natgillin/translations-raw huggingface dataset:
The absolute bioavailability is about 64%.
Absolutna biološka uporabnost je približno 64 %.
Tell your doctor if you think this applies to you.
Povejte zdravniku, če mislite, da to velja za vas.
How do I know that the injection is complete?
Kako vem, da je postopek injiciranja zaključen?
This will make sure you get your full dose.
Tako boste zagotovili, da ste prejeli celotni odmerek.
There may be new information.
Morda bodo v njej na voljo nove informacije.
The individual daily dose is to be maintained throughout the stimulation period.
Posamezen dnevni odmerek je treba vzdrževati ves čas spodbujevalnega obdobja.
Your doctor will decide if you can give yourself further doses of this medicine at home, but only after receiving adequate training.
Zdravnik bo odločil, ali si lahko zdravilo dajete sami doma, vendar samo po opravljenem ustreznem usposabljanju.
Therefore the AMH result from a blood sample (taken within the last 12 months) should be available before you start treatment.
Zato mora biti rezultat AMH iz vzorca krvi (odvzetega v zadnjih 12 mesecih) na voljo pred začetkom zdravljenja.
Why do I have to count to 5 while holding the injection button?
Zakaj moram med držanjem gumba za injiciranje šteti do 5?
• Do not store the pen in extreme temperatures, direct sunlight or very cold conditions, such as in a car or freezer.
• Injekcijskega peresnika ne shranjujte pri ekstremnih temperaturah, na neposredni sončni svetlobi ali v zelo hladnih razmerah, kot na primer v avtomobilu ali zamrzovalniku.
OHSS may progress rapidly (within 24 hours to several days) to become a serious medical event.
SHSJ se lahko hitro (v 24 urah do nekaj dneh) razvije v resen zdravstven zaplet.
It most often occurs after hormonal treatment has been discontinued.
Najpogosteje se pojavi po prekinitvi hormonskega zdravljenja.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 December 2016
Datum prve odobritve: 12. december 2016
0.66 (priming dose)
0,66 (pripravljalni odmerek)
Summary of safety profile
Povzetek profila varnosti
Multiple pregnancy may lead to medical complications for you and your babies.
Večplodna nosečnost lahko vodi v zdravstvene zaplete pri vas in vaših otrocih.
2300 Copenhagen S Denmark
2300 København S
Examples of prescribed dose (in micrograms)
Primeri predpisanega odmerka (v mikrogramih)
The risk of having a side effect is described by the following categories:
Tveganje za neželene učinke je opisano z naslednjimi kategorijami:
Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
Poškodbe jajčnikov zaradi zmanjšane oskrbe s krvjo je mogoče omejiti z zgodnjo diagnozo in takojšnjo detorzijo.
If your body´s response to treatment is too weak or too strong, your doctor may decide to stop treatment with REKOVELLE.
Če je odziv vašega telesa na zdravljenja prešibak ali premočan, se lahko zdravnik odloči za prekinitev zdravljenja z zdravilom REKOVELLE.
It must be discarded afterwards.
Zatem ga je treba zavreči.
Please contact your doctor as soon as you notice that you forgot a dose.
Zdravnika obvestite takoj, ko opazite, da ste pozabili vzeti odmerek.
The first injection should be performed under direct medical supervision.
Prvo injekcijo je treba uporabiti pod neposrednim zdravniškim nadzorom.
Page numbers refer to the printed Instructions For Use booklet and not to actual page numbers in this document.
1 Številke strani se nanašajo na natisnjena navodila za uporabo in ne na dejansko oštevilčenje tega dokumenta.
When you feel a light resistance it is safely on.
Ko začutite rahel upor, je varno nameščena.
Before starting treatment with this medicine, a doctor should check you and your partner for possible causes of your fertility problems.
Pred začetkom zdravljenja s tem zdravilom mora zdravnik pri vas in vašem partnerju preveriti možne vzroke vaših težav s plodnostjo.
• See “Disposal” at Page 181.
• Glejte razdelek »Odstranjevanje« na strani 181.
• properly labeled to warn of hazardous waste inside the container.
• je pravilno označena z opozorili o nevarnih odpadkih v posodi.
mcg: micrograms
µg: mikrogrami
For storage conditions after first use of the medicinal product, see section 6.3.
Za pogoje shranjevanja po prvi uporabi zdravila glejte poglavje 6.3.
Furthermore, the syndrome may be more severe and more protracted if pregnancy occurs.
Prav tako je lahko sindrom hujši in dolgotrajnejši v primeru nosečnosti.
(Dial to 11)
(obrnite do 11)
The relevance of these findings for the clinical use of REKOVELLE is limited.
Pomen teh ugotovitev za klinično rabo zdravila REKOVELLE je omejen.
• upright and stable during use,
• je med uporabo pokončna in stabilna;
The patients were up to 40 years of age and had regular menstrual cycles presumed to be ovulatory.
Bolnice so bile stare do 40 let in so imele redne menstrualne cikle z domnevno ovulacijo.
EXP After first use: Use within 28 days.
EXP Po prvi uporabi: Uporabite v 28 dneh.
Change the needle.
Zamenjajte iglo.
• You will hear or feel a click when the needle is safely on.
• Zaslišali boste klik ali začutili, kdaj je igla varno nameščena.
Clear and colourless solution with a pH of 6.0-7.0.
Bistra in brezbarvna raztopina z vrednostjo pH 6,0-7,0.
Treatment with gonadotropins may further increase the risk for aggravation or occurrence of such events.
Zdravljenje z gonadotropini lahko še dodatno poveča tveganje za poslabšanje ali pojav tovrstnih dogodkov.
Before use - (Step 1)
Pred uporabo - (1. korak)
• you have had an early menopause
• če imate zgodnjo menopavzo;
For example, if the number in column C is 5.34, round your remaining dose to 5.33.
Če je na primer v stolpcu C vrednost 5,34, svoj preostali odmerek zaokrožite na 5,33.
The needles are for single-use only.
Igle so namenjene samo za enkratno uporabo.
If the number in column C is 9.67, round your remaining dose to 9.66.
Če je vrednost v stolpcu C 9,67, svoj preostali odmerek zaokrožite na 9,66.
What REKOVELLE is and what it is used for 2.
Kaj je zdravilo REKOVELLE in za kaj ga uporabljamo 2.
If you do not have a sharps disposal container, you may use a household container that is:
Če nimate posode za odstranjevanje ostrih predmetov, lahko uporabite gospodinjsko posodo, ki:
The dose should be based on a recent determination of AMH (i.e. within the last 12 months) measured by the following diagnostic test from Roche: ELECSYS AMH Plus immunoassay (see section 4.4).
Odmerek mora temeljiti na nedavno določeni vrednosti AMH (tj. v zadnjih 12 mesecih), izmerjene s sledečim diagnostičnim testom družbe Roche: imunski test ELECSYS AMH Plus (glejte poglavje 4.4).
There may be state or local laws about how you should throw away used needles.
Državni ali lokalni zakoni morda določajo, kako je treba uporabljene igle zavreči med odpadke.
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili brez recepta.
• have difficulty in breathing
• če težko dihate.
• If a broken needle remains stuck in the body or remains under the skin, get medical help right away.
• Če zlomljena igla ostane v telesu ali pod kožo, nemudoma poiščite zdravniško pomoč.
Frequently Asked Questions (FAQ)
Pogosto zastavljena vprašanja
Safety - immunogenicity
Varnost - imunogenost
After first use: Use within 28 days.
Po prvi uporabi: Uporabite v 28 dneh.
The first injection of this medicine should be given under the supervision of a doctor or a nurse.
Prvo injekcijo tega zdravila boste prejeli pod nadzorom zdravnika ali medicinske sestre.
Although limited, data did not indicate a need for a different dosing regimen of REKOVELLE in this patient population (see section 4.4).
Podatki, čeprav omejeni, niso pokazali potrebe po drugačnem režimu odmerjanja zdravila REKOVELLE pri tej populaciji bolnic (glejte poglavje 4.4).
In all patients with anti-FSH antibodies, titres were undetectable or very low and without neutralising capacity.
Pri vseh bolnicah s protitelesi proti FSH so bili titri nezaznavni ali zelo nizki in brez sposobnosti nevtraliziranja.
• you have been told by another doctor that pregnancy would be dangerous for you
• če vam je kateri drug zdravnik odsvetoval nosečnost kot nevarno za vas,
• you suffer from bleeding from the vagina without any known cause
• če imate krvavitev iz nožnice brez znanega vzroka;
The most important effect resulting from parenteral administration of FSH is the development of multiple mature follicles.
Najpomembnejši učinek parenteralne uporabe FSH je razvoj več zrelih foliklov.
• Doses should be rounded off to nearest increment, X.00, X.33 or X.66 micrograms.
• Odmerke je treba zaokrožiti na najbližji korak, tj. X,00, X,33 ali X,66 mikrogramov.
Single blastocyst transfer on day 5 was compulsory with the exception of patients 38-40 years in whom double blastocyst transfer was performed if no good-quality blastocysts were available.
Na peti dan je bil obvezen prenos ene blastociste, z izjemo bolnic, starih 38-40 let, pri katerih so izvedli prenos dveh blastocist, če ni bilo na voljo blastocist dobre kakovosti.
• You may also screw on the needle.
• Iglo lahko tudi privijete.
Treatment should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Zdravljenje je treba uvesti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem težav s plodnostjo.
Do not touch the injection button yet.
Gumba za injiciranje se še ne dotikajte.
If the patient had adequate ovarian response in the previous cycle without developing OHSS, the same daily dose should be used.
Če je imela bolnica v prejšnjem ciklu zadosten odziv jajčnikov, ne da bi se razvil SHSJ, je treba uporabljati enak dnevni odmerek.
The maximum daily dose for the first treatment cycle is 12 micrograms.
Največji dnevni odmerek za prvi cikel zdravljenja je 12 mikrogramov.
In these women, the benefits of gonadotropin administration need to be weighed against the risks.
Pri teh ženskah je treba pretehtati koristi uporabe gonadotropinov glede na tveganja.
For calculation of the REKOVELLE dose, the body weight is to be measured without shoes and overcoat just prior to start of stimulation.
Pri izračunu odmerka zdravila REKOVELLE je treba telesno maso izmeriti brez čevljev in vrhnjih oblačil neposredno pred začetkom spodbujanja.
It should be noted however that pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events.
Vendar moramo upoštevati, da tudi sama nosečnost in SHSJ povečujeta tveganje za trombembolične dogodke.
• Read Step 11 and 12 at Page 14 to 151 before giving your injection.
• Pred injiciranjem preberite 11. in 12. korak na straneh 14 do 151.
• The REKOVELLE pre-filled pen and the needles are for use by only one person and should not be shared with others.
• Napolnjen injekcijski peresnik REKOVELLE in igle lahko uporablja samo ena oseba in ga ne sme deliti z drugimi ljudmi.
How are injections given
Kako dajati injekcije
The AMH concentration is to be expressed in pmol/L and is to be rounded off to the nearest integer.
Vrednost AMH mora biti izražena v pmol/l in zaokrožena na najbližje celo število.
• The number ‘0' is lined up with the dose indicator.
• Število »0« je poravnano s kazalnikom odmerka.
This is when your follicles develop too much and become large cysts.
To pomeni, da se folikli prekomerno razvijejo in postanejo velike ciste.
Pharmacotherapeutic group: Sex hormones and modulators of the genital systems, gonadotropins, ATC code: G03GA10
Farmakoterapevtska skupina: spolni hormoni in zdravila za uravnavanje delovanja spolovil, gonadotropni hormoni, oznaka ATC: G03GA10
What you need to know before you use REKOVELLE 3.
Kaj morate vedeti, preden boste uporabili zdravilo REKOVELLE 3.
Your doctor will monitor the effect of REKOVELLE treatment, and treatment is stopped when an appropriate number of egg sacs are present.
Zdravnik bo spremljal učinek zdravljenja z zdravilom REKOVELLE in ga prekinil, ko bo prisotno ustrezno število jajčnih mešičkov.
Conversely, increasing body weight leads to a decrease in the number of oocytes retrieved (only clinically relevant for REKOVELLE doses below 12 micrograms).
Obratno pa povečanje telesne mase povzroči zmanjšanje števila pridobljenih oocitov (to je klinično pomembno samo za odmerke zdravila REKOVELLE, manjše od 12 mikrogramov).
Twisting of the ovary could cut off the blood flow to the ovary.
Zasuk jajčnikov lahko prekine dotok krvi do jajčnikov.
Follitropin delta is expected to be eliminated similarly to other follitropins, i.e. mainly by the kidneys.
Za folitropin delta se pričakuje, da se bo izločal podobno kot drugi folitropini, tj. predvsem skozi ledvice.
Then slowly remove the needle from the injection site by pulling it straight out of the skin.
Nato počasi odstranite iglo z mesta injiciranja tako, da jo naravnost izvlečete iz kože.
Because of the risk of developing OHSS patients should be followed for at least two weeks after triggering of final follicular maturation.
Zaradi tveganja za razvoj SHSJ je treba bolnice spremljati še vsaj dva tedna po sprožitvi končnega zorenja foliklov.
In particular, patients should be evaluated for hypothyroidism and hyperprolactinemia, and the appropriate specific treatment should be given.
Bolnice je treba pregledati zlasti glede hipotiroidizma in hiperprolaktinemije ter jim zagotoviti ustrezno specifično zdravljenje.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• preobčutljivost za zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1
The REKOVELLE dose is fixed for the whole treatment period with no adjustments to increase or decrease your daily dose.
Odmerek zdravila REKOVELLE je stalen v celotnem obdobju zdravljenja, brez povečevanja ali zmanjševanja vašega dnevnega odmerka.
Your doctor may ask you to stop using this medicine (see section 4).
Zdravnik vam lahko odsvetuje nadaljnjo uporabo tega zdravila (glejte poglavje 4).
The fraction of follitropin delta excreted unchanged in the urine was estimated to 9%.
Frakcija folitropina delta, izločenega z urinom v nespremenjeni obliki, je bila ocenjena na 9 %.
Studies in animals have shown reproductive toxicity with REKOVELLE doses above the recommended maximal dose in humans (section 5.3).
Študije na živalih so pokazale reproduktivno toksičnost odmerkov zdravila REKOVELLE, ki so bili večji od priporočenih največjih odmerkov za ljudi (poglavje 5.3).
Follow the instructions carefully even if you have used a similar injection pen before.
Natančno preberite navodila, četudi ste že uporabljali podoben injekcijski peresnik.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container.
Ko je posoda za odstranjevanje ostrih predmetov skoraj polna, morate upoštevati lokalne smernice za pravilno odstranjevanje posode za odstranjevanje ostrih predmetov med odpadke.
What if the dose knob cannot be turned to the required dose?
Kaj naj storim, če gumba za odmerjanje ni mogoče obrniti do želenega odmerka?
Therefore, in cases of ovarian hyperstimulation it is prudent to withhold hCG and advise the patient to refrain from coitus or to use barrier contraceptive methods for at least 4 days.
Zato je smiselno, da se v primeru hiperstimulacije jajčnikov hCG ne uporabi, bolnici pa se svetuje vzdržnost od spolnih odnosov ali uporaba barierne metode kontracepcije najmanj štiri dni.
Other medicines and REKOVELLE
Druga zdravila in zdravilo REKOVELLE
A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation.
Določena stopnja povečanja jajčnikov je pričakovani učinek nadzorovanega spodbujanja jajčnikov.
The maximum daily dose is 24 micrograms.
Največji dnevni odmerek znaša 24 mikrogramov.
Gonadotropin therapy requires time commitment by physicians and supportive healthcare professionals, as well as the availability of appropriate monitoring facilities.
Zdravljenje z gonadotropinom zahteva od zdravnika in zdravstvenega osebja čas ter razpoložljivost ustrezne opreme za spremljanje zdravljenja.
Ovarian hyperstimulation syndrome may possibly occur, which is described in section 4.
Lahko se pojavi sindrom hiperstimulacije jajčnikov, ki je opisan v poglavju 4.
• The dose scale of the pen is numbered from 0 to 20 micrograms.
• Velikosti odmerka injekcijskega peresnika so oštevilčene od 0 do 20 mikrogramov.
Before first use, store in the original package in order to protect from light.
Pred prvo uporabo shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
For the next treatment cycle, your doctor will in this case give you either a higher or a lower daily dose of REKOVELLE than before.
V tem primeru vam bo za naslednji cikel zdravljenja zdravnik dal večji ali manjši dnevni odmerek zdravila REKOVELLE kot prej.
The dosing regimen is specific for REKOVELLE and the microgram dose cannot be applied to other gonadotropins.
Režim odmerjanja je specifičen za zdravilo REKOVELLE in odmerek v mikrogramih ne velja za druge gonadotropine.
Infertility treatment can increase the risk of this happening, especially if you are overweight or you or someone in your family (blood relative) have a known blood clotting disease (thrombophilia).
Zdravljenje neplodnosti lahko poveča tovrstno tveganje, zlasti če imate prekomerno telesno maso ali če vi ali član vaše družine (krvni sorodnik) trpi za znano boleznijo strjevanja krvi (trombofilijo).
The incidence of anti-FSH antibodies after treatment with REKOVELLE was 1.1% in cycle 1, 0.8% in cycle 2 and 1.1% in cycle 3.
Pojavnost protiteles proti FSH je bila po zdravljenju z zdravilom REKOVELLE 1,1 % v 1. ciklu, 0,8 % v 2. ciklu in 1,1 % v 3. ciklu.
In distinction to uncomplicated ovarian enlargement, OHSS is a condition that can manifest itself with increasing degrees of severity.
Za razliko od povečanja jajčnikov brez zapletov je SHSJ stanje, ki se lahko izrazi z naraščajočo stopnjo resnosti.
Do not use this medicine if you are pregnant or breast-feeding.
Nosečnost in dojenje Ne uporabljajte tega zdravila, če ste noseči ali dojite.
• Use the pen only for the medical condition it is prescribed for and as directed by your healthcare provider.
• Injekcijski peresnik uporabljajte samo za zdravstveno stanje, za katerega je predpisan in po navodilih vašega zdravstvenega delavca.
Follitropin delta leads to greater exposure than follitropin alfa.
Folitropin delta vodi k večji izpostavljenosti kot folitropin alfa.
The number of oocytes retrieved increases with the dose of REKOVELLE and serum AMH concentration.
Število pridobljenih oocitov se povečuje z odmerkom zdravila REKOVELLE in serumsko koncentracijo AMH.
• Sleepiness/drowsiness
• zaspanost/dremavost,
Treatment with REKOVELLE should be initiated day 2 or 3 after start of menstrual bleeding, and continue until adequate follicular development (≥3 follicles ≥17 mm) has been achieved, which on average is by the ninth day of treatment (range 5 to 20 days).
Zdravljenje z zdravilom REKOVELLE je treba uvesti drugi ali tretji dan po začetku menstrualne krvavitve in z njim nadaljevati, dokler ni dosežen zadosten razvoj foliklov (≥ 3 folikli ≥ 17 mm), kar v povprečju traja do devetega dne zdravljenja (razpon od 5 do 20 dni).
The terminal elimination half-life after single subcutaneous administration is 40 hours and after multiple subcutaneous administration is 28 hours.
Končni razpolovni čas izločanja po enkratnem subkutanem odmerku je 40 ur in po večkratnih subkutanih odmerkih 28 ur.
Before starting to use this medicine, tell your doctor if:
Pred začetkom zdravljenja s tem zdravilom obvestite svojega zdravnika:
For women with AMH <15 pmol/L the daily dose is 12 micrograms, irrespective of body weight.
Pri ženskah z vrednostjo AMH < 15 pmol/l je dnevni odmerek 12 mikrogramov ne glede na telesno maso.
Safe and effective use of REKOVELLE calls for monitoring of ovarian response with ultrasound alone, or in combination with measurement of serum estradiol levels, on a regular basis.
Za varno in učinkovito uporabo zdravila REKOVELLE je potrebno redno spremljanje odziva jajčnikov, ali samo z ultrazvokom ali v kombinaciji z merjenjem serumskih vrednosti estradiola.
Immunogenicity in terms of development of anti-FSH antibodies is a potential risk of gonadotropin therapy (see section 5.1).
Imunogenost v smislu razvoja protiteles proti FSH je potencialno tveganje pri zdravljenju z gonadotropinom (glejte poglavje 5.1)
At the end of the treatment any unused solution must be discarded.
Po končanem zdravljenju je treba neuporabljeno raztopino zavreči.
Because follitropin delta is produced in the human cell line PER.C6, the glycosylation profile is different from follitropin alfa and follitropin beta.
Ker se folitropin delta pridobiva iz človeške celične linije PER.C6, se profila glikozilacije folitropina alfa in folitropina beta razlikujeta.
It is more commonly seen in patients with polycystic ovarian syndrome and usually regresses without treatment.
Pogosteje nastopi pri bolnicah s sindromom policističnih jajčnikov in navadno izzveni brez zdravljenja.
Store in refrigerator (2 °C - 8 °C).
Shranjujte v hladilniku (2 °C - 8 °C).
These rates were similar to the incidence of pre-existing anti-FSH antibodies before exposure to REKOVELLE in cycle 1 which was 1.4%, and comparable to the incidences of anti-FSH antibodies after treatment with follitropin alfa.
Te vrednosti so bile podobne pojavnosti predhodno prisotnih protiteles proti FSH pred izpostavljenostjo zdravilu REKOVELLE v 1. ciklu, ki je znašala 1,4 %, in primerljive s pojavnostjo protiteles proti FSH po zdravljenju s folitropinom alfa.
Children and adolescents (under 18 years of age)
Otroci in mladostniki (mlajši od 18 let) To zdravilo se ne uporablja pri otrocih in mladostnikih.
Step 11 and 12:
11. in 12. korak:
Follitropin delta had a negative effect on fertility and early embryonic development in rats when administered in doses ≥0.8 micrograms/kg/day which is above the recommended maximal dose in humans.
Folitropin delta je imel negativen vpliv na plodnost in zgodnji embrionalni razvoj pri podganah v odmerkih ≥ 0,8 mikrograma/kg/dan, kar presega priporočeni največji odmerek za ljudi.
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
• jo je mogoče zapreti s tesno prilegajočim se pokrovom, odpornim na prebadanje, iz katerega ostri predmeti ne morejo izstopiti;
The overdose of follitropin delta resulted in pharmacological or exaggerated pharmacological actions.
V prevelikih odmerkih je folitropin delta povzročil farmakološke ali pretirane farmakološke učinke.
• After the needle is inserted, place your thumb on the injection button.
• Ko je igla zabodena, položite palec na gumb za injiciranje.
Multiple pregnancy carries an increased risk of adverse maternal and perinatal outcomes.
Večplodna nosečnost predstavlja povečano tveganje za neželene izide za mater in neželene perinatalne izide.
The two co-primary endpoints were ongoing pregnancy rate and ongoing implantation rate in the fresh cycle, defined as at least one intrauterine viable fetus 10-11 weeks after transfer and number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts transferred, respectively.
Dva primarna opazovana dogodka sta bila delež nosečnosti in delež vsaditev v svežem ciklu, opredeljena kot najmanj en znotrajmaternični uspešen fetus 10-11 tednov po prenosu in število znotrajmaterničnih uspešnih fetusov 10-11 tednov po prenosu, deljeno s številom prenesenih blastocist.
Do not try to inject yourself until you have been shown the right way to give your injections by your healthcare provider.
Ne poskušajte zdravila injicirati sami, dokler vam zdravstveni delavec ne pokaže pravilnega injiciranja.
The effect of an overdose is unknown, nevertheless, there is a risk that OHSS may occur (see section 4.4).
Učinek prevelikega odmerjanja ni znan, vendar pa obstaja tveganje za pojav SHSJ (glejte poglavje 4.4).