FrancophonIA/ELRC3.0 huggingface dataset:
English: Gaucher disease is a rare recessively inherited metabolic disorder that results from a deficiency of the lysosomal enzyme acid β-glucosidase.
Slovenian: Mehanizem delovanja Gaucherjeva bolezen je redka, recesivno podedovana presnovna motnja, ki je posledica pomanjkanja lizosomskega encima kisla β-glukozidaza.
English: In an ICGG Gaucher Registry analysis of a large cohort of patients (n=528) with Gaucher disease type 1, a time- and dose-dependent effect for Cerezyme was observed for haematological and visceral parameters (platelet count, haemoglobin concentration, spleen and liver volume) within the dose range of 15, 30 and 60 U/kg body weight once every 2 weeks.
Slovenian: Pri analizi Gaucherjevega registra Mednarodne sodelovalne skupine za Gaucherjevo bolezen (International Collaborative Gaucher Group (ICGG) Gaucher Registry) velike skupine bolnikov (n=528) z Gaucherjevo boleznijo tipa 1, so pri hematoloških in visceralnih parametrih (število trombocitov, koncentracija hemoglobina, volumen vranice in jeter) v razponu odmerkov 15, 30 in 60
English: Unopened vials: Store in a refrigerator (2°C - 8°C)
Slovenian: Neodprte viale: Shranjujte v hladilniku (2 °C - 8 °C)
English: It is supplied as a powder which will be mixed with sterile water before it is given.
Slovenian: Na razpolago je v obliki praška, ki se pred dajanjem zmeša s sterilno vodo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 5 VIALS, 25 VIALS)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA (1 VIALA, 5 VIAL, 25 VIAL)
English: Cerezyme, 400 Units, is presented as a powder for concentrate for solution for infusion (in a vial, pack size of 1, 5 or 25).
Slovenian: Cerezyme, 400 enot, je na voljo v obliki praška za koncentrat za raztopino za infundiranje (v vialah, pakiranih po 1, 5 ali 25).
English: But, if you suffer with any shortness of breath you should tell your doctor.
Slovenian: Če imate kakršnokoli obliko kratke sape, obvestite svojega zdravnika.
English: Mannitol, sodium citrate (to adjust pH), citric acid monohydrate (to adjust pH), polysorbate 80.
Slovenian: Manitol, natrijev citrat (za uravnavanje pH), citronska kislina monohidrat (za uravnavanje pH), polisorbat 80.
English: Your doctor may advise that you can be treated at home provided you meet certain criteria.
Slovenian: Če izpolnjujete določene kriterije, vam zdravnik lahko svetuje, da se zdravite doma.
English: The most frequent disease manifestations are hepatosplenomegaly, thrombocytopenia, anaemia, and skeletal pathology, The skeletal abnormalities are frequently the most debilitating and disabling features of Gaucher disease.
Slovenian: Najbolj pogosti bolezenski znaki so hepatosplenomegalija, trombocitopenija, anemija in patologija skeleta.
English: EU/1/97/053/003 1 vial of powder for concentrate for solution for infusion EU/1/97/053/004 5 vials of powder for concentrate for solution for infusion EU/1/97/053/005 25 vial of powder for concentrate for solution for infusion
Slovenian: EU/1/97/053/003 1 viala praška za koncentrat za raztopino za infundiranje EU/1/97/053/004 5 vial praška za koncentrat za raztopino za infundiranje EU/1/97/053/005 25 vial praška za koncentrat za raztopino za infundiranje
English: This medicine contains sodium and is administered in 0.9% sodium chloride intravenous solution.
Slovenian: To zdravilo vsebuje natrij in se aplicira v 0,9 % intravenski raztopini natrijevega klorida.
English: Glucosylceramide is a natural substance in the body, made of sugar and fat.
Slovenian: Glukozilceramid je naravna snov v telesu,
English: C.
Slovenian: S
English: • Guide for Healthcare Professionals Treating Patients with Gaucher Disease.
Slovenian: Cerezyme • Priročnik za zdravstveno osebje, ki obravnava bolnike z Gaucherjevo boleznijo
English: Disease management should be directed by physicians knowledgeable in the treatment of Gaucher disease.
Slovenian: Nadzor in zdravljenje bolezni mora voditi zdravnik, ki ima izkušnje z zdravljenjem Gaucherjeve bolezni.
English: This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Slovenian: To zdravilo vsebuje natrij in se aplicira v 0,9 % intravenski raztopini natrijevega klorida (glejte poglavje 6.6).
English: The product diluted in 0.9% sodium chloride intravenous solution will retain chemical stability if stored up to 24 hours at 2°C and 8°C under protection from light; but microbiological safety will depend on the reconstitution and dilution having been performed aseptically.
Slovenian: Z 0,9 % raztopino natrijevega klorida za intravensko uporabo razredčeno zdravilo je kemično stabilno 24 ur pri temperaturi od 2 do 8 ºC in zaščiteno pred svetlobo; mikrobiološka neoporečnost zdravila pa zavisi od uporabe aseptične tehnike pri pripravi in redčenju raztopine.
English: To be taken into consideration by patients on a controlled sodium diet.
Slovenian: To je pomembno upoštevati pri bolnikih, ki so na dieti z nadzorovano količino natrija.
English: Cerezyme 200 Units, is presented as a powder for concentrate for solution for infusion (in a vial, pack size of 1 or 25).
Slovenian: Cerezyme, 200 enot, je na voljo v obliki praška za koncentrat za raztopino za infundiranje (v vialah, pakiranih po 1 ali 25).
English: Excipients: mannitol, sodium citrate, citric acid monohydrate and polysorbate 80.
Slovenian: Pomožne snovi: manitol, natrijev citrat, citronska kislina monohidrat, polisorbat 80.
English: It can occur whether the patient is treated with Cerezyme or not.
Slovenian: Pojavi se lahko neodvisno od prejemanja zdravila Cerezyme.
English: Cerezyme contains sodium
Slovenian: Zdravilo Cerezyme vsebuje natrij
English: The powder for concentrate for solution for infusion has to be reconstituted with water for injections, diluted with 0.9% sodium chloride intravenous solution and then administered by intravenous infusion.
Slovenian: Prašek za koncentrat za raztopino za infundiranje raztopimo z vodo za injekcije in raztopino razredčimo z 0,9 % raztopino natrijevega klorida za intravensko uporabo.
English: Infusion site discomfort, infusion site burning, infusion site swelling, injection site sterile abscess, chest discomfort*, fever, rigors, fatigue
Slovenian: pekoča bolečina na mestu aplikacije, otekanje na mestu aplikacije, sterilni absces na mestu aplikacije, neugodje v prsih*, zvišana telesna temperatura, okorelost, utrujenost
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 25 VIALS)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA (1 VIALA, 25 VIAL)
English: Cerezyme 400 Units powder for concentrate for solution for infusion This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Slovenian: Cerezyme 400 enot prašek za koncentrat za raztopino za infundiranje To zdravilo vsebuje natrij in se aplicira v intravenski 0,9 % raztopini natrijevega klorida (glejte poglavje 6.6).
English: Patients with Gaucher disease may also have a low grade inflammatory profile.
Slovenian: Pri bolnikih z Gaucherjevo boleznijo lahko opazimo tudi nizko stopnjo vnetja.
English: Initial doses of 60 U/kg of body weight once every 2 weeks have shown improvement in haematological and visceral parameters within 6 months of therapy and continued use has either stopped progression of or improved bone disease.
Slovenian: tedna so se hematološki in visceralni parametri zboljšali v 6 mesecih, nadaljnje zdravljenje pa je bodisi zaustavilo napredovanje bolezni kosti ali zboljšalo njeno bolezensko stanje.
English: After reconstitution, the solution contains 1.24 mmol sodium (400 U/10 mL).
Slovenian: Po rekonstituciji vsebuje raztopina 1,24 mmol natrija (400 e/10 mL).
English: After reconstitution, the solution contains 0.62 mmol sodium (200 U/5 mL).
Slovenian: Po rekonstituciji vsebuje raztopina 0,62 mmol natrija (200 e/5 mL).
English: Treatment with Cerezyme at a dose of 60 U/kg body weight once every 2 weeks, showed improvement in bone pain as early as 3 months, decrease in bone crises within 12 months, and improvement in bone mineral density after 24 months of treatment (Sims et al, 2008).
Slovenian: mesecih in izboljšanja mineralne gostote kosti po 24 mesecih zdravljenja (Sims et al, 2008).
English: Infusion of Cerezyme at home may be considered for patients who are tolerating their infusions well for several months.. Decision to have patient move to home infusion should be made after evaluation and recommendation by the treating physician.
Slovenian: Odločitev, da bolnik začne dobivati infuzije doma, se lahko sprejme po ovrednotenju in priporočilu s strani lečečega zdravnika.
English: Determine the number of vials to be reconstituted based on the individual patient's dosage regimen and remove the vials from the refrigerator.
Slovenian: Število vial se določi na podlagi bolnikove individualne sheme odmerjanja.
English: Cerezyme 200 Units powder for concentrate for solution for infusion This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Slovenian: Cerezyme 200 enot prašek za koncentrat za raztopino za infundiranje To zdravilo vsebuje natrij in se aplicira v intravenski 0,9 % raztopini natrijevega klorida (glejte poglavje 6.6).
English: After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase per ml (200 U/5 ml).
Slovenian: Po rekonstituciji vsebuje raztopina 40 enot (približno 1,0 mg) imigluceraze na ml (200 e/5 ml).
English: Please contact your doctor if you would like to be treated at home.
Slovenian: Če se želite zdraviti doma, se posvetujte s svojim zdravnikom.
English: Before further dilution, visually inspect the reconstituted solution in each vial for foreign particles and discoloration.
Slovenian: Preden raztopino nadalje razredčite, preverite vsako vialo, ali raztopina ne vsebuje delcev in ali ni obarvana.
English: sodium chloride intravenous solution will retain chemical stability if stored up to 24 hours at 2°C and 8°C under protection from light; but microbiological safety will depend on the reconstitution and dilution having been performed aseptically.
Slovenian: Z 0,9 % raztopino natrijevega klorida za intravensko uporabo razredčeno zdravilo je kemično stabilno 24 ur pri temperaturi od 2 do 8ºC in zaščiteno pred svetlobo; mikrobiološka neoporečnost zdravila pa zavisi od uporabe aseptične tehnike pri pripravi in redčenju raztopine.
English: Therefore no conclusions on the effect of enzyme replacement therapy on the neurological manifestations of the disease can be drawn.
Slovenian: Učinkovitost zdravila Cerezyme pri nevroloških manifestacijah bolezni ni bila raziskana, zato ne moremo sklepati o učinku encimsko nadomestnega zdravljenja pri nevroloških manifestacijah bolezni.
English: Close monitoring of the pregnancy and clinical manifestations of Gaucher disease is necessary for the individualization of dose according to the patient's needs and therapeutic response.
Slovenian: Za individualizacijo odmerkov glede na bolnikove potrebe in odziv na zdravljenje je treba skrbno nadzirati nosečnost in klinične manifestacije Gaucherjeve bolezni.
English: One vial contains 200 units of imiglucerase.
Slovenian: Ena viala vsebuje 200 enot imigluceraze.
English: How Cerezyme is given
Slovenian: Kako vam bo zdravilo Cerezyme dano
English: Flushing*, hypotension*
Slovenian: hipotenzija*
English: One vial contains 400 units of imiglucerase.
Slovenian: Ena viala vsebuje 400 enot imigluceraze.
English: After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase per ml (400 U/10 ml).
Slovenian: Po rekonstituciji vsebuje raztopina 40 enot (približno 1,0 mg) imigluceraze na ml (400 e/10 ml).
English: Dyspnoea*, coughing*
Slovenian: Dispneja*, kašljanje*
English: Imiglucerase
Slovenian: - srbenje
English: After reconstitution, promptly dilute vials and do not store for subsequent use.
Slovenian: Raztopino, pripravljeno z vodo za injekcije, takoj razredčite in je ne shranjujte za naslednjo uporabo.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL / VIAL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: After reconstitution, each vial of Cerezyme contains 400 units of imiglucerase in 10.0 ml (40 units per ml).
Slovenian: Po pripravi raztopine ena viala zdravila Cerezyme vsebuje 400 enot imigluceraze v 10,0 ml (40 enot na ml).
English: The non-neurological manifestations of Gaucher disease include one or more of the following conditions:
Slovenian: Pri ne-nevroloških manifestacijah Gaucherjeve bolezni se pojavlja eden ali več naslednjih simptomov: • anemija, ko smo izključili druge vzroke zanjo, kot npr. pomanjkanje železa,
English: Cerezyme is supplied as a white to off-white powder.
Slovenian: Zdravilo Cerezyme je na voljo kot bel do belkast prašek.
English: Patients diagnosed with pulmonary hypertension, in particular, should receive adequate doses of Cerezyme to ensure control of underlying Gaucher disease as well as be evaluated for the need of additional pulmonary hypertension specific treatments.
Slovenian: Za bolnike z diagnozo pljučne hipertenzije še posebno velja, da morajo prejemati ustrezne odmerke zdravila
English: Cerezyme 200 Units Powder for concentrate for solution for infusion Cerezyme 400 Units Powder for concentrate for solution for infusion
Slovenian: Cerezyme 200 enot prašek za koncentrat za raztopino za infundiranje Cerezyme 400 enot prašek za koncentrat za raztopino za infundiranje
English: Patients should be advised to discontinue infusion of the product and contact their physician if these symptoms occur.
Slovenian: Če se našteti simptomi pojavijo, moramo infundiranje prekiniti, bolnik pa naj se posvetuje z zdravnikom.
English: Cerezyme 200 Units powder for concentrate for solution for infusion Each vial contains 200 units* of imiglucerase**.
Slovenian: Cerezyme 200 enot prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 200 enot* imigluceraze**.
English: Arthralgia, backache*
Slovenian: Artralgija, bolečine v hrbtu*
English: After reconstitution, each vial of Cerezyme contains 200 units of imiglucerase in 5.0 ml (40 units per ml).
Slovenian: Po pripravi raztopine ena viala zdravila Cerezyme vsebuje 200 enot imigluceraze v 5,0 ml (40 enot na ml).
English: Cerezyme 200 Units powder for concentrate for solution for infusion 2 years
Slovenian: Cerezyme 200 enot prašek za koncentrat za raztopino za infundiranje 2 leti
English: Medical or healthcare professionals are encouraged to register Gaucher patients, including those with chronic neuronopathic manifestations of the disease, in the “ICGG Gaucher Registry”.
Slovenian: vključno s tistimi s kroničnimi nevronopatskimi manifestacijami bolezni, v register 'ICGG Gaucher
English: Cerezyme 400 Units powder for concentrate for solution for infusion 3 years
Slovenian: Cerezyme 400 enot prašek za koncentrat za raztopino za infundiranje 3 leta
English: Any unused solution should be discarded.
Slovenian: Neuporabljeno raztopino zavrzite.
English: Cerezyme 400 Units powder for concentrate for solution for infusion Each vial contains 400 units* of imiglucerase**.
Slovenian: Cerezyme 400 enot prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 400 enot* imigluceraze**.
English: 25 vials of powder for concentrate for solution for infusion.
Slovenian: 25 vial praška za koncentrat za raztopino za infundiranje.
English: How Cerezyme is stored
Slovenian: Shranjevanje zdravila Cerezyme
English: There are no cases of overdose of Cerezyme reported.
Slovenian: Če ste uporabili večji odmerek zdravila Cerezyme, kot bi smeli Ni poročil o primerih prevelikega odmerjanja.
English: The reconstituted volume allows accurate withdrawal of 5.0 ml (equal to 200 units) from each vial.
Slovenian: Volumen pripravljene raztopine v eni viali zadošča za natančni odvzem nominalnega volumna, ki je 5,0 ml (ustreza 200 enotam).
English: The product diluted in 0.9%
Slovenian: Plazemski očistek je znašal 9,8 do
English: The reconstituted volume allows accurate withdrawal of 10.0 ml (equal to 400 units) from each vial.
Slovenian: Volumen pripravljene raztopine v eni viali zadošča za natančni odvzem nominalnega volumna, ki je 10,0 ml (ustreza 400 enotam).
English: In a study investigating 2 cohorts of patients treated with a median dose of 80 U/kg body weight every 4 weeks and a median dose of 30 U/kg body weight every 4 weeks, among the patients with bone marrow burden score ≥ 6, more patients in the higher dose cohort (33%; n=22) achieved a decrease in the score of 2 points after 24 months of Cerezyme treatment compared with patients in the lower dose cohort (10%; n=13) (de Fost et al, 2006).
Slovenian: V študiji z 2 skupinama bolnikov, ki so jih zdravili s povprečnim odmerkom v višini 80 enot/kg telesne mase na vsake 4 tedne in povprečnim odmerkom v višini 30 enot/kg telesne mase na vsake 4
English: 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.
Slovenian: Cerezyme 400 enot prašek za koncentrat za raztopino za infundiranje Prašek v eni viali raztopite s 10,2 ml vode za injekcije.
English: Instructions for use - reconstitution, dilution and administration Each vial of Cerezyme is for single use only.
Slovenian: Navodila za uporabo - priprava raztopine, redčenje in dajanje
English: 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).
Slovenian: Za to manifestacijo ne moremo priporočiti posebnega režima odmerjanja (glejte poglavje 5.1).
English: What you need to know before you are given Cerezyme.
Slovenian: Kaj je zdravilo Cerezyme in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Cerezyme Kako vam bo zdravilo Cerezyme dano
English: Cerezyme 400 Units powder for concentrate for solution for infusion The reconstituted solution contains 40 units imiglucerase per ml.
Slovenian: Cerezyme 400 enot prašek za koncentrat za raztopino za infundiranje Pripravljena raztopina vsebuje 40 enot imigluceraze/ml.
English: 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.
Slovenian: Cerezyme 200 enot prašek za koncentrat za raztopino za infundiranje Prašek v eni viali raztopite s 5,1 ml vode za injekcije.
English: Cerezyme 400 Units Powder for concentrate for solution for infusion imiglucerase
Slovenian: Cerezyme 400 enot prašek za koncentrat za raztopino za infundiranje imigluceraza
English: The reconstituted solution contains 40 units imiglucerase per ml.
Slovenian: Pripravljena raztopina vsebuje 40 enot imigluceraze/ml.
English: UNIQUE IDENTIFIER - 2D BARCODE
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
English: Then dilute the combined volumes with 0.9% sodium chloride intravenous solution to a total volume of 100 to 200 ml.
Slovenian: 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.
English: Cerezyme 200 Units Powder for concentrate for solution for infusion imiglucerase
Slovenian: Cerezyme 200 enot prašek za koncentrat za raztopino za infundiranje imigluceraza
English: • thrombocytopenia
Slovenian: • trombocitopenija,
English: Immune system disorders Hypersensitivity reactions
Slovenian: Bolezni imunskega sistema
English: Dilution
Slovenian: Dojenje
English: - The other ingredients are: mannitol, sodium citrate, citric acid monohydrate and polysorbate 80.
Slovenian: Po rekonstituciji vsebuje raztopina 40 enot imigluceraze na ml. - Druge sestavine so: manitol, natrijev citrat, citronska kislina monohidrat, polisorbat 80.
English: Cerezyme is a white to off-white powder.
Slovenian: prašek za koncentrat za raztopino za infundiranje Zdravilo Cerezyme je prašek bele oz. umazano bele barve.
English: Do not use vials exhibiting foreign particles or discoloration.
Slovenian: Vial, v katerih opazite delce, in tistih, v katerih se je raztopina obarvala, ne smete uporabiti.
English: Sanofi S.p.A. Tel: +39 059 349 811
Slovenian: Tel: +39 059 349 811
English: Contents of the pack and other information .
Slovenian: 5 Shranjevanje zdravila Cerezyme Vsebina pakiranja in dodatne informacije
English: 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
Slovenian: - izpuščaji/lokalizirano otekanje kože ali obloge v ustih ali grlu
English: EU/1/08/494/005 STELARA 130 mg Concentrate for solution for infusion
Slovenian: 130 mg koncentrat za raztopino za infundiranje
English: Intravenous use vial (glass)
Slovenian: Za intravensko uporabo (steklena) viala 26 ml (5 mg/ml)
English: The quantity of ImmunoGam you will need will be determined by your doctor or nurse.
Slovenian: Količino zdravila ImmunoGam, ki jo potrebujete, določita vaš zdravnik ali medicinska sestra.
English: Hypersensitivity to any of the components.
Slovenian: Preobčutljivost za katerokoli sestavino.
English: Manufacturer Cangene Corporation 155 Innovation Drive Winnipeg, MA R3T 5Y3
Slovenian: Izdelovalec Cangene Corporation 155 Innovation Drive Winnipeg, MA R3T 5Y3
English: This should be taken into account in patients with
Slovenian: To je treba upoštevati pri bolnikih s
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF
Slovenian: • POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: Ask your doctor for advice before using this medicine.
Slovenian: Posvetujte se z zdravnikom, preden uporabite to zdravilo.
English: The following side effect can be serious and has been observed occasionally.
Slovenian: Neželeni učinek je lahko resen in je bil opažen v posameznih primerih.
English: • There are no available data on drug interactions of ImmunoGam with other medications.
Slovenian: • Ni razpoložljivih podatkov o interakcijah zdravila ImmunoGam z drugimi zdravili.
English: 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).
Slovenian: 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).
English: • Immunoglobulin A: Please tell your doctor if your blood does not have immunoglobulin A (IgA).
Slovenian: • Imunoglobulin A: obvestite zdravnika, če vaša kri ne vsebuje imunoglobulina A (IgA).
English: [Justification for not including Braille accepted]
Slovenian: [Sprejeta je utemeljitev, da Braillova pisava ni potrebna]
English: The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials.
Slovenian: Varnost tega zdravila pri nosečnicah ni bila preverjena v kontroliranih, kliničnih preskušanjih.
English: 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.
Slovenian: 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.
English: • Allergic reaction: There is a chance that you may experience an allergic reaction after administration of this medicine.
Slovenian: • Alergijska reakcija: Obstaja možnost, da se po uporabi tega zdravila pri vas pojavi alergijska reakcija.
English: Immunoglobulins are normal constituents of the human body.
Slovenian: Imunoglobulini so normalne sestavine človeškega telesa.