natgillin/translations-raw huggingface dataset:
Cerezyme 400 Units powder for concentrate for solution for infusion Reconstitute each vial with 10.2 ml water for injections; avoid forceful impact of water for injections on the powder and, by mixing gently, avoid foaming of the solution.
Cerezyme 400 enot prašek za koncentrat za raztopino za infundiranje Prašek v eni viali raztopite s 10,2 ml vode za injekcije.
Instructions for use - reconstitution, dilution and administration Each vial of Cerezyme is for single use only.
Navodila za uporabo - priprava raztopine, redčenje in dajanje
The efficacy of Cerezyme on neurological symptoms of chronic neuronopathic Gaucher patients has not been established and no special dosage regimen can be recommended for these manifestations (see section 5.1).
Za to manifestacijo ne moremo priporočiti posebnega režima odmerjanja (glejte poglavje 5.1).
What you need to know before you are given Cerezyme.
Kaj je zdravilo Cerezyme in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Cerezyme Kako vam bo zdravilo Cerezyme dano
Cerezyme 400 Units powder for concentrate for solution for infusion The reconstituted solution contains 40 units imiglucerase per ml.
Cerezyme 400 enot prašek za koncentrat za raztopino za infundiranje Pripravljena raztopina vsebuje 40 enot imigluceraze/ml.
Cerezyme 200 Units powder for concentrate for solution for infusion Reconstitute each vial with 5.1 ml water for injections; avoid forceful impact of water for injections on the powder and, by mixing gently, avoid foaming of the solution.
Cerezyme 200 enot prašek za koncentrat za raztopino za infundiranje Prašek v eni viali raztopite s 5,1 ml vode za injekcije.
Cerezyme 400 Units Powder for concentrate for solution for infusion imiglucerase
Cerezyme 400 enot prašek za koncentrat za raztopino za infundiranje imigluceraza
The reconstituted solution contains 40 units imiglucerase per ml.
Pripravljena raztopina vsebuje 40 enot imigluceraze/ml.
UNIQUE IDENTIFIER - 2D BARCODE
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
Then dilute the combined volumes with 0.9% sodium chloride intravenous solution to a total volume of 100 to 200 ml.
10,0 ml pripravljene raztopine iz ene viale in skupno odvzeto količino razredčite z 0,9 % raztopino natrijevega klorida za intravensko uporabo do volumna 100 do 200 ml. Raztopino za infundiranje rahlo premešajte.
Cerezyme 200 Units Powder for concentrate for solution for infusion imiglucerase
Cerezyme 200 enot prašek za koncentrat za raztopino za infundiranje imigluceraza
• thrombocytopenia
• trombocitopenija,
Immune system disorders Hypersensitivity reactions
Bolezni imunskega sistema
- The other ingredients are: mannitol, sodium citrate, citric acid monohydrate and polysorbate 80.
Po rekonstituciji vsebuje raztopina 40 enot imigluceraze na ml. - Druge sestavine so: manitol, natrijev citrat, citronska kislina monohidrat, polisorbat 80.
Cerezyme is a white to off-white powder.
prašek za koncentrat za raztopino za infundiranje Zdravilo Cerezyme je prašek bele oz. umazano bele barve.
Do not use vials exhibiting foreign particles or discoloration.
Vial, v katerih opazite delce, in tistih, v katerih se je raztopina obarvala, ne smete uporabiti.
Contents of the pack and other information .
5 Shranjevanje zdravila Cerezyme Vsebina pakiranja in dodatne informacije
Common ( may affect up to 1 in 10 people): - breathlessness - coughing - hives/ localised swelling of the skin or lining of the mouth or throat - itching - rash
- izpuščaji/lokalizirano otekanje kože ali obloge v ustih ali grlu
EU/1/08/494/005 STELARA 130 mg Concentrate for solution for infusion
130 mg koncentrat za raztopino za infundiranje
Intravenous use vial (glass)
Za intravensko uporabo (steklena) viala 26 ml (5 mg/ml)
The quantity of ImmunoGam you will need will be determined by your doctor or nurse.
Količino zdravila ImmunoGam, ki jo potrebujete, določita vaš zdravnik ali medicinska sestra.
Hypersensitivity to any of the components.
Preobčutljivost za katerokoli sestavino.
Manufacturer Cangene Corporation 155 Innovation Drive Winnipeg, MA R3T 5Y3
Izdelovalec Cangene Corporation 155 Innovation Drive Winnipeg, MA R3T 5Y3
This should be taken into account in patients with
To je treba upoštevati pri bolnikih s
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
Ask your doctor for advice before using this medicine.
Posvetujte se z zdravnikom, preden uporabite to zdravilo.
The following side effect can be serious and has been observed occasionally.
Neželeni učinek je lahko resen in je bil opažen v posameznih primerih.
• There are no available data on drug interactions of ImmunoGam with other medications.
• Ni razpoložljivih podatkov o interakcijah zdravila ImmunoGam z drugimi zdravili.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernico CHMP o sistemih upravljanja tveganja za zdravila za uporabo v humani medicini je treba predložiti posodobljen načrt obvladovanja tveganja hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
• Immunoglobulin A: Please tell your doctor if your blood does not have immunoglobulin A (IgA).
• Imunoglobulin A: obvestite zdravnika, če vaša kri ne vsebuje imunoglobulina A (IgA).
[Justification for not including Braille accepted]
[Sprejeta je utemeljitev, da Braillova pisava ni potrebna]
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials.
Varnost tega zdravila pri nosečnicah ni bila preverjena v kontroliranih, kliničnih preskušanjih.
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.
• Allergic reaction: There is a chance that you may experience an allergic reaction after administration of this medicine.
• Alergijska reakcija: Obstaja možnost, da se po uporabi tega zdravila pri vas pojavi alergijska reakcija.
Immunoglobulins are normal constituents of the human body.
Imunoglobulini so normalne sestavine človeškega telesa.
If any of the side effects mentioned in this leaflet gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika, medicinsko sestro/zdravstvenika ali farmacevta.
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
• v 60 dneh po doseženem pomembnem mejniku na področju farmakovigilance ali zmanjševanja tveganja,
Instruction for Use and Handling and Disposal
Navodila za uporabo, ravnanje z zdravilom in odstranjevanje
ADR frequency category*
Kategorija pogostnosti neželenega učinka*
If the recipient is a carrier of HBsAg, there is no benefit in administering this medicinal product.
Če je prejemnik nosilec HBsAg, uporaba zdravila nima koristnih učinkov.
Important information about some of the ingredients of ImmunoGam
Pomembne informacije o nekaterih sestavinah zdravila ImmunoGam
Excipients: Maltose (see package leaflet for further information) and polysorbate 80
Pomožne snovi: maltoza (za več informacij glejte navodilo za uporabo) in polisorbat 80
This should be taken into account in patients with diabetes mellitus.
To je treba upoštevati pri bolnikih s sladkorno
Your doctor will decide if ImmunoGam can be used during pregnancy and breastfeeding.
Vaš zdravnik bo presodil, ali lahko zdravilo ImmunoGam uporabite med nosečnostjo in v obdobju dojenja.
• Please tell your doctor or nurse, if you are taking or have recently taken any other medicines, including medicines obtained without a prescription e.g. herbal medicines.
• Obvestite svojega zdravnika ali medicinsko sestro, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi zdravilo brez recepta, npr. zdravilo rastlinskega izvora.
IgA content is less than 40 micrograms/ml.
Vsebnost IgA je manjša od 40 mikrogramov/ml.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem
ImmunoGam has an elimination half-life of 3 - 4 weeks.
Razpolovna doba izločanja zdravila ImmunoGam je 3-4 tedne.
Patients who have an IgA deficiency may develop an allergic reaction to this medicine.
Pri bolnikih, ki imajo pomanjkljivost IgA, se lahko pojavi alergijska reakcija na to zdravilo.
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection.
Sum alergijske ali anafilaktične reakcije zahteva takojšnjo prekinitev injiciranja.
In case of shock, standard medical treatments for shock should be implemented.
V primeru šoka je treba izvajati standardno medicinsko zdravljenje za šok.
• Do not use ImmunoGam after the expiry date which is stated on the label and carton.
• Zdravila ImmunoGam ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in škatli.
Hypersensitivity to human immunoglobulins, especially in very rare cases of IgA deficiency when the patient has antibodies against IgA.
Preobčutljivost za človeške imunoglobuline, zlasti v zelo redkih primerih pomanjkljivosti IgA, ko ima bolnik protitelesa proti IgA.
In animals, acute toxicity testing is of no relevance as higher doses result in overloading.
Preskusi akutne toksičnosti pri živalih niso smiselni, saj večji odmerki povzročijo nasičenost.
ImmunoGam contains a small quantity of IgA (less than 40 micrograms/ml).
ImmunoGam vsebuje majhno količino IgA (manj kot 40 mikrogramov/ml).
Immunoglobulins are excreted into milk but no harmful effects on the neonate are to be expected.
Imunoglobulini se izločajo v materino mleko, vendar ni pričakovati škodljivih učinkov na novorojenca.
ImmunoGam belongs to a group of medicines containing immunoglobulins (antibodies which can protect against certain infections), which are present in your blood.
Zdravilo ImmunoGam spada v skupino zdravil, ki vsebujejo imunoglobuline (protitelesa, ki lahko ščitijo proti določenim okužbam), kakršne imate v svoji krvi.
Do not use solutions that are cloudy or have deposits.
Ne uporabljajte raztopin, ki so motne, ali imajo usedlino.
• ImmunoGam contains maltose (10%w/w).
• Zdravilo ImmunoGam vsebuje maltozo (10 % m/m).
Repeated-dose toxicity testing and embryo-fetal toxicity studies are impractical due to induction of, and interference with antibodies.
Preskusi toksičnosti ponavljajočih se odmerkov in študije toksičnosti za zarodek/plod so nepraktične zaradi indukcije protiteles in interference protiteles.
The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 2.0 in predložen v modulu 1.8.1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
Like all medicines, ImmunoGam can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo ImmunoGam neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the fetus and the neonate are to be expected.
Klinične izkušnje z imunoglobulini kažejo, da ni pričakovati škodljivih učinkov na potek nosečnosti ali na plod in novorojenca.
• Keep the vial in the outer carton in order to protect from light.
• Shranjujte vialo v zunanji kartonski škatli za zagotovitev zaščite pred svetlobo.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.3 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet se zavezuje, da bo izpeljal vse študije in dodatne aktivnosti v zvezi s farmakovigilanco, navedene v načrtu farmakovigilance, kot je bilo dogovorjeno v različici 1.3 načrta obvladovanja tveganja, predloženega v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom in v skladu z vsemi nadaljnjimi posodobitvami načrta za obvladovanje tveganja, odobrenimi s strani Odbora za zdravila za uporabo v humani medicini (CHMP).
Pharmacotherapeutic group: Hepatitis B immunoglobulin, ATC code: J06BB04
Farmakoterapevtska skupina: Humani imunoglobulin proti hepatitisu tipa B, oznaka ATC: J06BB04
- The other ingredients are maltose and polysorbate 80.
- Pomožni snovi sta maltoza in polisorbat 80.
This also applies to any unknown or emerging viruses or other types of infections.
To velja tudi za neznane ali porajajoče se viruse in druge povzročitelje okužb.
Take special care with ImmunoGam General warnings related to ImmunoGam:
Bodite posebno pozorni pri uporabi zdravila ImmunoGam Splošna opozorila z zdravilom ImmunoGam:
ImmunoGam contains small amounts of IgA.
Zdravilo ImmunoGam vsebuje majhne količine IgA.
Keep the vial in the outer carton in order to protect from light.
Shranjujte vialo v zunanji kartonski škatli za zagotovitev zaščite pred svetlobo.
- Prevention of hepatitis B in case of accidental exposure in non-immunised subjects: At least 500 IU, depending on the intensity of exposure, as soon as possible after exposure, and preferably
- Preprečevanje hepatitisa B v primeru nenamerne izpostavitve necepljene osebe: Najmanj 500 i.e., odvisno od intenzivnosti izpostavitve, čim prej po izpostavitvi in po možnosti v
- In case of accidental exposure in non-immunised subjects (including persons whose vaccination is
- v primeru nenamerne izpostavitve necepljene osebe (vključno z osebami, katerih cepljenje je nepopolno
In all these situations, vaccination against hepatitis B virus is highly recommended.
V vseh omenjenih situacijah je cepljenje proti virusu hepatitisa B zelo priporočljivo.
If intramuscular administration is contraindicated (bleeding disorders), the injection can be administered subcutaneously if no intravenous medicinal product is available.
Če je intramuskularno dajanje kontraindicirano (bolezni strjevanja krvi), lahko injiciranje opravite subkutano, če ni na voljo intravenskega zdravila.
Vaccination against hepatitis B virus is highly recommended.
Cepljenje proti virusu hepatitisa B je zelo priporočljivo.
WHAT IMMUNOGAM IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO IMMUNOGAM IN ZA KAJ GA UPORABLJAMO
What ImmunoGam looks like and contents of the pack
Izgled zdravila ImmunoGam in vsebina pakiranja
ImmunoGam does not effect your ability to drive or use machines.
Zdravilo ImmunoGam ne vpliva na sposobnost vožnje in upravljanja s stroji.
After administration of this medicinal product, an interval of at least 3 months should elapse before vaccination with live attenuated virus vaccines.
Po uporabi tega zdravila morajo preteči vsaj trije meseci pred cepljenjem s cepivom, ki vsebuje živ,
In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, ImmunoGam should be given only if the expected benefits outweigh the
Pri bolnikih s hudo trombocitopenijo ali kakršno koli motnjo strjevanja krvi, ki kontraindicirata intramuskularno injiciranje, se zdravilo ImmunoGam uporabi le, če so pričakovane koristi večje od z zdravilom povezanega
If a large volume (greater than 2 ml for children or greater than 5 ml for adults) is required, it is recommended that the administration of ImmunoGam be divided doses at different sites.
Če je treba uporabiti velik volumen (več kot 2 ml za otroke ali več kot 5 ml za odrasle), je priporočljivo, da se odmerek zdravila ImmunoGam razdeli in uporabi na različnih predelih telesa.
Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Izdelovalci teh zdravil med obdelavo krvi ali plazme uporabljajo postopke, ki inaktivirajo ali odstranijo viruse.
Human hepatitis B immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against hepatitis B virus surface antigen (HBsAg).
Človeški imunoglobulin proti hepatitisu B vsebuje v glavnem imunoglobulin G (IgG) s specifično visoko vsebnostjo protiteles proti površinskemu antigenu virusa hepatitisa B (HBsAg).
• Store in a refrigerator (2 to 8°C).
• Shranjujte v hladilniku (od 2 °C do 8 °C).
After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Po injiciranju imunoglobulina lahko prehodno zvišanje titrov različnih pasivno prenesenih protiteles v bolnikovi krvi povzroči lažno pozitivne rezultate seroloških preiskav.
Some types of blood glucose testing systems (for example, those based on the glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase methods) falsely interpret the maltose contained in ImmunoGam as glucose.
Določeni sistemi za merjenje glukoze v krvi (npr. sistemi na osnovi metod glukoza-dehidrogenazapirolokinolinkinon (GDH-PQQ) ali glukoza-barvilo-oksidoreduktaza) lahko maltozo v zdravilu ImmunoGam lažno določijo kot glukozo.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed from blood donors on to patients.
Pri zdravilih, ki so izdelana iz človeške krvi ali plazme, se izvajajo določeni postopki za preprečevanje prenosa okužb od darovalcev krvi na bolnike.
No effects on ability to drive and use machines have been observed.
Vplivi na sposobnost vožnje in upravljanja s stroji niso bili ugotovljeni.
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 postopki za preprečevanje okužb zaradi uporabe zdravil, pripravljenih iz človeške krvi ali plazme, so izbira darovalcev, presejanje posameznih darovanih enot in združenih vzorcev plazme za specifične označevalce okužbe ter vključitev stopenj izdelave, ki učinkovito inaktivirajo/odstranijo viruse.
Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.
Imunoglobulini niso bili povezani s hepatitisom A ali okužbo s parvovirusom B19, ker so verjetno protitelesa proti tem okužbam, ki so v zdravilu, zaščitna.
HOW TO STORE IMMUNOGAM
SHRANJEVANJE ZDRAVILA IMMUNOGAM
Individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA.
Pri osebah s pomanjkljivostjo IgA se lahko razvijejo protitelesa proti IgA, kar lahko privede do anafilaktične reakcije po prejemu krvnih komponent, ki vsebujejo IgA.
These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections.
Ti ukrepi so natančna izbira darovalcev krvi in plazme, da se izključijo osebe, ki so morda okužene, in preiskave vsake darovane enote ter združenih vzorcev plazme za znake virusov ali okužbe.
Undesirable effects reported during clinical trials with ImmunoGam, that was administered intramuscularly (injected into a muscle), were uncommon (affects 1 to 10 users in 1,000).
Neželeni učinki zdravila, ugotovljeni v kliničnih preskušanjih zdravila ImmunoGam po intramuskularni uporabi (injiciranju v mišico) zdravila, ki so se šteli za povezane z zdravilom ImmunoGam, so bili občasni (pri 1 do 10 ljudeh od 1.000 ljudi).
The physician must therefore weigh the benefit of treatment with ImmunoGam against potential risk of hypersensitivity reactions.
Zdravnik mora zato pretehtati korist zdravljenja z zdravilom ImmunoGam in možno tveganje
The measures taken are considered effective for enveloped viruses such as HIV, HBV, and HCV.
Izvedeni postopki se štejejo za učinkovite proti virusom z ovojnico, kot so HIV, HBV in HCV.
Also, cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated glucose readings.
Poleg tega pa lahko pravi primeri hipoglikemije ostanejo nezdravljeni, če hipoglikemijo maskirajo lažno zvišani rezultati za glukozo.
ImmunoGam 312 IU/ml solution for injection.
ImmunoGam, 312 i.e./ml, raztopina za injiciranje.
• Human hepatitis B immunoglobulin injections can induce a drop in blood pressure with an allergic reaction, even in patients who have tolerated previous treatments with immunoglobulin.
• Človeški imunoglobulin proti hepatitisu B lahko sproži padec krvnega tlaka z alergijsko reakcijo, celo pri bolnikih, ki so predhodno prenašali zdravljenje z imunoglobulinom.
It is strongly recommended that every time you receive a dose of ImmunoGam, the name and batch number of the product are recorded in your physician's notes in order to maintain a record of the batches used.
Zelo priporočljivo je, da se vsakič, ko prejmete odmerek zdravila ImmunoGam, v kartoteko pri vašem zdravniku zabeleži ime in številko serije zdravila, da se zagotovi sledljivost serije uporabljenega zdravila.
ImmunoGam may cause a rise of various transferred antibodies which may result in misleading positive results of certain blood serum tests.
Zdravilo ImmunoGam lahko povzroči zvišanje ravni različnih prenesenih protiteles, kar se kaže kot lažno pozitivni rezultati določenih preiskav krvnega seruma.
If a large volume (>2 ml for children or >5 ml for adults) is required, it is recommended to administer this
Če je treba uporabiti velik volumen (>2 ml za otroke ali >5 ml za odrasle), je priporočljivo, da odmerek razdelite in ga uporabite na različnih predelih telesa.
ImmunoGam contains 0.16 g of maltose in a 500 IU dose.
Zdravilo ImmunoGam v odmerku 500 i.e. vsebuje 0,16 g maltoze.
For safety with respect to transmissible agents, see section 4.4
Varnost v zvezi s povzročitelji nalezljivih bolezni je opisana v poglavju 4.4.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus.
Izvajani postopki se smatrajo za učinkovite proti virusom z ovojnico, kot so virus človeške imunske pomanjkljivosti (HIV), virus hepatitisa B in virus hepatitisa C.
ImmunoGam is presented as a solution for injection in a glass vial.
Zdravilo ImmunoGam je raztopina za injiciranje v stekleni viali.
For intramuscular administration of ImmunoGam, the only manifestations of overdose would be pain and tenderness at the injection site.
Pri intramuskularni uporabi zdravila ImmunoGam bi bila edina znaka prevelikega odmerjanja bolečina in občutljivost na mestu injiciranja.
Rarely, human hepatitis B immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who have tolerated previous treatment with immunoglobulin.
V redkih primerih lahko človeški imunoglobulin hepatitisa B sproži padec krvnega tlaka z anafilaktično reakcijo, celo pri bolnikih, ki so tolerirali predhodno zdravljenje z imunoglobulinom.
* Frequency has been evaluated using the following criteria: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).
*Pogostnost je bila razvrščena v naslednje skupine: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100).