natgillin/translations-raw huggingface dataset:
What measures are being taken to ensure the safe and effective use of Hetlioz?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Hetlioz?
Improved results were seen in a subset of patients after 7 months of treatment, which indicate that patients may take weeks or months to respond.
Boljše rezultate so opazili pri podskupini bolnikov po sedmih mesecih zdravljenja, kar kaže na to, da lahko včasih traja več tednov ali mesecev, da se bolniki odzovejo.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Hetlioz's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Hetlioz večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Hetlioz.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Hetlioz.
In the second study, 57 patients first received Hetlioz for around 11 weeks.
V drugi študiji je 57 bolnikov sprva prejemalo zdravilo Hetlioz približno 11 tednov.
The medicine should be taken without food.
Zdravilo Hetlioz je treba jemati brez hrane.
Hetlioz is intended for long-term use.
Zdravilo Hetlioz je namenjeno dolgotrajni uporabi.
These are usually mild or moderate in severity and temporary.
Ti neželeni učinki so po resnosti navadno blagi ali zmerni in so prehodni.
The most common side effects with Hetlioz (which may affect more than 3 in 100 people) are headache, somnolence, nausea (feeling sick) and dizziness.
Najpogostejši neželeni učinki zdravila Hetlioz (ki lahko prizadenejo več kot 3 osebe od 100) so glavobol, somnolenca (bolezenska zaspanost), navzeja (slabost) in omotica.
The main measure of effectiveness was the percentage of patients who were able to adjust to the 24-hour clock, which was calculated by looking at how the amount of melatonin breakdown products changed in the patient's urine over time.
Glavno merilo učinkovitosti je bil odstotek bolnikov, ki so se uspeli prilagoditi na 24-urni dan, kar so izračunali s pomočjo določanja, kako se je količina produktov razgradnje melatonina v urinu bolnikov spreminjala s časom.
The summary of the opinion of the Committee for Orphan Medicinal Products for Hetlioz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Hetlioz je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Hetlioz is available as 20 mg capsules and can only be obtained with a prescription.
Zdravilo Hetlioz je na voljo v obliki 20-miligramskih kapsul in se izdaja le na recept.
Other information about Hetlioz
Druge informacije o zdravilu Hetlioz
What benefits of Hetlioz have been shown in studies?
Kakšne koristi je zdravilo Hetlioz izkazalo v študijah?
The CHMP noted that only around 20% of patients would be able to benefit from treatment with Hetlioz, but in view of the lack of approved treatments for non-24-hour sleep-wake disorder, which is a debilitating condition, this modest response was still considered important.
Odbor CHMP je izpostavil, da bi imelo od zdravljenja z zdravilom Hetlioz korist le približno 20 % bolnikov, vendar pa je z vidika pomanjkanja odobrenih zdravljenj za motnjo ne-24-urnega cikla spanja in budnosti, ki je izčrpavajoča motnja, ta skromen odziv še vedno pomemben.
A risk management plan has been developed to ensure that Hetlioz is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Hetlioz je bil pripravljen načrt obvladovanja tveganj.
In people with normal perception of light and dark, melatonin is produced in hours of darkness and promotes sleep by acting on melatonin receptors in specific areas of the brain.
Pri osebah z normalnim zaznavanjem svetlobe in teme se melatonin tvori v času teme in spodbuja spanje z delovanjem na melatoninske receptorje v določenih delih možganov.
Non-24hour sleep-wake disorder is a condition that occurs almost exclusively in people who are completely blind, where patients have sleep patterns that are not synchronised with day and night and often follow a cycle that is longer than the standard 24-hour clock.
Ne-24-urni cikel spanja in budnosti je motnja, ki se pojavlja skoraj izključno pri popolnoma slepih osebah in pri kateri imajo bolniki vzorce spanja, ki niso usklajeni z dnevom in nočjo ter pogosto sledijo ciklu, daljšemu od standardnega 24-urnega dneva.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Hetlioz, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What are the risks associated with Hetlioz?
Kakšna tveganja so povezana z zdravilom Hetlioz?
A hormone called melatonin plays a key role in co-ordinating the body's sleep-wake cycle.
Hormon, imenovan melatonin, ima ključno vlogo pri usklajevanju cikla spanja in budnosti v telesu.
For more information about treatment with Hetlioz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Hetlioz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Regarding safety, Hetlioz was shown to be well tolerated, causing only few mild side effects.
V zvezi z varnostjo se je izkazalo, da bolniki zdravilo Hetlioz dobro prenašajo in da je povzročilo le nekaj blagih neželenih učinkov.
The active substance in Hetlioz, tasimelteon, acts on the same receptors as melatonin to promote sleep and regulate sleep patterns.
Zdravilna učinkovina v zdravilu Hetlioz, tasimelteon, deluje na iste receptorje kot melatonin ter tako spodbuja spanje in ureja spalne vzorce.
The full EPAR and risk management plan summary for Hetlioz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Hetlioz sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is not intended to provide practical advice on how to use Hetlioz.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Why is Hetlioz approved?
Zakaj je bilo zdravilo Hetlioz odobreno?
For practical information about using Hetlioz, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Hetlioz naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The first study, which involved a total of 84 totally blind patients with non-24-hour sleep-wake disorder, compared Hetlioz with placebo (a dummy treatment).
V prvi študiji, ki je vključevala skupno 84 popolnoma slepih bolnikov z ne-24-urnim ciklom spanja in budnosti, so zdravilo Hetlioz primerjali s placebom (zdravilom brez zdravilne učinkovine).
Of the 10 patients who remained on Hetlioz, 9 people remained adjusted to 24-hour clock at the end of the study, compared with 2 of the 10 patients who were switched to placebo.
Od 10 bolnikov, ki so še naprej prejemali zdravilo Hetlioz, jih je ob koncu študije devet ostalo prilagojenih na 24-urni dan, v primerjavi z dvema od 10 bolnikov, ki so prejemali placebo.
What is Hetlioz and what is it used for?
Kaj je zdravilo Hetlioz in za kaj se uporablja?
By taking it at a suitable time each day it can help to reset the sleep-wake cycle to more standard timing.
Z vsakodnevnim jemanjem ob ustreznem času lahko to zdravilo pomaga cikel spanja in budnosti uskladiti z običajnejšim časovnim razporedom.
For the full list of all side effects and restrictions with Hetlioz, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Hetlioz glejte navodilo za uporabo.
Because the number of patients with non-24-hour sleep-wake disorder is low, the disease is considered ‘rare', and Hetlioz was designated an ‘orphan medicine' (a medicine used in rare diseases) on 23 February 2011.
Ker je bolnikov z motnjo ne-24-urnega cikla spanja in budnosti malo, velja ta bolezen za redko, zato je bilo zdravilo Hetlioz 23. februarja 2011 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Hetlioz has been shown to be effective at helping patients adjust to the standard 24-hour clock in 2 main studies.
Zdravilo Hetlioz se je izkazalo kot učinkovito v dveh glavnih študijah, v katerih je pomagalo bolnikom pri prilagajanju na standardni 24-urni dan.
Hetlioz is a medicine used to treat totally blind adults with non-24-hour sleep-wake disorder.
Hetlioz je zdravilo, ki se uporablja za zdravljenje ne-24-urnega cikla spanja in budnosti pri popolnoma slepih odraslih.
Hetlioz contains the active substance tasimelteon.
Zdravilo Hetlioz vsebuje zdravilno učinkovino tasimelteon.
Those patients who were able to adjust to the 24-hour clock (20 patients in total) were then given Hetlioz or placebo for a further 8 weeks to study how well the effect of Hetlioz was maintained.
Bolniki, ki so se uspešno prilagodili na 24-urni dan (skupno 20 bolnikov), so nadaljnjih osem tednov prejemali zdravilo Hetlioz ali placebo z namenom ugotavljanja trajanja učinka zdravljenja z zdravilom Hetlioz.
20% of patients who received Hetlioz (8 out of 40) were able to adjust to the 24-hour clock after 1 months of treatment, compared with around 3% of patients on placebo (1 out of 38).
Na 24-urni dan se je po enem mesecu zdravljenja uspešno prilagodilo 20 % (8 od 40) bolnikov, ki so prejemali zdravilo Hetlioz , v primerjavi s približno 3 % (1 od 38) bolnikov, ki so prejemali placebo.
How is Hetlioz used?
Kako se zdravilo Hetlioz uporablja?
How does Hetlioz work?
Kako zdravilo Hetlioz deluje?
This summary was last updated in 01-2012.
Povzetek je bil nazadnje posodobljen 01-2012.
It must also not be used in the following groups:
Prav tako ga ne smejo uporabljati naslednje skupine bolnikov:
The main measure of effectiveness was how long the patients lived.
Glavno merilo učinkovitosti je bil čas preživetja bolnikov.
The recommended dose for one cycle of treatment is 25 mg/m2 twice a day (in the morning and evening) for three weeks, followed by a one-week rest period.
Priporočeni odmerek za en cikel zdravljenja je 25 mg/m2 dvakrat na dan (zjutraj in zvečer) tri tedne, čemur sledi en teden premora.
As a result, it prevents the growth of cancer cells and eventually kills them.
Posledica tega je, da zavira rast tumorskih celic in jih nazadnje tudi uniči.
Teysuno capsules are taken with water at least one hour before or after a meal.
Kapsule zdravila Teysuno se jemljejo z vodo vsaj eno uro pred obrokom ali po njem.
• pregnant or breast-feeding women;
• noseče ali doječe ženske;
• patients who should not be receiving cisplatin.
• bolniki, ki ne smejo prejemati cisplatina.
The European Commission granted a marketing authorisation valid throughout the European Union for Teysuno on 14 March 2011.
Evropska komisija je dovoljenje za promet z zdravilom Teysuno, veljavno po vsej Evropski uniji, odobrila dne 14. marca 2011.
The full EPAR for Teysuno can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Teysuno je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Both medicines were given with cisplatin.
Obe zdravili so dajali skupaj s cisplatinom.
• patients with a deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD) as well as patients who, within the previous four weeks, have been treated with a medicine that inhibits this enzyme;
• bolniki s pomanjkanjem encima dihidropirimidin dehidrogenaza (DPD) ter bolniki, ki so bili pretekle štiri tedne zdravljeni z zdravilom, ki zavira ta encim;
It is used in combination with cisplatin (another anticancer medicine).
Uporablja se v kombinaciji s cisplatinom (drugim zdravilom proti raku).
It is available as capsules containing 15 mg tegafur with 4.35 mg gimeracil and 11.8 mg oteracil, and as capsules containing 20 mg tegafur with 5.8 mg gimeracil and 15.8 mg oteracil.
Na voljo je v kapsulah, ki vsebujejo 15 mg tegafurja s 4,35 mg gimeracila in 11,8 mg oteracila, ter kapsulah, ki vsebujejo 20 mg tegafurja s 5,8 mg gimeracila in 15,8 mg oteracila.
• patients with severe kidney problems requiring dialysis;
• bolniki s hudimi ledvičnimi težavami, ki potrebujejo dializo;
The CHMP decided that Teysuno's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor CHMP je zaključil, da so koristi zdravila Teysuno večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
This is a summary of the European public assessment report (EPAR) for Teysuno.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Teysuno.
The cycle is repeated every four weeks, including once cisplatin administration is stopped after six cycles.
Ta cikel zdravljenja se ponovi vsake štiri tedne, tudi ko se zdravljenje s cisplatinom po šestih ciklih prekine.
Tegafur is a ‘prodrug' that is converted in the body to a chemical called 5-fluorouracil (5-FU).
Tegafur je „predzdravilo“, ki se v telesu pretvori v kemično snov, imenovano 5-fluorouracil (5-FU).
Treatment with Teysuno capsules was as effective as treatment with 5-FU infusions.
Zdravljenje s kapsulami zdravila Teysuno je bilo enako učinkovito kot zdravljenje z infuzijami 5-FU.
The dose to be taken is calculated based on the active substance tegafur and the patient's body surface area (calculated using the patient's height and weight).
Odmerek zdravila se izračuna na podlagi zdravilne učinkovine tegafur in bolnikove telesne površine (izračunane na podlagi bolnikove višine in telesne mase).
Teysuno must not be used in people who are hypersensitive (allergic) to any of the active substances or any of the other ingredients.
Zdravila Teysuno ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) katero koli zdravilno učinkovino ali katero koli drugo sestavino zdravila.
5-FU is similar to pyrimidine, a substance found in the genetic material of cells (DNA and RNA).
5-FU je podoben pirimidinu, tj. snovi, ki je prisotna v genetskem materialu celic (DNK in RNK).
What benefit has Teysuno shown during the studies?
Kakšne koristi je zdravilo Teysuno izkazalo med študijami?
Patients receiving Teysuno with cisplatin lived for an average of 8.6 months compared with 7.9 months for patients receiving 5-FU with cisplatin.
Bolniki, ki so prejemali zdravilo Teysuno skupaj s cisplatinom, so v povprečju živeli 8,6 meseca, bolniki, ki so prejemali 5-FU s cisplatinom, pa 7,9 meseca.
Teysuno is a medicine that contains the active substances tegafur, gimeracil and oteracil.
Teysuno je zdravilo, ki vsebuje zdravilne učinkovine tegafur, gimeracil in oteracil.
The two other active substances in Teysuno allow tegafur to be effective at lower doses and with fewer side effects: gimeracil by preventing the breakdown of 5-FU and oteracil by reducing the activity of 5FU in normal, non-cancerous tissue in the gut.
Drugi dve zdravilni učinkovini v zdravilu Teysuno omogočata učinkovitost tegafurja tudi pri manjših odmerkih in z manj neželenimi učinki: gimeracil s preprečevanjem razgrajevanja 5-FU in oteracil z zmanjševanjem delovanja 5-FU v normalnem, nerakavem tkivu prebavil.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Teysuno.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Teysuno, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Other information about Teysuno
Druge informacije o zdravilu Teysuno:
Teysuno is used together with cisplatin, in a 4-week cycle starting on the day of the cisplatin administration.
Zdravilo Teysuno se uporablja skupaj s cisplatinom v štiritedenskem ciklu, ki se začne na dan uporabe cisplatina.
In the main study, Teysuno was compared with the anticancer medicine 5-FU given as an infusion in 1,053 adults with advanced gastric cancer.
V glavni študiji so zdravilo Teysuno primerjali z zdravilom proti raku 5-FU, ki se je dajalo kot infuzija, pri 1 053 bolnikih z napredovalim rakom želodca.
• patients with severe leucopenia, neutropenia, or thrombocytopenia (low levels of white cells or platelets in the blood);
• bolniki s hudo levkopenijo, nevtropenijo ali trombocitopenijo (nizkimi ravnmi belih krvnih celic ali trombocitov v krvi),
For more information about treatment with Teysuno, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Teysuno preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What is the risk associated with Teysuno?
Kakšna tveganja so povezana z zdravilom Teysuno?
Teysuno should only be prescribed by a qualified doctor experienced in treating cancer patients with anticancer medicines.
Zdravilo Teysuno sme predpisati le usposobljen zdravnik, ki ima izkušnje z uporabo zdravil proti raku pri rakavih bolnikih.
The main active substance in Teysuno, tegafur, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the ‘anti-metabolites' group.
Zdravilna učinkovina zdravila Teysuno, tegafur, je citotoksik (zdravilo, ki uniči celice, ki se delijo, kot na primer rakave celice) iz skupine antimetabolitov.
For the full list of all side effects reported with Teysuno, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Teysuno, glejte navodilo za uporabo.
Why has Teysuno been approved?
Zakaj je bilo zdravilo Teysuno odobreno?
In patients treated with Teysuno in combination with cisplatin, the most common severe side effects (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts) and fatigue (tiredness).
Najpogostejši hudi neželeni učinki (opaženi se pri več kot 1 od 10 bolnikov) pri bolnikih, ki so se zdravili z zdravilom Teysuno v kombinaciji s cisplatinom, so nevtropenija (nizka raven nevtrofilcev, vrste belih krvnih celic), anemija (majhno število rdečih krvničk) in utrujenost.
Teysuno is used to treat adults with advanced gastric (stomach) cancer.
Zdravilo Teysuno se uporablja za zdravljenje odraslih z napredovalim rakom želodca.
In the body, 5-FU takes the place of pyrimidine and interferes with the enzymes involved in making new DNA.
V telesu zavzame mesto pirimidina in ovira encime, ki sodelujejo pri tvorjenju nove DNK.
For more information on the use of Teysuno, including how to use it with cisplatin, see the summary of product characteristics (also part of the EPAR).
Za več informacij o uporabi zdravila Teysuno glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
• patients currently receiving another fluoropyrimidine (a group of anticancer medicines that includes
• bolniki, ki trenutno prejemajo drugi fluoropirimidin (skupino zdravil proti raku, v kateri je tudi zdravilo Teysuno) ali ki so imeli hude in nepričakovane reakcije na fluoropirimidine;
What is Teysuno used for?
Za kaj se zdravilo Teysuno uporablja?
How does Teysuno work?
Kako zdravilo Teysuno deluje?
What is Teysuno?
Kaj je zdravilo Teysuno?
How has Teysuno been studied?
Kako je bilo zdravilo Teysuno raziskano?
How is Teysuno used?
Kako se zdravilo Teysuno uporablja?
Allergic reactions to these substances may occasionally be serious.
Alergične reakcije na te snovi so občasno lahko resne.
Do not use in dogs and cats less than 8 weeks old.
Ne uporabite pri psih in mačkah, mlajših od 8 tednov.
(periodontal 2008)
(periodontalna 2008)
ATCvet code: QJ01DD91.
Oznaka ATCvet: QJ01DD91.
4.8 Interaction with other medicinal products and other forms of interaction
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
For the full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
(See also Section 12 ‘Special Warnings - For the animal'.)
(Glejte tudi poglavje 12 » Posebna opozorila - za živali«)
were 2.3 %, 2.7 %, 3.1 % and 1.4 %,
so bili 2,3 %, 2,7 %, 3,1 % in 1,4 %.
(e.g. S. xylosus, S. schleiferi, S. epidermidis) is 9.5 %.
(npr. S. xylosus, S. schleiferi, S. epidermidis) je 9,5 %.
Do not use in small herbivores (including guinea pigs and rabbits).
Ne uporabite pri malih rastlinojedih (vključno z morskimi prašički in zajci).
Do not freeze.
Zdravilo ne sme zmrzniti.
For use only for the following infections which require prolonged treatment.
Za uporabo samo pri naslednjih infekcijah, ki zahtevajo podaljšano zdravljenje.
Periodontal isolates were collected during a European (France and Belgium) clinical efficacy and safety field study (2008).
Izolati periodontalnih obolenj so bili zbrani med evropsko (Francija in Belgija) terensko študijo klinične učinkovitosti in varnosti (2008).
Veterinarians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.
Veterinarji se morajo zavedati, da se alergični simptomi lahko ponovno pojavijo po prekinitvi simptomatske terapije.
Elimination half-life is long - approximately 5.5 days.
Razpolovna doba izločanja je dolga - približno 5,5 dni.
(See also Section 4.5 ‘Special Precautions for Use'.)
(Glejte poglavje 4.5 »Posebni varnostni ukrepi«).
Elimination half-life is long - approximately 6.9 days.
Razpolovna doba izločitve je dolga - približno 6,9 dni.
As with other cephalosporins, the colour of the reconstituted solution may darken during this period.
Kot pri ostalih cefalosporinih, barva rekonstituirane raztopine med tem obdobjem lahko potemni.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.
Zdravilo naj bi uporabili na osnovi testov občutljivosti in upoštevali lokalno protimikrobno politiko.
Store in the original package in order to protect from light (before and after reconstitution).
Shranjujte v originalni ovojnini, da se zaščiti pred svetlobo (pred rekonstitucijo in po njej).
Cefovecin is primarily eliminated unchanged via the kidneys.
Cefovecin se primarno izloča nespremenjen skozi ledvice.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili za uporabo v veterinarski medicini.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
Handle this product with care to avoid exposure, taking all recommended precautions.
Z zdravilom ravnajte previdno, da se izognete izpostavljanju, in upoštevajte vsa priporočena opozorila.
Dogs and cats.
Psi in mačke.
If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning.
Če se po izpostavljanju pojavijo simptomi, kot je kožni izpuščaj, obiščite zdravnika ter mu pokažite to opozorilo.