natgillin/translations-raw huggingface dataset:
Examples of such circumstances are:
Taki primeri so:
What kind of monitoring is required during the infusion?
Kakšno nadziranje je potrebno med infundiranjem?
Read this section carefully.
Prosimo, da pozorno preberete to poglavje.
Of these, 72 completed the 12 months of treatment.
Od njih jih je 72 končalo 12-mesečno zdravljenje.
• If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
• Če predložitev PSUR in posodobitev RMP sovpadata, se ju lahko predloži istočasno.
Stability after first opening:
Obstojnost po prvem odprtju:
The following dose regimens are given as a guideline.
Naslednji režimi odmerjanja so podani kot smernice.
*Produced from the plasma of human donors.
*Izdelano iz plazme človeških darovalcev.
Which circumstances increase the risk of having side effects?
Katere okoliščine povečajo tveganje za nastanek neželenih učinkov?
In certain circumstances, special precautions may be necessary.
V nekaterih primerih bodo nujni posebni previdnostni ukrepi.
IgG and IgG complexes are broken down in the cells of the reticuloendothelial system.
IgG in kompleksi IgG se razgradijo v celicah retikuloendotelijskega sistema.
In case of shock, standard medical treatment for shock should be implemented.
V primeru šoka je potrebno standardno zdravljenje za šok.
The approximate percentage of IgG subclasses is as follows:
Približni odstotek podrazredov IgG je naslednji:
Privigen is used for the treatment of adults and children (0-18 years) in the following situations:
Zdravilo Privigen se uporablja za zdravljenje odraslih in otrok (0-18 let) v naslednjih primerih:
It is usually prepared from pooled plasma from not fewer than 1,000 donors.
Navadno se pripravlja iz zbirov plazme od vsaj 1000 darovalcev.
Very Common (may occur with more than 1 in 10 patients):
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
*The dose is based on the dose used in the clinical studies conducted with Privigen.
*Odmerek temelji na odmerku, ki je bil uporabljen v kliničnih študijah, izvedenih z zdravilom Privigen.
If insufficient treatment effect is seen after 6 months, the treatment should be discontinued.
Če se po 6 mesecih ugotovi, da je učinek zdravljenja nezadosten, je treba zdravljenje prekiniti.
Frequencies were evaluated according to the following conventions: 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).
Pogostnosti so bile ocenjene po naslednjem dogovoru: 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).
You must not take it if you suffer from hyperprolinaemia (see also section 2 “What you need to know before you are given Privigen”).
Zdravila ne jemljite, če imate hiperprolinemijo (glejte tudi poglavje 2 "Kaj morate vedeti, preden boste prejeli zdravilo Privigen").
All other patients should be observed for at least 20 minutes after administration.
Vse druge bolnike je potrebno opazovati vsaj 20 minut po dajanju.
For instruction, see section 6.6.
Za navodila glejte poglavje 6.6.
• you are receiving Privigen for the first time or after a long break in treatment (e.g. several months).
● zdravilo Privigen prejemate prvič ali pa zdravilo Privigen prejemate po dolgi prekinitvi zdravljenja (na primer po več mesecih).
If this happens, you should not drive or use machines until these effects have disappeared.
V tem primeru ne upravljajte vozila ali strojev, dokler učinki ne izzvenijo.
Anyone experiencing such symptoms should immediately be transported to a hospital emergency room for evaluation and treatment.
Vsakega bolnika, ki ima te simptome, je treba takoj prepeljati v urgentno enoto bolnišnice za oceno simptomov in zdravljenje.
In these cases you will be closely observed during the whole infusion and for at least 1 hour afterwards.
V teh primerih vas bodo skrbno opazovali med celotnim infundiranjem in vsaj še eno uro po njem.
This may happen particularly if you are a patient at risk, for example if you are elderly or if you suffer from a heart or kidney disease.
To se lahko zgodi predvsem, če ste bolnik s tveganjem, na primer, če ste starejša oseba ali imate srčno ali ledvično bolezen.
It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3-5 days equilibrium is reached between the intra- and extravascular compartments.
Relativno hitro se porazdeli med plazmo in ekstravaskularno tekočino, in po približno 3-5 dneh doseže ravnovesje med intra- in ekstravaskularnimi predeli.
• increase in blood creatinine level,
• zvišani ravni kreatinina v krvi,
This also applies to any unknown or emerging viruses and other types of infections.
To velja tudi za katere koli neznane ali nove viruse ter druge vrste okužb.
The dose calculation for children and young patients is not different from that for adults.
Izračun odmerka za otroke in mlade bolnike se ne razlikuje od izračuna za odrasle.
Adequate doses of this medicinal product may restore abnormally low immunoglobulin G levels to the normal range.
Ustrezni odmerki tega zdravila lahko vrnejo nenormalno nizko raven imunoglobulina G na normalno vrednost.
The two CIDP studies were performed with 28 and 207 patients, respectively.
Dve študiji CIDP sta bili opravljeni pri 28 in 207 bolnikih.
The treatment required depends on the nature and severity of the adverse reaction.
Potrebno zdravljenje je odvisno od narave in resnosti neželenih učinkov.
L-proline is a physiological, nonessential amino acid.
L-prolin je fiziološka, neesencialna aminokislina.
Solution for infusion (10%) Contains 1 vial.
Raztopina za infundiranje (10 %) Vsebuje 1 vialo.
This medicinal product must not be mixed with other medicinal products except those mentioned in the section below.
Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v spodnjem poglavju.
B) to treat certain inflammatory disorders (immunomodulation).
B) Zdravljenje nekaterih vnetnih motenj (imunomodulacija).
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
In post marketing reports it is observed that the proportion of haemolysis cases to all case reports occurring in children is slightly higher than in adults.
V poročilih iz obdobja trženja so opazili, da je delež primerov hemolize za vse poročane primere, ki so se pojavili pri otrocih nekoliko višji kot pri odraslih.
12.3 (10.4-18.8) (3-week schedule) 9.4 (7.3-13.2) (4-week schedule)
12,3 (10,4-18,8) (3-tedenski urnik) 9,4 (7,3-13,2) (4-tedenski urnik)
Secondary immunodeficiencies (as defined in 4.1)
Sekundarna imunska pomanjkljivost (kot je opredeljeno v poglavju 4.1)
It is characterised by inflammation of blood vessels throughout the body.
Zanjo je značilno vnetje krvnih žil po celem telesu.
If you tolerate this well, your doctor can gradually increase the infusion rate.
Če ga boste dobro prenašali, bo zdravnik postopoma povečal hitrost infundiranja.
Privigen does not contain sucrose, maltose or glucose.
Zdravilo Privigen ne vsebuje saharoze, maltoze ali glukoze.
Overdose is very unlikely to occur because Privigen is usually administered under medical supervision.
Ni verjetno, da bo prišlo do prevelikega odmerjanja, ker se zdravilo Privigen običajno daje samo pod zdravniškim nadzorom.
Solution for infusion (10%)
Raztopina za infundiranje (10 %)
If you receive Privigen while you are breast-feeding the antibodies in this medicine will also be found in the breast milk.
Če prejmete zdravilo Privigen, ko dojite, bodo protitelesa tega zdravila tudi v materinem mleku.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
For your personal safety, treatment with Privigen will take place under the supervision of your doctor or healthcare professional.
Zaradi vaše osebne varnosti, bo zdravljenje z zdravilom Privigen potekalo pod nadzorom zdravnika ali zdravstvenega delavca.
Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Bolnike je treba skrbno spremljati in opazovati, če se pojavijo kateri koli simptomi med celotnim časom infundiranja.
Such vaccinations should be postponed for at least 3 months after the last infusion of Privigen.
Tako cepljenje je treba odložiti za vsaj tri mesece po zadnjem infundiranju zdravila Privigen.
• Do not use this medicine if you notice that the solution is cloudy or contains particles floating within the solution.
• Ne uporabljajte tega zdravila, če opazite, da je raztopina motna ali vsebuje delce.
Patients should receive concomitant treatment with acetylsalicylic acid.
Bolniki se morajo sočasno zdraviti z acetilsalicilno kislino.
Although Privigen does not contain sugar, it may be diluted with a special sugar solution (5% glucose), which could affect your blood sugar level.
Čeprav zdravilo Privigen ne vsebuje sladkorja, ga je mogoče razredčiti s posebno sladkorno raztopino (5 % glukoza), kar lahko vpliva na vašo raven sladkorja v krvi.
Some published studies pertaining to hyperprolinaemia have shown that longterm, high doses of L-proline have effects on brain development in very young rats.
Nekatere objavljene študije v zvezi s hiperprolinemijo so pokazale, da dolgotrajna uporaba velikih odmerkov L-prolina vpliva na razvoj možganov pri zelo mladih podganah.
You will usually be observed during the whole infusion and for at least 20 minutes thereafter.
Navadno vas bodo opazovali med celotnim infundiranjem in vsaj še 20 minut po njem.
In these rare cases allergic reactions such as a sudden fall in blood pressure or shock may occur (see also section 4 “Possible side effects”).
V teh redkih primerih alergijskih reakcij se lahko pojavi nenaden padec krvnega tlaka ali šok (glejte tudi poglavje 4 "Možni neželeni učinki").
• You may be allergic (hypersensitive) to immunoglobulins without knowing it.
• Morda ste alergični (preobčutljivi) na imunoglobuline, pa tega ne veste.
• You are diabetic.
● Ste sladkorni bolnik.
Within each frequency grouping, undesirable effects are presented in order of decreasing frequency.
Znotraj vsake skupine pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Tell your doctor or healthcare professional if you are using, have recently used or might use any other medicines.
Obvestite svojega zdravnika ali zdravstvenega delavca, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
Patients with hyperprolinaemia type I or II.
Bolniki s hiperprolinemijo tipa I ali II.
If, in spite of this, you receive more Privigen than you should, your blood may become too thick (hyperviscous) which might increase the risk of developing blood clots.
Če kljub temu prejmete več zdravila Privigen, kot bi smeli, lahko kri postane pregosta (hiperviskozna) kar lahko poveča tveganje za nastanek krvnih strdkov.
This medicinal product must not be mixed with other medicinal products, diluents, or solvents except those mentioned in section 6.6.
Zdravila ne smemo mešati z drugimi zdravili, redčili ali vehikli, razen s tistimi, ki so omenjeni v poglavju 6.6.
CSL Behring (Australia) Pty Ltd 189-209 Camp Road Broadmeadows, Vic 3047, Australia
CSL Behring (Australia) Pty Ltd 189-209 Camp Road Broadmeadows, Vic 3047, Avstralija
Long-term experience has shown that no harmful effects during the course of the pregnancy or to the newborn are to be expected.
Dolgotrajne izkušnje so pokazale, da ni pričakovati škodljivih učinkov na potek nosečnosti ali novorojenca.
Tell your doctor if you are known to have medical problems.
Obvestite zdravnika, če imate znane zdravstvene težave.
This medicine contains trace amounts of IgA (not more than 25 micrograms/ml).
To zdravilo vsebuje količine IgA v sledovih (ne več kot 25 mikrogramov/ml).
In the case of measles, this impairment may persist for up to 1 year.
Pri ošpicah lahko to poslabšanje traja do 1 leta.
IVIg is not indicated in patients with selective IgA deficiency where the IgA deficiency is the only abnormality of concern.
Ig ni indiciran pri bolnikih s selektivnim pomanjkanjem IgA, kjer je pomanjkanje IgA edina nepravilnost, ki povzroča skrb.
However, in studies where the dosing was designed to reflect the clinical indications for Privigen, no effects on brain development were observed.
Vendar pa v študijah, kjer je bilo odmerjanje načrtovano tako, da je ustrezalo kliničnim indikacijam zdravila Privigen, niso opazili nikakršnih učinkov na možgane.
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 infundiranju imunoglobulina lahko prehodno povečanje različnih, pasivno prenesenih protiteles v bolnikovi krvi povzroči lažno pozitivne rezultate seroloških preiskav.
1038 infusions were administered, 272 (in 16 patients) in the 3-week schedule and 766 (in 64 patients) in the 4-week schedule.
Dali so 1038 infuzij, od tega 272 (16 bolnikom) v 3-tedenskem režimu in 766 (64 bolnikom) v 4-tedenskem režimu.
Although limited data is available, it is expected that the same warnings, precautions and risk factors apply to the paediatric population.
Čeprav je podatkov malo, je pričakovati, da so opozorila, previdnostni ukrepi in dejavniki tveganja pri pediatrični populaciji enaki.
Other medicines and Privigen
Druga zdravila in zdravilo Privigen
Immunoglobulins are also known as antibodies and are blood proteins that help your body to fight infections.
Imunoglobini so znani tudi kot protitelesa in so krvne beljakovine, ki pomagajo vašemu telesu pri boju proti okužbam.
The pharmacokinetic parameters for Privigen were determined in a clinical study in PID patients (see section 5.1).
Farmakokinetični parametri za zdravilo Privigen so bili določeni v klinični študiji pri bolnikih s PID (glejte poglavje 5.1).
Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.
Bolniki, ki med zdravljenjem doživijo neželene učinke, morajo počakati, da izzvenijo, preden vozijo ali upravljajo stroje.
In Privigen clinical studies with paediatric patients, the frequency, nature and severity of adverse reactions did not differ between children and adults.
V kliničnih študijah zdravila Privigen s pediatričnimi bolniki se pogostnost, narava in resnost neželenih učinkov pri otrocih in odraslih niso razlikovali.
Experimental studies of the excipient L-proline carried out in animals found no direct or indirect toxicity affecting pregnancy, embryonal or foetal development.
Eksperimentalne študije pomožne snovi L-proline na živalih ne kažejo posrednih ali neposrednih toksičnih učinkov na nosečnost, embrionalni ali fetalni razvoj.
For storage conditions after first opening of the medicinal product and after dilution, see section 6.3.
Za pogoje shranjevanja po prvem odprtju in redčenju zdravila glejte poglavje 6.3.
When may slowing or stopping the infusion be required?
Kdaj bo treba infuzijo upočasniti ali ustaviti?
The posology in children and adolescents (0-18 years) is not different from that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned conditions.
Odmerjanje pri otrocih in mladostnikih (0 - 18 let) se ne razlikuje od odmerjanja pri odraslih, saj je odmerjanje za posamezne indikacije navedeno po telesni masi in prilagojeno kliničnemu izidu zgoraj navedenih bolezni.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.4).
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 (glejte tudi poglavje 4.4).
As this event was commonly reported in non-O blood group patients receiving high doses for non-PID indications, increased vigilance is recommended.
Ker o tem učinku pogosto poročajo pri bolnikih, ki nimajo krvne skupine 0 in prejemajo visoke odmerke za indikacije, ki niso PID, se priporoča povečano nadziranje.
After receiving Privigen, the efficacy of certain vaccinations may be impaired.
Po zdravljenju z zdravilom Privigen je lahko učinkovitost nekaterih cepiv zmanjšana.
Depending on the clinical response (e.g. infection rate), adjustment of the dose and/or the dose interval may be considered in order to aim for higher trough levels.
Glede na klinični odziv (tj. stopnjo okužbe) je treba razmisliti o prilagoditvi odmerka in/ali intervala odmerjanja, da se dosežejo višje najnižje ravni.
• It is strongly recommended that every time you are given a dose of Privigen the name and batch number of the product are recorded in order to maintain a record of the batches used.
• Močno se priporoča, da se vsakič, ko prejmete odmerek zdravila Privigen, zapišete ime in serijo zdravila, da bi vzdrževali evidenco uporabljenih serij.
9 patients responded after receiving the initial induction dose by week 4, 16 patients responded by week 10.
9 bolnikov se je odzvalo po prejemu začetnega indukcijskega odmerka do 4. tedna, 16 bolnikov pa do
Cerebrospinal fluid studies are frequently positive with pleocytosis up to several thousand cells per mm3, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dl.
Študije likvorja so pogosto pozitivne za pleocitozo do nekaj tisoč celic na mm3, pretežno iz granulocitnih vrst, ravni beljakovin pa so zvišane do nekaj sto mg/dl.
The safety and efficacy of Privigen was evaluated in 6 prospective, open-label, single-arm, multicenter studies performed in Europe (ITP, PID and CIDP studies) and the USA (PID study).
Varnost in učinkovitost zdravila Privigen je bila ocenjena v 6 prospektivnih, odprtih, multicentričnih študijah z eno skupino, ki so bile opravljene v Evropi (študije z ITP, PID in CIDP) in ZDA (študija s PID).
In this study, the median half-life of Privigen in PID patients was 36.6 days.
V tej študiji je bila mediana razpolovnega časa zdravila Privigen pri bolnikih s PID 36,6 dneva.
Following clinical deterioration during IVIg withdrawal, clinical improvement of CIDP was primarily defined by a decrease of ≥ 1 point at the adjusted INCAT score.
Po kliničnem poslabšanju med odtegnitvijo IVIg je bilo klinično izboljšanje CIDP opredeljeno predvsem z zmanjšanjem prilagojene ocene INCAT za ≥ 1 točko.
EU/1/08/446/001 EU/1/08/446/002 EU/1/08/446/003 EU/1/08/446/004 EU/1/08/446/005 EU/1/08/446/006 EU/1/08/446/007
EU/1/08/446/001 EU/1/08/446/002 EU/1/08/446/003 EU/1/08/446/004 EU/1/08/446/005
• if you are allergic to human immunoglobulins or to proline.
• če ste alergični na humane imunoglobuline ali prolin.
The dosing and intervals may have to be adapted according to the individual course of the disease.
Odmerjanje in intervale je morda treba prilagoditi v skladu s potekom bolezni pri posamezniku.
Once the vial has been entered under aseptic conditions, its contents should be used promptly.
Ko vialo predrete pod aseptičnimi pogoji, morate njeno vsebino porabiti takoj.
The duration of treatment beyond 25 weeks should be subject to the physician's discretion based upon the patient response and maintenance response in the long-term.
Odločitev o trajanju zdravljenja več kot 25 tednov je v presoji zdravnika na podlagi bolnikovega odziva in dolgoročnega vzdrževalnega odziva.
Overall, in 42 subjects (74 %) the platelet count increased at least once to ≥ 50×109 / l within 6 days after the first infusion, which was well within the expected range.
Na splošno se je pri 42 preiskovancih (74 %) število trombocitov najmanj enkrat povečalo na ≥ 50×109/l v 6 dneh po prvi infuziji, kar je bilo v pričakovanem razponu.
25 patients (aged 13-69 years) participated in the pharmacokinetic (PK) assessment.
Petindvajset bolnikov (starih od 13-69 let) je sodelovalo v farmakokinetični oceni.
After receiving Privigen, the results of certain blood tests (serological tests) may be impaired for a certain time.
Po prejemu zdravila Privigen so lahko rezultati nekaterih krvnih (seroloških) preiskav nekaj časa poslabšani.
Tell your doctor prior to treatment.
Zdravniku to povejte pred zdravljenjem.
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, ki jih povzroča uporaba zdravil, pripravljenih iz človeške krvi ali plazme, vključujejo izbiro krvodajalcev, presejanje posameznih donacij in zbirov plazme za posebne označevalce okužbe ter vključevanje učinkovitih proizvodnih korakov za inaktivacijo/odstranjevanje virusov.
The half-life may vary from patient to patient.
Razpolovni čas se lahko pri bolnikih razlikuje.
• if you suffer from hyperprolinaemia type I or II (a genetic disorder causing high levels of the amino acid proline in the blood).
• če imate hiperprolinemijo tipa I ali II (genska motnja, ki povzroča preveč aminokisline prolin v krvi).
Trough levels should be measured and assessed in conjunction with the patient's clinical response.
Najnižjo raven je treba meriti in oceniti v povezavi s kliničnim odzivom bolnika.
For patients suffering from diabetes mellitus and requiring dilution of Privigen to lower concentrations, the presence of glucose in the recommended diluent should be taken into account.
Za bolnike, ki imajo sladkorno bolezen ali pri katerih je treba zdravilo Privigen razredčiti do nižjih koncentracij, je treba upoštevati prisotnost glukoze v priporočeni raztopini za redčenje.
Increase in serum creatinine level and/or acute renal failure have been observed.
Opazili so zvišanje ravni kreatinina v serumu in/ali akutno ledvično odpoved.
• you are receiving Privigen at a high infusion rate or
● zdravilo Privigen prejemate pri veliki hitrosti infundiranja ali
• severe hypersensitivity reactions such as a sudden fall in blood pressure or anaphylactic shock
• hudih preobčutljivostnih reakcijah, kot je nenadno znižanje krvnega tlaka ali anafilaktični šok
Most adverse drug reactions (ADRs) observed in the six clinical studies were mild to moderate in nature.
Večina neželenih učinkov zdravila (Adverse Drug Reaction - ADR), opaženih v teh šestih kliničnih študijah, je bilo blagih do zmernih.
A total of 43 of the 207 patients achieved a better CIDP status as assessed by the adjusted INCAT score compared to their CIDP status at study entry.
Skupno 43 od 207 bolnikov je glede na prilagojeno oceno INCAT doseglo boljše stanje CIDP kakor so ga imeli ob vstopu v študijo.
Contents of the pack and other information What Privigen contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Privigen
For the non dominant hand similar results were observed in both PRIMA and PATH trials.
Rezultati za nedominantno roko so bili v preskušanju PRIMA in preskušanju PATH podobni.
In rare and isolated cases, the following side effects have been reported with immunoglobulin preparations:
V redkih in posameznih primerih so pri pripravkih imunoglobulina poročali o naslednjih neželenih učinkih:
Privigen contains 100 mg/ml (10%) human protein of which at least 98% is IgG.
Zdravilo Privigen vsebuje 100 mg/ml (10 %) človeške beljakovine, od katere je vsaj 98 % IgG.
AMS may occur more frequently in association with high-dose (2 g/kg) IVIg treatment.
AMS se lahko pogosteje pojavi v povezavi z velikimi odmerki (2 g/kg) zdravljenja z i.v.
Six clinical studies were performed with Privigen, which included patients with PID, ITP and CIDP.
Z zdravilom Privigen so opravili šest študij; ki so vključevale bolnike s PID, ITP in CIDP.