natgillin/translations-raw huggingface dataset:
In response to the questions related to toxicity, the applicant argues that due to the pharmacologic effect of ephedrine and the individual variation in receptor density no safety margin can be determined and increasing doses will be associated to increased intensity and frequency of well known adverse effects. 
Vlagatelj na vprašanja o toksičnosti odgovarja z ugotovitvijo, da zaradi farmakološkega učinka efedrina in variacije med posameznimi živalmi glede gostote receptorjev, ni mogoče določiti varnostne meje, višanje odmerka pa bo povezano z intenzivnostjo in pogostostjo dobro poznanih neželenih učinkov.
For the reason of very limited treatment options, high risk of euthanasia if treatment fails or is not affordable, ephedrine is a substance of other eventual choice - Propalin instead Enurace and vice versa, considering that sympathicomimetic treatment of urinary incontinence is far better than hormonal treatment (an alternative is surgical therapies as colposuspension, urethropexy and the endoscopic injection of collagen in refractory cases). 
Ker je pri urinski inkontinenci zelo malo možnosti za zdravljenje in obstaja veliko tveganje evtanazije, če zdravljenje ne uspe ali ni finančno dostopno, velja zdravilo efedrin kot druga alternativna možnost, tj. zdravilo Propalin namesto zdravila Enurace in obratno, zlasti če upoštevamo, da je simpatikomimetično zdravljenje urinske inkontinence veliko boljše od hormonskega zdravljenja (alternativna možnost so kirurški posegi, kot so kolposuspenzija, uretropeksija in endoskopsko injiciranje kolagena v neodzivnih primerih).
Efficacy data are connected to several shortcomings and the amount of data available is sparse. 
Podatkov o učinkovitosti je malo in imajo več pomanjkljivosti.
There is no doubt that treatment of the dog with Enurace may involve an occurrence of adverse reactions due to peculiar activity of ephedrine. 
Zdravljenje psic z zdravilom Enurace nedvomno lahko vključuje pojav neželenih učinkov zaradi posebnosti efedrina.
The data provided by the applicant show that Enurace 50 is an effective medicinal product for treatment of urinary incontinence in ovariohysterectomised bitches. 
Podatki, ki jih je predložil vlagatelj, kažejo, da je zdravilo Enurace 50 učinkovito zdravilo za zdravljenje urinske inkontinence pri psicah z ovariohisterektomijo.
Taking the benefit of the treatment into account and the relatively low level of adverse effects, as it appears from PMS studies, the risk/benefit balance is considered favourable. 
Če upoštevamo koristne učinke zdravljenja in relativno nizko pojavnost neželenih učinkov, ki je razvidna iz postmarketinških raziskav, se lahko šteje, da je razmerje med tveganji in koristmi ugodno.
ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER 
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, ŽIVALSKIH VRST, POTI UPORABE ZDRAVILA IN IMETNIKOV DOVOLJENJA ZA PROMET
The use of human labelled preparations or dosage forms obtained from a compounding pharmacy which contain ephedrine constitute a much more dangerous alternative for treatment of urinary incontinence in dogs if the product with a marketing authorisation and a proved efficacious use in the RMS for many years is not available. 
Uporaba pripravkov, označenih za človeka, ali oblik odmerjanja, pridobljenih iz sestavljenih zdravil, ki vsebujejo efedrin, predstavljajo veliko bolj nevarno alternativo za zdravljenje urinske inkontinence pri psih v primeru, če zdravilo z dovoljenjem za promet in dokazano učinkovitostjo v referenčni državi članici več let ne bo dostopno.
The dog's cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment. 
Pred zdravljenjem z Enurace 50 je treba pozorno preveriti delovanje kardiovaskularnega sistema psa in ga med zdravljenjem periodično nadzorovati.
Italy could accept the application with revised wording in the SPC . 
Italija bi lahko sprejela vlogo s popravljenim besedilom Povzetka glavnih značilnosti zdravila.
With regard to the related to cardiovascular diseases, the SPC is to be modified under section 4.5 to include the sentence “the dog's cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment”. 
Glede srčno-žilnih bolezni je treba poglavje 4.5 Povzetka glavnih značilnosti zdravila dopolniti s stavkom „pred začetkom zdravljenja z zdravilom Enurace 60 je treba natančno določiti funkcionalnost srca in ožilja ter to funkcionalnost redno spremljati v času zdravljenja“.
Section 4.5 of the SPC and Section 12 of the Package Leaflet: 
poglavje 4.5 v Povzetku glavnih značilnosti zdravila in poglavje 12 Navodila za uporabo:
50 mg Female dogs 
50 mg Psice Samo za peroralno uporabo skupaj s hrano
Special precautions for use 
4.5 Posebni previdnostni ukrepi
The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) for a 60 day procedure in accordance with Article 33(1) of Directive 2001/82/EC, as amended. 
Zadeva je bila skladno s členom 33(1) Direktive 2001/82/ES, kakor je bila spremenjena, napotena na Koordinacijsko skupino za medsebojno priznavanje in decentralizirane postopke CMD(v).
Although toxicity data for the target animal may be scarce, the adverse effects connected to ephedrine treatment are well known from human use, and the applicant has provided some post-marketing information regarding the use in dogs. 
Čeprav je podatkov o toksičnosti za ciljno žival malo, so neželeni učinki zdravljenja z efedrinom dobro poznani pri ljudeh.
Treatment is given in 28-day cycles. 
Zdravljenje poteka v 28-dnevnih ciklih.
Further information on Empliciti can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/empliciti. 
Nadaljnje informacije o zdravilu Empliciti so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/empliciti.
Empliciti received a marketing authorisation valid throughout the EU on 11 May 2016. 
Za zdravilo Empliciti je bilo 11. maja 2016 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency therefore decided that Empliciti's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Empliciti večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Empliciti? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Empliciti?
What is Empliciti and what is it used for? 
Kaj je zdravilo Empliciti in za kaj se uporablja?
What benefits of Empliciti have been shown in studies? 
Kakšne koristi zdravila Empliciti so se pokazale v študijah?
It is given once a week for the first 2 cycles and less frequently in subsequent cycles. 
V prvih dveh ciklih zdravljenja se daje enkrat na teden, v naslednjih ciklih pa manj pogosto.
Other information about Empliciti 
Druge informacije o zdravilu Empliciti
Why is Empliciti authorised in the EU? 
Zakaj je bilo zdravilo Empliciti odobreno v EU?
As for all medicines, data on the use of Empliciti are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Empliciti stalno spremljajo.
Although side effects, particularly infections, were more common with Empliciti, the risks on the whole appear manageable. 
Čeprav so bili neželeni učinki, zlasti okužbe, pri zdravilu Empliciti pogostejši, se zdijo tveganja zdravila v splošnem obvladljiva.
Side effects reported with Empliciti are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Empliciti, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Empliciti have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Empliciti upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
An overview of Empliciti and why it is authorised in the EU 
Pregled zdravila Empliciti in zakaj je odobreno v EU
The dose of Empliciti depends on the patient's weight. 
Odmerek zdravila Empliciti je odvisen od bolnikove telesne mase.
What are the risks associated with Empliciti? 
Kakšna tveganja so povezana z zdravilom Empliciti?
The most common side effects with Empliciti (which may affect more than 1 in 10 people) are headache, tiredness, fever, diarrhoea, sore throat, nose and throat infections, cough, pneumonia (lung infection), low levels of white blood cells and weight loss. 
Najpogostejši neželeni učinki zdravila Empliciti (ki se lahko pojavijo pri več kot 1 bolniku od 10) so glavobol, utrujenost, povišana telesna temperatura, driska, vnetje žrela, okužbe nosu in žrela, kašelj, pljučnica (pljučna okužba), nizke ravni belih krvnih celic in zmanjšanje telesne mase.
Elotuzumab also attaches to SLAMF7 on the cancer cells, making them more vulnerable to attack by the immune cells. 
Elotuzumab se veže tudi na SLAMF7 na rakavih celicah, ki tako postanejo bolj ranljive za napad imunskih celic.
For more information about using Empliciti, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Empliciti glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
In addition, the cancer cleared partially or completely in 79% of patients treated with the Empliciti combination compared with 66% of patients treated with the other two medicines. 
Poleg tega je bil rak delno ali v celoti odpravljen pri 79 % bolnikov, zdravljenih z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom, v primerjavi s 66 % bolnikov, ki so bili zdravljeni z drugima dvema zdraviloma.
A second main study involved 117 multiple myeloma patients who had received at least two other treatments previously, including a proteasome inhibitor and lenalidomide. 
V drugo glavno študijo je bilo vključenih 117 bolnikov z multiplim mielomom, ki so predhodno prejeli vsaj dve drugi zdravljenji, vključno z zaviralci proteazoma in lenalidomidom.
The active substance in Empliciti, elotuzumab, is a monoclonal antibody that attaches to SLAMF7, a protein on immune cells, causing the cells to attack the multiple myeloma cancer cells and thereby slow down the disease. 
Učinkovina v zdravilu Empliciti, elotuzumab, je monoklonsko protitelo, ki se veže na SLAMF7, tj. beljakovino na površini imunskih celic, kar povzroči, da celice začnejo napadati rakave celice multiplega mieloma in tako upočasnijo napredovanje bolezni.
Adding Empliciti to lenalidomide and dexamethasone can delay the worsening of multiple myeloma and improve clearance of the cancer in patients whose disease did not improve with previous treatment or whose disease came back. 
Dodajanje zdravila Empliciti k lenalidomidu in deksametazonu lahko upočasni slabšanje stanja multiplega mieloma in izboljša možnosti za odstranitev raka pri bolnikih, pri katerih se bolezen s prejšnjim zdravljenjem ni izboljšala ali se je ponovila.
To prevent infusion reactions, the patient is given an anti-inflammatory medicine, an antihistamine and paracetamol before every infusion. 
Bolnik mora za preprečitev reakcij na infundiranje pred vsakim dajanjem zdravila prejeti protivnetno zdravilo, antihistaminik in paracetamol.
How is Empliciti used? 
Kako se zdravilo Empliciti uporablja?
For the full list of side effects and restrictions of Empliciti, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Empliciti glejte navodilo za uporabo.
All patients had previously received other treatments but the treatments had not worked or the cancer had come back. 
Vsi bolniki so pred tem že bili zdravljeni, vendar brez uspeha oziroma se je bolezen ponovila.
Treatment must be started and supervised by a doctor experienced in treating multiple myeloma, and the medicine can only be obtained with a prescription. 
Zdravljenje mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem multiplega mieloma.
In patients who had already been treated with at least two treatments including a proteasome inhibitor and lenalidomide (and the treatment had not worked or the disease had come back), Empliciti plus pomalidomide and dexamethasone delayed worsening of the disease, compared with just pomalidomide and dexamethasone. 
Pri bolnikih, ki so že bili zdravljeni z vsaj dvema drugima zdraviloma, vključno z zaviralcem proteazoma in lenalidomidom (vendar zdravljenje ni bilo uspešno ali pa se je bolezen ponovila), je zdravilo Empliciti v kombinaciji s pomalidomidom in deksametazonom podaljšalo čas do poslabšanja bolezni v primerjavi z zdravljenjem samo s pomalidomidom in deksametazonom.
Patients treated with a combination of Empliciti plus pomalidomide and dexamethasone lived on average for over 5.5 months longer without their disease getting worse compared with patients treated with pomalidomide and dexamethasone. 
Bolniki, ki so se zdravili s kombinacijo zdravila Empliciti ter pomalidomida in deksametazona, so v povprečju živeli več kot 5,5 meseca dlje brez poslabšanja bolezni v primerjavi z bolniki, ki so se zdravili s pomalidomidom in deksametazonom.
In a main study of 646 multiple myeloma patients a combination of Empliciti plus lenalidomide and dexamethasone was compared with only lenalidomide and dexamethasone. 
V glavni študiji s 646 bolniki z multiplim mielomom so zdravilo Empliciti v kombinaciji z lenalidomidom in deksametazonom primerjali s kombinacijo lenalidomida in deksametazona.
It is used together with two other medicines (lenalidomide and dexamethasone) and is given to adults who have received at least one previous cancer treatment. 
Uporablja se v kombinaciji z dvema drugima zdraviloma (lenalidomidom in deksametazonom) pri odraslih bolnikih, ki so pred tem že prejemali vsaj eno drugo zdravilo za zdravljenje raka.
The average time before the disease got worse was 18.5 months in patients treated with the Empliciti combination compared with 14.3 months in those treated with just lenalidomide and dexamethasone. 
Povprečni čas do poslabšanja bolezni je bil 18,5 meseca pri bolnikih, zdravljenih z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom, v primerjavi s 14,3 meseca pri bolnikih, zdravljenih samo z lenalidomidom in deksametazonom.
Patients' previous treatment should have included the multiple myeloma medicines lenalidomide and a class of medicines called proteasome inhibitors (e.g. bortezomib, carfilzomib and ixazomib). 
Predhodno zdravljenje mora vključevati zdravilo lenalidomid in enega od zdravil iz razreda zaviralcev proteazoma (npr. bortezomib, karfilzomib in iksazomib), ki se uporabljajo za zdravljenje multiplega mieloma.
The patient is also given other cancer medicines (dexamethasone with either lenalidomide or pomalidomide) during each cycle. 
Bolnik v vsakem ciklu zdravljenja prejme tudi druga zdravila za zdravljenje raka (deksametazon v kombinaciji z lenalidomidom ali pomalidomidom).
Empliciti is given as an infusion (drip) into a vein. 
Zdravilo Empliciti se daje z infundiranjem (kapalno infuzijo) v veno.
Empliciti is also used together with the medicines pomalidomide and dexamethasone to treat multiple myeloma that was previously treated with at least two other treatments but the cancer had come back. 
Zdravilo Empliciti se uporablja tudi v kombinaciji s pomalidomidom in deksametazonom za zdravljenje multiplega mieloma, ki je bil predhodno že zdravljen z vsaj dvema drugima zdraviloma, vendar se je rak ponovil.
Empliciti is a medicine for treating multiple myeloma (a cancer of the bone marrow). 
Empliciti je zdravilo za zdravljenje multiplega mieloma (raka kostnega mozga).
Empliciti contains the active substance elotuzumab. 
Zdravilo Empliciti vsebuje učinkovino elotuzumab.
How does Empliciti work? 
Kako zdravilo Empliciti deluje?
If you see more than one drop: 
Če vidite več kot eno kapljo:
What do the arrows mean? 
Kaj pomenijo puščice?
This is normal. 
To je običajno.
If it is not, do not use. 
Če ni, je ne uporabite.
Date of first authorisation: 20 November 2006 Date of latest renewal: 22 July 2016 
Datum prve odobritve: 20. november 2006 Datum zadnjega podaljšanja: 22. julij 2016
• unusual taste in the mouth 
• nenavaden okus v ustih
The injection is complete when: 
Injiciranje je končano, ko:
• loss of energy and strength 
• izguba energije in moči
The arrows mean you are ready for the next step. 
Puščice pomenijo, da ste pripravljeni za naslednji korak.
It is not known if this medicine may harm your unborn child. 
Ni znano ali lahko to zdravilo škoduje vašemu nerojenemu otroku.
Continue to follow your food and exercise plan. 
Nadaljujte s sledenjem vašega načrta prehranjevanja in telesne vadbe.
It will not harm you or affect your dose. 
Ne bo vam škodoval ali vplival na vaš odmerek.
Twice daily 
dvakrat dnevno
Replace the needle and repeat the step above. 
Zamenjajte iglo in ponovite zgornji korak.
Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or using machines). 
Prosimo, imejte to možno težavo v mislih v vseh situacijah, v katerih lahko sebe ali druge izpostavite tveganju (npr. vožnja avtomobila ali uporaba strojev).
GETTING STARTED 
KAKO ZAČETI
Then, move on to section 2 - getting started. 
Nato nadaljujte s poglavjem 2 - kako začeti.
Do not give this medicine to children and adolescents less than 18 years as there is no experience with this medicine in this age group. 
Tega zdravila ne dajajte otrokom in mladostnikom, mlajšim od 18 let, ker z uporabo tega zdravila v tej starostni skupini ni izkušenj.
A small drop of liquid may appear. 
Lahko se pojavi majhna kaplja tekočine.
- How to inject this medicine. 
- Kako si injicirati to zdravilo.
• You may not have received your full dose. 
• Morda niste prejeli vašega celotnega odmerka.
Do not inject another dose. 
Ne injicirajte si še enega odmerka.
Do not change your dose unless your doctor has told you to. 
Vašega odmerka ne spreminjajte, razen če vam je to predpisal vaš zdravnik.
You should see your doctor immediately if you experience symptoms such as 
Takoj se obrnite na svojega zdravnika, če imate simptome kot so
• Wash hands prior to use. 
• Pred uporabo si umijte roke.
(See section 3 “How to use Byetta”). 
(Glejte poglavje 3 “Kako uporabljati zdravilo Byetta”).
How do I throw away my needles? 
Kako naj zavržem moje igle?
Lipid profiles should be monitored regularly. 
Redno moramo nadzorovati profile maščob.
• You are now ready for your first dose of Byetta. 
• Sedaj ste pripravljeni za vaš prvi odmerek zdravila Byetta.
Spontaneous reports data (unknown denominator) 
Spontano prijavljeni podatki (neznan imenovalec).
COMMONLY ASKED QUESTIONS 
POGOSTA VPRAŠANJA
Swords Laboratories T/A Lawrence Laboratories Unit 12 Distribution Centre, Shannon Industrial Estate, Shannon, Co. Clare Ireland 
Swords Laboratories T/A Lawrence Laboratories Unit 12 Distribution Centre, Shannon Industrial Estate, Shannon, Co. Clare Irska
These reductions in HbA1c were generally observed at 12 weeks after initiation of treatment. 
Ta zmanjšanja HbA1c so navadno opazili 12 tednov po začetku zdravljenja.
How can I tell when the injection is complete? 
Kako vem, kdaj je injiciranje končano?
The mean age of subjects was 59 years and the mean duration of diabetes was 12.3 years. 
Srednja starost je bila 59 let in srednje trajanje diabetesa 12,3 let.
These instructions do not take the place of talking with your healthcare professional about your medical condition or your treatment. 
Ta navodila ne nadomeščajo odgovorov zdravstvenega delavca glede vašega zdravstvenega stanja ali vašega zdravljenja.
Use this medicine at any time within the 60 minutes (1 hour) before your meal. 
To zdravilo uporabite kadarkoli v roku 60 minut (1 ure) pred vašim obrokom.
You may remove them with an alcohol wipe or alcohol swab. 
Odstranite jih lahko z alkoholnim robčkom ali alkoholno krpico.
• This pen is not recommended for use by people who are blind or who cannot see well enough. 
• Tega injekcijskega peresnika ne priporočamo uporabljati slepim ali osebam, ki ne vidijo dovolj dobro.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznam EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Consult with your healthcare professional about how to handle a partial dose. 
Posvetujte se s svojim zdravstvenim delavcem, kako ravnati v primeru delnega odmerka.
Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis. 
Uporabo agonistov receptorjev GLP-1 povezujejo s tveganjem za razvoj akutnega pankreatitisa.
Also contains metacresol. 
Vsebuje tudi metakrezol.
If you stop using this medicine this can affect your blood sugar levels. 
Če prenehate uporabljati to zdravilo, lahko to vpliva na vašo raven sladkorja v krvi.
Hypoglycaemia may reduce your ability to concentrate. 
Hipoglikemija lahko zmanjša vašo sposobnost za koncentracijo.
Animal studies did not indicate direct harmful effects with respect to fertility or pregnancy. 
Študije na živalih niso pokazale neposrednih škodljivih učinkov glede plodnosti ali nosečnosti.
Read and follow the directions in this section only after you've read section 1-what you need to know about your Byetta pen. 
Preberite in sledite navodilom v tem poglavju šele potem, ko ste prebrali poglavje 1 - kaj morate vedeti o vašem injekcijskem peresniku Byetta.
• Hives and difficulties to breathe 
• izpuščaj in težave z dihanjem
• increased sweating 
• povečano znojenje
An additional 6% of patients had higher titre antibodies at 30 weeks. 
Dodatnih 6 % bolnikov je po 30 tednih imelo višje titre protiteles.
These arrows show the direction to pull or turn the dose knob in the next step. 
Te puščice kažejo smer za izvlečenje ali obračanje gumba za odmerjanje v naslednjem koraku.
Exenatide should not be used during pregnancy and the use of insulin is recommended. 
Eksenatida ne smemo uporabljati med nosečnostjo in priporoča se uporaba insulina.
There are no adequate data from the use of exenatide in pregnant women. 
O uporabi eksenatida pri nosečih ženskah nimamo ustreznih podatkov.
What if I cannot pull, turn, or push the dose knob? 
Kaj naj storim, če ne morem izvleči, obračati ali pritisniti gumba za odmerjanje?
The safety and efficacy of exenatide in children and adolescents under 18 years of age have not been established (see section 5.2). 
Varnosti in učinkovitosti eksenatida pri otrocih in mladostnikih, mlajših od 18 let, niso ugotovili (glejte poglavje 5.2).
In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products. 
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
• nausea, (nausea is most common when first starting this medicine, but decreases over time in most patients) 
• slabost (slabost je najpogostejša, ko prvič začnete s tem zdravilom, vendar pri večini bolnikov s časom mine)
Frequencies are defined as: 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) and not known (cannot be estimated from the available data). 
Pogostnosti so opredeljene kot: 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) in neznana pogostnost (ni mogoče oceniti na podlagi razpoložljivih podatkov).