natgillin/translations-raw huggingface dataset:
Important information about some of the ingredients of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Pomembne informacije o nekaterih sestavinah cepiva Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Take special care with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics:
Bodite posebno pozorni pri uporabi cepiva Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics:
PSUR submission when Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is used during an influenza pandemic:
Predloţitev PSUR za cepivo Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics med pandemijo gripe:
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.5 ml
VSEBINA, IZRAŢENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
Post-marketing surveillance
Spremljanje v obdobju trţenja
Marketing Authorisation Holder Novartis Vaccines and Diagnostics S.r.l.
Imetnik dovoljenja za promet z zdravilom Novartis Vaccines and Diagnostics S.r.l.
The side effects listed below have occurred with Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics in clinical studies in adults, including the elderly:
Neţeleni učinki, opisani v nadaljevanju, so se pojavili po cepljenju odraslih oseb in starostnikov s cepivom Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics v kliničnih študijah:
• if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to egg and, chicken protein, ovalbumin, formaldehyde,
• če ste imeli kakršnakoli alergijsko reakcijo, ki ni bila nenadna, ţivljenje ogroţajoča, na katerokoli sestavino cepiva, na jajčne in piščančje beljakovine, na ovalbumin, formaldehid, kanamicinsulfat in neomicinsulfat (antibiotika) ali cetiltrimetilamonijev bromide (CTAB) (glejte poglavje 6, Dodatne informacije).
** geometric mean ratios of SRH ° measured by HI assay ≥ 40 °° geometric mean ratios of HI
Faktor serokonverzije (95-odstotni IZ)** * izmerjeno s testom SRH ≥ 25 mm ** razmerja geometričnih srednjih vrednosti za SRH ° izmerjeno s testom HI ≥ 40 °° razmerja geometričnih srednjih vrednosti za HI
A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14) 7.5 micrograms haemagglutinin Adjuvant: MF59C.1 oil composed of squalene, polysorbate 80 and sorbitan trioleate.
Sev* virusa influence s površinskimi antigeni (hemaglutinin in nevraminidaza): sevu A/Vietnam/1194/2004 (H5N1) podobnega seva (NIBRG-14) 7,5 mikrogramov** na 0,5 ml odmerek * razmnoţen v jajcih ** izraţeno v mikrogramih hemaglutinina
st nd or booster) were similar and are listed according to the following frequency:
Stopnje neţelenih učinkov, o katerih so poročali po kateremkoli odmerku cepljenja (tj. 1., 2. ali obnovitvenem) so bile podobne in so naštete v skladu z naslednjo pogostnostjo:
There are no data on co-administration of Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics with other vaccines.
Podatkov o sočasni uporabi cepiva Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics z drugimi cepivi ni.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR SYRINGE
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2
Stopnja serozaščite*, stopnja serokonverzije* in factor serokonverzije** za protitelesa proti HA na sev H5N1 A/turkey/Turkey/05 po 2. odmerku pri odraslih, starih od 18 do 60 let, izmerjeno s testoma SRH in HI, so bili kot sledi:
What Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is and what it is used for 2.
KAJ JE CEPIVO PREPANDEMIC INFLUENZA VACCINE (H5N1) (SURFACE ANTIGEN, INACTIVATED, ADJUVANTED) NOVARTIS VACCINES AND DIAGNOSTICS IN ZA KAJ GA UPORABLJAMO
Possible side effects
MOŢNI NEŢELENI UČINKI
inactivated, adjuvanted) Novartis Vaccines and Diagnostics may be administered but a protective immune response may not be elicited.
• v prisotnosti imunske pomanjkljivosti se cepivo Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics lahko daje, vendar ni nujno, da bo doseţen zaščitni imunski odziv.
How Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is given
KAKO SE DAJE CEPIVO PREPANDEMIC INFLUENZA VACCINE (H5N1) (SURFACE ANTIGEN, INACTIVATED, ADJUVANTED) NOVARTIS VACCINES AND DIAGNOSTICS
Skin and subcutaneous tissue disorders
Bolezni krvi in limfatičnega sistema Prehodna trombocitopenija
Study V87P3 21 days after 2
Študija V87P3 21. dni po 2. odmerku n = 30
General disorders and administration site conditions Asthenia.
Splošne teţave in spremembe na mestu aplikacije atenija
(H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics dose, SRH CHMP criteria were achieved in all the vaccine schedule groups after 3 weeks from the 2nd vaccination.
(surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, je bilo v šestem mesecu serozaščitenih.
nd dose
IME ZDRAVILA
Rare: Convulsions, eye swelling and anaphylaxis.
Krči, oteklost oči in anafilaksa
Systemic
GMR
What Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics contains
Kaj vsebuje cepivo Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
It is available as tablets (160 mg/20 mg; 320 mg/40 mg).
Na voljo je v obliki tablet (160 mg/20 mg; 320 mg/40 mg).
It can be used in adults and children aged 6 months and over and weighing 5 kg or more.
Uporablja se lahko pri odraslih in otrocih, starejših od šest mesecev, ki tehtajo 5 kg ali več.
The tablets may be crushed and mixed with water if needed.
Tablete se lahko po potrebi zdrobijo in zmešajo z vodo.
Eurartesim is taken once a day for three consecutive days, at the same time each day.
Zdravilo Eurartesim se jemlje enkrat na dan tri zaporedne dni ob isti uri.
‘Uncomplicated' means the disease does not involve severe, life-threatening symptoms.
„Nezapletena“ pomeni, da se pri bolezni ne pojavljajo hudi, življenjsko nevarni simptomi.
The European Commission granted a marketing authorisation valid throughout the European Union for Eurartesim on 27 October 2011.
Evropska komisija je dovoljenje za promet z zdravilom Eurartesim, veljavno po vsej Evropski uniji, izdala 27. oktobra 2011.
The dose is determined by the patient's body weight.
Odmerek je odvisen od bolnikove telesne mase.
It is chemically related to other widely available medicines used to treat malaria.
Kemično je povezan z drugimi široko dostopnimi zdravili za zdravljenje malarije.
The company will also complete a study on Eurartesim's effects on the heart.
Družba bo tudi izvedla študijo o učinkih zdravila Eurartesim na srce.
The full EPAR for Eurartesim 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 Eurartesim je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The tablets are swallowed with water when the stomach is empty, at least three hours before or after a meal.
Tablete je treba pogoltniti z vodo na prazen želodec vsaj tri ure pred ali po obroku.
Other information about Eurartesim
Druge informacije o zdravilu Eurartesim
This is a summary of the European public assessment report (EPAR) for Eurartesim.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Eurartesim.
For more information about treatment with Eurartesim, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Eurartesim preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
The company that markets Eurartesim will provide all doctors expected to prescribe or use Eurartesim with an educational pack containing important information on the correct use of the medicine, including a checklist of the medicines that Eurartesim must not be given with, to reduce the risk of QTc interval prolongation.
Družba, ki trži zdravilo Eurartesim, bo vsem zdravnikom, za katere se pričakuje, da bodo predpisovali ali uporabljali zdravilo Eurartesim, posredovala izobraževalno gradivo s pomembnimi informacijami o pravilni uporabi zdravila, vključno s seznamom zdravil, s katerimi se zdravilo Eurartesim ne sme dajati, da se zmanjša tveganje za podaljšanje intervala QTc.
It must not be used in patients who have or are at risk of QTc interval prolongation or cardiac arrhythmias (unstable heart rhythm) or who are taking medicines that can affect heart rhythm.
Ne smejo ga uporabljati bolniki, ki imajo ali pri katerih obstaja tveganje za podaljšanje intervala QTc ali srčne aritmije (nestabilnega srčnega ritma) in tisti, ki jemljejo zdravila, ki lahko vplivajo na srčni ritem.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Eurartesim have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Eurartesim upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
The CHMP noted the potential risk for QTc interval prolongation, and included restrictions in the product information to minimise the risk to patients.
CHMP je upošteval možno tveganje za podaljšanje intervala QTc in za zmanjšanje tveganja za bolnike v informacije o zdravilu vključil omejitve.
Malaria is an infection caused by a parasite known as Plasmodium and spread through the bite of an infected mosquito.
Malarija je okužba, ki jo povzroča parazit, imenovan plazmodij, in se prenaša z ugrizom okuženega komarja.
What benefit has Eurartesim shown during the studies?
Kakšne koristi je zdravilo Eurartesim izkazalo med študijami?
Although the exact way in which it kills the parasite is not fully understood, it is believed to damage the parasite membrane.
Čeprav natančen mehanizem delovanja, s katerim zdravilo uniči parazit, še ni popolnoma znan, se domneva, da poškoduje njegovo membrano.
Eurartesim must not be used in patients with severe malaria.
Ne sme se uporabljati pri bolnikih s hudo malarijo.
The Eurartesim carton is to include instructions to take the medicine at least 3 hours before or after food.
Ovojnina zdravila Eurartesim mora vsebovati navodilo, da se zdravilo daje vsaj tri ure po hrani ali pred njo.
In adults, the most common side effects with Eurartesim (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), headache, QTc interval prolongation (an alteration of the electrical activity of the heart, which can cause a life-threatening abnormality of heart rhythm), tachycardia (rapid heartbeat), weakness, and fever.
Najpogostejši neželeni učinki zdravila Eurartesim pri odraslih (opaženi pri 1 do 10 bolnikih od 100) so anemija (nizko število rdečih krvnih celic), glavobol, podaljšanje intervala QTc (sprememba električne aktivnosti srca, ki lahko povzroči življenjsko nevaren nenormalen srčni ritem), tahikardija (pospešen srčni utrip), oslabelost in povišana telesna temperatura.
What measures are being taken to ensure the safe use of Eurartesim?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Eurartesim?
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 Eurartesim.
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.
The Committee noted that Eurartesim meets World Health Organization recommendations for P. falciparum malaria treatment by offering a new alternative artemisinin combination therapy containing two active substances which work in different ways.
Odbor je ugotovil, da zdravilo Eurartesim izpolnjuje priporočila Svetovne zdravstvene organizacije za zdravljenje malarije P. falciparum, saj ponuja novo alternativno kombinirano zdravljenje z artemizininom, ki vsebuje dve zdravilni učinkovini, ki delujeta na različna načina.
Therefore, the Committee concluded that the benefits of Eurartesim outweigh its risks and recommended that it be granted marketing authorisation.
Zato je CHMP zaključil, da so koristi zdravila Eurartesim večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Eurartesim piperaquine tetraphosphate / artenimol
Eurartesim piperakin tetrafosfat/artenimol
Artenimol is a derivative of the naturally occurring substance artemisinin.
Artenimol je derivat naravne snovi artemizinin.
The active substances in Eurartesim, piperaquine tetraphosphate and artenimol, are antimalarial substances which kill the P. falciparum parasite.
Zdravilni učinkovini v zdravilu Eurartesim, piperakin tetrafosfat in artenimol, sta antimalarika, ki ubijeta parazit P. falciparum.
The main measure of effectiveness was the proportion of patients who were cured 63 days after treatment.
Glavno merilo učinkovitosti je bil odstotek bolnikov, ki so bili po 63 dneh zdravljenja ozdravljeni.
In children, the most common side effects with Eurartesim (seen in more than 1 patient in 10) were influenza (flu), cough and fever.
Najpogostejši neželeni učinki zdravila Eurartesim pri otrocih (opaženi pri več kot 1 od 10 bolnikov) so influenca (gripa), kašelj in povišana telesna temperatura.
In the first study, 63 days after treatment 97% of patients who received Eurartesim had been cured, compared with 95% of patients treated with the comparator medicine.
V prvi študiji je bilo po 63 dneh zdravljenja z zdravilom Eurartesim ozdravljenih 97 % bolnikov v primerjavi s 95 %bolnikov, ki so jih zdravili s primerjalnim zdravilom.
The main measure of effectiveness was the proportion of patients who were cured 28 days after treatment.
Glavno merilo učinkovitosti je bil odstotek bolnikov, ki so bili po 28 dneh zdravljenja ozdravljeni.
Eurartesim is used to treat uncomplicated malaria caused by the Plasmodium falciparum parasite.
Zdravilo Eurartesim se uporablja za zdravljenje nezapletene malarije, ki jo povzroča parazit Plasmodium falciparum.
In the second study, 28 days after treatment 93% of patients who received Eurartesim had been cured, compared with 95% of patients treated with the comparator medicine.
V drugi študiji je bilo po 28 dneh zdravljenja z zdravilom Eurartesim ozdravljenih 93 % bolnikov v primerjavi s 95 % bolnikov, ki so jih zdravili s primerjalnim zdravilom.
The CHMP considered that Eurartesim had been shown to be effective in treating uncomplicated P. falciparum malaria while the side effects were similar to those seen with comparable treatments.
CHMP je menil, da je zdravilo Eurartesim dokazano učinkovito pri zdravljenju nezapletene malarije P. falciparum, njegovi neželeni učinki pa so podobni tistim, ki so jih opazili pri primerljivih zdravilih.
Piperaquine tetraphosphate is a so-called bisquinolone.
Piperakin tetrafosfat je t. i. biskinolon.
What is the risk associated with Eurartesim?
Kakšna tveganja so povezana z zdravilom Eurartesim?
In the second study, Eurartesim was compared with another medicine containing artemether and lumefantrine in 1,553 children.
V drugi študiji so zdravilo Eurartesim pri 1 553 otrocih primerjali z drugim zdravilom proti malariji, ki vsebuje artemeter in lumefantrin.
Eurartesim is a malaria medicine that contains the active substances piperaquine tetraphosphate and artenimol.
Eurartesim je zdravilo, ki vsebuje zdravilni učinkovini piperakin tetrafosfat in artenimol.
Eurartesim was investigated in two main studies in patients with uncomplicated P. falciparum malaria.
Zdravilo Eurartesim so raziskovali v dveh glavnih študijah pri bolnikih z nezapleteno malarijo, ki jo je povzročila okužba s P. falciparum.
For the full list of all side effects with Eurartesim, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Eurartesim, glejte navodilo za uporabo.
Eurartesim was shown to be effective in treating uncomplicated P. falciparum malaria.
Dokazano je bilo, da je zdravilo Eurartesim učinkovito pri zdravljenju nezapletene malarije P. falciparum.
In the first study, Eurartesim was compared with another malaria medicine containing artesunate and mefloquine in 1,150 patients.
V prvi študiji so pri 1 150 bolnikih primerjali zdravilo Eurartesim z drugim zdravilom proti malariji, ki vsebuje artezunat in meflokin.
Why has Eurartesim been approved?
Zakaj je bilo zdravilo Eurartesim odobreno?
How has Eurartesim been studied?
Kako je bilo zdravilo Eurartesim raziskano?
What is Eurartesim used for?
Za kaj se zdravilo Eurartesim uporablja?
What is Eurartesim?
Kaj je zdravilo Eurartesim?
How does Eurartesim work?
Kako zdravilo Eurartesim deluje?
It is thought to work by blocking a step in the parasite's metabolism needed for its survival.
Domnevajo, da zavira postopek v presnovi parazita,
How is Eurartesim used?
Kako se zdravilo Eurartesim uporablja?
They may also have episodes of depression.
Imajo lahko tudi epizode depresije.
Its exact mechanism of action is unknown, but it attaches to several different receptors on nerve cells in the brain.
Natančen mehanizem njegovega delovanja ni znan, znano pa je, da se veže na več različnih receptorjev na živčnih celicah v možganih.
In this way, aripiprazole helps to change the activity of the nerve cells which are thought to give rise to psychotic or manic symptoms and preventing them from returning.
Na ta način aripiprazol pomaga spremeniti delovanje živčnih celic, ki naj bi povzročale psihotične ali manične simptome, in preprečuje njihovo ponovitev.
This means that it is similar to a ‘reference medicine', but it contains aripiprazole at a new strength in addition to existing strengths: while the reference medicine, Abilify, is available as 5, 10, 15 and 30 mg, Aripiprazole Sandoz is also available as 20 mg tablets.
To pomeni, da je podobno „referenčnemu zdravilu“, vendar poleg obstoječih jakosti vključuje novo jakost aripiprazola: referenčno zdravilo Abilify je na voljo v jakostih 5, 10, 15 in 30 mg, zdravilo Aripiprazole Sandoz pa tudi kot 20 mg tablete.
The full EPAR and risk management plan summary for Aripiprazole Sandoz 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 Aripiprazole Sandoz sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This disrupts signals transmitted between brain nerve cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
S tem je moten prenos signalov med živčnimi celicami v možganih prek „nevrotransmitorjev“ (živčnih prenašalcev), tj. kemičnih snovi, ki omogočajo sporazumevanje med celicami.
This is a summary of the European public assessment report (EPAR) for Aripiprazole Sandoz.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Aripiprazole Sandoz.
The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Sandoz is broken down in the body.
Odmerek je treba prilagoditi pri bolnikih, ki jemljejo druga zdravila, ki vplivajo na razgradnjo zdravila Aripiprazole Sandoz v telesu.
The Committee recommended that Aripiprazole Sandoz be approved for use in the EU.
Priporočil je, da se zdravilo Aripiprazole Sandoz odobri za uporabo v EU.
Because Aripiprazole Sandoz is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Aripiprazole Sandoz biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters.
To pomeni, da aripiprazol z aktiviranjem teh receptorjev deluje kot dopamin in 5-hidroksitriptamin, vendar šibkeje kot nevrotransmitorji.
Aripiprazole is thought to act mainly by being a ‘partial agonist' at the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
Aripiprazol domnevno deluje predvsem kot „delni agonist“ receptorjev za nevrotransmitorja dopamin in 5-hidroksitriptamin (imenovan tudi serotonin).
What measures are being taken to ensure the safe and effective use of Aripiprazole Sandoz?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Aripiprazole Sandoz?
Aripiprazole Sandoz is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults whose illness has improved with the medicine in the past.
Zdravilo Aripiprazole Sandoz se uporablja pri odraslih za zdravljenje zmernih do hudih maničnih epizod ter preprečevanje novih maničnih epizod pri odraslih, katerih bolezen se je v preteklosti z zdravilom že izboljšala.
The company provided data from the published literature on aripiprazole.
Družba je predstavila podatke o aripiprazolu iz objavljene literature.
Aripiprazole Sandoz is used in patients with the following mental illnesses:
Zdravilo Aripiprazole Sandoz se uporablja pri bolnikih z naslednjimi duševnimi boleznimi:
What are the benefits and risks of Aripiprazole Sandoz?
Kakšne so koristi in tveganja, povezani z zdravilom Aripiprazole Sandoz?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Sandoz has been shown to have comparable quality and to be bioequivalent to Abilify.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Aripiprazole Sandoz primerljivo raven kakovosti kot zdravilo Abilify ter da mu je biološko enakovredno.
A risk management plan has been developed to ensure that Aripiprazole Sandoz is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Aripiprazole Sandoz je bil pripravljen načrt obvladovanja tveganj.
For more information about treatment with Aripiprazole Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Aripiprazole Sandoz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
In addition, when used for patients aged 13 years or older with moderate to severe manic episodes in bipolar I disorder, the company that markets Aripiprazole Sandoz will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in these patients.
Poleg tega bo družba, ki trži zdravilo Aripiprazole Sandoz, za bolnike, stare 13 let ali več, z zmernimi do hudimi maničnimi epizodami pri bipolarni motnji I pripravila izobraževalno gradivo za bolnike, njihove negovalce in zdravnike, ki bo pojasnjevalo varno uporabo tega zdravila pri teh bolnikih.
For practical information about using Aripiprazole Sandoz, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Aripiprazole Sandoz naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.