FrancophonIA/ELRC3.0 huggingface dataset:
English: Twinrix Paediatric is a combined vaccine formulated by pooling bulk preparations of the purified, inactivated hepatitis A (HA) virus and purified hepatitis B surface antigen (HBsAg), separately adsorbed onto aluminium hydroxide and aluminium phosphate.
Estonian: Twinrix Junior on kombineeritud vaktsiin, mis sisaldab puhastatud inaktiveeritud A-hepatiidi (HA) viirust ja puhastatud B-hepatiidi pinnaantigeeni (HBsAg) eraldi adsorbeerituna alumiiniumhüdroksiidile ning alumiiniumfosfaadile.
English: ≥ 1/10,000 to < 1/1,000
Estonian: ≥ 1/10 000 kuni < 1/1000 Väga harv: < 1/10 000
English: The anti-HBs and anti-HAV antibody titres observed following a primary vaccination course with the combined vaccine are in the range of what is seen following vaccination with the monovalent vaccines.
Estonian: Pärast esmast vaktsineerimist kombineeritud vaktsiiniga määratud anti-HBs ja anti-HAV antikehade tiitrid on samades piirides kui pärast vaktsineerimist monovalentsete vaktsiinidega.
English: In situations where a booster dose of both hepatitis A and hepatitis B are desired, Twinrix Paediatric can be given.
Estonian: Situatsioonides, kus on soovitav nii A-hepatiidi kui B-hepatiidi vastane korduv vaktsineerimine, võib manustada vaktsiini Twinrix Junior.
English: Twinrix Paediatric is not recommended for postexposure prophylaxis (e.g. needle stick injury).
Estonian: Twinrix Junior ei ole näidustatud nakatumisvõimaluse järgseks profülaktikaks (nt pärast süstlanõela torget).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Twinrix Paediatric, suspension for injection
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Twinrix Junior, süstesuspensioon
English: - If you get / your child gets any side effects, talk to your doctor or pharmacist.
Estonian: - Kui teil/teie lapsel tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti või apteekriga.
English: While it is not expected that recombinant hepatitis B virus surface antigen would have adverse effects on pregnancies or the fetus it is recommended that vaccination should be delayed until after delivery unless there is an urgent need to protect the mother against hepatitis B infection.
Estonian: on siiski soovitatav vaktsineerimine kuni sünnituseni edasi lükata, välja arvatud juhul, kui naist on kiiresti vaja B-hepatiidi viiruse põhjustatud nakkuse eest kaitsta.
English: The dose of 0.5 ml (360 ELISA Units HA/10 µg HBsAg) is recommended for infants, children and adolescents from 1 year up to and including 15 years of age.
Estonian: 1...15-aastastele (kaasa arvatud) lastele ja noorukitele on soovitatav annus 0,5 ml (360 ELISA ühikut HA/10 µg HBsAg).
English: România GlaxoSmithKline (GSK) SRL
Estonian: Ireland GlaxoSmithKline (Ireland) Ltd
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFATURER RESPONSIBLE FOR BATCH RELEASE
Estonian: BIOLOOGILIST) TOIMEAINETE TOOTJA JA RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAV TOOTJA
English: No data on concomitant administration of Twinrix Paediatric with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated.
Estonian: Puuduvad andmed Twinrix Junior vaktsiini samaaegse kasutamise kohta spetsiifiliste A-hepatiidi või B-hepatiidi immuunglobuliinidega.
English: Twinrix Paediatric should not be given if
Estonian: Twinrix Junior'i ei tohi manustada:
English: It is unknown whether Twinrix Paediatric is excreted in human breast milk.
Estonian: Ei ole teada, kas Twinrix Junior eritub rinnapiima.
English: What Twinrix Paediatric looks like and contents of the pack Suspension for injection in pre-filled syringe.
Estonian: Kuidas Twinrix Junior välja näeb ja pakendi sisu Süstesuspensioon süstelis.
English: • A temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barré syndrome)
Estonian: • Ajutine närvipõletik, mis põhjustab jäsemete valu, nõrkust ja halvatust ning mis võib süveneda,
English: How Twinrix Paediatric is given
Estonian: Kuidas Twinrix Junior'it manustatakse
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 February 1997
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV
English: Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)
Estonian: Väga harv (võivad esineda kuni 1 juhul 10 000 vaktsiiniannuse kohta):
English: Influenza like illness*, chills*
Estonian: harv gripitaoline haigestumine*, külmavärinad*
English: 12-15 years, all subjects followed up retained ≥15 mIU/ml anti-HAV antibody and 85% had anti-HBs antibody ≥10 mIU/ml.
Estonian: 10ndal aastal pärast Twinrix Junior'i manustamise alustamist 0, 1. ja 6. kuul lastel vanuses 12...15 aastat säilis kõigil jälgitud isikutel anti-HAV antikeha tase ≥15 mIU/ml ning 85% oli anti-HBs antikehad ≥10 mIU/ml.
English: Twinrix Paediatric is indicated for use in non immune infants, children and adolescents from 1 year up to and including 15 years who are at risk of both hepatitis A and hepatitis B infection.
Estonian: A-hepatiidi ja B-hepatiidi vastane aktiivne immuniseerimine 1 kuni 15-aastastel lastel ja noorukitel, kellel on nii A-hepatiiti kui B-hepatiiti nakatumise oht ja kes ei ole immuunsed.
English: Vasculitis
Estonian: • Iiveldus
English: How to store Twinrix Paediatric
Estonian: Kuidas Twinrix Junior'i säilitada
English: It is not known whether Twinrix Paediatric will prevent HA and HB in such cases.
Estonian: Ei ole teada, kas neil juhtudel hoiab Twinrix Junior ära haigestumise.
English: 10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
Estonian: 10 süstelit + 20 nõela 10 x 1 annust (0,5 ml)
English: Uncommon Upper respiratory tract infection*
Estonian: Vaskulaarsed häired harv hüpotensioon*
English: Arthralgia*
Estonian: harv artralgia*
English: • Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
Estonian: • Kergemini tekkivad verejooksud või verevalumid teatud tüüpi vererakkude (trombotsüütide ehk vereliistakute) vähesuse tõttu
English: Clinical trials Infections and infestations
Estonian: Kliinilised uuringud Infektsioonid ja infestatsioonid aeg-ajalt ülemiste hingamisteede infektsioon*
English: Alternatively, subjects primed with Twinrix Paediatric may be administered a booster dose of either of the monovalent vaccines.
Estonian: Teise võimalusena võib isikutel, kes on esmase vaktsinatsiooni saanud vaktsiiniga Twinrix Junior, korduvaks vaktsineerimiseks kasutada monovalentseid vaktsiine.
English: Twinrix Paediatric, Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Estonian: Twinrix Junior, süstesuspensioon süstelis A-hepatiit (inaktiveeritud) ja B-hepatiit (rDNA) vaktsiin (HAB), (adsorbeeritud).
English: Gastrointestinal symptoms, nausea Uncommon Diarrhoea, vomiting, abdominal pain
Estonian: Seedetrakti häired sage seedetrakti sümptomid, iiveldus aeg-ajalt kõhulahtisus, oksendamine, kõhuvalu
English: 10 x 1 dose (0.5 ml)
Estonian: 10 x 1 annust (0,5 ml) 50 süstelit
English: years all subjects followed up retained ≥15 mIU/ml anti-HAV antibody and 97% had anti-HBs antibody ≥10 mIU/ml.
Estonian: 5ndal aastal pärast Twinrix Junior'i manustamise alustamist 0, 1. ja 6. kuul lastel vanuses 1...11 aastat säilis kõigil jälgitud isikutel anti-HAV antikeha tase ≥15 mIU/ml ning 97% oli anti-HBs antikehad
English: 10 pre-filled syringes + 10 needles 10 x 1 dose (0.5 ml)
Estonian: 10 süstelit + 10 nõela 10 x 1 annust (0,5 ml)
English: Talk to you doctor or pharmacist before you receive Twinrix Paediatric if:
Estonian: Enne Twinrix Junior'i manustamist pidage nõu oma arsti või apteekriga:
English: Twinrix Paediatric is a vaccine used in infants, children and adolescents from 1 year up to and including 15 years to prevent two diseases: hepatitis A and hepatitis B. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.
Estonian: Twinrix Junior on vaktsiin, mida kasutatakse 1...15-aastastel lastel ja noorukitel, et ära hoida kahte haigust: A-hepatiiti ja B-hepatiiti.
English: NAME OF THE MEDICINAL PRODUCT Twinrix Paediatric - Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Estonian: Twinrix Junior - süstesuspensioon süstelis A-hepatiit (inaktiveeritud) ja B-hepatiit (rDNA) vaktsiin (HAB), (adsorbeeritud)
English: For some categories of subjects or patients exposed to HBV (e.g. haemodialysis or immunocompromised patients) a precautionary attitude should be considered to ensure a protective antibody level ≥ 10IU/l.
Estonian: Antikehade tiitrid riskigrupi isikutel (nt hemodialüüsi saavad või immuunpuudulikkusega patsiendid)
English: Common (these may occur with up to 1 in 10 doses of the vaccine)
Estonian: Sage (võivad esineda kuni 1 juhul 10 vaktsiiniannuse kohta):
English: • Nausea
Estonian: • Lööve
English: ≥ 1/1,000 to < 1/100
Estonian: Aeg-ajalt: ≥ 1/1000 kuni < 1/100 Harv:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Estonian: VÄLISPAKENDIL JA SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED
English: • Purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme)
Estonian: • Lillakas või punakas nahapinnast kõrgem lööve (lame lihhen), raskekujuline nahalööve
English: Uncommon (these may occur with up to 1 in 100 doses of the vaccine)
Estonian: Aeg-ajalt (võivad esineda kuni 1 juhul 100 vaktsiiniannuse kohta):
English: Urticaria, pruritus*
Estonian: • Nõgeslööve, sügelus
English: 50 x 1 dose (0.5 ml)
Estonian: 50 x 1 annust (0,5 ml) 1 süstel + 1 nõel
English: GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Estonian: GlaxoSmithKline (GSK) SRL Tel: + 40 (0)21 3028 208
English: Metabolism and nutrition disorders
Estonian: Ainevahetus- ja toitumishäired sage isutus
English: Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Estonian: Harv (võivad esineda kuni 1 juhul 1000 vaktsiiniannuse kohta):
English: Posology - Dosage
Estonian: • Lihasevalu
English: Lymphadenopathy
Estonian: Intramuskulaarne
English: • Joint swelling, muscular weakness
Estonian: • Liigeste turse, lihasnõrkus
English: The full EPAR for Zoledronic acid Actavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ravimi Zoledronic acid Actavis kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Actavis on 20 April 2012.
Estonian: Euroopa Komisjon andis ravimi Zoledronic acid Actavis müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 20. aprillil 2012.
English: A risk management plan has been developed to ensure that Zoledronic acid Actavis is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada ravimi Zoledronic acid Actavis võimalikult ohutu kasutamine.
English: In addition, the company that markets Zoledronic acid Actavis will provide a card to inform patients about the risk of osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) and to instruct them to contact their doctor if they experience symptoms.
Estonian: Lisaks varustab ravimi Zoledronic acid Actavis turustaja patsiendid teabekaardiga, milles selgitatakse lõualuu osteonekroosi riski (lõualuu kahjustus, mis võib tekitada valu, suuhaavandeid või hammaste logisemist) ning soovitatakse neil sümptomite ilmnemisel pöörduda arsti poole.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zoledronic acid Actavis.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: What measures are being taken to ensure the safe and effective use of Zoledronic acid Actavis?
Estonian: Mis meetmed võetakse, et tagada ravimi Zoledronic acid Actavis ohutu ja efektiivne kasutamine?
English: No additional studies were needed as Zoledronic acid Actavis is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa.
Estonian: Lisauuringuid ei olnud vaja, sest Zoledronic acid Actavis on geneeriline infusiooniravim, mis sisaldab sama toimeainet kui võrdlusravim Zometa.
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Actavis has been shown to be comparable to Zometa.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Zoledronic acid Actavis võrreldavus ravimiga Zometa.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Actavis, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi Zoledronic acid Actavis omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Because Zoledronic acid Actavis is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Zoledronic acid Actavis on geneeriline ravim, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: For more information about treatment with Zoledronic acid Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate ravimiga Zoledronic acid Actavis toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The usual dose of Zoledronic acid Actavis is one infusion of 4 mg over at least 15 minutes.
Estonian: Ravimi Zoledronic acid Actavis tavaannus on 4 mg, mida manustatakse ühe vähemalt 15 minutit kestva infusioonina.
English: This means that Zoledronic acid Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Estonian: See tähendab, et ravim Zoledronic acid Actavis on sarnane võrdlusravimiga Zometa, millel juba on Euroopa Liidus müügiluba.
English: Zoledronic acid Actavis is a medicine that contains the active substance zoledronic acid (4 mg).
Estonian: Zoledronic acid Actavis on ravim, mis sisaldab toimeainena soledroonhapet (4 mg).
English: It is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Estonian: Seda turustatakse infusioonilahuse (veeni tilgutatava lahuse) kontsentraadina.
English: The Committee recommended that Zoledronic acid Actavis be given marketing authorisation.
Estonian: Komitee soovitas anda ravimi Zoledronic acid Actavis müügiloa.
English: Zoledronic acid Actavis can be used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Estonian: Ravimit Zoledronic acid Actavis kasutatakse luutüsistuste ennetamiseks patsientidel, kellel on kaugelearenenud vähk, mis kahjustab luukude.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid Actavis.
Estonian: See on ravimi Zoledronic acid Actavis Euroopa avaliku hindamisaruande kokkuvõte.
English: Zoledronic acid Actavis must only be used by a doctor who has experience in the use of this type of medicine given into a vein.
Estonian: Ravimist Zoledronic acid Actavis tohib patsiendile määrata üksnes seda tüüpi veenisiseste ravimite kasutamises kogenud arst.
English: By preventing the breakdown of bones, Zoledronic acid Actavis also helps to reduce the amount of calcium released into the blood.
Estonian: Luukoe lagunemist peatades aitab Zoledronic acid Actavis vähendada verre eralduva kaltsiumi kogust.
English: Zoledronic acid Actavis can also be used to treat the hypercalcaemia caused by tumours.
Estonian: Ravimit Zoledronic acid Actavis tohib kasutada ka kasvajast põhjustatud hüperkaltseemia raviks.
English: Other information about Zoledronic acid Actavis
Estonian: Muu teave ravimi Zoledronic acid Actavis kohta
English: What is Zoledronic acid Actavis?
Estonian: Mis on Zoledronic acid Actavis?
English: When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys.
Estonian: Kui ravimit kasutatakse luutüsistuste ennetamiseks, tohib infusiooni korrata iga 34 nädala tagant ning patsiendid peavad lisaks võtma kaltsiumi ja D-vitamiini.
English: Zoledronic acid Actavis is a ‘generic medicine'.
Estonian: Zoledronic acid Actavis on geneeriline ravim.
English: The active substance in Zoledronic acid Actavis, zoledronic acid, is a bisphosphonate.
Estonian: Ravimi Zoledronic acid Actavis toimeaine soledroonhape on bisfosfonaat.
English: Why has Zoledronic acid Actavis been approved?
Estonian: Miks Zoledronic acid Actavis heaks kiideti?
English: Zoledronic acid Actavis zoledronic acid
Estonian: Zoledronic acid Actavis on retseptiravim.
English: How is Zoledronic acid Actavis used?
Estonian: Kuidas ravimit Zoledronic acid Actavis kasutatakse?
English: How does Zoledronic acid Actavis work?
Estonian: Kuidas Zoledronic acid Actavis toimib?
English: How has Zoledronic acid Actavis been studied?
Estonian: Kuidas ravimit Zoledronic acid Actavis uuriti?
English: What is Zoledronic acid Actavis used for?
Estonian: Milleks ravimit Zoledronic acid Actavis kasutatakse?
English: These can cause:
Estonian: Need võivad põhjustada:
English: Distribution into testes is relatively low.
Estonian: Jaotumine testistesse on suhteliselt väike.
English: • if you already use other medicines that affect your heart;
Estonian: • kui kasutate teisi ravimeid, mis mõjutavad teie südant
English: Plasma concentrations decrease rapidly during the first two hours and slowly thereafter.
Estonian: Plasma kontsentratsioon väheneb esimese kahe tunni jooksul järsult ning pärast seda aeglaselt.
English: Recovery > 21 days
Estonian: Taastumine > 21 päeva
English: Other medicines and Novantrone
Estonian: Muud ravimid ja Novantrone
English: - Fever or infections.
Estonian: - Palavik või infektsioonid
English: Do not give this medicine to children and adolescents from birth up to age of 18 years as safety and efficacy in children and adolescents have not been established.
Estonian: Ärge andke ravimit lastele ja noorukitele alates sünnist kuni 18 aasta vanuseni, kuna ohutus ja toime laste ning noorukite puhul on ebaselge.
English: Recovery ≤ 21 days
Estonian: Taastumine ≤ 21 päeva
English: The dosage of the medicine will be adjusted in accordance with the results of these tests.
Estonian: Ravimiannus reguleeritakse vastavalt nende testide tulemustele.
English: UNIQUE IDENTIFIER - 2D BARCODE <Not applicable>
Estonian: AINULAADNE IDENTIFIKAATOR - 2D-vöötkood <Ei kohaldata>
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA <Not applicable>
Estonian: AINULAADNE IDENTIFIKAATOR - INIMLOETAVAD ANDMED <Ei kohaldata>
English: Opportunistic infections
Estonian: Opportunistlikud infektsioonid
English: Single and repeat toxicity studies were conducted in mouse, rat, dog, rabbits, and monkey.
Estonian: Viidi läbi üksik ja korduvtoksilisuse uuringud hiirte, rottide, koerte, küülikute ja ahvidega.
English: 1,500 cells/mm3);
Estonian: 1,500 rakku/mm3).
English: Withhold until recovery, then repeat prior dose.
Estonian: Peatage annustamine kuni taastumiseni, seejärel korda eelnevat annust.
English: In men, no data are available.
Estonian: Meeste kohta andmed puuduvad.
English: Adjustments of the anticoagulant dose may be necessary in order to maintain the desired level of anticoagulation.
Estonian: Antikoagulandi annust võib olla vaja muuta, et säilitada antikoagulatsiooni soovitud taset.
English: Anaphylaxis/anaphylactoid reactions (including shock)
Estonian: Anafülaksia/anafülaktoidsed reaktsioonid (sealhulgas šokk)
English: If this happens, the infusion must be stopped and restarted in another vein.
Estonian: Kui see juhtub, tuleb infusioon peatada ning alustada manustamist teise veeni kaudu.
English: There is little experience in children and adolescents.
Estonian: Laste ja noorukitel kasutamise kohta on vähe teavet.
English: Any duration
Estonian: Mistahes kestus
English: In addition your blood will be tested regularly during the treatment.
Estonian: Lisaks võetakse teilt ravi ajal regulaarselt vereanalüüse.
English: Most complete remissions will occur following the initial course of induction therapy.
Estonian: Enamik täielikke remissioone ilmneb pärast esmast induktsioonravi protseduuri.
English: In cases of overdosage patients should be monitored closely.
Estonian: Üleannustamise korral tuleb patsiente hoolikalt jälgida.
English: Infection (including fatal outcome)
Estonian: Infektsioon (sealhulgas surmaga lõppev)
English: No effects were observed on pup development or fertility in the two generation study in rats.
Estonian: Mõju poegade arengule või viljakusele rottide kahe generatsiooni uuringus ei vaadeldud.
English: • if you use Novantrone in high doses (>14 mg/m2 per day x 3 days).
Estonian: • Kui te kasutate Novantrone't suurtes annustes (> 14 mg/m2 ööpäevas x 3 päeva).
English: [To be completed nationally] OTHER SPECIAL WARNING(S), IF NECESSARY [To be completed nationally] EXPIRY DATE [To be completed nationally] SPECIAL STORAGE CONDITIONS [To be completed nationally] SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Estonian: [Täidetakse riiklikult] TEISED ERIHOIATUSED (VAJADUSEL) [Täidetakse riiklikult] KÕLBLIKKUSAEG [Täidetakse riiklikult] SÄILITAMISE ERITINGIMUSED [Täidetakse riiklikult] ERINÕUDED KASUTAMATA JÄÄNUD RAVIMPREPARAADI VÕI SELLEST TEKKINUD JÄÄTMEMATERJALI HÄVITAMISEKS, VASTAVALT VAJADUSELE
English: Safety and efficacy have not been established.
Estonian: Ohutus ja tõhusus pole kindlaks tehtud.
English: Extravasation*
Estonian: Ekstravasatsioon*
English: Ask your doctor or pharmacist if you are not sure whether your medicine is one of the medicines listed above.
Estonian: Küsige nõu oma arstilt või apteekrilt, kui te pole kindel, kas teie kasutatav ravim on loetletud ülalolevas nimekirjas.
English: You may require a blood transfusion.
Estonian: Vajalikuks võib osutuda vereülekande tegemine.
English: Very Common (may affect more than 1 in 10 people)
Estonian: Väga sage (võib esineda rohkem kui 1 inimesel 10-st)
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Estonian: Tervishoiutöötajatel palutakse teavitada kõigist võimalikest kõrvaltoimetest riikliku teavitamissüsteemi, mis on loetletud V lisas, kaudu .
English: If you are taking any of these, your doctor might need to prescribe an alternative medicine for you.
Estonian: Kui kasutate mõnda neist ravimitest, võib arst teile määrata teise ravimi.
English: To date, only isolated cases of severe local reactions (necroses) have been described due to extravasation.
Estonian: Praeguseni on kirjeldatud vaid üksikuid ekstravasatsioonist tingitud raske lokaalse reaktsiooni (nekroosi) juhtumeid.
English: Novantrone prevents cancer cells from growing, as a result of which they eventually die.
Estonian: Novantrone takistab kasvajarakkude kasvamist, mille tulemusena need lõpuks surevad.
English: Pharmacotherapeutic group: Antineoplastic agents, Anthracyclines and related substances ATC-Code: L01DB07
Estonian: Farmakoterapeutiline rühm: Kasvajavastased ained, antratsükliinid ja sarnased ained ATC-kood: L01DB07
English: This is in general a transient neutropenia with the lowest count of leucocytes at day 10 after the infusion and recovered around day 20.
Estonian: See on üldiselt mööduv neutropeenia, mille korral on lekotsüütide arv madalaim 10. päeval pärast infusiooni ning mis taastub umbes 20. päevaks.