natgillin/translations-raw huggingface dataset:
A slight increase in rectal temperature, of up to 1.2 °C for 4 days, may affect up to 1 in 10 animals following vaccination.
Do štiri dni po cepljenju se lahko pojavi rahlo povišanje rektalne temperature za največ 1,2 °C pri največ 1 živali od 10.
If someone is accidentally injected with this product, they must seek medical advice immediately even if only a very small amount is injected.
V primeru nenamernega injiciranja cepiva je treba nemudoma poiskati zdravniško pomoč, četudi je bila morda injicirana zelo majhna količina.
The vaccine is given to cattle and sheep as an injection under the skin whilst for pigs the injection is given into a muscle.
Cepivo se govedu in ovcam injicira pod kožo, medtem ko se prašičem injicira v mišico.
In addition, studies in published papers were provided, which examined the effect of vaccination in cattle, sheep, and pigs.
Predložene so bile tudi študije iz objavljenih člankov, v katerih so proučevali učinek cepiva pri govedu, ovcah in prašičih.
When it is given to cattle, pigs and sheep, the immune system recognises the virus as ‘foreign' and makes antibodies against it.
Ko z njim cepijo govedo, prašiče in ovce, njihov imunski sistem prepozna virus v cepivu kot „tujek‟ in začne proti njemu tvoriti protitelesa.
They usually resolve over a four-week period after vaccination but may last longer in a small number of animals.
Običajno izginejo v štirih tednih po cepljenju, pri majhnem številu živali pa tudi kasneje.
Laboratory studies for the individual strains were conducted in cattle or pigs.
Opravljene so bile laboratorijske študije za posamezne seve pri govedu in prašičih.
One, two or four weeks after vaccination animals were exposed to the appropriate strain of live foot-and-mouth disease virus.
V njih so živali eden, dva ali štiri tedne po cepljenju izpostavili ustreznemu sevu virusa slinavke in parkljevke.
Aftovaxpur DOE is a vaccine used to vaccinate cattle, sheep and pigs from two weeks of age against foot-and-mouth disease.
Zdravilo Aftovaxpur DOE je cepivo, ki se uporablja za cepljenje goveda, ovac in prašičev od drugega tedna starosti dalje proti slinavki in parkljevki.
Foot-and-mouth disease affects cloven-hoofed animals and causes fever, followed by blisters on the inside of the mouth and on the feet which may rupture and lead to lameness.
Slinavka in parkljevka prizadene parkljarje in povzroča povišano telesno temperaturo, ki ji sledijo mehurjasti izpuščaji v gobcu in na parkljih, ki lahko počijo in povzročijo šepavost.
Why is Aftovaxpur DOE authorised in the EU?
Zakaj je zdravilo Aftovaxpur DOE odobreno v EU?
Other information about Aftovaxpur DOE
Druge informacije o zdravilu Aftovaxpur DOE
An overview of Aftovaxpur DOE and why it is authorised in the EU
Pregled zdravila Aftovaxpur DOE in zakaj je odobreno v EU
Swellings (up to 12 cm diameter in ruminants and 4 cm in pigs) at the injection site occur in most animals after vaccination.
Pri večini živali se po cepljenju pojavijo otekline (premera do 12 cm pri prežvekovalcih in 4 cm pri prašičih) na mestu injiciranja.
Aftovaxpur DOE contains strains of foot-and-mouth disease virus that have been inactivated so they cannot cause the disease.
Cepivo Aftovaxpur DOE vsebuje seve virusa slinavke in parkljevke, ki so bili inaktivirani, tako da ne morejo več povzročati bolezni.
Aftovaxpur DOE is a vaccine.
Zdravilo Aftovaxpur DOE je cepivo.
Aftovaxpur DOE is available as a liquid emulsion for injection and can only be obtained with a prescription.
Zdravilo Aftovaxpur DOE je na voljo v obliki tekoče emulzije za injiciranje in se izdaja le na recept.
What are the risks associated with Aftovaxpur DOE?
Kakšna tveganja so povezana z zdravilom Aftovaxpur DOE?
Aftovaxpur DOE contains up to three strains of inactivated (killed) foot-and-mouth disease virus.
Cepivo Aftovaxpur DOE vsebuje največ tri seve inaktiviranega (uničenega) virusa slinavke in parkljevke.
What is Aftovaxpur DOE and what is it used for?
Kaj je zdravilo Aftovaxpur DOE in za kaj se uporablja?
What benefits of Aftovaxpur DOE have been shown in studies?
Kakšne koristi je zdravilo Aftovaxpur DOE izkazalo v študijah?
The studies showed that Aftovaxpur DOE leads to adequate blood levels of antibodies against foot-andmouth disease strains following a single vaccination.
Študije so pokazale, da se po enkratnem cepljenju s cepivom Aftovaxpur DOE tvorijo zadostne ravni protiteles v krvi proti sevom virusa slinavke in parkljevke.
Aftovaxpur DOE is an emulsion containing liquid paraffin.
Cepivo Aftovaxpur DOE je emulzija, ki vsebuje tekoči parafin.
Aftovaxpur DOE contains an adjuvant (liquid paraffin) to enhance the immune response.
Cepivo Aftovaxpur DOE vsebuje adjuvans (tekoči parafin), ki spodbuja imunski odziv.
Aftovaxpur DOE (Foot-and-mouth disease vaccine, killed)
Aftovaxpur DOE (cepivo proti slinavki in parkljevki,
How is Aftovaxpur DOE used?
Kako se zdravilo Aftovaxpur DOE uporablja?
How does Aftovaxpur DOE work?
Kako zdravilo Aftovaxpur DOE deluje?
Treatment should be continued long-term.
Zdravljenje naj se nadaljuje daljše obdobje.
These effects are usually mild or moderate and do not last.
Neželeni učinki so običajno blagi ali zmerni in hitro izzvenijo.
At the start of the study patients in both groups had an average score of 10.
Ob začetku študije je bil povprečen rezultat 10 točk v obeh skupinah bolnikov.
What measures are being taken to ensure the safe and effective use of Cystadrops?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cystadrops?
The recommended dose is 1 drop in each eye 4 times a day during waking hours.
Priporočeni odmerek je ena kapljica v vsako oko štirikrat na dan v času budnosti.
The score ranges from 0 to 28, with 0 corresponding to no crystals.
Lestvica ima razpon od 0 do 28 točk, pri čemer 0 točk pomeni popolno odsotnost kristalov.
This is a summary of the European public assessment report (EPAR) for Cystadrops.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cystadrops.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cystadrops'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 Cystadrops večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Regarding safety, although side effects related to the eye are very common, they are usually manageable.
Z vidika varnosti so neželeni učinki, ki prizadenejo oko, navadno obvladljivi, četudi so zelo pogosti.
The doctor may decrease the dose progressively to 1 drop a day depending on the results of eye examinations.
Zdravnik lahko odmerek postopoma zmanjša na eno kapljico dnevno glede na rezultate očesnega pregleda.
The summary of the opinion of the Committee for Orphan Medicinal Products for Cystadrops 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 Cystadrops je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The most common side effects with Cystadrops (which may affect more than 1 in 10 people) are related to the eye and include pain, itching and irritation in the eye, increased lacrimation (watering eyes), blurred vision and ocular hyperaemia (red eye).
Najpogostejši neželeni učinki zdravila Cystadrops (ki lahko prizadenejo več kot 1 osebo od 10) so povezani z očmi in vključujejo bolečine v očesu, srbenje in draženje očesa, povečano solzenje, zamegljen vid in okularno hiperemijo (pordelost očesa).
The medicine also improved other symptoms of cystinosis such as photophobia.
To zdravilo izboljšuje tudi druge simptome cistinoze, kot je denimo fotofobija.
Because the number of patients with cystinosis is low, the disease is considered ‘rare', and Cystadrops was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 November 2008.
Ker je bolnikov s cistinozo malo, velja ta bolezen za redko, zato je bilo zdravilo Cystadrops 7. novembra 2008 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cystadrops have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Cystadrops upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Other information about Cystadrops
Druge informacije o zdravilu Cystadrops
For more information about treatment with Cystadrops, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Cystadrops preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Cystadrops contains the active substance mercaptamine (also known as cysteamine).
Zdravilo Cystadrops vsebuje zdravilno učinkovino merkaptamin (znano tudi kot cisteamin).
Damage from the build-up of cystine crystals inside the cells of the cornea can cause serious vision problems.
Poškodbe zaradi kopičenja cistinskih kristalov v celicah roženice lahko povzročijo resne težave z vidom.
The active substance in Cystadrops, mercaptamine, reacts with cystine to dissolve it and to form substances that can be removed from the cells.
Zdravilna učinkovina v zdravilu Cystadrops, merkaptamin, reagira s cistinom tako, da ga raztopi in pretvori v snovi, ki se lahko odstranijo iz celic.
Cystadrops was shown to be more effective than the comparator at decreasing corneal cystine crystals after 3 months of treatment: in patients using Cystadrops the IVCM score decreased by 4.6 points compared with a decrease of 0.5 points in patients using the comparator.
Zdravilo Cystadrops se je po treh mesecih zdravljenja izkazalo za učinkovitejše od primerjalnega zdravila pri zmanjševanju cistinskih kristalov v roženici: pri bolnikih, ki so uporabljali zdravilo Cystadrops se je rezultat na lestvici IVCM zmanjšal za 4,6 točke, medtem ko se je pri bolnikih, ki so uporabljali primerjalno zdravilo, zmanjšal za 0,5 točke.
Treatment with Cystadrops also led to reductions in photophobia (eye discomfort in bright light).
Zdravljenje z zdravilom Cystadrops je zmanjšalo tudi fotofobijo (ščemenje v očeh zaradi premočne svetlobe).
What is Cystadrops and what is it used for?
Kaj je zdravilo Cystadrops in za kaj se uporablja?
It is not intended to provide practical advice on how to use Cystadrops.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The full EPAR for Cystadrops 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 Cystadrops je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cystinosis is an inherited disease where a natural substance called cystine builds up in the body forming damaging crystals, particularly in the kidneys and cornea (the transparent layer in front of the eye).
Cistinoza je dedna bolezen, pri kateri se naravna snov, imenovana cistin, kopiči v telesu in tvori škodljive kristale, zlasti v ledvicah in roženici (prosojni plasti na sprednjem delu očesa).
Mercaptamine eye drop solutions made up locally in pharmacies or hospitals have been used for many years for the management of eye symptoms of cystinosis.
Raztopina merkaptamina v obliki kapljic za oko, pripravljena v lokalnih lekarnah ali bolnišnicah, se že več let uporablja za obvladovanje simptomov cistinoze.
What benefits of Cystadrops have been shown in studies?
Kakšne koristi je zdravilo Cystadrops izkazalo v študijah?
Cystadrops has been compared with another less concentrated mercaptamine eye drop solution in one main study involving 32 patients from 2 years of age with cystinosis.
Zdravilo Cystadrops so primerjali z drugimi kapljicami za oko, ki vsebujejo nižjo koncentracijo merkaptamina, v eni glavni študiji, v kateri je sodelovalo 32 bolnikov s cistinozo, ki so bili starejši od dveh let.
Cystadrops is an eye medicine used in patients from 2 years of age who have cystinosis.
Cystadrops je zdravilo za oči za uporabo pri bolnikih, starejših od dveh let, ki imajo cistinozo.
For practical information about using Cystadrops, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Cystadrops naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
What are the risks associated with Cystadrops?
Kakšna tveganja so povezana z zdravilom Cystadrops?
The main measure of effectiveness was based on the reduction in corneal cystine crystals as seen under the microscope and quantified using a score called the IVCM score.
Glavno merilo učinkovitosti je bilo zmanjšanje cistinskih kristalov v roženici, kar so ugotavljali z mikroskopom na podlagi ocenjevalne lestvice IVCM.
Why is Cystadrops approved?
Zakaj je bilo zdravilo Cystadrops odobreno?
Cystadrops is used to reduce the build-up of cystine crystals in the cornea.
Zdravilo Cystadrops se uporablja za zmanjševanje tvorjenja cistinskih kristalov v roženici.
When it is applied to the eye, the amount of cystine in the cells of the cornea decreases, limiting damage to the eye.
Po vnosu zdravila v oko se količina cistina v celicah roženice zmanjša, s čemer se zmanjša tudi obseg poškodb očesa.
For the full list of all side effects and restrictions with Cystadrops, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Cystadrops glejte navodilo za uporabo.
Cystadrops can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in the management of cystinosis.
Predpisovanje in izdaja zdravila Cystadrops je le na recept, zdravljenje z njim pa se sme uvesti in izvajati samo pod nadzorom zdravnika z izkušnjami z zdravljenjem cistinoze.
In addition, Cystadrops has been shown in a study to be effective at decreasing corneal cystine crystals.
Poleg tega je študija pokazala, da je zdravilo Cystadrops učinkovito pri zmanjševanju cistinskih kristalov v roženici.
How is Cystadrops used?
Kako se zdravilo Cystadrops uporablja?
How does Cystadrops work?
Kako zdravilo Cystadrops deluje?
Cystadrops is available as eye drops.
Na voljo je v obliki kapljic za oko.
It is available as tablets (50 and 150 mg).
Na voljo je v obliki tablet (50 in 150 mg).
Patients should also take vitamin D and calcium supplements if they do not get enough from their diet.
Bolniki bi morali jemati tudi dodatke vitamina D in kalcija, če slednjih ne dobivajo v zadostni količini s prehrano.
The full EPAR for Ibandronic Acid Teva 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 Ibandronic Acid Teva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The tablets must always be taken after the patient has fasted overnight for at least six hours and at least 30 minutes before the first food or drink of the day.
Tableto je treba vedno vzeti zjutraj na tešče, ko bolnik ni jedel vsaj šest ur, in vsaj 30 minut pred prvim zaužitjem hrane ali pijače.
The patient must also not lie down for one hour after taking the tablets.
Poleg tega bolnik eno uro po zaužitju tablete ne sme leči.
Medicines are bioequivalent when they produce the same levels of the active substance in the body.
Zdravila so biološko enakovredna, ko dosegajo enake ravni zdravilne učinkovine v telesu.
This means that Ibandronic Acid Teva is similar to a ‘reference medicine' already authorised in the European Union (EU).
To pomeni, da je podobno referenčnemu zdravilu, ki je že odobreno v Evropski uniji (EU).
It stops the action of osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Ta zavira delovanje osteoklastov, celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
The tablet must always be taken after an overnight fast, one hour before any food or drink except for water.
Tableto je treba vedno vzeti zjutraj na tešče po celonočnem postu, eno uro pred zaužitjem hrane ali pijače (razen vode).
For treating osteoporosis, one 150-mg tablet is taken once a month.
Pri zdravljenju osteoporoze se jemlje ena 150-miligramska tableta enkrat na mesec.
For more information about treatment with Ibandronic Acid Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Ibandronic Acid Teva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The European Commission granted a marketing authorisation valid throughout the EU for Ibandronic Acid Teva on 17 September 2010.
Evropska komisija je dovoljenje za promet z zdravilom Ibandronic Acid Teva, veljavno po vsej Evropski uniji, izdala 17. septembra 2010.
For the prevention of skeletal events, one 50-mg tablet is taken once a day.
Pri preprečevanju z okostjem povezanih dogodkov se jemlje ena 50-miligramska tableta enkrat dnevno.
The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases and in women with osteoporosis.
Zmanjšanje izgube kostne mase pripomore k manjši verjetnosti zloma, kar pomaga preprečiti zlome pri bolnikih z rakom in kostnimi metastazami ter ženskah z osteoporozo.
This is a summary of the European public assessment report (EPAR) for Ibandronic Acid Teva.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ibandroic Acid Teva.
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 Ibandronic Acid Teva.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Because Ibandronic Acid Teva is a generic medicine and is bioequivalent to the reference medicines, its benefits and risks are taken as being the same as the reference medicines's.
Ker je zdravilo Ibandronic Acid Teva generično zdravilo in je biološko enakovredno referenčnima zdraviloma, so njegove koristi in tveganja enaki kot pri referenčnih zdravilih.
The CHMP concluded that, in accordance with EU requirements, Ibandronic Acid Teva has been shown to have comparable quality and to be bioequivalent to Bondronat and Bonviva.
Odbor CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ibandronic Acid Teva primerljivo raven kakovosti kot zdravili Bondronat in Bonviva ter da jima je biološko enakovredno.
Ibandronic Acid Teva 150 mg is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures.
Zdravilo Ibandronic Acid Teva v odmerku 150 mg se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah v obdobju po menopavzi, pri katerih obstaja tveganje za pojav zlomov.
Because Ibandronic Acid Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicines.
Ker je zdravilo Ibandronic Acid Teva generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnima zdraviloma.
The reference medicines for Ibandronic Acid Teva are Bondronat and Bonviva.
Referenčni zdravili za zdravilo Ibandronic Acid Teva sta Bondronat in Bonviva.
Ibandronic Acid Teva 50 mg is used to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone).
Zdravilo Ibandronic Acid Teva se uporablja za preprečevanje z okostjem povezanih dogodkov (zlomov kosti ali z okostjem povezanih zapletov, ki zahtevajo zdravljenje) pri bolnicah z rakom dojke in kostnimi metastazami (ko se rak razširi na kosti).
What are the benefits and risks of Ibandronic Acid Teva?
Kakšne so koristi in tveganja, povezani z zdravilom Ibandronic Acid Teva?
Other information about Ibandronic Acid Teva:
Druge informacije o zdravilu Ibandronic Acid Teva:
Therefore, the CHMP's view was that, as for Bondronat and Bonviva, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi, tako kot pri zdravilih Bondronat in Bonviva, odtehtajo znana tveganja.
Ibandronic Acid Teva ibandronic acid
Ibandronic Acid Teva ibandronska kislina
The Committee recommended that Ibandronic Acid Teva be given marketing authorisation.
Priporočil je, da se za zdravilo Ibandronic Acid Teva izda dovoljenje za promet.
Ibandronic Acid Teva is a ‘generic medicine'.
Ibandronic Acid Teva je generično zdravilo.
Ibandronic Acid Teva must be taken with a full glass of plain water (but not mineral water) while standing or sitting up, and the tablets should not be chewed, sucked or crushed.
Zdravilo Ibandronic Acid Teva je treba vzeti v stoječem ali sedečem položaju in popiti poln kozarec navadne (ne mineralne) vode.
Ibandronic Acid Teva is a medicine that contains the active substance ibandronic acid.
Ibandronic Acid Teva je zdravilo, ki vsebuje zdravilno učinkovino ibandronska kislina.
The active substance in Ibandronic Acid Teva, ibandronic acid, is a bisphosphonate.
Zdravilna učinkovina v zdravilu Ibandronic Acid Teva, ibandronska kislina, je difosfonat.
Why has Ibandronic Acid Teva been approved?
Zakaj je bilo zdravilo Ibandronic Acid Teva odobreno?
How has Ibandronic Acid Teva been studied?
Kako je bilo zdravilo Ibandronic Acid Teva raziskano?
What is Ibandronic Acid Teva?
Kaj je zdravilo Ibandronic Acid Teva?
How does Ibandronic Acid Teva work?
Kako zdravilo Ibandronic Acid Teva deluje?
How is Ibandronic Acid Teva used?
Kako se zdravilo Ibandronic Acid Teva uporablja?
What is Ibandronic Acid Teva used for?
Za kaj se zdravilo Ibandronic Acid Teva uporablja?
The following studies are the most important.
Najpomembnejše so naslednje študije.
These measures will help the environment.
Taki ukrepi pomagajo varovati okolje.
The reason for this is not known.
Razlog za to ni znan.
Take this medicine one or two times a day every day with food.
Zdravilo vzemite enkrat ali dvakrat na dan s hrano.
Some people had other illnesses or were taking other medicines.
Nekateri so imeli druge bolezni ali so jemali še druga zdravila.
In some patients additional factor VIII was given.
Nekaterim bolnikom so dali dodatni faktor VIII.
If it is nearly time for the next dose, just take that one.
Če pa je že skoraj čas za naslednji odmerek, vzemite samo tega naslednjega.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 November 2017
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 10 November 2017
There are some other medicines that can only be used under certain circumstances as described below.
Nekatera druga zdravila pa smete uporabljati le v določenih okoliščinah, kot je opisano spodaj.
After first opening, use within 100 days.
Po prvem odprtju porabite v roku 100 dni.
To be taken with food.
Zaužije se s hrano.
The possibility of medicinal product interaction cannot be excluded.
Možnosti za medsebojno delovanje zdravil ni mogoče izključiti.
If you think you are pregnant or you are planning to become pregnant, it is very important that you discuss this with your doctor.
Če domnevate, da ste noseči, ali če načrtujete nosečnost, je zelo pomembno, da se o tem pogovorite z zdravnikom.
Appropriate doses for this combination, with respect to efficacy and safety, have not been established.
Ustrezni odmerki te kombinacije, kar zadeva učinkovitost in varnost, niso ugotovljeni.
The expiry date refers to the last day of that month.
Roka uporabnosti zdravila se nanaša na zadnji dan navedenega meseca.