natgillin/translations-raw huggingface dataset:
Date of first authorisation: 14/06/2012 Date of last renewal: 29/03/2017
Datum pridobitve dovoljenja za promet: 14. 06. 2012 Datum zadnjega podaljšanja dovoljenja za promet: 29. 03. 2017
The active substances being a principle of biological origin intended to produce passive immunity are not within the scope of Regulation (EC) No 470/2009.
Učinkovine biološkega izvora, namenjene vzbujanju pasivne imunosti, niso vključena v Uredbo (ES) št. 470/2009.
Reduced activity and lack of appetite on the day of vaccination commonly occurred and/or a sometimes painful and hard swelling up to 10 cm diameter for up to 25 days were very commonly observed at the site of injection.
Zmanjšana aktivnost in pomanjkanje apetita sta se pogosto pojavila na dan cepljenja in/ali včasih trde in boleče otekline s premerom do 10 cm, ki so trajale do 25 dni, so bile zelo pogosto opažene na mestu injiciranja.
Pharmacotherapeutic group: Immunologicals for Suidae, inactivated bacterial vaccine.
Farmakoterapevtska skupina: imunološka zdravila za suidae, inaktivirano bakterijsko cepivo.
2 International units of beta antitoxin according to Ph. Eur.
2 Internacionalne enote beta antitoksina po Ph. Eur.
Administer 1 dose (2 ml) of vaccine per animal in the neck in the area behind the ear.
Dajte 1 odmerek (2 ml) cepiva na žival v vrat v predel za ušesom.
In post marketing experience: Hypersensitivity reactions may occur in very rare cases.
Preobčutljivostne reakcije se lahko pojavijo v zelo redkih primerih.
No adverse reactions other than those mentioned in section 4.6 have been observed.
Zasledili niso nikakršnih neželenih učinkov, ki bi se razlikovali od tistih, ki so našteti v poglavju 4.6.
An increase in body temperature up to 2°C was very commonly observed on the day of vaccination.
Prehodno povišanje telesne temperature za približno 2 ºC je bilo zelo pogosto opaženo na dan cepljenja.
Before use allow the vaccine to reach room temperature.
Pred uporabo naj se cepivo ogreje na sobno temperaturo.
Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Tega zdravila za uporabo v veterinarski medicini ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki.
The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
SPC so dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem cepivu za uporabo v veterinarski medicini, niso vključene v Uredbo (ES) št.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali v teku enega zdravljenja) - pogosti (pojavijo se pri več kot 1 živali toda manj kot pri 10 živalih od 100 živali) - občasni (pojavijo se pri več kot 1 živali toda manj kot pri 10 živalih od 1000 živali) - redki (pojavijo se pri več kot 1 živali toda manj kot pri 10 živalih od 10.000 živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere)
Protection of piglets is achieved by colostrum intake.
Zaščita pujskov je dosežena z zaužitjem kolostruma.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years Shelf life after first opening the vial: 10 hours
Rok uporabnosti zdravila za uporabo v veterinarski medicini v pakiranju za prodajo: 2 leti Rok uporabnosti po prvem odpiranju viale: 10 ur
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO ''SAMO ZA ŽIVALI'' IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je smiselno
Each dose of 2 ml contains:
V odmerku po 2 ml:
Revaccination: A single revaccination is carried out 2 to 4 weeks before the expected date of farrowing.
Revakcinacija: En odmerek 2 do 4 tedne pred pričakovano prasitvijo.
Vaccination results in an antibody response with neutralizing activity against LT toxin.
Cepljenja sproži nastanek protiteles, ki nevtralizirajo LT toksin.
Pigs (sows and gilts)
Prašiči (svinje in mladice)
100, 200 and 250 ml
100, 200 in 250 ml
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
≥ 20 IU
≥ 20 IE
≥20 IU2
≥20 IE2
EU/2/12/141/004 EU/2/12/141/005 EU/2/12/141/006 EU/2/12/141/007 EU/2/12/141/008 EU/2/12/141/009
EU/2/12/141/005 EU/2/12/141/006 EU/2/12/141/007 EU/2/12/141/008 EU/2/12/141/009
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Zato se za uporabo tega cepiva pred uporabo katerega koli drugega zdravila ali po njem odločamo od primera od primera.
Shelf life after first opening the container: 10 hours.
Rok uporabnosti po prvem odpiranju vsebnika: 10 ur
1 Mean antibody titre (Ab) obtained after vaccination of mice with a 1/20 or 1/40 sow dose
1 Srednji titer protiteles po cepljenju miši z 1/20 ali 1/40 odmerka za svinje.
A slight redness and/or roughness may transiently occur after a double dose vaccination.
Po dvojnem odmerku cepiva se lahko prehodno pojavi rahla rdečina in/ali hrapavost.
EXP {month/year} Once broached, use within 10 hours.
Načeto vialo porabite v 10 urah.
Walton Manor, Walton, Milton Keynes
Walton Manor, Walton, Milton Keynes Buckinghamshire, MK7 7AJ, Združeno kraljestvo
Pig pictogram
Piktogram prašiča
LT toxoid
LT toksoid
Shake vigorously before use and at intervals during use.
Pred uporabo in v razmakih med uporabo dobro pretresite.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
BESEDILO ''SAMO ZA ŽIVALI'' Samo za živali
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ni podatkov o varnosti in učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
150 mg For the full list of excipients, see section 6.1
Za celoten seznam pomožnih snovi glejte poglavje 6.1
Sodium chloride Potassium chloride Disodium hydrogen phosphate Potassium dihydrogenphosphate Simethicone
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid kalijev klorid dinatrijev hidrogenfosfat kalijev dihidrogenfosfat Simetikon
Porcilis ColiClos suspension for injection for pigs
Porcilis ColiClos suspenzija za injiciranje za prašiče
E.coli: fimbrial adhesins, LT toxoid C. perfringens toxoid
E.coli: fimbrijski adhezini, LT toksoid C. perfringens: toksoid
C. perfringens type C toxoid
C. perfringens: toksoid tip C
Porcilis ColiClos suspension for injection
Porcilis ColiClos suspenzija za injiciranje
- LT toxoid
- toksoid LT
20 ml (10 doses) 50 ml (25 doses)
20 ml (10 odmerkov) 50 ml (25 odmerkov)
For the passive immunisation of progeny by active immunisation of sows and gilts to reduce mortality and clinical signs during the first days of life, caused by those E. coli strains, which express the adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P) and caused by C. perfringens type C.
S tem se zmanjša smrtnost in klinični znaki v prvih dnevih po rojstvu, ki jo povzročajo sevi E.coli, ki izločajo fimbrijske adhezine F4ab (K88ab), F4ac (K88ac), F5 (K99) ali F6 (987P) in ki jih povzroča tip C C. perfringens.
Name and address of the manufacturers responsible for batch release
Ime in naslov izdelovalca, odgovornega za sprostitev serije
Clostridium perfringens component: - Type C (strain 578) beta toxoid
Komponenta C. perfringens: - beta toksoid tip C (sev 578)
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
BESEDILO ''ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM''
dl-α-tocopheryl acetate
dl-α-tokoferilacetat
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki daje zdravilo živalim V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali nalepko na zunanji ovojnini.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
POSEBNI PREVIDNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
Primary vaccination: Sows/gilts which have not yet been vaccinated with the product are given a primary injection 6 to 8 weeks before the expected date of farrowing and a second injection 4 weeks later.
Shema cepljenja: Prvo cepljenje: Svinjam oz. mladicam, ki še niso bile cepljene, se prvi odmerek cepiva da 6 do 8
100 ml (50 doses) 200 ml (100 doses) 250 ml (125 doses)
100 ml (50 odmerkov) 200 ml (100 odmerkov) 250 ml (125 odmerkov)
20 ml (10 doses) 50 ml (25 doses) 100 ml (50 doses) 200 ml (100 doses) 250 ml (125 doses)
20 ml (10 odmerkov) 50 ml (25 odmerkov) 100 ml (50 odmerkov) 200 ml (100 odmerkov) 250 ml (125 odmerkov)
Lot
Brejost
Escherichia coli components: - F4ab fimbrial adhesin
Komponente E. coli: - fimbrijski adhezin F4ab
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROSTITEV SERIJE
Per dose of 2 ml: E. coli: F4ab fimb.
V odmerku po 2 ml: E. coli: fimbrijski adhezin F4ab fimbrijski adhezin F4ac fimbrijski adhezin F5
Adjuvant: dl-α-tocopheryl acetate
Dodatek dl-α-tokoferilacetat
Marketing authorisation holder:
V postmarketinškh izkušnjah:
Cardboard box with a vial of 20, 50, 100, 200 or 250 ml
Kartonska škatla z vialo po 20, 50, 100, 200 ali 250 ml
- F5 fimbrial adhesin
- fimbrijski adhezin F5
4.8 Interaction with other medicinal products and other forms of interaction
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ni podatkov o varnosti in učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
Aqueous, white to nearly white suspension for injection.
Vodna, bela do skoraj bela suspenzija za injiciranje za prašiče Vsak odmerek po 2 ml vsebuje:
IM
C .
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX
PODATKI NA ZUNANJI OVOJNINI ¸ ŠKATLA
Immunological properties of the product: To stimulate active immunity in order to provide passive immunity to the progeny against enterotoxicosis caused by E. coli expressing fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99), F6 (987P) and against (necrotic) enteritis caused by C. perfringens type C.
Cepivo za spodbujanje aktivne imunosti svinj oz. mladic za razvoj pasivne imunosti potomcev proti enterotoksikozi, ki jo povzročijo sevi E. coli, ki izločajo fimbrijske adhezine F4ab (K88ab), F4ac
Cardboard box with a PET vial of 20, 50, 100, 200 or 250 ml.
Kartonska škaltla z vialo iz PET z 20, 50, 100, 200 ali 250 ml.
- F6 fimbrial adhesin
- fimbrijski adhezin F6
Cardboard box with a glass vial of 20, 50, 100 or 250 ml.
Velikosti pakiranj: Kartonska škatla s stekleno vialo z 20, 50, 100 ali 250 ml.
WITHDRAWAL PERIOD
DATUM IZTEKA ROKA UPORABNOSTI
To stimulate active immunity in order to provide passive immunity to the progeny against enterotoxicosis caused by E. coli expressing fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99), F6 (987P) and against (necrotic) enteritis caused by C. perfringens type C. Vaccination results in an antibody response with neutralizing activity against LT toxin.
(K88ac), F5 (K99), F6 (987P), in proti (nekrotičnemu) enteritisu, ki ga povzroča tip C C. perfringens.
- F4ac fimbrial adhesin
- fimbrijski adhezin F4ac
Name and address of the manufacturers of the biological active substances
Ime in naslov izdelovalcac biološke zdravilne učinkovine Intervet International B.V.
Polysorbate 80
Polisorbat 80 voda za injekcije
For animal treatment only.
Samo za živali -Rp-Vet.
Cardboard box with PET vial of 20 ml, 50 ml, 100 ml, 200 ml or 250 ml.
Kartonska škatla z vialo iz PET po 20 ml, 50 ml, 100 ml, 200 ml ali 250 ml Kartonska škatla z vialo iz stekla tipa I po 20 ml, 50 ml, 100 ml ali 250 ml Viale so zaprte z zamaškom iz halogenbutilne gume in zavarjene z aluminijasto zaporko.
Withdrawal period: Zero days
KARENCA Karenca: Nič dni
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE VIAL LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA STIČNIH OVOJNINAH
Date of first authorisation: 16 December 2014 Date of latest renewal:
Datum prve odobritve: 16. december 2014 Datum zadnjega podaljšanja:
This applies to the following medicines:
To velja za naslednja zdravila:
Regularly check your breasts.
Redno si pregledujte dojke.
This medicine is not for use in children and adolescents below 18 years old.
To zdravilo ni namenjeno za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
• if you have cancer.
• če imate raka.
Therapy should then be continued as before.
Nato mora zdravljenje nadaljevati enako kot prej.
See your doctor as soon as possible if you notice any changes, such as:
Čimprej obiščite zdravnika, če opazite kakršnekoli spremembe, kot so:
The occurrence of such a reaction is more likely in the first year of treatment.
Pojav take reakcije je verjetnejši v prvem letu zdravljenja.
The data from the largest randomised trial are summarised below:
Podatki iz največjega randomiziranega preskušanja so povzeti spodaj:
Treatment should not be restarted until the woman is completely mobilised.
Zdravljenja se ne sme začeti znova, dokler bolnica ni povsem mobilna.
Ask your doctor when you can start taking this medicine again.
Vprašajte zdravnika, kdaj lahko ponovno začnete jemati to zdravilo.
• if you are seriously overweight (BMI >30 kg/m
• če ste izrazito pretežki (ITM > 30 kg/m
You are advised to:
Svetujemo vam, da:
Do not take this medicine if you are pregnant, or if you think you might be pregnant.
Ne jemljite tega zdravila, če ste noseči ali mislite, da bi lahko bili noseči.
The extra risk depends on how long you take HRT.
To dodatno tveganje je odvisno od tega, koliko časa uporabljate HNZ.
Tell your doctor if you have any medical problems or illnesses.
Povejte zdravniku, če imate kakršnekoli zdravstvene težave ali bolezni.
In order for this medicine to work, it should be taken daily as prescribed.
Da bo zdravilo delovalo, ga morate jemati vsak dan, kot je predpisano.
There is no evidence that HRT will prevent a heart attack.
Ni dokazov, da bo HNZ preprečilo srčno kap.
The risk ratio is not constant but will increase with increasing duration on use.
Razmerje tveganja ni konstantno, ampak se veča z daljšanjem časa uporabe.
Once you have started this medicine you should see your doctor for regular check-ups (at least once a year).
Ko začnete uporabljati to zdravilo, morate obiskovati zdravnika zaradi rednih pregledov (vsaj enkrat na leto).
In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually, and treatment should only be continued as long as the benefit outweighs the risk.
V vsakem primeru je treba vsaj enkrat na leto natančno oceniti tveganja in koristi, zdravljenje pa se lahko nadaljuje le, če so koristi večje od tveganja.
Relief of menopausal symptoms was achieved during the first few weeks of treatment.
Lajšanje menopavzalnih simptomov so dosegli v prvih nekaj tednih zdravljenja.
Reasons for immediate withdrawal of therapy
Razlogi za takojšnjo prekinitev zdravljenja
• any lumps you can see or feel
• kakršnekoli zatrdline, ki jih lahko vidite ali začutite.
No overall differences in safety or efficacy were observed between women aged >65 years and younger women, but greater sensitivity of some older individuals cannot be ruled out.
Med ženskami, starimi > 65 let in mlajšimi, na splošno niso opazili razlik v varnosti ali učinkovitosti, vendar večje občutljivosti nekaterih starejših žensk ni mogoče izključiti.
• Painful red bumps on the skin
• boleče rdeče bule na koži;
If you notice any of the following:
Če opazite karkoli izmed spodaj navedenega:
Other things that can increase the risk of stroke include:
Drugi dejavniki, ki lahko zvečajo tveganje za možgansko kap, vključujejo:
Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary.
Zdravnik vam bo poskusil predpisati najmanjši odmerek za zdravljenje vašega simptoma, ki naj bi bilo čim krajše.
These findings are considered rat-specific and presumably not relevant in humans.
Te ugotovitve so specifične za podgane in domnevno niso pomembne za ljudi.
The experience treating women older than 65 years is limited.
Izkušnje z zdravljenjem žensk, starejših od 65 let, so omejene.
Free T4 and free T3 concentrations are unaltered.
Koncentraciji prostega T3 in T4 se ne spremenita.
The relative risk does not change with age or time since menopause.
Relativno tveganje se ne spremeni s starostjo ali časom od menopavze.
Call your doctor or pharmacist.
Pokličite zdravnika ali farmacevta.
Speak to your doctor for advice.
Za nasvet se posvetujte z zdravnikom.
• Difficulty wearing contact lenses
• težave pri nošenju kontaktnih leč.
• Discolouration of the skin on the face or other parts of the body
• obarvanje kože na obrazu ali drugih delih telesa;
DUAVIVE is used for:
Zdravilo DUAVIVE se uporablja za:
Women should be advised what changes in their breasts should be reported to their doctor or nurse (see ‘Breast cancer' below).
Ženskam je treba svetovati, o katerih spremembah na dojkah morajo poročati zdravniku ali medicinski sestri (glejte »Rak dojke« spodaj).
Serious venous thromboembolic events may occur rarely (less than 1 case per 1,000 patients).
Redko se lahko pojavijo resni venski trombembolični dogodki (manj kot 1 primer na 1.000 bolnic).
No foetal developmental anomalies were observed.
Razvojnih anomalij plodov niso opazili.
EU/1/14/960/001 28 tablets
EU/1/14/960/001 28 tablet
You can take the tablet at any time of the day, with or without food; however, it is advisable to take your tablet at the same time each day as this will help to remind you to take your medicine.
Tableto lahko vzamete kadarkoli v dnevu, s hrano ali brez nje, priporočamo pa, da jo vzamete vsak dan ob istem času, saj si boste tako lažje zapomnili, da jo morate vzeti.
This might lead to irregular bleeding.
To lahko privede do neobičajne krvavitve.
This may include an examination of your breasts and/or an internal examination, if necessary, or if you have any special concerns.
Morda se bo odločil opraviti telesni pregled, ki lahko vključuje pregled dojk in/ali notranji pregled, če je potreben, ali če imate kakršnekoli posebne skrbi.
• drinking too much alcohol
• pretirano pitje alkohola;
If you feel drowsy after taking this medicine, you should avoid driving or operating machines.
Če po jemanju tega zdravila občutite dremavost, se morate izogibati vožnji ali upravljanju strojev.
You will only be prescribed this medicine if your symptoms seriously hinder your daily life and your doctor determines that other types of HRT are not appropriate for you.
To zdravilo vam bodo predpisali samo, če vas simptomi resno ovirajo pri vsakdanjem življenju in če vaš zdravnik ugotovi, da druge oblike hormonskega nadomestnega zdravljenja (HNZ) za vas niso primerne.
• migraine-like headaches which happen for the first time
• glavobole, podobne migreni, ki se pojavijo prvič;
Investigations, including appropriate imaging tools, e.g., mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.
Preiskave, vključno s slikanjem z ustreznimi orodji (npr. mamografijo), je treba opraviti skladno s trenutno veljavno prakso za presejalne preglede, prilagojeno kliničnim potrebam posameznice.
• if you have systemic lupus erythematosus (SLE).
• če imate sistemski eritematozni lupus (SLE);
The use of DUAVIVE carries risks, which need to be considered when deciding whether to start taking it, or whether to carry on taking it.
Uporaba zdravila DUAVIVE vključuje tveganja, ki jih je treba upoštevati pri odločitvi, ali boste začeli jemati to zdravilo in ali boste jemanje nadaljevali.
CE/BZA was evaluated in 4,868 post-menopausal women who participated in 5 phase 3 trials.
Kombinacijo CE/BZA so ocenjevali pri 4.868 ženskah v postmenopavzi, ki so sodelovale v 5 preskušanjih 3. faze.
Stop taking DUAVIVE and see a doctor immediately
Prenehajte jemati zdravilo DUAVIVE in takoj obiščite zdravnika
If you forget to take a tablet, take it as soon as you remember.
Če pozabite vzeti tableto, jo vzemite takoj, ko se spomnite.
• if you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots
• če imate kakršnokoli težavo s strjevanjem krvi, ki zahteva dolgotrajno zdravljenje z zdravilom za preprečevanje krvnih strdkov;
• if you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, if you need to have surgery)
• če niste zmožni daljše hoje zaradi večjega kirurškega posega, poškodbe ali bolezni (glejte tudi poglavje 3 »Če vam bodo opravili kirurški poseg«);
Pfizer Ireland Pharmaceuticals, Little Connell, Newbridge, County Kildare, Ireland.
Proizvajalec Pfizer Ireland Pharmaceuticals, Little Connell Newbridge, County Kildare, Irska.
During these check-ups, discuss with your doctor the benefits and risks of continuing with DUAVIVE.
Pri teh pregledih se z zdravnikom posvetujte o koristih in tveganjih nadaljevanja jemanja zdravila DUAVIVE.
Some medicines may interfere with the effect of DUAVIVE.
Nekatera zdravila lahko vplivajo na učinek zdravila DUAVIVE.
• any of the conditions mentioned under ‘Do not take DUAVIVE'
• katerokoli bolezen, omenjeno v poglavju »Ne jemljite zdravila DUAVIVE«;
Food had little or no effect on the exposure of CE.
Hrana je imela majhen vpliv ali sploh ni imela vpliva na izpostavljenost CE.
The major route of excretion of radiolabeled BZA is the faeces, and less than 1% of the dose is eliminated in urine.
Glavna pot izločanja radioaktivno označenega BZA je blato, manj kot 1 % odmerka pa se izloči z urinom.
The concentrations of this glucuronide are approximately 10-fold higher than those of unchanged BZA in plasma.
Koncentracije tega glukuronida so približno 10-krat večje kot koncentracije nespremenjenega BZA v plazmi.
Longterm exposure to CE/BZA for up to 2 years was evaluated; 3,322 women were exposed to CE/BZA for at least 1 year, and 1,999 women were exposed for 2 years.
Ocenili so dolgotrajno izpostavljenost CE/BZA, ki je trajala do 2 leti; 3.322 žensk je bilo izpostavljenih kombinaciji CE/BZA najmanj 1 leto, 1.999 žensk pa je bilo izpostavljenih 2 leti.
During the menopause, the amount of the oestrogen produced by a woman's body drops.
Med menopavzo se količina estrogena, ki ga proizvaja telo, zmanjša.
The level of risk is dependent on duration of use (see section 4.4).
Stopnja tveganja je odvisna od trajanja uporabe (glejte poglavje 4.4).
If this happens, you should avoid driving or operating machines until your doctor tells you that it is safe to do so.
Če se to zgodi, se morate izogibati vožnji ali upravljanju strojev, dokler vam zdravnik ne pove, da je to varno.
Oestrogen therapy will not prevent memory loss.
Zdravljenje z estrogenom ne preprečuje izgube spomina.
- Porphyria.
- Porfirija.
It is not known whether bazedoxifene is excreted in human milk.
Ni znano, ali se bazedoksifen izloča v materino mleko.
Negligible (1%) amounts of BZA are eliminated in urine.
Z urinom se izloči zanemarljiva (1 %) količina BZA.
This medicinal product contains sorbitol which may affect the bioavailability of other concomitantly administered medicinal products.
To zdravilo vsebuje sorbitol, ki lahko vpliva na biološko uporabnost drugih sočasno uporabljenih zdravil.