natgillin/translations-raw huggingface dataset:
Mechanism of action Moxifloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative pathogens.
Mehanizem delovanja In vitro deluje moksifloksacin na širok spekter po Gramu pozitivnih in po Gramu negativnih patogenov.
It appears that the C8-methoxy moiety contributes to enhanced activity and lower selection of resistant
Zdi se, da C8- metoksi skupina (v primerjavi s C8- H- skupino) prispeva k večji dejavnosti in manjši selekciji odpornih mutantov po Gramu pozitivnih bakterij.
Interference with culture test Moxifloxacin therapy may give false negative culture results for Mycobacterium spp. by suppression of mycobacterial growth.
13 Vpliv na test kulture Zaradi zdravljenja z moksifloksacinom so lahko rezultati testa kulture pri Mycobacterium spp. lažno negativni zaradi supresije rasti mikobakterije.
Escherichia coli, Bacillus spp., Enterococcus spp., and Klebsiella spp. were reduced, as were the anaerobes Bacteroides vulgatus, Bifidobacterium spp., Eubacterium spp., and Peptostreptococcus spp..
Vpliv na črevesno floro pri ljudeh Pri prostovoljcih so po peroralnem jemanju moksifloksacina opazili naslednje spremembe v črevesni flori: število Escherichia coli, Bacillus spp., Enterococcus spp. in Klebsiella spp. se je zmanjšalo, prav tako tudi število anaerobov Bacteroides vulgatus, Bifidobacterium spp., Eubacterium spp. in Peptostreptococcus spp.
For Bacteroides fragilis there was an increase.
Število Bacteroides fragilis se je zvečalo.
Mechanism of resistance Resistance mechanisms that inactivate penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not interfere with the antibacterial activity of moxifloxacin.
Mehanizem odpornosti Mehanizmi odpornosti, ki inaktivirajo peniciline, cefalosporine, aminoglikozide, makrolide in tetracikline ne vplivajo na protimikrobno aktivnost moksifloksacina.
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.
Odpornost proti moksifloksacinu in vitro je pridobljena postopoma in sicer s tarčnimi mutacijami v obeh tipih topoizomeraz II, girazi DNK in topoizomerazi IV.
Moxifloxacin is a poor substrate for active efflux mechanisms in Gram-positive organisms.
Moksifloksacin je nezadosten substrat za mehanizme aktivnega prehoda v po Gramu pozitivnih organizmih.
EUCAST clinical MIC breakpoints for moxifloxacin (31.01.2006):
01.
Organism Staphylococcus spp.
2006): organizem Staphylococcus spp.
S. pneumoniae Streptococcus Groups A, B, C, G H. influenzae and M. catarrhalis Enterobacteriaceae Non-species related breakpoints* * Non-species related breakpoints have been determined
S. pneumoniae Streptococcus skupine A, B, C, G H. influenzae in M. catarrhalis Enterobacteriaceae mejne vrednosti za nespecifične vrste * * Mejne vrednosti za nespecifične vrste so določili
≤ 0.5 mg/ l ≤ 0.5 mg/ l ≤ 0.5 mg/ l ≤ 0.5 mg/ l ≤ 0.5 mg/ l mainly on the basis of
občutljiva ≤ 0, 5 mg/ l ≤ 0, 5 mg/ l ≤ 0, 5 mg/ l ≤ 0, 5 mg/ l ≤ 0, 5 mg/ l ≤ 0, 5 mg/ l zlasti na podlagi
> 0.5 mg/ l > 1 mg/ l > 0.5 mg/ l > 1 mg/ l > 1 mg/ l
odporna > 1 mg/ l > 0, 5 mg/ l > 1 mg/ l > 0, 5 mg/ l > 1 mg/ l > 1 mg/ l
pharmacokinetic/ pharmacodynamic data and are independent of MIC distributions of specific species.
farmakokinetičnih/ farmakodinamičnih podatkov in so neodvisne od MIK za specifične vrste.
Clinical and Laboratory Standards Institute™ (CLSI), formerly NCCLS breakpoints are presented in the below table for MIC testing (mg/ l) or disc diffusion testing (zone diameter [mm]) using a 5-µg moxifloxacin disc.
Mejne vrednosti Kliničnih in laboratorijskih standardnih predpisovTM (CLSI- Clinical and Laboratory Standards InstituteTM) (prej mejne vrednosti NCCLS) so predstavljene v spodnji preglednici glede na preskušanje minimalnih inhibicijskih koncentracij (mg/ l) ali preskušanje z disk- difuzijsko metodo (premer pasu (mm)), uporaba 5- mikrogramskega diska moksifloksacina.
13 Clinical and Laboratory Standards Institute™ (CLSI) MIC and disc diffusion breakpoints for Staphylococcus spp. and fastidious organisms (M100-S17, 2007) and MIC breakpoints for anaerobes (M11-A7, 2007):
14 Mejne vrednosti Kliničnih in laboratorijskih standardnih predpisovTM (CLSI- Clinical and Laboratory Standards InstituteTM) glede na preskušanje MIK in disk- difuzijsko metodo za Staphylococcus spp. in občutljive mikroorganizme (M100- S17, 2007) in mejne vrednosti glede na preskušanje MIK za anaerobne mikroorganizme (M11- A7, 2007):
Organism S. pneumoniae
organizem S. pneumoniae
Susceptible ≤ 1 mg/ l ≥ 18 mm
občutljiva ≤ 1 mg/ l ≥ 18 mm
Intermediate 2 mg/ l 15 - 17 mm
vmesna 2 mg/ l 15– 17 mm
Resistant ≥ 4 mg/ l ≤ 14 mm
odporna ≥ 4 mg/ l ≤ 14 mm
1 mg/ l 21 - 23 mm
1 mg/ l 21– 23 mm
Anaerobes
Anaerobni mikroorganizmi
The prevalence of acquired resistance may vary geographically and with time for selected species and local information of resistance is desirable, particularly when treating severe infections.
Predvsem pri zdravljenju hudih okužb so zaželene lokalne informacije o odpornosti.
14 Commonly susceptible species Aerobic Gram-positive micro-organisms Gardnerella vaginalis Staphylococcus aureus* (methicillin-susceptible) Streptococcus agalactiae (Group B) Streptococcus milleri group* (S. anginosus, S. constellatus and S. intermedius) Streptococcus pneumoniae* Streptococcus pyogenes* (Group A) Aerobic Gram-negative micro-organisms Haemophilus influenzae* Haemophilus parainfluenzae* Klebsiella pneumoniae*# Moraxella (Branhamella) catarrhalis* Anaerobic micro-organisms Fusobacterium spp.
15 splošno občutljive vrste aerobni, po Gramu pozitivni mikroorganizmi Gardnerella vaginalis Staphylococcus aureus * (občutljivi za meticilin) Streptococcus agalactiae (skupina B) Streptococcus skupine milleri * (S. anginosus, S. constellatus in S. intermedius) Streptococcus pneumoniae * Streptococcus pyogenes * (skupina A) aerobni, po Gramu negativni mikroorganizmi Haemophilus influenzae * Haemophilus parainfluenzae * Klebsiella pneumoniae * # Moraxella (Branhamella) catarrhalis * anaerobni mikroorganizmi Fusobacterium spp.
Prevotella spp. “ Other” micro-organisms Chlamydophila (Chlamydia) pneumoniae* Chlamydia trachomatis* Coxiella burnetii Legionella pneumophila Mycoplasma genitalium Mycoplasma hominis Mycoplasma pneumoniae* Species for which acquired resistance may be a problem Aerobic Gram-positive micro-organisms Staphylococcus aureus (methicillin-resistant)+ Aerobic Gram-negative micro-organisms Enterobacter cloacae* Escherichia coli* Klebsiella oxytoca Neisseria gonorrhoeae*+ Inherently resistant organisms Aerobic Gram-negative micro-organisms Pseudomonas aeruginosa *Activity has been satisfactorily demonstrated in susceptible strains in clinical studies in the approved clinical indications. # ESBL-producing strains are commonly resistant to fluoroquinolones + Resistance rate > 50% in one or more countries
Prevotella spp. drugi mikroorganizmi Chlamydophila (Chlamydia) pneumoniae * Chlamydia trachomatis * Coxiella burnetii Legionella pneumophila Mycoplasma genitalium Mycoplasma hominis Mycoplasma pneumoniae * vrste, pri katerih je pridobljena odpornost lahko vprašljiva aerobni, po Gramu pozitivni mikroorganizmi Staphylococcus aureus (odporni proti meticilinu) + aerobni, po Gramu negativni mikroorganizmi Enterobacter cloacae * Escherichia coli * Klebsiella oxytoca Neisseria gonorrhoeae* + odporni organizmi aerobni, po Gramu negativni mikroorganizmi Pseudomonas aeruginosa * Učinek na občutljive seve so zadovoljivo dokazali v kliničnih študijah pri odobrenih kliničnih indikacijah. # ESBL- pozitivni sevi so navadno odporni proti fluorokinolonom. + stopnja odpornosti > 50% v eni ali več državah
Absorption and Bioavailability Following oral administration moxifloxacin is rapidly and almost completely absorbed.
Absorpcija in biološka uporabnost Moksifloksacin se po peroralni uporabi absorbira hitro in skoraj popolnoma.
The absolute bioavailability amounts to approximately 91%.
Absolutna biološka uporabnost je približno 91%.
Pharmacokinetics are linear in the range of 50 - 800 mg single dose and up to 600 mg once daily dosing over 10 days.
Farmakokinetika je linearna po zaužitju enkratnega odmerka v razponu 50 – 800 mg in med desetdnevnim jemanjem do 600 mg enkrat na dan.
Following a 400 mg oral dose peak concentrations of 3.1 mg/ l are reached within 0.5 - 4 h post administration.
Koncentracija je največja pol do štiri ure po zaužitju 400 mg peroralnega odmerka in znaša 3, 1 mg/ l.
Peak and trough plasma concentrations at steady-state (400 mg once daily) were 3.2 and 0.6 mg/ l, respectively.
Največja plazemska koncentracija pri dinamičnem ravnovesju (400 mg enkrat na dan) je 3, 2 mg/ l, najmanjša pa 0, 6 mg/ l.
At steady-state the exposure within the dosing interval is approximately 30% higher than after the first dose.
Pri dinamičnem ravnovesju je izpostavljenost v intervalu odmerjanja približno za 30% večja kot po prvem odmerku.
15 Distribution Moxifloxacin is distributed to extravascular spaces rapidly; after a dose of 400 mg an AUC of 35 m·gh/ l is observed.
Po dajanju 400 mg odmerka je AUC 35 mg⋅h/ l.
The steady-state volume of distribution (Vss) is approximately 2 l/ kg.
Razporeditveni volumen pri dinamičnem ravnovesju (Vss) je približno 2 l/ kg.
In vitro and ex vivo experiments showed a protein binding of approximately 40 - 42% independent of the concentration of the drug.
V poskusih in vitro in ex vivo so dokazali, da se ne glede na koncentracijo zdravila na plazemske beljakovine veže približno 40 – 42% učinkovine.
Tissue Plasma Saliva Blister fluid Bronchial mucosa Alveolar macrophages Epithelial lining fluid Maxillary sinus Ethmoid sinus Nasal polyps Interstitial fluid Female genital tract* * intravenous administration of a 1 10 h after administration 2 unbound concentration 3 from 3 h up to 36 h post dose 4 at the end of infusion
bronhialna sluznica alveolni makrofagi epitelijska tekočina maksilarni sinus etmoidni sinus nosni polipi intersticijska tekočina
Concentration 3.1 mg/ l 3.6 mg/ l 1.61 mg/ l 5.4 mg/ kg 56.7 mg/ kg 20.7 mg/ l 7.5 mg/ kg 8.2 mg/ kg 9.1 mg/ kg 1.02 mg/ l 10.24 mg/ kg single 400 mg dose
5, 4 mg/ kg 56, 7 mg/ kg 20, 7 mg/ l 7, 5 mg/ kg 8, 2 mg/ kg 9, 1 mg/ kg 1, 02 mg/ l
Plasma ratio - 0.75 - 1.3 1.71 1.7 - 2.1 18.6 - 70.0 5-7 2.0 2.1 2.6 0.8 - 1.42,3 1.724
1, 7 – 2, 1 18, 6 – 70, 0 5- 7 2, 0 2, 1 2, 6 0, 8 – 1, 42, 3
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).
Presnova Moksifloksacin se biotransformira v II. fazi, izloča pa se z urinom in žolčem/ blatom, in sicer kot nespremenjeno zdravilo, pa tudi v obliki žveplove spojine (M1) in glukuronida (M2).
Elimination Moxifloxacin is eliminated from plasma with a mean terminal half life of approximately 12 hours.
Izločanje Povprečna končna razpolovna doba izločanja moksifloksacina iz plazme je približno 12 ur.
The mean apparent total body clearance following a 400 mg dose ranges from 179 to 246 ml/ min.
Dejanski povprečni skupni očistek iz telesa po odmerku 400 mg je 179- 246 ml/ min.
Renal clearance amounted to about 24 - 53 ml/ min suggesting partial tubular reabsorption of the drug from the kidneys.
Ledvični očistek je približno 24 – 53 ml/ min, kar kaže na delno tubulno reabsorpcijo zdravila v ledvicah.
After a 400 mg dose, recovery from urine (approximately 19% for unchanged drug, approximately 2.5% for M1, and approximately 14% for M2) and faeces (approximately 25% of unchanged drug, approximately 36% for M1, and no recovery for M2) totalled to approximately 96%.
Po zaužitju 400 mg odmerka se z urinom (približno 19% nespremenjenega zdravila, približno 2, 5% v obliki M1 in približno 14% v obliki M2) in blatom (približno 25% nespremenjenega zdravila, približno 36% v obliki M1, v obliki M2 se ne izloča) izloči približno 96% učinkovine.
As renal function decreases,
17 Farmakokinetika moksifloksacina se pri bolnikih z motnjami v delovanju ledvic (tudi z očistkom kreatinina > 20 ml/ min/ 1, 73 m2) pomembno ne razlikuje.
16 concentrations of the M2 metabolite (glucuronide) increase by up to a factor of 2.5 (with a creatinine clearance of < 30 ml/ min/ 1.73 m2).
Z oslabitvijo ledvične funkcije se koncentracije presnovka M2 (glukoronid) povečajo do 2, 5- krat (očistek kreatinina < 30 ml/ min/ 1, 73 m2).
On the basis of the pharmacokinetic studies carried out so far in patients with liver failure (Child Pugh A, B), it is not possible to determine whether there are any differences compared with healthy volunteers.
Na podlagi do sedaj opravljenih farmakokinetičnih študijah pri bolnikih z okvaro jeter (Child- Pugh A, B), ni mogoče dokazati, ali obstajajo kakršnekoli razlike v primerjavi z zdravimi prostovoljci.
18 1.
18 NAVODILO ZA UPORABO
[Invented name] is used in adults for treating the following bacterial infections:
[izmišljeno ime] se pri odraslih uporablja za zdravljenje naslednjih bakterijskih okužb:
- Sudden worsening of chronic bronchitis (acute exacerbation of chronic bronchitis)
- nenadno poslabšanje kroničnega bronhitisa (akutna eksacerbacija kroničnega bronhitisa),
- Infection of the lungs (pneumonia) acquired outside the hospital, except severe cases
- pljučnica (pnevmonija), pridobljena izven bolnišnice, razen hudih oblik,
- Acute infection of the sinuses (acute bacterial sinusitis)
- akutna okužba obnosnih votlin (akutni bakterijski sinusitis),
- Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease),
- blage do zmerne okužbe ženskih notranjih spolovil (medenična vnetna bolezen) ter okužbe
including infections of the fallopian tubes and infections of the uterus mucous membrane.
jajcevodov in maternične sluznice.
Before you take [Invented name] …, Take special care …, Before taking [Invented name] 400 mg film-coated tablets).
Kaj morate vedeti..., Bodite posebno pozorni..., Pred jemanjem zdravila [izmišljeno ime] 400 mg filmsko obložene tablete).
BEFORE YOU TAKE [INVENTED NAME] 400 MG FILM-COATED TABLETS
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO [IZMIŠLJENO IME] 400 MG FILMSKO OBLOŽENE TABLETE
Do not take [Invented name] 400 mg film-coated tablets
Ne jemljite zdravila [izmišljeno ime] 400 mg filmsko obložene tablete
- If you are allergic (hypersensitive) to the active ingredient moxifloxacin, any other quinolone
- če ste alergični na (preobčutljivi za) zdravilno učinkovino moksifloksacin, druge kinolone ali
antibiotics or any of the other ingredients (see section 6.
katerokoli sestavino (glejte poglavje 6.
Further information) of [Invented name] 400 mg film-coated tablets.
Dodatne informacije) zdravila [izmišljeno ime] 400 mg filmsko obložene tablete,
- If you are pregnant or breast-feeding.
- če ste noseči ali dojite,
- If you are under 18 years of age.
- če ste mlajši od 18 let,
- If you have a history of tendon disease or disorder which was related to treatment with
- če se je po zdravljenju s kinolonskimi antibiotiki pri vas že pojavil tendinitis ali poškodba kite
quinolone antibiotics (see sections Take special care... and 4.
(glejte poglavje Bodite posebno pozorni... in 4.
- If you were born with or have had any condition with certain abnormal electrocardiogram
- če imate prirojene motnje ali kakršnekoli druge spremembe v elektrokardiogramu (EKG, zapis
(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).
električnih potencialov srca), če se je pri vas porušilo ravnovesje soli v krvi, še posebej, če imate nezdravljeno nizko koncentracijo kalija v krvi (hipokaliemijo), če imate zelo počasen srčni utrip (bradikardija), če imate oslabelo srce (srčno popuščanje), če ste že imeli motnje srčnega ritma (aritmije), ali če jemljete druga zdravila, ki povzročajo določene motnje v EKG- ju (glejte poglavje Jemanje drugih zdravil).
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.
[izmišljeno ime] lahko povzroči določene spremembe v EKG- ju (npr. podaljšanje QT dobe – t. j. upočasnjeno prevajanje električnih signalov).
- If you have a severe liver disease or increased liver enzymes (transaminases) higher than 5 times
- če imate hudo jetrno bolezen ali zvečano vrednost jetrnih encimov (transaminaz), ki za več kot
the upper normal limit.
petkrat presega zgornjo normalno mejo.
Before taking [Invented name] 400 mg film-coated tablets
Pred jemanjem zdravila [izmišljeno ime] 400 mg filmsko obložene tablete
- [Invented name] can change your heart’ s ECG.
- [izmišljeno ime] lahko vpliva na vaš EKG srca.
If you are currently taking any medicine that
Če jemljete druga zdravila, ki zmanjšajo
decrease your blood potassium levels, consult your doctor before taking [Invented name].
vrednost kalija v krvi, se posvetujte s svojim zdravnikom preden vzamete [izmišljeno ime].
He/ she may wish to perform an ECG to measure your heart rhythm.
Če bo presodil, da je potrebno, vam bo posnel EKG, na podlagi katerega bo ovrednotil vaš srčni ritem.
- If you suffer from epilepsy or a condition which makes you likely to have convulsions, consult
- Če imate epilepsijo ali stanja, ki povzročajo krče, se morate pred začetkom jemanja zdravila
your doctor before taking [Invented name].
[izmišljeno ime] posvetovati s svojim zdravnikom.
- If you or any member of your family have glucose-6-phosphate dehydrogenase deficiency (a
- Če imate vi ali katerikoli član vaše družine pomanjkanje glukoza- 6- fosfat dehidrogenaze (redko
rare hereditary disease), inform your doctor, who will advise whether [Invented name] is suitable for you.
prirojeno bolezen), o tem obvestite svojega zdravnika, ki vam bo svetoval ali je [izmišljeno ime] primerno zdravilo za vas.
- If you have a complicated infection of the female upper genital tract (e. g. associated with an
- Če imate zapleteno okužbo ženskih notranjih spolovil (npr. s spremljajočim abscesom v
abscess of the fallopian tubes and ovaries or of the pelvis), for which your doctor considers an intravenous treatment necessary, treatment with [Invented name] tablets is not appropriate.
jajcevodih in jajčnikih ali medenici), za katero vaš zdravnik oceni, da je potrebno intravensko zdravljenje, zdravljenje s tabletami [izmišljeno ime] ni primerno.
- For the treatment of mild to moderate infections of the female upper genital tract your doctor
- Za zdravljenje blagih do zmernih okužb ženskih notranjih spolovil vam bo zdravnik predpisal v
should prescribe another antibiotic in addition to [Invented name].
kombinaciji s tabletami [izmišljeno ime] še drug antibiotik.
Therefore, you should
- Tveganje za srčne nepravilnosti se lahko zveča z zvečanjem odmerka, zato morate upoštevati
adhere to the dosage.
odmerjanje.
- There is a rare chance that you may experience a severe, sudden allergic reaction (an
- Obstaja majhna verjetnost, da se že po prvi uporabi pojavi huda, nenadna alergijska reakcija
anaphylactic reaction/ shock) even with the first dose, with the following symptoms: tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing.
(anafilaktična reakcija/ šok) z naslednjimi znaki: tesnoba v prsnem košu, vrtoglavica, omedlevica ali omotica ob vstajanju.
- [Invented name] may cause a rapid and severe inflammation of the liver which could lead to
- [izmišljeno ime] lahko povzroči nenadno in hudo vnetje jeter, kar lahko povzroči smrtno
life-threatening liver failure (see section 4.
nevarno jetrno odpoved (glejte poglavje 4.
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).
Če se razvijejo znaki, kot so nenadno slabo počutje in/ ali slabotnost, porumenela beločnica, temen urin, srbenje kože, nagnjenost h krvavitvi ali zaradi jeter povzročena bolezen možganov (znaki zmanjšane jetrne funkcije ali nenadno in hudo vnetje jeter), prosimo, da se pred nadaljevanjem zdravljenja posvetujete z zdravnikom.
- You may develop diarrhoea whilst taking, or after taking, antibiotics including [Invented name].
Če se
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.
pojavi huda in trdovratna driska ali če v blatu opazite kri ali sluz, takoj prenehajte jemati [izmišljeno ime] in se posvetujte s svojim zdravnikom.
- [Invented name] may occasionally cause pain and inflammation of your tendons, particularly if
- [izmišljeno ime] lahko včasih povzroči bolečino in vnetje kit, predvsem pri starejših ali ob
you are elderly or if you are currently being treated with corticosteroids.
Takoj ko se pojavijo bolečine ali vnetje, morate prenehati jemati [izmišljeno ime], prizadeti ud pa mora mirovati.
At the first sign of any pain or inflammation you should stop taking [Invented name], rest the affected limb and consult your doctor immediately.
Če ste starejši in imate težave z ledvicami, poskrbite za zadosten vnos tekočine, kajti dehidracija
- If you are elderly with existing kidney problems take care that your fluid intake is sufficient
-
because dehydration may increase the risk of kidney failure.
lahko zveča tveganje za ledvično odpoved.
- If your eyesight becomes impaired or if you have any other eye disturbances whilst taking
- Če se pri vas med jemanjem zdravila [izmišljeno ime] pojavijo kakršnekoli motnje vida ali
[Invented name], consult an eye specialist immediately.
očesne spremembe, se takoj posvetujte z oftalmologom.
You
- Kinolonski antibiotiki lahko povzročijo večjo občutljivost vaše kože na sončno ali UV svetlobo.
should avoid prolonged exposure to sunlight or strong sunlight and should not use a sunbed or any other UV lamp while taking [Invented name].
Med jemanjem zdravila [izmišljeno ime] se morate izogibati daljšemu izpostavljanju sončni svetlobi ali močni sončni svetlobi in ne smete uporabljati solarija ali drugih UV svetilk.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines besides [Invented name], including medicines obtained without a prescription.
Jemanje drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
For [Invented name] be aware of the following:
Pri jemanju zdravila [izmišljeno ime] bodite pozorni:
- If you are taking [Invented name] and other medicines that affect your heart there is an
Če jemljete [izmišljeno ime] in druga zdravila, ki vplivajo na srce, obstaja zvečano tveganje za
increased risk for altering your heartbeat.
spremembe srčnega utripa.