natgillin/translations-raw huggingface dataset:
Common (may affect up to 1 in 10 people) - Severe bleeding or bruising; - Violent shaking (seizures) and loss of consciousness; - Problems with your liver (e.g., change in color of your skin or urine or stool and laboratory results of elevated liver enzymes or bilirubin).
- težave z jetri (npr. spremenjena barva kože ali urina ali blata in rezultati laboratorijskih preiskav, ki kažejo na zvišano raven jetrnih encimov ali bilirubina).
flushing or swelling of the airways, because major allergic reactions to Oncaspar can occur.
- če ste imeli hude alergijske reakcije na druge oblike asparaginaze, npr. srbenje, vročinske oblive in otekanje dihalnih poti, ker lahko pride do hujših alergijskih reakcij na zdravilo Oncaspar;
Method of administration Oncaspar can be given by intramuscular (IM) injection or intravenous (IV) infusion.
Zdravilo Oncaspar se lahko daje z intramuskularno (i.m.)
Acute renal failure may develop in rare cases during treatment with L-asparaginase-containing regimens.
Med zdravljenjem s shemami, ki vsebujejo L-asparaginazo, se lahko v redkih primerih razvije akutna ledvična odpoved.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Oncaspar 750 U/ml powder for solution for injection/infusion.
IME ZDRAVILA IN POT(I) UPORABE Oncaspar 750 e./ml prašek za raztopino za injiciranje/infundiranje.
Serum amylase can rise during and also after the conclusion of Oncaspar therapy.
Med zdravljenjem z zdravilom Oncaspar in po njegovem zaključku se lahko zviša raven amilaze v serumu.
For smaller volumes, the preferred route of administration is intramuscular.
Pri manjših količinah je priporočeno intramuskularno dajanje.
After dilution, the solution should be used immediately.
Raztopino je treba uporabiti takoj po redčenju.
Each vial contains 3,750 U of pegaspargase.
Ena viala vsebuje 3.750 enot pegaspargaze.
In view of the unpredictability of adverse reactions, Oncaspar should be administered only by health care personnel experienced in the use of cancer chemotherapeutic medicinal products.
Zaradi nepredvidljivosti neželenih učinkov lahko zdravilo Oncaspar dajejo le zdravstveni delavci,
Table 3: Pharmacokinetic Parameters After a Single IV Dose of Oncaspar 2,500 U/m2 BSA
odmerke zdravila Oncaspar 2.500 e./m2 BSA.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Oncaspar 750 U/ml solution for injection/infusion.
IME ZDRAVILA IN POT(I) UPORABE Oncaspar 750 e./ml raztopina za injiciranje/infundiranje.
Very common (may affect more than 1 in 10 people) - Changes in the function of the pancreas; - Weight loss; - Leg pain (which could be a symptom of thrombosis), chest pain or shortness of breath (which may be a symptom of blood clots in the lungs, called pulmonary embolism); - Loss of appetite, general weakness, vomiting, diarrhoea, nausea; - Increased blood sugar levels.
- bolečina v nogah (ki je lahko simptom tromboze), bolečina v prsih ali zasoplost (ki sta lahko simptoma krvnih strdkov v pljučih, kar imenujemo pljučna embolija),
Particularly in patients with known hypersensitivity to the other forms of L-asparaginase, hypersensitivity reactions to Oncaspar can occur during the therapy, e.g., anaphylaxis.
zlasti pri bolnikih z znano preobčutljivostjo na druge oblike L-asparaginaze.
Unless otherwise prescribed, the recommended posology in adults aged >21 years is 2,000 U of pegaspargase (equivalent to 2.67 ml Oncaspar)/m2 body surface area every 14 days.
pegaspargaze (ustreza 2,67 ml zdravila Oncaspar)/m2 telesne površine vsakih 14 dni.
Table 2: Event-free survival rate at 3, 5 and 7 years (Study CCG-1962) Oncaspar native E. coli L-asparaginase
V Preglednici 2 je povzeto preživetje brez dogodkov (EFS - event-free survival) v skupini, ki je prejemala zdravilo Oncaspar, in skupini, ki je prejemala nativno L-asparaginazo iz E. coli.
The type of adverse reactions of Oncaspar is similar with that of native non-pegylated L-asparaginase (e.g., native E. coli asparaginase).
Zdravljenje prve izbire (bolniki z ALL brez preobčutljivosti za nativno L-asparaginazo iz E. coli)
If you get any side effects you think might be related to your chemotherapy , talk to your doctor.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom.
Very common: Rash
Zelo pogosti: embolija**
Common (may affect up to 1 in 10 people) - Decreased number of red blood cells; - Build-up of fluid in the stomach (ascites); - Fever and flu-like symptoms; - Mouth sores; - Back, joint or abdominal pain; - High levels of fat and cholesterol in your blood; low potassium in your blood.
- bolečine v hrbtu, sklepih ali trebuhu, - visoka raven maščobe in holesterola v krvi, nizka raven kalija v krvi.
Do not use if the solution is cloudy or a precipitate has formed.
Zdravila ne uporabljajte, če raztopina postane motna ali če nastane oborina.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 3,750 U of pegaspargase After reconstitution, 1 ml of solution contains 750 U of pegaspargase (750 U/ml).
Po rekonstituciji 1 ml raztopine vsebuje 750 enot pegaspargaze (750 e./ml).
Other medicines and Oncaspar Tell your doctor if you are using, have recently used or might use any other medicines This is important as Oncaspar may increase the side effects of other medicines through its effect on the liver which plays an important role in removing medicines from the body.
Zaradi tega zdravila ste lahko bolj dovzetni za okužbe; - če ste imeli slabo delovanje jeter ali uporabljate druga zdravila, ki lahko poškodujejo jetra; Če zdravilo Oncaspar uporabljamo v kombinaciji z drugimi načini zdravljenja raka, se lahko pojavijo poškodbe jeter in centralnega živčnega sistema; - če imate bolečine v trebuhu.
Oncaspar may cause central nervous system dysfunctions manifesting as convulsions, and less frequently confusional state and somnolence (mildly impaired consciousness).
redkeje pa kot stanje zmedenosti in somnolenca (blago oslabljena zavest).
international normalised ratio increased, hypokalaemia, blood cholesterol increased, hypofibrinogenaemia, gamma-glutamyl transferase increased Not known: Blood urea increased, anti-pegaspargase antibodies, neutrophil count decreased, platelet count decreased, hyperammonaemia
Zelo pogosti: zmanjšana telesna masa, hipoalbuminemija, zvišana raven alanin aminotransferaze, zvišana raven aspartat-aminotransferaze, hipertrigliceridemija, znižana raven fibrinogena v krvi, zvišana raven lipaze, zvišana raven amilaze, podaljšan aktivirani parcialni tromboplastinski čas, zvišana raven bilirubina v krvi Pogosti: podaljšan protrombinski čas, zvišano internacionalno normalizirano razmerje, hipokaliemija, zvišana raven holesterola v krvi, hipofibrinogenemija, zvišana raven gama-glutamil transferaze
NAME OF THE MEDICINAL PRODUCT Oncaspar 750 U/ml solution for injection/infusion pegaspargase
IME ZDRAVILA Oncaspar 750 e./ml raztopina za injiciranje/infundiranje
History of pancreatitis, including pancreatitis related to previous L-asparaginase therapy (see section 4.4).
Anamneza pankreatitisa, vključno s pankreatitisom v povezavi s predhodnim zdravljenjem z L
NAME OF THE MEDICINAL PRODUCT Oncaspar 750 U/ml powder for solution for injection/infusion pegaspargase
IME ZDRAVILA Oncaspar 750 e./ml prašek za raztopino za injiciranje/infundiranje
When Oncaspar is used in combination with other cancer treatments, liver and central nervous system damage can occur.
Zaradi tega zdravila ste lahko bolj dovzetni za okužbe; - če ste imeli slabo delovanje jeter ali uporabljate druga zdravila, ki lahko poškodujejo jetra; Če zdravilo Oncaspar uporabljamo v kombinaciji z drugimi načini zdravljenja raka, se lahko pojavijo poškodbe jeter in centralnega živčnega sistema;
There have been rare reports of cholestasis, icterus, hepatic cell necrosis and hepatic failure with fatal outcome.
Poročali so o redkih primerih holestaze, ikterusa,
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
6.1 Seznam pomožnih snovi dinatrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat monohidrat natrijev klorid saharoza natrijev hidroksid (za uravnavanje pH) klorovodikova kislina (za uravnavanje pH)
14 October 2016 EMA/656265/2016 EMEA/H/C/004003
14. oktober 2016 EMA/656265/2016 EMEA/H/C/004003
It was to be used in patients whose disease had come back after previous treatment.
Uporabljalo naj bi se pri bolnicah, pri katerih se je bolezen po predhodnem zdravljenju ponovno pojavila.
The company presented the results of one main study involving 456 patients with ovarian cancer that had come back 6 months or more after one previous treatment with platinum-based medicine.
Družba je predstavila rezultate glavne študije, ki je vključevala 456 bolnic z rakom jajčnikov, ki so se vrnile šest mesecev ali več po enem predhodnem zdravljenju z zdravilom na osnovi platine.
The main measure of effectiveness was the length of time patients lived without their disease getting worse (progression-free survival).
Glavno merilo učinkovitosti je bil čas, ki so ga bolnice preživele brez poslabšanja bolezni (preživetje brez napredovanja).
The company had not responded to the last round of questions at the time of the withdrawal.
Družba v času umika ni odgovorila na zadnja vprašanja.
The CHMP was concerned about the reliability of the study results following a routine inspection at the clinical study sites which revealed that the study had not been conducted in full compliance with Good Clinical Practice (GCP).
Odbor CHMP je imel zadržke o zanesljivosti rezultatov študije zaradi rutinskega inšpekcijskega pregleda na lokacijah klinične študije, s katerim so odkrili, da študija ni bila v celoti opravljena v skladu z dobro klinično prakso.
In addition, the observed improvement in progression-free survival with Zemfirza was considered modest and there were concerns regarding the medicine's side effects, particularly diarrhoea and tiredness, which led to many patients stopping treatment early.
Poleg tega je bilo opaženo izboljšanje preživetja brez napredovanja z zdravilom Zemfirza ocenjeno kot skromno in obstajali so pomisleki o neželenih učinkih zdravila, zlasti driski in utrujenosti, zaradi česar so številne bolnice predčasno prekinile zdravljenje.
On 19 September 2016, AstraZeneca AB officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zemfirza, for the treatment of ovarian cancer.
Družba AstraZeneca AB je dne 19. septembra 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Zemfirza, namenjenim zdravljenju raka jajčnikov.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zemfirza could not have been approved for the treatment of ovarian cancer.
Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil CHMP, je Odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Zemfirza ni mogoče odobriti za zdravljenje raka jajčnikov.
By blocking VEGF receptors, this medicine is expected to reduce blood supply to the cancer cells, thus slowing down the growth and spread of the cancer.
Z zaviranjem receptorjev VEGF naj bi to zdravilo zmanjšalo dotok krvi do rakavih celic ter tako upočasnilo rast in širjenje raka.
What was Zemfirza expected to be used for?
Za kaj naj bi se zdravilo Zemfirza uporabljalo?
In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing its application because of the questions still remaining at this late stage of the review.
Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da se je za umik vloge odločila zaradi vprašanj, ki so v pozni fazi pregleda še vedno ostajala odprta.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Zemfirza had not been shown to outweigh its risks and had requested further clarification from the company.
Zato je CHMP v času umika menil, da koristi zdravila Zemfirza ne odtehtajo z njim povezanih tveganj in je od družbe zahteval dodatna pojasnila.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Zemfirza.
Družba je CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Zemfirza.
Zemfirza was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 29 July 2014 for treatment of ovarian cancer.
Zdravilo Zemfirza je bilo dne 29. julija 2014 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih boleznih) za zdravljenje raka jajčnikov.
Zemfirza was expected to be used to treat women with cancer of the ovaries, including cancer of the fallopian tubes that connect the ovaries to the womb and cancer of the peritoneum (the membrane lining the abdomen).
Zdravilo Zemfirza naj bi se uporabljalo za zdravljenje žensk z rakom jajčnikov, vključno z rakom jajcevodov, ki povezujejo jajčnike z maternico, in rakom peritoneja (sluznice, ki obdaja trebuh).
Withdrawal of the marketing authorisation application for Zemfirza (cediranib)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Zemfirza (cediranib)
The active substance in Zemfirza, cediranib, blocks the activity of ‘vascular endothelial growth factor' (VEGF) receptors.
Zdravilna učinkovina v zdravilu Zemfirza, cediranib, zavira aktivnost receptorjev vaskularnega endotelijskega rastnega faktorja (VEGF).
Zemfirza is a cancer medicine that contains the active substance cediranib.
Zemfirza je zdravilo za zdravljenje raka, ki vsebuje zdravilno učinkovino cediranib.
These receptors are found in high amounts on blood vessel cells and are involved in the development of new blood vessels that supply nutrients to cancer cells.
Ti receptorji so v veliki meri prisotni na celicah krvnih žil in so vključeni v razvoj novih krvnih žil, ki rakavim celicam dovajajo hranila.
How does Zemfirza work?
Kako zdravilo Zemfirza deluje?
What is Zemfirza?
Kaj je zdravilo Zemfirza?
In the study, Zemfirza was compared with placebo (a dummy treatment) and was given together with platinum-based medicines during initial treatment and subsequently on its own during a maintenance period.
V začetnem obdobju so ga dajali skupaj z zdravilom na osnovi platine, v vzdrževalnem obdobju pa samostojno.
Do not
Komplet ne
Higher doses may be justified in some clinical circumstances.
Višje doze so opravičljive v določenih kliničnih okoliščinah.
This material will then be injected into your vein.
Ta pripravek bo potem injiciran v vašo veno.
Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of local competent official organisations.
Njegov prevzem, shranjevanje, uporaba, premeščanje in uničenje so predmet posebnih predpisov in/ali ustreznih pooblastil pristojnih lokalnih uradnih organov.
The doctor can also determine how much disease there is.
Zdravnik lahko določi tudi, kako razširjena je bolezen.
The radiolabelled product should not contain more than 10% free technetium.
Radioaktivno označen pripravek ne sme vsebovati več kot 10% prostega tehnecija.
This dose of radioactivity is safe and will be gone from the body in about 24
Doza radioaktivnosti je varna in se bo izločila iz telesa v 24 urah.
For instructions for preparation see section 6.6.
Za navodila za pripravo glejte poglavje 6.6.
No interactions with other medicines have been described to date.
Medsebojno delovanje z drugimi zdravili do sedaj ni bilo opisano.
This helps your doctor make a diagnosis and evaluate the extent of your illness.
To bo vašemu zdravniku pomagalo postaviti diagnozo in oceniti stopnjo vaše bolezni.
These benefits were also accompanied by a substantial reduction (85.4%) in the number of patients who would require other diagnostic imaging
Te prednosti so bile spremljane tudi z znatnim zmanjšanjem (85,4%) števila bolnikov, ki bi potrebovali druge diagnostične postopke slikanja.
• It does not contain all the information about your medicine that you may need to know, so please refer to the Summary of Product Characteristics or ask your doctor or nurse if you have any questions.
• Navodilo ne vsebuje vseh informacij o zdravilu, ki jih boste morda potrebovali, zato poglejte Povzetek glavnih značilnosti zdravila ali se posvetujte z zdravnikom ali sestro, če imate vprašanja.
Reconstituted and radiolabelled material - 4 hours.
Rekonstituiran in radioaktivno označen material - 4 ure.
% Free Technetium = Activity in top half of strip × 100
% prostega tehnecija = aktivnost v zgornji polovici ploščice x 100
Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Za vsako žensko z izostalo menstruacijo naj velja, da je noseča, dokler ni dokazano nasprotno.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines
Prosimo, da obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če
It should be noted, however, that these studies did not assess genotoxicity, carcinogenic potential, or toxicity to reproduction.
Potrebno pa je upoštevati, da te študije niso ovrednotile genotoksičnosti, karcinogenega potenciala ali vpliva na sposobnost razmnoževanja.
Patients have been given four times the amount you will receive with no adverse reactions.
Bolniki so prejeli štirikrat večjo količino zdravila, kot ga boste prejeli vi, in niso imeli neželenih učinkov.
Post-marketing experience currently comprises greater than 70,000 vials sold, with two reports of self
Postmarketinška izkušnja trenutno zajema preko 70.000 prodanih vial zdravila in 2 poročili o
In vitro, a positive binding to lymphocytes up to 2-6% has been shown.
In vitro je bila pokazana pozitivna vezava na limfocite v obsegu 2-6%.
The resulting solution has a pH of 4.5-5.5 and is intended for intravenous use only.
Tako pripravljena raztopina ima pH 4,5 - 5,5 in je namenjena samo za intravensko uporabo.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 February 1997
DATUM PRIDOBITVE / PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 14. februar 1997
Immunoscintigraphy should be performed one to eight hours after injection.
Imunoscintigrafija naj bo opravljena eno do osem ur po injiciranju.
There are, as yet, limited data on safety following repeated use.
Do sedaj so na razpolago le omejeni podatki o varnosti ponovnega vnosa zdravila.
Administration of LeukoScan to young subjects should only be performed after consideration of the possible risks and benefits to the individual subject.
Vnos zdravila LeukoScan mladim osebam naj se izvede samo po pretehtanju možnih tveganj in koristi za posameznika.
• It is possible to have a serious allergic reaction to LeukoScan.
• Možno je, da na zdravilo LeukoScan odreagirate z resno alergijsko reakcijo.
• If you have any further questions, please ask your doctor.
• Če imate dodatna vprašanja, se posvetujte z zdravnikom.
You produce many different kinds of antibodies.
Telo tvori veliko različnih vrst protiteles.
An antibody is a natural substance made by the body which binds to foreign substances to help remove them from your body.
Protitelo je naravna, v telesu proizvedena snov, ki se veže na tuje snovi z namenom, da bi jih pomagala odstraniti iz vašega telesa.
Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practices (GMP) for pharmaceuticals.
Uporabljati je potrebno ustrezne aseptične previdnostne ukrepe, ki so v skladu z zahtevami dobre proizvodne prakse (GMP) za zdravila.
It is produced in mice and purified so that it can be used in humans.
Nastaja v telesu miši in je prečiščeno, tako, da se lahko uporablja pri ljudeh.
The unreconstituted contents of the vial before radiolabelling are not to be directly administered to patients.
Nerekonstituirana vsebina viale pred označevanjem z radionuklidom ne sme biti direktno aplicirana bolnikom.
If you have any further questions on the use of this product, ask your doctor.
Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom.
The magnitude of these increases were assessed by the investigators to be of no clinical consequence on an individual patient basis.
Raziskovalci so ocenili, da ti porasti niso imeli kliničnih posledic za posameznega bolnika.
Do not store above 25°C.
Shranjujte pri temperaturi do 25ºC.
Add the prepared eluate into the shielded vial, shake and allow the labelling reaction to proceed for ten minutes.
Dodajte pripravljeni eluat v vialo, nameščeno v zaščitnem vsebniku, stresajte in pustite, da reakcija označevanja teče 10 minut.
SPECT acquisition parameters recommended are: 60 projections in a 360o step-and-shoot technique, 30 seconds per view in at least a 64 x 64 matrix.
Priporočeni SPECT parametri so: 60 projekcij v 360° “step-and-shoot” tehniki, 30 sekund za posamezno smer, z matriko najmanj 64 x 64.
• If you know that you are allergic (hypersensitive) to sulesomab or any protein which comes from a mouse, tell your doctor.
• Če veste, da ste alergični (preobčutljivi) na sulezomab ali katerokoli beljakovino, ki izhaja iz miši, o tem povejte svojemu zdravniku.
If your doctor decides to give it to you again after several weeks or several months, your blood should be tested first to see if you have developed an allergy to
Če se bo vaš zdravnik po nekaj tednih ali nekaj mesecih odločil, da vam ga bo dal še enkrat, je potrebno najprej pregledati vašo kri in pogledati, če ste razvili alergijo na zdravilo LeukoScan.
For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit.
Pri vsakem bolniku mora biti izpostavljenost ionizirajočemu sevanju upravičljiva na osnovi možne koristi za bolnika.
Patients with known allergies or hypersensitivity to mouse proteins.
Bolniki z znanimi alergijami ali preobčutljivostjo na mišje beljakovine.
Human Anti-mouse Antibody (HAMA)
Človeška protitelesa proti mišjemu antigenu (HAMA)
B. CONDITIONS OF THE MARKETING AUTHORISATION • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE; PREDPISANI IMETNIKU
Do not refrigerate or freeze.
Po pripravi ne shranjujte v hladilniku.
• If the prepared solution of LeukoScan appears discoloured or contains particles, it should not be
• Če je pripravljena raztopina zdravila LeukoScan videti razbarvana ali vsebuje delce, ne sme biti
When the solvent front is within 1 cm of the top of the strip, remove it, cut it in half and place each into a glass tube.
Ko fronta topila doseže 1 cm do zgornjega roba ploščice, ploščico vzemite iz komore, prerežite na pol in vsako od polovic namestite v stekleno cevko.
These include a small increase in the number of certain white blood cells called eosinophils (but without any apparent symptoms) and rash.
Poročila so vključevala majhen porast v številu določenih belih krvnih celic, imenovanih eozinofilci, (vendar brez vidnih simptomov) in izpuščaj.
4.5 Interactions with other medicinal products and other forms of interaction Formal drug interaction studies have not been performed, but no drug interactions have been described to date, including patients receiving antibiotics.
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Uradne študije medsebojnega delovanja z drugimi zdravili niso bile izvedene, vendar do danes ni bila opisana nobena reakcija medsebojnega delovanja z drugimi zdravili, vključno z antibiotiki.
4.4 Special warnings and special precautions for use Safety and diagnostic accuracy in persons under 21 years of age have not been established.
Varnost in diagnostična natančnost pri osebah, mlajših od 21 let, nista bili določeni.
Total volume in vial equals 1.5 ml.
Celokupni volumen v viali znaša 1,5 ml.
Some side effects, although not common, have been reported.
Poročali so o nekaterih neželenih učinkih, ki pa niso bili pogosti.
These revealed no remarkable findings.
Te niso podale pomembnejših izsledkov.
None of these were considered serious, and all resolved without sequelae.
Nobeden od teh dogodkov ni bil resen in vsi so minili brez