natgillin/translations-raw huggingface dataset:
The company that markets Intuniv must also provide nationally agreed educational material for healthcare professionals before launching the medicine on the market.
Poleg tega mora družba, ki trži zdravilo Intuniv, pred dajanjem zdravila na trg zagotoviti izobraževalno gradivo za zdravstvene delavce, odobreno na nacionalni ravni.
Intuniv is used to treat attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years when stimulant medicines are not appropriate or do not control their symptoms well enough.
Zdravilo Intuniv se uporablja za zdravljenje motnje pozornosti s hiperaktivnostjo (ADHD - attention deficit hyperactivity disorder) pri otrocih in mladostnikih, starih od 6 do 17 let, pri katerih stimulanti niso primerni ali pa z njimi ni mogoče zadovoljivo obvladati simptomov.
The most common side effects with Intuniv are sleepiness (in nearly half of all patients), headache (in more than a quarter), tiredness (in about 1 patient in 5), and upper abdominal pain and sedation (both in around 1 in 10).
Najpogostejši neželeni učinki zdravila Intuniv so zaspanost (pri skoraj polovici vseh bolnikov), glavobol (pri več kot četrtini), utrujenost (pri približno 1 bolniku od 5) ter bolečina v zgornjem delu trebuha in sedacija (oba pri približno 1 bolniku od 10).
Two other short-term studies involving 631 patients also showed Intuniv at various doses improving ADHD scores more than placebo.
Tudi dve drugi kratkotrajni študiji, v katerih je sodelovalo 631 bolnikov, sta pokazali, da je zdravilo Intuniv v različnih odmerkih v večji meri izboljšalo rezultate za ADHD kot placebo.
Intuniv treatment must be started by a doctor specialised in childhood or adolescent behavioural problems.
Zdravljenje z zdravilom Intuniv mora uvesti zdravnik, specializiran za vedenjske motnje v otroštvu in mladostništvu.
More serious side effects are less common and include: low blood pressure and weight gain (both in around 1 patient in 30), slow heart rate (1 in 60) and fainting (in less than 1 in 100).
Resnejši neželeni učinki so manj pogosti in vključujejo: nizek krvni tlak in povečanje telesne mase (oba pri približno 1 bolniku od 30), počasen srčni utrip (pri 1 bolniku od 60) in omedlevica (pri manj kot 1 bolniku od 100).
Several studies have shown Intuniv improving ADHD symptom scores (ADHD-RS-IV) in children and adolescents.
Več študij je pokazalo, da je zdravilo Intuniv izboljšalo rezultate na lestvici za ocenjevanje simptomov ADHD (ADHD-RS-IV) pri otrocih in mladostnikih.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Intuniv, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Intuniv in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What is Intuniv and what is it used for?
Kaj je zdravilo Intuniv in za kaj se uporablja?
For more information about treatment with Intuniv, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Intuniv preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The dose of Intuniv requires careful adjustments, taking account side effects and benefits seen in the patient.
Odmerek zdravila Intuniv je treba skrbno prilagajati glede na neželene učinke in koristi, opažene pri bolniku.
For practical information about using Intuniv, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Intuniv naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Why is Intuniv approved?
Zakaj je bilo zdravilo Intuniv odobreno?
The CHMP therefore concluded that the benefits of Intuniv outweigh the risks recommended that it be approved for authorisation in the EU.
Zato je zaključil, da so koristi zdravila Intuniv večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet v EU.
In a long-term maintenance study in 301 children and adolescents aged 6 to 17 years treatment failures occurred in 49% of patients taking Intuniv compared with 65% of those taking placebo.
V študiji dolgotrajnega vzdrževalnega zdravljenja pri 301 otroku in mladostniku, starem od 6 do 17 let, je bilo zdravljenje neuspešno pri 49 % bolnikov, ki so jemali zdravilo Intuniv, in pri 65 % bolnikov, ki so jemali placebo.
The active substance in Intuniv is guanfacine.
Zdravilna učinkovina v zdravilu Intuniv je gvanfacin.
In a study of 337 children aged 6 to 17 years, the reduction in ADHD symptoms with Intuniv treatment after 10 to 13 weeks was 24 points compared with a reduction of 15 points seen with placebo (a dummy treatment) and 19 points seen with atomoxetine (an ADHD medicine).
V študiji, v kateri je sodelovalo 337 otrok, starih od 6 do 17 let, so se simptomi ADHD po 10 do 13 tednih zdravljenja z zdravilom Intuniv zmanjšali za 24 točk v primerjavi s 15 točkami pri uporabi placeba (zdravila brez zdravilne učinkovine) in 19 točkami pri uporabi atomoksetina (zdravila za ADHD).
How is Intuniv used?
Kako se zdravilo Intuniv uporablja?
In another study of 312 adolescents aged 13 to 17, the reduction in ADHD scores at 13 weeks was 25 points with Intuniv and 19 points with placebo.
V drugi študiji, v kateri je sodelovalo 312 mladostnikov, starih od 13 do 17 let, so se rezultati za ADHD po 13 tednih znižali za 25 točk pri uporabi zdravila Intuniv in za 19 točk pri uporabi placeba.
The recommended starting dose for all patients is 1 mg taken by mouth once a day.
Priporočeni začetni odmerek za vse bolnike je 1 mg, ki se jemlje peroralno enkrat na dan. Za informacije o prilagajanju odmerka in preiskavah, ki jih mora izvesti zdravnik, glejte povzetek glavnih značilnosti zdravila.
How does Intuniv work?
Kako zdravilo Intuniv deluje?
Results in children aged below 12 years are not yet available.
Rezultati pri otrocih, starih manj kot 12 let, še niso na voljo.
The addition of ribavirin was not needed for most patients.
Dodajanje ribavirina pri večini bolnikov ni bilo potrebno.
Regarding safety, the treatment is well tolerated.
Z vidika varnosti bolniki zdravljenje dobro prenašajo.
What measures are being taken to ensure the safe and effective use of Harvoni?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Harvoni?
The European Commission granted a marketing authorisation valid throughout the European Union for Harvoni on 17 November 2014.
Evropska komisija je dovoljenje za promet z zdravilom Harvoni, veljavno po vsej Evropski uniji, izdala 17. novembra 2014.
It must also not be used together with the following medicines which can reduce the effects of Harvoni:
Prav tako se ne sme uporabljati skupaj z naslednjimi zdravili, ki lahko zmanjšajo njegove učinke:
Sofosbuvir has been authorised as Sovaldi since January 2014.
Sofosbuvir je od januarja 2014 odobren kot zdravilo Sovaldi.
Patients whose infection was resistant to other antiviral medicines could also benefit from extending treatment to 24 weeks.
Bolnikom, katerih okužba je bila odporna proti drugim protivirusnim zdravilom, je prav tako koristilo podaljšanje zdravljenja na 24 tednov.
The full EPAR and risk management plan summary for Harvoni 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 Harvoni sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Harvoni.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Harvoni.
• rifampicin and rifabutin (antibiotics);
• rifampicinom in rifabutinom (antibiotičnima zdraviloma);
The European Medicines Agency decided that Harvoni's benefits are greater than its risks and recommended that it be approved for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Harvoni večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
Other information about Harvoni
Druge informacije o zdravilu Harvoni
The most common side effects with Harvoni (which may affect more than 1 in 10 people) are tiredness and headache.
Najpogostejša neželena učinka zdravila Harvoni (ki lahko prizadeneta več kot 1 osebo od 10) sta utrujenost in glavobol.
It is not intended to provide practical advice on how to use Harvoni.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Harvoni is available as tablets which contain 90 mg ledipasvir and 400 mg sofosbuvir.
Zdravilo Harvoni je na voljo v obliki tablet, ki vsebujejo 90 mg ledipasvirja in 400 mg sofosbuvirja.
In these studies, patients were given Harvoni, with or without ribavirin, for 8, 12 or 24 weeks, depending on the characteristics of the patients.
V teh študijah so bolnikom zdravilo Harvoni, v kombinaciji z ribavirinom ali brez njega, dajali 8, 12 ali 24 tednov, odvisno od posameznega bolnika.
What benefits of Harvoni have been shown in studies?
Kakšne koristi je zdravilo Harvoni izkazalo v študijah?
Sofosbuvir blocks the action of a protein called ‘NS5B RNA-dependent RNA polymerase', while ledipasvir targets a protein called ‘NS5A'.
Sofosbuvir zavira delovanje encima, imenovanega „RNA polimeraza NS5B, odvisna od RNA“, medtem ko ledipasvir zavira beljakovino, imenovano „NS5A“.
What are the risks associated with Harvoni?
Kakšna tveganja so povezana z zdravilom Harvoni?
Around 94% to up to 99% of patients given Harvoni alone had no sign of the virus 12 weeks after the end of treatment.
Pri približno 94 do 99 % bolnikov, ki so prejemali samo zdravilo Harvoni, 12 tednov po koncu zdravljenja ni bilo znakov virusa.
Harvoni must not be used together with the cholesterol medicine rosuvastatin.
Zdravilo Harvoni se ne sme uporabljati skupaj z zdravilom za zdravljenje holesterola, rosuvastatinom.
There are several varieties (called genotypes) of hepatitis C virus and Harvoni is recommended for use in patients with virus of genotypes 1, 4, 5 and 6 and for some patients with genotype 3.
Znanih je več različic (imenovanih genotipi) virusa hepatitisa C. Zdravilo Harvoni je priporočeno za uporabo pri bolnikih z virusom genotipa 1, 4, 5 in 6 ter pri nekaterih bolnikih z genotipom 3.
What is Harvoni and what is it used for?
Kaj je zdravilo Harvoni in za kaj se uporablja?
Supportive data showed that Harvoni in combination with ribavirin would be of benefit for some patients with genotype 3 virus.
Podporni podatki so pokazali, da bi lahko zdravilo Harvoni v kombinaciji z ribavirinom koristilo nekaterim bolnikom, okuženim z virusom genotipa 3.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Harvoni have also 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 Harvoni upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For the full list of all side effects and restrictions with Harvoni, see the package leaflet.
Za celoten seznam vseh neželenih učinkov in omejitev pri zdravilu Harvoni glejte navodilo za uporabo.
• carbamazepine, phenobarbital and phenytoin (medicines for epilepsy);
• karbamazepinom, fenobarbitalom in fenitoinom (zdravili za zdravljenje epilepsije);
Results of the studies also showed that patients who have compensated cirrhosis (scarring of the liver but the liver continues to work adequately) had a higher likelihood of clearing the virus when treatment was extended to 24 weeks.
Rezultati študij so pokazali tudi, da je bila pri bolnikih s kompenzirano cirozo (brazgotinjenjem jeter, pri čemer pa jetra še dalje ustrezno delujejo) verjetnost uničenja virusa večja, kadar je bilo zdravljenje podaljšano na 24 tednov.
For more information about treatment with Harvoni, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Harvoni preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Why is Harvoni approved?
Zakaj je bilo zdravilo Harvoni odobreno?
In all three studies, the main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus 12 weeks after the end of treatment.
Glavno merilo učinkovitosti v vseh treh študijah je bilo število bolnikov, pri katerih krvne preiskave 12 tednov po koncu zdravljenja niso pokazale prisotnosti virusa hepatitisa C.
By blocking these proteins, Harvoni stops the hepatitis C virus from multiplying and infecting new cells.
Zdravilo Harvoni z zaviranjem teh beljakovin prepreči virusu hepatitisa C, da bi se razmnoževal in okužil nove celice.
Harvoni is also being investigated in a study in children aged 3 to 18 years infected with hepatitis C. Results from 100 patients aged 12 to 18 years (all of whom had hepatitis C genotype 1) showed that 98% of them had no sign of the virus 12 weeks after the end of treatment.
Zdravilo Harvoni se proučuje tudi v študiji pri otrocih, starih od 3 do 18 let, okuženih s hepatitisom C. Pri 98 % od 100 bolnikov, starih od 12 do 18 let, ki so vsi imeli hepatitis C genotipa 1, so rezultati pokazali, da dvanajst tednov po koncu zdravljena niso imeli nobenih znakov virusa.
For practical information about using Harvoni, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Harvoni naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The duration of treatment with Harvoni and whether it is used alone or in combination with another medicine called ribavirin depends on the genotype of the virus and the nature of the liver problems patients have, for example if they have liver cirrhosis (scarring) or their liver is not working properly.
Odločitev o trajanju zdravljenja z zdravilom Harvoni in o tem, ali se bo uporabljalo kot samostojno zdravilo ali v kombinaciji z drugim zdravilom, imenovanim ribavirin, je odvisna od genotipa virusa in vrste bolnikovih težav z jetri, kot sta ciroza (brazgotinjenje) jeter ali njihovo nepravilno delovanje.
Harvoni has been investigated in three main studies involving a total of around 2,000 adult patients infected with hepatitis C of genotype 1 whose liver function was normal.
Zdravilo Harvoni so proučevali v treh glavnih študijah, v katerih je skupno sodelovalo približno 2 000 odraslih bolnikov, okuženih s hepatitisom C genotipa 1, pri katerih je jetrna funkcija normalna.
Harvoni can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C.
Predpisovanje in izdaja zdravila je le na recept, zdravljenje pa mora uvesti in spremljati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s kroničnim hepatitisom C.
Harvoni is an antiviral medicine used to treat adults and children from 12 years of age with chronic (long-term) hepatitis C, an infectious disease that affects the liver caused by the hepatitis C virus.
Zdravilo Harvoni je protivirusno zdravilo, namenjeno zdravljenju odraslih in otrok, starih 12 let ali več, s kroničnim (dolgotrajnim) hepatitisom C (nalezljivo boleznijo, ki prizadene jetra in jo povzroča virus hepatitisa C).
The active substances in Harvoni, ledipasvir and sofosbuvir, block two proteins essential for the hepatitis C virus to multiply.
Zdravilni učinkovini zdravila Harvoni, ledipasvir in sofosbuvir, zavirata dve beljakovini, ki ju virus hepatitisa C potrebuje za razmnoževanje.
The company that markets Harvoni will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Harvoni.
Družba, ki trži zdravilo Harvoni, bo za oceno tveganja ponovitve raka jeter po zdravljenju z neposredno delujočimi protivirusnimi zdravili, kot je Harvoni, izvedla študijo pri bolnikih, ki so preboleli raka jeter.
Benefit of Harvoni was also shown for patients with genotype 4, 5 and 6, for those with decompensated cirrhosis (when the liver does not work adequately) and for those who had received a liver transplant.
Zdravilo se je izkazalo za koristno tudi pri bolnikih, okuženih z virusom genotipa 4, 5 in 6, bolnikih z dekompenzirano cirozo (pri kateri jetra ne delujejo več ustrezno) in bolnikih s presajenimi jetri.
Harvoni, with or without ribavirin, is highly beneficial for many patients with hepatitis C virus, including those who have had a liver transplant and/or who have compensated or decompensated cirrhosis.
Menila je, da zdravljenje z zdravilom Harvoni, ki se uporablja skupaj z ribavirinom ali brez njega, zelo koristi številnim bolnikom, okuženim z virusom hepatitisa C, vključno s tistimi s presajenimi jetri in/ali kompenzirano ali dekompenzirano cirozo.
How does Harvoni work?
Kako zdravilo Harvoni deluje?
How is Harvoni used?
Kako se zdravilo Harvoni uporablja?
Harvoni contains the active substances ledipasvir and sofosbuvir.
Vsebuje zdravilni učinkovini ledipasvir in sofosbuvir.
• St John's wort (a herbal preparation used to treat depression and anxiety).
• šentjanževko (rastlinskim pripravkom za zdravljenje depresije).
1 ml (20 mg/ml) 10 pre-filled syringes
1 ml (20 mg/ml) 10 napolnjenih injekcijskih brizg
2.5 mg Solution for injection
2,5 mg Raztopina za injiciranje
18 August 2011 EMA/685524/2011 EMEA/H/C/002366
18. avgust 2011 EMA/773581/2011 EMEA/H/C/002366
It was to be available as white tablets.
Na voljo naj bi bilo v belih tabletah.
The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Dopis, s katerim družba agencijo obvešča o umiku vloge, je na voljo pod zavihkom „All documents (Vsi dokumenti).
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.
Zmanjšanje izgube kostne mase pripomore k manjši verjetnosti zloma, kar je koristno za preprečevanje zlomov pri bolnikih z rakom in metastazami v kosteh.
On 21 July 2011, Hexal AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ibandronic Acid Hexal, for the prevention of skeletal events in patients with breast cancer and bone metastases.
Družba Hexal AG je 21. julija 2011 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za dovoljenje za promet z zdravilom Ibandronic Acid Hexal za preprečevanje z okostjem povezanih dogodkov pri bolnicah z rakom dojke in metastazami v kosteh.
Ibandronic Acid Hexal was to be 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 Hexal naj bi se uporabljalo za preprečevanje z okostjem povezanih dogodkov (zlomov kosti ali z okostjem povezanih zapletov, ki zahtevajo zdravljenje) pri bolnicah z rakom dojke in metastazami v kosteh (ko se je rak razširil v kosti).
Because Ibandronic Acid Hexal was developed as a generic medicine, the company presented the results of studies carried out to investigate whether it is ‘bioequivalent' to the reference medicine.
Ker je bilo zdravilo Ibandronic Acid Hexal razvito kot generično zdravilo, je družba predložila rezultate študij, ki so bile opravljene za proučitev, ali je zdravilo biološko enakovredno referenčnemu zdravilu.
The CHMP concluded that, in accordance with EU requirements, Ibandronic Acid Hexal had been shown to have comparable quality and to be bioequivalent to Bondronat.
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ibandronic Acid Hexal primerljivo raven kakovosti kot zdravilo Bondronat in da mu je biološko enakovredno.
The Committee recommended that Ibandronic Acid Hexal be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Ibandronic Acid Hexal odobri dovoljenje za promet.
Therefore, the CHMP's view was that, as for Bondronat, the benefit outweighs the identified risk.
Zaradi tega je CHMP menil, da njegove koristi tako kot pri zdravilu Bondronat odtehtajo z njim povezana tveganja.
Ibandronic Acid Hexal was developed as a ‘generic medicine'.
Zdravilo Ibandronic Acid Hexal je bilo razvito kot „generično zdravilo“.
This means that Ibandronic Acid Hexal was intended to be similar to a ‘reference medicine' already authorised in the European Union called Bondronat.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji, in sicer zdravilu Bondronat.
Ibandronic Acid Hexal is a medicine that contains the active substance ibandronic acid.
Ibandronic Acid Hexal je zdravilo, ki vsebuje zdravilno učinkovino ibandronska kislina.
Ibandronic Acid Hexal is expected to work in the same way as the reference medicine, Bondronat.
Zdravilo Ibandronic Acid Hexal naj bi delovalo na enak način kot referenčno zdravilo Bondronat.
The active substance in Ibandronic Acid Hexal and Bondronat, ibandronic acid, is a bisphosphonate.
Zdravilna učinkovina v zdravilih Ibandronic Acid Hexal in Bondronat ibandronska kislina je difosfonat.
What is Ibandronic Acid Hexal?
Kaj je zdravilo Ibandronic Acid Hexal?
How is Ibandronic Acid Hexal expected to work?
Kako naj bi zdravilo Ibandronic Acid Hexal delovalo?
What was Ibandronic Acid Hexal expected to be used for?
Za kaj naj bi se zdravilo Ibandronic Acid Hexal uporabljalo?
Therefore pack sizes of 100g should be withdrawn from all EU member states where they are currently authorised.
Velikost pakiranja po 100 g je zato treba umakniti iz vseh držav članic EU, kjer je trenutno odobreno.
National Competent Authorities of Member States or reference Member States, if applicable, shall ensure that the following conditions are fulfilled by the MAHs:
Pristojni nacionalni organi držav članic ali referenčnih držav članic bodo zagotovili, kadar je to primerno, da imetniki dovoljenj za promet z zdravilom izpolnjujejo naslednje pogoje:
The maximum duration of a treatment course with 0.01% w/w estradiol containing medicinal products for topical use is limited to 4 weeks (not repeated use).
Najdaljše trajanje cikla zdravljenja z zdravili za topično uporabo, ki vsebujejo 0,01 % m/m estradiola, je omejeno na 4 tedne (brez ponavljajoče se uporabe).
As the maximum duration of a treatment course with 0.01% w/w estradiol containing medicinal products for topical use is limited to 4 weeks (not repeated use), the MAHs should provide a detailed plan including precise short timelines on the adaptation of the lower pack size (25g) and the withdrawal of the 35g and 50g pack sizes, in all EU member states where they are currently authorised.
Ker je najdaljše trajanje cikla zdravljenja z zdravili za topično uporabo, ki vsebujejo 0,01 % m/m estradiola, omejeno na 4 tedne (brez ponavljajoče se uporabe), bo imetnik dovoljenja za promet z zdravilom predložil podroben načrt, vključno z natančnim kratkim odmerjanjem ob prehodu na manjše pakiranje (25 g) in umiku velikosti pakiranja po 35 g ter 50 g v vseh državah članicah EU, kjer so ta zdravila trenutno odobrena.
250 mg Capsule, hard
250 mg kapsula, trda peroralna uporaba pretisni omot (PVC/alu) 100 kapsul
250 mg Powder for concentrate for solution for
250 mg Prašek za koncentrat za raztopino za
Intravenous use Vial (glass)
Intravenski uporaba Viala (steklo)
Angiox
Ovojnina
Combinations not recommended
Kombinacije, ki niso priporočene
See section “Look out for side effects” and section 4.
Glejte poglavje “Bodite pozorni na neželene učinke” in poglavje 4.
• if you have kidney or liver problems
• če imate težave z ledvicami ali jetri