natgillin/translations-raw huggingface dataset:
The pivotal clinical trial supporting the approval of Osigraft did not include the use of synthetic bone void fillers. 
Pri ključnih kliničnih preskušanjih, ki podpirajo odobritev zdravila Osigraft, niso uporabili sintetičnih polnil za kosti.
When reconstituted, Osigraft has the consistency of wet sand, which facilitates its implantation and placement at bone site defects. 
Po rekonstituciji ima Osigraft konsistenco mokrega peska, kar olajša vsaditev in namestitev na mestu poškodbe kosti.
The matrix is also osteoconductive and it allows bone in-growth into the defect area from the surrounding healthy bone. 
Matriks ima tudi osteokonduktivne lastnosti in omogoča vraščanje kosti iz zdrave kosti v okolici v območje poškodbe.
Women of childbearing potential are advised to use effective contraception up to at least 12 months after treatment. 
Ženskam v rodni dobi se svetuje, da vsaj še 12 mesecev po zdravljenju uporabljajo učinkovito kontracepcijo.
Powder in a glass vial (Type 1, borosilicate) sealed with a stopper (butyl rubber) and a crimp cap (aluminium). 
Prašek v steklenih vialah (vrsta 1, borosilikat), zaprtih z zamaškom (butilna guma) in zaporko (aluminij).
There is a possibility that new antibodies can form in your body after treatment with Osigraft. 
Obstaja možnost, da se po zdravljenju z zdravilom Osigraft v telesu oblikujejo nova protitelesa.
Motion in the non-union site may disrupt the fracture healing process. 
Premikanje na mestu nezaraslega zloma lahko prekine proces zdravljenja.
Anti-OP-1 antibodies have the ability to neutralise the in vitro biological activity of at least BMP-6. 
Protitelesa proti OP-1 lahko in vitro nevtralizirajo biološko aktivnost vsaj beljakovine BMP-6.
During surgery Osigraft is placed directly at the injury site in contact with the damaged bone surfaces. 
Med operacijo se zdravilo Osigraft namesti neposredno na mesto poškodbe v stiku s poškodovanimi površinami kosti.
Animal studies were conducted that cannot rule out effects of anti-OP-1 antibodies on embryo-foetal development (see section 5.3). 
Opravili so študije na živalih, ki so pokazale, da ni mogoče izključiti učinkov protiteles proti OP-1 na razvoj zarodka in ploda (glejte poglavje 5.3).
Treatment of non-union of tibia of at least 9 month duration, secondary to trauma, in skeletally mature patients, in cases where previous treatment with autograft has failed or use of autograft is unfeasible. 
Zdravljenje nezaraslega zloma golenice, ki traja vsaj 9 mesecev, po telesni poškodbi, pri bolnikih z zrelim okostjem, v primerih, ko predhodno zdravljenje z avtolognim presadkom ni uspelo ali avtologno presajanje ni izvedljivo.
including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome 
vključno z reumatoidnim artritisom, sistemskim lupusom eritematozusom, sklerodermo,
To avoid breakage, do not tap the bottom of the vial when transferring contents. 
Pri prenašanju vsebine ne trkajte po dnu viale, da je ne razbijete.
Using your thumb, pry up the edge of the stopper. 
S palcem dvignite rob zamaška.
Sterile sodium chloride solution for injection and contents of the Osigraft vial are transferred to a sterile bowl and mixed with a sterile spatula or curette. 
Sterilno raztopino natrijevega klorida za injiciranje in vsebino viale zdravila Osigraft je treba prenesti v sterilno posodo ter premešati s sterilno spatulo ali kireto.
Special care is taken during surgery to prevent Osigraft leaking into the surrounding tissue in order to avoid the possibility of new bone growing outside the treated non-union location. 
Posebno previdno morate ravnati med kirurškim posegom zato, da preprečite iztekanje zdravila Osigraft v obkostna tkiva in tako izognete možnosti rasti nove kosti izven obravnavanega mesta nezaraslega zloma.
As human IgG is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-fed during Osigraft therapy (see section 5.3). 
Pri človeku se protitelesa IgG izločajo v mleko, morebitno tveganje za dojenčka pa je neznano, zato ženske med zdravljenjem z zdravilom Osigfraft ne smejo dojiti (glejte poglavje 5.3).
Osigraft is contraindicated in children and adolescents (less than 18 years old) and the skeletally immature (see section 4.2). 
Zdravilo Osigraft je kontraindicirano pri otrocih in mladostnikih (pod osemnajst let starosti) in pri skeletno nezrelih osebah (glejte poglavje 4.2).
Do not use suction or irrigation directly at the implant site as the particles of Osigraft may be removed. 
Mesta vsaditve ne sesajte ali izpirajte neposredno, ker lahko odstranite delce zdravila Osigraft.
Osigraft is contraindicated in children and adolescents (less than 18 years old) and the skeletally immature (see section 4.3). 
Zdravilo Osigraft je kontraindicirano pri otrocih in mladostnikih (pod osemnajst let starosti) in pri skeletno nezrelih osebah (glejte poglavje 4.3).
For instructions on reconstitution of the medicinal product before administration, see section 
Za navodila o rekonstituiranju zdravila pred uporabo glejte poglavje 6.6.
Close soft tissues around the defect containing the product using suture material of choice. 
Mehka tkiva v okolici poškodbe, ki vsebujejo zdravilo, zašijte z materialom po izbiri.
Using sterile technique, remove the vial from its packaging. 
Z uporabo sterilne tehnike vzemite vialo iz ovojnine.
Women of childbearing potential should be advised to use effective contraception up to at least 12 months after treatment. 
Ženskam v rodni dobi je treba svetovati, da vsaj še 12 mesecev po zdravljenju uporabljajo učinkovito kontracepcijo.
The radiographic healing results of the Osigraft treatment group were slightly inferior compared to the autograft control group (68% and 79% respectively). 
Radiografski rezultati celjenja so bili pri skupini, ki so jo zdravili z Osigraftom, nekoliko slabši (68 %) kot pri kontrolni skupini, ki so jo zdravili z avtolognim presadkom (79 %).
Puncture of the stopper with a needle may result in particles of stopper material contaminating the powder. 
Če zamašek prebodete z iglo, lahko delci njegovega materiala kontaminirajo prašek.
What Osigraft looks like and contents of the pack Osigraft is supplied as white to off-white powder packaged in an amber coloured glass vial (pack size of 1) within a blister pack, comprised of a plastic tray and lid, in a carton. 
Osigraft je na voljo v obliki belega do belkastega praška, pakiranega v rumeni stekleni viali (velikost pakiranja je 1) znotraj pretisnega omota, ki je sestavljen iz plastičnega podstavka in pokrova, v škatli.
Closure is critical for containment of the implant in the area of the bone defect. 
Zaprtje teh tkiv je pomembno, da se implantat zadrži v območju poškodbe kosti.
Lift the plastic flip-top and remove the crimp from the vial. 
Odprite plastični pokrov in z viale odstranite zaporko.
Apply the reconstituted product to the prepared osseous site using a sterile instrument such as a spatula or curette. 
Nanesite rekonstituirano zdravilo na pripravljeno mesto v kosti s sterilnim instrumentom, na primer spatulo ali žličko.
This provides an appropriate bioresorbable scaffold for the anchorage dependent cell proliferation and differentiation processes induced by the active substance. 
To je ustrezen, biološko razgradljiv nosilec za proliferacijo celic, odvisno od sidranja, in proces diferenciacije, ki ga sproža učinkovina.
Read the package leaflet before use. 
Pred uporabo natančno preberite navodilo!
Heterotopic ossification commonly occurs in humans following accidental or surgical trauma. 
Pri človeku se po nezgodni ali kirurški travmi pogosto pojavlja heterotopična okostenitev.
Osigraft should be given to breast-feeding women only when the attending physician decides that the benefits outweigh the risks. 
Z zdravilom Osigraft se lahko doječe ženske zdravi le, če se zdravnik odloči, da potencialne koristi prevladajo nad možnim tveganjem.
Eptotermin alfa, the active substance, initiates bone formation through the induction of cellular differentiation in mesenchymal cells, which are recruited to the implant site from bone marrow, periosteum and muscle. 
Učinkovina, eptotermin alfa, sproži tvorbo kosti z indukcijo diferenciacije mezenhimskih celic, ki se iz kostnega mozga, pokostnice in mišic preselijo na mesto vsadka.
Implanted material dislodged from the non-union site can cause ectopic ossification in the surrounding tissues with potential complications. 
Vsajena snov, ki se odstrani z mesta nezaraslega sklepa, lahko povzroči ektopično okostenitev z morebitnimi zapleti v obkostnih tkivih.
The new bone remodels naturally, cortices are formed and marrow elements are generated. 
Nova kost se preoblikuje po naravni poti, nastanejo skorje in elementi kostnega mozga.
The following table of adverse reactions was compiled from those observed and recorded during clinical trials. 
Spodnja tabela neželenih učinkov je bila sestavljena iz neželenih učinkov, ki so jih opazili in zabeležili med kliničnimi preskušanji.
Marketing Authorisation Holder Olympus Biotech International Limited 40 Upper Mount Street Dublin 2 
Imetnik dovoljenja za promet z zdravilom Olympus Biotech International Limited 40 Upper Mount Street Dublin 2
After closure of the soft tissues around the bone defect, irrigate field if necessary to remove any of the product which may have become dislodged during soft tissue closure. 
Ko zaprete mehka tkiva v okolici poškodbe kosti, jih po potrebi izperite in odstranite ostanke zdravila, ki so bili med zapiranjem morda odstranjeni.
Method of administration: Intraosseous use. 
Način uporabe Za intraosno uporabo.
Special care must be taken to prevent any leakage of Osigraft due to wound irrigation, defective closure of surrounding tissue or inadequate haemostasis. 
Posebno morate biti previdni, da preprečite iztekanje zdravila Osigraft zaradi izpiranja rane, nepravilnega zaprtja obkostnih tkiv ali neustrezne preprečitve krvavitve.
The use of Osigraft with a synthetic bone void filler may lead to a risk of increase in local inflammation, infection and occasional migration of the implanted materials and is therefore not recommended (see section 4.5). 
Uporaba zdravila Osigraft skupaj s sintetičnim polnilom za kosti lahko poveča tveganje za lokalna vnetja, okužbe in občasno premikanje vsajenega materiala, zato ni priporočena (glejte poglavje 4.5).
One vial of Osigraft contains 1 g of powder including 3.3 mg of eptotermin alfa and the excipient bovine collagen. 
Ena viala Osigrafta vsebuje 1 g praška s 3,3 mg eptotermina alfa in pomožno snovjo - govejim kolagenom.
Post market surveillance data has signalled that the use of the product in combination with a synthetic bone void filler may lead to an increase in local inflammation, infection and occasional migration of the implanted materials and it is therefore not recommended. 
Podatki po prihodu zdravila na trg kažejo, da uporaba zdravila v kombinaciji s sintetičnim polnilom za kosti lahko poveča pogostnost lokalnih vnetij, okužb in občasno premikanja vsajenega materiala in zato ni priporočena.
What Osigraft contains 
Kaj vsebuje zdravilo Osigraft
Precaution for use 
NAVODILO ZA UPORABO
Antibodies to eptotermin alfa were found in sera from pooled foetal and umbilical cord blood at levels that correlated to that of the maternal blood. 
Ravni protiteles proti eptoterminu alfa, ki so jih našli v serumu iz zbrane fetalne krvi in krvi popkovnice, so ustrezale ravnem v krvi matere.
The reconstituted product is administered by direct surgical placement at the non-union site in contact with the prepared bone surface. 
Rekonstituirano zdravilo se uporablja z neposrednim kirurškim nanosom na nezaraslo mesto v stiku s pripravljeno površino kosti.
This group of medicines cause new bone to grow at the location where the surgeon has placed (implanted) it. Osigraft is implanted in adult patients with fractures of the tibia which have failed to heal for at least 9 month duration in cases where treatment with autograft (transplanted bone from your hip) has failed or should not be used. 
Zdravilo Osigraft se vsadi odraslim bolnikom z zlomi golenice, ki se niso zacelili v najmanj 9 mesecih in sicer v primerih, ko zdravljenje z avtolognim presadkom (presajena kost iz lastnega kolka) ni uspelo ali se ga ne sme uporabiti.
eptotermin alfa. 
- Navodilo shranite.
The surrounding soft tissues are then closed around the implant. 
Nato se okrog vsadka zaprejo obkostna mehka tkiva.
The active substance is eptotermin alfa (a recombinant human Osteogenic protein 1 produced in a recombinant Chinese hamster ovary (CHO) cell line). 
Zdravilna učinkovina je eptotermin alfa, rekombinantni humani osteogenski protein, pridobljen iz celic jajčnikov kitajskega hrčka (CHO - Chinese Hamster Ovary) s tehnologijo rekombinantne DNA.
The use of Osigraft with a synthetic bone void filler may lead to a risk of increase in local inflammation, infection and occasional migration of the implanted materials and is therefore not recommended. 
Uporaba zdravila Osigraft skupaj s sintetičnim polnilom za kosti lahko poveča tveganje za lokalna vnetja, okužbe in občasno premikanje vsajenega materiala, zato ni priporočena.
Repeat Use 
Ponovna uporaba
Sarcoma was associated with the long-term presence of the heterotopic bone. 
S prisotnostjo heterotropične kosti je bil povezan nastanek sarkoma.
- if you are receiving chemotherapy, radiation treatment or immunosuppression 
- če so v bližini mesta nezraslega zloma tumorji; - če prejemate kemo-, radio- ali imunosupresivno terapijo.
An immune response to Osigraft should be considered and appropriate tests for the presence of antibodies in serum should be performed in cases where an immune-mediated undesirable effect is suspected, including cases where the product is ineffective. 
V primerih, kjer sumite na neželene učinke imunskega izvora, vključno s primeri, ko zdravilo Osigraft ne učinkuje, morate pretehtati možnost imunskega odziva na zdravilo in opraviti ustrezne teste za prisotnost protiteles v serumu.
Osigraft 3.3 mg powder for suspension for implantation eptotermin alfa 
Osigraft 3,3 mg prašek za suspenzijo za implantacijo eptotermin alfa
Depending on the size of the bone defect, more than one 1 g vial of Osigraft may be required. 
Morda bo potrebna več kot ena 1-g viala zdravila Osigraft, odvisno od velikosti poškodbe kosti.
Osigraft does not provide any biomechanical strength and should be used with internal or external fixation where initial mechanical stabilisation is required. 
Če je potrebna mehanska stabilizacija, ga morate uporabljati z notranjo ali zunanjo učvrstitvijo.
Bovine collagen (vacuum dried). 
6.1 Seznam pomožnih snovi goveji kolagen (vakuumsko posušen)
Provide adequate haemostasis to ensure that the implanted material is not dislodged from the surgical site. 
Poskrbite za ustrezno preprečitev krvavenja in tako zagotovite, da se vsajena snov ne odstrani z mesta kirurškega posega.
This medicine should not be used after the expiry date which is printed on the carton and the blister.The expiry date refers to the last day of that month. 
Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
No association with clinical outcome or adverse event could be observed in clinical studies. 
Pri kliničnih raziskavah niso opazili povezave s kliničnim izidom ali neželenimi učinki.
Detectable levels of IgG and IgM antibodies to eptotermin alfa developed and were found in the serum of all exposed adult animals. 
V serumu vseh izpostavljenih živali so našli zaznavne ravni protiteles IgG in IgM proti eptoterminu alfa.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 3,3 mg
Women of child-bearing potential should inform their surgeon of the possibility of pregnancy prior to treatment with the medicine. 
Ženske v rodni dobi Ženske v rodni dobi morajo pred zdravljenjem z zdravilom obvestiti zdravnika o možni zanositvi.
Experience from controlled clinical trials is limited to stabilisation of tibial non-union site using concomitant intramedullary nailing. 
Izkušnje iz nadzorovanih kliničnih raziskav so omejene na stabilizacijo nezaraslega zloma golenice s sočasno intramedularno učvrstitvijo z vijaki.
Post procedural tenderness (Tenderness) 
Občutljivost po posegu (Občutljivost)
Antibodies to OP-1 protein were detected in 66% of patients in the tibial non-union study following the administration of eptotermin alfa. 
V študiji nezraslih zlomov golenice so po uporabi eptotermina alfa pri 66 % bolnikov odkrili protitelesa proti beljakovini OP-1.
- if your doctor determines that you have inadequate skin coverage (at the fracture site) and inadequate blood supply at your site of surgery. 
- če zdravnik oceni, da mesto nezraslega zloma ni ustrezno pokrito s kožo ali da mesto kirurškega
However, use of Osigraft does not guarantee repair; additional surgery may be required. 
Vendar uporaba Osigrafta ne zagotavlja okrevanja, zato bodo morda potrebne dodatne operacije.
Remove excess fluid if necessary by suctioning adjacent to the implant site or carefully blotting the area with sterile sponge. 
Če je potrebno, odvečno tekočino odstranite s sesanjem ob mestu vsaditve ali s sterilno gobico
Each vial contains 3.3 mg eptotermin alfa*. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 3,3 mg eptotermina alfa*.
Osigraft 3.3 mg powder for suspension for implantation 
IME ZDRAVILA Osigraft 3,3 mg prašek za suspenzijo za implantacijo
Use of Osigraft does not guarantee repair, additional surgery may be required. 
Uporaba Osigrafta ne zagotavlja okrevanja, zato bodo morda potrebne dodatne operacije.
It is recommended that breast-feeding be discontinued following treatment. 
Po vsaditvi je priporočeno dojenje prekiniti.
A statistically significant increase in foetal malformations (misaligned sternabrae) was seen in litters of the OP-1 immunized group. 
Pri potomcih skupine, ki je bila imunizirana proti OP-1, so opazili statistično pomembno povečanje fetalnih deformacij (neporavnanost sternabre).
Laboratory studies have shown that antibodies to the eptotermin alfa component of this medicine could react with similar antibodies that the body makes naturally. 
Ponovna uporaba zdravila Osigraft ni priporočena, ker pri bolnikih niso bile izvedene klinične raziskave večkratnih kirurških zdravljenj v različnih obdobjih.Laboratorijske raziskave so pokazale, da protitelesa proti eptotermin alfa, ki je sestavina tega zdravila, lahko reagirajo s podobnimi protitelesi, ki jih telo proizvaja po naravni poti.
Once the vacuum is broken, remove the vial stopper while holding the vial upright to prevent loss of powder. 
Vialo pri tem držite pokonci, da bi preprečili izgubo praška.
Each vial contains 3.3 mg of eptotermin alfa* *Produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology For a full list of excipients, see section 6.1. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 3,3 mg eptotermina alfa* * Pridobljen iz celic jajčnikov kitajskega hrčka (CHO - Chinese Hamster Ovary) s tehnologijo rekombinantne DNA
Post procedural swelling (Swelling) 
Zatekanje po posegu (Zatekanje)
- for treating non-union resulting from pathological (disease-related) fractures, metabolic bone 
- pri vretenčnih zlomih (zlomih hrbtenice); - za zdravljenje nezraslih zlomov, ki so nastali zaradi patoloških zlomov (povezanih z boleznimi),
Bovine Collagen 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE 
ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
Izgled zdravila Osigraft in vsebina pakiranja
You will be monitored by your doctor if there is any medical suspicion that new antibodies have formed. 
V kolikor obstaja sum, da je prišlo do nastanka novih protiteles, boste pod nadzorom svojega zdravnika.
Where practical, surgical manipulations to the site should be completed prior to implantation of the product. 
Če je možno, končajte kirurške posege na tem mestu pred vsaditvijo zdravila.
The Tibial Nonunion pivotal trial compared Osigraft with autograft, with a primary efficacy endpoint at 9 months post-treatment. 
V ključni raziskavi nezraslega zloma golenice so primerjali Osigraft z avtolognim presadkom.
common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data 
• občasni (pojavijo se pri 1 do 10 bolnikih od 1.000 bolnikov)
3.3 mg of eptotermin alfa 
IME ZDRAVILA IN POT(I) UPORABE Osigraft eptotermin alfa
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve: 18.05.2001
White to off-white granular powder. 
prašek za suspenzijo za implantacijo bel ali belkast zrnast prašek
These are both normal and do not need to be removed 
Oba sta normalna in vam ju ni treba odstraniti.
No reduced efficacy was observed. 
Zmanjšane učinkovitosti niso opazili.
The expiry date refers to the last day of that month. 
datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca;
• If you have an active infection which your doctor thinks is important. 
• če imate aktivno okužbo, ki jo je vaš zdravnik ocenil za pomembno.
Date of first authorisation: 16 January 2009 Date of latest renewal: 19 September 2013 
Datum prve odobritve: 16. januar 2009 Datum zadnjega podaljšanja: 19. september 2013
Also tell your doctor if you have recently been near anyone who might have tuberculosis. 
Zdravniku povejte tudi, če ste bili pred kratkim v bližini osebe, ki bi lahko imela tuberkulozo.
The safety profiles of the recommended dose and half of the recommended dose were comparable. 
Varnostna profila priporočenega odmerka in polovice priporočenega odmerka sta bila primerljiva.
Always have the outer carton of the medicine with you, even if it is empty. 
Vedno imejte pri sebi škatlico zdravila, tudi če je prazna.
• Reduce the signs and symptoms of your disease. 
• zmanjšanje simptomov in znakov vaše bolezni,
PGA = Physician Global Assessment 
PGA = zdravnikova splošna ocena (Physician Global Assessment)
The following doses are usually the same as the starting dose. 
Nadaljni odmerki so običajno enaki začetnemu odmerku.
Regulation of CYP450 enzymes 
Regulacija encimov CYP450
Children (6-11 years) 
Otroci (6-11 let)
Serious outcomes have included respiratory failure and prolonged hospitalisation. 
Resni izidi so vključevali odpoved dihanja in podaljšanje hospitalizacije.
CDLQI of 0 or 1 indicates no effect on child's quality of life. 
CDLQI 0 ali 1 kažeta, da ni vpliva na otrokovo kakovost življenja.
The key efficacy results are shown in Table 6 below. 
Ključni izsledki o učinkovitosti so prikazani v Preglednici 6 spodaj.
It should be administered over at least one hour. 
Infundirati ga je treba najmanj eno uro.
Health-related quality of life 
Z zdravjem povezana kakovost življenja
If these symptoms occur, appropriate therapy should be instituted. 
Če se ti simptomi pojavijo je treba uvesti ustrezno zdravljenje.
If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it. 
Če zdravnik meni, da obstaja pri vas tveganje za tuberkulozo, vam bo morda predpisal zdravila zanjo.
This leaflet has been written for the person taking the medicine. 
To navodilo je napisano za osebe, ki zdravilo uporabljajo.
Chemical and physical in-use stability has been demonstrated for 8 hours at 15-25°C. 
Kemična in fizikalna stabilnost pripravljene raztopine je bila dokazana za 8 ur pri temperaturi 1525 °C.
Endoscopic Normalization 
Endoskopska normalizacija
Specific studies have not been conducted in patients who had recently received live viral or live bacterial vaccines. 
Specifične študije še niso bile opravljene pri bolnikih, ki so pred kratkim prejeli živa virusna ali živa bakterijska cepiva.
The basis for this analysis was that at least 100 patients (> 5% of the studied population) were treated concomitantly with these medicinal products for at least 90% of the study period. 
Osnova za to analizo je bila, da so najmanj 100 bolnikov (> 5% preučevane populacije) sočasno zdravili z omenjenimi zdravili najmanj 90% trajanja študije.