natgillin/translations-raw huggingface dataset:
Novartis Pharma GmbH, Roonstrasse 25, Nuernberg D-90429 , Germany
SI - Slovenija Novartis Pharma GmbH, Roonstrasse 25, Nuernberg D-90429 , Germany
9 mg/ml concentrate for solution for infusion - 10 ml
9 mg/ml koncentrat za raztopino za infundiranje - 10 ml
Disodium pamidronate pentahydrate powder and solvent for solution for infusion
Disodium pamidronate pentahydrate prašek in vehikel za raztopino za infundiranje parenteralna uporaba
Farmoz - Sociedade Técnico Medicinal, S.A.
PT - Portugalska Farmoz - Sociedade Técnico Medicinal, S.A.
6 mg/ml concentrate for solution for infusion - 10 ml
6 mg/ml koncentrat za raztopino za infundiranje- 10 ml
300MG/CAP HARD CAPSULE
300MG/CAP trda kapsula
Ibandronic acid containing medicinal products with Marketing Authorisation in the European Union
Zdravila, ki vsebujejo ibandronsko kislino in so pridobila dovoljenje za promet v Evropski uniji
CLODRONATO ABC 300 mg/10 ml
CLODRONATO ABC 300 mg/10 ml raztopina za injiciranje
AREDIA 30 mg polvo y disolvente para solución para perfusión solution for infusion
AREDIA 30 mg polvo y disolvente para solución para perfusión raztopina za infundiranje intravenska uporaba
SE - Sweden Sanofi-aventis AB Box 14142
Sanofi-aventis AB Box 14142
Estrada Marco do GriloZemouto
PT - Portugalska Alter, S.A. Estrada Marco do GriloZemouto
PL - Poland ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, 89073, Germany
PL - Poljska ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, 89073, Germany
PHARMACEUTICALS S.R.L.,Str.
RO - Romunija S.C. TEVA PHARMACEUTICALS S.R.L.,Str.
Bluefish Pharmaceuticals ABTorsgatan 11
HU - Madžarska Bluefish Pharmaceuticals ABTorsgatan 11
NL - Netherlands Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ
NL - Nizozemska Arrow Generics Limited Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ
DK - Denmark LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266
HU - Madžarska LABORMED-PHARMA S.A., Theodor Pallady Boulevard 44B, Sector 3, RO-032266
ACTAVIS S.R.L.
RO - Romunija ACTAVIS S.R.L.
ToLife - Produtos Farmacêuticos, S.A.´ Avenida do Forte, 3Edificio Suécia III, Piso 1 2794-093 Carnaxide, Portugal
PT - Portugalska ToLife - Produtos Farmacêuticos, S.A.´ Avenida do Forte, 3Edificio Suécia III, Piso 1
400MG/CAP HARD CAPSULE
400MG/CAP trda kapsula
CLODRONATO TEVA 300 mg/10 ml
CLODRONATO TEVA 300 mg/10 ml raztopina za injiciranje
425, IS-220 Hafnarfjördur, Iceland
IS-220 Hafnarfjörour, Islândia
LV - Latvia ratiopharm GmbH, GrafArco-Str.3, 89079 Ulm, Germany
LV - Latvija ratiopharm GmbH, GrafArco-Str.3, 89079 Ulm, Germany
75MG/TAB FILM COATED TABLET
75MG/TAB filmsko obložena tableta
SK - Slovakia Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria
SK - Slovaška Torrex Chiesi -Pharma GmbH, Gonzagagasse 16/16, 1010 Viena, Austria
Didronate tablet
Ostac obložena tableta
NL - Netherlands Bayer B.V. Energieweg 1
NL - Nizozemska Bayer B.V.
Decomed Farmacêutica, S.A.
PT - Portugalska Decomed Farmacêutica, S.A.
Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour Islândia
Reykjavíkurvegi, 76-78, IS-220 Hafnarfjörour
Bonefos capsules
trda kapsula
Ratiopharm Hungária Kft. Uzsoki u. 36/A 1145 Budapest Hungary
HU - Madžarska Ratiopharm Hungária Kft. Uzsoki u. 36/A
Aredia 30 mg prašek in vehikel za koncentrat za raztopino za powder and solvent for solution for injection
Aredia 30 mg prašek in vehikel za koncentrat za raztopino za infundiranje prašek in vehikel za raztopino za infundiranje
Pamidronato Azevedos 15 mg Pó para perfusão
Pamidronato Azevedos 15 mg Pó para perfusão prašek za raztopino za infundiranje
RISEDRONATE / TEVA 35MG/TAB FILM COATED TABLET
RISEDRONATE / TEVA 35MG/TAB filmsko obložena tableta
Tablet and Capsule soft Oral Use
tableta in mehka kapsula
PAMIRED 60 powder for solution for infusion powder for solution for infusion
PAMIRED 60 powder for solution for infusion prašek in vehikel za raztopino za infundiranje parenteralna uporaba
NL - Netherlands Pharmachemie B.V. Swensweg 5
NL - Nizozemska Pharmachemie B.V.
TEVA PHARMACEUTICALS S.R.L.
RO - Romunija TEVA PHARMACEUTICALS S.R.L.
PAMIDRONATO DISODICO COMBINO PHARM 15 mg polvo para solución para perfusión solution for infusion
PAMIDRONATO DISODICO COMBINO PHARM 15 mg polvo para solución para perfusión raztopina za infundiranje intravenska uporaba
30MG/TAB FILM COATED TABLET
30MG/TAB filmsko obložena tableta
Laboratórios Atral, S.A. Rua da Estação, 42 - Vala do Carregado, 2600-726 Castanheira do Ribatejo
PT - Portugalska Laboratórios Atral, S.A. Rua da Estação, 42 - Vala do Carregado,
DK - Denmark Hospira UK Limited, Queensway, Royal
NO - Norveška Hospira UK Limited, Queensway, Royal
Germed Farmacêutica, Lda.
Fabricação Farmacêutica, Lda.
NORIFAZ Trio 35 mg film- és rágótabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate film-coated tablet and chewing tablet
NORIFAZ Trio 35 mg film- és rágótabletta mgRisedronate sodium (equivalent to 40,17 mg Risedronate sodium hemipentahydr ate filmsko obložena tableta in žvečljiva tableta
film-coated tablets + effervescent granules
filmsko obložena tableta + šumeče granule
Alendronic acid containing medicinal products with Marketing Authorisation in the European Union
Zdravila, ki vsebujejo alendronsko kislino in so pridobila dovoljenje za promet v Evropski uniji
300 mg/5ml solution for infusion
300 mg/5ml raztopina za injiciranje
PAMIRED 30 powder for solution for infusion powder for solution for infusion
PAMIRED 30 powder for solution for infusion prašek in vehikel za raztopino za infundiranje parenteralna uporaba
Pamidronato Azevedos 90 mg Pó para perfusão
Pamidronato Azevedos 90 mg Pó para perfusão prašek za raztopino za infundiranje
Tablet and film-coated tablet
filmsko obložena tableta in žvečljiva tableta
60 mg/10 ml powder and solvent
60 mg/10 ml prašek in vehikel
NL - Netherlands Roche Nederland B.V. Beneluxlaan 2a
NL - Nizozemska Roche Nederland B.V.
PAMIDRONATO DISODICO COMBINO PHARM 90 mg polvo para solución para perfusión solution for infusion
PAMIDRONATO DISODICO COMBINO PHARM 90 mg polvo para solución para perfusión raztopina za infundiranje intravenska uporaba
Pamidronato Azevedos 30 mg Pó para perfusão
Pamidronato Azevedos 30 mg Pó para perfusão prašek za raztopino za infundiranje
35MG/TAB FILM COATED TABLET
35MG/TAB filmsko obložena tableta
Pamidronato Azevedos 60 mg Pó para perfusão
Pamidronato Azevedos 60 mg Pó para perfusão prašek za raztopino za infundiranje
Etidronic acid containing medicinal products with Marketing Authorisation in the European Union
Zdravila, ki vsebujejo etidronsko kislino in so pridobila dovoljenje za promet v Evropski uniji
PAMIDRONATO DISODICO COMBINO PHARM 60 mg polvo para solución para perfusión solution for infusion
PAMIDRONATO DISODICO COMBINO PHARM 60 mg polvo para solución para perfusión raztopina za infundiranje intravenska uporaba
12,6 mg/ ml powder and solvent for solution for injection
12,6 mg/ ml prašek in vehikel za raztopino za infundiranje
300 mg/5 ml solution
300 mg/5 ml raztopina
Teva Pharma - Produtos Farmacêuticos, Lda.
PT - Portugalska Teva Pharma - Produtos Farmacêuticos, Lda.
Risedronat Adamed Pharma film-coated tablet Oral use
Risedronato de sódio Pharmakern obložena tableta peroralna uporaba
Sindronat capsules, hard
Sindronat trda kapsula
Mylan, Lda.
Medicinal, Lda.
BG - Bulgaria ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
BG - Bolgarija ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
FI - Finland ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
FI - Finska ratiopharm GmbH, GrafArco-Strasse 3, 89079 Ulm, Germany
ACIDO CLODRONICO 100 mg/3,3 ml
ACIDO CLODRONICO 100 mg/3,3 ml raztopina za injiciranje intramuskularna uporaba, intravenska uporaba
AREDIA DRY POWDER 90 mg
AREDIA DRY POWDER 90 mg prašek za raztopino za injiciranje
15 mg/5 ml powder and solvent
15 mg/5 ml prašek in vehikel
Risedronic acid containing medicinal products with Marketing Authorisation in the European Union
Zdravila, ki vsebujejo risedronsko kislino in so pridobila dovoljenje za promet v Evropski uniji
AREDIA 15 mg polvo y disolvente para solución para perfusión
AREDIA 15 mg polvo y disolvente para solución para perfusión raztopina za infundiranje intravenska uporaba
90 mg/10 ml powder and solvent
90 mg/10 ml prašek in vehikel
6mg/ml solution for infusion
6mg/ml raztopina za infundiranje intravenska uporaba
film coated tablets and efervescent granules
filmsko obložena tablet in šumeče granule
Tiludronic acid containing medicinal products with Marketing Authorisation in the European Union
Zdravila, ki vsebujejo tiludronsko kislino in so pridobila dovoljenje za promet v Evropski uniji
NO - Norway ratiopharm GmbH, GrafArco-Strasse 3, D-89070 Ulm Germany
NO - Norveška ratiopharm GmbH, GrafArco-Strasse 3, D-89070
SE - Sweden Accord Healthcare Limited Sage House
RO - Romunija ACCORD HEALTHCARE LIMITED, Sage house, 319
Merck Sharp & Dohme Magyarország Kft. Alkotás u. 48-50.
HU - Madžarska Merck Sharp & Dohme Magyarország Kft.
Pamidronic acid containing medicinal products with Marketing Authorisation in the European Union
Zdravila, ki vsebujejo pamidronsko kislino in so pridobila dovoljenje za promet v Evropski uniji
PAMIDRONATO DISODICO COMBINO PHARM 30 mg polvo para solución para solution for infusion
PAMIDRONATO DISODICO COMBINO PHARM 30 mg polvo para solución para perfusión raztopina za infundiranje intravenska uporaba
Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.
PT - Portugalska Ratiopharm - Comércio e Indústria de Produtos
NL - Netherlands Mylan B.V. Dieselweg 25
NL - Nizozemska Mylan B.V.
Pamidronaat dinatrium 30 mg
Risedronat Genericon 30 mg
DK - Denmark Ratiopharm GmbH, GrafArco-Strasse 3, DE-89079
DK - Danska ratiopharm GmbH, GrafArco-Strasse 3, DE-89079 Ulm, Germany
CLODRONATO ABC 100 mg/3,3 ml
CLODRONATO ABC 100 mg/3,3 ml raztopina za injiciranje intramuskularna uporaba, intravenska uporaba
BE - Belgium Arrow Generics Limited 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom
NO - Norveška Arrow Generics Ltd, 2 Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, united Kingdom
Bonefos capsules 400 mg hard capsules
Bonefos capsules 400 mg trda kapsula
Film-Coated Tablets and effervescent granules
filmsko obložena tablet in šumeča zrnca
3mg/ml solution for infusion
3mg/ml raztopina za infundiranje intravenska uporaba
AREDIA DRY POWDER 15 mg
AREDIA DRY POWDER 15 mg prašek za raztopino za injiciranje
SE - Sweden Zaklad Farmaceutyczny Adamed Pharma S.A., ul.
Zaklad Farmaceutyczny Adamed Pharma S.A., ul.
Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B, 2770-229 Paço de Arcos Portugal
Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D.
DE - Germany Actavis Group PTC ehf Reykjavikurvegur 76 - 78
RO - Romunija Actavis Group PTC ehf Reykjavikurvegi 76-78, 220
Island
Islândia
BE - Belgium Merck Sharp & Dohme B.V. Clos du Lynx, 5- 1200
NO - Norveška Merck Sharp and Dohme B.V., Postbus 581,
90MG/VIAL POWDER AND SOLUTION FOR INFUSION
90MG/VIAL prašek in vehikel za raztopino za infundiranje
ISUS - Produtos Farmacêuticos e Cosméticos, S.A. Rua António Quadros, 9GEscritório 3, 1600-875 Lisboa Portugal
Cosméticos, S.A. Rua António Quadros, 9GEscritório 3,
Neridronic acid containing medicinal products with Marketing Authorisation in the European Union
Zdravila, ki vsebujejo neridronsko kislino in so pridobila dovoljenje za promet v Evropski uniji
AREDIA DRY POWDER 30 mg
AREDIA DRY POWDER 30 mg prašek za raztopino za injiciranje
PT - Portugal
Lisboa Portugal
Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira,
PT - Portugalska Farmoz - Sociedade Técnico Medicinal, S.A. Rua da
70mg film-coated tablets
30 mg filmsko obložena tableta
The CHMP considered that this information does not impact the safety and efficacy profile of MACI but that in the absence of an authorised manufacturing site, the requirements laid down in Article 41 of Directive 2001/83/EC are no longer met.
Odbor CHMP je menil, da ta podatek ne vpliva na profil varnosti in učinkovitosti zdravila MACI, vendar ker odobrenega mesta proizvodnje ni, niso več izpolnjene zahteve, opredeljene v členu 41 Direktive
• The Committee concluded that in view of the absence of an authorised manufacturing site for the active substance, finished product and batch release, the requirements laid down in Article 41 of
• odbor CHMP je zaključil, da zaradi neobstoja odobrenega mesta za proizvodnjo zdravilne učinkovine in končnega izdelka ter sproščanje serij niso več izpolnjene zahteve, opredeljene v
For the suspension of the marketing authorisation to be lifted, the MAH shall register a site for manufacture of the active substance, finished product and batch release.
Za preklic začasnega umika dovoljenja za promet z zdravilom mora imetnik dovoljenja za promet z zdravilom registrirati mesto za proizvodnjo zdravilne učinkovine in končnega izdelka ter sproščanje
Ref. EMEA/477488/2008
EMEA/548389/2008
International non-proprietary name (INN): dalbavacin
Mednarodno nelastniško ime (INN): dalbavacin
This kills the bacteria causing the infection.
To ubije bakterije, ki povzročajo okužbo.
The main measure of effectiveness was the number of patients whose infection was treated successfully and who did not need further treatment with any other antibiotics.
Glavno merilo učinkovitosti je bilo število bolnikov, katerih okužbe so bile uspešno ozdravljene in niso potrebovali nadaljnjega zdravljenja z drugimi antibiotiki.
The company presented the results of one main study that compared the effects of EXULETT with those of linezolid (another antibiotic) in 873 adults.
Družba je predstavila izsledke ene glavne študije, v kateri so primerjali učinke zdravila EXULETT z učinki linezolida (drugega antibiotika) pri 873 odraslih bolnikih.
These bacteria include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
Med temi bakterijami sta tudi Staphylococcus aureus (vključno z obliko, odporno na meticilin, znano kot „MRSA“) in Streptococcus pyogenes.
Questions and answers on the withdrawal of the marketing application for EXULETT
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom EXULETT
The effects of EXULETT were first tested in experimental models before being studied in humans.
Učinki zdravila EXULETT so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The patients included in this study were required to have complicated skin and soft tissue infections (such as abscesses or wound infections) that were due to Gram-positive bacteria.
Bolniki, vključeni v to študijo, so morali imeti zapletene okužbe kože in mehkega tkiva (kot so ognojki ali okužbe ran), ki so jih povzročile Gram pozitivne bakterije.
In addition, the CHMP was concerned over the relevance of the results of the main study, since not all of the patients included in the study seemed to have an infection that was severe enough to need antibiotic treatment given by infusion into a vein.
Poleg tega je imel CHMP pomisleke tudi glede ustreznosti izsledkov glavne študije, saj se je zdelo, da niso imeli vsi bolniki, vključeni v študijo, dovolj hude okužbe, ki bi zahtevala antibiotično zdravljenje s kapalno infuzijo v veno.
There were also concerns over whether EXULETT could be manufactured with consistent good quality.
Pojavili so se tudi dvomi ali bi bilo izdelovanje zdravila EXULETT vedno enako kakovostno.
The CHMP was concerned that the results of the single main study were too limited to support the approval of the medicine because of the way the study had been carried out, and was of the opinion that another study would be needed to confirm the results.
CHMP je izrazil zaskrbljenost, da morda izsledki ene same glavne študije ne zadostujejo za podporo odobritvi zdravila, zlasti zaradi načina, na katerega je bila študija izvedena, in da bi bilo treba za potrditev izsledkov opraviti novo študijo.
‘Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Zapletene okužbe so takšne okužbe, ki jih je težko zdraviti, ker so razširjene v tkiva globoko pod kožo, ker je morda potrebna operacija ali ker ima bolnik še druga stanja, ki utegnejo vplivati na zdravljenje.
What are the consequences of the withdrawal for patients undergoing clinical trials with EXULETT?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila EXULETT?
The active substance in EXULETT, dalbavancin, is an antibiotic that belongs to the group ‘glycopeptides'.
Zdravilna učinkovina zdravila EXULETT, dalbavancin, je antibiotik, ki spada v skupino glikopeptidov.
On 9 September 2008, Pfizer Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for EXULETT, for the treatment of complicated skin and soft tissue infections in adults when known or suspected to be caused by susceptible Gram-positive bacteria.
Družba Pfizer Limited je dne 9. septembra 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom EXULETT , namenjenim zdravljenju zapletenih kožnih okužb in okužb mehkih tkiv pri odraslih, kjer je znano ali obstaja sum, da jih povzročajo občutljive Gram pozitivne bakterije.
EXULETT is a powder that is made up into a solution for infusion (drip into a vein).
Zdravilo EXULETT je prašek za pripravo raztopine za infundiranje (dajanje v veno).
Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that EXULETT could not have been approved for the treatment of complicated skin and soft tissue infections in adults when known or suspected to be caused by susceptible Gram-positive bacteria.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila EXULETT ni mogoče odobriti za zdravljenje zapletenih okužb kože ali okužb mehkih tkiv pri odraslih, kjer je znano ali obstaja sum, da jih povzročajo občutljive Gram pozitivne bakterije.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials of EXULETT.
Družba je CHMP obvestila, da umik vloge za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila EXULETT, nima posledic.
It is expected to work by stopping the bacteria making their cell walls.
Zdravilo naj bi preprečilo bakterijam gradnjo celičnih sten.
EXULETT was to be used only when the infection was known or thought to be caused by types of bacteria that are classified as ‘Gram-positive' and that would be killed by the medicine.
Zdravilo EXULETT naj bi se uporabljalo samo, kadar je znano ali domnevano, da so okužbo povzročile bakterije, znane kot Gram pozitivne bakterije, ki bi jih zdravilo ubilo.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of EXULETT had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
CHMP je zato v času umika menil, da koristi zdravila EXULETT niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
How is EXULETT expected to work?
Kako naj bi zdravilo EXULETT delovalo?
EXULETT was to be used to treat adults with complicated infections of the skin and the ‘soft tissues' below the skin.
Zdravilo EXULETT naj bi se uporabljalo za zdravljenje odraslih z zapletenimi okužbami kože in podkožnih mehkih tkiv.
What was EXULETT expected to be used for?
Za kaj naj bi se zdravilo EXULETT uporabljalo?
What is EXULETT?
Kaj je zdravilo EXULETT?
(Best response rates)
(Najboljše odzivnosti)
In addition, children have been treated in two phase I studies and one phase II study.
Poleg tega so zdravili otroke v dveh študijah prve faze in eni študiji druge faze.
• Risk Management Plan (RMP) Not applicable.
• Načrt za obvladovanje tveganj (RMP)
Molecular response**
Molekularni odziv**
Return to chronic phase (RTC)
vrnitev v kronično fazo (RTC)
• Slowing of growth in children and adolescents.
• upočasnjena rast pri otrocih in mladostnikih.
% of patients (CI95%)
% bolnikov (IZ95 %)
A limited number of patients were enrolled in phase I studies (n=10).
Omejeno število bolnikov so vključili v študije prve faze (n=10).
A major response (0-35%) combines both complete and partial responses.
Pomemben odziv (0-35 %) združuje popolni in delni odziv.
A complete haematological response was achieved in 95% of patients.
Popoln hematološki odziv je bil dosežen pri 95 % bolnikov.
In all clinical studies 38-40% of patients were ≥ 60 years of age and 10-12% of patients were ≥ 70 years of age.
V vseh kliničnih študijah je bilo 38-40 % bolnikov starih ≥ 60 let, 10-12 % bolnikov pa je bilo starih ≥ 70 let.
If you think you may be allergic but are not sure, ask your doctor for advice.
Če mislite, da bi bili lahko alergični, a niste prepričani, se posvetujte z zdravnikom.
Other adverse reactions were reported with lower or equal frequency.
Pri drugih neželenih reakcijah so poročali o manjši ali enaki pogostnosti.
• Stir with a spoon until the tablets have completely dissolved.
• Mešajte z žlico, dokler se tablete popolnoma ne raztopijo.
(Of note, out of the 411 patients, 353 were treated in an expanded access program without primary response data collected.)
od 411 bolnikov jih je bilo 353 zdravljenih v programu razširjenega dostopa brez zbranih podatkov o primarnem odzivu.)
Capsule, hard
kapsula, trda
The annual rate of progression to accelerated phase or blast crisis decreased with time on therapy and was less than 1% annually in the fourth and fifth years.
Letna stopnja napredovanja v pospešeno fazo ali blastno krizo je upadala s trajanjem zdravljenja in je bila v četrtem in petem letu manj kot 1 % letno.
• Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection).
• ponovitev (reaktivacija) okužbe s hepatitisom B, če ste imeli hepatitis B v preteklosti (okužba jeter).
- Swallow the capsules whole with a large glass of water.
Kapsule pogoltnite cele z velikim kozarcem vode.
The amount of Imatinib Teva given will depend on your child's condition, body weight and height.
Potrebna količina zdravila Imatinib Teva bo odvisna od otrokovega stanja, telesne mase in višine.
PVC/PE/PVdC/PE/PVC//Al blisters OPA/Al/PVC//Al blisters
PVC/PE/PVdC/PE/PVC//Al pretisni omoti OPA/Al/PVC//Al pretisni omoti
Date of latest renewal: 18 September 2017
Datum prve odobritve: 8. januar 2013 Datum zadnjega podaljšanja: 18. september 2017
• Once the tablet has dissolved, drink everything in the glass straight away.
• Ko se tableta raztopi, takoj popijte celotno vsebino kozarca.
Pericarditis*, cardiac tamponade*
perikarditis*, tamponada srca*
If you have any questions about how Imatinib Teva works or why this medicine has been prescribed for you, ask your doctor.
Če imate kakšna vprašanja glede tega, kako zdravilo Imatinib Teva deluje ali zakaj vam je bilo predpisano to zdravilo, vprašajte svojega zdravnika.
The duration of imatinib therapy can vary with the treatment programme selected, but generally longer exposures to imatinib have yielded better results.
Trajanje zdravljenja z imatinibom je lahko različno glede na izbrani program zdravljenja, vendar pa je na splošno daljša izpostavljenost imatinibu prinesla boljše rezultate.
The median duration of therapy in study B2225 was 6.2 months, with a maximum duration of 24.3 months.
Mediano trajanje zdravljenja v študiji B2225 je bilo 6,2 meseca z najdaljšim trajanjem 24,3 meseca.
- If you are being treated for Ph-positive ALL:
Če se zdravite zaradi Ph pozitivne ALL:
Your doctor may prescribe a higher or lower dose depending on how you respond to the treatment.
Zdravnik vam lahko predpiše večji ali manjši odmerek, odvisno od tega, kako se odzivate na zdravljenje.
In this study, 31% of patients achieved a haematological response (36% in previously untreated patients and 22% in previously treated patients).
V tej študiji je 31 % bolnikov doseglo hematološki odziv (36 % pri predhodno nezdravljenih bolnikih in 22 % pri predhodno zdravljenih bolnikih).