FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatic effects
Slovenian: Učinki na jetra
English: Yellow, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-12.5” printed in grey ink on one side.
Slovenian: Rumene, ovalne (približno 9,1 mm dolge in 5,1 mm široke), bikonveksne, filmsko obložene tablete s sivima oznakama “TAK” in “ALG-12.5” na eni strani.
English: Significantly more patients receiving 25 mg alogliptin (34.8%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving placebo (18.2%) at Week 26 (p=0.002).
Slovenian: V 26. tednu je ciljne vrednosti HbA1c ≤ 7,0 % doseglo pomembno več bolnikov, ki so prejemali alogliptin v odmerku 25 mg (34,8 %), v primerjavi z bolniki, ki so prejemali placebo (18,2 %) (p=0,002).
English: The addition of 25 mg alogliptin once daily to glyburide therapy (mean dose = 12.2 mg) resulted in statistically significant improvements from baseline in HbA1c at Week 26 when compared to the addition of placebo (Table 2).
Slovenian: Alogliptin kot dodatek k zdravljenju s sulfonilsečnino Dodatek alogliptina v odmerku 25 mg enkrat na dan k zdravljenju z gliburidom (povprečni odmerek = 12,2 mg) je v 26. tednu povzročil statistično pomembna izboljšanja glede na izhodiščne vrednosti HbA1c v primerjavi z dodatkom placeba (tabela 2).
English: At Week 104, the HbA1c reduction by 25 mg alogliptin plus metformin (-0.72%, Table 3) was greater than that produced by glipizide plus metformin (-0.59%).
Slovenian: V 104. tednu je bilo pri uporabi alogliptina v odmerku 25 mg in metformina zmanjšanje vrednosti HbA1c (-0,72 %, tabela 3) večje kot pri uporabi glipizida in metformina (-0,59 %) Povprečna sprememba vrednosti glukoze v plazmi na tešče glede na izhodiščno vrednost je bila v 52. tednu pri uporabi alogliptina v odmerku 25 mg z metforminom pomembno večja od tiste pri uporabi glipizida in metformina (p<0,001).
English: The addition of 25 mg alogliptin once daily to metformin hydrochloride therapy (mean dose = 1,847 mg) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2).
Slovenian: Alogliptin kot dodatek k zdravljenju z metforminom Pri dodatku alogliptina v odmerku 25 mg enkrat na dan k zdravljenju z metforminijevim kloridom (povprečni odmerek = 1.847 mg) so bila v 26. tednu dosežena statistično pomembna izboljšanja glede na izhodiščne vrednosti HbA1c in vrednosti glukoze v plazmi na tešče v primerjavi z dodatkom placeba (tabela 2).
English: Light red, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-25” printed in grey ink on one side.
Slovenian: Svetlo rdeče, ovalne (približno 9,1 mm dolge in 5,1 mm široke), bikonveksne, filmsko obložene tablete s sivima oznakama “TAK” in “ALG-25” na eni strani.
English: Light pink, oval (approximately 9.1 mm long by 5.1 mm wide), biconvex, film-coated tablets with “TAK” and “ALG-6.25” printed in grey ink on one side.
Slovenian: Svetlo rožnate, ovalne (približno 9,1 mm dolge in 5,1 mm široke), bikonveksne, filmsko obložene tablete s sivima oznakama “TAK” in “ALG-6.25” na eni strani.
English: Alogliptin as add-on therapy to a thiazolidinedione with metformin The addition of 25 mg alogliptin once daily to 30 mg pioglitazone and metformin hydrochloride therapy (mean dose = 1,867.9 mg) resulted in improvements from baseline in HbA1c at Week 52 that were both non-inferior and statistically superior to those produced by 45 mg pioglitazone and metformin hydrochloride therapy (mean dose = 1,847.6 mg, Table 3).
Slovenian: Alogliptin kot dodatek k zdravljenju s tiazolidindionom in z metforminom Dodatek alogliptina v odmerku 25 mg enkrat na dan k zdravljenju s 30 mg pioglitazona in z metforminijevim kloridom (povprečni odmerek = 1.867,9 mg) je v 52. tednu povzročil izboljšanja glede na izhodiščne vrednosti HbA1c.
English: Hepatobiliary disorders hepatic dysfunction including hepatic failure not known
Slovenian: Bolezni jeter, žolčnika in žolčevodov okvara delovanja jeter, vključno z odpovedjo jeter neznana
English: Clinically meaningful reductions in HbA1c compared to control were also observed with 25 mg alogliptin regardless of baseline background treatment.
Slovenian: Pri uporabi alogliptina v odmerku 25 mg so bila klinično pomembna zmanjšanja vrednosti HbA1c v primerjavi s kontrolo opažena tudi ne glede na osnovno zdravljenje v izhodišču.
English: Symptoms include excessive thirst, frequent urination, loss of appetite, nausea or vomiting and rapid weight loss - if you are taking an anti-diabetic medicine known as sulphonylurea (e.g. glipizide, tolbutamide, glibenclamide) or insulin.
Slovenian: Simptomi vključujejo pretirano žejo, pogosto uriniranje, izgubo apetita, siljenje na bruhanje ali bruhanje in hitro izgubljanje telesne mase.
English: Its use during the first three months of pregnancy is not recommended.
Slovenian: Njegova uporaba ni priporočljiva v prvih treh mesecih nosečnosti.
English: Overall, the company presented the results of nine main studies involving a total of almost 9,000 patients with essential hypertension.
Slovenian: Skupno je družba predstavila rezultate devetih glavnih študij, v katere je bilo skupaj vključenih skoraj 9 000 bolnikov z esencialno hipertenzijo.
English: ‘Essential' means that no specific cause for the hypertension can be found.
Slovenian: Izraz „esencialna“ pomeni, da za hipertenzijo ni očitnega vzroka.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Riprazo HCT on 13 April 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Riprazo HCT, veljavno po vsej Evropski uniji, odobrila dne 13. aprila 2011.
English: It is available as tablets (150 mg aliskiren and 12.5 mg hydrochlorothiazide; 150 mg aliskiren and 25 mg hydrochlorothiazide; 300 mg aliskiren and 12.5 mg hydrochlorothiazide; 300 mg aliskiren and 25 mg hydrochlorothiazide).
Slovenian: Na voljo je v obliki tablet (150 mg aliskirena in 12,5 mg hidroklorotiazida; 150 mg aliskirena in 25 mg hidroklorotiazida; 300 mg aliskirena in 12,5 mg hidroklorotiazida; 300 mg aliskirena in 25 mg hidroklorotiazida).
English: The full EPAR for Riprazo HCT can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Riprazo HCT je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It must not be used in women who are more than three months pregnant or breast-feeding.
Slovenian: Ne smejo ga uporabljati ženske, ki so noseče več kot tri mesece ali tiste, ki dojijo.
English: Aliskiren on its own has been authorised in the European Union (EU) since August 2007 as Rasilez, Sprimeo and Riprazo.
Slovenian: Zdravilo Aliskiren je kot samostojno zdravilo v Evropski uniji (EU) odobreno od avgusta 2007 pod imeni Rasilez, Sprimeo in Riprazo.
English: This is a summary of the European public assessment report (EPAR) for Riprazo HCT.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Riprazo HCT.
English: This authorisation was based on the authorisation of Rasilez HCT in 2009 (‘informed consent').
Slovenian: Odobritev je temeljila na dovoljenju za promet z zdravilom Rasilez HCT iz leta 2009 („privolitev po pojasnilu“).
English: The studies lasted for between eight weeks and a year, and the main measure of effectiveness was the change in blood pressure either during the resting phase of the heartbeat (diastolic) or when the chambers of the heart were contracting (systolic).
Slovenian: Študije so trajale od osem tednov do enega leta, glavno merilo učinkovitosti pa je bila sprememba krvnega tlaka med mirovalno fazo srčnega utripa (diastolični tlak) ali med krčenjem komor srca (sistolični tlak).
English: The most common side effect with Riprazo HCT (seen in between 1 and 10 patients in 100) is diarrhoea.
Slovenian: Najpogostejši neželeni učinek zdravila Riprazo HCT (opažen pri 1 do 10 bolnikih od 100) je driska.
English: It should be taken with a light meal preferably at the same time each day, but grapefruit juice should not be taken together with Riprazo
Slovenian: Vzeti ga je treba z lahkim obrokom, najbolje vsak dan ob istem času, vendar pa se zdravilo Riprazo HCT ne sme vzeti skupaj z grenivkinim sokom.
English: After two to four weeks of taking Riprazo HCT, the dose can be increased in patients whose blood pressure remains uncontrolled.
Slovenian: Po dveh do štirih tednih jemanja zdravila Riprazo HCT se lahko odmerek poveča pri bolnikih, pri katerih krvni tlak še vedno ni uravnan.
English: For more information about treatment with Riprazo HCT, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Riprazo HCT preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: Most studies involved patients with mild to moderate hypertension and one involved patients with severe hypertension.
Slovenian: V večino študij so bili vključeni bolniki z blago do zmerno hipertenzijo, v eno pa bolniki s hudo hipertenzijo.
English: The CHMP decided that Riprazo HCT's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Riprazo HCT večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Riprazo HCT is used to treat essential hypertension (high blood pressure) in adults.
Slovenian: Zdravilo Riprazo HCT se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih.
English: Riprazo HCT was more effective than placebo in reducing blood pressure.
Slovenian: Zdravilo Riprazo HCT je bilo pri zniževanju krvnega tlaka učinkovitejše od placeba.
English: EPAR summary for the public aliskiren / hydrochlorothiazide
Slovenian: Povzetek EPAR za javnost aliskiren/hidroklorotiazid
English: What benefit has Riprazo HCT shown during the studies?
Slovenian: Kakšne koristi je zdravilo Riprazo HCT izkazalo med študijami?
English: The dose depends on the doses of aliskiren and/or hydrochlorothiazide that the patient was taking before.
Slovenian: Odmerek je odvisen od odmerkov aliskirena in/ali hidroklorotiazida, ki jih je bolnik jemal prej.
English: 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 Riprazo HCT.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Riprazo HCT, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: It must not be taken with ciclosporin, itraconazole or other medicines known as ‘potent P-glycoprotein inhibitors' (such as quinidine).
Slovenian: Ne sme se jemati skupaj s ciklosporinom, itrakonazolom ali drugimi zdravili, znanimi kot „močni zaviralci Pglikoproteina“ (kot je kinidin).
English: By lowering blood pressure, the risk caused by high blood pressure, such as having a stroke, is reduced.
Slovenian: Z znižanjem krvnega tlaka se zmanjša tveganje, povezano z visokim krvnim tlakom, kot je kap.
English: Three additional studies were carried out to show that the active substances were absorbed in the body in the same way when they taken as separate tablets and as Riprazo HCT.
Slovenian: Izvedene so bile še tri dodatne študije, s katerimi je bilo dokazano, da se zdravilni učinkovini, ki se jemljeta v obliki ločenih tablet, absorbirata v telo enako kot zdravilo Riprazo HCT.
English: It works by increasing urine output, reducing the amount of fluid in the blood and reducing blood pressure.
Slovenian: Deluje tako, da poveča izločanje seča, zaradi česar se zmanjša količina tekočine v krvi in zniža krvni tlak.
English: Other information about Riprazo HCT
Slovenian: Druge informacije o zdravilu Riprazo HCT:
English: The studies compared the combination of aliskiren and hydrochlorothiazide with placebo (a dummy treatment), with aliskiren or hydrochlorothiazide taken alone, or with other medicines for hypertension (valsartan, irbesartan, lisinopril or amlodipine).
Slovenian: V študijah so primerjali kombinacijo aliskirena in hidroklorotiazida s placebom (zdravilom brez zdravilne učinkovine), aliskirenom ali hidroklorotiazidom kot samostojnima zdraviloma ali drugimi zdravili za zdravljenje hipertenzije (valsartanom, irbesartanom, lizinoprilom ali amlodipinom).
English: For the full list of all side effects reported with Riprazo HCT, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Riprazo HCT, glejte navodilo za uporabo.
English: Riprazo HCT must not be used in people who are hypersensitive (allergic) to aliskiren, hydrochlorothiazide, any of the other ingredients or sulfonamides.
Slovenian: Zdravila Riprazo HCT ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) aliskiren, hidroklorotiazid, katero koli drugo sestavino zdravila ali sulfonamide.
English: Riprazo HCT is used in patients whose blood pressure is not adequately controlled by aliskiren or hydrochlorothiazide taken alone.
Slovenian: Zdravilo Riprazo HCT se uporablja pri bolnikih, pri katerih krvni tlak ni ustrezno uravnan z jemanjem samo aliskirena ali hidroklorotiazida.
English: The company presented information used in the assessment of aliskiren and from the published literature to support its application for Riprazo HCT, as well as information from additional studies.
Slovenian: Družba je v podporo svoji vlogi za zdravilo Risprazo HCT predstavila informacije, ki so bile uporabljene pri oceni aliskirena, ter informacije iz objavljene literature in dodatnih študij.
English: It can also be used in patients whose blood pressure is adequately controlled with aliskiren and hydrochlorothiazide taken as separate tablets, to replace the same doses of the two active substances.
Slovenian: Lahko pa se uporablja tudi pri bolnikih, pri katerih je krvni tlak ustrezno uravnan z aliskirenom in hidroklorotiazidom, ki ju bolniki jemljejo kot ločeni tableti, kot nadomestitev istih odmerkov dveh zdravilnih učinkovin.
English: The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Slovenian: Kombinacija obeh zdravilnih učinkovin daje boljše rezultate pri zniževanju krvnega tlaka kot vsako posamezno zdravilo posebej.
English: Patients previously taking only aliskiren or hydrochlorothiazide may need to take the two substances as separate tablets and adjust the doses before switching to Riprazo HCT.
Slovenian: Bolniki, ki so predhodno jemali samo aliskiren ali hidroklorotiazid, bodo morda morali vzeti obe učinkovini v ločenih tabletah in odmerke pred prehodom na zdravilo Riprazo HCT prilagoditi.
English: In patients whose blood pressure was not adequately controlled on either aliskiren or hydrochlorothiazide alone, switching to the combination resulted in greater falls in blood pressure than remaining on one active substance alone.
Slovenian: Pri bolnikih, pri katerih krvni tlak ni bil ustrezno uravnan samo z jemanjem aliskirena ali hidroklorotiazida, je prehod na kombinacijo zdravil povzročil večji padec krvnega tlaka kot jemanje samo ene zdravilne učinkovine.
English: It must not be used in patients who have had angioedema (swelling under the skin) with aliskiren, hereditary angioedema or angioedema of no obvious cause, who have severe kidney or liver impairment, or whose blood potassium levels are too low or blood calcium levels are too high.
Slovenian: Ne sme se uporabljati pri bolnikih, pri katerih se je zaradi jemanja aliskirena pojavil angioedem (podkožno otekanje), pri bolnikih z dednim angioedemom ali angioedemom brez jasnega vzroka, pri bolnikih s hudo jetrno oziroma ledvično okvaro ali pri bolnikih, ki imajo prenizke ravni kalija oziroma previsoke ravni kalcija.
English: Riprazo HCT in combination with an ‘angiotensin converting enzyme (ACE) inhibitors' or ‘angiotensin receptor blockers' (ARBs) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Slovenian: Zdravilo Riprazo HCT se v kombinaciji z zaviralcem angiotenzinske konvertaze ali zaviralcem angiotenzinskih receptorjev ne sme uporabljati pri bolnikih s sladkorno boleznijo oziroma zmerno ali hudo okvaro ledvic.
English: In patients already adequately controlled with the two active substances, the dose of Riprazo HCT must contain the same doses of aliskiren and hydrochlorothiazide that the patient was taking before.
Slovenian: Pri bolnikih, pri katerih je krvni tlak že uravnan z obema zdravilnima učinkovinama, mora odmerek zdravila Riprazo HCT vsebovati enak odmerek aliskirena in hidroklorotiazida, kot ju je bolnik jemal prej.
English: What is the risk associated with Riprazo HCT?
Slovenian: Kakšna tveganja so povezana z zdravilom Riprazo HCT?
English: Riprazo HCT is a medicine that contains the active substances aliskiren and hydrochlorothiazide.
Slovenian: Riprazo HCT je zdravilo, ki vsebuje zdravilni učinkovini aliskiren in hidroklorotiazid.
English: Why has Riprazo HCT been approved?
Slovenian: Zakaj je bilo zdravilo Riprazo HCT odobreno?
English: It blocks the activity of a human enzyme called renin, which is involved in the production of a substance called angiotensin I in the body.
Slovenian: Zavira dejavnost človeškega encima, imenovanega renin, ki v telesu sodeluje pri tvorjenju snovi, imenovane angiotenzin I. Angiotenzin I se pretvori v hormon angiotenzin II, ki deluje kot močan vazokonstriktor (učinkovina, ki oži žile).
English: Riprazo HCT contains two active substances, aliskiren and hydrochlorothiazide.
Slovenian: Zdravilo Riprazo HCT vsebuje dve zdravilni učinkovini, aliskiren in hidroklorotiazid.
English: How has Riprazo HCT been studied?
Slovenian: Kako je bilo zdravilo Riprazo HCT raziskano?
English: What is Riprazo HCT?
Slovenian: Kaj je zdravilo Riprazo HCT?
English: What is Riprazo HCT used for?
Slovenian: Za kaj se zdravilo Riprazo HCT uporablja?
English: How is Riprazo HCT used?
Slovenian: Kako se zdravilo Riprazo HCT uporablja?
English: How does Riprazo HCT work?
Slovenian: Kako zdravilo Riprazo HCT deluje?
English: Repeat this action vigorously for at least 15 seconds.
Slovenian: Postopek odločno ponavljajte vsaj 15 sekund.
English: Vaccination is the best way to protect against these diseases.
Slovenian: Cepljenje je najboljši način zaščite proti tema boleznima.
English: Most people recover completely but the illness is usually severe enough to keep people ill for about a month.
Slovenian: Večina ljudi popolnoma okreva, toda bolezen je običajno tako huda, da so bolniki bolni približno mesec dni.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 1996
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 20. september 1996
English: Date of latest renewal: 28 August 2006
Slovenian: Datum zadnjega podaljšanja: 28. avgust 2006
English: Hold the syringe upright in a closed hand.
Slovenian: Brizgo držite pokončno v zaprti dlani.
English: 1 month later
Slovenian: 1 mesec pozneje
English: 7 days later
Slovenian: 7 dni pozneje
English: • you have a severe infection with a high temperature (over 38°C).
Slovenian: • imate hujšo okužbo z visoko telesno temperaturo (višjo od 38 ˚C).
English: Such reactions may occur before leaving the doctor's surgery.
Slovenian: Take reakcije se lahko zgodijo, preden zapustite ambulanto.
English: at an elected date
Slovenian: na izbrani dan
English: - neomycin.
Slovenian: - neomicin.
English: Young children may not develop jaundice.
Slovenian: Majhni otroci včasih ne razvijejo zlatenice.
English: The vaccine should never be given into a vein.
Slovenian: Cepiva se nikoli ne sme dajati v žilo.
English: The vaccine may contain traces of neomycin which is used during the manufacturing process (see section 4.3).
Slovenian: Cepivo lahko vsebuje sledi neomicina, ki se uporablja v proizvodnem procesu (glej poglavje 4.3).
English: Protection against hepatitis A and hepatitis B develops within 2-4 weeks.
Slovenian: Zaščita pred virusom hepatitisa A in hepatitisa B se razvije v 2-4 tednih.
English: - Primary vaccination schedule
Slovenian: - Osnovna shema cepljenja
English: • you have a poor immune system due to illness or drug treatment.
Slovenian: • imate oslabel imunski sistem zaradi bolezni ali jemanja zdravil.
English: Do not use this medicine after the expiry date which is stated on the carton.
Slovenian: Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
English: The first dose will be given on an elected date.
Slovenian: Prvi odmerek boste prejeli na izbrani dan.
English: b. If the vaccine still does not appear as a uniform hazy white suspension - tip upside down and back again for at least another 15 seconds - then inspect again.
Slovenian: b. če cepivo še vedno ni videti kot enotna, motno bela suspenzija - brizgo ponovno prevračajte na glavo in spet nazaj za vsaj nadaljnjih 15 sekund - nato ponovno preglejte cepivo.
English: Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus.
Slovenian: Simptomi hepatitisa A se običajno pojavijo 3 do 6 tednov po stiku z virusom.
English: Shake the syringe by tipping it upside down and back again.
Slovenian: Brizgo pretresite tako, da jo prevračate na glavo in spet nazaj.
English: This schedule may be given to adults only needing a rapid protection (e.g. overseas travellers).
Slovenian: To shemo cepljenja se lahko uporablja samo pri odraslih, ki potrebujejo hitro zaščito (npr. pri popotnikih).
English: • you have experienced any health problems after previous administration of a vaccine.
Slovenian: • ste po predhodnem cepljenju imeli kakršne koli zdravstvene težave.
English: The vaccine has not been tested in patients with impaired immunity.
Slovenian: Cepivo ni bilo preizkušeno pri bolnikih z oslabljeno imunostjo.
English: 21 days after the first dose
Slovenian: 21 dni po prvem odmerku
English: None of the components in the vaccine are infectious.
Slovenian: Nobena od sestavin tega cepiva ni kužna.
English: If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this vaccine.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden prejmete to cepivo.
English: You will receive a total of three injections over 6 months.
Slovenian: Skupaj boste prejeli tri injekcije cepiva v 6 mesecih.
English: Guidelines for boosting are based on the assumption that antibodies are required for protection; anti-HAV antibodies have been predicted to persist for at least 10 years.
Slovenian: Smernice za poživitveno cepljenje temeljijo na predpostavki, da so za zaščito nujno potrebna protitelesa; anti-HAV protitelesa naj bi se po ocenah ohranila najmanj 10 let.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or neomycin.
Slovenian: Preobčutljivost na zdravilni učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1, ali neomicin.
English: After a few days the whites of eyes and skin may become yellowish (jaundice).
Slovenian: Po nekaj dneh lahko koža in/ali beločnice postanejo rumenkaste barve (zlatenica).
English: Pack sizes of 1, 10 and 25 with or without needles.
Slovenian: Velikosti pakiranja: 1, 10 ali 25 z iglami ali brez njih.
English: • A temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barré syndrome)
Slovenian: • začasno vnetje živcev, ki povzročajo bolečino, šibkost in paralizo v ekstremitetah in često napredujejo proti prsnemu košu in obrazu (Guillain-Barré-jev sindrom),