natgillin/translations-raw huggingface dataset:
Cardboard box containing one 500 ml bottle (high-density polyethylene) containing 490 ml of solution or one 1000 ml bottle containing 980 ml of solution, sealed with a high density polyethylene cap, with or without a metering pump, with two different lengths dip tubes (22 and 24 cm) made of ethylenevinyl acetate. 
Kartonska škatla vsebuje eno 500 ml plastenko (polietilen visoke gostote), ki vsebuje 490 ml raztopine ali eno 1.000 ml plastenko, ki vsebuje 980 ml raztopine, zaprto s polietilensko zaporko visoke gostote, z ali brez odmerne črpalke z dvema potopnima cevkama (22 in 24 cm) narejenima iz etilen-vinil acetata.
10) Always replace the bottle in the box. 
10) Vedno namestite plastenko nazaj v škatlo.
Administer after colostrum feeding, or after milk or milk replacer feeding only, using an appropriate device for oral administration. 
Zdravilo dajemo po hranjenju s kolostrumom, mlekom ali mlečnim nadomestkom z ustreznim pripomočkom za peroralno dajanje.
4 ml pump 
4 ml črpalka
6) Restrain the calf and insert the nozzle of the metering pump into its mouth. 
6) Omejite gibanje teletu in vstavite šobo odmerne črpalke v njegov gobec.
Cardboard box with a 500 ml bottle containing 490 ml or a 1000 ml bottle containing 980 ml, with or without a dosing pump. 
Kartonska škatla vsebuje 500 ml plastenko, ki vsebuje 490 ml raztopine ali 1.000 ml plastenko, ki vsebuje 980 ml raztopine, z ali brez odmerne črpalke.
Boxes with a metering pump: 
Škatle z odmerno črpalko:
9) Always replace the bottle in the box. 
9) Vedno namestite plastenko nazaj v škatlo.
PSUR submission for Kriptazen shall be synchronised and submitted at the same frequency as for the reference product, Halocur. 
Posebne farmakovigilančne zahteve: Oddajanje PSUR za Kriptazen naj bo usklajeno in oddano v enakih intervalih kot je za referenčno zdravilo, Halocur.
Cattle (new born calves): - Prevention of diarrhoea due to diagnosed Cryptosporidium parvum, in farms with history of 
Novorojena teleta: - preprečevanje driske pri diagnozi okužbe s Cryptosporidium parvum na farmah, na katerih se je
- Avoid skin, eye or mucosal contact with the product. 
- Izogibajte se stiku zdravila s kožo, očmi ali sluznicami.
- Reduction of diarrhoea due to diagnosed Cryptosporidium parvum. 
- ublažitev driske pri diagnozi okužbe s Cryptosporidium parvum.
METHOD AND ROUTE(S) OF ADMINISTRATION For oral use. 
NAČIN IN POT(I) UPORABE
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe
NAME OF THE VETERINARY MEDICINAL PRODUCT Kriptazen 0.5 mg/ml oral solution for calves halofuginone 
Kriptazen 0,5 mg/ml, peroralna raztopina za teleta halofuginon
7) Pull the trigger of the metering pump completely for release of the adequate dose. 
7) Popolnoma potegnite za sprožilec odmerne črpalke, da se sprosti celotni odmerek.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: 
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Once broached, use by … 
Odprto zdravilo uporabite do…
3) Remove the protector cap from the tip of the nozzle of the pump. 
3) Odstranite zaščitno zaporko z vrha šobe črpalke.
Each package also contains a plastic metering pump delivering 4 to 12 ml and two dip tubes (one to fit a 500 ml bottle and one to fit a 1000 ml bottle). 
Vsako pakiranje vsebuje tudi plastično odmerno črpalko, ki odmerja 4 do 12 ml volumna in dve potopni cevki (ena se prilega 500 ml plastenki, druga pa 1.000 ml plastenki).
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER VIRBAC 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary. 
Da zagotovite dajanje pravilnega odmerka, je nujno potrebna uporaba brizge ali katerega koli drugega primernega pripomočka za peroralno aplikacijo.
Unchanged halofuginone is the major component in the tissues. 
Glavna sestavina v tkivih je nespremenjeni halofuginon.
The active substance, halofuginone, is an antiprotozoal agent of the quinazolinone derivatives group (nitrogenous polyheterocycles). 
5.1 Farmakodinamične lastnosti Zdravilna učinkovina halofuginon je antiprotozoik iz skupine derivatov kinazolina (dušični piliheterocikli).
[Bottle without a pump:] To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary. 
[Plastenka brez črpalke:] da zagotovite dajanje pravilnega odmerka, je nujno potrebna uporaba brizge ali katerega koli drugega primernega pripomočka za peroralno aplikacijo.
The active substance in Kriptazen is an allowed substance as described in Table 1 of the annex to Commission Regulation (EU) No 37/2010: 
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina v Kriptazen je dovoljena učinkovina, kot je navedena v tabeli 1(dovoljene snovi) priloge
- People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution. 
- Osebe z znano preobčutljivostjo na učinkovino ali katero koli pomožno snov, naj zdravilo dajejo
5) Prime the pump by pressing the trigger gently, until a drop appears at the tip of the nozzle. 
5) Pripravite črpalko z nežnim pritiskom na sprožilec, dokler se ne pojavi kapljica na vrhu šobe.
4) Prime the pump by pressing the trigger gently, until a drop appears at the tip of the nozzle. 
4) Pripravite črpalko z nežnim pritiskom na sprožilec dokler se ne pojavi kapljica na vrhu šobe.
1) Choose the dip tube designed for the height of the bottle (the shorter one for the 490 ml bottle and the longer one for the 980 ml) and insert it into the free hole located in the base of the pump cap. 2) Remove the cap of the bottle and screw the pump on. 
1) Izberite cevko, ki je oblikovana glede na višino plastenke (kratka za 490 ml plastenko in daljša za 980 ml plastenko) in jo vstavite v prosto odprtino, ki se nahaja na bazi črpalkine zaporke.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 
PODATKI NA ZUNANJI OVOJNINI Zunanji karton
Bottle with a pump: To ensure a correct dosage, the most appropriate metering pump should be selected, depending on the weight of the animals to be treated. 
Plastenka s črpalko: da zagotovite pravilni odmerek, je potrebno izbrati najprimernejšo odmerno črpalko, glede na težo živali, ki jo zdravite.
Each package also contains a plastic metering pump delivering 4 ml volumes and two dip tubes (one to fit a 500 ml bottle and one to fit a 1000 ml bottle). 
4 ml črpalka Vsako pakiranje vsebuje tudi plastično odmerno črpalko, ki odmerja 4 ml volumna in dve potopni cevki (ena se prilega 500 ml plastenki, druga pa 1.000 ml plastenki).
[Bottle with a 4 to 12 ml pump:] To ensure a correct dosage, the most appropriate metering pump should be selected, depending on the weight of the animals to be treated. 
[Plastenka s 4 do 12 ml črpalko:] da zagotovite pravilni odmerek, je potrebno izbrati najprimernejšo odmerno črpalko, glede na težo živali, ki jo zdravite.
5) Restrain the calf and insert the nozzle of the metering pump into its mouth 6) Pull the trigger of the metering pump completely for release of a dose that equals 4 ml of solution. 
6) Popolnoma potegnite za sprožilec odmerne črpalke, da se sprosti odmerek, ki je enak 4 ml raztopine.
Bottle without a pump: To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary. 
Plastenka brez črpalke: da zagotovite dajanje pravilnega odmerka, je nujno potrebna uporaba brizge ali katerega koli drugega primernega pripomočka za peroralno aplikacijo.
Antiparasitic agents/ Agents acting against protozoa 
Antiparazitiki/ antiprotozoiki
Indications for use, specifying the target species 
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For oral use in calves after feeding. 
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
Muscle Fat 
Jetra Ledvica
[Bottle with a 4 ml pump:] To ensure a correct dosage, the most appropriate metering pump should be selected, depending on the weight of the animals to be treated. 
[Plastenka s 4 ml črpalko:] da zagotovite pravilni odmerek, je potrebno izbrati najprimernejšo odmerno črpalko, glede na težo živali, ki jo zdravite.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 490 ml or 980 ml 
Plastenka 490 ml ali 980 ml
(as lactate salt) Excipients: 
(v obliki soli laktata)
9) Always replace the cap on the tip of the nozzle after use. 
9) Po uporabi vedno ponovno namestite zaporko na vrh šobe.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. 
B POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE
Marker residue Animal species MRLs 
Živalska vrsta MRL Ciljna tkiva Druge določbe Terapevtske indikacije
Special precautions to be taken by the person administering the veterinary medicinal product to animals: - People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution. 
- Osebe z znano preobčutljivostjo na učinkovino ali katerokoli pomožno snov, naj zdravilo dajejo - Večkratni stik z zdravilom lahko povzroči kožne alergije.
8) Always replace the cap on the tip of the nozzle after use. 
8) Po uporabi vedno ponovno namestite zaporko na vrh šobe.
METHOD AND ROUTE(S) OF ADMINISTRATION Oral use in calves after feeding. 
Za peroralno uporabo pri teletih po krmljenju.
NAME OF THE VETERINARY MEDICINAL PRODUCT Kriptazen 0.5 mg/ml oral solution for calves. 
Kriptazen 0,5 mg/ml, peroralna raztopina za teleta.
Special precautions for use 
B. NAVODILO ZA UPORABO
Overdose (symptoms, emergency procedures, antidotes), if necessary 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), (če je potrebno) Ker se po dvakratnem terapevtskem odmerku lahko pojavijo znaki toksičnosti, morate natančno upoštevati priporočeno odmerjanje.
PHARMACEUTICAL FORM Oral solution. 
FARMACEVTSKA OBLIKA
WITHDRAWAL PERIOD(S) Withdrawal periods: Meat and offal: 13 days. 
Karenca: Meso in organi: 13 dni.
EU/1/15/1024/002 Keytruda 25 mg/ml 
25 mg/ml koncentrat za raztopino za infundiranje viala (steklo) 4 ml
EU/1/15/1024/001 Keytruda 50 mg Powder for concentrate for solution for infusion 
50 mg prašek za koncentrat za raztopino za infundiranje viala (steklo)
The exact cause is not known. 
Natančen vzrok ni znan.
The estimated 1-year survival rate was 41%. 
Ocenjeni delež 1-letnega preživetja je znašal 41 %.
Other forms of interaction 
Druge oblike interakcij
Appendix V. 
Prilogi V.
However, the role of this biomarker (PD-L1 expression) has not been fully elucidated. 
Vendar pa vloga tega biološkega označevalca (ekspresija PD-L1) ni bila povsem pojasnjena.
Safety and efficacy in elderly patients 
Varnost in učinkovitost pri starejših bolnikih
Probability of Survival 
Verjetnost preživetja
Tell your doctor if you are taking or have recently taken any other medicines. 
Obvestite zdravnika, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo.
• Details on how to minimise the safety concern through appropriate monitoring and management 
• Podrobnosti, kako zmanjšati varnostna tveganja z ustreznim nadziranjem in ukrepanjem.
Baseline characteristics were generally balanced between the two groups. 
Izhodiščne lastnosti so bile na splošno med skupinama uravnotežene.
Dose escalation or reduction is not recommended. 
Povečanje ali zmanjšanje odmerka ni priporočljivo.
It is important that you keep this Alert Card and show it to your partner or caregivers. 
Pomembno je, da imate opozorilno kartico vedno pri sebi in jo pokažete partnerju ali osebam, ki
The majority of patients were white (93%) and male (76%). 
Večina bolnikov je bila belcev (93 %) in moškega spola (76 %).
The primary efficacy outcome measure was overall survival (OS). 
Primarno merilo izida učinkovitosti je bilo celokupno preživetje (OS - overall survival).
Patients were enrolled regardless of their PD-L1 status. 
Bolnike so vključili ne glede na status PD-L1.
You will also find this information in the Patient Alert Card you have been given by your doctor. 
Te informacije lahko najdete tudi na opozorilni kartici za bolnika, ki vam jo je dal zdravnik.
OTHER SPECIAL WARNING(S), IF NECESSARY For single use only. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Samo za enkratno uporabo.
A risk to the breast-fed infant cannot be excluded. 
Tveganja za dojenega otroka ne moremo izključiti.
Do not try to treat your symptoms with other medicines on your own. 
Simptomov ne poskušajte zdraviti sami z drugimi zdravili.
The majority of adverse reactions were mild to moderate (Grade 1 or 2). 
Večina neželenih učinkov je bila blagih do zmernih (stopnja 1 ali 2).
It is important that you keep the Alert Card with you during treatment. 
Pomembno je, da imate med zdravljenjem opozorilno kartico pri sebi.
None of these patients received high-dose corticosteroids. 
Nobeden od teh bolnikov ni prejemal visokih odmerkov kortikosteroidov.
The observed OS benefit was consistently demonstrated across subgroups of patients. 
Opažena korist za celokupno preživetje je bila konsistentna po vseh podskupinah bolnikov.
Efficacy results are shown in Table 3. 
Rezultati učinkovitosti so prikazani v preglednici 3.
Because many medicinal products, including antibodies, can be secreted in human milk, a risk to the newborns/infants cannot be excluded. 
Ker se številna zdravila, vključno s protitelesi, lahko izločajo v materino mleko, tveganja za dojenega novorojenca/otroka ne moremo izključiti.
• That Nivolumab BMS treatment may increase the risk of: 
• Pri zdravljenju z zdravilom Nivolumab BMS se lahko poveča tveganje za:
Nivolumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG. 
Pričakuje se, da nivolumab razpade do manjših peptidov in aminokislin preko katabolnih poti na enak način kot endogeni IgG.
Please note that these signs and symptoms are sometimes delayed, and may develop weeks or months after your last dose. 
Ti znaki in simptomi so včasih zakasneli in se lahko pojavijo šele več tednov ali mesecev po prejemu zadnjega odmerka zdravila.
Studies in animals have shown embryofoetal toxicity (see section 5.3). 
Študije na živalih so pokazale embriofetalno toksičnost (glejte poglavje 5.3).
Key secondary efficacy outcome measures were investigator-assessed objective response rate (ORR) and progression-free survival (PFS). 
Ključni sekundarni merili učinkovitosti sta bili raziskovalčeva ocena deleža objektivnega odziva (ORR - objective response rate) in preživetje brez napredovanja bolezni (PFS - progression-free survival).
Guidelines for permanent discontinuation or withholding of doses are described in Table 1. 
Smernice za trajno ukinitev zdravljenja ali zadržanje odmerka so navedene v preglednici 1.
• Relevant information (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) for the following safety concerns: 
• Relevantne podatke (npr. o resnosti, jakosti, pogostnosti, času pojava, reverzibilnosti neželenega učinka, kot je primerno) za naslednja varnostna tveganja:
The safety and efficacy of Nivolumab BMS in children below 18 years of age have not been established. 
Varnost in učinkovitost zdravila Nivolumab BMS pri otrocih, mlajših od 18 let, nista bili dokazani.
Because of the small sample size, no definitive conclusions can be drawn from these data. 
Ti podatki zaradi majhne velikosti vzorca ne omogočajo definitivnih zaključkov.
Do not shake the vial. 
Viale ne stresajte.
No overall differences in safety or efficacy were reported between elderly ( ≥ 65 years) and younger patients (< 65 years). 
O posebnih razlikah v varnosti in učinkovitosti med starostniki (≥ 65 let) in mlajšimi bolniki (< 65 let)
Children and adolescents Nivolumab BMS should not be used in children and adolescents below 18 years of age. 
Zdravila Nivolumab BMS se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000). 
Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
The average EQ-VAS increased over time for both treatment groups, indicating better overall health status for patients remaining on treatment. 
Povprečna ocena EQ-VAS se je sčasoma povečala v obeh skupinah zdravljenja, kar kaže boljše splošno zdravstveno stanje bolnikov,
To continue the exploration of the optimal cut-off for PD-L1 positivity based on current assay method used to further elucidate its value as predictive of nivolumab efficacy. 
Nadaljevati raziskave optimalne mejne vrednosti PD-L1 pozitivnosti na osnovi trenutne testne metode za dodatno ovrednotenje njene napovedne vrednosti za učinkovitost nivolumaba.
Effective contraception should be used for at least 5 months following the last dose of Nivolumab BMS. 
Učinkovito kontracepcijo je treba uporabljati še vsaj 5 mesecev po zadnjem odmerku zdravila Nivolumab BMS.
The value of biomarkers to predict the efficacy of nivolumab should be further explored, specifically: 
Dodatno je treba raziskati vrednost bioloških označevalcev za predvidevanje učinkovitosti nivolumaba, in sicer:
Overall survival Events 
Celokupno preživetje
See “Description of selected adverse reactions; laboratory abnormalities” below. 
Glejte “Opis izbranih neželenih učinkov; Laboratorijsko ugotovljene nepravilnosti” v nadaljevanju.
Results for growth indices, as well as teratogenic, neurobehavioral, immunological, and clinical pathology parameters throughout the 6-month postnatal period were comparable to the control group. 
Rezultati indeksov rasti, pa tudi teratogeni, nevrovedenjski, imunološki in klinični patološki parametri so bili do 6 meseca po kotitvi primerljivi s kontrolno skupino.
Pack size of 1 vial. 
Pakiranje z 1 vialo.
Prior to launch of Nivolumab BMS in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority. 
Pred začetkom trženja zdravila Nivolumab BMS mora imetnik dovoljenja za promet z zdravilom v vsaki državi članici s pristojnim nacionalnim organom dogovoriti vsebino in obliko izobraževalnega programa, vključno s komunikacijskimi mediji, načinom distribucije in vseh drugih vidikih programa.
Nivolumab is not recommended during pregnancy and in women of childbearing potential not using effective contraception unless the clinical benefit outweighs the potential risk. 
Uporaba nivolumaba ni priporočljiva pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije, razen v primeru, ko klinična korist odtehta možno tveganje.
Inflammation of the liver (hepatitis). 
vnetje jeter (hepatitis).
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. 
Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne Navodilo shranite.
There are no data on the use of nivolumab in pregnant women. 
Podatkov o uporabi nivolumaba pri nosečnicah ni.
Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of nivolumab (see “Description of selected adverse reactions” below). 
Večina teh neželenih učinkov, vključno z resnimi, je minila po uvedbi ustreznega zdravljenja ali prekinitvi zdravljenja z nivolumabom (glejte “Opis izbranih neželenih učinkov” v nadaljevanju).
The amount of Nivolumab BMS you will be given will be calculated based on your body weight. 
Količina zdravila Nivolumab BMS, ki jo boste prejeli, se izračuna na osnovi telesne mase.
The European Medicines Agency has deferred the obligation to submit the results of studies with nivolumab in all subsets of the paediatric population in the treatment of malignant solid tumours (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z nivolumabom za vse podskupine pediatrične populacije pri zdravljenju malignih solidnih tumorjev (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The PD-1 receptor is a negative regulator of T-cell activity that has been shown to be involved in the control of T-cell immune responses. 
Receptor PD-1 je negativni regulator T-celične aktivnosti, za katerega je bilo dokazano, da sodeluje pri nadzoru T-celičnega imunskega odziva.
Patients should be monitored continuously (at least up to 5 months after the last dose) as an adverse reaction with nivolumab may occur at any time during or after discontinuation of nivolumab therapy. 
Bolnike je treba neprestano nadzirati (še vsaj do 5 mesecev po aplikaciji zadnjega odmerka), saj se neželeni učinki nivolumaba lahko pojavijo v katerem koli času med zdravljenjem ali po ukinitvi zdravljenja z nivolumabom.
• Signs or symptoms of the safety concern and when to seek attention from a HCP 
• Znake ali simptome varnostnih tveganj in navodilo, kdaj poiskati zdravniško pomoč.
Nivolumab attaches to a target protein called programmed death-1 receptor (PD-1) that can switch off the activity of T cells (a type of white blood cell that forms part of the immune system, the body's natural defences). 
Nivolumab se pritrdi na ciljno beljakovino, imenovano receptor za programirano celično smrt-1 (PD-1), ki lahko zavre aktivnost celic T (vrsta belih krvnih celic, ki so sestavni del imunskega sistema, naravne obrambe telesa).
Be aware of important symptoms of inflammation. 
Pozorni morate biti na pomembne simptome vnetja.
Grade 2 pneumonitis 
Pnevmonitis stopnje 2
The Kaplan-Meier curves for OS are shown in Figure 1. 
Kaplan-Meierjevi krivulji celokupnega preživetja sta prikazani na sliki 1.
Nivolumab BMS may cause changes in the results of tests carried out by your doctor. 
Zdravilo Nivolumab BMS lahko povzroči spremembe v izvidih preiskav, ki jih bo opravil zdravnik.
For instructions on the handling of the medicinal product before administration, see section 6.6. 
Za navodila glede ravnanja z zdravilom pred aplikacijo glejte poglavje 6.6.
Use a separate infusion line for the infusion. 
Za infundiranje morate uporabiti ločeno infuzijsko linijo.
Because of potential adverse reactions such as fatigue (see section 4.8), patients should be advised to use caution when driving or operating machinery until they are certain that nivolumab does not adversely affect them. 
Zaradi možnih neželenih učinkov, kot je utrujenost (glejte poglavje 4.8), je treba bolnikom svetovati previdnost pri vožnji ali upravljanju s stroji, dokler se z gotovostjo ne izkaže, da nivolumab pri njih nima škodljivih vplivov na tovrstne aktivnosti.
Treatment modification 
Prilagoditev zdravljenja
Inflammation or problems with your kidneys. 
vnetje ali težave z ledvicami.
The solution has a pH of approximately 6.0 and an osmolality of approximately 340 mOsm/kg. 
pH vrednost raztopine je približno 6,0, osmolalnost pa približno 340 mOsm/kg.
Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
Zatem jih mora predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o
Frequencies reflect the proportion of patients who experienced a worsening from baseline in laboratory measurements. 
Pogostnost odraža delež bolnikov s poslabšanjem glede na izhodiščne laboratorijske izvide.