natgillin/translations-raw huggingface dataset:
The marketing authorisation holder was requested to provide additional data and justification that the efficacy claims and duration of immunity of Porcilis PRRS are not altered when the vaccine is administered mixed with Porcilis M Hyo.
Imetnik dovoljenja za promet z zdravilom je bil pozvan, naj predloži dodatne podatke in utemeljitev, da se zahteve učinkovitosti in trajanje imunosti za zdravilo Porcilis PRRS ne spremenijo, če se cepivo daje mešano s cepivom Porcilis M Hyo.
Freeze-dried vaccine:
Cepivo v obliki liofilizata:
2.1 In-use shelf-life proposed after mixing the two products (Porcilis PRRS and Porcilis M Hyo)
2.1 Predlagani rok uporabnosti po mešanju obeh zdravil (Porcilis PRRS in Porcilis M Hyo)
4.8 Interaction with other medicinal products and other forms of interaction Safety and efficacy data for intramuscular injection are available in finishing pigs from 4 weeks of age onwards, which demonstrate that this vaccine can be mixed with Porcilis M Hyo.
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Na voljo so podatki o varnosti in učinkovitosti pri prašičih pitancih od 4 tednov starosti, ki dokazujejo, da lahko cepivo mešamo s cepivom Porcilis Hyo.
The marketing authorisation holder considered that, based on the Guideline on requirements for concurrent administration of immunological veterinary medicinal products1, the efficacy data of the individual products, including duration of immunity, can be applied for the concurrent use of them if absence of immunological interference is demonstrated.
Imetnik dovoljenja za promet z zdravilom je menil, da je na podlagi smernice glede zahtev za sočasno uporabo imunoloških zdravil za uporabo v veterinarski medicini1 podatke o učinkovitosti posameznih zdravil, vključno s trajanjem imunosti, mogoče uporabiti za sočasno uporabo teh zdravil, če je dokazana odsotnost imunološkega medsebojnega vpliva.
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS
DOPOLNILA, KI NAJ BODO VKLJUČENA V USTREZNE RAZDELKE POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA
As regards justifying why no potency test of the Porcilis M Hyo component has been carried out on the mixed vaccines both immediately after mixing and after the proposed in-use shelf life, the marketing authorisation holder has justified not performing a potency test for the Porcilis M Hyo component on the mixed vaccines that by provision of safety and efficacy studies using the mixed product the marketing authorisation holder has shown that there are no interactions within the mixture affecting the potency of the mixed product.
Kar zadeva vprašanje, zakaj ni bil izveden preskus jakosti komponente Porcilis M Hyo z mešanimi cepivi neposredno po mešanju in po izteku predlaganega roka uporabnosti, je imetnik dovoljenja za promet z zdravilom odgovoril, da preskusa jakosti komponente Porcilis M Hyo z mešanimi cepivi ni izvedel, ker je že s predložitvijo študij varnosti in učinkovitosti z uporabo mešanega zdravila pokazal, da v mešanici ni interakcij, ki bi vplivale na jakost mešanega zdravila.
Duration of immunity of Porcilis PRRS has also not been demonstrated for simultaneous administration.
Prav tako ni bilo dokazano trajanje imunosti po dajanju zdravila Porcilis PRRS za sočasno uporabo.
List of the names, pharmaceutical form, strength of the Veterinary medicinal products, animal species, routes of administration, withdrawal period, marketing authorisation holders in the Member states
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, NAČINOV
Newly introduced PRRS virus-naïve animals (e.g. replacement gilts from PRRS virusnegative herds) should be vaccinated prior to pregnancy.
Nove živali, ki niso okužene z virusom PRRS (npr. nadomestne mladice iz čred, ki niso okužene z virusom PRRS), je treba cepiti pred brejostjo.
It is indicated for use in breeding and finishing pigs from 2 weeks of age.
Namenjeno je za uporabo pri prašičih, namenjenih za razplod in za zakol, starejših od 2 tednov.
1 CVMP Guideline on data requirements to support in-use stability claims for veterinary vaccines (EMEA/CVMP/IWP/250147/2008-CONSULTATION) - http://www.ema.europa.eu/pdfs/vet/iwp/25014708en.pdf
1 CVMP Guideline on data requirements to support in-use stability claims for veterinary vaccines (Smernica o zahtevah glede podatkov v podporo zahtevkov po stabilnosti cepiv za uporabo v veterinarski medicini) (EMEA/CVMP/IWP/250147/2008-CONSULTATION) - http://www.ema.europa.eu/pdfs/vet/iwp/25014708en.pdf opaziti znatno izboljšanje rezultatov pri vzreji (zmanjšana morbidnost, ki jo povzroča okužba z virusom PRRS in boljša dnevna rast in sprememba krme) do konca dobe vzreje.
Maternally derived antibodies may interfere with the response to vaccination.
Na odgovor na cepljenje lahko vplivajo od matere pridobljene protitelesa.
The variation of concern consists of allowing the mixing of two vaccines, Porcilis PRRS and Porcilis M Hyo, before administration.
Zadevna sprememba vključuje dovoljenje za mešanje dveh cepiv, Porcilis PRRS in Porcilis M Hyo, pred uporabo.
Scientific conclusions and grounds for the granting of the variation of the marketing authorisations
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA ODOBRITEV SPREMEMBE DOVOLJENJ ZA PROMET Z ZDRAVILOM
Vaccination scheme: A single dose is given to pigs from 2 weeks of age onwards.
Shema cepljenja: Enkratni odmerek prašičem od starosti 2 tednov.
2.2 Justification of the current claim for Porcilis PRRS concerning a significant improvement of rearing results (reduced morbidity due to PRRS infection, and a better daily growth and feed conversion) until the end of the fattening period when mixed with Porcilis M Hyo.
2.2 Utemeljitev trenutne navedbe za zdravilo Porcilis PRRS, ki zadeva znatno izboljšanje rezultatov pri vzreji (zmanjšana morbidnost, ki jo povzroča okužba z virusom PRRS in boljša dnevna rast in sprememba krme) do konca dobe vzreje, kadar je mešano z zdravilom Porcilis M Hyo.
Concerning Porcilis M Hyo the marketing authorisation holder has submitted data of adjuvant content (dl-α-tocopherol acetate), pH and sterility of the mixture after reconstitution of 2 batches of Porcilis PRRS in 2 batches of Porcilis M Hyo after storage for 3 hours at room temperature.
Za zdravilo Porcilis M Hyo je imetnik dovoljenja za promet z zdravilom predložil podatke o vsebini adjuvansa (dl--tokoferol acetat), vrednosti pH in sterilnosti mešanice po rekonstituciji dveh serij zdravila Porcilis PRRS v dveh serijah zdravila Porcilis M Hyo po 3 urah hranjenja pri sobni temperaturi.
The marketing authorisation holder has justified that the current duration of immunity for Porcilis PRRS is still supported when the two products are mixed.
Imetnik dovoljenja za promet z zdravilom je utemeljil, da je trenutno trajanje imunosti za zdravilo Porcilis PRRS ob mešanju obeh zdravil še vedno podprto.
The proposed vaccination scheme for finishing pigs with the mixed product is: first administration of Porcilis M Hyo from one week of age followed by the administration of Porcilis PRRS mixed with Porcilis M Hyo from 4 weeks of age.
Predlagana shema cepljenja za prašiče, ki se redijo za zakol, v mešanem zdravilu je: prvo dajanje zdravila Porcilis M Hyo od starosti enega tedna dalje, čemur sledi dajanje mešanice zdravil Porcilis PRRS in Porcilis M Hyo od starosti 4 tednov dalje.
A single dose (2 ml) of Porcilis PRRS mixed with Porcilis M Hyo is given intramuscularly in the neck.
Cepimo z enkratnim odmerkom (2 ml) Porcilisa PRRS, pomešanega s Porcilisom H Hyo, intramuskularno na vratu.
- the CVMP considered that stability of the mixed product up to 1 hour after mixing as claimed on the Summary of Product Characteristics was supported by the data provided, - the CVMP considered that the efficacy of the mixed vaccine regarding the PRRS component was sufficiently supported by the data provided, the CVMP has recommended the granting of the variation of the Marketing Authorisations for Porcilis PRRS and associated names (see Annex I).
- CVMP meni, da so predloženi podatki zadostno podprli učinkovitost mešanega cepiva z vidika komponente PRRS, je CVMP priporočil odobritev spremembe dovoljenj za promet z zdravilom Porcilis PRRS in povezanimi imeni (glejte Dodatek I).
The marketing authorisation holder has provided data of the PRRS virus titration after mixing Porcilis PRRS with Porcilis M Hyo at 0, 1, 2 and 3 hours.
Imetnik dovoljenja za promet z zdravilom je predložil podatke o titraciji virusa PRRS po mešanju zdravila Porcilis PRRS z zdravilom Porcilis M Hyo po 0, 1, 2 in 3 urah.
Safety and efficacy data for intramuscular injection are available in finishing pigs from 4 weeks of age onwards, which demonstrate that this vaccine can be mixed with Porcilis M Hyo.
Na voljo so podatki o varnosti in učinkovitosti pri prašičih pitancih od 4 tednov starosti, ki dokazujejo, da lahko cepivo mešamo s cepivom Porcilis Hyo.
However, it was considered that all the claims to appear in the SPC should be demonstrated.
Vendar so menili, da bi morale biti dokazane vse navedbe v povzetku glavnih značilnosti zdravila.
The marketing authorisation holder provided data for PRRS virus titres of two batches of Porcilis PRRS reconstituted with each of ten batches of Porcilis M Hyo after 0, 1, 2 and 3 hours of storage at room temperature.
Imetnik dovoljenja za promet z zdravilom je predložil podatke za titre virusa PRRS za dve seriji zdravila Porcilis PRRS, ki sta bili rekonstituirani z vsako od desetih serij zdravila Porcilis M Hyo po 0, 1, 2 in 3 urah hranjenja pri sobni temperaturi.
Porcilis M Hyo
Porcilis PRRS Porcilis M Hyo
No information is available on the safety and efficacy of the use of Porcilis PRRS mixed with Porcilis M Hyo in breeding animals or during pregnancy.
O varnosti in učinkovitosti uporabe Porcilisa PRRS, pomešanega s cepivom Porcilis M Hyo, pri vzrejnih živalih in med brejostjo ni podatkov
The marketing authorisation holder has justified by reference to the available data that the current efficacy claims for Porcilis PRRS are still supported when the two products are mixed.
S sklicevanjem na razpoložljive podatke je utemeljeval, da so trenutne navedbe o učinkovitosti za zdravilo Porcilis PRRS ob mešanju obeh zdravil še vedno podprte.
1 CVMP Guideline on requirements for concurrent administration of immunological veterinary medicinal products (EMEA/CVMP/550/02-FINAL) - http://www.ema.europa.eu/pdfs/vet/iwp/055002en.pdf vaccines were mixed resulting in maintenance of the same level of efficacy by investigating one efficacy parameter, reduction in viraemia (reduction of 70-75% after simultaneous use and reduction of 72-75% after use of Porcilis PRRS alone).
Imetnik dovoljenja za promet z zdravilom je dokazal, da ni imunološkega medsebojnega vpliva ob mešanju cepiv, kar pomeni, da se ohrani ista raven učinkovitosti ob proučevanju enega parametra učinkovitosti „zmanjšanje viremije“ (zmanjšanje za 70-75 % po sočasni uporabi in zmanjšanje za 72-75 % po samostojni uporabi zdravila Porcilis PRRS).
The vaccine may be reconstituted shortly before vaccination for simultaneous use with Porcilis M Hyo in finishing pigs from 4 weeks of age and the following instructions should be used:
Pri simultani uporabi s Porcilisom M Hyo cepivo rekonstituiramo tik pred cepljenjem prašičev pitancev od starosti 4 tednov po naslednjih navodilih:
Batch release protocols for the in-use stability studies of Porcilis PRRS and Porcilis M Hyo were provided.
Protokoli za sproščanje serije, ki veljajo za študije stabilnosti zdravil Porcilis PRRS in Porcilis M Hyo med uporabo, so bili predloženi.
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET
DOPOLNILA, KI NAJ BODO VKLJUČENA V USTREZNE RAZDELKE NAVODILA ZA UPORABO
85701 Unterschleißheim Germany
Unterschleißheim Nemčija
Luxembourg Intervet International BV Wim de Körverstraat 35
Luksemburg Intervet International BV
+ 20 ml
10 odmerkov + 20 ml
+ 50 ml
25 odmerkov + 50 ml
+ 200 ml
100 odmerkov + 200 ml
The marketing authorisation holder has demonstrated that the degree of protection conveyed by the individual products has not been altered by mixing the products by several laboratory challenge studies and field studies.
Z več dodatnimi laboratorijskimi študijami in terenskimi študijami je dokazal, da se z mešanjem zdravil stopnja zaščite posameznega zdravila ni spremenila.
Belgium Intervet International BV Wim de Körverstraat 35
Wim de Körverstraat 35
+ 100 ml
50 odmerkov + 100 ml
Whereas
nič dni
Amendments to the summary of product characteristics and package leaflet
DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
Withdrawal period
6.3 Rok uporabnosti
The product literature of Porcilis M Hyo should also be consulted before administration of the mixed product.
Pred dajanjem mešanega cepiva je treba prebrati informacije o cepivu Porcilis Hyo.
Member State/EEA
Država članica
Deseril Tablets 1mg 1mg
Tablete Deseril 1 mg 1 mg
Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
Marketing Authorisation Holder Invented name
Izmišljeno ime
Long-term exposure (at least 48 weeks)
Dolgotrajna izpostavljenost (najmanj 48 tednov)
(See sections 4.5 and 5.2.)
(gl. poglavji 4.5 in 5.2).
, increased appetite.
, povečan apetit
Date of first authorisation: 27 September 2007 Date of latest renewal: 26 July 2012
Datum prve odobritve: 27. september 2007 Datum zadnjega podaljšanja: 26. julij 2012
There are no adequate and well-controlled studies in pregnant women.
Pri nosečnicah niso bile opravljene dovolj dobro kontrolirane raziskave.
Your doctor will tell you how many Zalasta tablets to take and how long you should continue to take them.
Zdravnik vam bo povedal, koliko tablet Zalasta morate vzeti in kako dolgo naj bi jih jemali.
Interaction studies have only been performed in adults.
Raziskave interakcij so izvajali samo pri odraslih.
If this happens do not drive or operate any tools or machines.
Če se to zgodi, ne vozite in ne upravljajte orodij ali strojev.
Close medical supervision and monitoring should continue until the patient recovers.
S skrbnim zdravstvenim nadzorovanjem in opazovanjem je treba nadaljevati, dokler si bolnik ne opomore.
Try to take your tablets at the same time each day.
Tablete poskušajte jemati vsak dan ob isti uri.
Some fatal cases have been reported in this particular group of patients.
Poročali so o nekaj smrtnih izidih pri tej skupini bolnikov.
Such factors possibly contribute to the higher average exposure observed in adolescents.
Možno je, da taki dejavniki vplivajo na večjo povprečno izpostavljenost, ki so jo opazili pri mladostnikih.
Show the doctor your pack of tablets.
Zdravniku pokažite svojo škatlo tablet.
Your doctor may suggest you to reduce the dose gradually before stopping treatment.
Vaš zdravnik vam bo morda predlagal postopno zmanjševanje odmerka, preden bo ukinil zdravilo.
No studies on the effects on the ability to drive and use machines have been performed.
Raziskave o vplivu na sposobnost za vožnjo in upravljanje strojev niso bile narejene.
In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
Pri nekaterih bolnikih so poročali o predhodnem povečanju telesne mase, kar bi lahko bil predisponirajoči dejavnik.
Do not stop taking your tablets just because you feel better.
Ne prenehajte jemati tablet, čeprav se počutite bolje.
These symptoms can temporally deteriorate or even arise after discontinuation of treatment.
Simptomi se lahko sčasoma poslabšajo, lahko pa se pojavijo celo po prenehanju zdravljenja.
Unlike some other antipsychotic agents, olanzapine increases responding in an “anxiolytic” test.
Za razliko od nekaterih drugih antipsihotikov olanzapin poveča odzivanje v "anksiolitičnem" testu.
However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n=467) as in male patients (n=869).
Vendar je olanzapin (5 do 20 mg) pokazal primerljiv profil varnosti tako pri bolnicah (n=467) kot pri bolnikih (n=869).
Olanzapine had no teratogenic effects.
Olanzapin ni povzročal teratogenih učinkov.
There are no controlled data on maintenance of effect or long term safety (see sections 4.4 and 4.8).
Nadzorovanih podatkov o vzdrževalnem učinku ali podatkov o dolgoročni varnosti ni (gl. poglavji 4.4 in 4.8).
As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.
Če ste stari več kot 65 let, vam lahko vaš osebni zdravnik nadzoruje krvni tlak.
It does not matter whether you take them with or without food.
Zaužijete jih lahko s hrano ali brez nje.
It is recommended that blood pressure is measured periodically in patients over 65 years.
Pri starejših od 65 let je zato priporočeno redno merjenje krvnega tlaka.
Do not use epinephrine, dopamine, or other sympathomimetic agents with betaagonist activity since beta stimulation may worsen hypotension.
Ne uporabljajte adrenalina, dopamina ali drugih simpatikomimetikov z betaagonističnim delovanjem, ker lahko beta stimulacija poslabša hipotenzijo.
If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke.
Če ste bolnik z demenco, morate vi ali vaš skrbnik/sorodnik povedati vašemu zdravniku, če ste kdaj doživeli možgansko kap ali "majhno" možgansko kap.
- If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
- če so vam v preteklosti ugotovili težave z očmi, npr. določeno vrsto glavkoma (zvišan očesni tlak).
If you forget to take Zalasta Take your tablets as soon as you remember.
Če ste tablete pozabili vzeti, jih vzemite takoj, ko se spomnite.
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Olanzapin je učinkovit za vzdrževanje kliničnega izboljšanja pri nadaljevanju zdravljenja bolnikov, pri katerih je prišlo do začetnega odziva na zdravljenje.
The higher incidence of death was not associated with olanzapine dose (mean daily dose 4.4 mg) or duration of treatment.
Večja smrtnost ni bila povezana z odmerkom olanzapina (povprečni dnevni odmerek je bil 4,4 mg) ali trajanjem zdravljenja.
The pharmacokinetic variability observed in the elderly is within the range for the non-elderly.
Farmakokinetična variabilnost, opažena pri starejših, je v okvirih razpona za mlajše.
In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 6 months.
Pri odraslih bolnikih, ki so končali 9- do 12-mesečno zdravljenje, se je povečevanje povprečnih vrednosti glukoze v krvi upočasnilo po približno 6 mesecih.
Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Zalasta and regularly during treatment.
Vaš zdravnik mora opraviti krvni test za preiskavo sladkorja v krvi in nivo določenih maščob pred začetkom jemanja zdravila Zalasta in redno tekom zdravljenja.
Do not take Zalasta - If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Zalasta: - če ste alergični na olanzapin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The median lethal doses were approximately 210 mg/kg (mice) and 175 mg/kg (rats).
Srednji letalni odmerki so bili približno 210 mg/kg za miši in 175 mg/kg za podgane.
In a study of Caucasians, Japanese, and Chinese subjects, there were no differences in the pharmacokinetic parameters among the three populations.
Raziskava, v kateri so sodelovali belci, Japonci in Kitajci, ni pokazala razlik v farmakokinetičnih parametrih.
Lipid alterations should be managed as clinically appropriate, particularly in dyslipidemic patients and in patients with risk factors for the development of lipids disorders.
Te spremembe je treba klinično ustrezno zdraviti, zlasti pri bolnikih z dislipidemijo in bolnikih z dejavniki tveganja za razvoj motenj lipidov.
In 44 patients with schizophrenia 65 years of age, dosing from 5 to 20 mg/day was not associated with any distinguishing profile of adverse events.
Pri 44 bolnikih s shizofrenijo, starejših od 65 let, odmerjanje od 5 do 20 mg/dan ni pokazalo razlike v profilu neželenih učinkov.
Although no clinical studies designed to compare adolescents to adults have been conducted, data from the adolescent trials were compared to those of the adult trials.
Posebnih kliničnih raziskav, v katerih bi primerjali mladostnike in odrasle, niso izvedli, so pa podatke iz preizkušanj na mladostnikih primerjali s podatki iz preizkušanj na odraslih.
A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
Raziskava ravnovesja snovi je pokazala, da se približno 57 % radioaktivno označenega olanzapina pojavi v urinu, predvsem v obliki presnovkov.
Caution should be exercised in patients who consume alcohol or receive medicinal products that can cause central nervous system depression.
Pri bolnikih, ki pijejo alkohol ali jemljejo zdravila, ki lahko povzročijo depresijo osrednjega živčevja, je potrebna previdnost.
Fatal outcomes have been reported for acute overdoses as low as 450 mg but survival has also been reported following acute overdose of approximately 2 g of oral olanzapine.
Poročali so o smrtnih izidih po akutnih prevelikih odmerjanjih tako majhnih odmerkov, kot je 450 mg, vendar so poročali tudi o preživetju po akutnem prevelikem odmerjanju z odmerkom približno 2 g peroralnega olanzapina.
If this has happened to you, tell your doctor.
Če se vam je zgodilo kaj takega, povejte svojemu zdravniku).
Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
O povečanih plazemskih koncentracijah prolaktina so poročali pri 47,4 % mladostnikov.
When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the starting dose.
Če je prisoten več kot en dejavnik, ki bi lahko prispeval k počasnejši presnovi (ženski spol, starostnik, nekadilec), pretehtajte, ali je treba zmanjšati začetni odmerek.
Olanzapine can be given without regards for meals as absorption is not affected by food.
Bolniki lahko jemljejo olanzapin ne glede na obroke, ker hrana ne vpliva na absorpcijo.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with olanzapine.
Bolnicam je treba svetovati, naj obvestijo svojega zdravnika, če med zdravljenjem z olanzapinom zanosijo ali če nameravajo zanositi.
Induction of CYP1A2
Zaviranje CYP1A2
Dementia-related psychosis and/or behavioural disturbances Olanzapine is not recommended for use in patients with dementia-related psychosis and/or behavioural disturbances because of an increase in mortality and the risk of cerebrovascular accident.
Psihoza, povezana z demenco, in/ali vedenjske motnje Olanzapin ni priporočljiv za uporabo pri bolnikih s psihozo, povezano z demenco, in/ali vedenjskimi motnjami zaradi povečane umrljivosti in tveganja za možganskožilne dogodke.
Równoległa 5, 02-235 Warszawa, Poland TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Równoległa 5, 02-235 Warszawa, Poljska TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Nemčija
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Demographic differences between the adolescents and adults include a lower average body weight and fewer adolescents were smokers.
Pri mladostnikih je bila povprečna telesna masa manjša, manj mladostnikov je bilo kadilcev.
The plasma clearance of olanzapine is lower in elderly versus young subjects, in females versus males, and in non-smokers versus smokers.
Plazemski očistek olanzapina je bil manjši pri starejših v primerjavi z mlajšimi, pri ženskah v primerjavi z moškimi in pri nekadilcih v primerjavi s kadilci.