natgillin/translations-raw huggingface dataset:
Medicinal product not subject to medical prescription.
Izdaja zdravila je brez recepta v lekarnah.
In the 2-year rodent studies an increased number of liver tumors was observed in rats (in one rat study only) and in female mice and was interpreted as being due to pantoprazole's high metabolic rate in the liver.
V 2-letnih študijah pri glodavcih so pri podganah (samo v 1 študiji) in pri mišjih samicah opazili povečano število jetrnih tumorjev, kar naj bi bila posledica močno povečanega presnavljanja
Coating: hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer, sodium lauril sulfate, polysorbate 80, triethyl citrate.
- Obloga: hipromeloza, povidon, titanov dioksid (E171), rumeni železov oksid (E172), propilenglikol, kopolimer metakrilne kisline in etilakrilata, natrijev lavrilsulfat, polisorbat 80 in trietilcitrat.
Patients should not take another proton pump inhibitor or H2 antagonist concomitantly.
Bolniki sočasno ne smejo jemati drugega zaviralca protonske črpalke ali antagonista histaminskih
What PANTECTA Control contains - The active substance is pantoprazole.
Kaj vsebuje zdravilo PANTECTA Control - Zdravilna učinkovina je pantoprazol.
This medicine may not bring immediate relief.
To zdravilo vam morda ne bo prineslo
PANTECTA Control is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila PANTECTA Control pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.
What PANTECTA Control is and what it is used for What you need to know before you take PANTECTA Control How to take PANTECTA Control Possible side effects
Kaj je zdravilo PANTECTA Control in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo PANTECTA Control
You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with PANTECTA Control, but this medicine is not meant to bring immediate relief.
Simptomi kislega refluksa in zgage se lahko ublažijo že po enem dnevu zdravljenja z zdravilom PANTECTA Control, vendar pa to zdravilo ni namenjeno za dosego takojšnjega olajšanja.
In animal studies (rats) 5 mg/kg was the observed NOAEL (No Observed Adverse Effect Level) for embryotoxicity.
Koncentracija, pri kateri ni mogoče opaziti neželenih učinkov (NOAEL; “No Observed Adverse Effect Level”), je v študijah pri živalih (podgane) za embriotoksičnost znašala 5 mg/kg.
- Frequency not known: hallucination, confusion (especially in patients with a history of these symptoms); decreased level of sodium in blood; decreased level of magnesium in blood.
- Pogostnost neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): halucinacije, zmedenost (še posebej pri bolnikih, ki so te bolezenske znake že imeli), zmanjšanje vrednosti natrija v krvi, zmanjšanje vrednosti magnezija v krvi.
If you have been suffering from repetitive heartburn or indigestion symptoms for some time, remember to see your doctor regularly.
Če ponavljajoča se zgaga in dispeptične težave trajajo že nekaj časa, morate redno obiskovati svojega
Printing ink
Tiskarsko črnilo šelak
If you take more PANTECTA Control than you should Tell your doctor or pharmacist if you have taken more than the recommended dose.
Če ste vzeli večji odmerek zdravila PANTECTA Control, kot bi smeli Če ste vzeli večji odmerek zdravila PANTECTA Control, kot bi smeli, o tem obvestite svojega zdravnika ali farmacevta.
Posology The recommended dose is 20 mg pantoprazole (one tablet) per day.
Priporočeni odmerek je 20 mg pantoprazola (ena tableta) na dan.
Special populations No dose adjustment is necessary in elderly patients or in those with impaired renal or liver function.
Pri starejših bolnikih in bolnikih z okvaro delovanja ledvic ali jeter odmerka ni treba prilagajati.
Core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate.
- Pomožne snovi so: - Jedro: brezvodni natrijev karbonat, manitol, krospovidon, povidon K90 in kalcijev stearat.
PANTECTA Control 20 mg gastro-resistant tablets
PANTECTA Control 20 mg gastrorezistentne tablete
Printing ink: shellac, red, black and yellow iron oxide (E172) and ammonia solution, concentrated.
- Tiskarsko črnilo: šelak, rdeči, črni in rumeni železov oksid (E 172) ter koncentrirana
PANTECTA Control 20 mg gastro-resistant tablets Pantoprazole
PANTECTA Control 20 mg gastrorezistentne tablete pantoprazol
There was no evidence of impaired fertility following the administration of pantoprazole in animal studies (see section 5.3).
Pri študijah na živalih uporaba pantoprazola ni vplivala na plodnost (glejte poglavje 5.3).
Do not take a double dose to make up for the forgotten dose.
Če ste pozabili vzeti zdravilo PANTECTA Control Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
You may need further blood tests - methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate your doctor may temporarily stop your PANTECTA Control treatment because pantoprazole can increase levels of methotrexate in the blood.
Če jemljete metotreksat, lahko zdravnik začasno prekine zdravljenje z zdravilom PANTECTA Control, saj lahko pantoprazol zviša vrednosti metotreksata v krvi.
Especially medicines containing one of the following active substances: - atazanavir (used to treat HIV-infection).
Zdravilo PANTECTA Control lahko vpliva na delovanje nekaterih drugih zdravil, še posebej zdravil, ki vsebujejo naslednje zdravilne učinkovine: - atazanavir (uporabljamo ga za zdravljenje okužbe z virusom HIV).
Therefore, pantoprazole must not be co-administered with atazanavir (see section 4.3).
Absorpcija atazanavirja je odvisna od pH. Zaradi tega se pantoprazola ne sme uporabljati sočasno z atazanavirjem (glejte poglavje 4.3).
Musculoskeletal and connective tissue disorders
Bolezni mišičnoskeletnega sistema in vezivnega tkiva artralgija, mialgija
- Uncommon side effects(may affect up to 1 in 100 people): headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; bellyache and discomfort; skin rash or hives; itching; feeling weak, exhausted or generally unwell; sleep disorders; increase in liver enzymes in a blood test.
- Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): glavobol, omotica, driska, siljenje na bruhanje, bruhanje, napihnjenost in vetrovi, zaprtost, suha usta, bolečina in neugodje v predelu trebuha, kožni izpuščaj ali koprivnica, srbenje, oslabelost, izčrpanost ali splošno slabo počutje, motnje spanja, zvišane vrednosti jetrnih encimov pri krvni
What PANTECTA Control looks like and contents of the pack The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on one side.
Izgled zdravila PANTECTA Control in vsebina pakiranja Gastrorezistentne tablete so rumene, ovalne, obojestransko izbočene filmsko obložene tablete z Zdravilo PANTECTA Control je na voljo v Alu/Alu pretisnih omotih s kartonsko oporo ali brez nje.
Tablets should be swallowed whole.
Tablete je treba pogoltniti cele skupaj s tekočino pred obrokom.
PANTECTA Control is used for the short-term treatment of reflux symptoms (for example heartburn, acid regurgitation) in adults.
Zdravilo PANTECTA Control uporabljamo za kratkotrajno zdravljenje simptomov refluksa (na primer zgaga, regurgitacija kisline) pri odraslih.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines PANTECTA Control may stop certain other medicines from working properly.
Druga zdravila in zdravilo PANTECTA Control Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
- If you get any side effects , talk to your doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali s farmacevtom.
PANTECTA Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.
PANTECTA Control 20 mg gastrorezistentnih tablet se ne sme žvečiti ali drobiti.
PANTECTA Control should not be used by children and adolescents under 18 years of age due to a lack of safety information in this younger age group..
Zdravila PANTECTA Control ne smejo jemati otroci in mladostniki, mlajši od 18 let.
PANTECTA Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Zdravilo PANTECTA Control je indicirano za kratkotrajno zdravljenje simptomov refluksa (npr. zgaga, regurgitacija kisline) pri odraslih.
spearmint, fatty and fried food, acidic food, spicy food, citrus fruits and fruit juices, tomatoes.
poprova meta, zelena meta, mastne in ocvrte jedi, kisla hrana, začinjena hrana, agrumi, sadni
Titanium dioxide (E171) Yellow iron oxide (E172) Propylene glycol
titanov dioksid (E171) rumeni železov oksid (E172) propilenglikol kopolimer metakrilne kisline in etilakrilata (1:1) natrijev lavrilsulfat polisorbat 80 trietilcitrat
Patients should not take pantoprazole as a preventive medicinal product.
Bolniki pantoprazola ne smejo
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila
Other medicines and PANTECTA Control
Zdravila PANTECTA
PANTECTA Control has no or negligible influence on the ability to drive and use machines.
Zdravilo PANTECTA Control nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji, vendar pa se lahko pojavijo neželeni učinki, kot so omotica in motnje vida (glejte poglavje 4.8).
Pantoprazole is converted to its active form, a cyclic sulphenamide, in the acidic environment in the parietal cells where it inhibits the H+, K+-ATPase enzyme, i. e. the final stage in the production of hydrochloric acid in the stomach.
Pantoprazol se v svojo aktivno obliko, ciklični sulfenamid, pretvori v kislem okolju parietalnih celic,
Sodium carbonate, anhydrous Mannitol (E421) Crospovidone
manitol (E421) krospovidon povidon K90 kalcijev stearat
Do not chew or break the tablet.
- Izogibajte se tesno oprijetim oblačilom ali nošenju pasov.
Pharmacotherapeutic group: : Drugs for acid related disorders,Proton pump inhibitors, ATC code: A02BC02
Farmakoterapevtska skupina: zdravila za kislinsko pogojene bolezni, zaviralci protonske črpalke,
Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease: - an unintentional loss of weight (not related to a diet or an exercise programme) - vomiting, particularly if repeated - vomiting blood; this may appear as dark coffee grounds in your vomit - you notice blood in your stools; which may be black or tarry in appearance - difficulty in swallowing or pain when swallowing - you look pale and feel weak (anaemia) - chest pain - stomach pain - severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.
Takoj obvestite svojega zdravnika, če pred ali po jemanju tega zdravila opazite katerega koli od spodaj navedenih simptomov, ki so lahko znaki druge, resnejše bolezni: - nenamerno izgubljanje telesne mase (ki ni posledica diete ali telesne vadbe),
Do not take PANTECTA Control tablets for more than 4 weeks without consulting your doctor.
Če se znaki bolezni ne izboljšajo po 2 tednih neprekinjenega jemanja tega zdravila, se posvetujte z Ne jemljite tablet PANTECTA Control več kot 4 tedne brez posveta pri zdravniku.
Stop taking PANTECTA Control when you are completely symptom-free.
Ko simptomi bolezni popolnoma minejo, zdravilo PANTECTA Control nehajte jemati.
Gastrointestinal disorders
Motnje ginekomastija
If you have no symptom-relief after taking this medicine for 2 weeks continuously, consult your doctor.
Če se znaki vaše bolezni poslabšajo ali ne izboljšajo v 2 tednih, se posvetujte z zdravnikom.
The recommended dose is one tablet a day.
Priporočeni odmerek je ena tableta na dan. Priporočenega odmerka 20 mg pantoprazola enkrat na dan
Your doctor may decide that you need some tests.
Morda bodo potrebne nadaljnje krvne preiskave.
TAKEDA ΕΛΛΑΣ Α.Ε Τηλ: +30 210 6729570 gr.info@takeda.com
Takeda Nycomed AS Tlf: + 47 6676 3030 infonorge@takeda.com
Pantoprazole should not be used during pregnancy.
Pantoprazola ne smete uporabljati
Oral use.
- Navodilo shranite.
The main measure of effectiveness was the reduction in the number of attacks.
Glavno merilo učinkovitosti je bilo zmanjšanje števila napadov.
Based on the information presented to the Committee, it was not clear whether this was due to the way the study was designed, the way the results were analysed, or to the medicine itself.
Glede na informacije, ki so bile predstavljene Odboru, ni bilo jasno, ali zaradi načina, na katerega je bila študija oblikovana, načina analize rezultatov ali zdravila samega.
Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
Interferoni so naravne snovi, ki jih proizvaja telo za obrambo proti napadom, kot so okužbe, ki jih povzročajo virusi.
Relapsing-remitting means that the patient has attacks (relapses) followed by periods with milder symptoms (remission).
Recidivno-remitentna pomeni, da ima bolnik napade (relapse), ki jim sledijo obdobja blažjih simptomov (remisije).
The company had requested a re-examination of the negative opinion, but this re-examination had not yet finished when the company withdrew.
Družba je zahtevala ponovno proučitev negativnega mnenja, ki pa še ni bila zaključena, ko se je odločila za umik svoje vloge.
It was to be available in prefilled syringes.
Na voljo naj bi bilo v napolnjenih injekcijskih brizgah.
Multiple sclerosis is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves.
Multipla skleroza je obolenje živcev, pri kateri vnetje uniči zaščitni ovoj okrog njih.
In contrast to these medicines, Biferonex is made in such a way that it does not contain the human blood protein, albumin.
V nasprotju s tema zdraviloma je zdravilo Biferonex proizvedeno tako, da ne vsebuje človeške krvne beljakovine, albumina.
Biferonex was intended for patients who had experienced two or more attacks in the previous two years.
Zdravilo Biferonex je bilo namenjeno bolnikom, ki so imeli dva ali več napadov v preteklih dveh letih.
The effects of Biferonex were first tested in experimental models before being studied in humans.
Učinki zdravila Biferonex so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Each patient received either Biferonex or placebo for two years.
Bolniki so dve leti prejemali bodisi zdravilo Biferonex ali placebo.
The company also used information relating to Avonex, and information from the published literature on other medicines containing interferon beta.
Družba je uporabila tudi informacije o zdravilu Avonex ter informacije iz objavljene literature o drugih zdravilih, ki vsebujejo interferon beta.
Biferonex contains the same active substance as other medicines called Avonex and Rebif, which have been authorised in the European Union since 1997 and 1998, respectively.
Zdravilo Biferonex vsebuje enako zdravilno učinkovino, kot drugi dve zdravili, imenovani Avonex in Rebif, odobreni v Evropski uniji leta 1997 oziroma 1998.
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Biferonex?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Biferonex?
It therefore concluded that using the published studies on these interferon beta-containing medicines to support the use of Biferonex was not justified, and that studies on Biferonex itself were required.
Zato je zaključil, da uporaba objavljenih študij teh zdravil, ki vsebujejo interferon beta, v podporo uporabi zdravila Biferonex ni bila upravičena ter da so bile študije zdravila Biferonex potrebne.
Biferonex is expected to work by modulating the activity of the immune system (the body's natural defences) and preventing relapses of multiple sclerosis.
Zdravilo Biferonex naj bi delovalo s spreminjanjem delovanja imunskega sistema (naravnega obrambnega mehanizma telesa) ter s preprečevanjem relapsov multiple skleroze.
The company presented the results of one main study, in which Biferonex was compared with placebo (a dummy treatment) in 339 adults with relapsing-remitting multiple sclerosis.
Družba je predstavila rezultate ene glavne študije, v kateri so zdravilo Biferonex primerjali s placebom (zdravilom brez zdravilne učinkovine) pri 339 odraslih z recidivno-remitentno multiplo sklerozo.
The CHMP was also of the opinion that the results of the single pivotal study of Biferonex did not show enough evidence that the medicine was effective.
CHMP je menil tudi, da rezultati ene same osrednje študije zdravila Biferonex niso v zadostni meri dokazali, da je zdravilo učinkovito.
What is Biferonex?
Kaj je zdravilo Biferonex?
On 28 May 2009, BioPartners GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Biferonex, for the treatment of relapsing-remitting multiple sclerosis.
Družba BioPartners GmbH je dne 28. maja 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Biferonex, namenjeno zdravljenju recidivno-remitentne multiple skleroze.
Questions and answers on the withdrawal of the marketing authorisation application for Biferonex interferon beta-1a
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Biferonex
Interferon beta-1a is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce interferon beta-1a.
Interferon beta-1b proizvajajo z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri celica prejme gen (DNK), s katerim lahko tvori interferon beta-1a.
Biferonex was expected to be used to treat adults with relapsing-remitting multiple sclerosis.
Zdravilo Biferonex naj bi se uporabljalo za zdravljenje odraslih z recidivno-remitentno multiplo sklerozo.
At the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Biferonex for the treatment of relapsing-remitting multiple sclerosis.
V času umika je CHMP izrazil negativno mnenje, v katerem priporoča zavrnitev dovoljenja za promet z zdravilom Biferonex za zdravljenje recidivno-remitentne multiple skleroze.
The company informed the CHMP that there are no clinical trials or compassionate use programmes ongoing with Biferonex.
Družba je obvestila CHMP, da klinična preizkušanja ali programi sočasne uporabe z zdravilom Biferonex ne potekajo.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Biferonex in the treatment of patients with relapsing-remitting multiple sclerosis did not outweigh its risks.
Zato je v času umika CHMP menil, da učinki zdravila Biferonex pri zdravljenju bolnikov z recidivnoremitentno multiplo sklerozo niso odtehtali tveganj, povezanih s tem zdravilom.
The Committee noted that there were differences between the active substance in Biferonex and other interferon beta-containing medicines available on the market.
Odbor je ugotovil, da so bile razlike med zdravilno učinkovino v zdravilu Biferonex in preostalimi zdravili, ki so na voljo na trgu in vsebujejo interferon beta.
The active substance in Biferonex, interferon beta-1a, belongs to the group ‘interferons'.
Zdravilna učinkovina zdravila Biferonex, interferon beta-1a, spada v skupino „interferonov“.
The interferon beta-1a in Biferonex acts in the same way as naturally produced interferon beta.
Interferon beta-1a v zdravilu Biferonex deluje enako kot naravno proizvedeni interferon beta.
Biferonex is a solution for injection that contains the active substance interferon beta-1a.
Zdravilo Biferonex je raztopina za injiciranje, ki vsebuje zdravilno učinkovino interferon beta-1a.
What was Biferonex expected to be used for?
Za kaj naj bi se zdravilo Biferonex uporabljalo?
How is Biferonex expected to work?
Kako naj bi zdravilo Biferonex delovalo?
Date of first authorization: 19 January 2006 Date of latest renewal: 06 December 2010
Datum prve odobritve: 19. januar 2006 Datum zadnjega podaljšanja: 06. december 2010
If this happens, you should wait until the reactions have disappeared.
Če se to zgodi, počakajte, da reakcije izzvenijo.
*CI - Confidence Interval
*IZ (Confidence Interval) interval zaupanja
4.5 Interactions with other medicinal products and other forms of interactions
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
The listed interactions apply both to adults and children.
Navedene interakcije se nanašajo na odrasle in otroke.
Adolescents (13 to 17 years)
Mladostniki (od 13 do 17 let)
Secondary immunodeficiencies (as defined in 4.1.)
Sekundarne imunske pomanjkljivosti (kot je opredeljeno v 4.1)
The treatment effect should be evaluated after each cycle; if no treatment effect is seen after 6 months, the treatment should be discontinued.
Učinek zdravljenja je treba ovrednotiti po vsakem ciklu; če po 6 mesecih zdravljenje nima vidnega učinka, je treba zdravljenje prekiniti.
Children (12 years or below)
Otroci (12 let ali manj)
Therefore, your baby may be protected from certain infections.
Vaš otrok bo torej morda tudi zavarovan pred določenimi okužbami.
Pharmacokinetic parameters for KIOVIG were determined in the two clinical studies in PID patients performed in Europe and the US.
Farmakokinetične parametre zdravila KIOVIG so določili v dveh kliničnih študijah pri bolnikih s PID, opravljenih v Evropi in ZDA.
These medicines contain human antibodies, which are also present in your blood.
Ta zdravila vsebujejo človeška protitelesa, ki so tudi v vaši krvi.
The median IgG half-life after administration of KIOVIG was 32.5 days.
Mediana vrednost razpolovne dobe IgG po dajanju zdravila KIOVIG je bila 32,5 dni.
Congenital AIDS
Kongenitalni AIDS
Other routes of administration have not been evaluated.
Drugih poti uporabe niso ovrednotili.
Your doctor will choose the appropriate intravenous immunoglobulin for you.
Vaš zdravnik bo izbral primeren intravenski imunoglobulin za vas.
The values obtained in the studies are comparable to parameters reported for other human immunoglobulins.
Vrednosti, ugotovljene v študijah, so primerljive s parametri za druge humane imunoglobuline.
The safety of KIOVIG has been demonstrated in several non-clinical studies.
Varnost zdravila KIOVIG so pokazali v več nekliničnih študijah.
Distribution of IgG subclasses (approx. values):
Porazdelitev podrazredov IgG (približne vrednosti):
All parameters were analysed separately for three age groups, children (below 12 years, n=5), adolescents (13 to 17 years, n=10), and adults (above 18 years of age, n=64).
Vse parametere so analizirali ločeno za tri starostne skupine, otroke (mlajše od 12 let, n=5), mladostnike (od 13 do 17 let, n=10), in odrasle (starejše od 18 let, n=64).
No evidence is available to require a dose adjustment.
Dokazov o tem, da bi bila potrebna prilagoditev odmerka, ni na voljo.
Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Pogostnosti so bile ovrednotene po naslednjih dogovorjenih kriterijih: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10 000); neznani (ocena pogostnosti iz razpoložljivih podatkov ni možna).
if you are allergic to immunoglobulins or to any other ingredients of this medicine (listed in section 6).
če ste alergični na imunoglobuline ali katero koli sestavino tega zdravila (navedeno v poglavju 6).