natgillin/translations-raw huggingface dataset:
The Patient's Booklet should contain the following key messages: 
Brošura za bolnike mora vsebovati naslednja ključna sporočila:
Thymanax should not be used in children and adolescents (under 18 years old). 
Zdravilo Thymanax se ne sme uporabljati pri otrocih in mladostnikih (mlajših od 18 let).
If you stop taking Thymanax Do not stop taking your medicine without the advice of your doctor even if you feel better. 
Če ste prenehali jemati zdravilo Thymanax Ne prenehajte jemati zdravila brez zdravniškega nasveta, niti če se počutite bolje.
In healthy volunteers agomelatine preserved sexual function in comparison with paroxetine. 
Pri zdravih prostovoljcih se je ob jemanju agomelatin, v primerjavi s paroksetinom, ohranjala spolna funkcija.
9 DATE OF THE FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation : 19 February 2009 
Datum prve odobritve: 19. februar 2009
You must not use Thymanax if your liver does not work properly. 
Zdravila Thymanax ne smete jemati, če vaša jetra ne delujejo pravilno.
Thymanax should therefore not be used in these patients. 
Zdravila Thymanax se zato pri teh bolnikih ne sme uporabljati.
The expected benefits of Thymanax are to reduce and gradually remove the symptoms related to your depression. 
Pričakovane koristi zdravila Thymanax so zmanjšanje in postopna odprava simptomov, povezanih z depresijo.
Bipolar disorder/ mania / hypomania 
Bipolarna motnja / manija / hipomanija
[EU/1/08/498/002] 14 film-coated tablets [EU/1/08/498/003] 28 film-coated tablets [EU/1/08/498/005] 56 film-coated tablets [EU/1/08/498/006] 84 film-coated tablets [EU/1/08/498/007] 98 film-coated tablets [EU/1/08/498/008] 100 film-coated tablets 
[EU/1/08/498/002] 14 filmsko obloženih tablet [EU/1/08/498/003] 28 filmsko obloženih tablet [EU/1/08/498/005] 56 filmsko obloženih tablet [EU/1/08/498/006] 84 filmsko obloženih tablet [EU/1/08/498/007] 98 filmsko obloženih tablet [EU/1/08/498/008] 100 filmsko obloženih tablet
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Thymanax therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. 
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Thymanax, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
There were mild non dose dependent decreases in body weight related to the pharmacological properties and some minor effects on male reproductive tract without any impairment on reproductive performances. 
Prišlo je do blagih, od odmerka neodvisnih znižanj telesne mase, povezanih s farmakološkimi lastnostmi, in nekaj manjših učinkov na reproduktivni trakt pri samcih, brez okvare uspešnosti razmnoževanja.
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Thymanax, are provided with patient booklets to be distributed to their patients being prescribed this medicine. 
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo vsi zdravniki, ki bodo predvidoma predpisovali ali uporabljali zdravilo Thymanax, prejeli brošure za bolnike, da jih bodo razdelili svojim bolnikom, katerim bodo predpisali to zdravilo.
There is no data on the influence of race on agomelatine pharmacokinetics. 
Podatkov o vplivu etnične pripadnosti na farmakokinetiko agomelatina ni.
Based on the evaluation of these tests your doctor will decide whether you should receive or continue using Thymanax (see also under “How to take Thymanax” in section 3). 
Glede na rezultate preiskav se bo zdravnik odločil, ali boste prejeli oz. nadaljevali z jemanjem zdravila Thymanax (glejte tudi poglavje 3 »Kako jemati zdravilo Thymanax«).
How to switch from an antidepressant medicine (SSRI/SNRI) to Thymanax? 
Kako zamenjati antidepresiv iz skupine SSRI/SNRI z zdravilom Thymanax?
- alcohol use disorder and /or substantial alcohol intake and in patients receiving concomitant medicinal products associated with risk of hepatic injury. 
- motnja uporabe alkohola in/ali uživanje znatnih količin alkohola, ali pri bolnikih, ki sočasno jemljejo zdravila, ki jih spremlja tveganje za poškodbe jeter.
Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu/ 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu.
Treatment with Thymanax should only be prescribed after careful consideration of benefit and risk in patients with hepatic injury risk factors e.g.: 
Zdravljenje z zdravilom Thymanax lahko predpišete le po skrbnem pretehtanju koristi in tveganja pri bolnikih s prisotnimi dejavniki tveganja za poškodbo jeter, kot so npr.:
What Thymanax is and what it is used for What you need to know before you take Thymanax How to take Thymanax 
Kaj je zdravilo Thymanax in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Thymanax Kako jemati zdravilo Thymanax
5 How to store Thymanax Contents of the pack and other information 
Shranjevanje zdravila Thymanax Vsebina pakiranja in dodatne informacije
The Marketing Authorisation Holder shall ensure that at launch and after launch all physicians who are expected to prescribe or use Thymanax are provided with the updated educational material containing the following: 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo ob prihodu na trg in po prihodu na trg vsi zdravniki, ki predpisujejo ali uporabljajo zdravilo Thymanax, prejeli posodobljeno izobraževalno gradivo, ki vsebuje naslednje:
As a precautionary measure, it is preferable to avoid the use of Thymanax during pregnancy. 
Zaradi previdnosti se je uporabi zdravila Thymanax med nosečnostjo bolje izogniti.
Thymanax is used in adults. 
Zdravilo Thymanax se uporablja pri odraslih.
If Thymanax is initiated while tapering the dosage of the previous medicine, possible discontinuation symptoms should not be confounded with a lack of early effect of Thymanax. 
Če vam bodo zdravilo Thymanax uvedli že v času zmanjševanja odmerka prejšnjega zdravila, možnih odtegnitvenih simptomov ne smete zamenjati z odsotnostjo zgodnjega učinka zdravila Thymanax.
Thymanax can be taken with or without food. 
Zdravilo Thymanax lahko jemljete s hrano ali brez nje.
Be vigilant about signs and symptoms that your liver may not be working properly - If you observe any of these signs and symptoms of liver problems: unusual darkening of the urine, light coloured stools, yellow skin/eyes, pain in the upper right belly, unusual fatigue (especially associated with other symptoms listed above), seek urgent advice from a doctor who may advise you to stop taking Thymanax. 
Bodite pozorni na znake in simptome, ki kažejo na morebitno nepravilno delovanje vaših jeter - Če opazite katere koli znake in simptome težav z jetri: neobičajno temen urin, svetlo obarvanje blata, rumena koža/oči, bolečina v zgornjem desnem delu trebuha, neobičajna utrujenost (še posebno, če je povezana z drugimi simptomi, navedenimi zgoraj), nujno poiščite pomoč zdravnika, ki vam bo morda svetoval prenehanje zdravljenja z zdravilom Thymanax.
Thymanax is not recommended in the treatment of depression in patients under 18 years of age since safety and efficacy of Thymanax have not been established in this age group. 
Zdravilo Thymanax ni priporočljivo za zdravljenje depresije pri bolnikih, ki so mlajši od 18 let, ker varnosti in učinkovitosti zdravila Thymanax pri tej starostni skupini niso proučevali.
Thymanax film-coated tablets may be taken with or without food. 
Filmsko obložene tablete zdravila Thymanax lahko bolniki jemljejo s hrano ali brez nje.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicineThymanax. 
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
During your treatment with Thymanax : 
Med zdravljenjem z zdravilom Thymanax:
Some patients may get increased levels of liver enzymes in their blood during treatment with Thymanax. 
Pri nekaterih bolnikih se lahko vrednosti jetrnih encimov med jemanjem zdravila Thymanax zvišajo.
Thymanax starts to act on symptoms of depression in most depressed people within two weeks of starting treatment. 
Pri večini bolnikov zdravilo Thymanax začne zmanjševati simptome depresije v dveh tednih po začetku zdravljenja.
If you have taken more Thymanax than you should, or if for example a child has taken medicine by accident, contact your doctor immediately. 
Če ste vzeli večji odmerek zdravila Thymanax, kot bi smeli Če ste vzeli večji odmerek zdravila Thymanax, kot bi smeli, ali če je na primer zdravilo nehote vzel otrok, takoj obvestite svojega zdravnika.
Other medicines and Thymanax 
Druga zdravila in zdravilo Thymanax
If you forget to take Thymanax 
Če ste pozabili vzeti zdravilo Thymanax
- If you have increased levels of liver enzymes before treatment, your doctor will decide if Thymanax is right for you. 
- Če imate pred zdravljenjem zvišane vrednosti jetrnih encimov, bo vaš zdravnik odločil, ali je zdravilo Thymanax primerno za vas.
INFORMATION IN BRAILLE Thymanax 25 mg 
PODATKI V BRAILLOVI PISAVI Thymanax 25 mg
Thymanax should not be used for the treatment of major depressive episodes in elderly patients with dementia since the safety and efficacy of Thymanax have not been established in these patients. 
Uporaba pri starejših z demenco Zdravila Thymanax ne smete predpisovati za zdravljenje velikih depresivnih epizod pri starejših bolnikih z demenco, ker varnosti in učinkovitosti zdravila Thymanax pri tovrstnih bolnikih niso proučevali.
• lactose monohydrate, maize starch, povidone (K30), sodium starch glycolate type A, stearic acid, magnesium stearate, colloidal anhydrous silica,hypromellose, glycerol, macrogol (6000), yellow iron oxide (E172) and titanium dioxide (E171). 
- Pomožne snovi so: laktoza monohidrat, koruzni škrob, povidon (K30), natrijev karboksimetilškrob (vrsta A), stearinska kislina, magnezijev stearat, brezvoden koloidni silicijev dioksid, hipromeloza, glicerol, makrogol (6000), rumeni železov oksid (E172) in titanov dioksid (E171);
Following discontinuation of Thymanax therapy liver function tests should be repeated until serum transaminases return to normal. 
Po prekinitvi zdravljenja z zdravilom Thymanax morate delovanje jeter pregledovati dokler se aminotransferaze v serumu ne vrnejo na normalne vrednosti.
These symptoms may also be due to the underlying disease (see section 4.4). 
Ta simptoma sta lahko prisotna tudi kot posledica osnovne bolezni (glejte poglavje stanje zmedenosti*
Thymanax should be used with caution in patients with a history of bipolar disorder, mania or hypomania and should be discontinued if a patient develops manic symptoms (see section 4.8). 
Pri bolnikih z bipolarno motnjo, manijo ali hipomanijo v anamnezi morate zdravilo Thymanax uporabljati previdno in zdravljenje prekiniti, če se pri bolniku razvijejo simptomi manije (glejte poglavje 4.8).
Your doctor may continue to give you Thymanax when you are feeling better to prevent your depression from returning. 
Zdravnik vam bo morda predpisoval zdravilo Valdoxan tudi še potem, ko se boste že počutili bolje, da bi preprečil ponovitev depresije.
Effect of Thymanax is not documented in patients aged 75 years and older. 
Učinka zdravila Thymanax pri bolnikih starih 75 let in več niso dokazali.
Thymanax is indicated for the treatment of major depressive episodes in adults. 
4.1 Terapevtske indikacije Zdravilo Thymanax je indicirano za zdravljenje velikih depresivnih epizod pri odraslih.
If your doctor changes your previous antidepressant medicine from an SSRI or SNRI to Thymanax, he/she will advise you on how you should discontinue your previous medicine when starting Thymanax. 
Če vam bo zdravnik zamenjal vaš prejšnji antidepresiv iz skupine SSRI ali SNRI z zdravilom Thymanax, vam bo ob uvedbi zdravila Thymanax svetoval o ustreznem načinu prenehanja zdravljenja s prejšnjim zdravilom.
Thymanax with alcohol 
Zdravilo Thymanax skupaj z alkoholom
Do not take Thymanax - if you are allergic to agomelatine or any of the other ingredients of this medicine (listed in section 
Kaj morate vedeti, preden boste vzeli zdravilo Thymanax Ne jemljite zdravila Thymanax - če ste alergični na agomelatin ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
No evidence of pharmacokinetic or pharmacodynamic interaction with medicinal products which could be prescribed concomitantly with Thymanax in the target population was found in phase I clinical trials: benzodiazepines, lithium, paroxetine, fluconazole and theophylline. 
V kliničnih preskušanjih faze I niso opazili dokazov o farmakokinetičnem ali famakodinamičnem medsebojnem delovanju zdravila Thymanax z zdravili, ki jih sočasno predpisujemo pri ciljni skupini bolnikov: benzodiazepini, litijem, paroksetinom, flukonazolom in teofilinom.
Available pharmacodynamic/toxicological data in animals have shown excretion of agomelatine/metabolites in milk (see section 5.3). 
toksikološki podatki pri živalih kažejo na izločanje agomelatina/presnovkov v mleko ( glejte poglavje 5.3).
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Servier (Ireland) Industries Ltd, 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Servier (Ireland) Industries Ltd,
You should not take Thymanax together with certain medicines (see also under “Do not take Thymanax” in section 2): fluvoxamine (another medicine used in the treatment of depression), ciprofloxacin (an antibiotic) can modify the expected dose of agomelatine in your blood. 
Thymanax« v poglavju 2): fluvoksamin (še enim zdravilom za zdravljenje depresije), ciprofloksacin (antibiotikom) lahko spremenita pričakovani odmerek agomelatina v krvi.
What Thymanax contains - The active substance is agomelatine. 
Kaj vsebuje zdravilo Thymanax - Učinkovina je agomelatin.
What Thymanax looks like and contents of the pack Thymanax 25 mg film-coated tablets (tablet) are oblong, orange-yellow with a blue imprint of ‘company logo' 
Izgled zdravila Thymanax in vsebina pakiranja Thymanax 25 mg filmsko obložene tablete (tablete) so podolgovate, oranžnorumene z modrim odtisom (logotip podjetja) na eni strani.
- Uncommon side effects (may affect up to 1 in 100 people): migraine, pins and needles in the fingers and toes (paraesthesia), blurred vision, restless legs syndrome (a disorder that is characterized by an uncontrollable urge to move the legs), ringing in the ears, excessive sweating (hyperhidrosis), eczema, pruritus, urticaria (hives), agitation, irritability, restlessness, aggressive behaviour, nightmares, mania/hypomania (see also under “Warnings and precautions” in section 2), suicidal thoughts or behaviour,confusion, weight decreased. 
- Občasni neželeni učinki (lahko se pojavijo pri največ 1 od 100 bolnikov): migrena, mravljinčenje in zbadanje v prstih na rokah ter nogah (parestezije), zamegljen vid, sindrom nemirnih nog (motnja za katero je značilna nenadzorovana nuja po premikanju nog), zvonjenje v ušesih, prekomerno znojenje (hiperhidroza), ekcemi, srbenje, urtikarija (koprivnica), vznemirjenost, razdraženost, nemir, napadalno vedenje, nočne more, manija/hipomanija (glejte tudi »Opozorila in previdnostni ukrepi« v poglavju 2), razmišljanje o samomoru in samomorilno obnašanje, zmedenost, zmanjšanje telesne mase.
- If you are suffering from dementia, your doctor will make an individual evaluation of whether it is right for you to take Thymanax. 
- Če imate demenco, bo vaš zdravnik individualno presodil, ali je za vas zdravljenje z zdravilom Thymanax primerno.
Caution should be exercised when Thymanax is administered to patients with pretreatment elevated transaminases (> the upper limit of the normal ranges and ≤3 times the upper limit of the normal range). 
• Previdnost je potrebna pri predpisovanju bolnikom z zvišanimi vrednostmi aminotransferaz pred zdravljenjem (> zgornjo mejo normalnih vrednosti in ≤ 3-kratno zgornjo mejo normalnih vrednosti);
NAME OF THE MARKETING AUTHORISATION HOLDER Servier (Ireland) Industries Ltd 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Servier (Ireland) Industries Ltd
Consequently, co-administration of Thymanax with potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) is contraindicated. 
Sočasno jemanje agomelatina z močnimi zaviralci CYP1A2 (npr. fluvoksaminom in ciprofloksacinom) je zato kontraindicirano.
Thymanax contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'. 
Zdravilo Valdoxan vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni ‘brez natrija'.
How to take THYMANAX 
Kako jemati zdravilo Thymanax
Experience with agomelatine in overdose has indicated that epigastralgia, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis or malaise have been reported. 
Pri izkušnjah s prevelikim odmerjanjem agomelatina so poročali o bolečini v epigastričnem predelu, somnolenci, utrujenosti, agitaciji, anksioznosti, napetosti, omotici, cianozi in občutku slabosti.
• printing ink : shellac, propylene glycol and indigo carmine aluminium lake (E132) 
črnilo: šelak, propilenglikol in indigotin (E132).
Caution should be exercised when prescribing Thymanax with moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin) which may result in increased exposure of agomelatine. 
Pri sočasnem predpisovanju zdravila Thymanax z zmernimi zaviralci CYP1A2 (npr. propranololom, enoksacinom) morate biti previdni, saj se lahko zveča izpostavljenost agomelatinu.
Marketing Authorisation Holder Servier (Ireland) Industries Ltd Gorey road, Arklow, Co. Wicklow Ireland 
IMETNIK DOVOLJENJA ZA PROMET Servier (Ireland) Industries Ltd Gorey Road, Arklow, Co. Wicklow Irska
These side effects include: - Very common side effects (may affect more than 1 in 10 people) :headache - Common side effects (may affect up to 1 in 10 people): dizziness, sleepiness (somnolence), difficulty in sleeping (insomnia), feeling sick (nausea), diarrhoea, constipation, abdominal pain, back pain, tiredness, anxiety, abnormal dreams, increased levels of liver enzymes in your blood, vomiting, weight increased. 
- Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov): omotica, zaspanost (somnolenca), težave s spanjem (nespečnost), siljenje na bruhanje (navzea), driska, zaprtje, bolečine v trebuhu, bolečine v hrbtu, utrujenost, tesnoba, nenormalne sanje, zvišana vrednost jetrnih encimov v krvi, bruhanje, povečanje telesne mase.
The experience of overdoses with Thymanax is limited but reported symptoms include pain in the upper part of the stomach, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis or malaise. 
Izkušnje s prevelikim odmerjanjem zdravila Thymanax so omejene, poročali pa so o simptomih, kot so bolečine v zgornjem delu želodca, zaspanost, utrujenost, razdraženost, zaskrbljenost, napetost,
If you have trouble with your kidneys, your doctor will make an individual evaluation of whether it is safe for you to take Thymanax. 
Če imate težave z ledvicami, bo zdravnik individualno presodil, ali je za vas zdravljenje z zdravilom
It is not advisable to drink alcohol while you are being treated with Thymanax. 
Med zdravljenjem z zdravilom Thymanax ni priporočljivo piti alkohola.
Thymanax contains lactose. 
Zdravilo Thymanax vsebuje laktozo.
You have been given Thymanax to treat your depression. 
Zdravnik vam ga je predpisal za zdravljenje depresije.
Thymanax 25 mg film-coated tablets agomelatine 
Thymanax 25 mg filmsko obložene tablete agomelatin
Thymanax contains lactose 
Zdravilo Thymanax vsebuje laktozo
Warnings and precautions There could be some reasons why Thymanax may not be suitable for you: 
V nekaterih primerih zdravilo Thymanax ni primerno za vas:
During treatment period Thymanax treatment should be discontinued immediately if: ‐ patient develops symptoms or signs of potential liver injury (such as dark urine, light coloured stools, yellow skin/eyes, pain in the upper right belly, sustained new-onset and unexplained fatigue). 
Med zdravljenjem Zdravljenje z zdravilom Thymanax je treba takoj prekiniti: ‐ če se pri bolniku pojavijo simptomi ali znaki možne poškodbe jeter (kot je temen urin,
How to store Thymanax 
Shranjevanje zdravila Thymanax
The calendar printed on the blister containing the tablets should help you remembering when you last took a tablet of Thymanax. 
Da ne bi pozabili, kdaj ste nazadnje vzeli tableto zdravila Thymanax, si lahko pomagate s koledarčkom, natisnjenim na pretisnem omotu s tabletami.
NAME OF THE MEDICINAL PRODUCT Thymanax 25 mg tablets agomelatine 
IME ZDRAVILA Thymanax 25 mg tablete agomelatin
The recommended dose of Thymanax is one tablet (25 mg) at bedtime. 
Običajen odmerek je ena tableta (25 mg) zdravila Thymanax pred spanjem.
Breastfeeding should be discontinued if you take Thymanax. 
Če jemljete zdravilo Thymanax, morate prenehati z dojenjem.
Thymanax 25 mg film-coated tablets are available in calendar blisters. 
Thymanax 25 mg filmsko obložene tablete so na voljo v koledarskih pretisnih omotih po 14, 28, 56,
1 NAME OF THE MEDICINAL PRODUCT Thymanax 25 mg film-coated tablets 
IME ZDRAVILA Thymanax 25 mg filmsko obložene tablete
You should discuss with your doctor on the best way of stopping your previous antidepressant medicine when starting Thymanax. 
Ob začetku zdravljenja z zdravilom Thymanax se morate posvetovati z zdravnikom o najboljšem možnem načinu prenehanja jemanja prejšnjega antidepresiva.
Thymanax is for oral use. 
Zdravilo Thymanax jemljite peroralno.
Servier Pharma SRL Tel: +4 021 528 52 80 
Tel: +4 021 528 52 80
Latvija SIA Servier Latvia 
România Servier Pharma SRL
(picture 6). 
(slika 4).
E-mail: info@dompe.com 
E-pošta: info@dompe.com
Week 4 Week 8 Week 4 Week 8 
4. teden 8. teden 4. teden 8. teden
It may harm them, 
Ko je nastavek za vialo pravilno nameščen,
• sensitivity to light; 
• občutljivost na svetlobo,
However, no dose adjustment is considered necessary in these populations. 
Kljub temu pri teh populacijah predvidoma ni potrebna prilagoditev odmerka.
The majority of side effects occur generally in and around the eyes. 
Na splošno se večina neželenih učinkov pojavi v očeh in okoli njih.
Patients should be instructed to wash their hands before use. 
Bolnikom je treba naročiti, da si pred uporabo zdravila umijejo roke.
The safety and efficacy of this medicinal product in children and adolescents below the age of 18 years have not been established. 
Varnost in učinkovitost tega zdravila pri otrocih in mladostnikih, starih do 18 let, nista bili dokazani.
This medicine should not be used in children and adolescents below 18 years of age, as there is not enough information about its use in this age group. 
Tega zdravila se pri otrocih in mladostnikih, starih do 18 let, ne sme uporabljati, saj ni dovolj podatkov o uporabi pri tej starostni skupini.
• abnormal sensation and discomfort in the eye, including feeling that there is something in the eye; 
• nenormalen občutek in neugodje v očesu, vključno z občutkom, da imate nekaj v očesu,
The use of this medicine should be avoided during pregnancy. 
Treba se je izogibati uporabi tega zdravila med nosečnostjo.
From a microbiological point of view, the method of opening (i.e. by connecting the vial adapter to the vial) precludes the risk of microbial contamination. 
Z mikrobiološkega vidika način odpiranja (tj. z namestitvijo nastavka za vialo na vialo) preprečuje tveganje za mikrobiološko kontaminacijo.
Contact lenses could interfere with the correct use of this medicine. 
Kontaktne leče bi lahko ovirale pravilno uporabo tega zdravila.
Fax +39 02 58383215 
Faks: +39 02 58383215
For instructions on preparation and handling of the medicinal product before administration, see section 6.6. 
Za navodila glede priprave in ravnanja s tem zdravilom pred dajanjem glejte poglavje 6.6.
pH 7.0-7.4 and osmolarity 280-320 mOsm/kg. 
Vrednost pH 7,0-7,4 in osmolarnost 280-320 mOsm/kg.
Pull down the lower eyelid. 
Povlecite spodnjo veko navzdol.
20122 Milano - Italy Tel. +39 02 583831 
20122 Milano - Italija Tel.: +39 02 583831
Using more OXERVATE than is recommended is not likely to be harmful. 
Uporaba večje količine zdravila OXERVATE od priporočene verjetno ni škodljiva.