FrancophonIA/ELRC3.0 huggingface dataset:
English: Kovaltry 250 IU powder and solvent for solution for injection Kovaltry 500 IU powder and solvent for solution for injection Kovaltry 1000 IU powder and solvent for solution for injection Kovaltry 2000 IU powder and solvent for solution for injection Kovaltry 3000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Estonian: Kovaltry 250 RÜ süstelahuse pulber ja lahusti Kovaltry 500 RÜ süstelahuse pulber ja lahusti Kovaltry 1000 RÜ süstelahuse pulber ja lahusti Kovaltry 2000 RÜ süstelahuse pulber ja lahusti Kovaltry 3000 RÜ süstelahuse pulber ja lahusti rekombinantne inimese VIII hüübimisfaktor (alfaoktokog)
English: INFORMATION IN BRAILLE Kovaltry 1000
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Kovaltry 1000
English: Dysgeusia uncommon
Estonian: Unetus sage
English: INFORMATION IN BRAILLE Kovaltry 3000
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Kovaltry 3000
English: INFORMATION IN BRAILLE Kovaltry 500
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Kovaltry 500
English: The reconstituted product must be filtered prior to administration to remove potential particulate matter in the solution.
Estonian: Eemaldamaks võimalikke lahuses sisalduvaid tahkeid osakesi, tuleb manustamiskõlblikuks muudetud ravim enne manustamist filtreerida.
English: • syringe plunger rod
Estonian: Peavalu, pearinglus sage
English: How to store Kovaltry
Estonian: Kuidas Kovaltry't säilitada
English: During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Estonian: Annuse ja korduva infusiooni manustamissageduse määramiseks on soovitatav ravikuuri ajal nõuetekohaselt mõõta VIII hüübimisfaktori sisaldust.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 250 IU contains (250 IU / 2.5 mL) = 100 IU octocog alfa per mL after reconstitution.
Estonian: TOIMEAINE(TE) SISALDUS Kovaltry 250 RÜ sisaldab (250 RÜ/2,5 ml) = pärast lahustamist 100 RÜ alfaoktokogi ml kohta.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 3000 IU contains (3000 IU / 5 mL) = 600 IU octocog alfa per mL after reconstitution.
Estonian: TOIMEAINE(TE) SISALDUS Kovaltry 3000 RÜ sisaldab (3000 RÜ/5 ml) = pärast lahustamist 600 RÜ alfaoktokogi ml kohta.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 2000 IU contains (2000 IU / 5 mL) = 400 IU octocog alfa per mL after reconstitution.
Estonian: TOIMEAINE(TE) SISALDUS Kovaltry 2000 RÜ sisaldab (2000 RÜ/5 ml) = pärast lahustamist 400 RÜ alfaoktokogi ml kohta.
English: 3000 IU) solvent (clear glass cylinder type 1 with grey bromobutyl rubber blend stopper)
Estonian: • üks süstel (läbipaistvast I tüüpi klaasist silinder halli broombutüülkummisegust punnkorgiga)
English: For reconstitution read package leaflet before use.
Estonian: Enne ravimi kasutamist lugege pakendi infolehte.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 500 IU contains (500 IU / 2.5 mL) = 200 IU octocog alfa per mL after reconstitution.
Estonian: TOIMEAINE(TE) SISALDUS Kovaltry 500 RÜ sisaldab (500 RÜ/2,5 ml) = pärast lahustamist 200 RÜ alfaoktokogi ml kohta.
English: 29 IU/kg 54 IU/kg)
Estonian: 29 RÜ/kg 54 RÜ/kg)
English: The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII , this risk being highest within the first 20 exposure days.
Estonian: Inhibiitorite tekkerisk on vastavuses haiguse raskusastme ja VIII hüübimisfaktori toimeajaga.
English: Treatment with Kovaltry will be started by a doctor who is experienced in the care of patients with haemophilia A. Always use this medicine exactly as described in this leaflet and as your doctor or pharmacist has told you.
Estonian: Kasutage seda ravimit alati täpselt nii, nagu on kirjeldatud selles infolehes ja nagu arst või apteeker on teile selgitanud.
English: 32 IU/kg 50 IU/kg)
Estonian: 32 RÜ/kg 50 RÜ/kg)
English: 31 IU/kg 72 IU/kg)
Estonian: 31 RÜ/kg 72 RÜ/kg)
English: Use only the components (vial adapter, pre filled syringe containing solvent and venipuncture set) provided with each package of this medicine.
Estonian: Kuidas Kovaltry't manustamiseks ette valmistada Kasutage ainult selle ravimi pakendis sisalduvaid vahendeid (viaaliadapter, lahustit sisaldav süstel ja veenipunktsiooni komplekt).
English: When infused into a haemophiliac patient, factor VIII binds to vWF in the patient's circulation.
Estonian: VIII hüübimisfaktori infusioonil hemofiiliahaigele seondub see haige vereringes oleva vWF-ga.
English: 28 IU/kg 39 IU/kg)
Estonian: 28 RÜ/kg 39 RÜ/kg)
English: • one venipuncture set
Estonian: • üks veenipunktsiooni komplekt.
English: 37 IU/kg 42 IU/kg)
Estonian: 37 RÜ/kg 42 RÜ/kg)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU (octocog alfa) (100 IU/mL after reconstitution).
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 250 RÜ (alfaoktokog) (pärast lahustamist 100 RÜ/ml).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Kovaltry 1000 IU contains (1000 IU / 2.5 mL) = 400 IU octocog alfa per mL after reconstitution.
Estonian: TOIMEAINE(TE) SISALDUS Kovaltry 1000 RÜ sisaldab (1000 RÜ/2,5 ml) = pärast lahustamist 400 RÜ alfaoktokogi ml kohta.
English: Do not increase the dose of Kovaltry to control your bleeding without checking with your doctor.
Estonian: Ilma arstiga konsulteerimata ärge suurendage verejooksu peatamiseks kasutatavat Kovaltry annust.
English: Kovaltry contains sodium
Estonian: Kovaltry sisaldab naatriumi
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU (octocog alfa) (600 IU/mL after reconstitution).
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 3000 RÜ (alfaoktokog) (pärast lahustamist 600 RÜ/ml).
English: Kovaltry 3000 IU powder and solvent for solution for injection One mL Kovaltry 3000 IU contains approximately 600 IU (3000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Estonian: 1 ml Kovaltry 3000 RÜ süstelahust sisaldab pärast süsteveega manustamiskõlblikuks muutmist ligikaudu 600 RÜ (3000 RÜ/5 ml) rekombinantset inimese VIII hüübimisfaktorit (INN: octocogum alfa).
English: Kovaltry 250 IU powder and solvent for solution for injection One mL Kovaltry 250 IU contains approximately 100 IU (250 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Estonian: 1 ml Kovaltry 250 RÜ süstelahust sisaldab pärast süsteveega manustamiskõlblikuks muutmist ligikaudu 100 RÜ (250 RÜ/2,5 ml) rekombinantset inimese VIII hüübimisfaktorit (INN: octocogum alfa).
English: Kovaltry is injected into a vein over 2 to 5 minutes depending on the total volume and your comfort level and should be used within 3 hours after reconstitution.
Estonian: Sõltuvalt süstitava lahuse mahust ja teie enesetundest, tuleb Kovaltry't süstida veeni 2 kuni 5 minuti jooksul.
English: Kovaltry 500 IU powder and solvent for solution for injection One mL Kovaltry 500 IU contains approximately 200 IU (500 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Estonian: 1 ml Kovaltry 500 RÜ süstelahust sisaldab pärast süsteveega manustamiskõlblikuks muutmist ligikaudu 200 RÜ (500 RÜ/2,5 ml) rekombinantset inimese VIII hüübimisfaktorit (INN: octocogum alfa).
English: 32 IU/kg 58 IU/kg)
Estonian: 32 RÜ/kg 58 RÜ/kg)
English: 31 IU/kg 43 IU/kg)
Estonian: 31 RÜ/kg 43 RÜ/kg)
English: Kovaltry 2000 IU powder and solvent for solution for injection One mL Kovaltry 2000 IU contains approximately 400 IU (2000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Estonian: 1 ml Kovaltry 2000 RÜ süstelahust sisaldab pärast süsteveega manustamiskõlblikuks muutmist ligikaudu 400 RÜ (2000 RÜ/5 ml) rekombinantset inimese VIII hüübimisfaktorit (INN: octocogum alfa).
English: 30 IU/kg 34 IU/kg)
Estonian: 30 RÜ/kg 34 RÜ/kg)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU (octocog alfa) (400 IU/mL after reconstitution).
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 1000 RÜ (alfaoktokog) (pärast lahustamist 400 RÜ/ml).
English: Kovaltry 1000 IU powder and solvent for solution for injection One mL Kovaltry 1000 IU contains approximately 400 IU (1000 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Estonian: 1 ml Kovaltry 1000 RÜ süstelahust sisaldab pärast süsteveega manustamiskõlblikuks muutmist ligikaudu 400 RÜ (1000 RÜ/2,5 ml) rekombinantset inimese VIII hüübimisfaktorit (INN: octocogum alfa).
English: 31 IU/kg 49 IU/kg)
Estonian: 31 RÜ/kg 49 RÜ/kg)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU (octocog alfa) (200 IU/mL after reconstitution).
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 500 RÜ (alfaoktokog) (pärast lahustamist 200 RÜ/ml).
English: Place the powder vial on a firm, non slip surface.
Estonian: Asetage pulbrit sisaldav viaal kindlale mittelibedale pinnale.
English: EU/1/15/1076/023 - 30 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL))
Estonian: EU/1/15/1076/023 - 30 x (Kovaltry 2000 RÜ - lahusti (5 ml); süstel (5 ml))
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU (octocog alfa) (400 IU/mL after reconstitution).
Estonian: PAKENDI SISU KAALU, MAHU VÕI ÜHIKUTE JÄRGI 2000 RÜ (alfaoktokog) (pärast lahustamist 400 RÜ/ml).
English: Warnings and precautions Talk to your doctor or pharmacist if you have: tightness in the chest, dizziness (including when you get up from sitting or lying down), itchy nettle-rash, wheezing, feeling sick or faint.
Estonian: • teil tekib pitsitustunne rinnus, pearinglus (sh istumast või lamamast püsti tõustes), sügelev nõgeslööve, vilistav hingamine, iiveldus või minestamistunne.
English: Attach the pre filled syringe to the threaded vial adapter by turning clockwise (F).
Estonian: Päripäeva keerates kinnitage süstel keermega viaaliadapteri külge (F).
English: EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL))
Estonian: EU/1/15/1076/024 - 30 x (Kovaltry 3000 RÜ - lahusti (5 ml); süstel (5 ml))
English: The most serious side effects are allergic reactions or severe allergic reaction.Stop injecting Kovaltry immediately and speak to your doctor at once if such reactions occur.
Estonian: Kõige tõsisemad kõrvaltoimed on allergilised reaktsioonid või raske allergiline reaktsioon.
English: - a blood clot in the blood vessel.
Estonian: Veenduge, et süstlasse ei satuks verd.
English: NAME OF THE MEDICINAL PRODUCT Kovaltry 250 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Estonian: RAVIMPREPARAADI NIMETUS Kovaltry 250 RÜ süstelahuse pulber ja lahusti rekombinantne inimese VIII hüübimisfaktor (alfaoktokog)
English: NAME OF THE MEDICINAL PRODUCT Kovaltry 3000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Estonian: RAVIMPREPARAADI NIMETUS Kovaltry 3000 RÜ süstelahuse pulber ja lahusti rekombinantne inimese VIII hüübimisfaktor (alfaoktokog)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 250 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Kovaltry 250 RÜ süstelahuse pulber rekombinantne inimese VIII hüübimisfaktor (alfaoktokog) Intravenoosne.
English: NAME OF THE MEDICINAL PRODUCT Kovaltry 2000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Estonian: RAVIMPREPARAADI NIMETUS Kovaltry 2000 RÜ süstelahuse pulber ja lahusti rekombinantne inimese VIII hüübimisfaktor (alfaoktokog)
English: NAME OF THE MEDICINAL PRODUCT Kovaltry 500 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Estonian: RAVIMPREPARAADI NIMETUS Kovaltry 500 RÜ süstelahuse pulber ja lahusti rekombinantne inimese VIII hüübimisfaktor (alfaoktokog)
English: EU/1/15/1076/017 - 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/018 - 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Estonian: EU/1/15/1076/017 - 30 x (Kovaltry 250 RÜ - lahusti (2,5 ml); süstel (3 ml)) EU/1/15/1076/018 - 30 x (Kovaltry 250 RÜ - lahusti (2,5 ml); süstel (5 ml))
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 3000 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Kovaltry 3000 RÜ süstelahuse pulber rekombinantne inimese VIII hüübimisfaktor (alfaoktokog) Intravenoosne.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 500 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Kovaltry 500 RÜ süstelahuse pulber rekombinantne inimese VIII hüübimisfaktor (alfaoktokog) Intravenoosne.
English: NAME OF THE MEDICINAL PRODUCT Kovaltry 1000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Estonian: RAVIMPREPARAADI NIMETUS Kovaltry 1000 RÜ süstelahuse pulber ja lahusti rekombinantne inimese VIII hüübimisfaktor (alfaoktokog)
English: EU/1/15/1076/006 - 1 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/016 - 1 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Estonian: EU/1/15/1076/006 - 1 x (Kovaltry 1000 RÜ - lahusti (2,5 ml); süstel (3 ml)) EU/1/15/1076/016 - 1 x (Kovaltry 1000 RÜ - lahusti (2,5 ml); süstel (5 ml))
English: EU/1/15/1076/002 - 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/012 - 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Estonian: EU/1/15/1076/002 - 1 x (Kovaltry 250 RÜ - lahusti (2,5 ml); süstel (3 ml)) EU/1/15/1076/012 - 1 x (Kovaltry 250 RÜ - lahusti (2,5 ml); süstel (5 ml))
English: EU/1/15/1076/021 - 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/022 - 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Estonian: EU/1/15/1076/021 - 30 x (Kovaltry 1000 RÜ - lahusti (2,5 ml); süstel (3 ml)) EU/1/15/1076/022 - 30 x (Kovaltry 1000 RÜ - lahusti (2,5 ml); süstel (5 ml))
English: EU/1/15/1076/019 - 30 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/020 - 30 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Estonian: EU/1/15/1076/019 - 30 x (Kovaltry 500 RÜ - lahusti (2,5 ml); süstel (3 ml)) EU/1/15/1076/020 - 30 x (Kovaltry 500 RÜ - lahusti (2,5 ml); süstel (5 ml))
English: EU/1/15/1076/004 - 1 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) EU/1/15/1076/014 - 1 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (5 mL))
Estonian: EU/1/15/1076/004 - 1 x (Kovaltry 500 RÜ - lahusti (2,5 ml); süstel (3 ml)) EU/1/15/1076/014 - 1 x (Kovaltry 500 RÜ - lahusti (2,5 ml); süstel (5 ml))
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 1000 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Kovaltry 1000 RÜ süstelahuse pulber rekombinantne inimese VIII hüübimisfaktor (alfaoktokog) Intravenoosne.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1076/008 - 1 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 13.
Estonian: EU/1/15/1076/008 - 1 x (Kovaltry 2000 RÜ - lahusti (5 ml); süstel (5 ml)) 13.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Kovaltry 2000 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Kovaltry 2000 RÜ süstelahuse pulber rekombinantne inimese VIII hüübimisfaktor (alfaoktokog) Intravenoosne.
English: Check with your doctor or pharmacist if you are not sure.
Estonian: Hoiatused ja ettevaatusabinõud Pidage nõu oma arsti või apteekriga, kui:
English: The following symptoms could be an early warning of these reactions: chest tightness/general feeling of being unwell dizziness a reduction in blood pressure, which may make you feel faint upon standing) feeling sick (nausea)
Estonian: Järgmised sümptomid võivad varakult hoiatada nende reaktsioonide tekkimisest:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1076/010 - 1 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 13.
Estonian: EU/1/15/1076/010 - 1 x (Kovaltry 3000 RÜ - lahusti (5 ml); süstel (5 ml)) 13.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 13.
Estonian: EU/1/15/1076/024 - 30 x (Kovaltry 3000 RÜ - lahusti (5 ml); süstel (5 ml)) 13.
English: These recommendations were considered appropriate.
Estonian: Neid soovitusi peeti sobivateks.
English: These should be included in a risk management plan.
Estonian: Need materjalid tuleb kaasata riskijuhtimiskavasse.
English: • The Committee considered the referral under Article 30 of Directive 2001/83/EC.
Estonian: • Komitee arutas direktiivi 2001/83/EÜ artikli 30 kohast esildist.
English: Other sections have only been partially harmonised as it is considered that these should be adapted nationally.
Estonian: Teisi lõike ühtlustati ainult osaliselt, sest leiti, et need tuleb kohandada riiklikult.
English: Overall summary of the scientific evaluation of Novantrone and associated names (see Annex I)
Estonian: Novantrone ja sarnaste nimetuste teadusliku hindamise üldkokkuvõte (vt I lisa)
English: Information of lesser relevance was removed in order to focus on the main information.
Estonian: Põhiteabele keskendumiseks eemaldati väiksema tähtsusega teave.
English: Section 5 - Pharmacological properties
Estonian: Lõik 5 - Farmakoloogilised omadused
English: The CHMP concluded that the level of evidence provided is limited.
Estonian: Inimravimite komitee otsustas, et esitatud tõestusmaterjali tase on piiratud.
English: In conclusion, the CHMP considered that the indication was not acceptable.
Estonian: Kokkuvõttes oli inimravimite komitee arvamusel, et see näidustus ei ole vastuvõetav.
English: In most studies no comparator was used or, when a comparator was used it appeared to be more effective.
Estonian: Enamikus uuringutes ei kasutatud võrdlusrühma; võrdlusrühma kasutamisel näis see olevat tõhusam.
English: Most of the existing statements on interactions across the MSs were supported.
Estonian: Toetati enamikke liikmesriigiti kehtivaid väiteid koostoimete kohta.
English: The CHMP was of the view that the scientific basis for this recommendation was weak and that information regarding vaccination schedule should rather be included in section 4.4 and 4.5, in line with clinical practice guidelines recommendations.
Estonian: Inimravimite komitee oli arvamusel, et selle soovituse teaduslik põhjendus oli nõrk, ja et vaktsineerimiskavaga seotud kliinilise praktika soovituslike suunistega kooskõlas teave tuleb lisada lõiku 4.4 ja 4.5.
English: However, no benefit in overall survival or other clinically relevant endpoints has been reported.
Estonian: Üldise elulemuse või muude kliiniliselt oluliste tulemusenäitajate osas ei ole siiski kasust teatatud.
English: Dilution recommendation and guidance for the choice of veins as well as warning regarding extravasation, were considered adequate.
Estonian: Lahjendamise soovitusi ja suuniseid veenide valiku kohta ning hoiatusi ekstravasatsiooni kohta peeti küllaldaseks.
English: In addition, the committee considered the advice of the Scientific Advisory Group Neurology and of the Pharmacovigilance Risk Assessment Committee.
Estonian: Lisaks sellele kaalus komitee neuroloogia teadusliku nõuanderühma ja ravimiohutuse riskihindamise komitee nõuandeid.
English: In addition, due to the dose dependent risk of cardiotoxicity, the maximum lifetime cumulative dose was limited to 72 mg/m2.
Estonian: Arvestades annussõltuvat kardiotoksilisuse riski, seati eluea maksimaalse kumulatiivse annuse ülempiiriks 72 mg/m2.
English: Relevant information available on risks of infertility was also harmonised.
Estonian: Ühtlustati ka asjakohane olemasolev teave viljatuse riski kohta.
English: The CHMP considered that the efficacy of mitoxantrone has been demonstrated in these studies.
Estonian: Inimravimite komitee otsustas, et mitoksantrooni tõhusus on nendes uuringutes tõestatud.
English: • The Committee considered that additional risk minimisation measures in the form of educational materials for the use of Novantrone and associated names in multiple sclerosis were necessary.
Estonian: • Komitee pidas vajalikuks täiendavaid riskivähendamise meetmeid õppematerjalide vormis Novantrone ja sarnaste nimetuste kasutamise kohta hulgiskleroosi korral.
English: Due to the divergent national decisions taken by MSs concerning the authorisation of the abovementioned product (and its associated names), the European Commission notified the European Medicines Agency of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised Product Information (PI) and thus to harmonise the PI across the EU.
Estonian: Et liikmesriigid on vastu võtnud erinevaid eespool nimetatud ravimi (ja sarnaste nimetuste) müügilubade otsuseid, teatas Euroopa Komisjon Euroopa Ravimiametile direktiivi 2001/83/EÜ artikli 30 alusel tehtavast esildisest, et lahendada erinevused liikmesriikides heakskiidetud ravimiteabes ja seega ühtlustada ravimiteave kogu Euroopa Liidus.
English: Changes introduced in the SmPC were consistently reflected in the labelling, however most sections were left to be completed nationally.
Estonian: Ravimi omaduste kokkuvõttes tehtud muudatusi kajastati järjepidevalt pakendi märgistuses, kuid enamik lõike tuleb täita riiklikult.
English: This section was restructured according to guidelines.
Estonian: Vastavalt juhistele tehti selles lõigus struktuurilisi muudatusi.
English: In multiple sclerosis a flexible dosing schedule was agreed in order to reflect those used in clinical trials and practices in the different member states.
Estonian: Hulgiskleroosi korral kiideti heaks paindlik annustamisskeem, et peegeldada kliinilistes uuringutes kasutatud skeeme ja praktikaid eri liikmesriikides.
English: In some member states, additional information was included on absence of interactions or pharmacokinetic and pharmacodynamic interactions without clinical relevance, this was not considered relevant to be included in the harmonised PI.
Estonian: Mõnes liikmesriigis sisaldas ravimiteave lisateavet kliiniliselt ebaoluliste koostoimete või farmakokineetiliste ja farmakodünaamiliste interaktsioonide puudumise kohta, kuid selle lisamist ühtlustatud ravimiteabesse ei peetud asjakohaseks.
English: Further it was considered that the interaction with immunosuppressive medicines should be mentioned.
Estonian: Oldi ka arvamusel, et ära tuleb mainida koostoimed immuunsupressiivsete ravimitega.
English: The CMHP was of the view that overall the evidence provided was insufficient, in particular considering the large heterogeneity among acute leukaemia patients.
Estonian: Inimravimite komitee oli arvamusel, et esitatud tõestusmaterjal oli üldiselt ebapiisav, eriti arvestades ägeda leukeemiaga patsientide suurt heterogeensust.
English: Novantrone and associated names are approved for marketing as a 2mg/ml concentrate for solution for infusion for intravenous use in most European Union (EU) Member States (MS).
Estonian: Novantrone ja sarnased nimetused on enamikus Euroopa Liidu (EL) liikmesriikides turustamiseks heaks kiidetud intravenoosse infusioonilahuse 2 mg/ml kontsentraadina.