natgillin/translations-raw huggingface dataset:
The approach of expressing the withdrawal period as time after treatment can only be acceptable if the studied sample from the distribution of dry periods is a fair representation of the true distribution of dry periods in practical circumstances.
Pristop izražanja karence kot časa po zdravljenju je mogoče sprejeti le, če je raziskovani vzorec iz porazdelitve obdobij presušitve ustrezna predstavitev resnične porazdelitve obdobij presušitve v praktičnih okoliščinah.
- 1 day after calving when dry period is more than 5 weeks;
- 1 dan po otelitvi, če je bilo obdobje presušitve daljše od 5 tednov;
The initial residue study in dairy cows with dry periods of 40 to 58 days was considered useful to establish the size of that safety span.
Prvotna raziskava ostankov v kravah molznicah z obdobji presušitve od 40 do 58 dni je bila upoštevana kot koristna za ugotavljanje velikosti tega varnostnega razpona.
To express the withdrawal period in milkings post-calving, one has to make several (e.g. 3) categories of dry periods which can be difficult to apply practically.
Za izražanje karence v številu molzenj po otelitvi, je potrebno določiti večje število kategorij (npr. 3) dob presušitve, kar je težko izvesti v praksi.
A new residue depletion study in milk was performed with dairy cows with a dry period of 36 days or less and it was submitted to substantiate a reduction of the established withdrawal period for milk requested in the variation procedure.
Izvedena je bila nova raziskava zmanjševanja ostankov v mleku pri kravah presušitvijo v trajanju 36 dni ali manj, ki je bila predložena kot utemeljitev za skrajšanje ugotovljene karence za mleko, zahtevane v postopku za variacijo.
An additional safety span is necessary to account for this uncertainty.
Da bi lahko izključili te nezanensljivosti, je potreben dodaten varnostni razpon.
The safety span of 1.5 days proposed by the representative of the MAHs was accepted.
Sprejet je bil varnostni razpon 1,5 dneva, ki ga je predlagal predstavnik imetnikov dovoljenja za promet z zdravilom.
The CVMP Note for Guidance on the determination of the withdrawal periods for milk (EMEA/CVMP/473/98-FINAL) describes how the withdrawal period for milk should be determined for dry-cow products.
Navodila za določanje karence za mleko (EMEA/CVMP/473/98-FINAL), ki jih je izdal CVMP, opisujejo, kako bi bilo potrebno določiti karenco za mleko za proizvode krav med presušitvijo.
The residues in milk from each cow were below the MRL at the first milking after calving.
Ostanki v mleku so bili ob prvi molži po otelitvi za vsako kravo pod MRL.
The representative of the MAHs determined the withdrawal period by statistical analysis (Time to safe concentration (TTSC) method) of the milk residue data where time points were expressed as milkings after treatment irrespective of the length of the dry period.
Predstavnik imetnikov dovoljenja za promet z zdravilom je karenco določil s statistično analizo (metoda: čas do varne koncentracije (time to safe concentration, TTSC)) podatkov o ostankih v mleku, kjer so bile časovne točke izražene kot molže po zdravljenju ne glede na trajanje presušitve.
Therefore, the Committee combined the results of both studies by (1) using the withdrawal period of 34.5 days after administration as estimated by the MAH and (2) using the results of the study with longer dry periods to derive a safety span.
Zato je Odbor združil rezultate obeh raziskav z uporabo (1) karence 34,5 dni po dajanju zdravila, kot je bila ocenjena s strani imetnika dovoljenja za promet z zdravilom, in (2) z uporabo rezultatov raziskave z daljšimi obdobji presušitve, da bi tako dobili varnostni razpon.
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION OF THE TERMS OF THE MARKETING AUTHORISATION
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA ZA PROMET Z ZDRAVILOM
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION OF THE TERMS OF THE MARKETING AUTHORISATION
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA ZA PROMET Z ZDRAVILOM
From the text of the guideline it appears most logical to conclude that the withdrawal period should be expressed as time after calving for a specified (range of) dry period.
Iz besedila navodil se lahko najbolj logično sklepa, da bi morala biti karenca izražena kot čas po otelitvi za natančno določeno dobo presušitve.
In the referral procedure the representative of the MAHs acknowledged that: - there is a depletion during the dry period, - there is a more rapid depletion after calving, and - the withdrawal period in the post-calving milk depends on the length of the dry period.
V napotitvenem postopku je predstavnik imetnikov dovoljenja za promet z zdravilom potrdil, da: - pride med presušitvijo do zmanjševanja ostankov, - po otelitvi nastopi hitrejše zmanjševanje in - je karenca za mleko po otelitvi odvisna od dolžine obdobja presušitve.
2.2 Derivation of withdrawal periods for milk Marketing authorisation holders approach
2.2 Izpeljava karence za mleko Pristop imetnika dovoljenja za promet z zdravilom
The scope of the referral was to establish if on the basis of the data available a withdrawal period of 35 days after treatment could be established for milk.
Namen napotitvenega postopka je bil ugotoviti, ali se lahko na osnovi razpoložljivih podatkov za mleko določi 35-dnevno karenco.
However, because in this case the TTSCs also depend on the dry period (positive trend), the estimation of the distribution is sensitive for the sample of study objects (cows with a certain dry period).
Vendar pa je v tem primeru ocena porazdelitve občutljiva na vzorec raziskovanih objektov (krave z določenim obdobjem presušitve), ker so vrednosti TTSC odvisne tudi od obdobij presušitve (pozitivni trend).
The residue depletion study in dairy cows with dry periods of 40 to 58 days on which the withdrawal period was established for the original Marketing Authorisation was also available.
Na razpolago je bila tudi raziskava zmanjševanja ostankov pri kravah molznicah z obdobji presušitve od 40 do 58 dni, na osnovi katere je bila ugotovljena karenca za prvotno dovoljenje za promet z zdravilom.
Withdrawal period after treatment
Karenca po zdravljenju
A safety span of 1.5 days as proposed by the representative of the MAHs was considered acceptable by the CVMP.
CVMP je predlog predstavnika imetnikov dovoljenja za promet z zdravilom, ki je znašal 1,5 dneva, smatral za sprejemljivega.
The obtained withdrawal period was 69 “milkings” after treatment, i.e. 34.5 days.
Izračunana doba karence je obsegala 69 „molzenj“ po zdravljenju, t.j.
The MAHs proposed a reduced withdrawal period of 35 days after treatment.
Imetniki dovoljenja za promet zzdravilom so predlagali spremembo karence na 35 dni po zdravljenju.
Further information on Delstrigo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/delstrigo.
Nadaljnje informacije o zdravilu Delstrigo so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/delstrigo.
The European Medicines Agency therefore decided that Delstrigo's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Delstrigo večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Delstrigo must not be used with certain medicines that may reduce its effectiveness.
Zdravilo Delstrigo se ne sme jemati skupaj z nekaterimi zdravili, ki lahko zmanjšajo njegovo učinkovitost.
What measures are being taken to ensure the safe and effective use of Delstrigo?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Delstrigo?
Other information about Delstrigo
Druge informacije o zdravilu Delstrigo
Side effects reported with Delstrigo are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Delstrigo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
As for all medicines, data on the use of Delstrigo are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Delstrigo stalno spremljajo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Delstrigo have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Delstrigo upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
For more information about using Delstrigo, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Delstrigo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Lamivudine and tenofovir disoproxil are already available in the European Union: lamivudine has been authorised since 1996 and tenofovir disoproxil since 2002.
Lamivudin in dizoproksiltenofovirat sta v Evropski uniji že na voljo: uporaba lamivudina je bila odobrena leta 1996, uporaba dizoproksiltenofovirata pa leta 2002.
In a study with 728 patients, 84% of patients treated with Delstrigo had undetectable levels of HIV in their blood (fewer than 40 copies/ml) after 48 weeks of treatment compared with 80% of patients given a combination of efavirenz, emtricitabine and tenofovir disoproxil.
V študiji, v katero je bilo vključenih 728 bolnikov, je bila po 48 tednih zdravljenja količina virusa HIV v krvi nezaznavna (nižja od 40 kopij/ml) pri 84 % bolnikov, ki so prejemali zdravilo Delstrigo, v primerjavi z 80 % bolnikov, ki so prejemali kombinacijo efavirenza, emtricitabina in dizoproksiltenofovirata.
Why is Delstrigo authorised in the EU?
Zakaj je zdravilo Delstrigo odobreno v EU?
Delstrigo keeps the amount of HIV in the blood at a low level.
Zdravilo Delstrigo ohranja nizko raven virusa HIV v krvi.
The most common side effects with doravirine (which may affect up to 1 in 10 people) are nausea (feeling sick) and headache.
Najpogostejši neželeni učinki doravirina (ki se lahko pojavijo pri največ 1 od 10 bolnikov) so navzeja (slabost) in bruhanje.
What benefits of Delstrigo have been shown in studies?
Kakšne koristi je zdravilo Delstrigo izkazalo v študijah?
An overview of Delstrigo and why it is authorised in the EU
Pregled zdravila Delstrigo in zakaj je odobreno v EU
What is Delstrigo and what is it used for?
Kaj je zdravilo Delstrigo in za kaj se uporablja?
What are the risks associated with Delstrigo?
Kakšna tveganja so povezana z zdravilom Delstrigo?
It can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.
Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
Delstrigo is an antiviral medicine used to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Zdravilo Delstrigo je protivirusno zdravilo za zdravljenje odraslih, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
It does not cure HIV infection or AIDS but it holds off the damage to the immune system and the development of infections and diseases associated with AIDS.
To zdravilo ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter prepreči razvoj okužb in bolezni, povezanih z aidsom.
In addition, Delstrigo's side effects are mostly mild.
Poleg tega so neželeni učinki zdravila Delstrigo običajno blagi.
Delstrigo is available as tablets, each containing doravirine 100 mg, lamivudine 300 mg and tenofovir disoproxil 245 mg.
Zdravilo Delstrigo je na voljo v obliki tablet, ki vsebujejo 100 mg doravirina, 300 mg lamivudina in 245 mg dizoproksiltenofovirata.
Tenofovir disoproxil is a ‘prodrug' of tenofovir, meaning that it is converted in the body to the active substance tenofovir.
Dizoproksiltenofovirat je „predzdravilo“ tenofovirja, kar pomeni, da se v telesu pretvori v zdravilno učinkovino tenofovir.
Delstrigo (doravirine / lamivudine / tenofovir disoproxil) EMA/873969/2018
Delstrigo (doravirin/lamivudin/dizoproksiltenofovirat) EMA/661904/2018
The medicine is not suitable for patients who are infected with HIV that is resistant to lamivudine, tenofovir disoproxil or to medicines in the same class as doravirine (non-nucleoside reverse transcriptase inhibitors or NNRTIs).
Zdravilo Delstrigo ni primerno za bolnike, okužene z virusom HIV, ki je odporen proti lamivudinu, dizoproksiltenofoviratu ali zdravilom iz istega razreda kot doravirin (nenukleozidni zaviralci reverzne transkriptaze, NNRTI).
For the full list of side effects and restrictions with Delstrigo, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Delstrigo glejte navodilo za uporabo.
Delstrigo is as effective at keeping HIV infection under control as similar HIV combination treatments.
Zdravilo Delstrigo je enako učinkovito pri obvladovanju okužbe z virusom HIV kot podobna kombinirana zdravila.
The three active substances in Delstrigo, doravirine, lamivudine and tenofovir disoproxil, block the activity of reverse transcriptase, an enzyme that allows HIV to reproduce itself in the cells it has infected.
Vse tri učinkovine zdravila Delstrigo doravirin, lamivudin in dizoproksiltenofovirat zavirajo dejavnost reverzne transkriptaze, tj. encima, ki virusu HIV omogoča razmnoževanje v okuženih celicah.
Delstrigo (doravirine / lamivudine / tenofovir disoproxil)
Delstrigo (doravirin/lamivudin/dizoproksiltenofovirat)
Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) and lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI).
Doravirin je nenukleozidni zaviralec reverzne transkriptaze (NNRTI) in lamivudin je nukleozidni analog, zaviralec reverzne transkriptaze (NRTI).
How does Delstrigo work?
Kako zdravilo Delstrigo deluje?
How is Delstrigo used?
Kako se zdravilo Delstrigo uporablja?
Delstrigo contains the active substances doravirine, lamivudine and tenofovir disoproxil.
Zdravilo Delstrigo vsebuje učinkovine doravirin, lamivudin in dizoproksiltenofovirat.
Delstrigo was as effective at keeping HIV infection under control as a similar HIV combination treatment in a main study involving patients with HIV infection who had not been treated before.
V glavni študiji, v katero so bili vključeni bolniki, okuženi z virusom HIV, ki niso bili predhodno zdravljeni, je bilo zdravilo Delstrigo prav tako učinkovito pri ohranjanju nadzora nad okužbo kot podobno kombinirano zdravilo za zdravljenje okužbe z virusom HIV.
(Invented) name Strength Pharmaceutical Form Route of Administration Packaging
(Izmišljeno) ime Jakost Farmacevtska oblika Pot uporabe
After reconstitution: Use within 2 hours.
Po pripravi: Uporabite v 2 urah.
Your doctor has prescribed TIENAM because you have one (or more) of the following types of infection:
Zdravnik vam je zdravilo TIENAM predpisal, ker imate eno (ali več) od naslednjih okužb:
Therefore it is unlikely that the suckling infant will be exposed to significant quantities.
Zato ni verjetno, da bi bil dojenček izpostavljen pomembni količini.
The time interval between the beginning of reconstitution and the end of intravenous infusion should not exceed two hours.
Časovni interval med začetkom priprave in koncem intravenske infuzije ne sme preseči 2 ur.
See also above under Central nervous system.
Glejte tudi zgoraj, pod naslovom Osrednje živčevje.
Do not stop using TIENAM until your doctor tells you to.
Ne prenehajte uporabljati zdravila TIENAM, dokler vam tega ne naroči zdravnik.
No further cilastatin appeared in the urine thereafter.
Pozneje se cilastatin v urinu ni več pojavil.
Slovenia: CONET
Slovenija: CONET
Small amounts of this medicine may pass into breast milk and it may affect the baby.
Majhna količina tega zdravila lahko pride v mleko in lahko vpliva na otroka.
However, usefulness of this procedure in the overdose setting is unknown.
Vendar uporabnost tega postopka v primeru prevelikega odmerjanja ni znana.
These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens.
Te reakcije so verjetnejše pri posameznikih z anamnezo občutljivosti za več alergenov.
CAUTION: THE MIXTURE IS NOT FOR DIRECT INFUSION.
OPOZORILO: MEŠANICA NI NAMENJENA ZA NEPOSREDNO INFUNDIRANJE!
If you have kidney problems or weigh less than 70 kg, your doctor may lower your dose.
Če imate težave z ledvicami ali tehtate manj kot 70 kg, vam bo zdravnik odmerek morda zmanjšal.
Italy: TIENAM (20 ml), IMIPEM (20 ml) and TENACID (20 ml) Latvia: TIENAM I.V.
Italija: TIENAM (20 ml), IMIPEM (20 ml) and TENACID (20 ml) Latvija: TIENAM I.V.
Serious anaphylactic reactions require immediate emergency treatment.
Resne anafilaktične reakcije zahtevajo takojšnje nujno zdravljenje.
The maximum total daily dose should not exceed 4000 mg/4000 mg per day.
Največji skupni dnevni odmerek ne sme preseči 4.000 mg/4.000 mg na dan.
Your doctor will decide how much TIENAM you need.
Zdravnik bo določil, koliko zdravila TIENAM potrebujete.
Mechanism of resistance Resistance to imipenem may be due to the following:
Odpornost proti imipenemu je lahko posledica:
Tell your doctor if you are taking ganciclovir which is used to treat some viral infections.
Zdravniku povejte, če jemljete ganciklovir, ki se uporablja za zdravljenje nekaterih virusnih okužb.
The resulting mixture should be agitated until clear.
Nastalo mešanico je treba pretresati, dokler ni bistra.
You may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells.
Pojavi se vam lahko pozitiven izvid določene preiskave (Coombsovega testa); takšen izvid kaže na prisotnost protiteles, ki lahko uničujejo rdeče krvne celice.
Your doctor will decide whether you should use TIENAM in combination with these medicines.
Zdravnik bo presodil, ali naj uporabljate zdravilo TIENAM v kombinaciji s temi zdravili.
WHAT TIENAM IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO TIENAM IN ZA KAJ GA UPORABLJAMO
25 vials
25 vial
4 Strains with MIC values above the susceptible breakpoint are very rare or not yet reported.
4 Sevi z MIC nad mejno vrednostjo občutljivosti so zelo redki ali še niso opisani.
TIENAM will be prepared and given to you by a doctor or another health care professional.
Zdravilo TIENAM bo pripravil in vam ga bo dal zdravnik ali drug zdravstveni delavec.
Until there is evidence regarding clinical response for confirmed isolates with MIC above the current resistant breakpoint they should be reported resistant.
Dokler ni dokazov o kliničnem odzivu za potrjene izolate z MIC nad trenutnimi mejnimi vrednostmi odpornosti, jih je treba poročati kot odporne.
6.6 Special precautions for disposal and other handling Each vial is for single use only.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Vsaka viala je namenjena samo za enkratno uporabo.
Actual body weight (kg) X standard dose 70 (kg)
dejanska telesna masa (kg) X standardni odmerek 70 (kg)
Individual urinary recoveries ranged from 5 to 40%, with an average recovery of 15-20% in several studies.
Individualno pojavljanje v urinu je bilo od 5 do 40%, povprečno pojavljanje v več študijah pa je bilo od 15 do 20%.
In studies of 178 paediatric patients ≥3 months of age, the reported adverse reactions were consistent with those reported for adults.
V študijah pri 178 pediatričnih bolnikih, starih ≥ 3 mesece, so se poročani neželeni učinki skladali s tistimi, o katerih so poročali pri odraslih.
The risk may vary with the underlying infection, age and general status of the patient so that the contribution of the antibiotic to the increase in INR (international normalised ratio) is difficult to assess.
Tveganje se lahko razlikuje glede na osnovno okužbo, starost in splošno stanje bolnika, tako da je težko oceniti, kolikšen je vpliv antibiotika na povečanje INR (internacionalnega normaliziranega razmerja).
Available evidence suggests that cilastatin prevents the nephrotoxicity by preventing entry of imipenem into the tubular cells.
Razpoložljivi dokazi kažejo, da cilastatin prepreči nefrotoksičnost, ker prepreči vstop imipenema v celice tubulov.
The medicinal product is supplied in packs of 1 vial, 10 vials and 25 vials.
Zdravilo je opremljeno v pakiranjih z 1 vialo, 10 vialami in 25 vialami.
Meningitis TIENAM is not recommended for the therapy of meningitis.
Meningitis Zdravilo TIENAM ni priporočljivo za zdravljenje meningitisa.
How to store TIENAM Further information
Shranjevanje zdravila TIENAM Dodatne informacije
This medicinal product must not be mixed with other medicinal products except those mentioned under Reconstitution.
Zdravila se ne sme mešati z drugimi zdravili razen s tistimi, ki so omenjena pod Priprava.
TIENAM belongs to a group of medicines called carbapenem antibiotics.
Zdravilo TIENAM spada v skupino zdravil, imenovanih karbapenemski antibiotiki.
At these doses, plasma levels of imipenem decline to below 1 μg/ml or less in four to six hours.
Pri teh odmerkih se plazemska raven imipenema zmanjša na 1 µg/ml ali manj v štirih do šestih urah.
Currently there are inadequate data to recommend use of TIENAM for patients on peritoneal dialysis.
Trenutno ni dovolj podatkov, da bi bilo mogoče priporočiti uporabo zdravila TIENAM pri bolnikih na peritonealni dializi.
Like all medicines, TIENAM can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo TIENAM neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
In exceptional circumstances where 0.9% sodium chloride cannot be used for clinical reasons, 5% glucose may be used instead.
V izjemnih primerih, v katerih se zaradi kliničnih razlogov 0,9 % raztopine natrijevega klorida ne more uporabiti, lahko namesto nje uporabite 5 % raztopino glukoze.
Rare staining of teeth and/or tongue
Redki obarvanje zob in/ali jezika
1 Proteus and Morganella species are considered poor targets for imipenem.
1 Vrsti Proteus in Morganella veljata za slaba cilja za imipenem.
Paediatric population <1 year of age Clinical data are insufficient to recommend dosing for children less than 1 year of age
Pediatrični bolniki, stari <1 leto Kliničnih podatkov ni dovolj, da bi bilo mogoče priporočiti odmerjanje za otroke, mlajše od 1 leta.
• Neisseria gonorrhoeae: There is insufficient evidence that Neisseria gonorrhoeae is a good target for therapy with imipenem.
Neisseria gonorrhoeae: ni dovolj dokazov, da je Neisseria gonorrhoeae primerna za zdravljenje z imipenemom.
For infusion times see Method of administration.
Za čas infundiranja glejte Način uporabe.
Imipenem and cilastatin are excreted into the mother's milk in small quantities.
Imipenem in cilastatin se v majhni količini izločata v materino mleko.
Gram-negative anaerobes: Bacteroides fragilis Bacteroides fragilis group Fusobacterium spp.
Gramnegativni anaerobi: Bacteroides fragilis Bacteroides fragilis skupina Fusobacterium spp.
Stenotrophomonas maltophilia (formerly Xanthomonas maltophilia, formerly Pseudomonas maltophilia)
Stenotrophomonas maltophilia (prej Xanthomonas maltophilia, prej Pseudomonas maltophilia)
If an allergic reaction to TIENAM occurs, discontinue the therapy immediately.
Če se pojavi alergijska reakcija na zdravilo TIENAM, je treba zdravljenje nemudoma prekiniti.
• Infections that you can catch during or after the delivery
• okužbo, ki se lahko pojavi med porodom ali po njem
Pack sizes of 1, 10 or 25 vials.
Velikosti pakiranj: 1, 10 ali 25 vial.
** EUCAST non-species related breakpoint is used.
** Uporabljene so mejne vrednosti po EUCAST, ki niso vezane na vrsto.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Za pogoje shranjevanja pripravljenega (rekonstituiranega) zdravila glejte poglavje 6.3.
Total daily dose for patients with normal renal function (mg/day)
skupni dnevni odmerek za bolnike z normalnim delovanjem ledvic (mg/dan)
Studies in pregnant monkeys have shown reproductive toxicity (see section 5.3).
Študije pri nosečih opicah so pokazale toksične učinke na sposobnost razmnoževanja (glejte poglavje 5.3).