natgillin/translations-raw huggingface dataset:
General disorders and administration site conditions Infusion site reactionsc a. Thrombophlebitis includes the preferred terms thrombophlebitis and infusion site thrombosis b. Phlebitis includes the preferred terms phlebitis, infusion site phlebitis, superficial phlebitis and injection site phlebitis c. Infusion site reactions includes the preferred terms injection site erythema, infusion site hypoaesthesia, 
b. Flebitis vključuje prednostne izraze flebitis, flebitis na mestu infuzije, površinski flebitis in flebitis na mestu vboda.
Hepatobiliary disorders 
Žilne bolezni tromboflebitis a flebitisb
Ask your doctor for advice before breast-feeding your baby. 
Preden začnete dojiti otroka, se posvetujte z zdravnikom.
Talk to your doctor or nurse if you are suffering from diarrhoea before being given Xerava. 
Če imate drisko, se pred prejemanjem zdravila Xerava posvetujte z zdravnikom ali medicinsko sestro.
Further information on Nordimet can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nordimet. 
Nadaljnje informacije za zdravilo Nordimet so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/nordimet.
Nordimet should be injected under the skin once a week on the same day each week. 
Zdravilo Nordimet se injicira pod kožo enkrat tedensko, vedno na isti dan v tednu.
Nordimet received a marketing authorisation valid throughout the EU on 18 August 2016. 
Za zdravilo Nordimet je bilo 18. avgusta 2016 izdano dovoljenje za promet, veljavno po vsej EU.
NSAIDs (non-steroidal anti-inflammatory drugs) have not worked well enough; 
NSAID (nesteroidna protivnetna zdravila) ne delujejo dovolj dobro;
It must not be used if the patient is pregnant, breastfeeding or is receiving live vaccines. 
Ne sme se uporabljati med nosečnostjo, dojenjem ali prejemanjem živih cepiv.
What measures are being taken to ensure the safe and effective use of Nordimet? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nordimet?
It should be prescribed only by doctors with expertise in the use of methotrexate and a full understanding of the risks of methotrexate treatment. 
Predpisovati bi ga morali le zdravniki s strokovnim znanjem o uporabi metotreksata in celovitim razumevanjem tveganj zdravljenja z metotreksatom.
The dose injected each week depends on which condition it is being used for and how well the treatment is working and, for children, on the child's height and weight. 
Odmerek, ki se vbrizga vsak teden, je odvisen od bolezni, za katero se zdravilo uporablja, in učinkovitosti zdravljenja, za otroke pa tudi od njihove višine in teže.
The Agency therefore decided that Nordimet's benefits are greater than its risks and it can be authorised for use in the EU. 
Zato je sklenila, da so koristi zdravila Nordimet večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Other information about Nordimet 
Druge informacije o zdravilu Nordimet
As for all medicines, data on the use of Nordimet are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Nordimet stalno spremljajo.
The company that markets Nordimet will send out follow-up questionnaires for dosing errors that result in overdose. 
Podjetje, ki trži zdravilo Nordimet, bo poslalo vprašalnike za nadaljnje spremljanje napak pri odmerjanju, ki privedejo do prevelikega odmerjanja.
What benefits of Nordimet have been shown in studies? 
Kakšne koristi zdravila Nordimet so se pokazale v študijah?
The company provided data from the published literature on methotrexate. 
Podjetje je predstavilo podatke o metotreksatu iz objavljene literature.
The European Medicines Agency concluded that Nordimet was comparable to its reference medicine. 
Evropska agencija za zdravila je zaključila, da je zdravilo Nordimet primerljivo z referenčnim zdravilom.
Side effects reported with Nordimet are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Nordimet, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
An overview of Nordimet and why it is authorised in the EU 
Pregled zdravila Nordimet in zakaj je odobreno v EU
• severe disabling psoriasis, a disease causing red, scaly patches on the skin, when other treatments have not worked well enough; 
• hude oslabitvene psoriaze, bolezni, ki povzroča rdeče, luskaste zaplate na koži, ko druge oblike zdravljenja ne delujejo dovolj dobro;
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nordimet have also 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 Nordimet upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
For more information about using Nordimet, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Nordimet glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Why is Nordimet authorised in the EU? 
Zakaj je bilo zdravilo Nordimet odobreno v EU?
What are the risks associated with Nordimet? 
Kakšna tveganja so povezana z zdravilom Nordimet?
Nordimet is a ‘hybrid medicine'. 
Zdravilo Nordimet je „hibridno zdravilo“.
• severe juvenile idiopathic arthritis (JIA), a joint disease in children, when medicines known as 
• hudega juvenilnega idiopatskega artritisa (JIA), bolezni sklepov pri otrocih, ko zdravila, znana kot
Nordimet is a medicine used to treat the following inflammatory conditions: 
Nordimet je zdravilo za zdravljenje naslednjih vnetnih stanj:
What is Nordimet and what is it used for? 
Kaj je zdravil Nordimet in za kaj se uporablja?
This means that it is similar to a ‘reference medicines' containing the same active substance, but Nordimet is available in more strengths. 
To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje enako učinkovino, vendar je zdravilo Nordimet na voljo v več jakostih.
The way methotrexate, the active substance in Nordimet, works in patients with arthritis and psoriasis is not completely understood, but the benefits of methotrexate are thought to be due to its ability to reduce inflammation and suppress an overactive immune system. 
Ni popolnoma znano, kako metotreksat, učinkovina v zdravilu Nordimet, učinkuje pri bolnikih z artritisom in psoriazo, domneva pa se, da so koristi metotreksata posledica njegove sposobnosti zmanjševanja vnetja in zaviranja čezmerno dejavnega imunskega sistema.
The reference medicine for Nordimet is Lantarel FS. 
Referenčno zdravilo za zdravilo Nordimet je zdravilo Lantarel FS.
The most common side effects with Nordimet (which may affect more than 1 in 10 people) are effects in the digestive system (such as inflammation of the lining of the mouth, indigestion, belly pain, feeling sick and loss of appetite) and blood tests showing changes in the liver. 
Najpogostejši neželeni učinki zdravila Nordimet (ki lahko prizadenejo več kot 1 osebo od 10) so učinki na prebavni sistem (kot so vnetje ustne sluznice, prebavne motnje, bolečine v trebuhu, slabost in izguba apetita) in krvne preiskave, ki kažejo spremembe delovanja jeter.
Nordimet must not be used in patients who abuse alcohol or those with liver or severe kidney problems, blood disorders, weakened immune system (body defences), severe or long-term infections such as tuberculosis and HIV infection, mouth ulcers, inflammation in the mouth, and ulcers in the digestive system. 
Zdravilo Nordimet se ne sme uporabljati pri bolnikih, ki zlorabljajo alkohol, ali bolnikih z obolenji jeter ali hudimi okvarami ledvic, krvnimi motnjami, oslabljenim imunskim sistemom (obrambnimi mehanizmi telesa), resnimi ali dolgotrajnimi okužbami, kot so tuberkuloza in okužba z virusom HIV, razjedami v ustih, vnetjem v ustih in razjedami v prebavnem sistemu.
• severe psoriatic arthritis, inflammation of the joints that occurs in patients with psoriasis. 
• hudega psoriatičnega artritisa, vnetja sklepov, ki se pojavlja pri bolnikih s psoriazo.
The most serious side effects include reduced production of blood cells, damage to the lung, liver, kidneys and nerves, thromboembolism (problems caused by clots in blood vessels), and severe allergic and skin reactions. 
Najresnejši neželeni učinki so zmanjšana tvorba krvnih celic, poškodbe pljuč, jeter, ledvic in živcev, tromboembolija (težave, ki jih povzročajo strdki v krvnih žilah) ter hude alergijske in kožne reakcije.
Because Nordimet has the same composition as the reference medicine its benefits are taken as being the same as those of Lantarel FS. 
Ker ima zdravilo Nordimet enako sestavo kot referenčno zdravilo, so njegove koristi enake kot pri zdravilu Lantarel FS.
• active rheumatoid arthritis, a disease causing inflammation in joints; 
• aktivnega revmatoidnega artritisa, bolezni, ki povzroča vnetje sklepov;
For the full list of side effects and restrictions of Nordimet, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Nordimet glejte navodilo za uporabo.
Nordimet is available as various strengths of injection and it can only be obtained with a prescription. 
Zdravilo Nordimet je na voljo v različnih jakostih, njegovo predpisovanje in izdaja pa je le na recept.
How does Nordimet work? 
Kako zdravilo Nordimet deluje?
How is Nordimet used? 
Kako se zdravilo Nordimet uporablja?
Nordimet contains the active substance methotrexate. 
Zdravilo Nordimet vsebuje učinkovino metotreksat.
No additional studies were needed as Nordimet is a hybrid medicine that is given by injection and contains the same active substance as the reference medicine, Lantarel FS. 
Ker je zdravilo Nordimet hibridno zdravilo, ki se daje z injekcijo in vsebuje enako učinkovino kot referenčno zdravilo Lantarel FS, niso bile potrebne nobene dodatne študije.
20 mg/mL Concentrate for solution for infusion 
20 mg/ml koncentrat za raztopino za infundiranje intravenska uporaba viala (steklo) 10 ml
The European Commission granted a marketing authorisation valid throughout the European Union for Mimpara on 22 October 2004. 
Evropska komisija je dovoljenje za promet z zdravilom Mimpara, veljavno po vsej Evropski uniji, izdala 22. oktobra 2004.
What measures are being taken to ensure the safe and effective use of Mimpara? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Mimpara?
The full EPAR for Mimpara can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Mimpara je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
‘Secondary' means that it is caused by another condition (serious kidney disease) while ‘primary' means there is no other cause. 
„Sekundarni“ pomeni, da ga povzroča druga bolezen (resna bolezen ledvic), „primarni“ pa, da zanj ni drugega vzroka.
Other information about Mimpara 
Druge informacije o zdravilu Mimpara
This is a summary of the European public assessment report (EPAR) for Mimpara. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Mimpara.
Of these, 45 went on to a fourth, long-term study looking at the effectiveness of Mimpara over a total of almost six years. 
Od teh jih je 45 sodelovalo v četrti, dolgoročni študiji, ki je preučevala učinkovitost zdravila Mimpara v trajanju skoraj šest let.
The capsules should not be swallowed whole but should be opened and the granules sprinkled in food or liquid. 
Kapsul se ne sme pogoltniti celih, ampak jih je treba odpreti in granule nasuti v hrano ali tekočino.
This means that it mimics the action of calcium in the body. 
To pomeni, da posnema delovanje kalcija v telesu.
Mimpara is a medicine used to treat: 
Zdravilo Mimpara se uporablja za zdravljenje:
The European Medicines Agency therefore concluded that Mimpara's benefits outweigh the risks and recommended that it be given marketing authorisation. 
Evropska agencija za zdravila je zato zaključila, da koristi zdravila Mimpara odtehtajo z njim povezana tveganja, in priporočila, da se zanj izda dovoljenje za promet.
What is Mimpara and what is it used for? 
Kaj je zdravilo Mimpara in za kaj se uporablja?
What are the risks associated with Mimpara? 
Kakšna tveganja so povezana z zdravilom Mimpara?
Why is Mimpara approved? 
Zakaj je bilo zdravilo Mimpara odobreno?
What benefits of Mimpara have been shown during the studies? 
Kakšne koristi je zdravilo Mimpara izkazalo v študijah?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mimpara have been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Mimpara upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
It is not intended to provide practical advice on how to use Mimpara. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For more information about treatment with Mimpara, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Mimpara preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Mimpara is available as tablets and as granules in capsules, to be taken with food or shortly after a meal. 
Zdravilo Mimpara je na voljo v obliki tablet in granul v kapsulah, jemati pa ga je treba skupaj s hrano ali kmalu po obroku.
The main measure of effectiveness was the number of patients whose blood calcium levels fell by more than 1 mg per decilitre by the time a maintenance dose had been found (between two and 16 weeks after the start of the study). 
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih so se ravni kalcija v krvi znižale za več kot 1 mg na deciliter do trenutka, v katerem je bil ugotovljen vzdrževalni odmerek (med dvema tednoma in 16 tedni po začetku študije).
With regard to the medicine's safety, side effects seen in patients are considered manageable. 
Glede varnosti zdravila veljajo neželeni učinki, opaženi pri bolnikih, za obvladljive.
In hyperparathyroidism, the parathyroid glands in the neck produce too much parathyroid hormone (PTH), which can lead to high levels of blood calcium, bone and joint pain and deformities of the arms and legs. 
Pri hiperparatiroidizmu obščitnice v vratu tvorijo preveč paratiroidnega hormona (PTH), kar lahko povzroči visoke ravni kalcija v krvi, bolečine v kosteh in sklepih ter deformacije rok in nog.
Mimpara must not be used in patients with hypocalcaemia (low blood calcium levels). 
Zdravilo Mimpara se ne sme uporabljati pri bolnikih s hipokalciemijo (nizko ravnijo kalcija v krvi).
The main measure of effectiveness was the reduction of PTH levels by 30%. 
Glavno merilo učinkovitosti je bilo znižanje ravni paratiroidnega hormona za 30 %.
For practical information about using Mimpara, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Mimpara naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
For the full list of side effects and restrictions of Mimpara, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Mimpara glejte navodilo za uporabo.
The reduction in PTH levels also leads to a decrease in blood calcium levels. 
Zaradi tega zmanjšanja se znižajo tudi ravni kalcija v krvi.
In children, Mimpara was compared with placebo in a study involving 43 children aged 6 to 18 years with serious kidney disease. 
Pri otrocih so zdravilo Mimpara primerjali s placebom v študiji, v katero je bilo vključenih 43 otrok, starih od 6 do 18 let, z resno boleznijo ledvic.
Mimpara produced a decrease in blood calcium of more than 1 mg/dl in 62% of the cancer patients (18 out of 29) and in 88% of the patients with primary hyperparathyroidism (15 out of 17). 
Zdravilo Mimpara je privedlo do znižanja ravni kalcija v krvi za več kot 1 mg/dl pri 62 % (18 od 29) bolnikov z rakom in pri 88 % (15 od 17) bolnikov s primarnim hipertiroidizmom .
The main measure of effectiveness was the number of patients who had a parathyroid hormone level below 250 micrograms per litre after 6 months. 
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bila raven paratiroidnega hormona po 6 mesecih nižja od 250 mikrogramov na liter.
In patients with secondary hyperparathyroidism, the recommended starting dose for adults is 30 mg once a day, while in children the daily starting dose depends on the child's weight. 
Pri odraslih bolnikih s sekundarnim hiperparatiroidizmom je priporočen začetni odmerek 30 mg enkrat na dan, pri otrocih pa je začetni dnevni odmerek odvisen od otrokove telesne mase.
Mimpara has been studied in a study involving 46 patients with hypercalcaemia, including 29 with parathyroid cancer, and 17 with primary hyperparathyroidism who could not have their parathyroid glands removed or in whom surgery to remove the parathyroid glands was not effective. 
Zdravilo Mimpara so preučevali v študiji, ki je vključevala 46 bolnikov s hiperkalciemijo, od tega 29 bolnikov s paratiroidnim karcinomom, in 17 bolnikov s primarnim hiperparatiroidizmom, pri katerih obščitnic ni bilo mogoče odstraniti ali pri katerih kirurška odstranitev obščitnic ni bila učinkovita.
The results supported the use of Mimpara for hypercalcaemia in patients with primary hyperparathyroidism. 
Rezultati so podprli uporabo zdravila Mimpara za zdravljenje hiperkalciemije pri bolnikih s primarnim hiperparatiroidizmom.
The most common side effects with Mimpara (in more than 1 patient in 10) are nausea (feeling sick) and vomiting. 
Najpogostejša neželena učinka zdravila Mimpara (ki se lahko pojavita pri več kot 1 bolniku od 10) sta navzea (slabost) in bruhanje.
The dose is adjusted, according to the patient's PTH and calcium levels. 
Odmerek je prilagojen glede na bolnikove ravni paratiroidnega hormona in kalcija.
• hypercalcaemia (high blood calcium levels) in adults with cancer of the parathyroid glands or with primary hyperparathyroidism when the parathyroid glands cannot be removed. 
• hiperkalciemije (visokih ravni kalcija v krvi) pri odraslih s paratiroidnim karcinomom (rakom obščitnic) ali s primarnim hiperparatiroidizmom, pri katerih odstranitev obščitnic ni mogoča.
The active substance in Mimpara, cinacalcet, is a calcimimetic agent. 
Zdravilna učinkovina zdravila Mimpara, cinakalcet, je kalcimimetik.
Parathyroid gland cancer or primary hyperparathyroidism 
Paratiroidni karcinom ali primarni hiperparatiroidizem
In this study, 55% (12 out of 22) children given Mimpara achieved a 30% reduction of PTH levels, compared with 19% (4 out of 21) children given placebo. 
V tej študiji so se ravni paratiroidnega hormona znižale za 30 % pri 55 % (12 od 22) otrok , ki so prejemali zdravilo Mimpara, v primerjavi z 19 % (4 od 21) otrok, ki so prejemali placebo.
Cinacalcet works by increasing the sensitivity of the calcium-sensing receptors on the parathyroid glands that regulate parathyroid hormone secretion. 
Cinakalcet deluje tako, da poveča občutljivost receptorjev za zaznavanje kalcija, ki so na obščitnicah in uravnavajo izločanje paratiroidnega hormona.
How is Mimpara used? 
Kako se zdravilo Mimpara uporablja?
Mimpara has been compared with placebo (a dummy treatment) in three main studies involving 1,136 adults with secondary hyperparathyroidism who were on dialysis because they had a serious kidney disease. 
Zdravilo Mimpara so primerjali s placebom (zdravilom brez zdravilne učinkovine) v treh glavnih študijah, v katere je bilo vključenih 1 136 odraslih bolnikov s sekundarnim hiperparatiroidizmom, ki so bili zaradi resne bolezni ledvic na dializi.
How does Mimpara work? 
Kako zdravilo Mimpara deluje?
Studies showed that Mimpara was effective in both adults and children at reducing levels of parathyroid hormone in patients with secondary hyperparathyroidism who were undergoing dialysis for kidney disease. 
Študije so pokazale, da je zdravilo Mimpara učinkovito znižalo ravni paratiroidnega hormona pri odraslih in otrocih s sekundarnim hiperparatiroidizmom, ki so bili zaradi bolezni ledvic na dializi.
Mimpara contains the active substance cinacalcet. 
Zdravilo Mimpara vsebuje zdravilno učinkovino cinakalcet.
A further three studies compared Mimpara with placebo in a total of 136 patients with primary hyperparathyroidism over up to a year. 
V nadaljnjih treh študijah so v času do enega leta primerjali učinkovitost zdravila Mimpara z učinkovitostjo placeba pri skupno 136 bolnikih s primarnim hiperparatiroidizmom.
In these studies, about 40% of the patients taking Mimpara had parathyroid hormone levels below 250 micrograms per litre, compared with about 6% of those taking placebo. 
V teh študijah so bile ravni paratiroidnega hormona nižje od 250 mikrogramov na liter pri 40 % bolnikov, ki so jemali zdravilo Mimpara, pri tistih, ki so jemali placebo, pa so bile takšne ravni dosežene pri 6 % bolnikov.
Mimpara brought about a 42% reduction in average PTH levels compared with an increase of 8% in patients taking placebo. 
Pri zdravilu Mimpara so se povprečne ravni paratiroidnega hormona znižale za 42 %, pri bolnikih, ki so jemali placebo, pa so se te ravni zvišale za 8 %.
The dose of Mimpara should be increased every two to four weeks up to 90 mg three or four times a day as necessary to reduce blood calcium to normal levels. 
Pri bolnikih s hiperkalciemijo, ki imajo hkrati še paratiroidni karcinom ali primarni hiperparatiroidizem, je priporočeni začetni odmerek zdravila Mimpara za odrasle 30 mg dvakrat na dan. Odmerek zdravila Mimpara je treba na vsake dva do štiri tedne povečevati do vrednosti 90 mg tri- ali štirikrat dnevno, kot je potrebno za znižanje ravni kalcija v krvi na normalno raven.
In addition, Mimpara reduced high calcium levels in the majority of patients with parathyroid gland cancer or primary hyperparathyroidism. 
Poleg tega je zdravilo Mimpara pri večini bolnikov s paratiroidnim karcinomom ali primarnim hiperparatiroidizmom znižalo visoke ravni kalcija v krvi.
• secondary hyperparathyroidism (overactive parathyroid glands) in adults and children aged 3 years and older with serious kidney disease who need dialysis (to clear their blood of waste products). 
3 leta ali več, z resno boleznijo ledvic, ki potrebujejo dializo (za čiščenje odpadnih snovi iz krvi);
Date of latest renewal: 15 March 2015 
Datum prve odobritve: 15. marec 2010 Datum zadnjega podaljšanja: 15. marec 2015
• if you are allergic to clopidogrel, acetylsalicylic acid (ASA) or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na klopidogrel, acetilsalicilno kislino (ASA) ali katerokoli sestavino tega zdravila (navedeno v poglavju 6),
• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 
• preobčutljivost za zdravilni učinkovini ali katerokoli pomožno snov, navedeno v poglavju 6.1,
Some other medicines may influence the use of Clopidogrel/Acetylsalicylic acid Zentiva or vice versa. 
Nekatera druga zdravila lahko vplivajo na uporabo zdravila Klopidogrel/acetilsalicilna kislina Zentiva in obratno.
DATE OF REVISION OF THE TEXT Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/ 
DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila : http://www.ema.europa.eu/.
The safety and efficacy of Clopidogrel/Acetylsalicylic acid Zentiva in children and adolescents under 18 years old have not been established. 
Varnost in učinkovitost zdravila Klopidogrel/acetilsalicilna kislina Zentiva pri otrocih in mladostnikih mlajših od 18 let nista ugotovljeni.