natgillin/translations-raw huggingface dataset:
Moxifloxacin gjennomgår en fase II-biotransformasjon og utskilles via urin, galle/fæces som uforandres legemiddel samt i form av sulfatforbindelser (M1) og et glukuronid (M2). M1 og M2 er de eneste relevante metabolittene hos menneske, og begge er mikrobiologisk inaktive. 
Moxifloxacin undergoes Phase II biotransformation and is excreted via renal and biliary/faecal pathways as unchanged drug as well as in the form of a sulpho-compound (M1) and a glucuronide (M2).
Bruk ikke [Legemidlets navn] - hvis du er allergisk (overfølsom) overfor virkestoffet moxifloxacin, andre antibiotika av typen kinoloner, eller et av de andre innholdsstoffene (se pkt. 
Do not take [Invented name] 400 mg film-coated tablets - If you are allergic (hypersensitive) to the active ingredient moxifloxacin, any other quinolone antibiotics or any of the other ingredients (see section 6.
In-vitro-resistens mot moxifloxacin opparbeides gradvis gjennom mutasjoner i både type II topoisomerase (DNA gyrase) og topoisomerase IV. Moxifloxacin er et lite egnet 
In vitro resistance to moxifloxacin is acquired through a stepwise process by target site mutations in both type II topoisomerases, DNA gyrase and topoisomerase IV. Moxifloxacin is a poor substrate for active efflux mechanisms in Gram-positive organisms.
5.3) er bruk av moxifloxacin hos barn og ungdom <18 år kontraindisert (se pkt. 
- Due to adverse effects on the cartilage in juvenile animals (see section 5.3) the use of moxifloxacin in children and adolescents < 18 years is contraindicated (see section 4.3).
som forlenger QT-intervallet (se også pkt. 4.5.) 
torsade de pointes) and cardiac arrest (see also section 4.3).
Dosering og administrasjonsmåte 
4.2 Posology and method of administration
skal moxifloxacin seponeres og passende behandling (behandling for sjokk) iverksettes. - Moxifloxacin har vist 
In these cases moxifloxacin should be discontinued and suitable treatment (e.g. treatment for shock) initiated.
til behandling med antibiotika av kinolontypen (se Vis forsiktighet ved bruk av [Legemidlets navn] og 4. Mulige bivikninger) - dersom du er født med eller har hatt noen episoder som har vist unormale forandringer på elektrokardiogrammet (EKG, hjerteundersøkelse ved hjelp av elektroder), dersom du har ubalanse i saltinnholdet i blodet, spesielt lave konsentrasjoner av kalium i blodet (hypokalemi) og som ikke korrigeres med medisiner, dersom du har veldig langsom hjerterytme (bradykardi), dersom du har svakt hjerte (hjertesvikt), dersom du har tidligere hatt unormal hjerterytme (arytmi), eller du tar andre medisiner 
- If you were born with or have had any condition with certain abnormal electrocardiogram (ECG, electrical recording of the heart) changes, have salt imbalance in the blood, especially low concentrations of potassium in the blood (hypokalaemia) which are currently not corrected by treatment, have a very slow heart rate (bradycardia), have a weak heart (heart failure), have a history of abnormal heart rhythms (arrhythmias), or you are taking other medicines that result in certain abnormal ECG changes (see section Taking other medicines).
QTcforlengelsen for moxifloxacin 6 ± 26 msek (1,4 % økning sammenlignet med utgangsverdien). 
In the analysis of ECGs obtained in the clinical trial program, QTc prolongation with moxifloxacin was 6 msec ± 26 msec, 1.4% compared to baseline.
i EKG, som er en forlengelse av QT-intervallet, det vil si en forlenget overføring av elektriske signaler. 
This is because [Invented name] can cause a certain change on the ECG, that is a prolongation of the QT-interval i.e delayed conduction of electrical signals.
Hvis dette blir alvorlig eller vedvarende, eller du merker at avføringen inneholder blod eller 
If this becomes severe or persistent or you notice that your stool contains blood or mucus you should stop taking [Invented name] immediately and consult your doctor.
som forårsaker infeksjoner, hvis infeksjonene skyldes bakterier som som er følsomme overfør virkestoffet moxifloxacin. 
[Invented name] works by killing bacteria that cause infections, if they are caused by bacteria that are susceptible to the active ingredient moxifloxacin.
Administrasjonsmåte 
Route of administration
som stopper eller minsker bevegelsen i tarmen. 
In this situation, you should not take medicines that stop or slow down bowel movement.
sett forandringer i hjertets elektrofysiologi (QTforlengelse) etter eksponering for moxifloxacin. 
Both in preclinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to moxifloxacin, in the form of QT prolongation.
Anbefalt dose skal derfor 
Therefore, the recommended dose should not be exceeded.
- Graviditet og amming (se pkt. 
- Pregnancy and lactation (see section 4.6).
Viktige opplysninger om noen av innholdsstoffene i [Legemidlets navn] [Legemidlets navn] inneholder laktose. 
Important information about some of the ingredients of [Invented name] 400 mg film-coated tablets [Invented name] tablets contain lactose.
- Pasienter med tidligere tendinitt og/eller seneruptur relatert 
- Patients with a history of tendon disease/disorder related to quinolone treatment.
Interferens med mikrobiologisk diagnostikk 
Interference with culture test
4.1 Indikasjoner 
4.1 Therapeutic indications
Spør lege eller apotek dersom du har noen spørsmål om bruken av dette legemidlet. 
Ask your doctor or pharmacist for advice before taking any medicine.
[Legemidlets navn] 400 mg filmdrasjerte tabletter er indisert ved behandling av følgende bakterielle infeksjoner: - Akutt eksaserbasjon av kronisk bronkitt - Samfunnservervet pneumoni , unntatt alvorlige tilfeller - Akutt bakteriell sinusitt (korrekt diagnostisert) - Lett til moderat bekkenbetennelse (det vil si infeksjoner 
[Invented name] 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections: - Acute exacerbation of chronic bronchitis - Community acquired pneumonia, except severe cases - Acute bacterial sinusitis (adequately diagnosed) - Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess.
Nærværet av den store bicykloamingruppen i C7-posisjon beskytter mot aktiv effluks, relatert 
The presence of the bulky bicycloamine substituent at the C-7 position prevents active efflux, associated with the norA or pmrA genes seen in certain Gram-positive bacteria.
- Kinolonantibiotika kan gjøre at huden 
- Quinolone antibiotics may make your skin become more sensitive to sunlight or UV light.
Hvis hjertearrytmier opptrer under behandling med moxifloxacin bør behandlingen stoppes og EKG-undersøkelse gjennomføres. - Tilfeller av fulminant hepatitt, som kan føre til livstruende leversvikt, har vært rapportert for moxifloxacin (se pkt 4.8). 
- Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with moxifloxacin (see section 4.8).
Interstitialvæske 
Interstitial fluid
[Legemidlets navn] 400 mg filmdrasjerte tabletter anbefales ikke som monoterapi ved lett til moderat bekkenbetennelse, men bør gis i kombinasjon med andre passende antibakterielle midler (f.eks. 
[Invented name] 400 mg film-coated tablets are not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate antibacterial agent (e.g. a cephalosporin) due to increasing moxifloxacin resistance of Neisseria gonorrhoeae unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded (see sections 4.4 and 5.1).
Nytten av moxifloxacinbehandling, spesielt ved mindre alvorlige infeksjoner 
The benefit of moxifloxacin treatment especially in infections with a low degree of severity should be balanced with the information contained in the warnings and precautions section.
14 dager [Legemidlets navn] 400 mg filmdrasjerte tabletter er brukt 
AVELOX 400 mg filmsko obložene tablete
Ekspertråd bør innhentes når den lokale forekomsten av resistens er 
As necessary, expert advice should be sought where the local prevalence of resistance is such that utility of the agent in at least some types of infections is questionable.
Chalmydia trachomatis* 
Blister fluid
cefalosporiner) på grunn av økende moxifloxacinresistens hos Neisseria gonorrhoeae, hvis ikke moxifloxacinresistente Neisseria gonorrhoeae kan utelukkes (se pkt. 
The CHMP considered that due to the emergence of fluoroquinolone-resistant N. gonorrhoeae strains moxifloxacin should not be used in empirical monotherapy of mild to moderate PID, unless a resistance against moxifloxacin can be ruled out.
type antibiotika i tillegg til [Legemidlets navn] for behandling av infeksjoner øvre del av kvinners underliv (se pkt 2 ”Hva du må ta hensyn 
[Invented name] tablets are not sufficient for sole therapy of this kind of infections and therefore another antibiotic in addition to [Invented name] tablets should be prescribed by your doctor for the treatment of infections of the female upper genital tract (see section 2.
Naturlig resistente arter 
Inherently resistant organisms
I slike tilfeller bør empirisk moxifloxacin bør gis i tillegg til et annet hensiktsmesig antibiotika (f.eks. celafosponrin) med mindre moxifloxacin-resistent Neisseria gonorrhoeae kan utelukkes. Dersom klinisk forbedring ikke oppnås etter 3 dagers behandling bør behandlingen revurderes. - På grunn av bruskskader hos voksende dyr (se pkt. 
Therefore in such cases empirical moxifloxacin should be co-administered with another appropriate antibiotic (e.g. a cephalosporin) unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded.
Konsentrasjon Vev/plasma forholdstall 
Site: Plasma ratio
Etmoidalsinus 
Ethmoid sinus
si hemodialyse og kontinuerlig ambulatorisk peritonealdialyse (se pkt. 
No adjustment of dosage is required in patients with mild to severely impaired renal function or in patients on chronic dialysis i.e. haemodialysis and continuous ambulatory peritoneal dialysis (see section 5.2 for more details).
Legemidler 
Tissue
sin blir mer følsom for sollys og UV-lys. Du bør unngå lengre 
You should avoid prolonged exposure to sunlight or strong sunlight and should not use a sunbed or any other UV lamp while taking [Invented name].
- Antibiotikarelatert kolitt (inkludert pseudomembranøs kolitt) har vært rapportert i forbindelse med bruk av bredspektrede antibiotika inklusive moxifluxacin. 
pseudomembranous colitis) has been reported in association with the use of broad spectrum antibiotics including moxifloxacin; therefore it is important to consider this diagnosis in patients who develop serious diarrhoea during or after the use of moxifloxacin.
Vev 
Saliva
serumkonsentrasjon 3,1 mg/l 
3.1 mg/l
- Samfunnservervet pneumoni 
Community acquired pneumonia 10
Haemophilus influenzae* 
Aerobic Gram-negative micro-organisms Haemophilus influenzae*
Én 400 mg tablett en gang daglig. 
Dosage (adults) One 400 mg film-coated tablet once daily.
Forsiktighet bør utvises hos pasienter med CNSforstyrrelser 
Use should be with caution in patients with CNS disorders which may predispose to seizures or lower the seizure threshold.
pneumoniae 
S. pneumoniae
Inntak av [Legemidlets navn] 
Invented name Name
PAKNINGSVEDLEGG 
Strength
som inneholder magnesium eller aluminium, slik som antacida mot sure oppstøt, eller ethvert legemiddel 
- Any medicine containing magnesium or aluminium such as antacids for indigestion, or any medicine containing iron or zinc, medicine containing didanosine or medicine containing sucralfate to treat gastrointestinal disorders can reduce the action of [Invented name] tablets.
Med mindre legen har fortalt deg noe annet, anbefales følgende behandlingstider: - Plutselig forverring av kronisk bronkitt (akutt eksaserbasjon av kronisk bronkitt) 5-10 dager - Infeksjoner 
Unless otherwise indicated by your doctor the recommended durations of use of [Invented name] are: - Sudden worsening of chronic bronchitis (acute exacerbation of chronic bronchitis) 10 days - Infection of the lungs acquired (pneumonia) outside the hospital, except severe cases days - Acute infection of the sinuses (acute bacterial sinusitis) days - Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease),
som gis i dette avsnittet. 
RECORDATI ESPAÑA, SL Crta.
ikke renal clearance av moxifloxacin. 
QT-prolongation is a known undesirable effect of moxifloxacin.
Gardnerella vaginalis 
Aerobic Gram-positive micro-organisms Gardnerella vaginalis
Sikkerhet og effekt av moxifloxacin hos barn og ungdom er 
Efficacy and safety of moxifloxacin in children and adolescents have not been established (see section 4.3).
Kontakt lege eller apotek hvis du er usikker. 
You should check with your doctor or pharmacist if you are not sure how to take [Invented name].
Alveolære makrofager 
Alveolar macrophages
Moxifloxacin distribueres meget raskt 
Moxifloxacin is mainly bound to serum albumin.
Pasienter 
Member State
- Dersom du har epilepsi eller en sykdom 
- If you are pregnant or breast-feeding.
[Legemidlets navn] brukes hos voksne for å behandle følgende bakterieinfeksjoner: - Plutselig forverring av kronisk bronkitt (akutt eksaserbasjon av kronisk bronkitt) - Infeksjoner 
It is approved for the treatment of the following bacterial infections if they are caused by bacteria susceptible to moxifloxacin: - Acute exacerbation of chronic bronchitis - Community acquired pneumonia, except severe cases - Acute bacterial sinusitis (adequately diagnosed).
som gjør at du kan få kramper må du snakke med legen din før du begynner å ta [Legemidlets navn]. 
- If you suffer from epilepsy or a condition which makes you likely to have convulsions, consult your doctor before taking [Invented name].
H. 
DE - Germany
infeksjon i bihulene (akutt bakteriell sinusitt) - Lette til moderate infeksjoner i øvre del av kvinners underliv (bekkennbetennelse), inkludert infeksjoner 
[Invented name] is used in adults for treating the following bacterial infections: - Sudden worsening of chronic bronchitis (acute exacerbation of chronic bronchitis) - Infection of the lungs (pneumonia) acquired outside the hospital, except severe cases - Acute infection of the sinuses (acute bacterial sinusitis) - Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infections of the fallopian tubes and infections of the uterus mucous membrane.
Bronkialslimhinne 
Bronchial mucosa
som plutselig sykdomsfølelse samtidig med at det hvite i øynene blir gult, mørk urin, kløe i huden, blødningstendenser eller 
Please contact your doctor before you continue the treatment if you develop signs such as rapidly feeling unwell and/or being sick associated with yellowing of the whites of the eyes, dark urine, itching of the skin, a tendency to bleed or liver induced disease of the brain (symptoms of a reduced liver function or a rapid and severe inflammation of the liver).
infusjon 
Introduction
QT-forlengelse, da dette kan føre til en øket risiko for ventrikkulær arrytmi (inkludert torsade de pointes) og hjertestans (se også pkt. 
Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions, such as acute myocardial ischaemia or QT prolongation as this may lead to an increased risk for ventricular arrhythmias (incl.
Etter en dose på 400 mg er AUC målt 
Avelox 400 mg tabletten
Nyre/leverfunksjonsnedsettelse 
Renal/hepatic impairment
Европейската комисия издава разрешение за употреба, валидно в рамките на Европейския съюз, за Filgrastim ratiopharm на ratiopharm GmbH на 15 септември 2008 г. 
The European Commission granted a marketing authorisation valid throughout the EU for Filgrastim ratiopharm to ratiopharm GmbH on 15 September 2008.
Поради това CHMP счита, че както при Neupogen ползите са по-големи от установените рискове. 
Therefore, the CHMP's view was that, as for Neupogen, the benefit outweighs the identified risk.
Това означава, че Filgrastim ratiopharm е подобен на друго биологично лекарство, вече одобрено в Европейския съюз (ЕС), и съдържа същото активно вещество (известно още като „референтно лекарство“). 
This means that Filgrastim ratiopharm is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine').
Възможни са други нежелани реакции при повече от 1 на 10 пациенти в зависимост от състоянието, за което се използва Filgrastim ratiopharm. 
Other side effects may be seen in more than 1 patient in 10, depending on the condition that Filgrastim ratiopharm is being used for.
През първия 21-дневен цикъл на химиотерапия пациентите, лекувани с Filgrastim ratiopharm или Neupogen, имат тежка неутропения за средно 1,1 дни спрямо 3,8 дни при получаващите плацебо. 
During the first 21-day chemotherapy cycle, patients treated with either Filgrastim ratiopharm or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo.
Активното вещество в Filgrastim ratiopharm, филграстим, е много подобно на човешкия протеин, наречен гранулоцит-колониостимулиращ фактор (G-CSF). 
The active substance in Filgrastim ratiopharm, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Комитетът по лекарствените продукти за хуманна употреба (CHMP) решава, че в съответствие с изискванията на ЕС, е доказано, че Filgrastim ratiopharm има същия профил на качество, безопасност и ефикасност като Neupogen. 
The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Filgrastim ratiopharm has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
за лечение на персистираща неутропения при пациенти с напреднала инфекция на човешки имунодефицитен вирус (HIV) за намаляване на риска от бактериални инфекции, когато други лечения са неподходящи. 
• to treat persistent neutropenia in patients with advanced human immunodeficiency virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Най-честата нежелана реакция при Filgrastim ratiopharm (наблюдавана при повече от 1 на 10 пациенти) е мускулно-скелетна болка (болки в мускулите и костите). 
The most common side effect with Filgrastim ratiopharm (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Filgrastim ratiopharm е сравнен с Neupogen и с плацебо (сляпо лечение) в едно основно проучване, обхващащо 348 пациенти с рак на млечната жлеза. 
Filgrastim ratiopharm was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer.
Пълният текст на EPAR относно Filgrastim ratiopharm може да се намери тук. 
The full EPAR for Filgrastim ratiopharm can be found here.
Filgrastim ratiopharm може да се използва също при пациенти, на които предстои да дарят кръвни стволови клетки за трансплантация, за да се подпомогне освобождаването на клетките от костния мозък. 
Filgrastim ratiopharm can also be used in patients who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Filgrastim ratiopharm обикновено се дава в специализирани онкологични центрове, въпреки че пациентите, които приемат лекарството чрез подкожно инжектиране, могат да се инжектират сами след получаване на съответното обучение. 
Filgrastim ratiopharm is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Filgrastim ratiopharm се използва за стимулиране на производството на бели кръвни клетки при 
Filgrastim ratiopharm is used to stimulate the production of white blood cells in the following
Замяната действа по същия начин както при естествено произвеждания G-CSF - като се стимулира костният мозък да произвежда повече 
The replacement acts in same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
В проучването се изследва продължителността на тежката неутропения през първия цикъл от цитотоксичната 
The study looked at the duration of severe neutropenia during the patients' first cycle of cytotoxic chemotherapy.
В него се разяснява как 
It contains the active
за намаляване продължителността на неутропенията (ниски стойности на неутрофилите, тип бели кръвни клетки) и честотата на фебрилната неутропения (неутропения с повишена температура) при пациенти, получаващи цитотоксична (убива клетките) химиотерапия 
• to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing);
Допълнителна информация за Filgrastim ratiopharm: 
Other information about Filgrastim ratiopharm:
За проучване на безопасността на Filgrastim ratiopharm са проведени две допълнителни проучвания при пациенти с рак на белите дробове и неходжкинов лимфом. 
To study the safety of Filgrastim ratiopharm, two further studies were carried out in patients with lung cancer and with non-Hodgkin's lymphoma.
за намаляване продължителността на неутропенията при пациенти, подложени на лечение за унищожаване на клетки от костния мозък, последвано от костномозъчна трансплантация (например при някои пациенти с левкемия), ако пациентите са с риск за продължителна 
• to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at a risk of long-term, severe neutropenia;
ЗА ОБЩЕСТВЕНА ОЦЕНКА (EPAR) FILGRASTIM RATIOPHARM 
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FILGRASTIM RATIOPHARM
При лечението с Filgrastim ratiopharm и Neupogen се постига подобно намаляване на продължителността на тежката неутропения. 
Treatment with Filgrastim ratiopharm and Neupogen brought about similar reductions in duration of severe neutropenia.
Filgrastim ratiopharm е проучен с цел да се покаже, че е равностоен на референтното лекарство 
Filgrastim ratiopharm was studied to show that it is comparable to the reference medicine, Neupogen.
Какви ползи от Filgrastim ratiopharm са установени в проучванията? 
What benefit has Filgrastim ratiopharm shown during the studies?
Filgrastim ratiopharm e „биоподобно“ лекарство. 
Filgrastim ratiopharm is a ‘biosimilar' medicine.
За повече информация за биоподобните 
For more information on biosimilar medicines, see the question-and-answer
Filgrastim ratiopharm е противопоказен за лица, които биха могли да проявят свръхчувствителност (алергични реакции) към филграстим или някоя от другите съставки. 
Filgrastim ratiopharm should not be used in people who may be hypersensitive (allergic) to filgrastim
Референтното лекарство за Filgrastim ratiopharm е Neupogen. 
The reference medicine for Filgrastim ratiopharm is Neupogen.
Filgrastim ratiopharm се прилага с подкожна инжекция или инфузия във вена. 
Filgrastim ratiopharm is given by injection under the skin or infusion into a vein.
Filgrastim ratiopharm е инжекционен или инфузионен разтвор (въвежда се капково във вена). 
Filgrastim ratiopharm is a solution for injection or for infusion (drip into a vein).
Комитетът препоръчва на Filgrastim ratiopharm 
The Committee recommended that Filgrastim ratiopharm be given marketing
За пълния списък на всички наблюдавани при Filgrastim 
For the full list of all side effects reported with Filgrastim ratiopharm, see the Package Leaflet.
Как действа Filgrastim ratiopharm? 
How does Filgrastim ratiopharm work?
за повишаване броя на неутрофилите и намаляване риска от инфекции при пациенти с 
• to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
Как да използвате Filgrastim ratiopharm? 
How has Filgrastim ratiopharm been studied?
Освен това, профилът на безопасност на клопидогрел при тази подгрупа пациенти не предизвика някакъв особен проблем. 
Moreover, the safety profile of clopidogrel in this subgroup of patients did not raise any particular concern.