolnikih s kronično ITP (64, 000/ µl), čeprav niso dosegli normalnih ravni.
Two clinical trials were performed with Flebogammadif, one for replacement therapy in patients with primary immunodeficiency (both in adults and in children above 10 years) and another for immunomodulation in adults patients with immune thrombocytopenic purpura.
Prvo kot nadomestno zdravljenje pri bolnikih s primarno imunsko pomanjkljivostjo (tako pri odraslih kot tudi pri otrocih starih nad 10 let) in drugo kot imunomodulacijo pri odraslih bolnikih z imunsko trombocitopenično purpuro.
Human normal immunoglobulin is immediately and completely bioavailable in the recipient’ s circulation after intravenous administration.
Humani polispecifični imunoglobulin je po intravenski uporabi takoj in v celoti biološko uporaben v krvnem obtoku prejemnika.
It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3-5 days equilibrium is reached between the intra- and extravascular compartments.
Sorazmerno hitro se porazdeli med plazmo in zunajžilnimi tekočinami, po približno 3– 5 dneh nastopi ravnovesje med znotrajžilnimi in zunajžilnimi razdelki.
Flebogammadif has a half-life of about 30-32 days.
Razpolovni čas zdravila Flebogammadif je od 30 do 32 dni.
The absence of mortality in the non-clinical studies performed with Flebogammadif with dosages up to 2500 mg/ kg, and the lack of any confirmed relevant adverse sign affecting respiratory, circulatory and central nervous system, of the treated animals supports the safety of Flebogammadif.
Prav tako v študijah niso potrdili pomembnih neželenih učinkov na respiratorni sistem, krvni obtok in centralni živčni sistem preizkušanih živali, kar potrjuje varnost zdravila Flebogammadif.
Repeated dose toxicity testing and embryo-foetal toxicity studies are impracticable due to induction of, and interference with antibodies.
Preizkusi toksičnosti s ponavljajočimi odmerki in študije embrio- fetalne toksičnosti so zaradi indukcije nastanka protiteles in interferenc s protitelesi neizvedljivi.
D-sorbitol Water for injections
D- sorbitol Voda za injekcije
This medicinal product must not be mixed with other medicinal products or intravenous fluids.
Zdravila ne smemo mešati z drugimi zdravili ali intravenskimi tekočinami.
It should be administered by a separate intravenous line.
Daje se naj z ločeno infuzijo.
9 10 ml, 50 ml, 100 ml, 200 ml or 400 ml solution in a vial (type II glass) with stopper (chloro-butyl- rubber).
10 ml, 50 ml, 100 ml, 200 ml ali 400 ml raztopine v vialah (steklo tipa II) z zamaškom (klorobutilna guma).
6.6.
9 6. 6.
Can Guasch, 2 - Parets del Vallès 08150 Barcelona - Spain
Can Guasch, 2 - Parets del Vallès 08150 Barcelona - Španija
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Polígono Levante Can Guasch, 2, E-08150 Parets del Vallès Barcelona, Spain
Polígono Levante Can Guasch, 2, E- 08150 Parets del Vallès Barcelona, Španija
Polígono Levante Can Guasch, 2 E-08150 Parets del Vallès Barcelona, Spain
Polígono Levante Can Guasch, 2 E- 08150 Parets del Vallès Barcelona, Španija
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• PPOGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
Medicinal product subject to medical prescription.
Izdaja zdravila na recept.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.0 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 (MAH) mora zagotoviti, da se sistem farmakovigilance, kot je opisan v verziji 1. 0, predstavljen v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet, uporablja in deluje pred in medtem ko je zdravilo na trgu.
Risk Management Plan The MAH commits to performing the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1 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.
Načrt za krizno upravljanje Imetnik dovoljenja za promet (MAH) se zavezuje, da bo izvajal farmakovigilančne aktivnosti, ki so podrobneje opisane v načrtu farmakovigilance, kot je bilo dogovorjeno v verziji 1. 1 načrta za krizno upravljanje (RMP), predstavljenem v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet in poznejše dopolnitve, za katere se je dogovoril CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, an updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernico o sistemih za krizno upravljanje (CHMP) z zdravili za uporabo pri ljudeh se mora predložiti posodobljen RMP istočasno z naslednjim periodičnim poročilom o varnosti (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
Prav tako je treba predložiti posodobljen RMP • Ko prejmete nove informacije, ki bi lahko vplivale na trenutne varnostne specifikacije, farmakovigilančni načrt ali dejavnosti za zmanjšanje tveganja • V roku 60 dni, ko ste dosegli pomemben mejnik (pri farmakovigilanci ali zmanjšanju tveganja) • Na zahtevo Evropske agencije za zdravila (EMEA)
12 Official batch release: in accordance with Article 114 Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Uradna sprostitev serije: v skladu s 114. členom dopolnjene in spremenjene Direktive 2001/ 83/ ES, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
LABELLING
14 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON (0.5 g, 2.5 g, 5 g, 10 g and 20 g)
ZUNANJA OVOJNINA (0, 5 g, 2, 5 g, 5 g, 10 g in 20 g)
Flebogammadif 50 mg/ ml solution for infusion Human normal immunoglobulin
Flebogammadif 50 mg/ ml raztopina za infundiranje Humani polispecifični imunoglobulin
D-sorbitol, water for injections.
D- sorbitol, voda za injekcije.
For intravenous use.
Za intravensko infundiranje.
17 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
16 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
VIAL LABEL (2.5 g, 5 g, 10 g and 20 g)
NALEPKA NA VIALI (2, 5 g, 5 g, 10 g in 20 g)
For intravenous use
Za intravensko infundiranje
To hang pull here
Da obesite, povlecite tukaj
Can Guasch, 2 - Parets del Vallès 08150 Barcelona - Spain
Can Guasch, 2 - Parets del Vallès 08150 Barcelona – Španija
VIAL LABEL (0.5 g)
NALEPKA VIALE (0, 5 g)
Flebogammadif 50 mg/ ml solution for infusion Human normal immunoglobulin For intravenous use
Flebogammadif 50 mg/ ml raztopina za infundiranje Humani polispecifični imunoglobulin Za intravensko infundiranje
PACKAGE LEAFLET
20 NAVODILO ZA UPORABO
Flebogammadif 50 mg/ ml solution for infusion Human normal immunoglobulin (IVIg)
Flebogammadif 50 mg/ ml raztopina za infundiranje humani polispecifični imunoglobulin (IVIg)
What Flebogammadif is and what it is used for 2.
Kaj je zdravilo Flebogammadif in za kaj ga uporabljamo 2.
Before you use Flebogammadif 3.
Kaj morate vedeti, preden boste uporabili zdravilo Flebogammadif 3.
How to use Flebogammadif 4.
Kako uporabljati zdravilo Flebogammadif 4.
How to store Flebogammadif 6.
Shranjevanje zdravila Flebogammadif 6.
WHAT FLEBOGAMMADIF IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO FLEBOGAMMADIF IN ZA KAJ GA UPORABLJAMO
Flebogammadif is one of the group of medicines called intravenous immunoglobulins.
Flebogammadif spada v skupino zdravil, ki jih imenujemo intravenski imunoglobulini.
These are used to treat conditions where the body’ s defence system against disease is not working properly.
Uporabljajo se za zdravljenje stanj, pri katerih obrambni sistem telesa proti boleznim ne deluje pravilno.
It is used to raise antibody levels in your blood.
Uporablja se za povečanje ravni protiteles v krvi.
A lower than normal level of antibodies in your blood results in the incorrect functioning of your body’ s defence (immune) system.
Prenizko raven protiteles v krvi povzroča nepravilno delovanje vašega obrambnega (imunskega) sistema.
The low levels of antibodies may be inherited or may have developed as you have grown older.
Nizke ravni protiteles so lahko podedovane ali pa se razvijejo kasneje.