natgillin/translations-raw huggingface dataset:
The 1 mg blister is printed with green ink and has one raised dot on the protruding end of each od
za Izbokline lahko otipate, tudi ko je pretisni omot že vstavljen, in se tako prepričate, da ste uporabili pravilni odmerek.
The 3 mg blister is printed with blue ink and has pr
a nj Potisnite insulinski pretisni omot do konca v režo za pretisni omot.
three raised dots on the protruding end of each blister. al
lje
The ra ised dots can be felt even when the blister in
vo do ā ve
is already inserted for reassurance that the correct dose is used. ic ed
Pripravite se na jemanje odmerka Prepričajte se, da je ustnik zaprt. a m ni lo vi ra Zd
M
Povlecite modro ročico navzven, kolikor daleč gre.
67 3.
67 Stisnite ročico, da se bo s tleskom zaprla.
Getting ready to take your dose Make sure that the mouthpiece is clos ed.
Vdihnite odmerek insulina V hitrem zaporedju storite naslednje korake.
ed ris ho ut ra Pull out the blue ha ndle as far as it will go.
a Primite insulinski inhalator in ga držite navpično,
n ge lo Squeeze the handle until it snaps shut. o tn uc od
Pritisnite modri gumb, da klikne, in glejte, ali se v komori lje pojavi insulinski oblaček. vo do ā ve
Stand or sit up straight. pr
Ko se pojavi oblaček, nemudoma zasukajte a
Breathe out normally. al in ic ed M
ustnik, ki naj bo sedaj obrnjen proti vam. m ni lo vi ra Zd
Inhale your insulin dose Perform the following steps in immediate sequence.
68 Hitro vtaknite ustnik v usta in našobite ustnice okrog njega, da insulin ne bo uhajal med ustnicami in ustnikom.
ed ris ho ut After the cloud appears, immediately turn the
Ne zamašite odprtine ustnika z jezikom ali zobmi.
ra mouthpiece around.
Ne pihajte v ustnik.
The mouthpiece should now be facing towards you.
Počasi in globoko vdihnite insulinski oblaček skozi usta v enem samem vdihu.
mouthpiece so the insulin will not leak out. od
et Ne pihajte v ustnik.
Take the mouthpiece out of your mouth. ed
om Vzemite ustnik iz ust.
Close your mouth and hold your breath for 5 M
pr Zaprite usta in za 5 sekund zadržite sapo.
Breathe out normally.
za Normalno izdihnite.
69 5.
a nj lje 5.
After your dose Turn the mouthpiece back to its clos ed position.
Po odmerku Zasukajte ustnik nazaj v zaprti položaj. vo do ā ve a
ed ris Press the grey button and pull out the insulin blister.
Pritisnite sivi gumb in izvlecite insulinski pretisni m
ho If you need another blister(s) as part of your
omot. ni
ut dose, repeat steps 2, 3 and 4.
Če vaš odmerek sestavlja več pretisnih omotov, ponovite korake 2, 3 in 4. lo vi ra
After your dosing is completed Squeeze the two chamber release buttons at the same time on the side of the base.
69 KAKO SKRBITE ZA INSULINSKI INHALATOR Pomembno je, da se ravnate po teh navodilih, tako da bo insulinski inhalator vedno čist in bo pravilno deloval.
Push the base n ge lo back into the chamber to store. o tn uc
Prepričajte se, da je beseda “ EXUBERA ” na vrhu obrnjena
HOW TO TAKE CARE OF YOUR INSULIN od
et proti vam.
INHALER It is important to follow these steps so that your pr
om pr za a nj Vtaknite kazalec v črni obroč na spodnjem delulje inhalatorja in ga povlecite, s čimer boste potegnili podnožje iz komore. vo do ā ve
insulin inhaler stays clean and works properly.
Z eno roko stisnite oba gumba za sprostitev a
Be sure al
komore, ki sta ob straneh spodnjega dela inhalatorja, in hkrati z drugo roko povlecite m
that the word “EXUBERA” at the top faces you. in ic ed M
podnožje povsem ven iz komore. ni lo vi ra Zd
70 Hold the black ring at the bottom of the base and use it to pull the base out of the chamber.
70 Čiščenje Komora in ustnik – enkrat na teden
ed With one hand, squeeze the two chamber release
et om pr Kako Razstavite insulinski inhalator.
ris Buttons at the same time on the side of the base while pulling the base all the way out of the chamber with the other hand.
za Zasukajte ustnik v odprti položaj.
ho ut ra n ge lo
Glejte sliko.
Cleaning o
a nj lje vo Ovlažite suho mehko krpo z blagim tekočim detergentom in z njo od zunaj in od znotraj do
Chamber and mouthpiece – once a week tn uc od pr al in
Komoro in ustnik temeljito splaknite s toplo ā
How ic
vodo. ve
Take your insulin inhaler apart. ed
Pustite komoro in ustnik, da se posušita na zraku.
Turn the mouthpiece to the open position.
Prepričajte se, da ni več vodnih kapljic, nato ustnik zaprite.
M
Komoro potisnite nazaj na a
Allow to air dry.
podnožje. m
ed For instructions on how to attach the chamber to the base refer to the section “Put your insulin inhaler together”.
Za navodila, kako sestaviti komoro s podnožjem, glejte poglavje “ Sestavite insulinski inhalator ”. ni
ris If the washed chamber is not dry prior to taking your next dose, use your spare chamber.
Če se oprana komora do takrat, ko morate vzeti naslednji odmerek, ne posuši, uporabite rezervno komoro. lo
ho Base - once a week
Podnožje - enkrat na teden vi ra Zd
Do not put the base in water. tn
71 Kako Podnožja ne smete potopiti v vodo.
Do not get the inside of the IRU wet. uc
Notranjosti nastavka za sproščanje insulina ne smete zmočiti.
Do not use soap or any other cleanser. od
Ne uporabljajte detergenta ali kakšnega drugega čistila.
Dampen a clean soft cloth with water. pr
et Ovlažite čisto mehko krpo z vodo.
While cleaning the top of the base be careful not to get any water into the IRU.
om Pri čiščenju zgornjega dela podnožja pazite, da v nastavek za sproščanje insulina ne bo prišla voda.
Do not take the IRU out at this time.
pr Nastavka za sproščanje insulina ne jemljite ven.
Keep the blue handle al
Modra ročica naj ostane zaprta.
Wipe only the TOP and OUTSIDE surfaces of ic
za Obrišite samo ZGORNJO in ZUNANJE površine podnožja.
Do not wipe the blister slot ed M
a Sestavite insulinski inhalator
72 Put your insulin inhaler together Line the top of the base with the open end of the chamber.
nj Poravnajte vrh podnožja z odprtim koncem komore.
The blue dot on the bottom of the chamber must be on the same side as the blue button.
Modra pika na dnu komore mora biti nalje isti strani kot modri gumb.
Squeeze the two chamber release buttons at the same time on the side of the base.
Hkrati stisnite oba gumba za sproščanje komore, vo ki sta ob straneh podnožja.
Push the base back into the chamber to store.
Potisnite podnožje nazaj v komoro in inhalator shranite. do ā ve a
ed ris ho Store your insulin inhaler in a dry place at room
Insulinski inhalator shranjujte na suhem pri sobni m
ut temperature.
temperaturi.
REPLACING YOUR INSULIN RELEASE
ZAMENJAVA NASTAVKA ZA ni
ra UNIT (IRU) Change the IRU
SPROŠČANJE INSULINA (Insulin release unit - IRU) lo
Every 2 weeks You should avoid taking EXUBERA in moist c onditions e.g. a bathroom following a steamy n ge lo shower as this will usually give you a lower insulin dose than you need (see package leaflet o
Zamenjajte nastavek za sproščanje insulina vi
on the blisters for advice). tn
na 2 tedna Zdravila EXUBERA ne smete uporabljati v ra
In this case you uc
vlažnem okolju, npr. v kopalnici po prhi, ki povzroči veliko pare, saj boste zaradi tega v telo Zd
must change the IRU prior to you next inhalation. od
V tem primeru morate pred naslednjo inhalacijo nastavek za sproščanje insulina (Insulin release unit - IRU) zamenjati.
How Take out the used IRU While the chamber is removed from the base pr
Zasukajte rabljeni nastavek za sproščanje insulina za približno četrt obrata v
(see “Take your insulin inhaler apart”), hold the base in your hand with the grey button facing al
et smeri, nasprotni od smeri urnega kazalca, proti simbolu odklepanja.
Turn the used IRU about a one-quarter turn counter clockwise towards the unlock symbol. in ic ed M
om pr Povlecite rabljeni nastavek za sproščanje insulina navzgor in ven iz podnožja ter ga zavrzite.
73 Pull the used IRU up and out of the base and discard.
za Varno zavrzite rabljeni nastavek za sproščanje insulina v skladu s predpisi ali povprašajte svojega zdravnika ali medicinsko sestro.
Dispose of the us ed IRU safely according to local requirements or check with your healthcare professional.
a nj lje vo Vložite novi nastavek za sproščanje insulina do
ed Put in a new IRU
Odvijte nastavek za sproščanje insulina iz ovojnine. ā
ris Remove the IRU from its packaging.
Na ve
ho Hold the new IRU so the top is facing you.
Z eno roko držite nastavek za sproščanje insulina in zasukajte vrh v smeri, nasprotni od smeri urnega kazalca, kolikor a
You will see a blue line on it.
daleč gre. m
While holding the IRU
Poravnajte modro črto na vrhu nastavka za ni
ut with one hand, turn the top counter-clockwise as far as it will go.
sproščanje insulina s simbolom odklepanja na vrhu podnožja. lo
ra Line up the blue line on the top of the IRU with the unlock symbol on the top of the base. n ge lo Push the IRU gently into the base.
Nežno potisnite nastavek za sproščanje insulina v vi
(If the new IRU o
(Če novi nastavek ra
does not drop into place or fits tightly, remove tn
za sproščanje insulina ne zdrsne na mesto ali če se preveč tesno prilega, ga izvlecite in poskusite Zd
and try again). uc
znova).
Turn the top of the IRU clockwise until the blue od
Sedaj je novi nastavek za sproščanje insulina pravilno nameščen na svojem mestu.
The new IRU is now locked in place. pr al in ic ed M
et om pr za a nj lje vo do ā ve a m ni lo vi ra Zd
Ref.
London, 25. september 2008 Sklic na dok.
EMEA/ 477488/ 2008
EMEA/ 548389/ 2008
On 9 September 2008, Pfizer Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for EXULETT, for the treatment of complicated skin and soft tissue infections in adults when known or suspected to be caused by susceptible Gram-positive bacteria.
Družba Pfizer Limited je dne 9. septembra 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom EXULETT, namenjenim zdravljenju zapletenih kožnih okužb in okužb mehkih tkiv pri odraslih, kjer je znano ali obstaja sum, da jih povzročajo občutljive Gram pozitivne bakterije.
EXULETT was to be used to treat adults with complicated infections of the skin and the ‘ soft tissues’ below the skin. ‘ Complicated’ means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Zapletene okužbe so takšne okužbe, ki jih je težko zdraviti, ker so razširjene v tkiva globoko pod kožo, ker je morda potrebna operacija ali ker ima bolnik še druga stanja, ki utegnejo vplivati na zdravljenje.
EXULETT was to be used only when the infection was known or thought to be caused by types of bacteria that are classified as ‘ Gram-positive’ and that would be killed by the medicine.
Zdravilo EXULETT naj bi se uporabljalo samo, kadar je znano ali domnevano, da so okužbo povzročile bakterije, znane kot Gram pozitivne bakterije, ki bi jih zdravilo ubilo.
These bacteria include Staphylococcus aureus (including ‘ methicillin-resistant’ forms known as ‘ MRSA’) and Streptococcus pyogenes.
Med temi bakterijami sta tudi Staphylococcus aureus (vključno z obliko, odporno na meticilin, znano kot „ MRSA “) in Streptococcus pyogenes.
The active substance in EXULETT, dalbavancin, is an antibiotic that belongs to the group ‘ glycopeptides’.
Zdravilna učinkovina zdravila EXULETT, dalbavancin, je antibiotik, ki spada v skupino glikopeptidov.
Based on the review of the data and the company’ s response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that EXULETT could not have been approved for the treatment of complicated skin and soft tissue infections in adults when known or suspected to be caused by susceptible Gram-positive bacteria.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila EXULETT ni mogoče odobriti za zdravljenje zapletenih okužb kože ali okužb mehkih tkiv pri odraslih, kjer je znano ali obstaja sum, da jih povzročajo občutljive Gram pozitivne bakterije.
Therefore, at the time of the withdrawal, the CHMP’ s view was that a benefit of EXULETT had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
CHMP je zato v času umika menil, da koristi zdravila EXULETT niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH BODO MORALE IZVAJATI DRŽAVE ČLANICE
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH BODO MORALE IZVAJATI DRŽAVE ČLANICE
The programme materials shall be provided via the following means: • Web-based • On CD • Printed on paper
Izobraževalni programi bodo dostopni: • na medmrežju • na zgoščenki (CD- ROM) • v papirni obliki
The programme shall convey the following key messages: • FABLYN increases risk of venous thromboembolism (VTE). • The approaches recommended for mitigation of risk of venous thromboembolism based on the SmPC, including contraindication of FABLYN in patients with active or past history of VTE. • FABLYN causes morphologic changes, particularly the cystic atrophy of endometrium.
Izobraževalni program mora vsebovati naslednja ključna sporočila: • Zdravilo FABLYN poveča tveganje za pojav venskih trombemboličnih dogodkov (VTE - venous thromboembolism). • Priporočeni pristopi zmanjšanja tveganja za pojava venskih trombemboličnih dogodkov temeljijo na SmPC, vključno s kontraindikacijo zdravila FABLYN pri bolnicah z aktivno vensko trombembolično boleznijo ali boleznijo v anamnezi. • Zdravilo FABLYN povzroča morfološke spremembe, še posebno cistično atrofijo endometrija.
It results in increased mean endometrial thickness. • Based on the clinical trials, the morphologic changes caused by FABLYN are benign and do not require further investigation unless vaginal bleeding occurs. • References to authoritative international guidelines relevant for uterine surveillance. • The need to stop treatment with FABLYN and investigate when unexplained uterine bleeding occurs.
Posledica je povečana povprečna debelina endometrija. • Na osnovi kliničnih preskušanj so morfološke spremembe, ki jih povzroči zdravilo FABLYN, benigne in ne zahtevajo nadaljnjih preiskav, razen pri pojavu krvavitev iz nožnice. • Navedba verodostojnih mednarodnih smernic, ki se nanašajo na spremljanje stanja maternice, kot reference. • Potreba po prekinitvi zdravljenja z zdravilom FABLYN in raziskavi vzrokov za pojav nepojasnjene krvavitve iz maternice.
It is available as triangular, peach-coloured tablets (500 micrograms).
Na voljo je v trikotnih tabletah breskove barve (500 mikrogramov).
Fablyn is used for the treatment of osteoporosis (a disease that makes bones fragile) in postmenopausal women (women who have been through the menopause).
Zdravilo Fablyn se uporablja za zdravljenje in preprečevanje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi.
When deciding whether to prescribe Fablyn or other treatments, doctors should consider whether the patient has any symptoms of the menopause, and the possible effects of treatment on the womb, the breast, and the heart and blood vessels.
Zdravnik mora, preden predpiše zdravilo Fablyn ali druga zdravljanja, ugotoviti prisotnost kakršnih koli znakov menopavze pri bolnici ter presoditi morebitne učinke zdravljenja na maternico, prsi, srce in krvne žile.
It can be taken at any time of day, with or without food or drink.
Vzame se lahko kadar koli podnevi, s hrano ali pijačo oziroma brez njih.
Patients may also receive calcium and vitamin D supplements if they do not get enough from their diet.
Bolnice lahko po potrebi jemljejo tudi dodatek kalcija in vitamina D, če ju ne dobivajo dovolj s prehrano.
Fablyn should be used with caution in women with severe liver or kidney problems.
Zdravilo Fablyn je treba pri bolnicah z resnimi obolenji jeter ali ledvic uporabljati previdno.
Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Osteoporoza nastane, ko rast nove kostne mase ni več zadostna, da bi nadomestila njeno naravno razgradnjo.
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture.
Ta upočasni razgradnjo kosti, zato se kosti ne zlomijo tako hitro.
Lasofoxifene acts as an ‘ agonist ’ of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body.
Lasofoksifen deluje kot agonist receptorjev estrogena (snov, ki stimulira receptorje za estrogen) v nekaterih telesnih tkivih.
Two doses of Fablyn (250 and 500 micrograms once a day) have been compared with placebo (a dummy treatment) in one main study involving almost 9,000 postmenopausal women with osteoporosis aged 60 to 80 years.
V eni glavni študiji, v katero je bilo vključenih skoraj 9 000 žensk po obdobju menopavze, starih od 60 do 80 let, so primerjali dva odmerka zdravila Fablyn (250 in 500 mikrogramov enkrat dnevno) s placebom (zdravilom brez zdravilne učinkovine).
The study also looked at existing spine fractures that got worse, new fractures in other parts of the body and the density of bones throughout the body.
Študija je proučevala tudi obstoječe zlome hrbtenice, katerih stanje se je poslabšalo, nove zlome v drugih delih telesa in gostoto kosti v celem telesu.
Over five years, 6% of the women taking Fablyn 500 micrograms had a new spine fracture (155 out of 2,748), compared with 9% of those taking placebo (255 out of 2,744).
V petih letih je 6% žensk, ki so jemale zdravilo Fablyn 500 mikrogramov imelo nove zlome hrbtenice (155 od 2 748), v primerjavi z 9% tistih, ki so jemale placebo (255 od 2 744).
Also, results with the 250-microgram dose were pointing to 500 micrograms being more effective.
Izidi z 250- mikrogramskim odmerkom so prav tako pokazali, da je 500- mikrogramski odmerek učinkovitejši.
Fablyn did not reduce the number of hip fractures to a level that would be relevant for patients.
Zdravilo Fablyn ni zmanjšalo število zlomov kolka v tolikšni meri, da bi bilo to za bolnice pomembno.
The most common side effect with Fablyn (seen in more than 1 patient in 10) is muscle cramps.
Najpogostejši neželeni učinek pri jemanju zdravila Fablyn (opažen pri več kot 1 bolnici od 10) so mišični krči.
Fablyn should not be used in people who may be hypersensitive (allergic) to lasofoxifene or any of the other ingredients.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Fablyn, glejte navodilo za uporabo. Zdravila Fablyn ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) lasofoksifen ali katere koli druge sestavine zdravila.
It must not be used in patients who have had problems with venous thromboembolism including deep vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal vein thrombosis (a blood clot at the back of the eye).
Ne sme se uporabljati pri bolnicah, ki so imeli težave zaradi venske tromboembolije vključno z globoko vensko trombozo (DTV), pljučno embolijo (krvnim strdkom v pljučih) in trombozo retinalne vene (krvni strdek v zadnjem delu očesa).
Fablyn is only for use in women who have been through the menopause, so it must not be used in women who could become pregnant, or women who are pregnant or breast-feeding.
Zdravilo Fablyn smejo uporabljati le ženske po menopavzi, zato ga ne smejo uporabljati ženske, ki bi lahko zanosile, nosečnice ali ženske, ki dojijo.
The Committee for Medicinal Products for Human Use (CHMP) decided that Fablyn’ s benefits are greater than its risks for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Fablyn pri zdravljenju osteoporoze pri ženskah v obdobju po menopavzi, pri katerih obstaja visoko tveganje za zlom kosti, večje od z njim povezanih tveganj.
The Committee recommended that Fablyn be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Fablyn odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of Fablyn?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Fablyn?
The company that makes Fablyn will make sure that an educational programme is available in all Member States for all healthcare workers who will prescribe Fablyn or order pelvic ultrasound scans for women taking the medicine.
Družba, ki izdeluje zdravilo Fablyn, bo zagotovilo, da bo izobraževalni program na voljo v vseh državah članicah za vse zdravstvene delavce, ki bodo predpisovali zdravilo Fablyn ali napotili ženske, ki jemljejo zdravilo na ultrazvočno slikanje medenice.
The programme will include information about the risk of venous thromboembolism, changes in the womb that may occur when taking the medicine, and the need to investigate unexplained bleeding from the womb.
Program bo vključeval podatke o tveganju nastanka venske tromboembolije, spremembah v maternici, ki se lahko pojavijo pri jemanju zdravila in potrebi po preiskavi nepojasnjenega krvavenja iz maternice.
Other information about Fablyn:
Druge informacije o zdravilu Fablyn:
The European Commission granted a marketing authorisation valid throughout the European Union for Fablyn to Pfizer Limited on 24 February 2009.
Evropska komisija je dovoljenje za promet z zdravilom Fablyn, veljavno po vsej Evropski uniji, odobrila družbi Pfizer Limited dne 24. februarja 2009.
The full EPAR for Fablyn can be found here.
Celotno javno poročilo o oceni zdravila (EPAR) za zdravilo Fablyn je na voljo tukaj.
Route of EU number
Številka EU
Blister (PV/ PVC/ alu) Blister (PV/ PVC/ alu) Blister (PV/ PVC/ alu) Bottle (HDPE)
Pretisni omot (PV/ PVC/ alu) Pretisni omot (PV/ PVC/ alu) Pretisni omot (PV/ PVC/ alu) Pretisni omot (HDPE)
7 tablets 28 tablets 30 tablets 90 tablets
7 tablet 28 tablet 30 tablet 90 tablet
Each film-coated tablet contains 71.34 mg lactose.
Ena filmsko obložena tableta vsebuje 71, 34 mg laktoze.
Triangular, peach-coloured, film-coated tablets debossed with “ Pfizer” on one side and “ OPR 05” on the other side.
Trikotne, filmsko obložene tablete breskove barve z vtisnjenim napisom “ Pfizer ” na eni strani in “ OPR 05 ” na drugi strani.
A significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated (see section 5.1).
Dokazali so, da zdravilo signifikantno zmanjša pogostnost vretenčnih zlomov in drugih zlomov kosti, ne pa zlomov kolka (glejte poglavje 5. 1).
When determining the choice of FABLYN or other therapies, including estrogens, for a postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Ko se pri ženski v postmenopavzi odločamo med zdravilom FABLYN in drugimi zdravili, vključno z estrogeni, moramo upoštevati simptome menopavze, vpliv na maternično tkivo in tkivo dojk ter tveganja in koristi za srčnožilni sistem (glejte poglavje 5. 1).
Supplemental calcium and/ or vitamin D should be added to the diet if daily intake is inadequate.
Če je dnevni vnos kalcija in/ ali vitamina D nezadosten, ju bo treba dodajati prehrani.
Postmenopausal women require an average of 1,500 mg/ day of elemental calcium.
Ženske v postmenopavzi potrebujejo povprečno po 1. 500 mg elementarnega kalcija na dan.
The recommended intake of vitamin D is 400-800 IU daily.
Priporočeni vnos vitamina D je 400- 800 i. e. na dan.
Therefore safety and efficacy have not been studied (see section 5.2).
Zato študije varnosti in učinkovitosti niso izvedli (glejte poglavje 5. 2).
2 Elderly women (65 years and older):
2 Starejše ženske (65 let in starejše):
No dose adjustment is necessary in elderly female patients (see section 5.2).
Pri starejših bolnicah prilagajanje odmerka ni potrebno (glejte poglavje 5. 2).