natgillin/translations-raw huggingface dataset:
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.
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).
AstraZeneca UK Limited Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA United Kingdom
AstraZeneca UK Limited Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA Velika Britanija
Note: This needs to be done after each injection
Opomba: To je treba narediti po vsakem injiciranju.
In the event of overdose, appropriate supportive treatment (possibly given parenterally) should be initiated according to the patient's clinical signs and symptoms.
V primeru prevelikega odmerjanja je potrebno začeti z ustreznim podpornim zdravljenjem (če je mogoče, danim parenteralno) glede na bolnikove klinične znake in simptome.
• A small air bubble is normal.
• Majhen zračni mehurček je običajen.
No clinically relevant effects on Cmax or AUC were observed.
Klinično pomembnih učinkov na Cmax ali AUC niso opazili.
In most patients who develop antibodies, antibody titres diminish over time and remain low through 82 weeks.
Pri večini bolnikov, ki razvijejo protitelesa, se titri protiteles s časom zmanjšajo in ostanejo nizki v obdobju 82 tednov.
The clinical experience in patients > 75 years is very limited.
Klinične izkušnje pri bolnikih > 75 let so zelo omejene.
It should be injected under the skin and not into a vein or into the muscle.
Injicirajte si ga pod kožo in ne v veno ali v mišico.
When the pen is empty, you cannot use it again.
Ko je injekcijski peresnik prazen, ga ne morete ponovno uporabiti.
Studies in animals have shown reproductive toxicity (see section 5.3).
Študije pri živalih so pokazale reproduktivno toksičnost (glejte poglavje 5.3).
Do not use an extra dose or increase the amount of your next dose to make up for the one you missed.
Ne uporabite dodatnega odmerka in ne povečajte količine vašega naslednjega odmerka, da bi nadomestili odmerek, ki ste ga izpustili.
In addition some other side effects have been reported (frequency not known, cannot be estimated from the available data).
Dodatno so poročali tudi o nekaterih drugih neželenih učinkih (pogostnost ni znana in je ni mogoče oceniti na podlagi razpoložljivih podatkov):
Why are there air bubbles in the cartridge?
Zakaj so v vložku zračni mehurčki?
− Some antibiotics may need to be taken an hour before your Byetta injection.
- nekatere antibiotike bo morda treba vzeti eno uro pred injiciranjem zdravila Byetta.
Your doctor should tell you how to treat low blood sugar.
Vaš zdravnik naj vam pove, kako zdraviti nizek sladkor v krvi.
Now that you have done the New Pen Setup, follow Section 3 for all of your injections.
Sedaj ko ste zaključili pripravo novega injekcijskega peresnika, sledite Poglavju 3 za vse vaše nadaljnje injekcije.
Changes in LDL-C or total cholesterol are possible, however, no predetermined dose adjustment is required.
Spremembe v LDL-C ali skupnem holesterolu so možne, vendar vnaprejšnja prilagoditev odmerka ni potrebna.
Exenatide is not a substitute for insulin.
Eksenatid ni nadomestilo za insulin.
Do not use this medicine after your meal.
Ne uporabite tega zdravila po vašem obroku.
If you are using Byetta and an insulin you must make two separate injections.
Če uporabljate zdravilo Byetta in insulin, morate pripraviti dve ločeni injekciji.
Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain.
Bolnike je potrebno obvestiti o značilnih simptomih akutnega pankreatitisa: vztrajni, hudi bolečini v trebuhu.
With continued therapy, the frequency and severity decreased in most patients who initially experienced nausea.
Z nadaljevanjem zdravljenja sta se pogostnost in resnost zmanjšali pri večini bolnikov, ki so na začetku občutili navzeo.
• The needle may be clogged, bent, or incorrectly attached.
• Igla je morda zamašena, zvita ali nepravilno pritrjena.
If you feel you should stop using this medicine, consult your doctor first.
Če menite, da bi prenehali uporabljati to zdravilo, se o tem najprej posvetujte s svojim zdravnikom.
Beta-cell function
Delovanje beta celic
- If you have type 1 diabetes or diabetic ketoacidosis (a dangerous condition that can occur in diabetes), as you should not use this medicine.
- Če imate sladkorno bolezen tipa 1 ali diabetično ketoacidozo (nevarno bolezensko stanje, ki se lahko pojavi pri sladkorni bolezni), ker ne smete uporabiti tega zdravila.
Instructions for use Byetta is for use by one person only.
Zdravilo Byetta je za uporabo le za eno osebo.
- If you are allergic to exenatide or any of the other ingredients of this medicine (listed in section 6).
- Če ste alergični na eksenatid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
• New Pen Setup is now done.
• Priprava novega peresnika je sedaj zaključena.
This medicine may reduce your appetite, the amount of food you eat, and your weight.
To zdravilo lahko zmanjša vaš apetit, količino zaužite hrane in vašo telesno maso.
Patients receiving medicinal products of either a narrow therapeutic ratio or medicinal products that require careful clinical monitoring should be followed closely.
Bolnike, ki dobivajo zdravila z ozkim terapevtskim razmerjem ali zdravila, ki zahtevajo skrben klinični nadzor, moramo skrbno spremljati.
For this group, the level of glycaemic control (HbA1c) was generally comparable to that observed in those without antibody titres.
Za to skupino je bila stopnja glikemičnega nadzora (HbA1c) na splošno primerljiva s stopnjo, opazovano pri tistih brez titrov protiteles.
If you use more of this medicine than you should, talk to a doctor or go to a hospital right away.
Če ste uporabili večji odmerek tega zdravila, kot bi smeli, se takoj posvetujte z zdravnikom ali odidite v bolnišnico.
Table 2: Combined results of the 30-week placebo-controlled studies (intent to treat patients)
Preglednica 2: Kombinirani rezultati 30 tedenskih, s placebom nadzorovanih študij (na zdravljenje pripravljeni bolniki)
If is in the dose window:
Če je v okencu za odmerjanje :
Gender and race Gender and race have no clinically relevant influence on exenatide pharmacokinetics.
Spol in rasa Spol in rasa nimata klinično značilnega vpliva na farmakokinetiko eksenatida.
These medical conditions can increase your chance of getting pancreatitis, or getting it again, whether or not you are taking this medicine.
Te motnje namreč povečujejo možnost, da dobite (ali znova dobite) pankreatitis, ne glede na to, ali uporabljate to zdravilo ali ne.
The active substance in this medicine slows stomach emptying so food passes more slowly through your stomach.
Zdravilna učinkovina v tem zdravilu upočasni praznjenje želodca, tako da hrana počasneje potuje skozi vaš želodec.
This medicine is for you; never share a Byetta pen with others.
To zdravilo je namenjeno vam osebno; injekcijskega peresnika Byetta nikoli ne delite z drugimi.
Paracetamol was used as a model medicinal product to evaluate the effect of exenatide on gastric emptying.
Paracetamol so uporabili kot model zdravila za vrednotenje učinkov eksenatida na praznjenje želodca.
• Tell your doctorif you have had pancreatitis, gallstones, alcoholism or very high triglycerides.
• Zdravniku morate povedati, če ste kdaj imeli pankreatitis, žolčne kamne, alkoholizem ali zelo visoke trigliceride.
NEEDLE PARTS (Needles Not Included)
SESTAVNI DELI IGLE (igle niso priložene)
If you miss a dose of this medicine, skip that dose and use your next dose at the next prescribed time.
Če ste pozabili na odmerek tega zdravila, ta odmerek izpustite in uporabite vaš naslednji odmerek ob naslednjem predpisanem času.
Pancreatitis can be a serious, potentially life-threatening medical condition.
Pankreatitis je lahko resna in celo smrtno nevarna bolezen.
Read this section completely before you begin.
Preden začnete, natančno preberite to poglavje.
See Commonly Asked Question 4.
Glejte Pogosta vprašanja, vprašanje št. 4.
Nonclinical studies have shown that exenatide is predominantly eliminated by glomerular filtration with subsequent proteolytic degradation.
Neklinične študije so pokazale, da se eksenatid izloča pretežno z glomerulno filtracijo z nadaljnjo proteolitično razgradnjo.
Specific recommendations regarding intake of such medicinal products in relation to immediate-release exenatide is given in section 4.5.
Posebna priporočila glede jemanja takih zdravil v zvezi z eksenatidom v obliki s takojšnjim sproščanjem so podana v poglavju 4.5.
However, exenatide does not impair the normal glucagon response and other hormone responses to hypoglycaemia.
Vendar eksenatid ne poslabša običajnega odgovora glukagona in ostalih hormonov na hipoglikemijo.
Other medicines and Byetta
Druga zdravila in zdravilo Byetta
If an injection is missed, the treatment should be continued with the next scheduled dose.
Če injekcijo izpustimo, moramo zdravljenje nadaljevati z naslednjim načrtovanim odmerkom.
Byetta is not an insulin and should therefore not be used as a substitute for insulin.
Zdravilo Byetta ni insulin in se zato ne sme uporabljati kot njegovo nadomestilo.
• If any part of your pen appears broken or damaged, do not use the pen.
• Če je kateri koli del vašega injekcijskega peresnika videti zlomljen ali poškodovan, tega peresnika ne uporabite.
International normalised ratio increased with concomitant warfarin, some reports associated with bleeding
Povišano mednarodno umerjeno razmerje s sočasno uporabo varfarina, nekaj poročil povezanih s krvavitvijo
• Swelling of theface, tongue or throat(angioedema)
• oteklost obraza, jezika ali žrela (angiodem)
If you are over 70 years old or have problems with your kidneys it may take longer than 30 days to tolerate the Byetta 5 micrograms dose and so your doctor may not increase your dose.
Če ste starejši od 70 let ali imate težave z ledvicami, bo morda potebno več kot 30 dni za doseg tolerance za odmerek 5 mikrogramov (µg) zdravila Byetta in vaš zdravnik odmerka morda ne bo zvišal.
Exenatide has minor influence on the ability to drive and use machines.
Eksenatid ima majhen vpliv na sposobnost vožnje in upravljanja s stroji.
Some of these events occurred in patients experiencing events that may affect hydration, including nausea, vomiting, and/or diarrhoea and/or receiving medicinal products known to affect renal function/hydration status.
Nekateri izmed teh dogodkov so se pojavili pri bolnikih, ki so izkusili stanja, ki lahko vplivajo na hidracijo, vključno z navzeo, bruhanjem in/ali diarejo in/ali so prejemali zdravila z učinkom na delovanje ledvic/stanje hidracije.
The European Medicines Agency has deferred the obligation to submit the results of studies with immediate-release exenatide in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odložila obveznost za predložitev rezultatov študij z eksenatidom v obliki s takojšnjim sproščanjem na eni ali več podskupinah pediatrične populacije z diabetesom mellitusom tipa 2 (za informacije o pediatrični uporabi glejte poglavje 4.2).
Digoxin, lisinopril and warfarin
Digoksin, lizinopril in varfarin
Resolution of pancreatitis has been observed with supportive treatment but very rare cases of necrotising or hemorrhagic pancreatitis and/or death have been reported.
Ob podpornem zdravljenju so opažali izboljšanje pankreatitisa, vendar so opisani tudi zelo redki primeri nekrotizirajočega ali hemoragičnega pankreatitisa in/ali smrt.
Do not use Byetta if it has been frozen.
Zdravila Byetta ne smete uporabiti, če je bilo zamrznjeno.
Examination of antibody-positive specimens from one long-term uncontrolled study revealed no significant cross-reactivity with similar endogenous peptides (glucagon or GLP-1).
Preiskava vzorcev s pozitivnimi protitelesi iz dolgoročne nenadzorovane študije ni pokazala značilne navzkrižne reaktivnosti s podobnimi endogenimi peptidi (glukagon ali GLP-1).
The reactions are listed below as MedDRA preferred term by system organ class and absolute frequency.
Neželeni učinki so navedeni kot MedDRA preferenčni izrazi glede na razred organskega sistema in absolutno pogostnost.
Pharmacotherapeutic group: Glucagon-like peptide-1 (GLP-1) analogues, ATC code: A10BJ01.
Farmakoterapevtska skupina: Analogi glukagonu podobnega peptida-1 (GLP-1), oznaka ATC: A10BJ01.
The experience in patients > 65 years and in patients with impaired renal function is limited.
Izkušnje pri bolnikih > 65 let in pri bolnikih z okvaro ledvic so omejene.
• Do not share your pen or needles as this may risk transmission of infectious agents.
• Svojega injekcijskega peresnika ali igel ne delite z drugimi, saj lahko tvegate prenos okuženih delcev.
The clinical studies comprised 3945 subjects (2997 treated with exenatide), 56% men and 44% women, 319 subjects (230 treated with exenatide) were ≥ 70 years of age and 34 subjects (27 treated with exenatide) were ≥ 75 years of age.
Klinične študije so vključevale 3945 oseb (2997 zdravljenih z eksenatidom), 56 % moških in 44 % žensk, 319 oseb (230 zdravljenih z eksenatidom) je bilo ≥ 70 let in 34 oseb (27 zdravljenih z eksenatidom) je bilo ≥ 75 let.
You should inject this medicine under the skin (subcutaneous injection) of your upper leg (thigh), stomach area (abdomen), or upper arm.
To zdravilo si morate injicirati pod kožo (subkutana injekcija) zgornjega dela vaše noge (stegno), področja trebuha (abdomna) ali nadlakti.
About half of this 6% (3% of the total patients given immediate-release exenatide in the controlled studies), had no apparent glycaemic response to immediate-release exenatide.
Približno polovica teh 6 % (3 % vseh bolnikov, ki so v nadzorovanih študijah dobivali eksenatid v obliki s takojšnjim sproščanjem), je imela nejasen glikemični odgovor na eksenatid v obliki s takojšnjim sproščanjem.
What Byetta is and what it is used for
Kaj je zdravilo Byetta in za kaj ga uporabljamo
Unscrew and dispose of properly.
Odvijte jo ter ustrezno zavrzite.
• Attach a new needle and repeat New Pen Setup, Steps B - E, in Section 2 of this user manual.
• Pritrdite novo iglo in ponovite pripravo novega injekcijskega peresnika, Korake B - E, v Poglavju 2 tega Priročnika za uporabo.
You have diabetes because your body does not make enough insulin to control the level of sugar in your blood or if your body is not able to use the insulin properly.
Sladkorno bolezen imate, ker vaše telo ne proizvede zadosti insulina za nadzor ravni sladkorja v vaši krvi ali ker vaše telo ne more pravilno uporabiti insulina.
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine, as it should not be used during pregnancy.
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo, saj med nosečnostjo zdravila Byetta ne smete uporabljati.
• When it is time for your next routine dose, go to Section 3, Step 1, and repeat Steps 1 -7.
• Ko je čas za vaš naslednji redni odmerek, pojdite na Poglavje 3, Korak 1 ter ponovite Korake
This prevents the liquid from leaking out.
To prepreči iztekanje tekočine.
The amino acid sequence of exenatide partially overlaps that of human GLP-1.
Aminokislinsko zaporedje eksenatida se delno prekriva z zaporedjem humanega GLP-1.
However, if you are also using a sulphonylurea or an insulin your doctor may tell you to check your blood sugar levels to adjust the dose of sulphonylurea or insulin.
Vendar, če uporabljate tudi sulfonilsečnino ali insulin, vam bo vaš zdravnik morda priporočal, da preverjate vaše ravni sladkorja v krvi za prilagoditev odmerka sulfonilsečnine ali insulina.
- Two pre-filled pens are available.
- Na voljo sta dva napolnjena injekcijska peresnika.
• If you do not see a stream or several drops come from the needle tip, repeat Steps C & D.
• Če iz konice igle ne izhaja curek ali nekaj kapelj, ponovite Koraka C in D.
60 doses (2.4 ml)
60 odmerkov (2,4 ml)
This may happen if the skin is pinched too tightly or if the pressure on the injection button is released before the needle is removed from the skin.
Do tega lahko pride, če kožo premočno stiskate ali če popustite pritisk na gumb za injiciranje, preden iglo izvlečete iz kože.
The most frequently reported single adverse reaction was nausea which was associated with the initiation of treatment and decreased over time.
Najpogostejši posamezni neželeni učinek je bila navzea, ki je bila povezana z začetkom zdravljenja in se je sčasoma zmanjšala.