FrancophonIA/ELRC3.0 huggingface dataset:
English: The expiry date on the cartridge label must always be checked before inserting the cartridge into Terrosa Pen.
Slovenian: Pred vstavljanjem vložka v pripomoček Terrosa Pen je treba vedno preveriti datum izteka roka uporabnosti zdravila na vložku.
English: • Screw the needle cap anti-clockwise to remove the pen needle.
Slovenian: • Pokrovček igle zavrtite v nasprotni smeri urinega kazalca, da odstranite iglo peresnika.
English: Marketing Authorisation Holder and Manufacturer Gedeon Richter Plc.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Gedeon Richter Plc.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja emfizem
English: Always follow instructions provided below and on the back page when using the Terrosa Pen.
Slovenian: Pri uporabi Terrosa Pen vedno upoštevajte spodnja navodila in navodila na zadnji strani.
English: Not applicable in case of cartridge and pen pack.}
Slovenian: Ne pride v poštev v primeru kompleta vložka in peresnika.}
English: b p≤0.001 compared with placebo.
Slovenian: bp ≤ 0,001 v primerjavi s placebom cPomembnega zmanjšanja incidence zlomov kolka niso dokazali.
English: A.
Slovenian: {3x}
English: Anaphylaxis
Slovenian: • zadihanost
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR CARTRIDGE AND PEN PACK
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA KOMPLET VLOŽKA IN PERESNIKA
English: Very common Common
Slovenian: Organski sistem Zelo pogosto Pogosto
English: Batch (Lot) number of each cartridge and the date of its first injection should be recorded by the patient on a calendar.
Slovenian: Dokumentiranje Bolnik mora na koledar zabeležiti številko serije (Lot) vsakega vložka in datum prvega injiciranja.
English: {3x} Store in a refrigerator.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each dose of 80 microliters contains 20 micrograms of teriparatide.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN En odmerek 80 mikrolitrov vsebuje 20 mikrogramov teriparatida.
English: Do not prime again after the first dose.
Slovenian: Po prvem odmerku peresnika ne pripravljate znova na prvo uporabo.
English: • if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness.
Slovenian: Pred ali med uporabo zdravila Terrosa se posvetujte s svojim zdravnikom: • če vas nenehno sili na bruhanje ali bruhate, imate zaprtje, pomanjkanje energije ali mišično šibkost.
English: Urinary incontinence, polyuria, micturition urgency, nephrolithiasis
Slovenian: Bolezni sečil inkontinenca urina, poliurija, pogosto siljenje na vodo, nefrolitiaza odpoved/okvara ledvic
English: • increase in blood uric acid level
Slovenian: • zvišan nivo sečnine v krvi
English: {Not applicable in case of cartridge and pen pack.}
Slovenian: {Ne pride v poštev v primeru kompleta vložka in peresnika} 18.
English: It is supplied in a cartridge.
Slovenian: Na voljo je v vložku.
English: General disorders and administration site condition
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost,
English: Cardiac disorders
Slovenian: Srčne bolezni palpitacije tahikardija
English: MARKETING AUTHORISATION HOLDER Gedeon Richter Plc.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Gedeon Richter Plc.
English: versus −1.9%; p<0.001) and total hip (3.8% versus 0.9%; p=0.005).
Slovenian: (0,29-0,68), p < 0,0001.
English: Pen preparation - First use/changing cartridges Follow the instructions every time you insert a new Terrosa cartridge into your Terrosa Pen.
Slovenian: Upoštevajte navodila vsakič, ko vstavite nov vložek Terrosa v napravo Terrosa Pen.
English: Immune system disorders
Slovenian: Bolezni imunskega sistema anafilaksa
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS LID FOIL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: NAME OF THE MARKETING AUTHORISATION HOLDER Gedeon Richter Plc.
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Gedeon Richter Plc.
English: Ypsomed AG
Slovenian: KG Dengelsberg
English: c A significant reduction in the incidence of hip fractures has not been demonstrated.
Slovenian: Vendar niso pokazali značilnega vpliva na razmerja zlomov.
English: In premenopausal women, the increase in BMD from baseline to 18 month endpoint was significantly greater in the teriparatide group compared with the alendronate group at the lumbar spine (4.2%
Slovenian: Pri ženskah pred menopavzo je bilo povišanje mineralne gostote kosti (BMD) z osnove na končno točko po 18 mesecih značilno višje v skupini s teriparatidom v primerjavi s skupino alendronata za ledveni del hrbtenice (4,2 % proti -1,9 %; p < 0,001) in celi kolk (3,8 % proti 0,9 %; p < 0,005).
English: Hepatic impairment
Slovenian: Žilne bolezni hipotenzija
English: Major non-vertebral fragility fracturesc (hip,
Slovenian: Večji nevretenčni zlomi zaradi krhkostic (kolk, koželjnica, nadlahtnica, rebra in medenica)
English: - Check the expiry date on the cartridge label before inserting the cartridge into the pen.
Slovenian: - Pred vstavljanjem vložka v peresnik preverite datum izteka roka uporabnosti zdravila na vložku.
English: Warranty
Slovenian: NALEPKA
English: How to store Terrosa
Slovenian: Shranjevanje zdravila Terrosa
English: The dose knob inadvertently turned clockwise after completing the injection.
Slovenian: Po končanem injiciranju gumb za odmerjanje nenamerno zavrtite v smeri urinega kazalca.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Use only with Terrosa Pen.
Slovenian: Uporabljati le s pripomočkom Terrosa Pen.
English: Removing the pen needle • Carefully attach the outer needle cap on the pen needle.
Slovenian: • Previdno pritrdite zunanji pokrovček igle na iglo peresnika.
English: The amount of Terrosa left in the cartridge is less than 80 microlitres.
Slovenian: Količina zdravila Terrosa v vložku je manjša od
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva bolečina v okončinah mišični krči mialgija, artralgija,
English: The recommended dose of Revasc is 15 mg twice daily.
Slovenian: Priporočen odmerek zdravila Revasc je 15 mg dvakrat dnevno.
English: The marketing authorisation was renewed on 9 July 2002 and on 9 July 2007.
Slovenian: Dovoljenje za promet z zdravilom je bilo podaljšano dne 9. julija 2002 in 9. julija 2007.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Revasc to Canyon Pharmaceuticals Limited on 9 July 1997.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Revasc, veljavno po vsej Evropski uniji, odobrila družbi Canyon Pharmaceuticals Limited dne 9. julija 1997.
English: Revasc is then given twice daily for 9 and up to a maximum of 12 days, or until the patient is able to walk, whichever occurs first.
Slovenian: Nato dajemo zdravilo Revasc dvakrat dnevno 9 do največ 12 dni ali dokler bolnik ne shodi, kar od tega se zgodi prej.
English: Revasc is intended for short-term use.
Slovenian: Zdravilo Revasc je namenjeno kratkotrajni uporabi.
English: The effectiveness of Revasc as an anticoagulant has been studied in four studies involving 1,621 patients who received Revasc.
Slovenian: Učinki zdravila Revasc kot antikoagulanta so bili raziskani v štirih študijah, ki so zajele 1621 bolnikov, ki so prejemali zdravilo Revasc.
English: The first injection should be started 5 to 15 minutes before surgery but after any anaesthesia.
Slovenian: Prvi odmerek je treba dati 5 do 15 minut pred operacijo, vendar po vsaki anesteziji.
English: Blood clotting can be a problem when blood flow is disturbed in any way.
Slovenian: Strjevanje krvi lahko predstavlja resno težavo, če je s tem pretok krvi na kakršen koli način oviran.
English: What is the risk associated with Revasc?
Slovenian: Kakšna tveganja so povezana z zdravilom Revasc?
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) REVASC EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) REVASC Povzetek EPAR za javnost
English: Some patients can have an allergic shock when they receive Revasc again, and doctors should be very careful when re-exposing a patient to the medicine or to another hirudin analogue.
Slovenian: Pri nekaterih bolnikih lahko pri ponovni uporabi zdravila Revasc nastopi alergijski šok, zato morajo biti zdravniki zelo pazljivi pri ponovnem izpostavljanju bolnika zdravilu ali drugemu analogu hirudina.
English: Thrombin is central to the complete process of blood clotting.
Slovenian: Trombin igra ključno vlogo v celovitem procesu strjevanja krvi.
English: What benefit has Revasc shown during the studies?
Slovenian: Kakšne koristi je zdravilo Revasc izkazalo med raziskavami?
English: Revasc was compared with unfractionated heparin or enoxaparin (other anticoagulants).
Slovenian: Zdravilo Revasc so primerjali z nefrakcioniranim heparinom ali enoksaparinom (drugi antikoagulanti).
English: The most common side effects with Revasc (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), nausea (feeling sick), wound secretion (oozing of fluid from wounds), hypotension (low blood pressure), deep thrombophlebitis (inflammation of deep veins that can be caused by a blood clot), fever, injection site mass (lumps at the site of injection), haematomas (collections of blood), oedema (swelling) in legs, and non-fatal allergic reactions.
Slovenian: Najpogostejši neželeni učinki zdravila Revasc (opaženi pri 1 do 10 izmed 100 bolnikov) so anemija (nizko število rdečih krvnih celic), navzeja (slabost), sekrecija iz rane (izločanje tekočine iz rane), hipotenzija (nizek krvni pritisk), globoki tromboflebitis (vnetje globokih ven, ki ga lahko povzroči krvni strdek), zvišana telesna temperatura, oteklina (oteklina na mestu vboda), hematomi (kopičenje krvi), edemi nog (zatekanje) in neusodne alergijske reakcije.
English: Revasc is an anticoagulant; it prevents the blood from coagulating (clotting).
Slovenian: Zdravilo Revasc je antikoagulant; preprečuje koagulacijo (strjevanje) krvi.
English: Revasc should not be used in people who may be hypersensitive (allergic) to desirudin or any of the other ingredients, who are pregnant, who have had recent bleeding, who have severe high blood pressure or severe liver or kidney problems, or who have a heart infection.
Slovenian: Zdravila Revasc se ne sme uporabljati pri ljudeh, ki utegnejo biti preobčutljivi za (alergični na) desirudin ali na katero koli drugo sestavino, pri nosečnicah, pri osebah, ki so nedavno krvavele, osebah z visokim krvnim tlakom ali hudim obolenjem jeter ali ledvic ali osebah z okužbo srca.
English: The Committee recommended that Revasc be given marketing authorisation.
Slovenian: Zato je priporočil odobritev dovoljenja za promet z zdravilom Revasc.
English: Revasc is intended to be given subcutaneously (under the skin), preferably in the abdomen (the tummy).
Slovenian: Zdravilo Revasc se daje subkutano (pod kožo), po možnosti v abdomen (trebuh).
English: Revasc is a powder and solvent in a vial, which is made up into a solution for injection.
Slovenian: Zdravilo Revasc je v obliki praška in vehikla v viali, ki se zmešata v raztopino za injiciranje.
English: Revasc is used in adult patients to prevent blood clotting after hip or knee replacement surgery.
Slovenian: Zdravilo Revasc se uporablja pri odraslih bolnikih za preprečevanje nastajanja krvnih strdkov po operacijah menjave kolka ali kolena.
English: Desirudin, the active substance in Revasc, is nearly identical to hirudin, the anticoagulant substance produced by leeches.
Slovenian: Desirudin, zdravilna učinkovina zdravila Revasc, je skoraj enaka antikoagulantni snovi hirudin, ki jo proizvajajo pijavke.
English: How has Revasc been studied?
Slovenian: Kako je bilo zdravilo Revasc raziskano?
English: The Committee for Medicinal products for Human Use (CHMP) decided that Revasc's benefits are greater than its risks to prevent deep vein thrombosis in patients undergoing hip or knee replacement.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Revasc pri preprečevanju globoke venske tromboze pri bolnikih, pri katerih se bo opravila menjava kolka ali kolena, večje od z njim povezanih tveganj.
English: As with other anticoagulants, a common side effect of Revasc is bleeding.
Slovenian: Kot pri drugih antikoagulantih je tudi pri zdravilu Revasc pogost neželeni učinek krvavitev.
English: It specifically blocks one of the substances involved in the clotting process, thrombin.
Slovenian: Le ta specifično blokira delovanje trombina, ene od snovi, ki sodelujejo v procesu strjevanja krvi.
English: By using Revasc during and after hip or knee surgery, the risk of a blood clot forming in the blood vessels of the legs (deep vein thrombosis) is greatly reduced.
Slovenian: Z uporabo zdravila Revasc med in po operaciji kolka ali kolena se tveganje za nastanek krvnih strdkov v nogah (globoka venska tromboza) močno zmanjša.
English: Revasc contains the active substance desirudin.
Slovenian: Zdravilo Revasc vsebuje zdravilno učinkovino desirudin.
English: In patients who have liver or kidney problems, the doctor will monitor blood clotting to see if the dosages may need to
Slovenian: Pri bolnikih z obolenjem jeter ali ledvic zdravnik nadzoruje strjevanje krvi in presoja o potrebi po uravnavanju odmerka.
English: The full EPAR for Revasc can be found here.
Slovenian: Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Revasc je na voljo tukaj.
English: The studies showed that desirudin was more effective than both comparator medicines in the prevention of deep vein thrombosis after hip replacement surgery.
Slovenian: Študije so pokazale, da je bil pri preprečevanju globoke venske tromboze po operaciji menjave kolka desirudin bolj učinkovit od primerjalnih zdravil.
English: Desirudin is produced by a method known as 'recombinant DNA technology': it is made by a yeast that has received a gene (DNA), which makes it able to produce the substance.
Slovenian: Proizvede ga kvasovka, ki je prejela gen (DNA), kar ji omogoča izdelavo te snovi.
English: problems) and the rate of deep vein thrombosis (the formation of a blood clot in one of the deep veins of the body, usually in the leg).
Slovenian: trombotičnih dogodkov (težav, ki jih povzročajo krvni strdki) in pogostost globoke venske tromboze (nastanek krvnega strdka v eni od globokih ven, najpogosteje v nogi).
English: A doctor who has experience in coagulation (clotting) disorders should start treatment with Revasc.
Slovenian: Zdravljenje z zdravilom Revasc mora predpisati zdravnik, ki ima izkušnje na področju motenj koagulacije (strjevanja).
English: For the full description of all side effects reported with
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Revasc, glejte Navodilo za uporabo.
English: The clinical consequence is uncertain.
Slovenian: Klinične posledice so negotove.
English: - Use in children below 18 years of age
Slovenian: - Uporaba pri otrocih, mlajših od 18 let.
English: For tablets/capsules/granules
Slovenian: Za tablete/kapsule/granule
English: [To be completed nationally, if necessary]
Slovenian: [Izpolni država članica, če je potrebno.]
English: Over 60kg
Slovenian: 1-3 leta več kot 60 kg
English: For all preparations
Slovenian: Za vse pripravke
English: These may be signs of an allergic reaction, which may be severe.
Slovenian: To so lahko znaki alergijske reakcije, ki je lahko huda.
English: The medicine will normally be given to you by a doctor or a nurse.
Slovenian: Zdravilo vam bo običajno dal zdravnik ali medicinska sestra.
English: The maximum recommended treatment duration is 5 days.
Slovenian: Najdaljši priporočeni čas zdravljenja je 5 dni.
English: Your doctor will decide whether or not you should be given this medicine.
Slovenian: Vaš zdravnik se bo odločil, če boste prejemali to zdravilo ali ne.
English: Anticholinergics and morphine derivatives
Slovenian: Antiholinergiki in derivati morfina
English: A large amount of data on pregnant women (more than 1000 exposed outcomes) indicates no malformative toxicity nor foetotoxicity.
Slovenian: Velika količina podatkov o nosečnicah (več kot 1.000 primerov izidov po izpostavljenosti) ne kaže nobenih malformacij niti toksičnosti za plod.
English: Frequencies are defined using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).
Slovenian: Stopnje pogostnosti so opredeljene po naslednjem dogovoru: 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), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Your doctor may perform blood tests to check your blood pigment levels.
Slovenian: Vaš zdravnik bo morda opravil krvne preiskave in preveril vaše koncentracije pigmenta v krvi.
English: Metoclopramide increases cyclosporine bioavailability (Cmax by 46% and exposure by 22%).
Slovenian: Metoklopramid poveča biološko razpoložljivost ciklosporina (Cmax za 46 % in izpostavljenost za 22 %).
English: The injectable treatment duration should be as short as possible and transfer to oral or rectal treatment should be made as soon as possible.
Slovenian: Trajanje zdravljenja z injiciranjem pripravka mora biti čim krajše in takoj ko je mogoče, je treba preiti na peroralno ali rektalno uporabo zdravila.
English: You doctor may prescribe you a treatment for these signs if necessary.
Slovenian: Zdravnik vam bo predpisal ustrezno zdravljenje teh simptomov, če bo potrebno.
English: Device / instruction for use
Slovenian: Pripomoček/navodila za uporabo
English: All indications (paediatric patients aged 1-18 years)
Slovenian: Vse indikacije (pediatrični bolniki, stari od 1 do 18 let)
English: - you are allergic to metoclopramide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - ste alergični na metoklopramid ali katerokoli sestavino tega zdravila (navedeno v poglavju
English: In such cases, metoclopramide should be immediately and permanently discontinued and appropriate measures initiated (such as treatment with methylene blue).
Slovenian: V tem primeru je treba zdravljenje z metoklopramidom takoj in trajno prekiniti ter uvesti primerne ukrepe (na primer zdravljenje z metilen modrim).
English: A symptomatic treatment and a continuous monitoring of the cardiovascular and respiratory functions should be carried out according to clinical status.
Slovenian: Potrebno je simptomatsko zdravljenje in stalno spremljanje srčno-žilnih in respiratornih funkcij, skladno s kliničnim statusom bolnika.
English: This may affect your vision and also interfere with your ability to drive and use machines.
Slovenian: To lahko vpliva na vaš vid ter vašo sposobnost vožnje in upravljanja s stroji.
English: If you forget to take {Tradename} Do not take a double dose to make up for a forgotten dose.
Slovenian: Če ste pozabili vzeti zdravilo Xyz Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Combination to be taken into account Due to the prokinetic effect of metoclopramide, the absorption of certain drugs may be modified.
Slovenian: Kombinacija, ki jo treba upoštevati Zaradi prokinetičnega učinka metoklopramida se absorpcija nekaterih zdravil lahko spremeni.
English: The use of metoclopramide with serotonergic drugs such as SSRIs may increase the risk of serotonin syndrome.
Slovenian: Uporaba metoklopramida s serotonergičnimi zdravili, kot so SSRI-ji, lahko poveča tveganje za pojav serotoninskega sindroma.
English: All indications (adult patients)
Slovenian: Vse indikacije (odrasli)
English: - Itching or skin rashes, swelling of the face, lips or throat, difficulty in breathing.
Slovenian: - srbenje ali kožni izpuščaji, otekanje obraza, ustnic ali grla, težave pri dihanju.
English: 2 What you need to know before you are given {Tradename}
Slovenian: 2 Kaj morate vedeti, preden boste vzeli zdravilo Xyz
English: [Appropriate measuring device must be provided with the product, and instructions for use must be included in the SmPC]
Slovenian: [K zdravilu mora biti priložena ustrezna merilna naprava, navodila za uporabo le-te pa morajo biti vključena v Povzetek glavnih značilnosti zdravila.]
English: Metoclopramide can be used during pregnancy if clinically needed.
Slovenian: Metoklopramid se lahko uporablja med nosečnostjo, če je to klinično potrebno.
English: Due to pharmacological properties (as other neuroleptics), in case of metoclopramide administration at the end of pregnancy, extrapyramidal syndrome in newborn cannot be excluded.
Slovenian: Zaradi farmakoloških lastnosti (kot pri drugih nevroleptikih), v primeru uporabe metoklopramida ob koncu nosečnosti, ni mogoče izključiti pojava ekstrapiramidnega sindroma pri novorojenčku.
English: These may occur in children or young adults and particularly when high doses are used.
Slovenian: Pojavijo se lahko pri otrocih in mladostnikih, zlasti pri uporabi velikih odmerkov.
English: It contains a medicine called “metoclopramide”.
Slovenian: Vsebuje zdravilno učinkovino, imenovano »metoklopramid«.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before being given this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali s farmacevtom, preden vzamete to zdravilo.
English: Talk to your doctor if you have liver problems.
Slovenian: Posvetujte se s svojim zdravnikom, če imate težave z jetri.
English: {Tradename} is not recommended if you are breast-feeding because metoclopramide passes into breast milk and may affect your baby.
Slovenian: Uporaba zdravila Xyz ni priporočena, če dojite, ker metoklopramid prehaja v materino mleko in lahko vpliva na vašega otroka.
English: Although the clinical significance is uncertain, patients should be monitored for adverse reactions.
Slovenian: Čeprav klinični pomen tega ni znan, je potrebno bolnike spremljati zaradi morebitnega pojava neželenih učinkov.
English: Convulsion especially in epileptic patients
Slovenian: Redki konvulzije, zlasti pri bolnikih z epilepsijo
English: 4.7 Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Vsi načini uporabe
English: These may be signs of a condition called neuroleptic malignant syndrome.
Slovenian: To so lahko znaki nevroleptičnega malignega sindroma.
English: Metoclopramide injection may prolong the duration of neuromuscular block (through inhibition of plasma cholinesterase).
Slovenian: Injiciranje metoklopramida lahko podaljša trajanje nevromuskularnega bloka (preko zaviranja plazemske holinesteraze).
English: Stop the treatment and talk straight away to your doctor, pharmacist or nurse if you experience one of the following signs while having this medicine: - uncontrollable movements (often involving head or neck).
Slovenian: Prekinite zdravljenje in se takoj posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro, če se med jemanjem tega zdravila pri vas pojavijo naslednji znaki: - nenadzorovani gibi (pogosto glave ali vratu).
English: Adverse reactions in the breast-fed baby cannot be excluded.
Slovenian: Pojava neželenih učinkov pri doječem otroku ni mogoče izključiti.
English: These signs usually occur at the beginning of treatment and may even occur after one single administration.
Slovenian: Ti znaki se običajno pojavijo na začetku zdravljenja in se lahko pojavijo tudi po zgolj enem odmerku.
English: For rectal formulation - you have recently experienced inflammation and/or bleeding from your back passage (anus/rectum) - you are below 18 years of age.
Slovenian: Za rektalne farmacevtske oblike - če ste pred kratkim imeli vnetje in/ali krvavitev iz danke (anus/rektum), - če ste mlajši od 18 let;
English: Do not take {Tradename} if any of the above apply to you.
Slovenian: Ne jemljite zdravila Xyz, če kaj od zgoraj naštetega velja za vas.