natgillin/translations-raw huggingface dataset:
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.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose. 
• Ne vzemite dvojnega odmerka (dveh odmerkov hkrati), če ste pozabili vzeti prejšnji odmerek.
The results of these interactions are summarized below: 
Vplivi teh interakcij so povzeti v nadaljevanju:
Suicide/suicide ideation 
Samomor in samomorilne misli
After the Commission Decision the Member State Competent Authorities, in liaison with the Reference Member State, will update the product information as required. 
Kot je zahtevano, bodo po odločbi komisije pristojni organi držav članic, po posvetovanju z referenčno državo članico, lahko posodobili informacije o zdravilu.
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for topiramate. 
Mehanizem tveganja še ni znan, vendar razpoložljivi podatki ne izključujejo možnosti povečanega tveganja za topiramat.
• Restlessness or increased mental and physical activity 
• nemir ali povečano duševno in telesno aktivnost
Key secondary outcomes (responder rate, migraine attack rate, use of rescue medication) demonstrated a consistent response. 
Ključni sekundarni izidi (stopnja odzivnosti, stopnja napadov migrene, uporaba reševalnega zdravila) so dokazali dosleden odziv.
The CHMP agreed the following wording for adults: 
CHMP se strinja z naslednjim besedilom za odrasle bolnike:
Generally, 13 to 17% of topiramate is bound to plasma protein. 
Običajno je 13 do 17 % topiramata vezanega na plazemske beljakovine.
However, if it is almost time for your next dose, skip the missed dose and continue as usual. 
Če pa je že skoraj čas za naslednji odmerek, preskočite pozabljeni odmerek in nadaljujte z jemanjem zdravila kot običajno.
41470 Neuss, Germany 
41470 Neuss, Nemčija
• Allergic reaction 
• alergijsko reakcijo.
5000 LT Tilburg The Netherlands 
5000 LT Tilburg Nizozemska
If at any time you have these thoughts, immediately contact your doctor. 
Če se tudi vam kadarkoli pojavijo takšne misli, nemudoma pokličite svojega zdravnika.
If your doctor decides to stop this medication, your dose may be decreased gradually over a few days. 
Če je zdravnik presodil, da morate prenehati z jemanjem tega zdravila, vam bo odmerek v nekaj dneh postopoma zmanjšal.
It is true that the trials were not specifically designed for recruiting resistant patients although limited information is available regarding the kind of patients finally involved in them (naïve vs previously treated/resistant patients). 
Res je, da preskušanja niso bila specifično zasnovana za vključevanje odpornih bolnikov, čeprav so na voljo omejeni podatki o vrsti bolnikov, ki so bili na koncu vključeni (predhodno nezdravljeni ali predhodno zdravljeni/odporni bolniki).
20% increase in AUC 
20 % povečanje vrednosti AUC
• Changes in mood or behaviour, including anger, nervousness, sadness 
• spremembe razpoloženja ali vedenja, vključno z jezo, razdražljivostjo, žalostjo
• Disturbances in sexual function (erectile dysfunction, loss of libido) 
• motnje spolnosti (erektilna disfunkcija, izguba libida)
Especially, tell your doctor or pharmacist if you are taking: 
Še posebej morate povedati svojemu zdravniku ali farmacevtu, če jemljete:
• to prevent migraine headaches in adults 
• za preprečevanje migrenskih glavobolov pri odraslih.
In one of the studies (TOPMAT-MIGR-003), which compared topimarate to propranolol, a similar efficacy profile was observed. 
V eni od študij (TOPMAT-MIGR-003), kjer so primerjali topimarat s propranololom, so ugotovili podoben profil učinkovitosti.
There are no adequate and well-controlled studies with Topamax in pregnant women. 
Ni zadostnih in dobro nadzorovanih študij z zdravilom Topamax pri nosečnicah.
Mood disturbances/depression 
Motnje razpoloženja in depresija
{Name and address} <{tel}> <{fax}> <{e-mail}> 
{Ime in naslov} <{tel}> <{fax}> <{e-mail}>
There is currently no evidence that migraine prophylaxis during pregnancy reduces the risk of stroke. 
Trenutno ni dokazov, da profilaksa migrene med nosečnostjo zmanjša tveganje kapi.
Use of lower initial doses has been reported, but has not been studied systematically. 
Poročali so tudi o uporabi manjših začetnih odmerkov, vendar le-teh niso sistematično proučevali.
Topiramate did not affect metformin tmax. 
Topiramat ni vplival na tmax metformina.
Adjunctive therapy for epilepsy in children and adults The proposed indication of adjunctive therapy is approved in all of 29 countries involved in the Article 30 procedure. 
Dodatna terapija epilepsije pri otrocih in odraslih bolnikih Predlagana indikacija dodatne terapije je odobrena v vseh 29 državah, vključenih v postopku po členu 30.
However there is no physiological or pharmacological reason to suspect that the mechanism of action of the drug or the pathophysiology of the illness would be any different in a child of 2 years versus a child of 10 years of age. 
Vendar ni fiziološkega ali farmakološkega razloga za dvom, da bi se mehanizma delovanja zdravila ali patofiziologija bolezni pri dveletnem otroku in desetletnem otroku razlikovala.
The embryofetal studies show clear evidence of the teratogenic potential of topiramate. 
Embriofetalne študije kažejo jasne dokaze teratogenega potenciala topiramata.
The supplemental dose may differ based on the characteristics of the dialysis equipment being used. 
Dodatni odmerek je lahko različen glede na lastnosti uporabljenih dializnih aparatov.
Therefore, it is reasonable to accept that if efficacy in a given indication has been shown in the paediatric population in general, then those results can be extrapolated to a given lower age limit. 
Zato je razumno sprejeti, da lahko po dokazani učinkovitosti za določeno indikacijo pri otrocih na splošno rezultate prenesemo na določeno spodnjo starostno mejo.