FrancophonIA/ELRC3.0 huggingface dataset:
English: Isotretinoin is a vitamin A derivative indicated for the treatment of severe forms of acne (such as nodular or conglobate acne or acne at risk of permanent scarring) resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy.
Slovenian: Izotretinoin je derivat vitamina A, ki je indiciran za zdravljenje hudih oblik aken (nodulocističnih oz. konglobiranih aken ali aken, ki lahko povzročijo brazgotine), ki se ne odzivajo na ustrezno standardno zdravljenje s sistemskimi antibakterijskimi zdravili in topično terapijo.
English: • the results of the bioequivalence study in fed conditions provided by the MAH,
Slovenian: • rezultatov študije biološke enakovrednosti pri jemanju zdravila s hrano, ki jih je predložil imetnik dovoljenja za promet,
English: The CHMP considered that the data submitted in support of this application failed to show bioequivalence between the test and the reference product, and that therefore the product is not approvable for the sought indications.
Slovenian: CHMP meni, da podatki, predloženi v podporo tej vlogi, ne dokazujejo biološke enakovrednosti med testiranim in referenčnim zdravilom, zaradi česar zdravila ni mogoče odobriti za omenjene indikacije.
English: Having regard to the fact that the absorption of Isotretinoin in fed state is larger than that observed in fasted state (which motivates the SPC recommendation of intake with food (as clearly mentioned in the Posology section of the SPC), the CHMP agreed that a study in the fed state was essential.
Slovenian: Ker je absorpcija zdravila Isotretinoin pri jemanju s hrano višja kot pri jemanju na tešče (to je tudi razlog, zakaj je v povzetku glavnih značilnosti zdravila v poglavju o odmerjanju priporočeno jemanje zdravila s hrano), se je CHMP strinjal, da je potrebno izvesti študijo o jemanju zdravila s hrano.
English: However, during the mutual recognition procedure, demonstration of bioequivalence in fed state was considered essential by the Concerned Member States and the matter was referred to the CHMP.
Slovenian: Med postopkom z medsebojnim priznavanjem pa so zadevne države članice menile, da je treba dokazati tudi biološko enakovrednost pri jemanju zdravila sočasno s hrano, zato je bila zadeva napotena na odbor CHMP.
English: Results of a study in healthy adult human male subjects under fed conditions (study No 122_ISOTR_10) were subsequently provided by the marketing authorisation holder.
Slovenian: Imetnik dovoljenja za promet z zdravilom je naknadno predložil rezultate študije jemanja zdravila s hrano, ki je bila izvedena med zdravimi odraslimi moškimi (študija št. 122_ISOTR_10).
English: The Committee further considered that it is not possible, on the basis of the data submitted in support of this application, to establish a positive benefit-risk balance for this product and that, in these circumstances, the marketing of the product constitutes a risk to public health.
Slovenian: Odbor nadalje meni, da na podlagi podatkov, predloženih v podporo vlogi, ni mogoče ugotoviti pozitivnega razmerja med koristmi in tveganji za to zdravilo in da zato trženje tega zdravila v danih okoliščinah predstavlja tveganje za javno zdravje.
English: The Committee further considered that it is not possible, on the basis of the data submitted in support of this application, to establish a positive benefit-risk balance for this product and, in these circumstances, the marketing of the product constitutes a risk to public health.
Slovenian: Odbor nadalje meni, da na podlagi navedenih podatkov ni mogoče ugotoviti pozitivnega razmerja med koristmi in tveganji za to zdravilo, zato trženje tega zdravila v danih okoliščinah predstavlja tveganje za javno zdravje.
English: Chemin de la Chatanérie 2 1023 Crissier-Lausanne SWITZERLAND
Slovenian: Chemin de la Chatanérie 2 1023 Crissier-Lausanne ŠVICA
English: ATCvet code: QI02AT01.
Slovenian: Oznaka ATCvet: QI02AT01
English: Merial Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCE
Slovenian: Merial Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCIJA
English: MARKETING AUTHORISATION NUMBER(S) EU/2/99/011/001
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/99/011/001
English: * microagglutination method
Slovenian: * z metodo mikroaglutinacije
English: Methyl parahydroxybenzoate ≤ 0.8 mg/ml.
Slovenian: Metilparahidroksibenzoat ≤ 0.8 mg/ml.
English: Dispose of waste material in accordance with local requirements.
Slovenian: Odpadne stvari odstranite v skladu z lokalnimi predpisi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/03/1999.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 29/03/1999.
English: Special warnings for each target species:
Slovenian: Posebna opozorila za vsako živalsko vrsto:
English: This should be borne in mind when planning vaccination programmes for calves, which receive Locatim.
Slovenian: To moramo upoštevati pri načrtovanju programa zaščitnih cepljenj za teleta, ki so prejela Locatim.
English: Date of last renewal: 05/12/2008.
Slovenian: Datum podaljšanja dovoljenja za promet: 05/12/2008
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Slovenian: Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove izdelavo, uvoz/vnos, posedovanje, prodajo, oskrbo in/ali uporabo imunološkega zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če ugotovi da:
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
English: The product is produced from colostrum collected from cows kept under field conditions.
Slovenian: Zdravilo je proizvedeno iz kolostruma krav , ki se vzrejajo v terenskih pogojih.
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.
Slovenian: bolezen, za katero se z zdravilom pridobi imunost, na zadevnem območju skoraj ni prisotna.
English: Keep the bottle in the outer carton.
Slovenian: Stekleničko shranjujte v zunanji ovojnini.
English: In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili za uporabo v veterinarski medicini.
English: Pregnancy and lactation: The product is not intended for use during pregnancy and lactation.
Slovenian: Brejost ali laktacija: Zdravilo ni namenjeno za uporabo v obdobju brejosti in laktacije.
English: 6.5 Nature and composition of immediate packaging Cardboard box with one 60 ml type III glass bottle closed with a polypropylene stopper with a polyethylene seal and a detachable lock-ring.
Slovenian: Kartonska škatla s 60 ml stekleničko iz stekla tipa III, ki je zaprta s polipropilenskim zamaškom in polietilenskim čepom s snemljivim zapornim prstanom.
English: Special precautions for use in animals: This product may contain antibodies against BVD virus.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih: Zdravilo lahko vsebuje protitelesa proti virusu goveje virusne diareje (BVD).
English: Reduction of mortality caused by enterotoxicosis associated with E. coli F5 (K99) adhesin during the first days of life as a supplement to colostrum from the dam.
Slovenian: Zmanjšanje stopnje umrljivosti zaradi enterotoksičnosti, ki jo povzroča adhezin E. coli F5 (K99) v prvih dneh po telitvi kot dodatek kolostrumu.
English: Store in a refrigerator (2 °C - 8 °C).
Slovenian: Shranjujte v hladilniku (2 C - 8 C).
English: In the absence of information specifically demonstrating the safety of more than one repeated dose, it is recommended that calves should only be dosed once.
Slovenian: Zaradi nezadostnih podatkov o varnosti večkratnega dajanja zdravila priporočamo, da teleta dobijo le en odmerek zdravila.
English: The product supplements the protective properties of normal colostrum against E. coli F5 (K99) adhesin.
Slovenian: Zdravilo dopolnjuje zaščitno vlogo normalnega kolostruma proti adhezinu E. coli F5 (K99).
English: Pack size: 60 ml bottle.
Slovenian: Pakiranje: 60ml steklenička.
English: Consequently, in addition to antibodies to E. coli F5 (K99) it also contains antibodies to other organisms, as a result of vaccination and/or exposure of the donor cows to organisms in their environment.
Slovenian: E. coli F5 (K99) lahko posledično vsebuje tudi protitelesa proti drugim organizmom, kar je posledica cepljenja ali/in izpostavljenja donorskih krav organizmom v njihovem okolju.
English: 4.7 Use during pregnancy or lactation
Slovenian: 4.7 Uporaba v obdobju brejosti in laktacije
English: A decision to use this immunological veterinary medicinal product before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Slovenian: Zato se za uporabo tega imunološkega zdravila pred ali po uporabi katerega koli drugega zdravila odločamo od primera od primera.
English: The product is not intended for use during pregnancy and lactation.
Slovenian: Zdravilo ni namenjeno za uporabo v obdobju brejosti in laktacije.
English: MANUFACTURER'S BATCH NUMBER Batch{number}
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE
English: No information is available on the safety and efficacy of this immunological veterinary medicinal product when used with any other veterinary medicinal product.
Slovenian: Ni podatkov o varnosti ter učinkovitosti ob uporabi tega imunološkega zdravila s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
English: The calf must be given other normal colostrum in addition to the product.
Slovenian: Teletu dajemo poleg zdravila še običajni kolostrum.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
Slovenian: BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN
English: The manufacture, import, possession, sale, supply and/or use of Locatim may be prohibited in a Member State on the whole or part of their territory pursuant to national legislation.
Slovenian: Izdelava,uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba Locatim je lahko v državi članici prepovedana na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
English: Oral administration of 60 ml as soon as possible, preferably given within the first 4 hours, but not later than 12 hours after birth.
Slovenian: Zdravilo dajemo čimprej peroralno v odmerku 60 ml, najbolje prve štiri ure in ne kasneje kot 12 ur po telitvi.
English: PHARMACEUTICAL FORM Oral solution
Slovenian: FARMACEVTSKA OBLIKA
English: The active substance being a principle of biological origin intended to produce passive immunity is not within the scope of Regulation (EC) No 470/2009.
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju pasivne imunosti, ni vključena v Uredbo(ES) št.
English: If the calf is reluctant to take the product, it may be administered via an ordinary syringe placed in the mouth.
Slovenian: Če tele zavrača zdravilo, lahko dajemo tekočino peroralno s pomočjo običajne brizge.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilna(e) učinkovina(e):
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLICA
English: The import, possession, sale, supply and/or use of this veterinary medicinal product may be prohibited in a Member State on the whole or part of its territory, see package leaflet for further information.
Slovenian: Izdelava, uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba tega zdravila je lahko državi članici prepovedana v na njenem celotnem ozemlju ali delu ozemlja; za nadaljnje informacije glej navodilo za uporabo.
English: LIECHTENSTEIN
Slovenian: KNEŽEVINA LIHTENŠTAJN
English: 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
English: ROUTE(S) OF ADMINISTRATION
Slovenian: NAČIN IN POT(I) UPORABE
English: Transient effects of temperature increase and respiration rate increase have been seen when the product is administered in a double dose.
Slovenian: Dvojni odmerek zdravila lahko prehodno povzroči povečanje telesne temperature in pohitreno dihanje.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: The product should be administered neat or diluted in milk or in milk replacer within the first 12 hours of the calf's life, preferably, as soon as it is receptive.
Slovenian: Zdravilo dajemo nerazredčeno ali razredčeno z mlekom ali mlečnim nadomestkom v prvih 12 urah po telitvi.
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin)
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Dvojni odmerek zdravila lahko prehodno povzroči povečanje telesne temperature in pohitreno dihanje.
English: TARGET SPECIES Neonatal calves less than 12 hours of age.
Slovenian: CILJNE ŽIVALSKE VRSTE Novorojena teleta v starosti manj kot 12 ur.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Locatim, oral solution for neonatal calves less than 12 hours of age
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Locatim peroralna raztopina za novorojena teleta v starosti manj kot 12 ur
English: BATCH NUMBER Batch {number}
Slovenian: ŠTEVILKA SERIJE lot {številka}
English: Biokema Anstalt, Pflugstrasse 12, 9490 Vaduz, Fürstentum LIECHTENSTEIN
Slovenian: Biokema Anstalt Pflugstrasse 12
English: The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Slovenian: (EU) št.37/2010 določa, da MRL ni potreben.
English: Any person intending to manufacture, import, possess, sell, supply and use Locatim must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Slovenian: Locatim, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo, uvozom oziroma vnosom, posedovanjem, prodajo, oskrbo in/ali uporabo.
English: This product may contain antibodies against BVD virus.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Zdravilo lahko vsebuje protitelesa proti virusu goveje virusne diareje (BVD).
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Slovenian: BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM” Zdravilo shranjujte nedosegljivo otrokom
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: Excipient
Slovenian: KARENCA
English: Fürstentum
Slovenian: OVOJNINAH
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
Slovenian: PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE
English: PACKAGE LEAFLET FOR: Locatim oral solution for neonatal calves less than 12 hours of age
Slovenian: NAVODILO ZA UPORABO Locatim peroralna raztopina za novorojena teleta v starosti manj kot 12 ur
English: Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin ≥ 2.8* log10/ml.
Slovenian: Goveji koncentrirani laktoserum vsebuje specifične imunoglubuline G proti adhezinu E. coli ≥ 2.8*
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin ≥2.8* log10/ml.
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGEIH SESTAVIN Goveji koncentrirani laktoserum vsebuje specifične imunoglubuline G proti adhezinu E. coli ≥ 2.8*
English: CONTRAINDICATIONS
Slovenian: ZDRAVILA
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Bovine concentrated lactoserum containing specific immunoglobulin G against E. coli F5(K99) adhesin >2.8 log10/ml
Slovenian: KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Goveji koncentrirani laktoserum vsebuje specifične imunoglubuline G proti adhezinu E. coli ≥ 2.8
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte nedosegljivo otrokom.
English: 69800 Saint Priest
Slovenian: 9490 Vaduz
English: Not applicable.
Slovenian: UPORABE, ČE JE SMISELNO
English: MARKETING AUTHORISATION HOLDER
Slovenian: IMETNIK(I) DOVOLJENJ(A) ZA PROMET
English: 60 ml.
Slovenian: log10/ml.
English: A.
Slovenian: DODATEK I
English: This usually takes approximately 60 seconds but can take up to 90 seconds.
Slovenian: To običajno traja približno 60 sekund, lahko pa traja do 90 sekund.
English: This helps to prevent infection.
Slovenian: To pomaga preprečiti okužbe.
English: It is important to use each dose at the scheduled time.
Slovenian: Pomembno je, da vsak odmerek uporabite ob načrtovanem času.
English: Subsequently, it may increase and become too high.
Slovenian: Nato se lahko raven zviša in je previsoka.
English: Effects were maintained throughout the 6-month follow-up period.
Slovenian: Učinki so se ohranili ves čas 6-mesečnega obdobja spremljanja.
English: No effect on safety or efficacy was observed.
Slovenian: Učinkov na varnost ali učinkovitost niso opazili.
English: The minimum effective dose should be used.
Slovenian: Uporabiti je treba najmanjši učinkoviti odmerek.
English: It is indicated in children and adolescents for long-term use.
Slovenian: Pri otrocih in mladostnikih je namenjeno za dolgotrajno uporabo.
English: Side effects can occur with the following frequencies:
Slovenian: Neželeni učinki se lahko pojavijo z naslednjimi pogostnostmi:
English: The clinical significance of this is unknown.
Slovenian: Klinični pomen tega učinka ni znan.
English: Follow the instructions carefully step by step.
Slovenian: Korak za korakom natančno sledite navodilom.
English: IGF-I levels should be acted upon, as indicated below.
Slovenian: Na ravni IGF-I se je treba odzvati, kot je navedeno spodaj.
English: Monitoring during treatment
Slovenian: Spremljanje med zdravljenjem
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05 August 2013
Slovenian: Datum prve odobritve: 05. avgust 2013
English: Samples should be drawn 4 days after the previous dose (Day 4).
Slovenian: Vzorci se jemljejo 4 dni po predhodnem odmerku (4. dan).
English: Macierzysz, 12, Poznanska, Str., 05-850 Ozarow Mazowiecki, Poland
Slovenian: Macierzysz, 12, Poznanska, Str., 05-850 Ozarow Mazowiecki, Poljska
English: The doctor will carefully monitor you during treatment as the effect of insulin may be reduced.
Slovenian: Zdravnik vas bo med zdravljenjem skrbno spremljal, saj se lahko učinek insulina zmanjša.
English: The accuracy of the growth hormone dose should therefore be controlled every 6 months.
Slovenian: Natančnost odmerka rastnega hormona je zato treba preveriti vsakih 6 mesecev.
English: It is not known if this medicine passes into breast milk.
Slovenian: Ni znano, ali zdravilo prehaja v mleko.
English: Not known, frequency cannot be estimated from the available data - a reduced response to insulin (insulin resistance)
Slovenian: Neznana, pogostnosti ni mogoče oceniti iz razpoložljivih podatkov - zmanjšan odgovor na insulin (odpornost na insulin)
English: The suspension is for immediate single use only.
Slovenian: Suspenzija je samo za takojšnjo enkratno uporabo.
English: If you have used too much of this medicine, initially your blood sugar may decrease and become too low.
Slovenian: Če ste uporabili preveč tega zdravila, se lahko najprej ravni vašega krvnega sladkorja znižajo in postanejo prenizke.
English: If necessary, your doctor will gradually increase this dose according to your individual response to the treatment and your blood levels of a growth factor called IGF-I.
Slovenian: Po potrebi bo vaš zdravnik ta odmerek postopoma povečeval glede na vaš individualni odziv na zdravljenje in vaše ravni rastnega dejavnika, imenovanega IGF-I v krvi.
English: Do not use this medicine if you notice that it cannot be properly mixed.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da ga ni mogoče pravilno premešati.
English: Biotransformation / Elimination
Slovenian: Biotransformacija / Izločanje
English: Individual doses may vary and your doctor will always prescribe the minimum effective dose based on your specific need.
Slovenian: Odmerki se za posameznega bolnika lahko razlikujejo, vaš zdravnik pa vam bo vedno predpisal najmanjši učinkoviti odmerek na podlagi vaših specifičnih potreb.
English: The dose will be calculated by your doctor as described below.
Slovenian: Odmerek bo izračunal zdravnik, kot je opisano spodaj.
English: Please also see the required adjustments described in section 2, ‘Other medicines and Somatropin Biopartners'.
Slovenian: Glejte tudi potrebne prilagoditve odmerkov, opisane v poglavju 2, »Druga zdravila in zdravilo Somatropin Biopartners«.
English: Treatment with this medicinal product should be continued until final height has been reached or until epiphyseal closure.
Slovenian: Zdravljenje s tem zdravilom morate nadaljevati do dosežene končne višine ali do zaprtja epifize.
English: If you are heavier than 40 kg, two vials must be used.
Slovenian: Če imate več kot 40 kg, sta potrebni dve viali.
English: LG Life Sciences, Ltd. 129, Seokam-ro Iksan-si, Jeollabuk-do South Korea
Slovenian: LG Life Sciences, Ltd. 129, Seokam-ro Iksan-si, Jeollabuk-do Južna Koreja
English: If the thyroid is not working properly, this medicine may not work as well as it should.
Slovenian: Če ščitnica ne deluje pravilno, to zdravilo morda ne bo delovalo tako dobro, kot bi moralo.
English: It is not known how often this may occur, but if you suspect that this is the case, contact your doctor since the treatment may have to be stopped.
Slovenian: Ni znano, kako pogosto se lahko to pojavi, vendar se ob sumu na to posvetujte s svojim zdravnikom, saj bo morda treba zdravljenje ustaviti.
English: Growth hormone regulates the growth and development of cells.
Slovenian: Rastni hormon uravnava rast in razvoj celic.
English: Injections should always be given on the same day of the week and at the same time of day because it is easier to remember.
Slovenian: Injekcije si vedno dajajte na isti dan v tednu in tudi ob istem času tega dneva, da si lažje zapomnite.
English: After reconstitution: From a microbiological point of view, the product must be used immediately.
Slovenian: Po rekonstituciji: Z mikrobiološkega vidika je treba zdravilo uporabiti takoj.
English: Your dose should be checked every 6 months by your doctor.
Slovenian: Zdravnik bo vsakih 6 mesecev preveril vaš odmerek.