natgillin/translations-raw huggingface dataset:
• excessive sweating
• čezmerno znojenje,
• low blood pressure (can cause light-headedness when you stand up)
• nizek krvni tlak (lahko povzroči omotičnost, ko vstanete),
Published data suggest that neonatal and infant consumption of breast milk does not result in substantial absorption of these maternal antibodies into circulation.
Objavljeni podatki kažejo, da zaužitje materinega mleka pri novorojenčkih in dojenčkih ne povzroči bistvene absorpcije teh materinih protiteles v obtok.
Ofatumumab should not be administered to pregnant women unless the possible benefit to the mother outweighs the possible risk to the foetus.
Ofatumumaba se ne sme uporabljati pri nosečnicah, razen če možna korist za mater odtehta možno tveganje za plod.
Patients received treatment for a minimum of 3 months until best response or up to a maximum of 12 cycles.
Bolniki so zdravljenje prejemali najmanj 3 mesece do najboljšega odgovora, ali do največ 12 ciklusov.
Do not use this medicine after the expiry date shown on the carton and vial label.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale.
HBV reactivation has been reported up to 12 months following completion of therapy.
O reaktivaciji HBV so poročali do 12 mesecev po dokončanju zdravljenja.
Any unused solution remaining after this time should be discarded.
Vso neuporabljeno raztopino, ki po tem času ostane, je treba zavreči.
Do not shake the ofatumumab vial for this inspection.
Ne stresajte viale ofatumumaba, da boste opravili ta pregled.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Pregnancy, breast-feeding and fertility Arzerra is not usually recommended for use during pregnancy.
Nosečnost, dojenje in plodnost Zdravila Arzerra po navadi ni priporočljivo uporabljati med nosečnostjo.
• if you have lung disease,
• če imate bolezen pljuč,
Baseline cytogenetic (FISH) data were available for 209 patients.
Izhodiščni citogenetski (FISH) podatki so bili na voljo za 209 bolnikov.
• If you have persistent stomach pain, see your doctor as soon as possible.
• Če imate dolgotrajne bolečine v trebuhu, čim prej pojdite k zdravniku.
Improvements also were demonstrated in components of the NCI-WG response criteria.
Izboljšanje je bilo ugotovljeno tudi po merilih NCI-WG za odziv.
Probability of Progression-free Survival
Verjetnost preživetja brez napredovanja
You will be given an initial infusion followed by a second infusion 7 days later.
Dobili boste začetno infuzijo, ki ji bo 7 dni pozneje sledila druga infuzija.
The usual dose
Običajen odmerek
Efficacy endpoint or haematological parameter a
Kriterij učinkovitosti ali hematološki parameter a
These could be symptoms of a blockage in the bowel, especially during the early stages of your treatment.
To so lahko simptomi zapore črevesja, zlasti v zgodnjih fazah zdravljenja.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
Check with your doctor if you think this may apply to you.
Posvetujte se z zdravnikom, če menite, da kaj od tega velja za vas.
Excludes patients' visits from date of first transfusion, treatment with erythropoietin, or treatment with growth factors.
a Izključuje obiske bolnika od datuma prve transfuzije, zdravljenja z eritropoetinom ali zdravljenja z rastnimi faktorji.
• blocked nose.
• zamašen nos.
A corresponding increase in reticulocyte counts seen in these monkeys was indicative of a regenerative response in the bone marrow.
Ugotovljeno povečanje števila retikulocitov pri teh opicah je pokazalo regenerativen odziv v kostnem mozgu.
Sodium acetate (E262)
Natrijev acetat (E262)
If you had these symptoms prior to treatment with Arzerra, tell your doctor immediately about any changes in these symptoms.
Če ste imeli te simptome že pred zdravljenjem z zdravilom Arzerra, morate zdravniku nemudoma povedati za vsako spremembo teh simptomov.
After this period, planning of a pregnancy in relation to the underlying disease, should be evaluated by the treating physician.
Po tem obdobju mora možnost načrtovanja nosečnosti z ozirom na osnovno bolezen oceniti lečeči zdravnik.
No large changes in the mean QTc interval (i.e. >20 milliseconds) were detected.
Odkrili niso nobenih velikih sprememb povprečnega intervala QTc (tj. > 20 milisekund).
Paediatric population No pharmacokinetic data are available in paediatric patients.
Pediatrična populacija Farmakokinetičnih podatkov za pediatrične bolnike ni.
The effect of ofatumumab on patients with prolonged QT intervals (e.g. acquired or congenital) is unknown.
Vpliv ofatumumaba na bolnike s podaljšanim intervalom QT (npr. pridobljenim ali prirojenim) ni znan.
The risks and benefits of vaccinating patients during Arzerra therapy should be considered.
Pretehtati je treba tveganja in koristi cepljenja bolnikov med zdravljenjem z zdravilom Arzerra.
Time after start of infusion (minutes)
Čas po začetku infuzije (minute)
There are no adequate and well-controlled studies in pregnant women to inform a product-associated risk.
Pri nosečnicah niso opravili ustreznih in dobro kontroliranih študij, da bi lahko podali oceno tveganja pri uporabi zdravila.
• low levels of red blood cells (anaemia).
• majhno število rdečih krvnih celic (anemija).
• high temperature
• visoka telesna temperatura,
If you notice these symptoms, contact your doctor as soon as possible.
Če opazite te simptome, se čim prej posvetujte z zdravnikom.
You need to take this into account if you are on a controlled sodium diet.
To morate upoštevati, če ste na dieti s kontroliranim vnosom natrija.
No substantial differences related to age were seen in safety and efficacy (see section 5.1).
Ugotovili niso nobenih bistvenih s starostjo povezanih razlik glede varnosti in učinkovitosti (glejte poglavje 5.1).
Therefore, the concomitant use of these agents with ofatumumab should be avoided.
Zato se je treba njihovi sočasni uporabi z ofatumumabom izogibati.
Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Znotraj posamezne skupine pogostnosti so neželeni učinki razvrščeni po padajoči resnosti.
Arzerra should be administered under the supervision of a physician experienced in the use of cancer therapy and in an environment where full resuscitation facilities are immediately available.
Zdravilo Arzerra je treba dajati pod nadzorom zdravnika, ki ima izkušnje pri uporabi zdravil proti raku, in v okolju, kjer je nemudoma na voljo vsa oprema za reanimacijo.
Pre- and post-natal development studies have not been performed.
Študije prenatalnega in postnatalnega razvoja niso bile izvedene.
A dose-ranging study (Hx-CD20-402) was conducted in 33 patients with relapsed or refractory CLL.
Študija razpona odmerka (Hx-CD20-402) je bila opravljena pri 33 bolnikih z relapsom ali neodzivno KLL.
What Arzerra is and what it is used for
Kaj je zdravilo Arzerra in za kaj ga uporabljamo
Time after start of infusion
Čas po začetku infuzije
These included bacterial, viral and fungal infections.
Med temi okužbami so bile bakterijske, virusne in glivične okužbe.
• problems with blood clotting
• težave s strjevanjem krvi,
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8 ºC, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur na temperaturi od 2 do 8 °C, razen če je priprava/redčenje opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
It is not known whether Arzerra works in children and adolescents.
Ni znano, ali zdravilo Arzerra deluje pri otrocih in mladostnikih.
Tell your doctor immediately if you have memory loss, trouble thinking, difficulty with walking or loss of vision.
Zdravniku morate nemudoma povedati, če se vam pojavijo poslabšanje spomina, motnje mišljenja, težave s hojo ali izguba vida.
Median Cumulative Illness Rating Score for Geriatrics (CIRS-G) was 9 and 31% of patients had a CIRS-G >10.
Mediana kumulativna ocena bolezni za geriatrične bolnike (Median Cumulative Illness Rating Score for Geriatrics, CIRS-G) je bila 9 in 31 % bolnikov je imelo CIRS-G > 10.
The European Medicines Agency has waived the obligation to submit the results of studies with Arzerra in all subsets of the paediatric population in chronic lymphocytic leukaemia (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Arzerra za vse podskupine pediatrične populacije za kronično limfocitno levkemijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
IRC-assessed primary and subgroup analyses of PFS, months
PFS v analizi primarne skupine in podskupin po oceni IRC, meseci
Patients received a median of 5 prior therapies, including rituximab (57%).
Bolniki so v povprečju dobili 5 predhodnih zdravljenj, vključno z rituksimabom (57 %).
More than half of the patients (56%) with CR were MRD negative following the completion of study treatment.
Več kot polovica bolnikov (56 %) s popolnim odzivom je imela po koncu preučevanega zdravljenja negativno MRD.
• high blood pressure
• visok krvni tlak,
Patients received treatment for a maximum of 6 cycles.
Bolniki so zdravljenje prejemali največ 6 ciklusov.
Patients with a history of cardiac disease should be monitored closely.
Bolnike z anamnezo bolezni srca je treba natančno nadzirati.
Patients who present with abdominal pain, especially early in the course of ofatumumab therapy, should be evaluated and appropriate treatment instituted.
Bolnike, ki se jim pojavijo bolečine v trebuhu, še zlasti v zgodnjem obdobju zdravljenja z ofatumumabom, je treba oceniti in jim uvesti ustrezno zdravljenje.
CLL is a cancer of the blood which affects a type of white blood cell called lymphocytes.
KLL je krvni rak, ki prizadene vrsto belih krvnih celic, imenovanih limfociti.
The median number of cycles completed in patients was 6 (total Arzerra dose of 6300 mg).
Mediano število dokončanih ciklusov pri bolnikih je bilo 6 (celotni odmerek zdravila Arzerra 6.300 mg).
Spleen weights decreased by approximately 15% in the low-dose group and by approximately 30% in the high-dose group, compared with control values.
V skupini z nižjimi odmerki se je masa vranice zmanjšala za približno 15 %, v skupini z višjimi odmerki pa za približno 30 % v primerjavi s kontrolnimi vrednostmi.
Vial 3 years.
Viala 3 leta
If you have or have had hepatitis B, tell your doctor before you are given Arzerra.
Če imate ali ste imeli hepatitis B, to povejte zdravniku, preden dobite zdravilo Arzerra.
Lonza Biologics plc 228 Bath Road Slough, Berks SL1 4DX United Kingdom
Lonza Biologics plc 228 Bath Road Slough, Berks SL1 4DX Velika Britanija
If you have had hepatitis B, Arzerra could cause it to become active again.
Če ste kdaj imeli hepatitis B, lahko zdravilo Arzerra povzroči ponovno aktiviranje bolezni.
What you need to know before you are given Arzerra
Kaj morate vedeti, preden boste prejeli zdravilo Arzerra
There are no data on the effects of ofatumumab on human fertility.
Podatkov o učinkih ofatumumaba na plodnost pri človeku ni.
The overall safety profile of ofatumumab is based on data from 1,168 patients in clinical trials in CLL (see section 5.1).
Ocena celotnega varnostnega profila ofatumumaba temelji na podatkih 1.168 bolnikov v kliničnih študijah KLL (glejte poglavje 5.1).
*These events are likely attributable to ofatumumab in the setting of an infusion-related reaction and typically occur after the start of infusion and within 24 hours after the completion of the infusion (see section 4.4).
* Te učinke je verjetno mogoče pripisati ofatumumabu v okviru z infundiranjem povezanih reakcij; običajno se pojavijo po začetku infundiranja in v 24 urah po koncu infundiranja (glejte poglavje 4.4).
Store the diluted infusion solution between 2C and 8 C and use within 24 hours.
Razredčeno raztopino za infundiranje shranjujte pri temperaturi od 2 C do 8 C in jo uporabite v 24 urah.
Although limited formal drug-drug interaction data exist for ofatumumab, there are no known clinically significant interactions with other medicinal products.
Formalnih podatkov o medsebojnem delovanju zdravil je za ofatumumab sicer malo, a znanih klinično pomembnih interakcij z drugimi zdravili ni.
Post-natal recovery has therefore not been demonstrated.
Postnatalno okrevanje tako ni bilo ugotovljeno.
A diagnosis of PML should be considered in any Arzerra patient who reports the new onset of or changes in pre-existing neurological signs and symptoms.
Na diagnozo PML je treba pomisliti pri vsakem bolniku, ki dobiva zdravilo Arzerra in navaja novonastale nevrološke znake in simptome ali spremembo že prej obstoječih znakov in simptomov.
Arzerra must not be mixed with, or administered as an infusion with other medicinal products or intravenous solutions.
Zdravila Arzerra se ne sme mešati z drugimi zdravili ali je dajati kot infuzije z drugimi zdravili ali intravenskimi raztopinami.
The excretion of ofatumumab in milk has not been studied in animals.
Izločanje ofatumumaba v mleku pri živalih ni raziskano.
With a median follow-up of approximately 34 months, 67 deaths (37%) in the OFA+FC arm and 69 deaths (38%) in the FC arm were reported.
Z medianim trajanjem opazovanja približno 34 mesecev je bilo poročanih 67 smrti (37%) v skupini OFA+FC in 69 smrti v skupini FC.
Peripheral B-cell counts remained low throughout the remainder of therapy in most patients and remained below baseline up to 15 months after the last dose in patients who responded.
Število perifernih celic B je pri večini bolnikov ostalo nizko ves preostali čas zdravljenja in je pri bolnikih, ki so se odzvali, ostalo nižje od izhodiščnega števila do 15 mesecev po zadnjem odmerku.
Common side effects that may show up in your blood tests: • low levels of platelets in the blood (cells that help blood to clot).
Pogosti neželeni učinki, ki se lahko pokažejo na preiskavah krvi: • majhno število trombocitov v krvi (celic, ki sodelujejo pri strjevanju krvi).
65 (6%) of the 1,168 patients experienced a fatal infection.
Pri 65 (6 %) od 1.168 bolnikov se je pojavila okužba s smrtnim izidom.
Approximately 90% of patients received 3-6 cycles of ofatumumab and 66% completed 6 cycles.
Približno 90 % bolnikov je prejelo 3-6 ciklusov ofatumumaba in 66 % bolnikov je zaključilo 6 ciklusov.
Arzerra is therefore not recommended for use in this patient population.
Zato se uporabe zdravila Arzerra pri tej skupini bolnikov ne priporoča.
The duration of response was 16 weeks (CI: 13, 19) and the time to next CLL therapy was 52.4 weeks (CI: 36.9 - non-estimable).
Odziv je trajal 16 tednov (IZ: od 13 do 19), čas do naslednjega zdravljenja KLL pa je bil 52,4 tedna (IZ: od 36,9 do neocenljivo).
Concentrate for solution for infusion (sterile concentrate).
Koncentrat za raztopino za infundiranje (sterilni koncentrat).
If you have been previously treated for CLL but the disease returns you will have a maximum of 7 infusions.
Če ste se že zdravili zaradi KLL, a se je bolezen pri vas ponovila, boste dobili največ 7 infuzij.
Serum samples from more than 1,000 patients across the CLL clinical programme were tested for anti-ofatumumab antibodies during and after treatment periods ranging from 8 weeks to 2 years.
Vzorce seruma več kot 1.000 bolnikov v celotnem kliničnem programu pri KLL so testirali glede protiteles proti ofatumumabu med zdravljenjem in v obdobju od 8 tednov do 2 leti po zdravljenju.
The usual dose of Arzerra for the first infusion is 300 mg.
Običajen odmerek zdravila Arzerra za prvo infundiranje je 300 mg.
If you have any questions on the use of Arzerra, ask the doctor or nurse who is giving you the infusion.
Če imate vprašanja o uporabi zdravila Arzerra, se posvetujte z zdravnikom ali medicinsko sestro, ki vam daje infuzijo.
The majority of patients (81%) received 1-2 prior lines of treatments (of whom approximately 50% received 1 prior treatment) and 21% of patients had received prior rituximab.
Večina bolnikov (81 %) je prejela 1-2 predhodni liniji zdravljenja (med njimi je približno 50 % prejelo eno predhodno zdravljenje).
Reactivation of HBV replication is often followed by hepatitis, i.e. increase in transaminase levels and, in severe cases, increase in bilirubin levels, liver failure, and death.
Reaktivaciji replikacije HBV pogosto sledi hepatitis, tj. zvišanje ravni transaminaz in, v hudih primerih, zvišanje koncentracije bilirubina, odpoved jeter in smrt.
How it is given Arzerra is given into a vein (intravenously) as an infusion (a drip) over several hours.
Zdravilo Arzerra se daje v veno (intravensko) kot infuzija (kapalna) v obdobju nekaj ur.
Age ≥75 years (n=119) Co-morbidity 0 or 1 (n=126) Co-morbidity 2 or more (n=321) ECOG 0, 1 (n=411) ECOG 2 (n=35)
Starost ≥ 75 let (n = 119) Komorbidnost 0 ali 1 (n = 126) Komorbidnost 2 ali več (n = 321) ECOG 0, 1 (n = 411) ECOG 2 (n = 35)
However, patients with hepatic impairment are unlikely to require dose modification (see section 5.2).
Vendar ni verjetno, da bi bolniki z okvaro jeter potrebovali prilagoditev odmerka (glejte poglavje 5.2).
If you are having any vaccinations tell your doctor, or the person giving you the vaccine, that you are being treated with Arzerra.
Če imate predvideno kakšno cepljenje, morate zdravniku ali osebi, ki vam da cepivo, povedati, da se zdravite z zdravilom Arzerra.
Patients with a history of decreased pulmonary function may be at a greater risk for pulmonary complications from severe reactions and should be monitored closely during infusion of Arzerra.
Bolniki z anamnezo zmanjšane pljučne funkcije imajo lahko večje tveganje pljučnih zapletov zaradi hudih reakcij, zato jih je treba med infundiranjem zdravila Arzerra natančno kontrolirati.
None of the patients had an increase of QTc to >500 msec. A concentration dependent increase in QTc was not detected.
Nobenemu bolniku se QTc ni podaljšal za > 500 msec. Od koncentracije odvisnega podaljšanja QTc niso odkrili.
Hepatitis B infection and reactivation, progressive multifocal leukoencephalopathy
okužba in reaktivacija okužbe z virusom hepatitisa B, progresivna multifokalna levkoencefalopatija
Medicines of this type (monoclonal antibodies) can cause infusion-related reactions, which are occasionally severe, and can cause death.
Zdravila te vrste (monoklonska protitelesa) lahko povzročijo z infundiranjem povezane reakcije, ki so včasih hude in lahko povzročijo smrt.
IRC-assessed secondary outcome
Sekundarni izid po oceni IRC
The effect of multiple doses of Arzerra on the QTc interval was evaluated in a pooled analysis of three open-label studies in patients with CLL (N=85).
Vpliv večkratnih odmerkov zdravila Arzerra na interval QTc so ocenili v kumulativni analizi treh odprtih študij pri bolnikih s KLL (N = 85).
The response rate in patients with prior rituximab therapy was 38% (95% CI: 23, 61).
Delež odziva pri bolnikih, predhodno zdravljenih z rituksumabom, je bil 38 % (95 % IZ: 23, 61).
• 300 mg on day 1 followed 1 week later by
• 300 mg 1. dan, nato čez 1 teden nadaljevanje z
Medicines of this type (monoclonal antibodies) can cause infusion reactions when they are injected into the body.
Zdravila te vrste (monoklonska protitelesa) lahko med injiciranjem v telo povzročijo infuzijske reakcije.
Based on available safety and efficacy data in the elderly, no dose adjustment is required (see section 5.2).
Na podlagi dosegljivih podatkov o varnosti in učinkovitosti, zbranih pri starejših osebah, odmerka ni treba prilagajati (glejte poglavje 5.2).
Live attenuated or inactivated vaccine efficacy may be impaired with ofatumumab.
Učinkovitost živih oslabljenih ali inaktiviranih cepiv se lahko zaradi ofatumumaba poslabša.
Pharmacotherapeutic group: antineoplasic agents, monoclonal antibodies, ATC code: L01XC10
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka ATC: L01XC10
As anticipated, a reduction in the IgG humoral immune response to keyhole limpet haemocyanin was noted, but there were no effects on delayed-type hypersensitivity responses.
Po pričakovanju so zabeležili manjši humoralni imunski odziv IgG na hemocianin školjke, ni pa bilo nobenih učinkov na pozno preobčutljivost.
What Arzerra is and what it is used for What you need to know before you are given Arzerra How Arzerra is given
Kaj je zdravilo Arzerra in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Arzerra
Other medicines and Arzerra
Druga zdravila in zdravilo Arzerra
The infusion must be completed within 24 hours after preparation.
Infundiranje mora biti dokončano v 24 urah po pripravi.
Intravenous administration of ofatumumab to pregnant cynomolgus monkeys at 100 mg/kg once weekly from days 20 to 50 of gestation did not elicit maternal or foetal toxicity or teratogenicity.
Intravensko dajanje ofatumumaba nosečim opicam cynomolgus v odmerku 100 mg/kg enkrat na teden od 20. do 50. dneva gestacije ni izzvalo toksičnih učinkov pri samici ali plodu in tudi ni imelo teratogenih učinkov.
Arzerra was also given to a group of patients (n=112) with bulky lymphadenopathy (defined as at least one lymph node >5 cm) who were also refractory to fludarabine.
Zdravilo Arzerra so dajali tudi skupini bolnikov (n = 112) z masivno limfadenopatijo (opredeljeno kot vsaj ena bezgavka > 5 cm), ki so bili prav tako neodzivni na fludarabin.
Before each infusion of Arzerra, you will be given pre-medication - medicines which help to reduce any infusion reactions.
Zdravila, uporabljena pred vsakim infundiranjem Pred vsakim infundiranjem zdravila Arzerra boste dobili t. i. premedikacijo - zdravila, ki pomagajo zmanjšati reakcije, povezane z infundiranjem.
Approximately 60% of patients received 3-6 cycles of Arzerra and 32% received 7-12 cycles.
Približno 60 % bolnikov je dobilo od 3 do 6 ciklusov zdravila Arzerra in 32 % jih je dobilo od 7 do 12 ciklusov.
Ofatumumab is a human monoclonal antibody (IgG1) that binds specifically to a distinct epitope encompassing both the small and large extracellular loops of the CD20 molecule.
Ofatumumab je humano monoklonsko protitelo (IgG1), ki se specifično veže na poseben epitop, ki zajema tako male kot velike zunajcelične zanke molekule CD20.
If you have not been previously treated for CLL you will have a maximum of 13 infusions.
Če se do zdaj še niste zdravili zaradi KLL, boste dobili največ 13 infuzij.
You will be given an infusion once a week for eight weeks.
Osem tednov boste dobivali po eno infuzijo na teden.
Two percent of the infusion-related reactions led to discontinuation of treatment.
V 2 % so z infundiranjem povezane reakcije povzročile prenehanje zdravljenja.
Adverse reactions reported in patients treated with ofatumumab as monotherapy and with ofatumumab in combination with chemotherapy, are listed below by MedDRA body system organ class and by frequency, using 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).
Neželeni učinki, opisani pri bolnikih, zdravljenih z ofatumumabom v monoterapiji in z ofatumumabom v kombinaciji s kemoterapijo, so navedeni spodaj po organskih sistemih MedDRA in pogostnosti v skladu z naslednjim dogovorom: 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), ni znano (ni mogoče oceniti iz razpoložljivih podatkov).