natgillin/translations-raw huggingface dataset:
Where the maximum total dose, as recommended in the product information, does not exceed 12 mg gentamicin base per kg bw in cattle and pigs, the wording below should be used:
Kadar največji skupni odmerek, kot je priporočen v informacijah o zdravilu, pri govedu in prašičih ne presega 12 mg gentamicinijeve baze na kg telesne mase, je treba uporabiti spodnje besedilo:
IM, IV: Meat and offal: 214 days.
: Meso in organi: 214 dni.
Cattle, dogs, cats IM, IV, SC
Gentafromm govedo, psi, mačke i.m., i.v., s.c.
Cattle, calves, pigs
govedo, teleta, prašiči i.m.
gentamicin 50000 UI/ml
gentamicin 50000 UI/ml teleta, prašički i.m.
IM, IV: Meat and offal: 228 days.
: Meso in organi: 228 dni.
Where the maximum total dose, as recommended in the product information, does not exceed 5 mg gentamicin base per animal in pigs, the wording below should be used:
Kadar največji skupni odmerek, kot je priporočen v informacijah o zdravilu, pri posameznem prašiču ne presega 5 mg gentamicinijeve baze na kg telesne mase, je treba uporabiti spodnje besedilo:
Where the maximum total dose, as recommended in the product information, does not exceed 50 mg gentamicin base per kg bw in pigs, the wording below should be used:
Kadar največji skupni odmerek, kot je priporočen v informacijah o zdravilu, pri prašičih ne presega 50 mg gentamicinijeve baze na kg telesne mase, je treba uporabiti spodnje besedilo:
Cattle, pigs, horses declared as not intended for slaughter for human consumption, dogs, cats
Gentacin govedo, prašiči, konji, ki niso namenjeni za zakol in prehrano ljudi, psi, mačke i.m., i.v., s.c.
Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Podlaga za dopolnilo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo ob upoštevanju naslednjega:
CVMP Note for guidance for the determination of withdrawal periods for milk (EMEA/CVMP/473/98)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004496.pdf CVMP EPMAR for gentamicin (EMA/CVMP/619817/2015)http://www.ema.europa.eu/docs/en_GB/document_library/Maximum_Residue_Limits__Report/2016/03/WC500203742.pdf
V študiji ostankov v mleku, opisani v evropskem javnem poročilu o najvišji mejni vrednosti ostanka (EPMAR) za gentamicin odbora CVMP (EMA/CVMP/619817/2015)
Cattle, calves, pigs, piglets, weaners, horses, foals, dogs, cats
Gentacin, injekcinis tirpalas govedo, teleta, prašiči, prašički, odstavljenci, konji, žrebeta, psi, mačke i.m., i.v., s.c.
Cattle (calves up to 250 kg), nonfood producing horses, dogs, cats
govedo (teleta do 250 kg), konji, ki niso namenjeni za proizvodnjo živil, psi, mačke i.m., počasi i.v.
Groups of 4 adult pigs receiving a dose of 4 mg/kg bw once a day for 5 days, were slaughtered at days 7, 21, 35, and 49 after the last administration, and kidney, liver, fat, muscle, and injection site were analysed.
Skupine po 4 odrasle živali so prejemale odmerek 4 mg/kg telesne mase enkrat na dan v obdobju 5 dni in so jih zaklali 7., 21., 35. oziroma 49. dan po zadnjem odmerku.
Genta-ject 10% gentamicin 100 mg/ml
Genta-ject 10% gentamicin 100 mg/ml teleta do 13. tedna starosti i.m.
Piglets, dogs, cats
prašički, psi, mačke i.m.
Cattle, pigs, dogs IM, SC, slow IV
govedo, prašiči, konji, psi, mačke s.c., i.m., počasi i.v.
Piglets:
Teleta:
Cattle, pigs, horses, dogs, cats
govedo, prašiči, konji, psi, mačke i.m., s.c.
Kidney, liver, skin+fat, muscle, and injection site (core and surrounding) were analysed using a validated HPLC/MS-MS method.
Z validirano metodo HPLC/MS-MS so analizirali ledvice, jetra, kožo z maščobo, mišice in mesto injiciranja (sredino in okolico).
IM, IV
i.m., i.v.
Kidney, liver, and the injection site (core and surrounding) were analysed using a validated HPLC/MS-MS method.
Z validirano metodo HPLC/MS-MS so analizirali ledvice, jetra in mesto injiciranja (sredino in okolico).
Genta
Karenca
Cattle (calves up to 250 kg), nonfood-producing horses
govedo (teleta do 250 kg), konji, ki niso namenjeni za proizvodnjo živil i.m., počasi i.v.
Cattle, pigs, dogs, cats, pet birds
govedo, prašiči, psi, mačke, hišne ptice i.m., i.v., s.c.
Otherwise, it can be regarded as meeting current standards, although muscle (other than injection site) and fat were not analysed; this can be accepted as these tissues are recognised as not limiting with regard to gentamicin residue depletion.
V drugih pogledih je izpolnjevala trenutne standarde, čeprav niso analizirali mišic (razen na mestu injiciranja) in maščobe.
The study is not GLP-compliant.
Ta študija ni bila opravljena v skladu z dobro laboratorijsko prakso.
Kidney, liver, fat, muscle, injection site (with no control surrounding sample) were analysed for residue depletion, using an LC-MS/MS method.
Izločanje ostankov so analizirali z metodo LC-MS/MS v ledvicah, jetrih, maščobi, mišicah in na mestu injiciranja (brez kontrolnega vzorca iz okolice).
Cattle, non-food producing horses, pigs, dogs, cats
govedo, prašiči, konji, ki niso namenjeni za zakol in prehrano ljudi, psi, mačke i.m., i.v., s.c.
IM, SC
ali s.c.
Cattle, calves, pigs, piglets, horses, dogs, cats
GENTA-JECT, injekcinis tirpalas govedo, teleta, prašiči, prašički, konji, psi, mačke i.m., i.v., s.c.
Cattle (calves up to 250 kg), nonfood-producing horses, dogs
govedo (teleta do 250 kg), konji, ki niso namenjeni za proizvodnjo živil, psi i.m., počasi i.v.
Alapis SA
Jakost
In the milk residue study described in the CVMP EPMAR for gentamicin (EMA/CVMP/619817/2015) five lactating cows were treated with repeated intramuscular doses of 4 mg gentamicin/kg bw/day for 3 days.
4, so krave v obdobju laktacije zdravili z večkratnimi intramuskularnimi odmerki 4 mg gentamicina/kg telesne mase na dan v obdobju 3 dni.
Calves, pigs, dogs
teleta, prašiči, psi i.m.
IM, IV, endo peritoneal
Gentacin teleta, psi i.m., i.v.
This medicine is the same as Aprovel, which is already authorised in the European Union (EU).
To zdravilo je enako zdravilu Aprovel, ki je že odobreno v Evropski uniji (EU).
‘Essential' means that the hypertension has no obvious cause.
„Esencialna“ pomeni, da za hipertenzijo ni jasnega vzroka.
It is available as tablets (75, 150 and 300 mg).
Na voljo je v obliki tablet (75, 150 in 300 mg).
Previously known as Irbesartan Winthrop.
Prej znano pod imenom Irbesartan Winthrop.
The main benefit was on the effect on blood creatinine levels.
Glavna korist je bil učinek na raven kreatinina v krvi.
The full EPAR for Irbesartan Zentiva can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Irbesartan Zentiva je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Irbesartan Winthrop on 19 January 2007.
Evropska komisija je dovoljenje za promet z zdravilom Irbesartan Winthrop, veljavno po vsej Evropski uniji, odobrila dne 19. januarja 2007.
Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.
Zdravljenje se začne z odmerkom 150 mg enkrat dnevno, ki ga običajno povečamo na 300 mg enkrat dnevno.
The name of the medicine was changed to Irbesartan Zentiva on 6 February 2012.
Ime zdravila je bilo 6. februarja 2012 spremenjeno v Irbesartan Zentiva.
The usual recommended dose of Irbesartan Zentiva is 150 mg once a day.
Običajni priporočeni odmerek zdravila Irbesartan Zentiva znaša 150 mg enkrat dnevno.
This is a summary of the European public assessment report (EPAR) for Irbesartan Zentiva.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Irbesartan Zentiva.
The company that makes Aprovel has agreed that its scientific data can be used for Irbesartan Zentiva.
Družba, ki izdeluje zdravilo Aprovel, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Irbesartan Zentiva.
This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a stroke.
Posledica tega je znižanje krvnega tlaka, zaradi česar se zmanjšajo tveganja, povezana z visokim krvnim tlakom, kot je denimo tveganje kapi.
For more information about treatment with Irbesartan Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Irbesartan Zentiva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
There was a 23% relative risk reduction compared with amlodipine.
V primerjavi z amlodipinom je bilo ugotovljeno 23-odstotno zmanjšanje relativnega tveganja.
EPAR summary for the public irbesartan
Povzetek EPAR za javnost irbesartan
When used with hydrochlorothiazide, the effects of the two medicines were additive.
Pri njegovi sočasni uporabi s hidroklorotiazidom se učinka obeh zdravil seštevata.
If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension can be added, such as hydrochlorothiazide.
Če krvni tlak ni zadostno nadzorovan, se odmerek lahko poveča na 300 mg dnevno ali dodajo druga zdravila za
The CHMP decided that Irbesartan Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Irbesartan Zentiva večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
For the treatment of kidney disease, Irbesartan Zentiva was studied in two large studies involving a total of 2,326 patients with type 2 diabetes.
Zdravilo Irbesartan Zentiva so glede zdravljenja ledvičnega obolenja preučevali v okviru dveh velikih študij, ki sta vključevali skupno 2 326 bolnikov s sladkorno boleznijo tipa 2.
The active substance in Irbesartan Zentiva, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Zdravilna učinkovina v zdravilu Irbesartan Zentiva, irbesartan, je „antagonist receptorjev angiotenzina II“, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
Other information about Irbesartan Zentiva
Druge informacije o zdravilu Irbesartan Zentiva
Its use in combination with hydrochlorothiazide was also examined in 1,736 patients.
Pri 1 736 bolnikih so proučevali tudi njegovo uporabo v kombinaciji s hidroklorotiazidom.
In this study, Irbesartan Zentiva was compared with placebo and with amlodipine.
V tej študiji so zdravilo Irbesartan Zentiva primerjali s placebom in amlodipinom.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Irbesartan Zentiva.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Irbesartan Zentiva, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Irbesartan Zentiva was used for two years or more.
Bolniki so zdravilo Irbesartan Zentiva jemali dve leti ali več.
Irbesartan Zentiva is used in adults who have essential hypertension (high blood pressure).
Zdravilo Irbesartan Zentiva se uporablja pri odraslih, ki imajo esencialno hipertenzijo (visok krvni tlak).
What benefit has Irbesartan Zentiva shown during the studies?
Kakšne koristi je zdravilo Irbesartan Zentiva izkazalo med študijami?
Irbesartan Zentiva in combination with aliskiren-containing medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Zdravilo Irbesartan Zentiva se v kombinaciji z zdravili, ki vsebujejo aliskiren (ki se uporablja za zdravljenje esencialne hipertenzije), ne sme uporabljati pri bolnikih s sladkorno boleznijo ali zmerno do hudo ledvično okvaro.
Irbesartan Zentiva was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients.
Zdravilo Irbesartan Zentiva so pri 712 bolnikih primerjali s placebom (zdravilom brez zdravilne učinkovine), pri 823 bolnikih pa z drugimi zdravili za zdravljenje visokega krvnega tlaka (atenololom, enalaprilom ali amlodipinom).
Irbesartan Zentiva is a medicine that contains the active substance irbesartan.
Irbesartan Zentiva je zdravilo, ki vsebuje zdravilno učinkovino irbesartan.
Irbesartan Zentiva must not be used in people who are hypersensitive (allergic) to irbesartan or any of the other ingredients.
Zdravila Irbesartan Zentiva ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) irbesartan ali katero koli drugo sestavino zdravila.
In patients with hypertension and type 2 diabetes, Irbesartan Zentiva is added to some other treatments for hypertension.
Pri bolnikih z visokim krvnim tlakom in sladkorno boleznijo tipa 2 se zdravilo Irbesartan Zentiva dodaja nekaterim drugim zdravilom za zdravljenje visokega krvnega tlaka.
By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen.
Irbesartan z zaviranjem receptorjev, na katere se angiotenzin II običajno veže, zavira delovanje tega hormona, kar omogoči razširitev krvnih žil.
For the full description of all side effects reported with Irbesartan Zentiva, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Irbesartan Zentiva, glejte navodilo za uporabo.
The most common side effect with Irbesartan Zentiva (seen in more than 1 patient in 10) is dizziness, hyperkalaemia (high blood potassium levels).
Najpogostejša neželena učinka zdravila Irbesartan Zentiva (opažena pri več kot 1 bolniku od 10) sta omotica in hiperkaliemija (visoka raven kalija v krvi).
One study looked at markers of kidney damage by measuring whether the kidneys were releasing the protein albumin into the urine.
V prvi študiji so proučevali označevalce poškodb ledvic, in sicer na podlagi merjenja, ali ledvice v urin izločajo beljakovino albumin.
In the blood pressure studies, Irbesartan Zentiva was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
V študijah krvnega tlaka je bilo zdravilo Irbesartan Zentiva pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba in je imelo podobne učinke kot druga zdravila za zdravljenje visokega krvnega tlaka.
The second study looked at whether Irbesartan Zentiva increased the time taken until the patients' blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died.
V drugi študiji so proučevali, ali zdravilo Irbesartan Zentiva podaljša čas, v katerem se raven kreatinina (označevalca ledvičnega obolenja) v krvi bolnikov podvoji, čas do pojava potrebe po presaditvi ledvic ali dializi oziroma čas do nastopa smrti.
What is the risk associated with Irbesartan Zentiva?
Kakšna tveganja so povezana z zdravilom Irbesartan Zentiva?
In the first kidney disease study, Irbesartan Zentiva was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion.
V prvi študiji ledvičnega obolenja je bilo zdravilo Irbesartan Zentiva učinkovitejše od placeba pri zmanjševanju tveganja za pojav poškodbe ledvic, merjene na podlagi izločanja beljakovin.
A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age.
Pri bolnikih na hemodializi (postopku čiščenja krvi) ali pri bolnikih, starejših od 75 let, lahko začetni odmerek znaša 75 mg.
Irbesartan Zentiva was originally studied in 11 trials for its effects on blood pressure.
Učinke zdravila Irbesartan Zentiva na krvni tlak so prvotno proučevali v 11 preskušanjih.
In the second kidney disease study, Irbesartan Zentiva reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant or dialysis, or death during the study by 20% in comparison with placebo.
V drugi študiji ledvičnega obolenja je zdravilo Irbesartan Zentiva v primerjavi s placebom za 20 % zmanjšalo relativno tveganje za podvojitev ravni kreatinina v krvi, za pojav potrebe po presaditvi ledvic ali dializi ali za nastop smrti med študijo.
Irbesartan Zentiva is also used to treat kidney disease in adults with hypertension and type 2 diabetes.
Zdravilo Irbesartan Zentiva se uporablja tudi za zdravljenje ledvičnega obolenja pri odraslih z visokim krvnim tlakom in sladkorno boleznijo tipa 2.
Why has Irbesartan Zentiva been approved?
Zakaj je bilo zdravilo Irbesartan Zentiva odobreno?
How has Irbesartan Zentiva been studied?
Kako je bilo zdravilo Irbesartan Zentiva raziskano?
What is Irbesartan Zentiva?
Kaj je zdravilo Irbesartan Zentiva?
How is Irbesartan Zentiva used?
Kako se zdravilo Irbesartan Zentiva uporablja?
What is Irbesartan Zentiva used for?
Za kaj se zdravilo Irbesartan Zentiva uporablja?
How does Irbesartan Zentiva work?
Kako zdravilo Irbesartan Zentiva deluje?
Date of first authorisation: 08 January 2014 Date of latest renewal: 20 November 2018
Datum prve odobritve: 08. januar 2014 Datum zadnjega podaljšanja: 20. november 2018
10 DATE OF REVISION OF THE TEXT
10 DATUM ZADNJE REVIZIJE BESEDILA
A risk of birth defects for your unborn child cannot be completely excluded.
Tveganja za prirojene napake pri vašem nerojenem otroku ni mogoče popolnoma izključiti.
Elderly (65 years and older)
Starejši (65 let in starejši)
Children (4 to 12 years)
Otroci (od 4 do 12 let)
You should not stop your treatment without discussing this with your doctor.
Zdravljenja ne smete prekiniti, ne da bi se o tem pogovorili z zdravnikom.
Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Trenutno dostopni podatki so opisani v poglavjih 4.8, 5.1 in 5.2, vendar priporočil za določanje odmerjanja ni mogoče izdelati.
Height (cm) x ks
Višina (cm) x ks
The elimination half-life was approximately 5 hours.
Razpolovni čas izločanja je bil približno 5 ur.
The mechanism of action of levetiracetam still remains to be fully elucidated.
Mehanizem delovanja levetiracetama še vedno ni popolnoma pojasnjen.
These effects should however decrease over time.
Vendar se jakost teh učinkov s časom zmanjša.
The lowest effective dose should be used.
Uporabiti je treba najmanjši učinkovit odmerek.
• infection;
• okužba;
Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a reduction of its effect.
Ne jemljite makrogola (učinkovina, ki se uporablja kot laksativ) eno uro pred in eno uro po jemanju levetiracetama, ker lahko zmanjša učinek levetiracetama.
Other unidentified components accounted only for 0.6% of the dose.
Druge, neidentificirane sestavine predstavljajo le 0,6 % odmerka.
Total Daily Dose
Celokupni dnevni odmerek
If not used immediately, in-use storage time and conditions are the responsibility of the user.
V primeru, da se ga ne uporabi takoj, je za čas in pogoje shranjevanja odgovoren uporabnik.
• encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms);
• encefalopatija (glejte podpoglavje “Takoj obvestite zdravnika” za podroben opis simptomov)
Available data in children did not suggest impact on growth and puberty.
Podatki, ki so na razpolago pri otrocih, ne kažejo na vpliv na rast in puberteto.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti cepiva za to cepivo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Dose adjustment is not required.
Prilagoditev odmerjanja ni potrebna.
The mechanism of this risk is not known.
Mehanizem tveganja še ni znan.
No impact on fertility was detected in animal studies (see section 5.3).
V študijah na živalih vpliva na plodnost niso odkrili (glejte poglavje 5.3).
* Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
* Prevalenca je bistveno večja pri japonskih bolnikih v primerjavi z ne-japonskimi bolniki.
Physiological changes during pregnancy may affect levetiracetam concentration.
Fiziološke spremembe med nosečnostjo lahko vplivajo na koncentracijo levetiracetama.
Cases of encephalopathy generally occurred at the beginning of the treatment (few days to a few months) and were reversible after treatment discontinuation.
Primeri encefalopatije so se običajno pojavili na začetku zdravljenja (od nekaj dni do nekaj mesecev) in so bili reverzibilni, ko se je zdravljenje prekinilo.
Dose in adults and adolescents (from 16 years of age):
Odmerjanje pri odraslih in mladostnikih (od 16. leta starosti):
He/she may decide if your dose should be adjusted.
Odločil se bo, ali je vaš odmerek potrebno prilagoditi.
This decrease is more pronounced during the third trimester (up to 60% of baseline concentration before pregnancy).
To zmanjšanje koncentracije je bolj izrazito v tretjem trimesečju (do 60 % glede na običajno koncentracijo pred nosečnostjo).
Then CLcr is adjusted for body surface area (BSA) as follows:
CLcr je prilagojen na telesno površino (BSA, body surface area) na naslednji način:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
Hydrolysis of the acetamide group was measurable in a large number of tissues including blood cells.
Hidrolizo acetamidne skupine so izmerili v številnih tkivih vključno s krvnimi celicami.
The pharmacokinetic and safety profiles did not identify any safety concerns.
Farmakokinetični in varnostni profil nista pokazala nobenih vplivov na varnost.
Levetiracetam Hospira must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
Zdravilo Levetiracetam Hospira morate prejeti dvakrat na dan, enkrat zjutraj in enkrat zvečer, vsak dan ob približno istem času.
EXP Use immediately after dilution.
EXP: Uporabite takoj po redčenju.
• limp or difficulty walking.
• šepanje ali težave pri hoji.
Tell your doctor immediately, or go to your nearest emergency department, if you experience:
Nemudoma obvestite zdravnika ali obiščite oddelek za nujno medicinsko pomoč, če opazite:
This leaflet was last revised in month/YYYY.
Navodilo je bilo nazadnje revidirano dne {mesec LLLL}.
Chemical and physical in-use stability of the diluted product stored in PVC bags has been demonstrated for 24 hours at 30 °C and at 2-8 °C.
Kemična in fizikalna stabilnost razredčenega zdravila med uporabo, shranjenega v PVC vrečkah, sta bili dokazani za obdobje 24 ur pri temperaturi 30 °C in pri od 2 do 8 °C.
Appropriate clinical management of pregnant women treated with levetiracetam should be ensured.
Zagotoviti je treba ustrezno klinično spremljanje nosečnic, ki se zdravijo z levetiracetamom.
However, long term effects on learning, intelligence, growth, endocrine function, puberty and childbearing potential in children remain unknown.
Vendar pa dolgoročni učinki na učenje, inteligenco, rast, delovanje žlez, puberteto in rodnost pri otrocih ostajajo neznani.