FrancophonIA/ELRC3.0 huggingface dataset:
English: Each syringe contains 0.5 mL solution.
Slovenian: Ena brizga vsebuje 0,5 ml raztopine.
English: Fresh Cycles of ENGAGE (18-36 years of age) (body weight greater than 60 kg and less than or equal to 90 kg)
Slovenian: Cikli z uporabo svežih zarodkov v študiji ENGAGE (18-36 let starosti) (telesna masa več kot 60 kg do vključno 90 kg)
English: Thromboembolic events, both in association with and separate from OHSS, have been reported following treatment with gonadotropins, including Elonva.
Slovenian: Po zdravljenju z gonadotropini, vključno z zdravilom Elonva, so poročali o tromoemboličnih pojavih, tako povezanih, kot tudi nepovezanih z OHSS.
English: Body weight is a determinant of exposure to corifollitropin alfa.
Slovenian: Izpostavljenost korifolitropinu alfa je odvisna od telesne mase.
English: How to store Elonva
Slovenian: Shranjevanje zdravila Elonva
English: o A history of Ovarian Hyperstimulation Syndrome (OHSS).
Slovenian: o če ste imeli sindrom hiperstimulacije jajčnikov (OHSS).
English: Ovarian torsion, adnexa uteri pain, premature ovulation, breast pain
Slovenian: OHSS, bolečine v medenici, neugodje v medenici, občutljivost dojk občasni torzija jajčnikov, bolečine v materničnih adneksih, prezgodnja ovulacija, bolečine v dojkah
English: Two of these four women became pregnant during the same treatment cycle in which antibodies were detected, suggesting that the presence of non-neutralizing antibodies after stimulation with Elonva is not clinically relevant.
Slovenian: To kaže, da prisotnost nenevtralizirajočih protiteles po stimulaciji z zdravilom Elonva ni klinično pomembna.
English: In patients with mild, moderate or severe renal insufficiency the rate of elimination of corifollitropin alfa may be reduced (see sections 4.2 and 5.2).
Slovenian: Pri bolnicah z blago, zmerno ali hudo ledvično insuficienco je lahko stopnja izločanja korifolitropina alfa zmanjšana (glejte poglavji 4.2 in 5.2), zato uporaba zdravila Elonva pri teh ženskah ni priporočljiva.
English: Reproductive system and breast disorders
Slovenian: Motnje reprodukcije in dojk pogosti
English: Components of the Elonva syringe with needle
Slovenian: Deli injekcijske brizge zdravila Elonva z iglo
English: - While waiting for the disinfectant to dry, break the label perforation and pull off the needle-cap - Leave the needle shield on the needle - Place the needle shield (containing the needle) on a clean dry surface, while preparing the syringe.
Slovenian: - Medtem ko čakate, da se razkužilo posuši, pretrgajte perforacijo na nalepki in snemite zaščitno zaporko igle.
English: This justifies replacement of the first seven injections of daily (rec)FSH with a single subcutaneous injection of Elonva in COS for the development of multiple follicles and pregnancy in an ART program (see section 4.2).
Slovenian: Zaradi dolgega razpolovnega časa izločanja so po uporabi priporočenega odmerka serumske koncentracije korifolitropina alfa zadostne, da ohranjajo rast več foliklov ves teden, kar opraviči zamenjavo prvih sedmih vsakodnevnih injekcij (rek)FSH z eno samo subkutano injekcijo zdravila Elonva pri nadzorovani stimulaciji jajčnikov, da bi dosegli razvoj več foliklov in zanositev v programu asistirane reprodukcije (glejte poglavje 4.2).
English: Talk to your doctor before using Elonva.
Slovenian: Pred začetkom uporabe zdravila Elonva se posvetujte z zdravnikom.
English: Table 3: Pregnancy Results from the FTET cycles of ENGAGE and PURSUE Intent-to-Treat Population (ITT)
Slovenian: Preglednica 3: Rezultati nosečnosti iz FTET ciklov študij ENGAGE in PURSUE Populacija z namenom zdravljenja (ITT)
English: Ovarian torsion has been reported after treatment with gonadotropins, including Elonva.
Slovenian: Po zdravljenju z gonadotropini, vključno z zdravilom Elonva, so poročali o torziji jajčnikov.
English: Elonva 100 micrograms solution for injection Elonva 150 micrograms solution for injection
Slovenian: Elonva 100 mikrogramov raztopina za injiciranje Elonva 150 mikrogramov raztopina za injiciranje
English: Each Elonva 150 micrograms solution for injection pre-filled syringe contains 150 micrograms in 0.5 millilitre (mL) solution for injection.
Slovenian: Ena napolnjena injekcijska brizga zdravila Elonva 150 mikrogramov raztopina za injiciranje vsebuje 150 mikrogramov korifolitropina alfa v 0,5 mililitra (ml) raztopine za injiciranje.
English: Elonva 100 µg recFSH 150 IU
Slovenian: Elonva 100 µg
English: Each Elonva 100 micrograms solution for injection pre-filled syringe contains 100 micrograms in 0.5 millilitre (mL) solution for injection.
Slovenian: Ena napolnjena injekcijska brizga zdravila Elonva 100 mikrogramov raztopina za injiciranje vsebuje 100 mikrogramov korifolitropina alfa v 0,5 mililitra (ml) raztopine za injiciranje.
English: Elonva 100 micrograms solution for injection
Slovenian: Elonva 100 mikrogramov raztopina za injiciranje
English: Box 20 5340 BH Oss The Netherlands
Slovenian: Kloosterstraat 6, 5349 AB Oss P.O. Box 20, 5340 BH Oss Nizozemska
English: Elonva 100 micrograms solution for injection Elonva 150 micrograms solution for injection corifollitropin alfa
Slovenian: Elonva 100 mikrogramov raztopina za injiciranje Elonva 150 mikrogramov raztopina za injiciranje korifolitropin alfa
English: - A single 100-microgram dose is recommended in women who weigh less than or equal to 60 kilograms and who are 36 years of age or younger.
Slovenian: - Za ženske, ki tehtajo 60 kilogramov ali manj in so stare 36 let ali manj, je priporočljiv enkraten odmerek 100 mikrogramov.
English: Elonva 150 micrograms solution for injection
Slovenian: Elonva 150 mikrogramov raztopina za injiciranje
English: In addition, ectopic pregnancy and multiple gestations have been reported.
Slovenian: Poleg tega so poročali o ektopični nosečnosti in večplodni nosečnosti, ki naj bi bili povezani z asistirano reprodukcijo ali posledično nosečnostjo.
English: - Keep the syringe pointing upwards - Screw the needle shield (containing the needle) clockwise onto the syringe.
Slovenian: - Pokrovček (v katerem je igla) v smeri urnega kazalca privijte na injekcijsko brizgo.
English: Elonva 150 micrograms injection corifollitropin alfa
Slovenian: Elonva 150 mikrogramov injekcija korifolitropin alfa s.c.
English: Elonva 100 micrograms injection corifollitropin alfa
Slovenian: Elonva 100 mikrogramov injekcija korifolitropin alfa s.c.
English: - Keep the syringe pointing upwards - Unscrew the syringe cap counter-clockwise.
Slovenian: - Odvijte zaščitno zaporko brizge nasprotno smeri urnega kazalca.
English: Each pre-filled syringe contains 150 micrograms of corifollitropin alfa in 0.5 mL solution for injection.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 150 mikrogramov korifolitropina alfa v 0,5 ml raztopine za injiciranje.
English: Always use Elonva exactly as your doctor has told you.
Slovenian: Pri uporabi zdravila Elonva natančno upoštevajte zdravnikova navodila.
English: Injection site haematoma, injection site pain, irritability
Slovenian: Splošne težave in spremembe na mestu aplikacije pogosti utrujenost občasni hematom na mestu injiciranja, bolečina na mestu injiciranja, razdražljivost
English: Each pre-filled syringe contains 150 micrograms of corifollitropin alfa* in 0.5 mL solution for injection.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 150 mikrogramov korifolitropina alfa* v 0,5 ml raztopine za injiciranje.
English: Each pre-filled syringe contains 100 micrograms of corifollitropin alfa in 0.5 mL solution for injection.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 100 mikrogramov korifolitropina alfa v 0,5 ml raztopine za injiciranje.
English: Elonva 150 micrograms solution for injection corifollitropin alfa
Slovenian: Elonva 150 mikrogramov raztopina za injiciranje korifolitropin alfa
English: OHSS, pelvic pain, pelvic discomfort, breast tenderness
Slovenian: bat brizga raztopina zaščitna zaporka perforacija igla zaščitna zaporka pokrovček
English: Elonva 100 micrograms solution for injection corifollitropin alfa
Slovenian: Elonva 100 mikrogramov raztopina za injiciranje korifolitropin alfa
English: Each pre-filled syringe contains 100 micrograms of corifollitropin alfa* in 0.5 mL solution for injection.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 100 mikrogramov korifolitropina alfa* v 0,5 ml raztopine za injiciranje.
English: - Now take the syringe between index and middle finger in the upward position - Place your thumb on the plunger - Carefully push the plunger upwards until a tiny droplet appears at the tip of the needle.
Slovenian: - Zdaj s kazalcem in sredincem primite injekcijsko brizgo in jo držite obrnjeno pokonci.
English: Ovarian and other reproductive system tumours
Slovenian: Tumorji na jajčnikih in na drugih delih rodil
English: There have been reports of ovarian and other reproductive system tumours in women who have had infertility treatment.
Slovenian: Pri ženskah, ki so se zdravile zaradi neplodnosti, so poročali o nastanku tumorjev na jajčnikih in na drugih delih rodil.
English: calendar blister (OPA/alu/PVC/alu)
Slovenian: peroralna uporaba koledarski pretisni omot (OPA/alu/PVC/alu)
English: Immediate Packaging Pack size calendar blister (PVC/PE/PVdC/alu)
Slovenian: Velikost pakiranja peroralna uporaba koledarski pretisni omot (PVC/PE/PVdC/alu)
English: MA (EU) number (Invented) name
Slovenian: Številka EU Izmišljeno ime
English: 5 vials + 5 cartridges
Slovenian: 5 vial + 5 vložkov
English: Pack size powder: vial (glass); solvent: vial (glass)
Slovenian: Prašek: viala (steklo) Vehikel: viala (steklo)
English: 1 vial + 1 cartridge
Slovenian: 1 viala + 1 vložek
English: Immediate Packaging Content (concentration)
Slovenian: Velikost pakiranja
English: This summary was last updated on 31.01.2008.
Slovenian: Ta povzetek je bil nazadnje posodobljen 31.01.2008.
English: • The results of the safety studies indicated that the product is safe for chickens.
Slovenian: • Rezultati raziskav o varnosti so pokazali, da je izdelek varen za piščance.
English: Because of the current epidemiological situation of avian influenza and the consequent threat to both human and animal health the committee recommended the granting of a Marketing Authorisation.
Slovenian: Zaradi trenutne epidemiološke situacije v zvezi z aviarno influenco in posledične grožnje za zdravje ljudi in živali je odbor priporočil odobritev dovoljenja za promet z zdravilom.
English: The data on the effectiveness of the vaccine was based on published scientific papers and internal company reports.
Slovenian: Podatki o učinkovitosti cepiva so temeljili na objavljenih znanstvenih razpravah in internih poročilih podjetja.
English: This is because control of avian influenza is the responsibility of national veterinary authorities in consultation with the European Commission.
Slovenian: Nadzor nad aviarno influenco je namreč v pristojnosti nacionalnih veterinarskih organov v povezavi z Evropsko komisijo.
English: Studies were carried out in one-day-old and 2 to 4 week-old chickens free of any infection.
Slovenian: Raziskave so se izvajale na en dan starih in 2 do 4 tedne starih piščancih, ki niso bili okuženi.
English: This vaccine has some of the same ingredients but different antigens (viruses), two of which are produced using the same process to that used for the avian influenza antigen of Nobilis Influenza.
Slovenian: To cepivo ima nekaj enakih sestavin, vendar različne antigene (viruse), od katerih se dva proizvajata po istem postopku, kot se uporablja za antigen aviarne influence zdravila Nobilis Influenza.
English: What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Slovenian: Koliko časa je potrebno počakati, preden se žival lahko zakolje in meso uporabi za prehrano ljudi (karenca)?
English: They included studies in other avian species (ducks, turkeys, pheasants), and studies using either the subcutaneous or intramuscular routes.
Slovenian: Vključevali so tudi raziskave na drugih vrstah ptic (race, purani, fazani) in raziskave z uporabo subkutanega ali intramuskularnega načina dajanja.
English: When it is given to chickens, the birds' immune system (their natural defence mechanism) learns how to make antibodies (a special type of protein) to fight the disease.
Slovenian: Ko ga piščanec prejme, se imunski sistem ptic (njihov naravni obrambni mehanizem) nauči tvoriti protitelesa (posebno vrsto beljakovine) za boj proti bolezni.
English: In the future, if the birds are exposed to the avian flu virus, the immune system will be able to make those antibodies quicker and this will help them fight the disease.
Slovenian: Če bodo ptice v prihodnosti izpostavljene virusu aviarne influence, bo njihov imunski sistem ta protitelesa tvoril hitreje in to jim bo pomagalo v boju proti bolezni.
English: The Committee for Medicinal Products for Veterinary use concluded that the vaccine has been shown to be effective in preventing clinical disease in poultry and could be a useful tool in controlling an outbreak of avian influenza infection.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini je sklenil, da je bila dokazana učinkovitost cepiva pri preprečevanju kliničnih bolezni pri perutnini in je lahko uporaben pripomoček pri nadzorovanju izbruha okužbe z aviarno influenco.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis Influenza H5N6 to Intervet International BV on 31.01.2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Nobilis Influenza H5N6, veljavno po vsej Evropski uniji, odobrila družbi Intervet International BV dne 31.01.2008.
English: The vaccine was assessed in the context of an emergency situation which means that further studies with Nobilis H5N6 are still ongoing and will be assessed.
Slovenian: Cepivo je bilo ocenjeno v izrednih razmerah, kar pomeni, da nadaljnje raziskave z zdravilom Nobilis Influenza H5N6 še vedno potekajo in bodo ovrednotene v prihodnosti.
English: This strain has been chosen because it protects birds against virulent H5N1 field strains (cross-protection), while allowing differentiation of vaccinated from infected birds.
Slovenian: Ta sev je bil izbran, ker varuje ptice pred virulentnimi divjimi sevi H5N1 (navzkrižna zaščita), hkrati pa omogoča razlikovanje cepljenih ptic od okuženih ptic.
English: • The vaccine is able to induce antibodies in a wide range of birds.
Slovenian: • Cepivo je sposobno spodbuditi nastajanje protiteles pri številnih vrstah ptic.
English: The person who gives the vaccine should be careful to avoid accidental self injection.
Slovenian: Oseba, ki daje cepivo, mora paziti, da si zdravila po nesreči ne samoinjicira.
English: The company carried out laboratory safety studies using a vaccine very similar to Nobilis Influenza H5N6.
Slovenian: Podjetje je izvedlo laboratorijske raziskave o varnosti v katerih je uporabilo cepivo, ki je zelo podobno zdravilu Nobilis Influenza H5N6.
English: The virus used for the vaccine carries the H5 (haemagglutinin 5) and N6 (neuramidase 6) antigens.
Slovenian: Virus, uporabljen za cepivo, vsebuje antigena H5 (hemaglutinin 5) in N6 (nevraminidaza 6).
English: Vaccinated birds can be differentiated from infected birds by a diagnostic test for antibodies against the N6 component.
Slovenian: Cepljene ptice je mogoče razlikovati od okuženih ptic z diagnostičnim testom za protitelesa proti sestavini N6.
English: • The vaccine has been shown to prevent clinical signs and mortality and reduce virus shedding in infected chickens.
Slovenian: • Dokazano je bilo, da cepivo preprečuje klinične znake in umrljivost ter zmanjšuje izločanje virusa pri okuženih piščancih.
English: Nobilis Influenza H5N6 is a vaccine containing an inactivated avian influenza virus H5N6 (inactivated means that the virus has been killed so that it cannot cause the disease any more).
Slovenian: Zdravilo Nobilis Influenza H5N6 je cepivo, ki vsebuje inaktivirani virus aviarne influence H5N6 (inaktiviran pomeni, da je bil virus ubit, zaradi česar ne more več povzročiti bolezni).
English: If you need more information about your animal's medical condition or treatment, contact your veterinarian.
Slovenian: Če potrebujete več informacij o uporabi tega izdelka, se posvetujte z vašim nacionalnim veterinarskim organom.
English: Nobilis Influenza H5N6 has been authorised under “Exceptional Circumstances”.
Slovenian: Zdravilo Nobilis Influenza H5N6 je bilo odobreno v »izjemnih okoliščinah«.
English: Nobilis Influenza H5N6 is a vaccine used in chickens to protect against avian influenza.
Slovenian: Zdravilo Nobilis Influenza H5N6 je cepivo, ki se uporablja pri piščancih za zaščito pred aviarno influenco.
English: The vaccine reduces the signs of flu and the excretion (shedding) of the virus by the infected birds.
Slovenian: Cepivo zmanjšuje znake gripe in izločanje virusa pri okuženih pticah.
English: • If the circulating avian influenza field virus has a different N component to the N6 included in the vaccine, it may be possible to differentiate between vaccinated from infected birds by using a diagnostic test to detect Neuraminidase antibodies.
Slovenian: • Če ima krožeči divji virus aviarne influence sestavino N, ki se razlikuje od sestavine N6 v cepivu, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti nevraminidazi.
English: The vaccine contains a mineral oil.
Slovenian: Cepivo vsebuje tekoči parafin.
English: They also tested the safety of three standard production batches of Nobilis Influenza H5N6.
Slovenian: Preizkušena je bila tudi varnost treh standardnih proizvodnih serij zdravila Nobilis Influenza H5N6.
English: Nobilis Influenza H5N6 is a vaccine.
Slovenian: Zdravilo Nobilis Influenza H5N6 je cepivo.
English: Other information about Nobilis Influenza H5N6:
Slovenian: Druge informacije o zdravilu Nobilis Influenza H5N6:
English: What benefit has Nobilis Influenza H5N6 shown during the studies?
Slovenian: Kakšne koristi je zdravilo Nobilis Influenza H5N6 izkazalo med raziskavami?
English: What is the risk associated with Nobilis Influenza H5N6?
Slovenian: Kakšna tveganja so povezana z zdravilom Nobilis Influenza H5N6?
English: Why has Nobilis Influenza H5N6 been approved?
Slovenian: Zakaj je bilo zdravilo Nobilis Influenza H5N6 odobreno?
English: What is Nobilis Influenza H5N6?
Slovenian: Kaj je zdravilo Nobilis Influenza H5N6?
English: How has Nobilis Influenza H5N6 been studied?
Slovenian: Kako je bilo zdravilo Nobilis Influenza H5N6 raziskano?
English: EMEA/V/C/125
Slovenian: EMEA/V/C/125 EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) NOBILIS INFLUENZA H5N6 Povzetek EPAR za javnost
English: What is Nobilis Influenza H5N6 used for?
Slovenian: Za kaj se zdravilo Nobilis Influenza H5N6 uporablja?
English: How does Nobilis Influenza H5N6 work?
Slovenian: Kako zdravilo Nobilis Influenza H5N6 deluje?
English: • about what you can do to prevent dehydration;
Slovenian: • glede tega, kaj lahko naredite, da bi preprečili dehidracijo;
English: This medicine can also help prevent heart disease.
Slovenian: To zdravilo lahko tudi pomaga preprečiti bolezni srca.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 May 2015
Slovenian: Datum prve odobritve: 27. maj 2015
English: However, a double dose should not be taken on the same time.
Slovenian: Vendar hkrati ne sme vzeti dvojnega odmerka.
English: The recommended dose is one tablet twice a day.
Slovenian: Priporočeni odmerek je ena tableta dvakrat dnevno.
English: Heart failure requiring hospitalization
Slovenian: Srčno popuščanje, ki zahteva hospitalizacijo
English: Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above.
Slovenian: Vaš zdravnik vam bo povedal, kako lahko zdravite nizke ravni krvnega sladkorja in kaj morate narediti, če se pojavi kateri od zgornjih znakov.
English: • if you are 85 years old or older as you should not start taking Synjardy;
Slovenian: • če ste stari 85 let ali več, saj ne smete začeti jemati zdravila Synjardy;
English: The mean volume of distribution (Vd) ranged between 63 - 276 l.
Slovenian: Povprečni volumen porazdelitve (Vd) je med 63 in 276 l.
English: Fournier's gangrene has to be treated immediately.
Slovenian: Fournierovo gangreno je treba takoj začeti zdraviti.
English: • fainting or loss of consciousness
Slovenian: • omedlevico ali izgubo zavesti.
English: The dose should be adjusted to or maintained at a maximum daily dose of 10 mg.
Slovenian: Odmerek je treba prilagoditi ali vzdrževati v največjem dnevnem odmerku 10 mg.
English: This medicine is not recommended for use in children and adolescents under 18 years, because it has not been studied in these patients.
Slovenian: To zdravilo se ne priporoča pri otrocih in mladostnikih, starih manj kot 18 let, saj ga pri teh bolnikih niso preučili.
English: Do not take Synjardy if you are pregnant.
Slovenian: Ne jemljite zdravila Synjardy, če ste noseči.
English: Metformin may act via 3 mechanisms:
Slovenian: Metformin lahko deluje na tri načine:
English: All patients should continue their diet with an adequate distribution of carbohydrate intake during the day.
Slovenian: Vsi bolniki morajo nadaljevati dieto z ustrezno porazdelitvijo vnosa ogljikovih hidratov preko dneva.
English: However, animal studies have shown adverse effects on postnatal development.
Slovenian: Vendar pa študije na živalih kažejo neželene učinke na postnatalni razvoj.
English: • if you have “type 1 diabetes” - this type usually starts when you are young and your body does not produce any insulin;
Slovenian: • če imate “sladkorno bolezen tipa 1” - ta tip se običajno pojavi v mladih letih in v tem primeru telo insulina sploh ne proizvaja;
English: Diet and exercise can help your body use its blood sugar better.
Slovenian: Dieta in telesna aktivnost vašemu telesu pomagata bolje porabiti krvni sladkor.
English: • Swallow the tablet whole with water.
Slovenian: • Tableto pogoltnite celo z vodo.
English: 1 (97.5% CI)
Slovenian: 1 (97,5-odstotni
English: • Severe renal failure (GFR <30 ml/min).
Slovenian: • Huda ledvična odpoved (GFR < 30 ml/min).
English: • if you are allergic to empagliflozin, metformin or any of the other ingredients of this medicine (listed in section 6);
Slovenian: • če ste alergični na empagliflozin, metformin ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: The reduction of cardiovascular death in these patients was consistent with the overall study population.
Slovenian: Znižanje srčno-žilne umrljivosti pri teh bolnikih je bilo skladno s celotno raziskovano populacijo.
English: Your doctor will adjust your dose as necessary and tell you exactly which strength of the medicine to take.
Slovenian: Zdravnik vam bo ustrezno prilagodil odmerek in vam natančno povedal, katero jakost zdravila morate jemati.
English: Treatment with empagliflozin may be restarted when the ketone values are normal and the patient's condition has stabilised.
Slovenian: Zdravljenje z empagliflozinom je mogoče znova uvesti, ko so vrednosti ketonov normalne in se bolnikovo stanje stabilizira.
English: 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), or very rare (<1/10,000), and not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene 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) in zelo redki (<1/10.000) ali neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: After the first 12 weeks glycaemic control was optimized independent of investigative treatment.
Slovenian: Po prvih 12 tednih se je urejenost glikemije optimizirala neodvisno od preiskušanega zdravljenja.
English: • if you have problems with your liver;
Slovenian: • če imate težave z jetri,
English: This medicinal product should not be used during breast feeding.
Slovenian: Tega zdravila se med dojenjem ne sme uporabljati.
English: • decreased vitamin B12 levels in the blood
Slovenian: • znižana raven vitamina B12 v krvi,
English: Do not stop taking Synjardy without first consulting your doctor.
Slovenian: Ne prenehajte jemati zdravila Synjardy, ne da bi se prej posvetovali z zdravnikom.