FrancophonIA/ELRC3.0 huggingface dataset:
English: After oral administration monepantel is readily absorbed and oxidised to a sulfone metabolite.
Estonian: Pärast suukaudset manustamist imendub monepanteel vabalt ja oksüdeerub sulfoonmetaboliidiks.
English: MANUFACTURER'S BATCH NUMBER Lot
Estonian: TOOTJAPOOLNE PARTII NUMBER Partii nr: {number}
English: Pack sizes of 250 ml, 500 ml, 1 l, 2.5 l, and 5 l Not all pack sizes may be marketed.
Estonian: Pakendi suurused 250 ml, 500 ml, 1 l, 2,5 l ja 5 l. Kõik pakendi suurused ei pruugi olla müügil.
English: 1 ml for each additional 10 kg Administer orally with a suitable dose device.
Estonian: 1 ml iga täiendava 10 kg kohta Suukaudne manustamine sobiva annustamisvahendiga.
English: Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Tests) in discussion with their animal health advisor.
Estonian: Kui oletatakse antihelmintikumidele resistentsuse kliinilisi juhte, tuleb läbi viia täiendavad uuringud, kasutades sobivaid analüüse (nt väljaheite analüüs munade arvu vähenemisele) pidades nõu oma loomaarstiga.
English: Argenta Dundee Limited Kinnoull Road Dunsinane Industrial Estate Dundee, DD2 3XR United Kingdom
Estonian: Argenta Dundee Limited Kinnoull Road Dunsinane Industrial Estate Dundee, DD2 3XR Ühendkuningriik
English: The veterinary medicinal product can be used in breeding sheep including pregnant and lactating ewes.
Estonian: Veterinaarravimit on lubatud kasutada suguloomadel, sealhulgas tiinetel ja lakteerivatel emasloomadel.
English: Disposal: read the package leaflet.
Estonian: Hävitamine: vt pakendi infolehte.
English: Antiparasitic agents/ Agents acting against endoparasites
Estonian: Parasiitide vastased ained/endoparas iitide vastase toimega ained
English: Elanco France S.A.S 26 Rue de la Chapelle F-68330 Huningue France
Estonian: Elanco France S.A.S 26 Rue de la Chapelle F-68330 Huningue Prantsusmaa
English: Where the results of the tests strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.
Estonian: Kui analüüsitulemused viitavad tugevale resistentsusele teatud antihelmintikumide suhtes, peab kasutama teise farmakoloogilisse klassi kuuluvat ja teistsuguse toimemehhanismiga antihelmintikumi.
English: The efficacy has not been established in sheep weighing less than 10 kg.
Estonian: Ei ole tõestatud efektiivsus vähem kui 10 kg kaaluvatele lammastele.
English: Medicines should not be disposed of via wastewater or household waste.
Estonian: Kasutamata jäänud ravimeid ega jäätmematerjali ei tohi ära visata kanalisatsiooni kaudu ega koos majapidamisprügiga.
English: The safety has not been established in sheep weighing less than 10 kg or under 2 weeks of age.
Estonian: Ei ole tõestatud ohutus vähem kui 10 kg kaaluvatele või alla 2 nädala vanustele lammastele.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND IMMEDIATE PACKAGE Cardboard box and HDPE bottle
Estonian: VÄLISPAKENDIL JA SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Pappkarp ja HDPE pudel
English: The veterinary medicinal product is administered as a single treatment.
Estonian: Veterinaarravimit manustatakse ühekordse ravina.
English: Special precautions for use in animals: The safety has not been established in sheep weighing less than 10 kg or under 2 weeks of age.
Estonian: Ettevaatusabinõud kasutamisel loomadel Ei ole tõestatud ohutus vähem kui 10 kg kaaluvatele või alla 2 nädala vanustele lammastele.
English: Dose table:
Estonian: Annustamise tabel:
English: Shelf life after first opening the immediate packaging: 1 year
Estonian: Kõlblikkusaeg pärast vahetu pakendi esmast avamist: 1 aasta.
English: Body weight, kg
Estonian: Kehamass, kg
English: Withdrawal period(s): 7 days.
Estonian: Keeluaeg: 7 päeva.
English: Pack sizes of 250 ml, 500 ml, 1 l, 2.5 l, and 5 l.
Estonian: Pakendi suurused 250 ml, 500 ml, 1 l, 2,5 l ja 5 l.
English: To ensure administration of a correct dose, bodyweight should be determined as accurately as possible.
Estonian: Et kindlustada korrektse annuse manustamine, tuleb kehamass määrata nii täpselt kui võimalik; tuleb kontrollida annustamisvahendi täpsust ja töökorras olekut.
English: ZOLVIX oral solution is a broad spectrum anthelmintic for the treatment and control of gastrointestinal nematode infections and associated diseases in sheep including lambs, hoggets, breeding rams and ewes.
Estonian: ZOLVIX suukaudne lahus on laiaspektriline antihelmintikum seedetrakti nematoodinfektsioonide ja nendega seostuvate haiguste raviks ja profülaktikaks lammastel, sh talledel, jääradel, suguloomadel ja emasloomadel.
English: Monepantel
Estonian: Monepanteel
English: Sheep
Estonian: Lammas.
English: EXPIRY DATE EXP {month/year} Once opened use within 1 year.
Estonian: KÕLBLIKKUSAEG Kõlblik kuni {kuu/aasta} Pärast pakendi avamist kasutada 1 aasta jooksul.
English: Each ml of ZOLVIX orange clear oral solution contains 25 mg of monepantel
Estonian: Iga ml ZOLVIX oranž selge suukaudset lahust sisaldab 25 mg monepanteeli.
English: Overdose (symptoms, emergency procedures, antidotes): No adverse effects were observed after a 10-fold overdose.
Estonian: Üleannustamine (sümptomid, esmaabi, antidoodid) Pärast 10-kordset üleannustamist ei täheldatud kõrvaltoimeid.
English: ATCvet code: QP52AX09.
Estonian: Farmakoterapeutiline rühm: antihelmintikumid ATCvet kood: QP52AX09
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription.
Estonian: B. TARNIMIS- JA KASUTAMISTINGIMUSED VÕI PIIRANGUD Retseptiravim.
English: Wash hands and exposed skin after handling the veterinary medicinal product.
Estonian: Pärast veterinaarravimiga töötamist pesta käed ja ravimiga kokkupuutunud nahapind.
English: Liver Kidney Milk
Estonian: Lihas Rasv Maks Neerud Piim
English: In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.
Estonian: Juhuslikul ravimi allaneelamisel pöörduda viivitamatult arsti poole ja näidata pakendi infolehte või pakendi etiketti.
English: Maize oil
Estonian: Maisiõli
English: Name and address of the manufacturers responsible for batch release
Estonian: Ravimipartii vabastamise eest vastutavate tootjate nimi ja aadress
English: Shelf life after first opening the container: 1 year.
Estonian: Kõlblikkusaeg pärast pakendi esmast avamist: 1 aasta.
English: The dose rate is 2.5 mg/kg bodyweight of monepantel.
Estonian: Monepanteeli doos on 2,5 mg/kg kehamassi kohta.
English: Monepantel acts on the nematode specific nicotinic acetylcholine receptor sub-unit HcoMPTL-1.
Estonian: Monepanteel toimib nematoodide spetsiifilisele nikotiin-atsetüülkoliini retseptori subtüübile Hco-MPTL-1.
English: Other provisions
Estonian: Sihtkoed Muud sätted
English: ZOLVIX was shown to be effective against strains of gastro-intestinal parasites, listed in section 4.2, resistant to (pro)benzimidazoles, levamisole, morantel, macrocyclic lactones and H. contortus strains resistant to salicylanilides.
Estonian: ZOLVIX oli efektiivne nende lõigus 4.2 loetletud seedetrakti parasiiditüvede puhul, mis on resistentsed (pro)bensimidasoolide, levamisooli, moranteeli ja makrotsükliliste laktoonide suhtes ning H. contortus tüvede puhul, mis on resistentsed salitsüülaniliidide suhtes.
English: In addition, the product was shown to be effective against 4th stage larvae of a strain of H. contortus in a laboratory study where a combination of abamectin with derquantel was not effective.
Estonian: Laboratoorses uuringus osutus see ravimpreparaat efektiivseks H. contortus tüve 4. staadiumi larvide vastu, samas kui abamektiini ja derkvanteeli kombinatsioon ei olnud efektiivne.
English: Marker residue
Estonian: Markerjääk
English: ZOLVIX was shown to be effective against strains of gastro-intestinal parasites, listed in section 4, resistant to (pro)benzimidazoles, levamisole, morantel, macrocyclic lactones and H. contortus strains resistant to salicylanilides.
Estonian: ZOLVIX oli efektiivne nende lõigus 4 loetletud seedetrakti parasiiditüvede puhul, mis on resistentsed (pro)bensimidasoolide, levamisooli, moranteeli ja makrotsükliliste laktoonide suhtes ning H. contortus tüvede puhul, mis on resistentsed salitsüülaniliidide suhtes.
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Estonian: A. RAVIMIPARTII VABASTAMISE EEST VASTUTAVAD TOOTJAD
English: STATEMENT OF ACTIVE SUBSTANCES Each ml contains 25 mg of monepantel
Estonian: TOIMEAINE(TE) SISALDUS Iga ml sisaldab 25 mg monepanteeli.
English: Ovine, caprine
Estonian: Lambad, kitse
English: MARKETING AUTHORISATION HOLDER Elanco GmbH
Estonian: MÜÜGILOA HOIDJA NIMI JA AADRESS Elanco Europe Ltd.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Dose table Bodyweight, kg
Estonian: ANNUSTAMINE LOOMALIIGITI, MANUSTAMISVIIS(ID) JA -MEETOD Annustamise tabel: Kehamass, kg
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Estonian: RAVIMIPARTII VABASTAMISE EEST VASTUTAVAD TOOTJAD
English: Each ml contains 25 mg of monepantel Excipient:
Estonian: Iga ml sisaldab 25 mg monepanteeli.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZOLVIX 25 mg/ml oral solution for sheep Monepantel
Estonian: VETERINAARRAVIMI NIMETUS ZOLVIX 25 mg/ml suukaudne lahus lammastele Monepanteel
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZOLVIX 25 mg/ml oral solution for sheep
Estonian: VETERINAARRAVIMI NIMETUS ZOLVIX 25 mg/ml suukaudne lahus lammastele
English: PHARMACEUTICAL FORM Oral solution.
Estonian: RAVIMVORM Suukaudne lahus.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Estonian: Ettevaatusabinõud veterinaarravimit loomale manustavale isikule Veterinaarravimi käsitsemisel tuleb kasutada järgnevaid isiklikke kaitsevahendeid: kindaid.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Estonian: TOIMEAINETE JA ABIAINETE SISALDUS
English: PACKAGE LEAFLET: ZOLVIX 25 mg/ml oral solution for sheep
Estonian: PAKENDI INFOLEHT ZOLVIX 25 mg/ml suukaudne lahus lammastele
English: CONTRAINDICATIONS
Estonian: Propüleenglükool
English: Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product.
Estonian: Veterinaarravimi käsitsemisel tuleb kasutada järgnevaid isiklikke kaitsevahendeid: kindaid.
English: Heinz-Lohmann-Str. 4
Estonian: RG24 9NL
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Estonian: MÜÜGILOA HOIDJA
English: Muscle Fat
Estonian: Tiinus ja laktatsioon
English: Losartan
Estonian: Losartaan 150
English: Drug substance
Estonian: Inimravimite komitee arvamus
English: 1 June 2018
Estonian: 1. juuni 2018
English: Withdrawal of the marketing authorisation application for Restaysis (ciclosporin) EMA/275525/2018
Estonian: Müügiloa taotluse tagasivõtmise teave: Restaysis (tsüklosporiin) EMA/275525/2018
English: Withdrawal of the marketing authorisation application for Restaysis (ciclosporin)
Estonian: Müügiloa taotluse tagasivõtmise teave: Restaysis (tsüklosporiin)
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Estonian: Taotlus võeti tagasi pärast seda, kui inimravimite komitee oli hinnanud ettevõtte esitatud dokumente ja koostanud ettevõttele vastamiseks küsimused.
English: How does Restaysis work?
Estonian: Kuidas Restaysis toimib?
English: What is Restaysis?
Estonian: Mis on Restaysis?
English: The CHMP concluded that the results presented by the company were not robust enough to demonstrate that Restaysis is effective.
Estonian: Inimravimite komitee järeldas, et ettevõtte esitatud tulemused ei olnud piisavalt kindlad Restaysise efektiivsuse tõendamiseks.
English: The active substance in Restaysis, ciclosporin, reduces the activity of cells of the immune system (the body's natural defences) that are involved in the processes that cause inflammation.
Estonian: Restaysise toimeaine tsüklosporiin vähendab põletikuprotsessides osalevate immuunsüsteemi (organismi looduslik kaitsemehhanism) rakkude aktiivsust.
English: On 25 April 2018, Allergan Pharmaceuticals International Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Restaysis, for the treatment of moderate dry eye disease.
Estonian: Allergan Pharmaceuticals International Limited teatas 25. aprillil 2018 inimravimite komiteele oma soovist võtta tagasi Restaysis müügiloa taotlus.
English: The company informed the CHMP that the withdrawal will have no consequences on ongoing clinical trials.
Estonian: Ettevõte teavitas inimravimite komiteed, et tagasivõtmisel puuduvad tagajärjed käimasolevatele kliinilistele uuringutele.
English: Restaysis is a medicine that contains the active substance ciclosporin.
Estonian: Restaysis on ravim, mis sisaldab toimeainena tsüklosporiini.
English: The company presented an analysis of the results from three studies with ciclosporin conducted in the 1990s in patients with moderate to severe dry eye disease, where Restaysis was compared with placebo (a dummy treatment).
Estonian: Ettevõte esitas analüüsitulemused kolme uuringu kohta, mis olid 1990ndatel tsüklosporiiniga tehtud mõõduka kuni raske kuiva silma sündroomiga patsientidel, kus Restaysist võrreldi platseeboga (näiva raviga).
English: Applying it directly to the eye was expected to reduce inflammation and the symptoms of the disease.
Estonian: Otse silma manustamisest eeldati põletikku ja haiguse sümptomeid vähendavat toimet.
English: It was to be available as eye drops.
Estonian: Seda kavatseti turustada silmatilkadena.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Estonian: Inimravimite komitee oli ettevõttele esitatud viimaste küsimuste vastused läbi vaadanud, kuid mõni probleem oli veel lahendamata.
English: The main measures of effectiveness were the number of patients with damaged eye surface and with blurred vision, after 6 months of treatment.
Estonian: Efektiivsuse põhinäitaja oli kahjustatud silmapinna ja häguse nägemisega patsientide arv 6kuulise ravi järel.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it withdrew its application because of the CHMP's view that the data provided did not allow concluding on a positive benefit-risk balance in the intended patient population.
Estonian: Ettevõtte kirjas, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, märgib ettevõte, et taotluse tagasivõtmine põhineb inimravimite komitee arvamusel, et esitatud andmete põhjal ei ole komiteel võimalik järeldada, et ravimi kasulikkuse ja riski tasakaal on kavandatud patsiendipopulatsioonis positiivne.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that, because of lack of proven effectiveness, the benefits of Restaysis did not outweigh its risks.
Estonian: Seetõttu oli inimravimite komitee müügiloa taotluse tagasivõtmise ajal arvamusel, et kuna ravimi efektiivsus ei ole tõendatud, ei ole ravimi Restaysis kasulikkus suurem kui sellega kaasnevad riskid.
English: What was Restaysis expected to be used for?
Estonian: Milleks kavatseti Restaysist kasutada?
English: Restaysis was expected to be used in adults with moderate dry eye disease that was inadequately controlled despite treatment with tear substitutes or eye lubricants.
Estonian: Restaysis kavatseti kasutada mõõduka kuiva silma sündroomiga täiskasvanute raviks, kelle haigus oli pisaraasendajate või silmaniisutajatega ebapiisavalt ohjatud.
English: 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 Restaysis could not have been approved for the treatment of moderate dry eye disease.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi komitee taotluse tagasivõtmise ajal põhjust ettevaatlikkuseks ja oli esialgsel seisukohal, et ravimi Restaysis kasutamist mõõduka kuiva silma sündroomi raviks ei ole võimalik heaks kiita.
English: Inflammation seems to have an important role in the development of dry eye disease, regardless of the cause of the disease.
Estonian: Sõltumata haiguse põhjusest näib, et kuiva silma sündroomi tekkes on oluline roll põletikul.
English: The analysis focused on a subgroup of patients with moderate dry eye disease.
Estonian: Analüüs keskendus mõõduka kuiva silma sündroomiga patsientide alarühmale.
English: In particular, the way the results were analysed in patients with moderate dry eye disease could have introduced a bias in favour of Restaysis.
Estonian: Tulemusi oli analüüsitud sellisel viisil, millega võidi saavutada mõõduka kuiva silma sündroomiga patsientidel Restaysise suhtes soodsalt kallutatud tulemused.
English: However, this difference was not statistically significant.
Estonian: Kuid see erinevus ei olnud statistiliselt oluline.
English: Read the following instructions carefully.
Estonian: Lugege alljärgnevaid juhiseid hoolikalt.
English: >50 to ≤60 >60 to ≤70 >70 to ≤80 >80 to ≤90 >90 to ≤100
Estonian: >50 kuni ≤60 >60 kuni ≤70 >70 kuni ≤80 >80 kuni ≤90 >90 kuni ≤100
English: Wait 1 to 3 minutes.
Estonian: Oodake 1-3 minutit.
English: 08757 Corbera de Llobregat (Barcelona) Spain
Estonian: 08757 Corbera de Llobregat (Barcelona) Hispaania
English: The dose reductions can be temporary or permanent.
Estonian: Annuste vähendamine võib olla ajutine või alaline.
English: Allow the area to dry for 10 seconds.
Estonian: Laske puhastatud kohal 10 sekundit kuivada.
English: • If you are pregnant.
Estonian: • kui olete rase;
English: • If you have severe heart problems.
Estonian: • kui teil on raskeid südamehäireid;
English: Your doctor or nurse will show you how to inject yourself.
Estonian: Arst või õde näitab teile, kuidas end ise süstida.
English: Other medicines and Ceplene
Estonian: Muud ravimid ja Ceplene
English: The recommended dosing regimen is presented in Tables 1 and 2.
Estonian: Soovitatav annustamisrežiim on esitatud tabelites 1 ja 2.
English: You must be monitored to check how you respond to treatment.
Estonian: Teid tuleb jälgida, et näha, kuidas te ravile reageerite.
English: The expiry date refers to the last day of that month.
Estonian: Kõblikkusaeg viitab kuu viimasele päevale.
English: The mean half-life was 0.75 to 1.5 hours in patients.
Estonian: Keskmine poolestusaeg oli patsientidel 0,75 kuni 1,5 tundi.
English: Your doctor may change your dose.
Estonian: Arst võib teie ravimiannust muuta.
English: If you have an infection, your doctor will closely monitor you.
Estonian: Kui teil on nakkus, jälgib arst teid tähelepanelikult.
English: Wash your hands thoroughly with soap and water.
Estonian: Peske käed hoolikalt vee ja seebiga.
English: Your doctor will also carry out some blood tests during treatment.
Estonian: Arst teeb ravi vältel ka mõne vereanalüüsi.
English: This is to be returned to the pharmacist for disposal.
Estonian: See tuleb viia hävitamiseks tagasi apteeki.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Estonian: Erandlikel asjaoludel lubatud ja vastavalt EÜ määruse nr 726/2004 artiklile 14 (8) rakendab müügiloa hoidja ettenähtud aja jooksul järgmisi meetmeid:
English: Decide where you will inject Ceplene.
Estonian: Otsustage, kuhu te Ceplene süstite.
English: Ceplene use is not recommended in children and adolescents, as there is no information available about using this medicine in this age group.
Estonian: Ceplene kasutamine lastel ja noorukitel ei ole soovitatav, sest teave ravimi kasutamise kohta selles vanuserühmas puudub.
English: Content of the pack and other information
Estonian: Pakendi sisu ja muu teave
English: These medicines help the body's immune system fight diseases like cancer by improving the immune system's natural role in fighting disease.
Estonian: Need ravimid aitavad organismi immuunsüsteemil võidelda näiteks selliste haiguste vastu nagu vähk, parandades immuunsüsteemi rolli haiguste vastu võitlemises.
English: Maximum plasma concentration is reached approximately 10 minutes after end of subcutaneous infusion.
Estonian: Suurim sisaldus plasmas saavutatakse ligikaudu 10 minutit pärast subkutaanse infusiooni lõppu.
English: Pharmacotherapeutic group: Immunostimulants, other immunostimulants, ATC code: L03AX14.
Estonian: Farmakoterapeutiline rühm:Immunostimulandid, teised immunostimulandid, ATC-kood: L03AX14.
English: Each dose is calculated from your body weight.
Estonian: Iga annus arvutatakse teie kehakaalu järgi.
English: NOTE: Dispensing of aldesleukin must be carried out under controlled aseptic conditions.
Estonian: TÄHELEPANU: Aldesleukiini manustamiseks ettevalmistamine peab toimuma kontrollitud aseptilistes tingimustes.
English: Biotransformation/Elimination
Estonian: Biotransformatsioon/eritumine
English: Noventia Pharma srl Via Carlo PISACANE 31 I-47121 Forli (FC) Italy
Estonian: Noventia Pharma srl Via Carlo PISACANE 31 I-47121 Forli (FC) Itaalia
English: 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), or not known (cannot be estimated from the available data).
Estonian: Esinemissagedus on määratletud kui väga sage (1/10), sage (1/100 kuni <1/10), aeg-ajalt (≥ 1/1000 kuni < 1/100), harv (≥ 1/10000 kuni < 1/1000), väga harv (< 1/10000) või teadmata (esinemissagedust ei saa hinnata olemasolevate andmete alusel).
English: Ask your pharmacist how to dispose of medicines no longer required.
Estonian: Küsige apteekrilt, kuidas hävitada ravimeid, mida te enam ei kasuta.
English: Do not try to inject yourself unless a qualified professional has trained you.
Estonian: Ärge proovige end süstida ise, kui pädev meditsiinitöötaja ei ole teid õpetanud.
English: Find a comfortable, well-lit place to sit and where you can lie back.
Estonian: Leidke mugav, hästi valgustatud koht, kuhu saate selga toetades istuda või pikali heita.
English: • If you are allergic (hypersensitive) to histamine or any of the other ingredients of this medicine (listed in section 6).
Estonian: • kui olete allergiline (ülitundlik) histamiini või selle ravimi mis tahes muu koostisosa suhtes (loetletud lõigus 6);
English: Do not use Ceplene
Estonian: Ärge kasutage Ceplene´t
English: Ceplene belongs to a group of medicines called immunomodulatory medicines.
Estonian: Ceplene kuulub ravimirühma, mida nimetatakse immunomodulaatoriteks.
English: Ceplene is indicated for use in adults.
Estonian: Ceplene on näidustatud kasutamiseks täiskasvanutel.
English: There are no data available on pharmacodynamic properties in children below 18 years of age.
Estonian: Puuduvad andmed farmakodünaamiliste omaduste kohta lastel vanuses alla 18-aastat.
English: What Ceplene contains
Estonian: Mida Ceplene sisaldab
English: Do not lay the syringe down or let the needle touch anything.
Estonian: Ärge asetage nõela käest ega laske nõelal millegi vastu puutuda.
English: The solution must be clear and colourless.
Estonian: Lahus peab olema selge ja värvitu.
English: Do not take any additional dose to make up for the forgotten doses.
Estonian: Ärge võtke unustatud ravimi kompenseerimiseks topeltannust.
English: Never inject Ceplene any faster or all at once.
Estonian: Ärge kunagi süstige Ceplenet kiiremini ega ühe liigutusega.
English: Results of this pilot study were used to design and implement a multi-national phase 3 trial.
Estonian: Eksperimentaaluuringu tulemusi kasutati rahvusvahelise III faasi uuringu väljatöötamiseks ja rakendamiseks.
English: The safety and efficacy of Ceplene in children below 18 years of age have not yet been established.
Estonian: Ceplene ohutus ning efektiivsus alla 18 aastaste laste puhul ei ole veel kindlaks tehtud.