natgillin/translations-raw huggingface dataset:
In phase III studies between 92.5 % and 100 % of recipients of RotaTeq achieved a significant rise in serum anti-rotavirus IgA after a three-dose regimen. 
V študijah III. faze je bil po cepljenju s tremi odmerki pri 92,5 % do 100 % cepljenih oseb dosežen signifikanten porast serumskih protirotavirusnih IgA protiteles.
DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
If your child gets any side effects, talk to your doctor or pharmacist. 
Če pri vašem otroku opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
Cases of gastroenteritis associated with vaccine virus have been reported post marketing in infants with severe combined immunodeficiency (SCID, see section 4.3). 
V obdobju trženja so pri dojenčkih s hudo kombinirano imunsko pomanjkljivostjo (SCID) poročali o primerih gastroenteritisa, povezanega s cepilnim virusom (glejte poglavje 4.3).
What RotaTeq looks like and contents of the pack 
Izgled cepiva RotaTeq in vsebina pakiranja peroralna raztopina
Administration of RotaTeq should be postponed in infants suffering from acute severe febrile illness. 
Cepljenje s cepivom RotaTeq je treba odložiti pri dojenčkih s hudo akutno boleznijo z zvišano telesno temperaturo.
Transmission of vaccine virus strains to non-vaccinated contacts has been observed post-marketing. 
V obdobju trženja cepiva so opazili prenos sevov cepilnega virusa na necepljene osebe, ki so bile v stiku s cepljeno osebo.
- If your child gets any side effects, talk to your doctor or pharmacist. 
- Če pri otroku opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Marketing Authorisation Holder: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France. 
Imetnik dovoljenja za promet z zdravilom: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, Francija
Please read the package leaflet for disposal of medicines no longer required 
Za odstranjevanje cepiva, ki ga ne potrebujete več, prosimo, preberite navodilo za uporabo.
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. 
Pri aplikaciji odmerkov za primarno imunizacijo veliko prezgodaj rojenih nedonošenčkov (rojenih pred ali v 28. tednu nosečnosti), še posebno tistih z respiratorno nezrelostjo v anamnezi, je treba upoštevati možno tveganje za apnejo in potrebo po 48 do 72 urnem spremljanju dihanja.
Puncture the dispensing tip by screwing cap clockwise until it becomes tight. 
Konico tube preluknjajte tako, da zaporko vrtite v smeri urnega kazalca, dokler ne začutite odpora.
RotaTeq contains sucrose. 
Cepivo RotaTeq vsebuje saharozo.
RotaTeq may be given to infants who were born early provided that the pregnancy had lasted at least 25 weeks. 
Cepivo RotaTeq lahko prejmejo nedonošenčki, ki so bili rojeni ne prej kot po 25 tednih nosečnosti.
Remove cap by turning it counterclockwise. 
Zaporko odstranite tako, da jo zavrtite proti smeri urnega kazalca.
In a subset of infants from 3 placebo-controlled clinical trials (n=6,130 recipients of RotaTeq and 5,560 placebo recipients), RotaTeq was evaluated for all adverse events within 42 days of vaccination with or without concomitant use of other paediatric vaccines. 
Pri podskupini dojenčkov, ki so bili vključeni v 3 s placebom nadzorovana klinična preskušanja (6.130 dojenčkov, ki so prejeli cepivo RotaTeq, in 5.560 dojenčkov, ki so prejeli placebo), so vrednotili vse neželene dogodke cepiva RotaTeq, ki so se pojavili v 42 dneh po cepljenju.
The safety and efficacy of RotaTeq were comparable between this subset of infants and infants born at term. 
Varnost in učinkovitost cepiva RotaTeq pri nedonošenčkih sta bili primerljivi z varnostjo in učinkovitostjo pri dojenčkih rojenih na rok.
The following other side effects reported with the use of RotaTeq were: 
Pri uporabi cepiva RotaTeq so poročali o naslednjih drugih neželenih učinkih:
How to use RotaTeq 
Kako uporabljati cepivo RotaTeq
The vaccine is to be administered orally without mixing with any other vaccines or solutions. 
Ne smete ga mešati s katerim koli drugim cepivom ali katero koli drugo raztopino.
Address: 
Naslov:
In REST, RotaTeq was administered to approximately 1,000 infants who were born at a gestational age of 25 to 36 weeks. 
V študiji REST so cepivo RotaTeq dajali približno 1.000 nedonošenčkom, ki so bili rojeni od 25. do 36. tedna nosečnosti.
No immunological correlate of protection has currently been identified for rotavirus vaccines. 
Pri cepivih proti rotavirusom povezave med imunskim odzivom in zaščito trenutno še niso odkrili.
RotaTeq should be administered promptly after removal from refrigeration. 
Ko cepivo RotaTeq vzamete iz hladilnika, ga morate takoj aplicirati.
- your child developed an allergic reaction after receiving a dose of RotaTeq or other rotavirus vaccine. 
- če se je po predhodno prejetem odmerku cepiva RotaTeq ali drugega cepiva proti rotavirusom pri njem pojavila alergijska reakcija.
Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora redki bronhospazem
The overall frequency of these serious adverse reactions was 0.1 % among recipients of RotaTeq and 0.2 % among placebo recipients. 
Pri otrocih, ki so prejeli cepivo RotaTeq, je bila pojavnost resnih neželenih učinkov 0,1 %, pri otrocih, ki so prejeli placebo, pa 0,2 %.
RotaTeq IS FOR ORAL USE ONLY. 
Cepivo RotaTeq JE SAMO ZA PERORALNO UPORABO.
Keep this vaccine out of the sight and reach of children. 
Cepivo shranjujte nedosegljivo otrokom!
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Text for the protective bag 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Merck Sharp & Dohme Corp. 
Ime izdelovalca: Merck Sharp & Dohme Corp.
Intussusception 
Invaginacija
Hospitalization due to RVGE 98% [83,100] 
1.895 cepljenih s 3 odmerki 2.102 necepljenih starih < 2 leti hospitalizacija zaradi RVGE 98 % [83,100]
Serious adverse reactions were assessed in all participants (36,150 recipients of RotaTeq and 35,536 placebo recipients) of 3 clinical trials for up to 42 days after each dose. 
Pri vseh otrocih (36.150 otrok, ki so prejeli cepivo RotaTeq, in 35.536 otrok, ki so prejeli placebo), ki so bili vključeni v 3 klinična preskušanja, so ocenili pojavnost resnih neželenih učinkov, ki so se pojavili v 42 dneh po vsakem odmerku.
Do not use RotaTeq if: 
Otrok ne sme prejeti cepiva RotaTeq:
What RotaTeq contains 
Kaj vsebuje cepivo RotaTeq
rotavirus type* G4 
rotaviruse tipa* G4
rotavirus type* G3 
rotaviruse tipa* G3
Subjects with congenital malformation of the gastrointestinal tract that could predispose to intussusception. 
Osebe s prirojenimi nepravilnostmi prebavil, ki bi lahko povzročile nagnjenost k invaginaciji.
rotavirus type* G1 
rotaviruse tipa* G1
rotavirus type* G2 
rotaviruse tipa* G2
Not known 
Opazovani dogodki
Merck Sharp and Dohme BV 
Ime izdelovalca: Merck Sharp and Dohme BV Naslov:
Method of administration Rotateq is for oral administration only. 
Način uporabe Cepivo RotaTeq je samo za peroralno uporabo.
Ask your doctor/health care professional if you want more information about side effects for RotaTeq. 
Če želite več informacij o neželenih učinkih cepiva RotaTeq, vprašajte zdravnika ali drugo zdravstveno osebje.
How to store RotaTeq 
Shranjevanje cepiva RotaTeq
RotaTeq is indicated for the active immunisation of infants from the age of 6 weeks to 32 weeks for prevention of gastroenteritis due to rotavirus infection (see sections 4.2, 4.4 and 5.1). 
Cepivo RotaTeq je indicirano za aktivno imunizacijo dojenčkov, starih od 6 do 32 tednov.
Clear the fluid from the dispensing tip by holding tube vertically and tapping the twist-off cap. 
Tubo držite v navpičnem položaju in s frcanjem pokrovčka iz konice tube odstranite tekočino.
Immune system disorders 
Bolezni imunskega sistema neznana anafilaktična reakcija
not less than 2.8 x 10 6 IU 
ne manj kot 2,8 x 10
RotaTeq is an oral vaccine that helps protect infants and young children against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infection and may be given to infants from the age of 6 weeks to 32 weeks (see section 3). 
Dojenčke in majhne otroke pomaga ščititi pred gastroenteritisom (driska in bruhanje), ki ga povzroča okužba z rotavirusom.
not less than 2.3 x 10 6 IU 
ne manj kot 2,3 x 10
A complete 3-dose vaccination series of RotaTeq should be administered (see section 4.2) to provide the level and duration of protection against rotavirus gastroenteritis that was observed in the clinical studies. 
Za takšen obseg in trajanje zaščite pred rotavirusnim gastroenteritisom, kot so ju opazili v kliničnih študijah, je potrebno cepljenje z vsemi 3 odmerki cepiva RotaTeq (glejte poglavje 4.2).
Do not dilute. 
Cepiva ne redčite.
Sodium dihydrogen phosphate monohydrate Sodium hydroxide 
6.1 Seznam pomožnih snovi saharoza natrijev citrat natrijev dihidrogenfosfat monohidrat natrijev hidroksid polisorbat 80 medij za gojišče (vsebuje anorganske soli, aminokisline in vitamine) prečiščena voda
not less than 2.0 x 10 6 IU 
ne manj kot 2,0 x 10
Contact a doctor/health care professional right away if your child experiences one of the following symptoms: 
Če se pri vašem otroku pojavi kateri koli izmed naslednjih simptomov, nemudoma obvestite zdravnika/zdravstveno osebje:
not less than 2.2 x 10 6 IU 
ne manj kot 2,2 x 10
If you forget an appointment for RotaTeq: 
Če ste pozabili na dogovorjen obisk za cepljenje s cepivom RotaTeq
During these trials, the most common circulating rotavirus genotype was G1P[8], while rotavirus genotypes G2P[4], G3P[8], G4P[8], and G9P[8] were identified less often. 
Med temi preskušanji je bilo najpogostejše kroženje rotavirusa genotipa G1P[8].
The doctor should re-assess the need of continuing treatment once a year. 
Zdravnik mora enkrat na leto ponovno oceniti potrebo po nadaljevanju zdravljenja.
Weight loss was more pronounced in women than in men. 
Izguba telesne mase je bila pri ženskah bolj izrazita kot pri moških.
The European Commission granted a marketing authorisation valid throughout the European Union for Saxenda on 23 March 2015. 
Evropska komisija je dovoljenje za promet z zdravilom Saxenda, veljavno po vsej Evropski uniji, izdala 23. marca 2015.
Saxenda is injected once per day, preferably at the same time every day. 
Zdravilo Saxenda se injicira enkrat na dan, po možnosti vsak dan ob istem času.
This is a summary of the European public assessment report (EPAR) for Saxenda. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Saxenda.
What measures are being taken to ensure the safe and effective use of Saxenda? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Saxenda?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Saxenda'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 Saxenda večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
• who are overweight (have a BMI between 27 and 30) and have weight-related complications such as diabetes, abnormally high levels of fat in the blood, high blood pressure or obstructive sleep apnoea (frequent interruption of breathing during sleep). 
• ki imajo čezmerno telesno maso (ITM med 27 in 30) in s tem povezane težave, kot so sladkorna bolezen, nenormalno visoke ravni maščob v krvi, visok krvni tlak ali obstruktivna apneja med spanjem (pogoste prekinitve dihanja med spanjem).
The full EPAR and risk management plan summary for Saxenda 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 Saxenda sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
• who are obese (have a body-mass index - BMI - of 30 or more); 
• ki so debeli (imajo indeks telesne mase oz. ITM 30 ali več);
Saxenda is a medicine used along with diet and exercise to help manage weight in adults: 
Saxenda je zdravilo, ki se uporablja skupaj z dieto in telesno vadbo za obvladovanje telesne mase pri odraslih:
The dose is then increased each week by 0.6 mg to a maximum of 3.0 mg per day. 
Začetni odmerek je 0,6 mg na dan. Odmerek se nato vsak teden poveča za 0,6 mg do največ 3,0 mg na dan.
The active substance in Saxenda, liraglutide, is a ‘glucagon-like peptide-1 (GLP-1) receptor agonist' that is already authorised in the EU as Victoza at lower doses (up to 1.8 mg per day) for the treatment of type 2 diabetes. 
Zdravilna učinkovina v zdravilu Saxenda, liraglutid, je „agonist receptorja za glukagonu podoben peptid-1 (GLP-1)“, ki je v EU v manjših odmerkih (največ 1,8 mg na dan) že odobren kot zdravilo Victoza za zdravljenje sladkorne bolezni tipa 2.
The CHMP considered that Saxenda has a modest (particularly in men) but still clinically relevant effect on weight loss. 
CHMP je menil, da ima zdravilo Saxenda skromen (zlasti pri moških), vendar kljub temu klinično pomemben učinek na zmanjšanje telesne mase.
A risk management plan has been developed to ensure that Saxenda is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Saxenda je bil pripravljen načrt obvladovanja tveganj.
Other information about Saxenda 
Druge informacije o zdravilu Saxenda
Further information on the long-term safety of liraglutide (particularly its effects on the heart and blood vessels) is expected from an ongoing study with Victoza. 
Podrobne podatke o dolgoročni varnosti liraglutida (zlasti o njegovih učinkih na srce in ožilje) naj bi zagotovila študija z zdravilom Victoza, ki že poteka.
When the figures for the main studies were re-analysed using a more conservative method that assumed that patients who did not complete the study (around 30%) would not have seen any improvement, similar but smaller weight reductions with Saxenda were noted. 
Ponovna analiza rezultatov iz glavnih študij, pri kateri so uporabili konzervativnejšo metodo s predpostavko, da pri bolnikih, ki niso dokončali študije (približno 30 %), ni bilo nobenega izboljšanja, je pokazala podobno, vendar manjše zmanjšanje telesne mase pri uporabi zdravila Saxenda.
The exact way that Saxenda works in weight loss is not fully understood, but it appears to act on the parts of the brain that regulate appetite, by attaching to GLP-1 receptors in brain cells and thereby increasing feelings of fullness and lowering feelings of hunger. 
Način, na katerega zdravilo Saxenda deluje pri zmanjšanju telesne mase, ni povsem pojasnjen, vendar verjetno deluje na dele možganov, ki uravnavajo tek, tako da se veže na receptorje za GLP-1 v možganskih celicah in s tem poveča občutek sitosti ter zmanjša občutek lakote.
It is not intended to provide practical advice on how to use Saxenda. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What benefits of Saxenda have been shown in studies? 
Kakšne koristi je zdravilo Saxenda izkazalo v študijah?
What is Saxenda and what is it used for? 
Kaj je zdravilo Saxenda in za kaj se uporablja?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Saxenda, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Saxenda in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For more information about treatment with Saxenda, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Saxenda preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Saxenda is available as a solution for injection in pre-filled pens. 
Zdravilo Saxenda je na voljo v obliki raztopine za injiciranje v napolnjenih injekcijskih peresnikih.
Why is Saxenda approved? 
Zakaj je bilo zdravilo Saxenda odobreno?
The most common side effects with Saxenda (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting, diarrhoea and constipation. 
Najpogostejši neželeni učinki zdravila Saxenda (ki lahko prizadenejo več kot 1 osebo od 10) so navzea (slabost), bruhanje, driska in zaprtje.
What are the risks associated with Saxenda? 
Kakšna tveganja so povezana z zdravilom Saxenda?
Patients in the studies were given the medicine as part of a weight loss programme involving counselling and advice on diet and exercise. 
Bolniki, ki so sodelovali v študiji, so prejemali zdravilo v okviru programa za zmanjšanje telesne mase, ki je vključeval še svetovanje o dieti in telesno vadbo.
Saxenda has been shown to be effective at reducing body weight in 5 main studies involving over 5,800 obese or overweight patients and lasting up to 56 weeks, in which Saxenda was compared with placebo (a dummy treatment). 
Zdravilo Saxenda se je izkazalo za učinkovito pri zmanjšanju telesne mase v petih glavnih študijah z več kot 5 800 debelimi bolniki ali bolniki s čezmerno telesno maso, ki so trajale do 56 tednov in v katerih so zdravilo Saxenda primerjali s placebom (zdravilom brez zdravilne učinkovine).
Looking at the results of the 5 studies together, Saxenda at a daily dose of 3 mg led to a 7.5% reduction in body weight, compared with a 2.3% reduction in patients taking placebo. 
Če upoštevamo rezultate vseh petih študij skupaj, se je telesna masa pri uporabi zdravila Saxenda v odmerku 3 mg na dan zmanjšala za 7,5 %, medtem ko se je pri bolnikih, ki so prejemali placebo, zmanjšala za 2,3 %.
Saxenda contains the active substance liraglutide. 
Zdravilo Saxenda vsebuje zdravilno učinkovino liraglutid.
Patients treated with Saxenda had a continuous decrease in body weight during the first 40 weeks of treatment, after which the weight loss achieved was maintained. 
Pri bolnikih, ki so jih zdravili z zdravilom Saxenda, se je telesna masa v prvih 40 tednih zdravljenja stalno zmanjševala, kasneje pa se je dosežena telesna masa ohranila.
For the full list of all side effects and restrictions with Saxenda, see the package leaflet. 
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Saxenda glejte navodilo za uporabo.
For practical information about using Saxenda, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Saxenda naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
BMI is a measurement that indicates body weight relative to height. 
ITM je merilo, ki se uporablja za oceno razmerja med telesno maso in višino.
Regarding safety, the most common side effects with Saxenda relate to the stomach and gut such as nausea. 
Kar zadeva varnost, so najpogostejši neželeni učinki zdravila Saxenda povezani z želodcem in črevesjem, eden od njih je na primer slabost.
Treatment with Saxenda should be stopped if patients have not lost at least 5% of their initial body weight after 12 weeks of treatment with 3 mg of Saxenda per day. 
Zdravljenje z zdravilom Saxenda je treba prekiniti, če bolniki po 12 tednih zdravljenja s 3 mg zdravila Saxenda na dan ne izgubijo vsaj 5 % izhodiščne telesne mase.
It is given as an injection under the skin in the thigh, upper arm or abdomen (belly). 
Injicira se v podkožje stegna, nadlakti ali trebuha.
To limit these effects, when starting treatment the dose of Saxenda is slowly increased over 4 weeks. 
Da bi omejili te neželene učinke, je treba prve štiri tedne zdravljenja odmerek zdravila Saxenda povečevati postopoma.
How does Saxenda work? 
Kako zdravilo Saxenda deluje?
How is Saxenda used? 
Kako se zdravilo Saxenda uporablja?
It is especially important to mention the following: 
Posebno pomembno je omeniti naslednje:
Death from any cause 
Smrt zaradi katerega koli vzroka
• twice daily by mouth 
• dvakrat na dan skozi usta
• Take one tablet: 
• Vzemite eno tableto:
Consider the benefits and risks of concomitant use. 
Potrebno je razmisliti o koristih in tveganjih sočasne uporabe.
Very common: low blood sugar 
Zelo pogosti: nizek krvni sladkor
If you miss a dose, take it as soon as you remember. 
Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite.
Data from the 73 % of patients who were taking metformin are presented in Table 2. 
Podatki za 73 % bolnikov, ki so prejemali metformin, so predstavljeni v preglednici 2.
The renal clearance was approximately 350 mL/min. 
Ledvični očistek je bil približno 350 ml/min.
Combinations requiring precautions for use 
Kombinacije, ki zahtevajo previdnost pri uporabi
Uncommon: dry mouth, headache 
Občasni: suha usta, glavobol
Food decreases the extent and slightly delays the absorption of metformin. 
Hrana zmanjša obseg in rahlo upočasni absorpcijo metformina.
All patients should continue their recommended diet with an adequate distribution of carbohydrate intake during the day. 
Vsi bolniki morajo nadaljevati s priporočeno dieto z ustrezno porazdelitvijo zaužitih ogljikovih hidratov tekom dneva.
Frequency categories are based on information available from metformin Summary of Product Characteristics available in the EU. 
Kategorije pogostnosti temeljijo na informacijah iz njegovega povzetka glavnih značilnosti zdravila, ki je na voljo v EU.
See section 2, Do not take Ristfor. 
Glejte poglavje 2, Ne jemljite zdravila Ristfor.
Ristfor is contraindicated in patients with: 
Zdravilo Ristfor je kontraindicirano pri:
This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation. 
To lahko povzroči resne zdravstvene težave, kot so bolezni srca, bolezni ledvic, slepota in amputacije.
• digoxin (to treat irregular heart beat and other heart problems). 
• digoksin (za zdravljenje nepravilnega bitja srca in drugih težav s srcem).
The expiry date refers to the last day of the month. 
Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Onset of these reactions occurred within the first 3 months after initiation of treatment with sitagliptin, with some reports occurring after the first dose. 
Te reakcije so se pojavile v prvih treh mesecih po začetku zdravljenja s sitagliptinom, v nekaterih poročilih pa po prvem odmerku.
The safety and efficacy of Ristfor in children and adolescents from birth to < 18 years of age have not been established. 
Varnost in učinkovitost zdravila Ristfor pri otrocih in mladostnikih, od rojstva do starosti < 18 let, nista bili dokazani.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data). 
Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000) in neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
* Incidence rate per 100 patient-years is calculated as 100 × (total number of patients with ≥ 1 event during eligible exposure period per total patient-years of follow-up). 
* Pojavnost na 100 bolnik-let je izračunana kot 100 × (celotno število bolnikov z ≥ 1 dogodkom med ustreznim obdobjem izpostavljenosti na celotno število bolnik-let spremljanja).
Analysis in the Intention-to-Treat Population Number of patients 
Analiza populacije z namenom zdravljenja Število bolnikov
If no adequate strength of Ristfor is available, individual monocomponents should be used instead of the fixed-dose combination. 
Če ni na voljo ustrezne jakosti zdravila Ristfor, je treba namesto fiksne kombinacije uporabiti posamične monokomponente.
A GFR should be assessed before initiation of treatment with metformincontaining products and at least annually thereafter. 
GFR je treba oceniti pred uvedbo zdravljenja z zdravili, ki vsebujejo metformin, nato pa vsaj enkrat letno.