natgillin/translations-raw huggingface dataset:
One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Turkey/Turkey/1/2005 administered after two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from Indonesia/5/2005 
En odmerek cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Turkey/Turkey/1/2005, uporabljen po enem ali dveh odmerkih cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz Indonesia/5/2005
The other ingredients are: thiomersal, sodium chloride, disodium hydrogen phosphate, 
• Pomožne snovi: Pomožne snovi so: tiomersal, natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat,
There are no data with Pumarix using the subcutaneous route. 
Podatkov o subkutani uporabi cepiva Pumarix ni.
Split influenza virus, inactivated, containing antigen* equivalent to: 
Po premešanju 1 odmerek (0,5 ml) vsebuje: razcepljen virus influence, inaktiviran, ki vsebuje antigene, ki ustrezajo:
“How Pumarix is 
Kako deluje cepivo Pumarix
In the event of other variation being observed, discard the 
Če opazite kakšno drugo spremembo, morate cepivo zavreči.
If any of the side effects below occur, please tell your doctor or nurse 
Če se pojavi kateri od spodaj navedenih neželenih učinkov, morate to nemudoma povedati zdravniku ali medicinski sestri.
Pharmacovigilance Plan or risk minimisation activities 
Načrt za obvladovanje tveganja (RMP)
PSURs 
NP
In addition, one group of six ferrets were immunized with vaccine candidate containing 3.75 µg H5N1 + full dose of AS03 and one control group included ferrets immunized with non-adjuvanted vaccine (3.75 micrograms HA). 
Razen tega pa so eno skupino šestih belih dihurjev cepili s kandidatnim cepivom, ki je vsebovalo 3,75 µg H5N1 + celoten odmerek AS03.
3seroconversion factor (i.e. ratio of the post-vaccination GMT and the pre-vaccination GMT) 
3Faktor serokonverzije: (tj. razmerje med geometrično sredino titra (GMT - geometric mean titre) po cepljenju in GMT pred cepljenjem).
Split influenza virus, inactivated, containing antigen* equivalent to: A/H5N1/Indonesia/5/2005 like strain used (PR8-IBCDC-RG2)3.75 micrograms** per 0.5 ml 
razcepljen virus influence, inaktiviran, ki vsebuje antigene*, ki ustrezajo: uporabljenemu sevu PR8-IBCDC-RG2, ki je podoben sevu A/Indonesia/05/2005 3,75 mikrogramov**na 0,5 ml odmerek
Ten days after the booster dose, the seroprotection rate against A/Turkey/Turkey/1/2005 and A/Indonesia/5/2005 was 99.2%. 
A/Turkey/Turkey/1/2005 in A/Indonesia/5/2005 99,2 %.
The following information is intended for healthcare professionals only: 
Naslednje informacije so namenjene samo zdravstvenemu osebju: Cepivo Pumarix je na voljo v dveh vsebnikih:
potassium dihydrogen phosphate, potassium chloride, water for injections What Pumarix looks like and contents of the pack The suspension is a translucent to off white opalescent suspension, which may sediment slightly. 
Izgled cepiva Pumarix in vsebina pakiranja Suspenzija je prozorna do sivo bela opalescentna suspenzija, ki lahko rahlo sedimentira.
Common: redness at the injection site, swelling at the injection site, fever, shivering Uncommon: injection site reactions (such as bruising, induration, pruritus, warmth), asthenia, chest 
Občasni: reakcije na mestu injiciranja (kot so modrice, zatrdlina, srbenje in občutek toplote), astenija, bolečina v prsnem košu, splošno slabo počutje
Pumarix suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) 
Pumarix suspenzija in emulzija za emulzijo za injiciranje cepivo proti pandemski gripi (H5N1) z delci virionov, inaktivirano (z adjuvansom)
Day 21 N=145 
n = 145
Uncommon: back pain, musculoskeletal stiffness, neck pain, muscle spasms, pain in extremity 
Zelo pogosti: bolečina v sklepih, bolečine v mišicah Občasni: bolečina v hrbtu, okorelost mišično-skeletnega sistema, bolečina v vratu, mišični krči, bolečina v okončinah
Full dose 
6 Polni odmerek
Uncommon: may affect up to 1 in 100 people 
Občasni:pojavijo se lahko pri največ 1 od 100 oseb
Immune response to A/Vietnam/1194/2004 3 to 5 years 
Imunski odziv proti A/Vietnam/1194/2004 21 dni po 2. odmerku
In particular, please tell your doctor or nurse if you are having any treatments (such as corticosteroid treatments or chemotherapy for cancer) that affect the immune system. 
kortikosteroide ali kemoterapijo za raka), ki vplivajo na imunski sistem.
Full dose N=41 
Polni odmerek n = 41
Immune response to A/Indonesia/5/2005 
Imunski odziv proti A/Indonesia/5/2005 18-60 let
The per-dose frequency of local and general solicited adverse reactions observed in the groups of children who received two adult (0.5 ml) doses was higher than that observed in the groups of children who received two half adult (i.e. 0.25 ml) doses, except for redness in the 6-9 years of age group. 
ki so prejeli dva odmerka za odrasle (0,5 ml), kot v skupinah otrok, ki so prejeli dva polovična odmerka za odrasle ( t.j.
Skin and subcutaneous tissue disorders Common: sweating Uncommon: pruritus, rash 
Bolezni kože in podkožja Pogosti: znojenje
• if you have previously had a sudden life-threatening allergic reaction to any ingredient of this vaccine (listed in section 6) or to anything else that may be present in very small amounts, such as: egg and chicken protein, ovalbumin, formaldehyde or sodium deoxycholate. 
• če ste kdaj imeli nenadno, življenje ogrožajočo alergijsko reakcijo na katerokoli sestavino tega cepiva (navedene v poglavju 6) ali na karkoli, kar je lahko prisotno v zelo majhnih količinah,
How to store Pumarix Keep this vaccine out of the sight and reach of children. 
Shranjevanje cepiva Pumarix Cepivo shranjujte nedosegljivo otrokom!
Instructions for mixing and administration of the vaccine: 
Datum in ura mešanja:
NAME OF THE MEDICINAL PRODUCT Pumarix suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) 
Navodilo za uporabo Pumarix suspenzija in emulzija za emulzijo za injiciranje cepivo proti pandemski gripi (H5N1) z delci virionov, inaktivirano (z adjuvansom)
Half dose N=44 
Polovični odmerek n = 44
General disorders and administration site conditions Very common: pain at the injection site, fatigue 
Zelo pogosti: bolečina na mestu injiciranja, utrujenost
Pumarix may be used in lactating women. 
Cepivo Pumarix se lahko uporabi v obdobju dojenja.
Product-specific data can be 
Drugi viri podatkov
In a clinical study (D-Pan-H5N1-009, -023), children aged 3 to 5 and 6 to 9 years old received two doses of either a full (0.5 ml) or a half dose (0.25 ml) of an AS03-adjuvanted vaccine containing 3.75 
V klinični študiji (D-Pan-H5N1-009, -023) so otroci, stari od 3 do 5 in od 6 do 9 let, dvakrat dobili bodisi polni odmerek (0,5 ml) bodisi polovični odmerek (0,25 ml) cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 (H5N1) na dan 0 in dan 21.
Excipients: Thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections 
Pomožne snovi: tiomersal, natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat, kalijev klorid, voda za injekcije suspenzija antigena za injiciranje 50 vial: suspenzija
AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and 
Adjuvans AS03, ki je sestavljen iz skvalena (10,69 miligramov), DL-α-tokoferola (11,86 miligramov) in polisorbata 80 (4,86 miligramov).
There are very limited safety and immunogenicity data available on the administration of an AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) manufactured using a different process and on administration of half a dose of the same vaccine (i.e. 1.875 µg HA and half the amount of AS03 adjuvant) at 0 and 21 days in children aged 3 to 9 years. 
AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 (H5N1), izdelanega z uporabo drugačnega postopka, in polovičnega odmerka istega cepiva (tj. 1,875 µg HA in pol količine adjuvansa AS03),
Full dose N=42 
Polni odmerek n = 42
Half dose N=42 
Polovični odmerek n = 42
Full dose N=43 
Polni odmerek n = 43
• Being sick, stomach pain, acid indigestion 
• slabost, bolečine v želodcu, dispepsija,
NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Pumarix Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) 
Suspenzija za emulzijo za injiciranje za cepivo Pumarix cepivo proti pandemski gripi (H5N1) z delci virionov, inaktivirano (z adjuvansom)
Talk to your doctor or nurse before you are given Pumarix: 
Preden dobite cepivo Pumarix, se posvetujte z zdravnikom ali medicinsko sestro:
Half dose N=43 
Polovični odmerek n = 43
• Itching, rash 
• drgetanje,
1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 
1Delež serološke zaščite: delež preiskovancev s titrom inhibicije hemaglutinacije (HI
See section 6.5 for the 
Za število odmerkov v viali glejte poglavje 6.5.
Administration of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) manufactured using a different process Paediatric population 
Uporaba cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 (H5N1),
2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4 
2Delež serokonverzije: delež preiskovancev, ki so bili pred cepljenjem seronegativni in imajo po cepljenju zaščitni titer ≥ 1:40, ali so bili pred cepljenjem seropozitivni in imajo 4-kraten porast titra.
After mixing: Use within 24 hours and do not store above 30°C. 
Po premešanju: Uporabite v 24 urah.
In a clinical study (Q-Pan-H5N1-010), a booster dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Turkey/Turkey/1/2005 was given 15 months after primary vaccination. 
V klinični študiji (Q-Pan-H5N1-010) je bil 15 mesecev po primarnem cepljenju uporabljen obnovitveni odmerek cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz
A clinical study (D-H5N1-009), evaluated the reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two adult (i.e. 0.5 ml) doses or two half adult (i.e. 0.25 ml) doses (21 days apart) of another Pandemic influenza vaccine (H5N1 A/Vietnam/1194/2004 manufactured in Dresden, Germany). 
V klinični študiji (D-H5N1-009) so ocenili reaktogenost pri otrocih, starih od 3 do 5 in od 6 do 9 let, ki so v presledku 21 dni prejeli bodisi dva odmerka za odrasle (t.j.
2seroconversion rate (i.e. proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and 
2Delež serokonverzije: (tj. delež preiskovancev, ki so bili pred cepljenjem seronegativni in imajo po cepljenju zaščitni titer ≥ 1:40, ali so bili pred cepljenjem seropozitivni in imajo 4-kraten porast titra),
Medicinal product subject to medical prescription. 
POGOJEV DOVOLJENJA ZA PROMET Z ZDRAVILOM
A 4-fold increase in serum neutralising antibody against A/Vietnam/1194/2004 was achieved in 44.7% of subjects at day 21, 53.2% at day 42 and 38.3% at day 180. 
Štirikratno povečanje serumskih titrov nevtralizirajočih protiteles proti A/Indonesia/5/2005 je bilo doseženo pri 76,6 % preiskovancev na dan 21, pri 97,9 % na dan 42 in pri 91,5 % na dan 180; na dan 42 in 180 je imelo 100 % preiskovancev titer vsaj 1:80.
2booster seroconversion rate: proportion of subjects who were either seronegative at pre-booster and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-booster and have a 4 
2Obnovitveni delež serokonverzije: delež preiskovancev, ki so bili seronegativni pred obnovitvenim odmerkom in imajo zaščitni titer po cepljenju ≥ 1:40, ali so bili pred obnovitvenim odmerkom seropozitivni in imajo 4-kraten porast titra.
How Pumarix is given 
Kako uporabljati cepivo Pumarix
Induration Pain 
Emulzija je belkastega
Split influenza virus, inactivated, containing antigen* equivalent to: *Antigen: A/Indonesia/5/2005 (H5N1) like strain used (PR8-IBCDC-RG2) 
razcepljen virus influence, inaktiviran, ki vsebuje antigene*, ki ustrezajo 3,75 mikrogramom hemaglutinina/odmerek *Antigen: uporabljen sev PR8-IBCDC-RG2, ki je podoben sevu A/Indonesia/05/2005 (H5N1)
The vaccine should be administered in accordance with the recommended posology (see section 4.2). 
Po mešanju je količina cepiva Pumarix v viali vsaj 5 ml. Cepivo je treba uporabiti v skladu s priporočenim odmerjanjem (glejte poglavje 4.2).
Pumarix contains thiomersal 
Nevtralizirajoča protitelesa v serumu
• two packs containing 25 vials of 2.5 ml emulsion (adjuvant) Marketing Authorisation Holder and Manufacturer GlaxoSmithKline Biologicals s.a. 
• dve pakiranji s 25 vialami po 2,5 ml emulzije (adjuvans)
• Diarrhoea, feeling sick 
• driska, siljenje na bruhanje.
Gastrointestinal disorders 
Delež serokonverzije
The vaccine should be administered in accordance with the recommended posology (see section 3. 
Po mešanju je količina cepiva Pumarix v viali vsaj 5 ml. Cepivo je treba uporabiti v skladu s priporočenim odmerjanjem (glejte poglavje 3 "Kako uporabljati cepivo Pumarix").
2seroconversion rate (i.e. proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and 3seroconversion factor (i.e. ratio of the post-vaccination GMT and the pre-vaccination GMT) Twenty-one days after the second dose, a 4-fold increase in serum neutralising antibody against A/Indonesia/5/2005 was achieved in 94.4% of subjects aged 18-60 years and in 80.4% of subjects over 60 years of age. 
2Delež serokonverzije: (tj. delež preiskovancev, ki so bili pred cepljenjem seronegativni in imajo po cepljenju zaščitni titer ≥ 1:40, ali so bili pred cepljenjem seropozitivni in imajo 4-kraten porast titra), 3Faktor serokonverzije: (tj. razmerje med geometrično sredino titra (GMT - geometric mean titre) po cepljenju in GMT pred cepljenjem).
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription. 
Podatke, specifične za zdravilo se lahko vrednoti med obdelavo signalov.
Excipients: Sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections 
Viala z emulzijo: natrijev klorid (NaCl) natrijev hidrogenfosfat (Na2HPO4) kalijev dihidrogenfosfat (KH2PO4) kalijev klorid (KCl) voda za injekcije
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Antigen suspension for Pumarix 
IME ZDRAVILA IN POT(I) UPORABE
DATE OF REVISION OF THE TEXT Detailed information on this medicinal product is available on the website of the European Medicines 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/
Due date 
21. dan
In another clinical study, 39 subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 fourteen months after they had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 administered on day 0 and day 21. 
z vsebnostjo 3,75 µg HA iz A/Indonesia/05/2005 štirinajst mesecev potem, ko so dobili dva odmerka cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 na dan 0 in 21.
At day 42, the neutralising antibody responses were as follows: Immune response to A/Vietnam/1194/2004 21 days after 2 
Protitelesa anti-HA Proti A/Vietnam 21 dni po obnovitvi
3booster factor: ratio of the post-booster geometric mean titre (GMT) and the pre-booster GMT. 
3Obnovitveni faktor: razmerje geometrične sredine titra po obnovitvenem odmerku in pred obnovitvenim odmerkom.
Split influenza virus inactivated, containing antigen equivalent to: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) 
Suspenzija antigena za cepivo Pumarix cepivo proti pandemski gripi uporabljen sev PR8-IBCDC-RG2, ki je podoben sevu A/Indonesia/05/2005 (H5N1) i.m.
Breast-feeding 
Občasni: limfadenopatija
• Feeling dizzy 
• Adjuvans:
Musculoskeletal and connective tissue disorders Very common: joint pain, muscle aches 
Bolezni mišično-skeletnega sistema in vezivnega tkiva
28 tablets 30 tablets 84 tablets 100 tablets 60 tablets 
28 tablet 30 tablet 84 tablet 100 tablet
Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Tablet container (HDPE) 
100 mg filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba pretisni omot (PVC/PVdC/alu) pretisni omot (PVC/PVdC/alu) pretisni omot (PVC/PVdC/alu) pretisni omot (PVC/PVdC/alu) vsebnik za tablete (HDPE)
Liver Very rare: 
Jetra Zelo redki:
Muscular and Joint System Very rare: 
Mišični in vezivni sistem Zelo redki:
Elderly patients may also be more susceptible to drug-associated effects on the QT interval. 
Prav tako so lahko starejši bolniki bolj občutljivi za z zdravili povezanim učinkom na interval QT.
4.4 Special warnings and precautions for use: 
4.4 Posebna opozorila in previdnostni ukrepi
Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhoea. 
Zdravila, ki zavirajo peristaltiko, so pri bolnikih, ki imajo resno drisko, kontraindicirana.
[Invented name] should only be used to treat these infections when usual antibiotics cannot be used or have not worked. 
Zdravilo [izmišljeno ime] je treba uporabljati za zdravljenje teh okužb samo, če se običajnih antibiotikov ne sme uporabljati ali če niso učinkoviti.
Before taking [Invented name] 400 mg film-coated tablets - [Invented name] can change your heart's ECG, especially if you are female, or if you are elderly. 
Pred jemanjem zdravila [izmišljeno ime] 400 mg filmsko obložene tablete - [izmišljeno ime] lahko vpliva na vaš EKG srca, posebno če ste ženskega spola ali starejša oseba.
- If you suffer from myasthenia gravis taking [Invented name] may worsen the symptoms of your disease. 
- Če imate miastenijo gravis, lahko jemanje zdravila [izmišljeno ime] poslabša znake vaše bolezni.
The following should be reflected as appropriate (the new text is shown in bold and underlined and text to be deleted is shown strikethrough): 
Upoštevajte naslednje (novo besedilo je prikazano z označenimi spremembami):
As women tend to have a longer baseline QTc interval compared with men, they may be more sensitive to QTcprolonging medications. 
Ker je pri ženskah izhodiščna vrednost intervala QTc daljša v primerjavi z moškimi, so ženske lahko bolj občutljive za zdravila, ki podaljšajo interval QTc.
4.7 Effects on ability to drive and use machines (…) However, fluoroquinolones including moxifloxacin may result in an impairment of the patient's ability to drive or operate machinery due to CNS reactions (e.g. dizziness, see section 4.8) or acute and short lasting loss of consciousness (syncope, see section 4.8). 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji (…) Vendar lahko fluorokinoloni (tudi moksifloksacin) zmanjšajo bolnikovo sposobnost za vožnjo ali upravljanja strojev zaradi reakcij centralnega živčnega sistema (npr. omotica, glejte poglavje 4.8) ali nenadne kratkotrajne nezavesti (sinkopa, glejte poglavje 4.8).
Rupture of tendon, inflammation of joints, muscle rigidity, worsening of the symptoms of myasthenia gravis 
pretrganje kite, vnetje v sklepih, mišična rigidnost, poslabšanje znakov miastenije gravis
Common ≥ 1/100 to < 1/10 
Organski sistem pogosti > 1/100 do < 1/10
- If you develop a skin reaction or blistering and/or peeling of the skin and/or mucosal reactions (see section 4. 
- Če se pojavijo spremembe na koži ali mehurčki in/ali luščenje kože in/ali spremembe na sluznici (glejte poglavje 4.
- [Invented name] may cause a rapid and severe inflammation of the liver which could lead to life-threatening liver failure (including fatal cases, see section 4. 
- [izmišljeno ime] lahko povzroči nenadno in hudo vnetje jeter, kar lahko povzroči življenjsko ogrožajočo jetrno odpoved (tudi smrtni primeri) (glejte poglavje 4.
[Invented name] is an antibiotic belonging to the quinolone family. 
Zdravilo [izmišljeno ime] je antibiotik, ki sodi v skupino kinolonov.
Moxifloxacin should be used to treat adequately diagnosed ABS and AECB only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed to resolve the infection. 
Moksifloksacin je treba uporabiti za zdravljenje ustrezno diagnosticiranega ABS in AEKB samo, če uporaba protimikrobnih zdravil, ki se priporočajo za začetno zdravljenje teh okužb ni primerna ali če ta za zdravljenje okužb niso več učinkovita.
[Invented name] is used in patients of 18 years and older for treating the following bacterial infections when caused by bacteria against which moxifloxacin is active: infection of the sinuses, sudden worsening of long term inflammation of the airways or infection of the lungs (pneumonia) acquired outside the hospital (except severe cases). 
Zdravilo [izmišljeno ime] se uporablja pri bolnikih starih 18 let ali več za zdravljenje naslednjih bakterijskih okužb, če jih povzročajo bakterije, pri katerih je moksifloksacin učinkovit: okužba obnosnih votlin, nenadno poslabšanje kroničnega bronhitisa ali pljučnica (pnevmonija), pridobljena izven bolnišnice (razen hudih oblik).
There have been very rare cases of the following side effects reported following treatment with other fluoroquinolones, which might possibly also occur during treatment with moxifloxacin: transient loss of vision, hypernatraemia, hypercalcaemia, haemolysis, rhabdomyolysis, photosensitivity reactions (see section 4.4). 
Med zdravljenjem z drugimi fluorokinoloni so poročali o zelo redkih primerih naslednjih neželenih učinkov, ki bi se prav tako lahko pojavili med zdravljenjem z moksifloksacinom: prehodna izguba vida, hipernatriemija, hiperkalciemija, hemoliza, rabdomioliza, fotosenzitivne reakcije (glejte poglavje 4.4).
ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET 
DODATEK III DODATEK K POVZETKU GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILU ZA UPORABO
[Invented name] works by killing bacteria that cause infections, if they are caused by bacteria that are susceptible to the active ingredient moxifloxacin. 
[izmišljeno ime] uničuje bakterije, ki povzročajo okužbe, in so občutljive za zdravilno učinkovino moksifloksacin.
Driving and using machines [Invented name] may make you feel dizzy or light-headed or you might faint for a short period. 
Vpliv na sposobnost upravljanja vozil in strojev [izmišljeno ime] lahko povzroči vrtoglavico, omotico ali kratkotrajno omedlevico.
- Community acquired pneumonia, except severe cases Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection. 
pljučnice, pridobljene v domačem okolju, razen hudih oblik Moksifloksacin je treba uporabiti samo, če uporaba protimikrobnih zdravil, ki se priporočajo za začetno zdravljenje te okužbe ni primerna.
Furthermore, there have been very rare cases of the following side effects reported following treatment with other quinolone antibiotics, which might possibly also occur during treatment with [Invented name]: transient loss of vision, increased blood sodium levels, increased blood calcium levels, increased breakdown of red blood cells, muscle reactions with muscle cell damage, increased sensitivity of the skin to sunlight or UV light. 
V zelo redkih primerih so po zdravljenju z drugimi kinolonskimi antibiotiki poročali o naslednjih neželenih učinkih, ki se lahko prav tako pojavijo med zdravljenjem z zdravilom [izmišljeno ime]: prehodna izguba vida, zvečane vrednosti natrija v krvi, zvečane vrednosti kalcija v krvi, zvečan razpad eritrocitov, mišične spremembe s poškodbo mišičnih celic, zvečana občutljivost kože za sončno ali UV svetlobo.
- Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated. 
- Pri bolnikih z miastenijo gravis, je treba moksifloksacin uporabljati previdno, ker se simptomi bolezni lahko poslabšajo.