natgillin/translations-raw huggingface dataset:
REMEDICA LTD, Aharnon str. P.O.box 51706, Lemesos, Cyprus domperidone PEPTOMET FILM COATED TABLETS 10MG 
REMEDICA LTD, Aharnon str. P.O.box 51706, Lemesos, Cyprus
Domperidone Motilium Tropfen 10 mg oral drops, suspension 
Motilium Tropfen 10 mg peroralne kapljice, suspenzija
ACTAVIS FRANCE La Boursidière Centre d'Affaires 92357 Le Plessis Robinson France domperidone DOMPERIDONE ACTAVIS 10 mg, comprimé pelliculé 
ACTAVIS FRANCE La Boursidière Centre d'Affaires 92357 Le Plessis Robinson France
Domperidone DOMPERIDONE SANDOZ 
DOMPERIDONE SANDOZ
Domperidone DOMPERIDONE ALMUS 
DOMPERIDONE ALMUS
5 mg oral suspension oral use 
5 mg peroralna suspenzija peroralna uporaba
QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest France domperidone DOMPERIDONE QUALIMED 10 mg, 
QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest France
B-2340, Beerse Belgium domperidone motilium 30 mg Suppositories 
B-2340, Beerse Belgium motilium 30 mg Suppositories
Domperidone Domerid Relief 10mg Tablets. 
Domerid Relief 10mg Tablets.
Domperidone DOMPERIDONE GERMED 
DOMPERIDONE GERMED
Domperidone Orosperidys 10 mg comprimidos bucodispersables 
Orosperidys 10 mg comprimidos bucodispersables
CRISTERS 22 quai Gallieni 92150 Suresnes France domperidone DOMPERIDONE CRISTERS 10 mg, comprimé orodispersible 
CRISTERS 22 quai Gallieni 92150 Suresnes France
domperidone DOMPERIDONE ALTER 10 mg, comprimé pelliculé 
DOMPERIDONE ALTER 10 mg, comprimé pelliculé
Belgium domperidone Motilium-60 supp 60 mg suppository rectal use 
Motilium-60 supp 60 mg svečka rektalna uporaba
20 mg effervescent granules 
20 mg šumeča zrnca
Šmarješka cesta 6 8501 Novo mesto Slovenia domperidone Tametil 10 mg filmsko obložene tablete 
Šmarješka cesta 6 8501 Novo mesto Slovenia
comprimé pelliculé 
Filmtabletten
Domperidone Domperidon JJC filmomhulde tabletten 10 mg 
Domperidon JJC filmomhulde tabletten 10 mg
Domperidone Motilium Fastmelts 10mg Tablets 
Motilium Fastmelts 10mg Tablets
Domperidone Motilium Rx 10 mg Film-coated Tablets. 
Motilium Rx 10 mg Filmcoated Tablets.
H-2045 Törökbálint Hungary domperidone Motilium 10 mg filmtabletta 
H-2045 Törökbálint Hungary
Belgium domperidone Motilium-30 supp 30 mg suppository rectal use 
Motilium-30 supp 30 mg svečka rektalna uporaba
Domperidone Motilium 60mg Suppositories 
Motilium 60mg Suppositories
Domperidone Motilium 10 mg comprimidos recubiertos con película 
Motilium 10 mg comprimidos recubiertos con película
SUBSTIPHARM 8, rue Bellini 75116 Paris France domperidone DOMPERIDONE GERDA 10 mg, comprimé pelliculé 
SUBSTIPHARM 8, rue Bellini 75116 Paris France
Germany domperidone DOMPERIDONE RATIOPHARM 10 mg, comprimé orodispersible 
DOMPERIDONE RATIOPHARM 10 mg, comprimé orodispersible
Domperidone COSTI 
COSTI
Domperidone Domperidon JJC zetpillen voor zuigelingen 10 mg 
Domperidon JJC zetpillen voor zuigelingen 10 mg
Domperidon ratiopharm 10 mg Filmtabletten 
Domperidonratiopharm 10 mg Filmtabletten
Domperidone Domperidona Gamir 1 mg/ml suspensión oral 
Domperidona Gamir mg/ml suspensión oral
5 mg effervescent granules 
5 mg šumeča zrnca
1MG/ML 
Motilium-1mg/ml
Domperidone Domperidon JJC zetpillen voor kinderen 30 mg 
Domperidon JJC zetpillen voor kinderen 30 mg
Domperidone Domperidon JJC zetpillen voor volwassenen 60 mg 
Domperidon JJC zetpillen voor volwassenen 60 mg
Domperidone Motilium 30 mg Suppositories 
Motilium 30 mg Suppositories
Domperidone Motilium 10 mg Suppositories 
Motilium 10 mg Suppositories
Austria domperidone Motilium 60 mgZäpfchen 
Motilium 60 mgZäpfchen
Domperidone Nauzelin 1 mg/ml suspensión oral 
Nauzelin 1 mg/ml suspensión oral
Domperidone Domperidon PCH 10, filmomhulde tabletten 10 mg 
Domperidon PCH 10, filmomhulde tabletten 10 mg
5 mg/5 ml oral solution 
5 mg/5 ml peroralna raztopina peroralna uporaba
49, avenue Georges Pompidou 92300 Levallois-Perret France domperidone DOMPERIDONE SANDOZ 10 mg, comprimé orodispersible 
49, avenue Georges Pompidou 92300 Levallois-Perret France
MEDICAMENT 10 mg, comprimé orodispersible 
OROPERIDYS 10 mg, comprimé orodispersible
Domperidone Domperidon Bellwood 10 mg, tabletten 
Domperidon Bellwood 10 mg, tabletten
Domperidone Domperidon Actavis 10 mg, omhulde tabletten 
Domperidon Actavis 10 mg, omhulde tabletten
Domperidone Domperidon Sandoz 10 mg, tabletten 
Domperidon Sandoz 10 mg, tabletten
Domperidone DOMERID 10mg Tablets. 
DOMERID 10mg Tablets.
Austria domperidone Motilium 30 mgZäpfchen 
Motilium 30 mgZäpfchen
Domperidone Motilium instant 
Motilium Instant
Domperidone Motilium 1 mg/ ml suspensión oral 
Motilium 1 mg/ ml suspensión oral
60 mg suppository rectal use 
60 mg svečka rektalna uporaba
Domperidon teva 10 mg film-coated tablet 
Domperidon teva 10 mg filmsko obložena tableta
DOMPERIDONE MOTILIUM 10 mg 10 mg film-coated tablet 
DOMPERIDONE MOTILIUM 10 mg 10 mg filmsko obložena tableta
Domperidone Domperidon Faribérica 10 mg, tabletten 
Domperidon Faribérica 10 mg, tabletten
Estrada Consiglieri Pedroso, 69 AQueluz de Baixo 
Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2730-055 Barcarena Portugal
Apothekers, zetpillen 
Pharmachemie, tabletten
Germany domperidone DOMPERIDONE RATIOPHARM 10 mg, comprimé pelliculé 
DOMPERIDONE RATIOPHARM 10 mg, comprimé pelliculé
10 mg suppository rectal use 
10 mg svečka rektalna uporaba
15, boulevard Charles de Gaulle 92700 Colombes France domperidone DOMPERIDONE BIOGARAN 10 mg, 
15, boulevard Charles de Gaulle 92700 Colombes France
Domperidone OROPERIDYS 10 mg 10 mg tablet 
DOMPERIDONE OROPERIDYS 10 mg
30 mg suppository rectal use 
30 mg svečka rektalna uporaba
92787 Issy-les-Moulineaux Cedex domperidone MOTILIUM 10 mg, comprimé pelliculé 
92787 Issy-les-Moulineaux Cedex
5 mg chewable tablet 
5 mg žvečljiva tableta
10 mg effervescent granules 
10 mg šumeča zrnca
Domperidone Domperidon Accord 10 mg, tabletten 
Domperidon Accord 10 mg, tabletten
Domperidone Kruidvat Domperidon 10 mg, tabletten 
Kruidvat Domperidon 10 mg, tabletten
Domperidone Motilium 1mg/ml Oral Suspension 
Domperidone 1mg/ml Oral Suspension
Domperidone PERIDON 
Domperidona Labesfal
Domperidone Domperidon Actavis 10 mg, tabletten 
Domperidon Actavis 10 mg, tabletten
MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France domperidone DOMPERIDONE MYLAN 10 mg, comprimé pelliculé 
MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
Motilium Instants 10 mg orodispersible tablet oral use 
Motilium Instants 10 mg orodisperzibilna tableta
Domperidone Domperidon Mylan 10 mg, tabletten 
Domperidon Mylan 10 mg, tabletten
Austria domperidone Motilium 10 mgZäpfchen 
Motilium 10 mgZäpfchen
Domperidone Domperidon Actavis 10 mg tablet 
Domperidon Actavis 10 mg tablets
Domperidone Domperidon Mdq 10 mg, tabletten 
Domperidon Mdq 10 mg, tabletten
75116 Paris domperidone DOMPERIDONE SGPHARM 20 mg, comprimé pelliculé sécable. 
DOMPERIDONE SG-PHARM 20 mg, comprimé pelliculé sécable.
4230 Skaelskoer Denmark domperidone Domperidon "Alternova" 
4230 Skaelskoer Denmark
Domperidone Domperidon Pharmacin 10 mg, tabletten 
Domperidon Pharmacin 10 mg, tabletten
Limassol CY-3505 Cyprus domperidone Costi 10mg Film coated tablets 
Limassol CY-3505 Cyprus
75116 Paris domperidone DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable 
DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable
Domperidone Domperidon Kela 10 mg, tabletten 
Domperidon Kela 10 mg, tabletten
92654 Boulogne Cedex France 
92931 Paris La Défense Cedex France
2770-229 Paço de Arcos Portugal domperidone Domperidona Ciclum 10 mg tablet 
2770-229 Paço de Arcos Portugal
75116 Paris domperidone DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable. 
DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable.
Domperidone DOMPERIDONE MYLAN GENERICS 
Domperidona Mylan
Greece domperidone CILROTON 
Domperidona Ciclum
Belgium domperidone Motilium pediatrie 1 mg/ml oral suspension oral use 
Motilium pediatrie 1 mg/ml peroralna suspenzija peroralna uporaba
Domperidone GERDI 
Domperidona Germed
Hungary domperidone Domperidon-EP 10 mg tabletta 
Domperidon-EP 10 mg tabletta
Motilium 
GENERICS
10 mg dispersible tablet 
10 mg disperzibilna tableta peroralna uporaba
Domperidone DOMPERIDONE ABC 10 mg tablet 
Domperidon AbZ 10 mg
20 mg orodispersible tablet oral use 
20 mg orodisperzibilna tableta
Domperidone mylan 10 mg film-coated tablet 
DOMPERIDONE MYLAN 10 mg, comprimé pelliculé
92787 Issy-les-Moulineaux Cedex domperidone MOTILIUM 10 mg, granulés effervescents en sachet-dose 
MOTILIUM 10 mg, granulés effervescents en sachet-dose
Apothekers 
Oroperidys
Domperidon-TEVA 10 mg Filmtabletten 
DomperidonTEVA 10 mg Filmtabletten
1 mg/ml oral suspension oral use 
1 mg/ml peroralna suspenzija peroralna uporaba
Einnehmen 
RIGES
DOMPERIDONE OROPERIDYS 10 mg 10 mg orodispersible tablet oral use 
Oroperidys 10 mg orodispersible tablets
Domperidone Domperidon 30 mg zetpillen 
Domperidon 30 mg zetpillen Samenwerkende Apothekers
Domperidone RAXAR 
DOMPERIDONE FG
Austria domperidone Motilium 10 mgFilmtabletten 
Motilium 10 mgFilmtabletten
Annex I List of medicinal products and presentations 
Priloga I Seznam imen in farmacevtskih oblik
3% without vasoconstrictor 
3% without vasoconstri ctor
Dental use Perineural use Submucosal use Infiltration 
Dentalna uporaba Perinevralna uporaba Submukozna uporaba Infiltracijska uporaba
Perineural use Infiltration 
Perinevralna uporaba Infiltriranje
BIOCAINE 3% PLAIN 
SCANDONEST 3% PLAIN BIOCAINE 3% PLAIN 3% Raztopina za injiciranje
SCANDONEST 30 mg/ml SOLUCIÓN INYECTABLE 
SCANDONEST 30 mg/ml SOLUCIÓN INYECTABLE 30 mg/ml
SCANDONEST 3% PLAIN, SOLUŢIE INJECTABILĂ 
SCANDONEST 3% PLAIN, SOLUŢIE INJECTABILĂ 3% Raztopina za injiciranje Dentalna uporaba
InfiltrationPerineural use 
Raztopina za injiciranje InfiltriranjePerinevralna uporaba
Laboratoires Septodont 58, rue du Pont de Créteil 94107 Saint-Maur-des-Fossés Cedex 
94107 Saint-Maurdes-Fossés Cedex France
MG/ML RAZTOPINA ZA INJICIRANJE 
Raztopina za injiciranje Uporaba pri zdravljenju dlesni
SCANDONEST 30 MG/ML, injekcinis tirpalas užtaise 
SCANDONEST 30 MG/ML, injekcinis tirpalas užtaise 30 mg/ml
Laboratoires Septodont 58, rue du Pont de Créteil 94100 Saint-Maur-des-Fossés France 
58, rue du Pont de Créteil
It was to be available as a solution for injection under the skin. 
Na voljo naj bi bila v obliki raztopine za injiciranje pod kožo.
The company stated that it intended to stop the development of the medicine, but that it plans to work with doctors, patients and local regulatory authorities to allow currently treated patients to access the remaining supply of Kyndrisa. 
Družba je navedla, da namerava ustaviti razvoj zdravila, vendar načrtuje sodelovanje z zdravniki, bolniki in lokalnimi regulativnimi organi in želi omogočiti trenutno zdravljenim bolnikom dostop do preostalih zalog zdravila Kyndrisa.
It causes progressive weakness and loss of muscle function, and usually leads to death in adolescence or early adulthood. 
Povzroča napredujočo oslabelost in zmanjševanje mišične funkcije ter navadno povzroča smrt v adolescenci ali zgodnji odrasli dobi.
Kyndrisa is a medicine that contains the active substance drisapersen. 
Kyndrisa je zdravilo, ki vsebuje zdravilno učinkovino drisapersen.
The Committee considered that data from the clinical studies did not sufficiently demonstrate a beneficial effect of Kyndrisa: the main study did not show any benefit in patients with the condition, while two other studies failed to consistently show a beneficial effect. 
Odbor je ocenil, da podatki iz kliničnih študij koristnega učinka zdravila Kyndrisa ne dokazujejo v zadostni meri: z glavno študijo niso dokazali koristi pri bolnikih s to boleznijo, drugi dve študiji pa koristnega učinka nista dosledno dokazali.
Withdrawal of the marketing authorisation application for Kyndrisa (drisapersen) EMA/430531/2016 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Kyndrisa (drisapersen) EMA/430531/2016
Withdrawal of the marketing authorisation application for Kyndrisa (drisapersen) 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Kyndrisa (drisapersen)
After the CHMP had assessed the company's responses to the last round of questions, there were still some important unresolved issues. 
Potem ko je ocenil odgovore družbe na zadnji sklop vprašanj, so nekatera pomembna vprašanja še vedno ostala nerešena.
Further, the safety profile of the medicine was not considered satisfactory, particularly because of the risk of persisting reactions at the injection site (such as swelling, inflammation and ulceration) which could have a negative impact on quality of life, and the risk of thrombocytopenia (low blood platelet counts) which could put patients at risk of serious bleeding complications. 
Poleg tega tudi varnostni profil zdravila ni bil ocenjen kot zadovoljiv, zlasti zaradi tveganja za trajne reakcije na mestu injiciranja (kot so otekanje, vnetje in razjede), ki bi lahko negativno vplivale na kakovost življenja, in tveganja za trombocitopenijo (nizko raven trombocitov), ki bi lahko povečalo tveganje za hude zaplete s krvavitvami.
Kyndrisa was investigated in three studies in a total of 290 patients with Duchenne muscular dystrophy. 
Zdravilo Kyndrisa so preučevali v treh študijah pri skupaj 290 bolnikih z Duchennovo mišično distrofijo.
Duchenne muscular dystrophy is a serious genetic disease, which mainly affects boys and is usually diagnosed before the age of 6. 
Duchennova mišična distrofija je huda genetska bolezen, ki večinoma prizadene dečke in se navadno diagnosticira pred 6. letom starosti.
The studies compared the effects of Kyndrisa with placebo (a dummy treatment) and the main measure of effectiveness was the change in the distance the patient could walk in six minutes after 24 or 48 weeks of treatment. 
V študijah so primerjali učinek zdravila Kyndrisa s placebom (zdravilom brez zdravilne učinkovine), glavno merilo učinkovitosti pa je bila sprememba razdalje, ki jo je bolnik lahko prehodil v šestih minutah po 24 ali 48 tednih zdravljenja.
Kyndrisa was expected to be used for the treatment of Duchenne muscular dystrophy in patients aged 5 years and older who are able to walk and whose disease is due to certain genetic mutations (defects) that can be treated with ‘exon 51 skipping technology'. 
Zdravilo Kyndrisa naj bi se uporabljalo za zdravljenje Duchennove mišične distrofije pri bolnikih, starih pet let in več, ki lahko hodijo, njihova bolezen pa je posledica določenih genetskih mutacij (okvar) in se lahko zdravi s „tehnologijo preskakovanja eksona 51“.
On 31 May 2016, BioMarin International Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Kyndrisa, for the treatment of Duchenne muscular dystrophy. 
Družba BioMarin International Limited je dne 31. maja 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Kyndrisa, namenjenim zdravljenju Duchennove mišične distrofije.
This technology enables the protein-making apparatus in cells to skip some areas of the dystrophin gene and allow the production of a shortened but partially working dystrophin protein. 
S to tehnologijo aparat za proizvodnjo beljakovin v celicah preskoči nekatera območja gena za distrofin in omogoči tvorbo krajše, vendar še delno delujoče distrofinske beljakovine.
What is Kyndrisa? 
Kaj je zdravilo Kyndrisa?
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Kyndrisa could not have been approved for the treatment of Duchenne muscular dystrophy. 
Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil odbor CHMP, je ta v času umika izrazil določene zadržke in je začasno menil, da zdravila Kyndrisa ni mogoče odobriti za zdravljenje Duchennove mišične distrofije.
Duchenne muscular dystrophy is caused by mutations in the gene for the protein dystrophin, which lead to the production of a non-functional dystrophin. 
Duchennovo mišično distrofijo povzročajo mutacije v genu za beljakovino distrofin, kar povzroči nastajanje nedelujočega distrofina.
What was Kyndrisa expected to be used for? 
Za kaj naj bi se zdravilo Kyndrisa uporabljalo?
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Kyndrisa did not outweigh its risks. 
Zato je CHMP v času umika menil, da koristi zdravila Kyndrisa ne odtehtajo z njim povezanih tveganj.
In its letter notifying the Agency of the withdrawal of application, the company stated that it would not be able to address the CHMP concerns regarding the results of the clinical studies within the expected timeframe. 
Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da v pričakovanem časovnem okviru ne bi mogla ukrepati v zvezi z zadržki odbora CHMP o rezultatih kliničnih študij.
This medicine works by ‘exon 51 skipping 
To zdravilo deluje s pomočjo „tehnologije preskakovanja eksona 51“.
Kyndrisa was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 27 February 2009 for Duchenne muscular dystrophy. 
Zdravilo Kyndrisa je bilo dne 27. februarja 2009 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za Duchennovo mišično distrofijo.
How is Kyndrisa expected to work? 
Kako naj bi zdravilo Kyndrisa delovalo?
OPEN HERE LIFT HERE 
ODPRITE TUKAJ DVIGNITE TUKAJ
Date of first authorisation: 28 March 2019 
Datum prve odobritve: 28. marec 2019
Important information: 
Pomembne informacije:
Long-term study (Study 3) 
Dolgoročna študija (študija 3)
More than 1,400 patients were treated for at least 12 months. 
Več kot 1.400 bolnikov so zdravili najmanj 12 mesecev.
Two dosing options are available: 
Na voljo sta dve možnosti odmerjanja:
d) Wash your hands with soap and water and dry well with a clean towel. 
d) Umijte si roke z milom in vodo ter jih dobro osušite s čisto brisačo.
The treatment benefit should be assessed within 3 months after initiation of treatment. 
Koristi zdravljenja je treba oceniti v 3 mesecih po uvedbi zdravljenja.
c) Remove the needle from your skin. 
c) Odstranite iglo iz kože.
Any further decision to continue treatment should be taken on an individual patient basis. 
Vsaka nadaljnja odločitev o nadaljevanju zdravljenja naj temelji na individualni oceni bolnika.
Your doctor will discuss and decide with you the most appropriate dosing schedule. 
Zdravnik se bo pogovoril z vami in izbral najprimernejši režim odmerjanja.
Do not remove pressure until the 3 steps below are complete. 
Pritiska ne popustite, dokler ne opravite naslednjih 3 korakov.
Human IgG is known to be excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period. 
Znano je, da se humani IgG izloča v materino mleko v prvih dneh po rojstvu, nato pa se kmalu zmanjša na manjše koncentracije; posledično tveganja za dojenega otroka v tem kratkem času ne moremo izključiti.
ATC code: Not yet assigned. 
Oznaka ATC: še ni bila dodeljena.
You wait another 10 seconds (to make sure all of the medicine is injected). 
Počakajte še 10 sekund (da se prepričate, da ste injicirali vse zdravilo).
This reduction in CGRP's activity reduces migraine attacks. 
To zmanjšanje aktivnosti CGRP zmanjša napade migrene.
No safety data are available in these patients. 
Podatki o varnosti za te bolnike niso na voljo.
Your doctor or nurse will explain to you or your caregiver how to give the injection. 
Zdravnik ali medicinska sestra bo vam ali vašemu negovalcu pojasnila, kako se injekcija daje.
All injection site reactions resolved, mostly within a few hours or days. 
Vse reakcije na mestu injiciranja so izzvenele, večinoma v nekaj urah ali dneh.
Intrinsic and extrinsic factors 
Intrinzični in ekstrinzični dejavniki
The safety and efficacy of AJOVY in children and adolescents below the age of 18 years have not yet been established. 
Varnost in učinkovitost zdravila AJOVY pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
How much and when to inject 
Koliko zdravila je treba injicirati in kdaj
Overall, 19% of the patients had previously used topiramate. 
Skupno 19 % bolnikov je predhodno uporabljalo topiramat.
This medicine also decreases the disability associated with migraine and it reduces the need for medicines used to treat migraine attacks. 
Poleg tega zdravilo zmanjša onesposobljenost, povezano z migreno in zmanjša potrebo po zdravilih, ki se uporabljajo za zdravljenje napadov migrene.
− Do not touch the needle. 
− Ne dotikajte se igle.
Patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) have not been studied. 
Bolnikov s hudo ledvično okvaro (eGFR < 30 ml/min/1,73 m2) niso preučili.
The treatment should be initiated by a physician experienced in the diagnosis and treatment of migraine. 
Zdravljenje mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem migrene.
Gently pinch up at least 2.5 cm of the skin that you have cleaned. 
Nežno stisnite vsaj 2,5 cm kože, ki ste jo pred tem očistili.
Make sure the name AJOVY appears on the label. 
Prepričajte se, da je na nalepki navedeno ime AJOVY.
The antibody responses were of low titer. 
Titer protiteles je bil nizek.
One of these 6 patients developed neutralising antibodies. 
6 bolnikov so se razvila nevtralizirajoča protitelesa.
61% of patients completing Study 3 achieved a 50% response in the last month of the study. 
bolnikov, ki so dokončali študijo 3, je doseglo 50-odstotni odziv v zadnjem mesecu študije.
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse effects and given appropriate symptomatic treatment if necessary. 
V primeru prevelikega odmerjanja je priporočljivo, da bolnika spremljamo glede kakršnih koli znakov ali simptomov neželenih učinkov in po potrebi uvedemo ustrezno simptomatsko zdravljenje.
Afterwards, use of fremanezumab could be considered during breast-feeding only if clinically needed. 
Po tem se lahko o uporabi fremanezumaba med dojenjem razmisli le, če je to klinično potrebno.
Frequency categories are based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000). 
Pogostnosti temeljijo na naslednjem dogovoru: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000).
It should not be administered by the intravenous or intramuscular route. 
Zdravila se ne sme dajati po intravenski ali intramuskularni poti.
Use a reminder method such as notes in a calendar or diary to help you remember your next dose so that you do not miss a dose or have a dose too soon after the last one. 
Uporabite nekakšen opomnik, na primer beležke na koledarju ali v dnevniku, da si boste lažje zapomnili, kdaj je čas za naslednji odmerek, tako da ga ne boste pozabili ali si odmerek dali prehitro po zadnjem.
No data on exposure-efficacy relationship in subjects with body weight >132 kg is available. 
Podatki o razmerju med izpostavljenostjo in učinkovitostjo pri preskušancih s telesno maso > 132 kg niso na voljo.
AJOVY reduces the frequency of migraine attacks and days with headache. 
Zdravilo AJOVY zmanjša pogostnost migrenskih napadov in dni z glavobolom.
− After you have injected all of the medicine, pull the needle straight out. 
− Ko ste injicirali vse zdravilo, takoj izvlecite iglo.
Pharmacotherapeutic group: Not yet assigned. 
Farmakoterapevtska skupina: še ni bila dodeljena.
Patients with certain major cardiovascular diseases were excluded from clinical studies (see section 5.1). 
Bolnike z nekaterimi hudimi srčno-žilnimi boleznimi so izključili iz kliničnih študij (glejte poglavje 5.1).
No formal clinical drug interaction studies have been performed with AJOVY. 
Uradnih kliničnih študij medsebojnega delovanja z zdravilom AJOVY niso izvedli.
No safety signal was observed during the 15-month combined treatment period. 
Med skupno 15-mesečnim obdobjem zdravljenja niso opazili nobenih opozorilnih signalov v zvezi z varnostjo.