natgillin/translations-raw huggingface dataset:
Non-clinical mechanistic studies are already planned or on-going for dapagliflozin- and empagliflozin-containing products; such study is also required to be undertaken by the MAH of canagliflozin-containing products. 
Za zdravila, ki vsebujejo dapagliflozin in empagliflozin, so neklinične študije mehanizma že načrtovane oziroma potekajo; tovrstno študijo morajo izvesti tudi imetniki dovoljenj za promet z zdravili, ki vsebujejo kanagliflozin.
Several postauthorisation safety studies are planned or ongoing in order to compare the incidence of DKA in SGLT2 inhibitors and other anti-hyperglycaemic agents. 
Načrtuje ali izvaja se več študij varnosti v obdobju po izdaji dovoljenja za promet z zdravilom, namenjenih primerjavi pojavnosti DKA pri zaviralcih SGLT2 in drugih antihiperglikemičnih zdravilih.
In addition, the PRAC considered that “DKA with atypical presentation” should be added as an important identified risk to the Risk Management Plan (RMP) of those products. 
Poleg tega je odbor PRAC menil, da je treba v načrt za obvladovanje tveganja (RMP) za ta zdravila kot pomembno znano tveganje vključiti „DKA z atipično sliko".
Further, restarting SGLT2 inhibitor medication in patients with previous DKA while on treatment is not recommended unless another clear precipitating factor is identified and resolved. 
Ponovna uvedba zdravljenja z zaviralcem SGLT2 pri bolnikih, pri katerih se je DKA med zdravljenjem že pojavila, ni priporočljiva, razen če se ugotovi in odpravi drug očiten sprožilni dejavnik.
DKA typically occurs in T1DM patients with high blood glucose concentrations. 
DKA se praviloma pojavi pri bolnikih s sladkorno boleznijo tipa 1 z visoko koncentracijo glukoze v krvi.
The PRAC, as a consequence, recommended the variation to the terms of the marketing authorisations for SGLT2 inhibitors-containing products. 
Posledično je odbor PRAC priporočil spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo zaviralce SGLT2.
Limited data from clinical trials suggest that DKA occurs with common frequency in T1DM patients. 
Omejeni podatki iz kliničnih preskušanj kažejo, da se DKA pri bolnikih s sladkorno boleznijo tipa 1 pojavlja s pogostnostjo „pogosto".
The PRAC considered that these should be included in the product information and physicians advised to consider the patient's history before initiating treatment with SGLT2 inhibitors. 
Odbor PRAC je menil, da je treba te dejavnike vključiti v informacije o zdravilu in zdravnike obvestiti, naj pred uvedbo zdravljenja z zaviralci SGLT2 proučijo bolnikovo anamnezo.
One hundred and two serious and sometimes life-threatening cases of DKA suggestive of a causal association were identified in T2DM patients for the three active substances, raising thus a safety signal. 
Za te tri zdravilne učinkovine so pri bolnikih s sladkorno boleznijo tipa 2 našli 102 resna in občasno življenjsko nevarna primera DKA, ki sta kazala na vzročno povezanost, kar je sprožilo varnostni signal.
• The PRAC concluded that a small excess risk of DKA associated with SGLT2 inhibitors treatment in patients with T2DM could not be excluded. 
• Odbor PRAC je zaključil, da nekoliko povišanega tveganja za DKA, povezanega z zdravljenjem z zaviralci SGLT2, pri bolnikih s sladkorno boleznijo tipa 2 ni mogoče izključiti.
No subset of the population at increased risk could be identified from the analysis of cases reported in clinical studies. 
Iz analize primerov, o katerih so poročali v kliničnih študijah, ni bilo mogoče določiti podskupine populacije s povečanim tveganjem.
Importantly, DKA with atypical presentation may occur in association with SGLT2 inhibitors. 
Zlasti pomembno je, da se v povezavi z zaviralci SGLT2 lahko pojavi DKA z atipično sliko.
Patients should be advised to contact a doctor in order to be tested for ketoacidosis and to discontinue SGLT2 inhibitor treatment if DKA is suspected or diagnosed. 
Bolnikom je treba svetovati, da se v primeru diagnoze DKA ali suma nanjo obrnejo na zdravnika, ki jih bo poslal na preiskave za ketoacidozo, in prekinejo zdravljenje z zaviralcem SGLT2.
The PRAC further concluded that a risk of DKA, including with atypical presentation, is also associated with SGLT2 inhibitors treatment in patients with T1DM. 
Odbor PRAC je nadalje menil, da je tveganje za DKA, vključno z atipično sliko, povezano tudi z zdravljenjem z zaviralci SGLT2 pri bolnikih s sladkorno boleznijo tipa 1.
However, cases reported with SLGT2 inhibitors occurred in patients with T2DM as well as T1DM. 
Primeri, o katerih so poročali v povezavi z zaviralci SLGT2, pa so se pojavili tako pri bolnikih s sladkorno boleznijo tipa 2 kot pri bolnikih s sladkorno boleznijo tipa 1.
• The PRAC further concluded that a risk of DKA, including with atypical presentation, is also associated with the use of SGLT2 inhibitors in patients with T1DM. 
• Odbor PRAC je nadalje zaključil, da je tveganje za DKA, vključno z atipično sliko, povezano tudi z zdravljenjem z zaviralci SGLT2 pri bolnikih s sladkorno boleznijo tipa 1.
therefore the populations may not share the same baseline risk of DKA and careful consideration should be given to any direct incidence comparison. 
Nadalje so v programih kliničnega razvoja zdravil uporabljali različna vključitvena in izključitvena merila, zato populacije nimajo enakega izhodiščnega tveganja za DKA in je treba skrbno proučiti neposredne primerjave pojavnosti.
In addition, the MAHs are required to clarify the mechanism behind SGLT2 inhibitors-induced DKA. 
Poleg tega morajo imetniki dovoljenj za promet z zdravili pojasniti mehanizem, s katerim zaviralci SGLT2 povzročajo DKA.
Some of these effects were severe. 
Nekateri neželeni učinki so bili hudi.
What measures are being taken to ensure the safe and effective use of Jevtana? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Jevtana?
The full EPAR for Jevtana 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 Jevtana je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Jevtana on 17 March 2011. 
Evropska komisija je dovoljenje za promet z zdravilom Jevtana, veljavno po vsej Evropski uniji, izdala 17. marca 2011.
This is a summary of the European public assessment report (EPAR) for Jevtana. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Jevtana.
What are the risks associated with Jevtana? 
Kakšna tveganja so povezana z zdravilom Jevtana?
It is given once every three weeks as an infusion lasting one hour, at a dose of 25 mg per square metre body surface area (calculated using the patient's weight and height). 
Daje se vsake tri tedne kot enourna infuzija v odmerku 25 mg na kvadratni meter telesne površine (izračunane na podlagi bolnikove telesne mase in višine).
The average overall survival for patients treated with Jevtana was 15.1 months compared with 12.7 months for patients given mitoxantrone. 
Povprečno skupno preživetje pri bolnikih, ki so jemali zdravilo Jevtana, je bilo 15,1 meseca v primerjavi z 12,7 meseca pri bolnikih, ki so jemali mitoksantron.
With their skeleton still in place, the cells cannot divide and they eventually die. 
Ker ogrodje ostane nespremenjeno, se celice ne morejo deliti in sčasoma odmrejo.
It is given in combination with prednisone or prednisolone, taken daily throughout treatment. 
Daje se v kombinaciji s prednizonom ali prednizolonom, ki se jemljeta vsak dan skozi celotno obdobje zdravljenja.
It decided that Jevtana's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Zaključil je, da so koristi tega zdravila večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
It must not be given to patients whose blood neutrophil count is below 1,500/mm3, who have severely reduced liver function or who recently received or are about to receive a yellow fever vaccine. 
Ne smejo ga jemati bolniki, pri katerih je število nevtrofilcev v krvi nižje od 1 500/mm3, bolniki, ki imajo hudo okvaro jeter, ali osebe, ki so nedavno bile ali bodo cepljene proti rumeni mrzlici.
For more information about treatment with Jevtana, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Jevtana preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Cabazitaxel works by blocking the ability of cancer cells to break down their internal ‘skeleton' that allows them to divide and multiply. 
Kabazitaksel deluje tako, da zavira sposobnost rakavih celic za razgradnjo njihovega notranjega „ogrodja“, ki jim omogoča, da se delijo in množijo.
The most common side effects with Jevtana (seen in more than 1 patient in 10) include anaemia (low red blood cell counts), leucopenia (low white blood cell counts), neutropenia (low counts of neutrophils, a type of white blood cell), thrombocytopenia (low blood platelet counts) and diarrhoea. 
Najpogostejši neželeni učinki zdravila Jevtana (opaženi pri več kot 1 bolniku od 10) so anemija (nizko število rdečih krvnih celic), levkopenija (nizko število belih krvnih celic), nevtropenija (nizko število nevtrofilcev, vrste belih krvnih celic), trombocitopenija (nizko število trombocitov) in driska.
This is cancer that affects the prostate gland in men that produces the liquid in semen. 
To je rak, ki prizadene prostato, žlezo pri moških, ki proizvaja semensko tekočino.
What benefits of Jevtana have been shown in studies? 
Kakšne koristi je zdravilo Jevtana izkazalo v študijah?
Before receiving Jevtana infusions, patients should first be given medicines to prevent allergic reactions and medicines to prevent vomiting. 
Pred infundiranjem zdravila Jevtana morajo bolniki najprej prejeti zdravila, ki preprečujejo alergijske reakcije, in zdravila, ki preprečujejo bruhanje.
Why has Jevtana been approved? 
Zakaj je bilo zdravilo Jevtana odobreno?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jevtana 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 Jevtana upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
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 Jevtana. 
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 doses should also be reduced in patients with mildly or moderately reduced liver function. 
Odmerek zdravila je treba zmanjšati tudi pri bolnikih z lažjo ali zmerno okvaro jeter.
Both medicines were given in combination with prednisone or prednisolone. 
Obe zdravili so dajali v kombinaciji z prednizonom ali prednizolonom.
What is Jevtana and what is it used for? 
Kaj je zdravilo Jevtana in za kaj se uporablja?
Other information about Jevtana 
Druge informacije o zdravilu Jevtana
Jevtana also affects non-cancer cells, such as blood and nerve cells, which can cause side effects. 
Zdravilo učinkuje tudi na nerakave celice, kot so krvne ali živčne celice, kar lahko povzroči neželene učinke.
Jevtana is used when the cancer has spread to other parts of the body (metastatic) despite treatments to prevent the production of testosterone or after surgical removal of the testes (castration). 
Zdravilo Jevtana se uporablja, kadar se je rak razširil na druge dele telesa (metastaziral) kljub zdravljenjem za zaviranje tvorjenja testosterona ali po kirurški odstranitvi mod (kastraciji).
The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the ability of Jevtana to prolong overall survival in castration-resistant metastatic prostate cancer patients was clinically important. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je menil, da je učinkovitost zdravila Jevtana pri celokupnem podaljšanju preživetja bolnikov z metastatskim, proti kastraciji odpornim rakom prostate klinično pomembna.
Jevtana can only be obtained with a prescription and should only be used in units specialising in chemotherapy (medicines to treat cancer) under the supervision of a doctor experienced in the use of chemotherapy. 
Predpisovanje in izdaja zdravila Jevtana je le na recept, uporabljati pa se sme samo v enotah, specializiranih za kemoterapijo (zdravila za zdravljenje raka), pod nadzorom zdravnika, ki ima izkušnje z uporabo tovrstnega zdravljenja.
Jevtana must not be used in people who are hypersensitive (allergic) to cabazitaxel, to any other taxane, or to any of the other ingredients. 
Zdravila ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) kabazitaksel, na kateri koli drugi taksan ali katero koli drugo sestavino zdravila.
Jevtana is used in combination with prednisone or prednisolone (anti-inflammatory medicines) in patients who have previously been treated with docetaxel (another cancer medicine). 
Uporablja se v kombinaciji s prednizonom ali prednizolonom (protivnetnima zdraviloma) pri bolnikih, ki so se že zdravili z docetakselom (drugim zdravilom za zdravljenje raka).
The active substance in Jevtana, cabazitaxel, belongs to the group of cancer medicines known as ‘taxanes'. 
Zdravilna učinkovina zdravila Jevtana, kabazitaksel, spada v skupino zdravil proti raku, ki so znana kot taksani.
The effects of Jevtana were compared with another cancer medicine, mitoxantrone. 
Učinke zdravila Jevtana so primerjali z učinki drugega zdravila za zdravljenje raka, mitoksantrona.
How is Jevtana used? 
Kako se zdravilo Jevtana uporablja?
For the full list of all side effects reported with Jevtana, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Jevtana, glejte navodilo za uporabo.
Jevtana is available as a concentrate and a solvent to be made up into a solution for infusion (drip) into a vein. 
Zdravilo Jevtana je na voljo v obliki koncentrata in vehikla za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
Jevtana is a cancer medicine used to treat men with metastatic castration-resistant prostate cancer. 
Jevtana je zdravilo proti raku, ki se uporablja za zdravljenje dveh vrst metastatskega, proti kastraciji odpornega raka prostate.
For more information, see the package leaflet. 
Več informacij je na voljo v navodilu za uporabo.
How does Jevtana work? 
Kako zdravilo Jevtana deluje?
Jevtana prolonged overall survival (the average length of time the patients lived) in one main study involving 755 men with metastatic castration-resistant prostate cancer who had previously been treated with docetaxel. 
V eni glavni študiji pri 755 moških z metastatskim, proti kastraciji odpornim rakom prostate, ki so se prej zdravili z docetakselom, je zdravilo Jevtana podaljšalo celokupno preživetje (povprečen čas, ko je bolnik živel).
Jevtana contains the active substance cabazitaxel. 
Zdravilo Jevtana vsebuje zdravilno učinkovino kabazitaksel.
The dose of Jevtana should be reduced or treatment stopped if the patient has certain side effects. 
Če se pri bolniku pojavijo določeni neželeni učinki, je treba odmerek zdravila Jevtana zmanjšati ali zdravljenje prekiniti.
monograph 0063. 
monografiji 0063.
* PD50- 50% protective dose in cattle as described in Ph. Eur. 
* ZO50 - 50% zaščitni odmerek za govedo, kot je predpisano v Ph. Eur.
A24 Cruzeiro and A Turkey 14/98 ≥ 6 PD50* 
A24 Cruzeiro in A Turkey 14/98 ≥ 6 PD50*
O Taiwan 3/97 and A Turkey 14/98 ≥ 6 PD50* 
O Taiwan 3/97 in A Turkey 14/98 ≥ 6 PD50*
A22 Iraq and A24 Cruzeiro ≥ 6 PD50* 
A22 Iraq in A24 Cruzeiro ≥ 6 PD50*
A Turkey 14/98 and Asia 1 Shamir ≥ 6 PD50* 
A Turkey 14/98 in Asia 1 Shamir ≥ 6 PD50*
O1 Manisa, O1 BFS and O Taiwan 3/97 ≥ 6 PD50* 
O1 Manisa and O1 BFS in O Taiwan 3/97 ≥ 6 PD50*
A22 Iraq and Asia1 Shamir ≥ 6 PD50* 
A22 Iraq in Asia1 Shamir ≥ 6 PD50*
O1 Manisa and O1 BFS ≥ 6 PD50* 
O1 Manisa in O1 BFS ≥ 6 PD50*
O Taiwan 3/97 and A22 Iraq ≥ 6 PD50* 
O Taiwan 3/97 in A22 Iraq ≥ 6 PD50*
O Taiwan 3/97 and A24 Cruzeiro ≥ 6 PD50* 
O Taiwan 3/97 in A24 Cruzeiro ≥ 6 PD50*
O1 Manisa and A22 Iraq ≥ 6 PD50* 
O1 Manisa in A22 Iraq ≥ 6 PD50*
A24 Cruzeiro and Asia 1 Shamir ≥ 6 PD50* 
A24 Cruzeiro in Asia 1 Shamir ≥ 6 PD50*
O1 BFS, O Taiwan 3/97 and A Turkey 14/98 ≥ 6 PD50* 
O1 BFS in O Taiwan 3/97 in A Turkey 14/98 ≥ 6 PD50*
O1 Manisa and A24 Cruzeiro ≥ 6 PD50* 
O1 Manisa in A24 Cruzeiro ≥ 6 PD50*
O1 Manisa, O1 BFS and A 24 Cruzeiro ≥ 6 PD50* 
O1 Manisa and O1 BFS in A 24 Cruzeiro ≥ 6 PD50*
A24 Cruzeiro, A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50* 
A24 Cruzeiro in A Turkey 14/98 in Asia1 Shamir ≥ 6 PD50*
O1 BFS, A24 Cruzeiro and A Turkey 14/98 ≥ 6 PD50* 
O1 BFS in A24 Cruzeiro in A Turkey 14/98 ≥ 6 PD50*
O1 BFS and A24 Cruzeiro ≥ 6 PD50* 
O1 BFS in A24 Cruzeiro ≥ 6 PD50*
O1 BFS and A22 Iraq ≥ 6 PD50* 
O1 BFS in A22 Iraq ≥ 6 PD50*
O1 BFS, A Turkey 14/98 and SAT2 Saudi Arabia ≥ 6 PD50* 
O1 BFS, A Turkey 14/98 & SAT2Saudi Arabia ≥ 6 PD50*
O1 Manisa, A24 Cruzeiro and A Turkey 14/98 ≥ 6 PD50* 
O1 Manisa in A24 Cruzeiro in A Turkey 14/98 ≥ 6 PD50*
O Taiwan 3/97 and Asia1 Shamir ≥ 6 PD50* 
O Taiwan 3/97 in Asia1 Shamir ≥ 6 PD50*
O Taiwan 3/97, A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50* 
O Taiwan 3/97 in A Turkey 14/98 in Asia1 Shamir ≥ 6 PD50*
A22 Iraq, A24 Cruzeiro and Asia1 Shamir ≥ 6 PD50* 
A22 Iraq in A24 Cruzeiro in Asia1 Shamir ≥ 6 PD50*
O1 Manisa, O Taiwan 3/97 and A24 Cruzeiro ≥ 6 PD50* 
O1 Manisa in O Taiwan 3/97 in A24 Cruzeiro ≥ 6 PD50*
O1 BFS, O Taiwan 3/97 and A24 Cruzeiro ≥ 6 PD50* 
O1 BFS in O Taiwan 3/97 in A24 Cruzeiro ≥ 6 PD50*
O Taiwan 3/97, A24 Cruzeiro and Asia1 Shamir ≥ 6 PD50* 
O Taiwan 3/97 in A24 Cruzeiro in Asia1 Shamir ≥ 6 PD50*
O1 Manisa, O Taiwan 3/97 and A22 Iraq ≥ 6 PD50* 
O1 Manisa in O Taiwan 3/97 in A22 Iraq ≥ 6 PD50*
O1 BFS, O Taiwan 3/97 and A22 Iraq ≥ 6 PD50* 
O1 BFS in O Taiwan 3/97 in A22 Iraq ≥ 6 PD50*
O1 Manisa, O Taiwan 3/97 and Asia1 Shamir ≥ 6 PD50* 
O1 Manisa in O Taiwan 3/97 in Asia1 Shamir ≥ 6 PD50*
O1 BFS, O Taiwan 3/97 and Asia1 Shamir ≥ 6 PD50* 
O1 BFS in O Taiwan 3/97 in Asia1 Shamir ≥ 6 PD50*
O Taiwan 3/97, A22 Iraq and Asia1 Shamir ≥ 6 PD50* 
O Taiwan 3/97 in A22 Iraq in Asia1 Shamir ≥ 6 PD50*
O1 BFS, A22 Iraq and Asia1 Shamir ≥ 6 PD50* 
O1 BFS in A22 Iraq in Asia1 Shamir ≥ 6 PD50*
O1 BFS, A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50* 
O1 BFS in A Turkey 14/98 in Asia1 Shamir ≥ 6 PD50*
O1 Manisa, A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50* 
O1 Manisa in A Turkey 14/98 in Asia1 Shamir ≥ 6 PD50*
O1 BFS, A22 Iraq and A24 Cruzeiro ≥ 6 PD50* 
O1 BFS in A22 Iraq in A24 Cruzeiro ≥ 6 PD50*
O1 BFS and Asia1 Shamir ≥ 6 PD50* 
O1 BFS in Asia1 Shamir ≥ 6 PD50*
O1 Manisa, A24 Cruzeiro and Asia1 Shamir ≥ 6 PD50* 
O1 Manisa in A24 Cruzeiro in Asia1 Shamir ≥ 6 PD50*
O1 Manisa and Asia1 Shamir ≥ 6 PD50* 
O1 Manisa in Asia1 Shamir ≥ 6 PD50*
O1 BFS, A24 Cruzeiro and Asia1 Shamir ≥ 6 PD50* 
O1 BFS in A24 Cruzeiro in Asia1 Shamir ≥ 6 PD50*
O1 Manisa, O1 BFS and Asia1 Shamir ≥ 6 PD50* 
O1 Manisa and O1 BFS in Asia1 Shamir ≥ 6 PD50*
O Taiwan 3/97, A22 Iraq and A24 Cruzeiro ≥ 6 PD50* 
O Taiwan 3/97 in A22 Iraq in A24 Cruzeiro ≥ 6 PD50*
O1 BFS and O Taiwan ≥ 6 PD50* 
O1 BFS in O Taiwan 3/97 ≥ 6 PD50*
O1 Manisa and O Taiwan ≥ 6 PD50* 
O1 Manisa in O Taiwan 3/97 ≥ 6 PD50*
O1 Manisa and A Turkey ≥ 6 PD50* 
O1 Manisa in A Turkey 14/98 ≥ 6 PD50*
O1 BFS and A Turkey ≥ 6 PD50* 
O1 BFS in A Turkey 14/98 ≥ 6 PD50*
In the general safety analyses, no specific safety concerns were identified. 
V splošnih analizah varnosti niso odkrili nobenih posebnih skrbi glede varnosti.
From 6 weeks to 32 weeks 
Od 6 do 32 tednov
The following information is intended for health care professionals only: 
Naslednje informacije so namenjene samo zdravstvenemu osebju:
Date of first authorisation: 27 June 2006 
Datum prve odobritve: 27. junij 2006
The results of these analyses are presented in the following tables. 
Rezultati teh analiz so predstavljeni v tabelah v nadaljevanju.
Store in a refrigerator (2 °C to 8 °C). 
Shranjujte v hladilniku (2 °C do 8 °C).
Effectiveness % [95%CI] 
Učinkovitost % [95 % IZ]
Date of latest renewal: 18 May 2011 
Datum zadnjega podaljšanja: 18. maj 2011
4.8 Undesirable effects a. Summary of the safety profile 
4.8 Neželeni učinki a. Povzetek varnostnega profila cepiva
There was an extension of REST conducted in Finland only. 
Študija REST je bila podaljšana le na Finskem.
Statistically significant 
statistično pomembno
See sections 4.2 and 5.1. 
Glejte poglavji 4.2. in 5.1.
Clinical trials of efficacy against rotavirus gastroenteritis were performed in Europe, the United States, Latin America, and Asia. 
Klinična preskušanja učinkovitosti proti rotavirusnemu gastroenteritisu so bila izvedena v Evropi, Združenih državah, Latinski Ameriki in Aziji.
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed. 
Ker je korist cepljenja v tej skupini otrok velika, se cepljenja ne sme odložiti ali opustiti.
A minor infection such as a cold should not be a problem, but talk to your doctor first. 
Blaga okužba, kot je prehlad, ni ovira, vendar se prej posvetujte z zdravnikom.
Parents/guardians should be advised to promptly report such symptoms to their healthcare provider. 
Staršem/spremljevalcem je treba svetovati, da o teh simptomih takoj poročajo zdravstvenemu osebju.
Study population 
Preučevana populacija
Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data) 
Pogostnost je označena kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100, < 1/10); občasni (≥ 1/1.000, < 1/100); redki (≥ 1/10.000, < 1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov)
The dose administered to mice was approximately 2.79 x 10 
Odmerek, ki so ga dali mišim, je bil približno 2,79 x 10
The frequency category was estimated based on observational study data. 
Kategorija pogostnosti je bila ocenjena na podlagi podatkov iz opazovalnih študij.
This may present as wheezing, coughing or difficulty breathing. 
To se lahko kaže kot piskanje, kašelj ali težave pri dihanju.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c (7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
RV seasons 
RV sezone
*RV-negative acute gastroenteritis controls 
*RV-negativne kontrole akutnega gastroenteritisa
In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products. 
Zaradi pomanjkanja študij kompatibilnosti, tega cepiva ne smemo mešati z drugimi zdravili.
• Not known (frequency cannot be estimated from the available data): irritability 
• neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): razdražljivost
Telephone: Telefax: 
Telefon: Faks:
The efficacy observed against G2P[4] most likely resulted from the G2 component of the vaccine. 
Učinkovitost, ki so jo opazili proti G2P[4], je najverjetneje povzročila G2 komponenta cepiva.
- your child has any disease which reduces his/her resistance to infection. 
- če ima katero koli bolezen, ki zmanjšuje njegovo odpornost proti okužbam.