FrancophonIA/ELRC3.0 huggingface dataset:
English: Data available on clinical efficacy of gallium (68Ga) edotreotide for the indication of predicting and monitoring of therapeutic response to peptide receptor radionuclide therapy (PRRT) in histologically confirmed metastatic NET are limited.
Slovenian: Razpoložljivi podatki glede klinične učinkovitosti [68Ga]galij-edotreotida za indikacijo predvidevanja in spremljanja terapevtskega odziva na radionuklidno terapijo s peptidnimi receptorji (PRRT) v histološko potrjenem metastatskem NET, so omejeni (glejte poglavje 5.1).
English: As an example, an increase in somatostatin receptor density can also occur in the following pathological conditions: subacute inflammations (areas of lymphocyte concentrations), thyroid diseases (e.g. thyroid autonomy and Hashimoto's disease), tumours of the pituitary gland, neoplasms of the lungs (small-cell carcinoma), meningiomas, mammary carcinomas, lympho-proliferative disease (e.g. Hodgkin's disease and non-Hodgkin lymphomas) and tumours arising from tissue embryologically derived from the neural crest (e.g. paragangliomas, medullary thyroid carcinomas, neuroblastomas, pheochromocytomas).
Slovenian: neoplazije pljuč (drobnocelični karcinom), meningiomi, karcinomi dojk, limfoproliferativna bolezen (npr. Hodgkinova bolezen in ne-Hodgkinovi limfomi) in tumorji, ki izhajajo iz tkiva, ki embriološko izhaja iz nevralnega grebena (npr. paragangliomi, medularni karcinomi ščitnice, nevroblastomi, feokromocitomi).
English: For radiolabelling with gallium (68Ga) chloride solution.
Slovenian: Za radioaktivno označevanje z raztopino [68Ga]galijevega klorida.
English: The visual inspection should be performed under a shielded screen for radioprotection purposes.
Slovenian: Pregled je treba, zaradi zaščite pred sevanjem, opraviti pod zaščitnim zaslonom.
English: How SomaKit TOC is stored 6.
Slovenian: Shranjevanje zdravila SomaKit TOC 6.
English: If possible, for more convenience in the preparation of radiolabelled SomaKit TOC, the heating platform should be placed right beside the generator.
Slovenian: SomaKit TOC grelno platformo postavite neposredno ob generator.
English: Before administration of SomaKit TOC
Slovenian: Pred uporabo zdravila SomaKit TOC
English: Close contact with infants should be restricted during the initial 8 hours following injection.
Slovenian: V prvih 8 urah po dajanju tega zdravila je treba omejiti tesne stike z dojenčkom.
English: Renal impairment / Hepatic impairment The safety and efficacy of gallium (68Ga) edotreotide have not been studied in patients with renal or hepatic impairment.
Slovenian: Varnosti in učinkovitosti [68Ga]galij-edotreotida niso preučevali pri bolnikih z okvaro ledvic ali jeter.
English: Lesion-detection rate was 75% (3/4) in the subgroup of patients with unknown primary tumour site of the prospective study of Frilling et al. 2010.
Slovenian: V prospektivni študiji Frilling et al. 2010 je bila stopnja odkrivanja lezij 75 % (3/4) za podskupino bolnikov z neznanim mestom primarnega tumorja.
English: Withdraw the syringe and the 0.2 µm sterile vent filter and move the vial to the hole of the dry bath at 95°C, using a plier.
Slovenian: Izvlecite injekcijsko brizgo in 0,2-µm sterilni odzračevalni filter ter vialo s kleščami prestavite na odprtino suhe kopeli pri 95 °C.
English: b. Apply a drop of the gallium (68Ga) edotreotide on a pencil line 1 cm from the bottom of the
Slovenian: b. Kapljo [68Ga]galij-edotreotida nanesite na črto svinčnika 1 cm od spodnjega roba traka
English: Administration of SomaKit TOC and conduct of the procedure After radiolabelling, SomaKit TOC is administered by intravenous injection.
Slovenian: Zdravilo SomaKit TOC se po radioaktivnem označevanju daje z intravensko injekcijo.
English: • One vial of powder for solution for injection: 10 ml Type I glass vial closed with a bromobutyl rubber stopper and sealed with a flip-off cap. Each vial contains 40 micrograms of edotreotide.
Slovenian: • Ena viala s praškom za raztopino za injiciranje: 10-mililitrska steklena viala (steklo tipa I) z zamaškom iz bromobutilne gume, zatesnjenim z zaporko (tipa »flip-off«).
English: m. The solution should be visually inspected prior to use.
Slovenian: m. Raztopino je treba pred uporabo pregledati.
English: In the study of Lee et al. 2015 in 13 GEP-NET patients, a total of 35 positive lesions were detected in 10 patients on either gallium (68Ga) edotreotide PET/CT or indium (111In) pentetreotide
Slovenian: V študiji Lee et al. 2015 je bilo pri 13 bolnikih z GEP NET odkritih skupno 35 pozitivnih lezij pri 10 bolnikih, tako s PET/CT z [68Ga]galij-edotreotidom kot tudi s SPECT/CT z [111In]indij-pentetreotidom, medtem ko pri 3 bolnikih niso odkrili nobene pozitivne lezije z nobeno od metod slikanja.
English: Figure 1: Radiolabelling procedure when using GalliaPharm generator Reconstitution with Galli Ad generator:
Slovenian: Slika 1: Postopek radioaktivnega označevanja pri uporabi generatorja GalliaPharm
English: What SomaKit TOC looks like and contents of the pack SomaKit TOC is a kit for radiopharmaceutical preparation containing: - A glass vial with black flip-off cap containing a white powder.
Slovenian: Izgled zdravila SomaKit TOC in vsebina pakiranja SomaKit TOC je komplet za pripravo radiofarmaka, ki vsebuje:
English: SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation Edotreotide
Slovenian: SomaKit TOC 40 mikrogramov komplet za pripravo radiofarmaka edotreotid
English: Renal / Hepatic impairment
Slovenian: Bolniki z ledvično ali jetrno okvaro
English: After radiolabelling, store below 25°C.
Slovenian: Po radioaktivnem označevanju shranjujte pri temperaturi do 25 ºC.
English: NAME OF THE MEDICINAL PRODUCT SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation
Slovenian: IME ZDRAVILA SomaKit TOC 40 mikrogramov komplet za pripravo radiofarmaka
English: Radiolabelled SomaKit TOC is suitable for PET medical imaging.
Slovenian: Radioaktivno označeno zdravilo SomaKit TOC je primerno za medicinsko slikanje s PET. Zajemanje mora vključevati celo telo od lobanje do sredine stegen.
English: Appearance
Slovenian: Videz
English: Acceptance Criteria Method colloidal gallium-68 species Labelling efficiency % Free gallium-68
Slovenian: Učinkovitost označevanja vzorec koloidnega galija-68
English: Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
Slovenian: Pri teh bolnikih obstaja možnost povečane izpostavljenosti sevanju, zato je treba skrbno pretehtati razmerje med koristmi in tveganji .
English: No adverse reactions related to gallium (68Ga) edotreotide have been reported.
Slovenian: 4.8 Neželeni učinki O neželenih učinkih, povezanih z [68Ga]galij-edotreotidom, niso poročali.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SomaKit TOC 40 micrograms solution for injection Gallium (68Ga) edotreotide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE SomaKit TOC 40 mikrogramov raztopina za injiciranje [68Ga]galij-edotreotid intravenska uporaba
English: The three remaining retrospective studies recruited small samples (ranging from 20 to 28 GEP-NET patients or those with cancer of unknown origin) and found that semiquantitative uptake in the pre-PRRT gallium (68Ga)
Slovenian: Preostale tri retrospektivne študije so uporabljale majhne vzorce (v razponu od 20 do 28 bolnikov z GEP NET ali bolnikov z rakom neznanega izvora) in so ugotovile, da je bil semikvantitativni privzem pri slikanju PET z [68Ga]galij edotreotidom pred PRRT povezan z odmerki, ki jih tumor absorbira ob vbrizganju v naslednjem prvem ciklu zdravljenja, da je pomagal pri razlikovanju med lezijami, opredeljenimi kot odzivnimi in neodzivnimi po treh ciklih PRRT, ter da je pomagal razlikovati metastaze v jetrih od normalnega jetrnega tkiva.
English: No radioactive metabolites were detected in serum within 4 hours after intravenous injection of gallium (68Ga) edotreotide.
Slovenian: V 4 urah po intravenskem injiciranju [68Ga]galij-edotreotida niso odkrili readioaktivnih presnovkov v serumu.
English: How SomaKit TOC is used
Slovenian: Kako uporabljati zdravilo SomaKit TOC
English: A lesion detection rate of 100% (40/40) versus 85% (34/40) was observed in the study of Hofmann et al. 2001 recruiting patients with histologically proven bronchial (n=2) or midgut (n=6) NETs.
Slovenian: V študiji Hofmann et al. 2001, ki je obravnavala bolnike s histološko dokazanimi NET bronhijev (n=2) in srednjega črevesa (n=6), so zaznali stopnjo odkrivanja lezij 100 % (40/40) v primerjavi s 85 % (34/40).
English: Store the vial containing the gallium (68Ga) edotreotide solution below 25°C until use.
Slovenian: Vialo z [68Ga]galij-edotreotidom do uporabe hranite pri temperaturi do 25 °C.
English: What you need to know before SomaKit TOC is used
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo SomaKit TOC Zdravila SomaKit TOC se ne sme uporabljati:
English: ITLC strip.
Slovenian: ITLC.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SomaKit TOC 40 micrograms powder for solution for injection edotreotide
Slovenian: IME ZDRAVILA IN POT(I) UPORABE SomaKit TOC 40 mikrogramov prašek za raztopino za injiciranje edotreotid i.v.
English: Formic acid
Slovenian: Stena želodca
English: Free gallium-68 = 0.9 to 1
Slovenian: % prostega galija-68
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: Powder: 1,10-phenanthroline, gentisic acid, mannitol (E421) Buffer: formic acid, sodium hydroxide (E524), water for injections See leaflet for further information.
Slovenian: Pufer: mravljinčna kislina, natrijev hidroksid (E524), voda za injekcije
English: GENERAL CLASSIFICATION FOR SUPPLY
Slovenian: Komplet v embalaži za prodajo
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SHIELD LABEL TO BE APPLIED AFTER RADIOLABELLING
Slovenian: NALEPKA ZA ŠČIT, KI JO JE TREBA NALEPITI PO RADIOAKTIVNEM OZNAČEVANJU
English: This medicinal product should be radiolabelled before administration to the patient.
Slovenian: Preden se zdravilo da bolniku, ga je treba radioaktivno označiti.
English: Do not store above 25°C after radiolabelling.
Slovenian: Po radioaktivnem označevanju shranjujte pri temperaturi do 25°C.
English: A schematic representation of the radiolabelling procedure is shown in
Slovenian: Shematski prikaz postopka radioaktivnega označevanja je prikazan na sliki 1.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS POWDER VIAL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: Material
Slovenian: Metoda
English: Concomitant use of somatostatin analogues It is preferable to perform imaging with gallium (68Ga) edotreotide the day(s) before the next administration of a somatostatin analogue.
Slovenian: Slikanje z [68Ga]galij-edotreotidom je treba po možnosti opraviti dan (nekaj dni) pred naslednjim dajanjem analoga somatostatina.
English: How SomaKit TOC is stored
Slovenian: Shranjevanje zdravila SomaKit TOC
English: SomaKit TOC contains sodium
Slovenian: Zdravilo SomaKit TOC vsebuje natrij.
English: For the detection of the primary GEP-NET site in case of rising levels of a relevant biochemical tumour marker or in case of proven NET metastasis, patient-based sensitivity and specificity of gallium (68Ga) edotreotide PET were 100% (4/4) and 89% (8/9), respectively, in the prospective study of Gabriel et al. 2007.
Slovenian: NET, od bolnika odvisni občutljivost in specifičnost PET z [68Ga ]galij-edotreotidom 100 % (4/4) oziroma 89 % (9/8).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains 40 micrograms of edotreotide.
Slovenian: Ena viala vsebuje 40 mikrogramov edotreotida.
English: OTHER Do not store above 25ºC
Slovenian: DRUGI PODATKI Shranjujte pri temperaturi do 25 °C.
English: You must inform the nuclear medicine doctor before the administration of SomaKit TOC if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.
Slovenian: Če obstaja možnost, da ste noseči, vam je izostala menstruacija ali dojite, o tem pred uporabo zdravila SomaKit TOC obvestite zdravnika nuklearne medicine.
English: Pregnancy and breast-feeding
Slovenian: OVOJNINAH VIALA S PUFROM
English: This will help protect the environment.
Slovenian: Takšni ukrepi pomagajo varovati okolje.
English: However, the risk of transmission is still possible.
Slovenian: Toda tveganje prenosa še obstaja.
English: Your doctor will discuss this with you.
Slovenian: Zdravnik se bo o tem z vami pogovoril.
English: • you are over 65 years of age
Slovenian: • če ste starejši od 65 let,
English: The CHMP found the new proposal acceptable.
Slovenian: CHMP je menil, da je novi predlog sprejemljiv.
English: 75014 PARIS France
Slovenian: 75014 PARIS Francija
English: The extent of exposure in this population is difficult to quantify.
Slovenian: Obseg izpostavljenosti v tej populaciji je težko količinsko opredeliti.
English: The estimated daily AUCs are appreciably greater.
Slovenian: Ocenjene dnevne AUC so občutno večje.
English: The level of information differs across Members States.
Slovenian: Raven informacij se razlikuje med državami članicami.
English: For maximum clinical benefit, the treatment should be started within 48 hours.
Slovenian: Za največjo klinično korist je treba zdravljenje začeti v 48 urah.
English: Symptoms and Signs
Slovenian: Simptomi in znaki
English: Specific documentation was submitted taking into account updated data.
Slovenian: Predložil je specifično dokumentacijo, v kateri je upošteval posodobljene podatke.
English: A recent metaanalysis (Lebrun-Vignes, 2007) provided additional supportive data for this indication.
Slovenian: Nedavna metaanaliza (Lebrun-Vignes, 2007) daje dodatne podporne podatke za to indikacijo.
English: Some Member States have recommendations of a higher dose than other member states in specific situations.
Slovenian: Nekatere države članice imajo v specifičnih situacijah priporočene večje odmerke kot druge države članice.
English: Rapid development of symptoms including:
Slovenian: Hiter nastanek simptomov, med katerimi so:
English: • seeing or hearing things that aren't there (hallucinations)
Slovenian: • videnje ali slišanje stvari, ki jih ni (halucinacije),
English: Nevertheless, given the relatively benign indication, a conservative approach might be appropriate to reduce the potential safety risk.
Slovenian: Kljub temu izgleda, da bo glede na relativno benigno indikacijo konzervativni pristop primeren za zmanjšanje potencialnega varnostnega tveganja.
English: 169 29 Solna, Sweden
Slovenian: 169 29 Solna, Švedska
English: These observations support safety of treatment of HSV in both groups although the possibility of increasing resistance should continuously be observed.
Slovenian: Ta opažanja podpirajo varnost zdravljenja HSV v obeh skupinah, vendar je treba stalno spremljati možnost povečanja odpornosti.
English: 105 Reykjavík, Iceland
Slovenian: 105 Reykjavík, Islandija
English: Similar type of data is presented but the level of factual detail varies significantly.
Slovenian: Predstavljeni so podobni podatki, vendar se raven podrobnosti zelo razlikuje.
English: The CHMP adopted a List of Questions on 20 November 2008 and other three Lists of outstanding issues.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je dne 20. novembra 2008 sprejel seznam vprašanj ter tri druge sezname nerešenih vprašanj.
English: This is important to prevent you passing the infection on to others.
Slovenian: To je pomembno, da ne boste okužbe prenesli na druge.
English: Patients should be observed closely for signs of toxicity.
Slovenian: Bolnike je treba natančno opazovati glede znakov toksičnosti.
English: The data were therefore not sufficient for subgroup analyses of efficacy and safety.
Slovenian: Podatki zato niso zadostovali za analizo učinkovitosti in varnosti v podskupinah.
English: Recommendations for use also show differences.
Slovenian: Razlikujejo se tudi priporočila za rabo.
English: • fall in blood pressure leading to collapse.
Slovenian: • padec krvnega tlaka, ki povzroči kolaps.
English: Treatment should be re-evaluated after 6 to 12 months of therapy.
Slovenian: Zdravljenje je treba ponovno oceniti po 6 do 12 mesecih zdravljenja.
English: Austria, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Iceland, Ireland, Latvia, Lithuania, Malta, Norway, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom: Valtrex
Slovenian: To zdravilo je odobreno v državah članicah EGP pod naslednjimi imeni: Avstrija, Bolgarija, Ciper, Češka, Estonija, Finska, Nemčija, Grčija, Islandija, Irska, Latvija, Litva, Malta, Norveška, Portugalska, Romunija, Slovaška, Slovenija, Španija, Švedska, Velika Britanija: Valtrex
English: 30 to 49 10 to 29
Slovenian: 30 do 49 10 do 29
English: Analysis of the published literature showed no new significant safety concerns for the babies or the mothers.
Slovenian: Analiza objavljenih podatkov ni pokazala novih pomembnih varnostnih zadržkov za dojenčke ali matere.
English: Creatinine clearance estimates were similar between treatments and between the two studies.
Slovenian: Ocene očistka kreatinina so bile podobne med zdravljenji in med obema študijama.
English: The CHMP considered that only studies of limited size and unknown quality have been reported.
Slovenian: CHMP je menil, da so bile predložene le študije omejene velikosti in neznane kakovosti.
English: The duration of treatment will usually be 90 days, but may need to be extended in high-risk patients.
Slovenian: Zdravljenje običajno traja 90 dni, vendar je lahko pri bolnikih z velikim tveganjem potrebno podaljšanje.
English: FI-02200 Espoo, Finland
Slovenian: FI-02200 Espoo, Finska
English: It is very important while you are taking Valtrex that you drink water regularly during the day.
Slovenian: Zelo pomembno je, da medtem, ko jemljete zdravilo Valtrex, čez dan redno pijete vodo.
English: Creatinine Clearance (mL/min)
Slovenian: Očistek kreatinina (ml/min)
English: 152 32 Halandri, Athens, Greece
Slovenian: 152 32 Halandri, Athens, Grčija
English: Although rare, this is thought to be associated with high peak concentrations rather than AUC.
Slovenian: Čeprav je to redko, naj bi bilo povezano z visokimi vrhovi koncentracij in ne z vrednostjo AUC.
English: • skin reaction after exposure to sunlight (photosensitivity).
Slovenian: • kožna reakcija po izpostavljenosti sončni svetlobi (fotosenzibilnost),
English: <10 or on dialysis
Slovenian: < 10 ali na dializi
English: France sanofi-aventis France 1 - 13 boulevard Romain Rolland
Slovenian: Francija sanofi-aventis Francija 1 - 13 boulevard Romain Rolland
English: People over 65 years of age or with kidney problems
Slovenian: Osebe, starejše od 65 let, in osebe, ki imajo težave z ledvicami
English: Based on the results of these two studies the International Herpes Management forum (IHMF) [Gilbert.
Slovenian: Na osnovi rezultatov teh dveh študij organizacija Mednarodni forum za obvladovanje herpesa (International Herpes Management forum - IHMF) [Gilbert.
English: Children The efficacy of Valtrex in children below the age of 12 years has not been evaluated.
Slovenian: Otroci Učinkovitost zdravila Valtrex ni ocenjena pri otrocih, mlajših od 12 let.
English: Uncommon side effects that may show up in blood tests:
Slovenian: Drugi neželeni učinki, ki se lahko pokažejo na preiskavah krvi:
English: The virulence of these variants resembles that of the wild-type virus.
Slovenian: Virulenca teh variant je podobna virulenci divjega tipa virusa.
English: • If you forget to take Valtrex, take it as soon as you remember.
Slovenian: • Če ste pozabili vzeti zdravilo Valtrex, ga vzemite, čim se spomnite.
English: Binding of valaciclovir to plasma proteins is very low (15%).
Slovenian: Vezava valaciklovirja na beljakovine v plazmi je zelo majhna (15 %).
English: The approved dosages were based on comparative estimates of systemic aciclovir exposure (Weller, 2000).
Slovenian: Odobreni odmerki temeljijo na primerjalnih ocenah sistemske izpostavljenosti aciklovirju (Weller, 2000).
English: Driving or using machines
Slovenian: Vožnja ali upravljanje s stroji
English: Some Member States have an additional contraindication for pregnancy and lactation.
Slovenian: Določene države članice imajo dodatno kontraindikacijo za nosečnost in dojenje.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF VALTREX AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA VALTREX IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: These studies were selected as most representative of the product safety profile for the general population exposed to valaciclovir and cover approximately 5855 subjects.
Slovenian: Te študije so bile izbrane kot najbolj reprezentativne za varnostni profil zdravila za splošno populacijo, izpostavljeno valaciklovirju, in zajemajo približno 5855 preiskovancev.
English: Transfer into breast milk
Slovenian: Prehajanje v materino mleko
English: 2007] recommends short course, high dose therapy for treatment of herpes labialis as an alternative to other approved regimens.
Slovenian: 2007] priporoča kratkotrajno visokoodmerno terapijo za zdravljenje labialnega herpesa kot alternativo drugim odobrenim režimom.
English: For higher doses (4000 mg or more per day), see section 4.4.
Slovenian: Za večje odmerke (4.000 mg ali več na dan) glejte poglavje 4.4.
English: /n.v., rue du Tilleul 13, B-1332 Genval, Belgium
Slovenian: /n.v., rue du Tilleul 13, B-1332 Genval, Belgija
English: Patients should be advised to start treatment as soon as possible after a diagnosis of herpes zoster.
Slovenian: Bolnikom je treba naročiti, naj zdravljenje začnejo čim prej po postavitvi diagnoze herpesa zostra.
English: The median aciclovir concentration in breast milk was 2.24 micrograms/ml (9.95 micromoles/L).
Slovenian: Mediana koncentracija aciklovirja v materinem mleku je bila 2,24 mikrograma/ml (9,95 mikromola/l).
English: For initial episodes, which can be more severe, treatment may have to be extended to ten days.
Slovenian: Za začetne epizode, ki so lahko hujše, je treba zdravljenje včasih podaljšati na deset dni.
English: Titanium dioxide
Slovenian: Titanov dioksid
English: GlaxoSmithKline agreed with the European Medicines Agency to harmonise the CMC quality data (Module 3) during this Article 30 referral.
Slovenian: Družba GlaxoSmithKline se je strinjala z Evropsko agencijo za zdravila glede uskladitve kakovostnih podatkov CMC (modul 3) v napotitvi po členu 30.
English: Dosing should begin as early as possible.
Slovenian: Zdravilo je treba začeti uporabljati čim prej.
English: • increase in substances produced by the liver.
Slovenian: • porast snovi, ki nastajajo v jetrih.
English: • You should take Valtrex for one day (two doses) only.
Slovenian: • Zdravilo Valtrex morate jemati samo en dan (dva odmerka).
English: This includes medicines obtained without a prescription, including herbal medicines.
Slovenian: To velja tudi za zdravila, ki ste jih dobili brez recepta, vključno z zeliščnimi pripravki.
English: France, Belgium, Denmark, Italy, Luxembourg, Netherlands: Zelitrex This leaflet was last approved in {MM/YYYY}.
Slovenian: Francija, Belgija, Danska, Italija, Luksemburg, Nizozemska: Zelitrex Navodilo je bilo odobreno {MM/LLLL}.
English: Packs of 10, 30, 42, 90 or 112 tablets Not all pack sizes may be marketed.
Slovenian: Pakiranja z 10, 30, 42, 90 ali 112 tabletami Na trgu ni vseh navedenih pakiranj.
English: • Take Valtrex at the same time each day.
Slovenian: • Zdravilo Valtrex vzemite vsak dan ob istem času.
English: Nausea and vomiting may also occur.
Slovenian: Pojavita se lahko tudi navzea in bruhanje.
English: Thus the effectiveness of different valaciclovir doses in patients with similar degrees of renal function could not been compared.
Slovenian: Zato učinkovitosti različnih odmerkov valaciklovirja pri bolnikih s podobnimi stopnjami ledvične funkcije niso primerjali.
English: The dose that you should take will depend on why your doctor has prescribed Valtrex for you.
Slovenian: Odmerek, ki ga boste morali jemati, bo odvisen od tega, čemu vam je zdravnik predpisal zdravilo Valtrex.