natgillin/translations-raw huggingface dataset:
The CHMP addressed a list of questions to the MAH, pointing out the sections of the products SmPC where divergences existed.
Odbor CHMP je imetniku dovoljenja za promet z zdravilom predložil seznam vprašanj, s katerimi je izpostavil poglavja, v katerih prihaja do razhajanj med povzetki glavnih značilnosti zdravila.
The information in this section was mainly consistent in the SmPC across the MSs.
Informacije v tem poglavju so bile v glavnem skladne v povzetku glavnih značilnosti zdravila po vseh državah članicah.
The information in this section was mainly consistent in the SmPC of Seroquel and Seroquel XR across all MSs.
Informacije v tem poglavju so bile v glavnem skladne v povzetku glavnih značilnosti zdravila za zdravilo Seroquel in zdravilo Seroquel XR po vseh državah članicah.
It was agreed that the harmonised wording related to section 4.5 is the already approved Seroquel and Seroquel XR MRP SmPC.
Dogovorjeno je bilo, da je usklajeno besedilo glede poglavja 4.5 že odobren povzetek glavnih značilnosti zdravila za zdravili Seroquel in Seroquel XR.
This section was also further amended to reflect the information already included in the package leaflet that exacerbation of pre-existing diabetes may occur.
Poglavje je bilo nadalje spremenjeno, tako da navaja možno poslabšanje že obstoječe sladkorne bolezni, kar pa je že vključeno v navodila za uporabo.
Due to the combination of the MRP/DCP and national granted MAs some divergent information has been identified in the product information (PI) for Seroquel and Seroquel XR.
Zaradi kombinacije postopka z medsebojnim priznavanjem in decentraliziranega postopka ter nacionalno odobrenih dovoljenj za promet z zdravilom je bilo v informacijah o zdravilu Seroquel in zdravilu Seroquel XR ugotovljenih nekaj razhajanj.
The final agreed wording is part of the harmonised SmPCs for Seroquel and for Seroquel XR.
Končno dogovorjeno besedilo je del usklajenega povzetka glavnih značilnosti zdravila za zdravili Seroquel in Seroquel XR.
At the start of this procedure, the wording on section 4.9 was under evaluation in an MRP type II variation.
V začetku tega postopka je bilo besedilo v poglavju 4.9 predmet ocene v okviru spremembe tipa II, odobrene s postopkom z medsebojnim priznavanjem.
Other warnings of this section i.e. Extrapyramidal symptoms, Tardive Dyskinesia, Seizures, Interactions, Weight, Hyperglycaemia, Elderly patients with dementia-related psychosis and Dysphagia were also harmonised for minor divergences identified among the SmPC approved in the several MSs.
Usklajena so bila tudi manjša razhajanja, ki so jih ugotovili med drugimi opozorili v tem poglavju povzetkov glavnih značilnosti zdravila, odobrenih v več državah članicah, tj. ekstrapiramidni simptomi, tardivna diskinezija, konvulzije, interakcije, telesna masa, hiperglikemija, starejši bolniki s psihozo, povezano z demenco in disfagija.
At the start of this procedure, the wording on section 4.6 was under evaluation in an MRP type II variation.
V začetku tega postopka je bilo besedilo v poglavju 4.6 predmet ocene v okviru spremembe tipa II, odobrene s postopkom z medsebojnim priznavanjem.
Following all the changes in the SmPC there were amendments made to the Package Leaflet.
V skladu z vsemi spremembami povzetka glavnih značilnosti zdravila so bile izvedene spremembe navodila za uporabo.
At the start of this procedure, the wording on this section was under evaluation in an MRP type II variation.
V začetku tega postopka je bilo besedilo v tem poglavju predmet ocene v okviru spremembe tipa II, odobrene s postopkom z medsebojnim priznavanjem.
The MAH proposed the harmonised text as per MRP SmPC which reflects the current knowledge and data on Seroquel and Seroquel XR.
Imetnik dovoljenja za promet z zdravilom je predlagal usklajeno besedilo v skladu s povzetkom glavnih značilnosti zdravila, odobrenim s postopkom z medsebojnim priznavanjem, ki odraža trenutno znanje in podatke o zdravilih Seroquel in Seroquel XR.
However, and since there were fatal post-marketing reports of agranulocytosis the harmonised wording reflects this information.
Vendar usklajeno besedilo odraža to informacijo, saj so v poročilih v obdobju trženja poročali o smrtnih primerih zaradi agranulocitoze.
Treatment with quetiapine should be reassessed in patients with suspected cardiomyopathy or myocarditis”.
Zdravljenje s kvetiapinom je treba ponovno oceniti pri bolnikih s sumom na kardiomiopatijo in miokarditis.“ Glejte povzetek glavnih značilnosti zdravila za zdravilo Seroquel in Prilogo III za zdravilo Seroquel XR.
Please see SmPC for Seroquel and for Seroquel XR in Annex III.
Glejte povzetek glavnih značilnosti zdravila za zdravilo Seroquel in Prilogo III za zdravilo Seroquel XR.
Ferring Magyarország Kft. Váci út 140.
Magyarország Kft. Váci út 140.
D-64289 Darmstadt
64289 Darmstadt
List of the invented name(s), pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, predlagateljev, imetnikov dovoljenja za promet z zdravilom v državah članicah
Ferring BV Polariavenue 132 2132JX HoofddorpNederland
Ferring BV Polariavenue 132 2132JX Hoofddorp -Nederland
AT - Austria Eli Lilly GmbH Kölblgasse 8- 10
AT - Avstrija Eli Lilly GmbH Kölblgasse 8- 10
ES - Spain LILLY, S.A. Avda.
ES - Španija LILLY, S.A. Avda.
ES - Spain FERRING, S.A.U Gobelas, 11.
ES - Španija FERRING, S.A.U Gobelas, 11.
75014 Paris- France
75014 Paris
Eli Lilly Sweden AB Box 721
SE - Švedska Eli Lilly Sweden AB Box 721
CZ - Czech Republic
CZ - Česká
11, Vienna Twin Tower Turm West 10.OG
Tower Turm West 10.OG
Quinta da FonteEdifício D. José - Piso 1, 2780-730 Paço d' Arcos, Portugal
Quinta da Fonte - Edifício D. José - Piso 1, 2780-730 Paço d' Arcos, Portugal
FR - France LILLY France 13, rue Pagès
FR - Francija LILLY France 13, rue Pagès
Ferring Läkemedel AB Box 4041
SE - Švedska Ferring Läkemedel AB Box 4041
3,33 MG/VIAL (MULTI DO
3,33 mg/VIALA (MULTI DO)
EL - Greece NOVO NORDISK HELLAS Panagouli 80 & Agias Triadas 65, Agia Paraskevi
Panagouli 80 & Agias Triadas 65, Agia Paraskevi
Eli Lilly farmacevtska družba, d.o.o., Brnčičeva 41g, 1231 LjubljanaČrnuče, Slovenia
SI - Slovenija Eli Lilly farmacevtska družba, d.o.o., Brnčičeva 41g, 1231 LjubljanaČrnuče, Slovenia
Rua Cesário Verde, nº 5, 4º Piso, Linda-a-Pastora, 2790-326 Queijas, Portugal
Rua Cesário Verde, nº 5, 4º Piso, Linda-aPastora, 2790-326 Queijas, Portugal
ES - Spain PFIZER, S.A.Avda.
ES - España PFIZER, S.A.Avda.
N14 9TP
N14 9TP United Kingdom
Ferring Phamraceuticals Limited, The Courtyard, Waterside Drive, Langley, Berkshire SL3 6EZ, UK
Phamraceuticals Limited, The Courtyard, Waterside Drive, Langley, Berkshire SL3 6EZ, UK
Rua Alexandre HerculanoEdifício 1, Piso 6, 2795-240 Linda-a-Velha, Portugal
Rua Alexandre HerculanoEdifício 1, Piso 6, 2795-240 Linda-aVelha, Portugal
SESTO FIORENTINO 50019 FIRENZE
GRAMSCI, 731/733 SESTO FIORENTINO 50019 FIRENZE
Pharmacia GmbH Linkstr.
DE - Nemčija Pharmacia GmbH Linkstr.
Eli Lilly ČR, s.r.o.
SK - Slovaška Eli Lilly ČR, s.r.o.
ES - Spain MERCK S.L.Maria de Molina, 40 28006 Madrid
ES - Španija MERCK S.L.Maria de Molina, 40
3991 RA Houten Netherlands
Grootslag 1-5 3991 RA Houten Netherlands
AT - Austria Novo Nordisk Pharma GmbH
AT - Avstrija Novo Nordisk Pharma GmbH
EL - Greece Pfizer Hellas S.A. Messoghion Ave., Neo Psychiko 15451, Athens, Greece
Pfizer Hellas S.A. 234, Messoghion Ave., Neo Psychiko 15451, Athens, Greece
Via Casilina, 125, Rome, 00176, Italy
A Via Casilina, 125, Rome, 00176, Italy
Ferring Lægemidler A/S, Kay Fiskers Plads 11, DK2300 Købenahvn S, Denmark
DK - Danska Ferring Lægemidler A/S, Kay Fiskers Plads 11, DK-2300
IT - Italy BAKER ITALIA SpA VIA DI PORTA PINCIANA, 6 00187 ROMA
BAKER ITALIA SpA VIA DI PORTA PINCIANA, 6
LV - Latvia Pfizer Health AB, Vetenskapsvagen 10,SE191 90 Sollentuna, Sweden
LV - Latvija Pfizer Health AB, Vetenskapsvagen 10,SE-191 90
NOVO NORDISK PHARMA SA
Novo Nordisk Pharma
Pfizer AS, Postboks 3, 1324 Lysaker, Norway
NO - Norveška Pfizer AS, Postboks 3, 1324
FI - Finland Ferring Lääkkeet Oy, Piispansilta 11 A, PL 23, 02241 Espoo, Finland
Ferring Lääkkeet Oy, Piispansilta 11 A, PL 23, 02241
Eli Lilly Nederland BV Grootslag 1-5
Eli Lilly Nederland BV
Ferring PortuguesaProdutos Farmacêuticos, Sociedade Unipessoal, Lda.
Farmacêuticos, Sociedade Unipessoal, Lda.
1,3 mg/ml or 3,3 mg/ml
1,3 mg/ml ali 3,3 mg/ml
Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
DK - Danmark Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
FR - France FERRING SAS 7, rue Jean-Baptiste Clément
FR - Francija FERRING SAS 7, rue Jean
IS - Iceland Merck AB SE-195 87 Stockholm Sweden
IS - Iceland Merck AB SE-195 87
Marousi 15123
GKYZI 3, MAROUSI 15125
94250 Gentilly- France
Baptiste Clément 94250 Gentilly
AT - Austria Pfizer Corporation Austria Gesellschaft m.b.H.
AT - Avstrija Pfizer Corporation Austria
FR - France NOVO NORDISK PHARMACEUTIQUE SAS Le Palatin
FR - Francija NOVO NORDISK PHARMACEUTIQUE SAS
8mg (24 NE) /1,5ml parenteral use
8 mg (24 NE) /1,5 ml
4MG/VIAL
4 mg/VIALA
5 mg /CARTRIDGE with preservative
5 mg /vložek s konzervansom
Subcutaneous use; Intramuscular use
Subkutana uporaba; Intramuskularna uporaba
8MG/VIAL
8 mg/VIALA
ET - Estonia Merck Serono S.p.A.
ET - Estonija Merck Serono S.p.A.
Ely Lilly Benelux SA 52, rue de l'Etuve B-1000 Bruxelles
52, rue de l'Etuve B-1000 Bruxelles
Urbanización La Florida.
Urbanización La
AT - Austria Merck Gesellschaft mbH Zimbagasse 5
AT - Avstrija Merck Gesellschaft mbH
IT - Italy FERRING SpA VIA SENIGALLIA, 18/2
FERRING SpA VIA SENIGALLIA,
EL - Greece Merck A.E. Hellas Kifisias Avenue 41-45 (Building B)
Merck A.E. Hellas Kifisias Avenue 41-45 (Building B) Marousi 15123 Athens
Pfizer Luxembourg SARL, 51 av. J.-F. Kennedy, 1855 Luxembourg
SI - Slovenija Pfizer Luxembourg SARL, 51 av. J.-F.
10MG/VIAL + 1ML SOLV
10 mg/VIALA + 1 ml RAZT
1,3 mg/ml or 3,3mg/ml after diluting with water
3,3 mg/ml po razredčenju z vodo
ET - Estonia Ferring GmbH Wittland 11
ET - Estonija Ferring GmbH Wittland 11
Novo Nordisk Pharma GmbH
DE - Nemčija Novo Nordisk Pharma GmbH
1100 Wien, Austria
1100 Wien,
PFIZER SA Bld de la Plaine,17 1050 Brussels Belgium
BE - Belgija PFIZER SA Bld de la Plaine,17
FERRING NV Hopmarkt 9 b3 9300 Aalst Belgium
BE - Belgija FERRING NV Hopmarkt 9 b3
Merck AB, 195 87 Stockholm, Sweden
NO - Norveška Merck AB, 195 87 Stockholm,
Subcutanous use, intramuscular use
Subkutana uporaba, intramuskularna uporaba
ET - Estonia Pfizer Enterprises SARL Round-Point du Kirchberg 51,Avenue J.F.Kennedy L-1855
ET - Estonija Pfizer Enterprises SARL Round-Point du Kirchberg
powder for injection intramuscular and subcutaneous use
Prašek za injekcijo intramuscular and Subkutana uporaba
Subcutaneous Intramuscular
Subkutana Intramuskularna
MT - Malta Eli Lilly & Co. Ltd. Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom
Eli Lilly & Co. Ltd. Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom
Lilly-Portugal, Produtos Farmacêuticos, Lda.
Lilly-Portugal, Produtos
Humatrope powder for injection subcutaneous & intramuscular
Prašek za injekcijo Subkutana & intramuscular
Novo Nordisk Pharma Riverside Business Park B-1070 Bruxelles
Riverside Business Park
Via Casilina, 125
Casilina 125, I
Boulevard international 55 1070 Brussels Belgium
Boulevard international 55
FR - France MERCK SANTE 37, rue Saint-Romain 69008 Lyon France
FR - Francija MERCK SANTE 37, rue Saint
Merck Serono GmbH Alsfelder Str. 17
Alsfelder Str. 17
Ferring Legemidler AS, Postboks 4445, 0403 Oslo, Norway
4445, 0403 Oslo,
EL - Greece FARMASERV LILLY AEBE 15TH Km NATIONAL HIGHWAY ATHENS-LAMIA KIFISSIA 14564, P.O.
NATIONAL HIGHWAY ATHENS-LAMIA KIFISSIA 14564, P.O. BOX 51288
Lilly Deutschland GmbH Teichweg 3
DE - Nemčija Lilly Deutschland GmbH
FR - France SANOFI AVENTIS France 1-13, boulevard Romain Rolland
FR - Francija SANOFI AVENTIS France
Elly Lilly Norge AS, Grensevien 99, 0663 Oslo, Norway
NO - Norveška Elly Lilly Norge AS, Grensevien
30 rue de Valmy 92800 Puteaux-France
30 rue de Valmy
FR - France PFIZER HOLDING France 23-25, avenue du Docteur Lannelongue
FR - Francija PFIZER HOLDING France
Subcutaneous
Subkutana
Ferring GmbH,Wittland 11, D-24109 Kiel, Germany
GmbH,Wittland 11, D-24109 Kiel, Germany
Pfizer Enterprises SARL, Rond-point du Kirchberg, 51, Avenue J.F.Kennedy, L1855 Luxembourg, Luxembourg
BG - Bolgarija Pfizer Enterprises SARL, Rond-point du Kirchberg, 51,
PL - Poland Industria Farmaceutica Serono S.p. A
PL - Poljska Industria Farmaceutica
DK-2880 Bagsvaerd Denmark
DK-2880
6MG/ CARTRIDGE
6mg /vložek
1,4 mg /CARTRIDGE
1,4 mg /vložek
Novo Nordisk A/S Novo Allé
SE - Švedska Novo Nordisk A/S Novo Allé
Roma, Italy
IT - Italija
Ferring GmbH Wittland 11
DE - Nemčija Ferring GmbH Wittland 11
Via Valbondione 113 00188 Rome Italy
00188 Rome Italy
powder for solution for injection
Prašek za raztopino za injiciranje
SISlovenia
Moraleja
Bocskai út 134-146.
Merck Kft. Bocskai út 134
Solution for Injeciton Subcutaneous
Prašek za injekcijo Subkutana
5,3 mg /CARTRIDGE
5,3 mg /vložek
NovoNordis A/S, Novo Alle, Basvaerd, DK
BG - Bolgarija Novo Nordisk A/S, Novo Alle, DK
8NX, England
CT13 9NJ, UK
1 mg /CARTRIDGE
1 mg /vložek
24MG/ CARTRIDGE
24 mg /vložek
DKDenmark
Lannelongue
Subcutanous use
Parenteralna uporaba
DK-2880 Bagsværd Denmark
2880, Denmark
AT - Austria Ferring Arzneimittel GmbH Wienerbergstr.
AT - Avstrija Ferring Arzneimittel
Solution for injection Single dose container s.c.
Raztopina za injiciranje v enoodmernem vsebniku
5 mg /CARTRIDGE
5 mg /vložek
Athens
Romain
Eli Lilly Danmark A/S, Nybrovej 110, DK-2800
DK - Danska Eli Lilly Danmark A/S, Nybrovej
LV - Latvia Merck Serono S.p.A., Via Casilina 125, I-00176
LV - Latvija Merck Serono S.p.A., Via
ES - Spain NOVO NORDISK A/SNovo AlleBagsvaerdDK-2880
ES - Španija NOVO NORDISK A/SNovo
12MG/ CARTRIDGE
12 mg/vložek
Feltham, Middlesex TW14 8NX0
Serono Ltd Bedfont Cross, Stanwell Road Feltham, Middlesex TW14 8NX0
10MG/1.5ML SOLUTION FOR INJECTION
10 mg/1,5 ml vložek Raztopina za injiciranje
Solution for injection Subcutanous use
Prašek za injekcijo Subkutana uporaba
NOVO NORDISK A/S Novo Allé, DK-2880 Bagsværd, Denmark
Novo Nordisk, A/S Novo Allé, DK2880 Bagsvaerd, Denmark
SKSlovakia
HUMadžarska
IT - Italy NOVO NORDISK A/S Novo Allé DK-2880
NOVO NORDISK A/S Novo Allé DK-2880
I-00176 Roma
00187 ROMA
Powder and solvent for solution for injection in pre-filled syringe
Prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi
mg/CARTRIDGE
J.F.Kennedy
15MG/1.5ML SOLUTION FOR INJECTION
15 mg/1,5 ml vložek Raztopina za injiciranje
sc
Kiel
Genotropin s.c.
Serono S.p.
10MG/1,5ML CARTRIDGE
1,3 mg/ml ali
FI - Finland Novo Nordisk A/S, Novo Allé, 2880 BAGSVAERD, Denmark
Novo Nordisk A/S, Novo Allé, 2880 BAGSVAERD, Denmark
5 mg/ 1,5 mg Solution for injection in pre-filled pen
5/1,5 mg/ml v napolnjenem injekcijskem peresniku
This cycle of treatment should be repeated every 2 to 6 weeks.
Tak cikel zdravljenja je treba ponoviti na dva do šest tednov.
Further information on Ivozall can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ivozall.
Nadaljnje informacije za zdravilo Ivozall so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/ivozall.
Doctors should review treatment in patients whose condition does not improve after one or two treatment cycles.
Zdravniki morajo pregledati zdravljenje pri bolnikih, pri katerih se stanje po enem ali dveh ciklih zdravljenja ne izboljša.
What measures are being taken to ensure the safe and effective use of Ivozall?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ivozall?
It is used when the disease has not responded to, or has come back (relapsed) after at least two other treatments and when no other treatment is expected to work.
Uporablja se, kadar se bolezen ne odzove ali se ponovi po vsaj dveh drugih zdravljenjih in kadar se ne pričakuje, da bi bile katere koli druge oblike zdravljenja učinkovite.
It belongs to the group of cancer medicines called ‘antimetabolites'.
Spada v skupino zdravil za zdravljenje raka, imenovanih antimetaboliti.
It is given by infusion lasting 2 hours every day for five days.
Daje se pet dni zapored z infundiranjem, ki traja po dve uri.
Other information about Ivozall
Druge informacije o zdravilu Ivozall
Treatment should be started and supervised by a doctor who has experience in the management of patients with acute leukaemias.
Zdravljenje lahko začne in nadzoruje zdravnik, ki ima izkušnje z zdravljenjem bolnikov z akutno levkemijo.
Because Ivozall is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Ivozall generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The European Medicines Agency concluded that, in accordance with EU requirements, Ivozall has been shown to be comparable to Evoltra.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Ivozall primerljivo z zdravilom Evoltra.
This stops the cells making new DNA and RNA and from dividing, thereby slowing down the growth of cancer cells.
Celice zato prenehajo izdelovati novo DNK in RNK ter se prenehajo deliti, s tem pa se upočasni rast rakavih celic.
An overview of Ivozall and why it is authorised in the EU
Pregled zdravila Ivozall in zakaj je odobreno v EU
As for every medicine, the company provided studies on the quality of Ivozall.
Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Ivozall.
Ivozall is a cancer medicine that is used to treat children and adults up to 21 years of age who have acute lymphoblastic leukaemia (ALL), a cancer of the lymphocytes (a type of white blood cell).
Ivozall je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje otrok in odraslih, starih do 21 let, ki imajo akutno limfoblastno levkemijo (ALL), tj. raka limfocitov (vrste belih krvnih celic).
What are the benefits and risks of Ivozall?
Kakšne so koristi in tveganja, povezani z zdravilom Ivozall?
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Evoltra, and do not need to be repeated for Ivozall.
Študije o koristih in tveganjih učinkovine pri odobrenem načinu uporabe so že bile izvedene z referenčnim zdravilom Evoltra, zato jih za zdravilo Ivozall ni treba ponoviti.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ivozall have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ivozall upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
As for all medicines, data on the use of Ivozall are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ivozall stalno spremljajo.
Side effects reported with Ivozall are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Ivozall, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Why is Ivozall authorised in the EU?
Zakaj je bilo zdravilo Ivozall odobreno v EU?
The recommended dose of Ivozall is based on the patient's height and weight.
Priporočeni odmerek zdravila Ivozall temelji na telesni višini in masi bolnika.
It is available as a solution for infusion (drip) into a vein.
Na voljo je kot raztopina za infundiranje (kapalno infuzijo) v veno.
What is Ivozall and what is it used for?
Kaj je zdravilo Ivozall in za kaj se uporablja?
For more information about using Ivozall, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Ivozall glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
There was no need for ‘bioequivalence' studies to investigate whether Ivozall is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Izvedba študije „bioekvivalence“, s katero bi raziskali, ali se zdravilo Ivozall absorbira podobno kot referenčno zdravilo in tako doseže enako raven učinkovine v krvi, ni bila potrebna.
This means that Ivozall contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Evoltra.
To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Evoltra.
This means that clofarabine resembles adenine and by taking adenine's place in the body, it interferes with the action of enzymes involved in making genetic material, called ‘DNA polymerase' and ‘RNA reductase'.
To pomeni, da je klofarabin podoben adeninu in s tem, ko ga nadomesti v telesu, moti delovanje encimov „DNK polimeraze“ in „RNK reduktaze“, ki sodelujeta pri izgradnji genetskega materiala.
Clofarabine is an ‘analogue' of adenine, one of the building blocks of the genetic material of cells (DNA and RNA).
Klofarabin je analog adenina, ki je eden od gradnikov genetskega materiala celic (DNK in RNK).
This is because Ivozall is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Zdravilo Ivozall se namreč daje z infundiranjem v veno, tako da učinkovina vstopa neposredno v krvni obtok.
The active substance in Ivozall, clofarabine, is a cytotoxic agent (a medicine that kills cells that are dividing, such as cancer cells).
Učinkovina zdravila Ivozall, klofarabin, je citotoksična snov (zdravilo, ki uničuje celice, ki se delijo, kot so npr. rakave celice).
Ivozall contains the active substance clofarabine and is a ‘generic medicine'.
Zdravilo Ivozall vsebuje učinkovino klofarabin in je generično zdravilo.
Ivozall can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Ivozall je le na recept.
Therefore, the Agency's view was that, as for Evoltra, the benefits of Ivozall outweigh the identified risks and it can be authorised for use in the EU.
Zato je menila, da koristi zdravila Ivozall enako kot pri zdravilu Evoltra odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
How does Ivozall work?
Kako zdravilo Ivozall deluje?
How has Ivozall been studied?
Kako je bilo zdravilo Ivozall raziskano?
How is Ivozall used?
Kako se zdravilo Ivozall uporablja?
In 2 out of 4 studies these differences were statistically significant.
V 2 študijah od 4 so bile te razlike statistično pomembne.
These results can be considered sufficient to support the proposed indication.
Ti rezultati lahko štejejo kot zadostni za podporo predlagani indikaciji.
• See a doctor right away.
• Nemudoma obiščite zdravnika.
Member State EU/EEA
Država članica (EU/EGP)
Not known cannot be estimated from the available data
neznana ni mogoče oceniti iz razpoložljivih podatkov
The main areas for harmonisation were as follows:
Glavna področja usklajevanja so bila naslednja:
Keep a list of all the medicines you take.
Napravite seznam vseh zdravil, ki jih jemljete.
This is further supported by the low discontinuation rate due to lack of efficacy.
To dodatno podpira nizka stopnja prekinitve uporabe zaradi pomanjkanja učinkovitosti.
• Hold the hard capsule upright so that you can read the word “TOP”
• Kapsulo držite pokonci, da boste lahko prebrali besedo “TOP”.
Topiramate is rapidly and well absorbed.
Topiramat se absorbira hitro in dobro.
• Never store any medicine and food mixture for use at a later time.
• Nikoli ne shranjujte mešanice zdravila in hrane za kasnejšo uporabo.
• If you forget to take a dose, take it as soon as you remember it.
• Če ste pozabili vzeti odmerek zdravila, ga vzemite takoj, ko se spomnite.
The youngest age involved in the clinical trials was 2 years old.
Najmlajši otroci, ki so sodelovali v kliničnih preskušanjih, so bili stari 2 leti.
56 Eirinis Avenue 56, Pefki, 15121, Greece
56 Eirinis Avenue 56, Pefki, 15121, Grčija
The results for European trial were inconclusive mainly due to a placebo response that was greater than expected.
Rezultati evropskega preskušanja niso bili prepričljivi, večinoma ker je bil odziv na placebo večji od pričakovanega.