natgillin/translations-raw huggingface dataset:
In humans, the apparent terminal volume of distribution is at least 90 l and the amount of dose reaching the bone is estimated to be 40 – 50% of the circulating dose.
Pri ljudeh znaša navidezni končni volumen porazdelitve najmanj 90 l, količina odmerka, ki doseže kosti, je ocenjena na 40 do 50% odmerka, ki je v krvnem obtoku.
Protein binding in human plasma is approximately 85% - 87% (determined in vitro at therapeutic ibandronic acid concentrations), and thus there is a low potential for interaction with other medicinal products due to displacement.
Vezava na plazemske beljakovine pri ljudeh je približno 85 - do 87 -% (določeno in vitro pri terapevtskih koncentracijah
Elimination Ibandronic acid is removed from the circulation via bone absorption (estimated to be 40 – 50% in postmenopausal women) and the remainder is eliminated unchanged by the kidney.
Izločanje Ibandronska kislina se odstrani iz obtoka s kostno absorpcijo (ocenjeno na 40 do 50% pri ženskah v postmenopavzi), ostanek pa se izloči skozi ledvice v nespremenjeni obliki.
Early plasma levels fall quickly, reaching 10% of the peak values within 3 and 8 hours after intravenous or oral administration, respectively.
Zgodnje plazemske koncentracije hitro padejo, 10% največje vrednosti dosežejo 3 ure po intravenskem dajanju in 8 ur po peroralnem dajanju.
24 Total clearance of ibandronic acid is low with average values in the range 84 - 160 ml/ min.
Skupni očistek ibandronske kisline je majhen, povprečna vrednost znaša od 84 do 160 ml/ min.
Renal clearance (about 60 ml/ min in healthy postmenopausal females) accounts for 50 – 60% of total clearance, and is related to creatinine clearance.
Ledvični očistek (okoli 60 ml/ min pri zdravih ženskah v postmenopavzi) znaša okoli 50 do 60% celotnega očistka in je povezan s kreatininskim očistkom.
Patients with renal impairment Renal clearance of ibandronic acid in patients with various degrees of renal impairment is linearly related to creatinine clearance (CLcr).
Bolniki z ledvično okvaro Renalni očistek ibandronske kisline pri bolnikih z različnimi stopnjami ledvične okvare je v linearni odvisnosti od kreatininskega očistka (CLcr).
No dose adjustment is necessary for patients with mild or moderate renal impairment (CLcr equal or above 30 ml/ min).
Za bolnike z blago ali zmerno ledvično okvaro (CLcr enak ali večji kot 30 ml/ min) prilagajanje odmerkov ni potrebno.
Subjects with severe renal impairment (CLcr less than 30 ml/ min) receiving daily oral administration of 10 mg ibandronic acid for 21 days, had 2 - 3 fold higher plasma concentrations than subjects with normal renal function and total clearance of ibandronic acid was 44 ml/ min.
Celokupni očistek ibandronske kisline je bil pri teh bolnikih 44 ml/ min.
After intravenous administration of 0.5 mg of ibandronic acid, total, renal, and non-renal clearances decreased by 67%, 77% and 50%, respectively, in subjects with severe renal failure, but there was no reduction in tolerability associated with the increase in exposure.
Zaradi povečane izpostavljenosti pa ni prišlo do zmanjšanja prenašanja zdravila.
The pharmacokinetics of ibandronic acid in patients with end-stage renal disease was only assessed in a small number of patients managed by haemodialysis, therefore, the pharmacokinetics of ibandronic acid in the patients not undergoing haemodialysis is unknown.
Farmakokinetika ibandronske kisline pri bolnikih, ki niso na hemodializi, ni poznana.
Elderly Population In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
26 Starejši bolniki Multivariantna analiza je pokazala, da starost za vse preizkušane farmakokinetične parametre ni neodvisen dejavnik.
Paediatric Population There are no data on the use of Bondenza in these age groups.
Pediatrični bolniki O uporabi Bondenze pri tej skupini bolnikov ni podatkov.
Toxic effects, e. g. signs of renal damage, were observed in dogs only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to clinical use.
Toksične učinke, na primer znake poškodbe ledvic, so opazili pri psih samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
25 Reproductive toxicity:
Vpliv na sposobnost razmnoževanja:
Specific studies for the 3-monthly dosing regimen have not been performed.
Specifičnih študij za 3- mesečno odmerjanje niso izvajali.
In studies with daily i. v. dosing regimen, there was no evidence for a direct foetal toxic or teratogenic effect of ibandronic acid in rats and rabbits.
V študijah z dnevnim intravenskim odmerjanjem pri podganah in kuncih, niso opazili neposrednih škodljivih vplivov na plod ali teratogenega delovanja ibandronske kisline.
Other adverse reactions to ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class.
Drugi neželeni učinki ibandronske kisline v študijah vplivov na sposobnost razmnoževanja pri podganah so bili pričakovano značilni za to skupino zdravil (bisfosfonati).
Sodium chloride Glacial acetic acid Sodium acetate trihydrate Water for injections
natrijev klorid koncentrirana ocetna kislina (ledocet) natrijev acetat trihidrat voda za injekcije
Bondenza solution for injection must not be mixed with calcium-containing solutions or other intravenously administered medicinal products.
Bondenze, raztopine za injiciranje, ne smemo mešati z raztopinami, ki vsebujejo kalcij, ali drugimi intravensko dajanimi zdravili.
Pre-filled syringes (5 ml) made of colourless type I glass, the grey rubber plunger stopper and tip cap are made of fluororesin-laminated butyl rubber, containing 3 ml of solution for injection.
6. 5 Vrsta ovojnine in vsebina
6.6 Special precautions for disposal
27 6. 6 Posebni varnostni ukrepi za odstranjevanje
Where the product is administered into an existing intravenous infusion line, the infusate should be restricted to either isotonic saline or 50 mg/ ml (5%) glucose solution.
Kadar se zdravilo daje v obstoječe intravenske infuzijske kanale, je infuzat lahko le izotonična raztopina natrijevega klorida ali 50 mg/ ml (5 -%) raztopina glukoze.
27 ANNEX II
28 DODATEK II
28 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Roche Pharma AG Emil- Barell- Strasse 1 D- 79639 Grenzach- Wyhlen Nemčija
Roche Diagnostics GmbH Sandhoferstrasse 116 D-68305 Mannheim Germany
Roche Diagnostics GmbH Sandhoferstrasse 116 D- 68305 Mannheim Nemčija
The MAH will continue to submit yearly PSURs, unless otherwise specified by the CHMP.
Imetnik dovoljenja za promet bo nadaljeval z oddajo letnih poročil o varnosti zdravila (PSUR), če ne bo odbor CHMP odločil drugače.
The MAH must ensure that the system of pharmacovigilance, as described in the document “ Description of the PharmacoVigilance system” submitted on 16 November 2005, and any subsequent updates, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, ki je opisan v dokumentu » Opis sistema farmakovigilance «, oddanem 16. novembra 2005, oziroma v kasnejših posodobitvah, vzpostavljen in da deluje pred začetkom trženja zdravila in toliko časa, kolikor bo zdravilo na trgu.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the Risk Management Plan (RMP) report No.
Imetnik dovoljenja za promet se zavezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v okviru načrta za obvladovanje tveganja (RMP, Risk Management Plan) (poročilo št.
1021880 submitted on 23 May 2006, and any subsequent updates of the RMP agreed by the CHMP.
1021880), oddanem 23. maja 2006 in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša odbor CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Po smernicah CHMP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini, mora biti posodobljen RMP predložen sočasno z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted:
30 Poleg tega je treba posodobljeni RMP predložiti:
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
ob prejemu nove informacije, ki lahko vpliva na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja;
29 • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
v 60 dneh po dosegu pomembnega mejnika (pri farmakovigilanci ali zmanjševanju tveganja);
• At the request of the EMEA
•
30 ANNEX III
na zahtevo EMEA.
31 A.
31 DODATEK III
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OZNAČEVANJE
See the package leaflet for further information
Za dodatne informacije glejte navodilo za uporabo
Once monthly tablet Oral use Read the package leaflet before use
mesečna tableta peroralna uporaba Pred uporabo preberite priloženo navodilo
Month 1 __/__/__ 3 film-coated tablets Month 2 __/__/__ 3 film-coated tablets Month 3 __/__/__ 3 film-coated tablets Note down the date you take your tablet Open
1. mesec __ / __ / __ 3 filmsko obložene tablete 2. mesec __ / __ / __ 3 filmsko obložene tablete 3. mesec __ / __ / __ 3 filmsko obložene tablete
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA( E) DOVOLJENJA ZA PROMET
EU/1/03/266/003 1 film-coated tablet EU/1/03/266/004 3 film-coated tablets
EU/ 1/ 03/ 265/ 003 1 filmsko obložena tableta EU/ 1/ 03/ 265/ 004 3 filmsko obložene tablete
34 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
35 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Blister foil
PRETISNI OMOT
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
36 PODATKI NA ZUNANJI OVOJNINI
Bondenza 3 mg solution for injection Ibandronic acid
Bondenza 3 mg raztopina za injiciranje ibandronska kislina
One pre-filled syringe of 3 ml solution contains 3 mg of ibandronic acid (as 3.375 mg of ibandronic acid, monosodium salt, monohydrate).
Ena napolnjena injekcijska brizga vsebuje 3 mg ibandronske kisline (kot 3, 375 mg natrijevega ibandronata monohidrata) v 3 ml raztopine.
solution for injection 1 pre-filled syringe + 1 injection needle 4 pre-filled syringes + 4 injection needles
raztopina za injiciranje 1 napolnjena injekcijska brizga + 1 injekcijska igla 4 napolnjene injekcijske brizge + 4 injekcijske igle
For intravenous use only Read the package leaflet before use
Samo za intravensko uporabo Pred uporabo preberite priloženo navodilo
EU/1/03/266/005 1 pre-filled syringe EU/1/03/266/006 4 pre-filled syringes
EU/ 1/ 03/ 265/ 005 1 napolnjena injekcijska brizga EU/ 1/ 03/ 265/ 006 4 napolnjene injekcijske brizge
37 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
38 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Bondenza 3 mg solution for injection Ibandronic acid For IV use only
Bondenza 3 mg raztopina za injiciranje ibandronska kislina Samo za i. v. uporabo
Bondenza 150 mg film-coated tablets Ibandronic acid
BONDENZA 150 mg filmsko obložene tablete ibandronska kislina
Planning when to take Bondenza with peel-off stickers for your personal calendar 1.
Načrtovanje jemanja Bondenze z nalepkami za vaš osebni koledar 1.
What Bondenza is and what it is used for 2.
Kaj je zdravilo Bondenza in za kaj ga uporabljamo 2.
Before you take Bondenza 3.
Kaj morate vedeti, preden boste vzeli zdravilo Bondenza 3.
How to take Bondenza 4.
Kako jemati zdravilo Bondenza 4.
How to store Bondenza 6.
Možni neželeni učinki 5 Shranjevanje zdravila Bondenza 6.
WHAT BONDENZA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO BONDENZA IN ZA KAJ GA UPORABLJAMO
Bondenza belongs to a group of medicines called bisphosphonates.
Bondenza spada v skupino zdravil, ki jih imenujemo bisfosfonati.
It contains ibandronic acid.
Vsebuje ibandronsko kislino.
It does not contain hormones.
Ne vsebuje hormonov.
Bondenza may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they won’t be able to see or feel a difference.
Zdravilo Bondenza zavre izgubo kostne mase tako, da zaustavi njeno nadaljnjo izgubo.
Bondenza may help lower the chances of breaking bones (fractures).
S tem kostno maso poveča pri večini bolnic, ki ga jemljejo, čeprav same ne bodo videle ali čutile razlike.
Bondenza is prescribed to you to treat osteoporosis because you have an increased risk of fractures.
Zdravilo Bondenza vam je zdravnik predpisal za zdravljenje osteoporoze, ker imate povečano tveganje za zlome.
- not enough calcium and vitamin D in the diet
- premajhen vnos kalcija in vitamina D s hrano,
- smoking, or drinking too much alcohol
- kajenje ali čezmerno pitje alkohola,
- not enough w alking or other weight-bearing exercise
- pomanjkanje hoje ali drugih telesnih aktivnosti,
- a family history of osteoporosis
- družinska obremenjenost z osteoporozo.
Many people with osteoporosis have no symptoms.
Veliko ljudi z osteoporozo nima simptomov.
If you have no symptoms you may not know if you have the condition.
Če nimate simptomov, morda ne boste vedeli, da imate to bolezen.
However, osteoporosis makes you more likely to break bones if you fall or hurt yourself.
Osteoporoza zveča tveganje za zlom kosti pri padcu ali poškodbi.
A broken bone after the age of 50 may be a sign of osteoporosis.
Zlom kosti po 50. letu je lahko znak osteoporoze.
Osteoporosis can also cause back pain, height loss and a curved back.
Osteoporoza prav tako lahko povzroči bolečino v hrbtu, zmanjšanje telesne višine in ukrivljen hrbet.
Bondenza prevents loss of bone from osteoporosis, and helps to rebuild bone.
Bondenza preprečuje izgubo kostne mase zaradi osteoporoze in pomaga pri ponovni gradnji kosti.
Therefore Bondenza makes bone less likely to break.
Bondenza zmanjša tveganje za zlom kosti.
40 A healthy lifestyle will also help you to get the most benefit from your treatment.
41 Zdrav način življenja vam bo prav tako pomagal, da bo vaše zdravljenje čimbolj uspešno.
This includes eating a balanced diet rich in calcium and vitamin D; walking or any other weight-bearing exercise; not smoking; and not drinking too much alcohol.
To vključuje uravnoteženo prehrano, bogato s kalcijem in vitaminom D, hojo ali druge telesne aktivnosti z vplivom na telesno maso, opustitev kajenja in zmerno pitje alkohola.
BEFORE YOU TAKE BONDENZA
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO BONDENZA
Do not take Bondenza
Ne jemljite zdravila Bondenza:
- If you are allergic (hypersensitive) to ibandronic acid, or to any of the other ingredients of
- če ste alergični (preobčutljivi) na ibandronsko kislino ali katerokoli sestavino zdravila
Bondenza.
Bondenza,
- If you have, or had in the past low blood calcium.
Prosimo,
Do not give Bondenza to children or adolescents.
Zdravila Bondenza ne dajajte otrokom in mladostnikom.
Take special care with Bondenza Some people need to be especially careful while they’re taking Bondenza.
Bodite posebno pozorni pri jemanju zdravila Bondenza Nekateri ljudje morajo biti pri jemanju zdravila Bondenza še posebno previdni.
Check with your doctor:
Posvetujte se s svojim zdravnikom:
- If you have any disturbances of mineral metabolism (such as vitamin D deficiency).
- če imate kakršne koli motnje presnove mineralov (kot je pomanjkanje vitamina D),
- If you can’t stand or sit upright for up to an hour at a time.
- če ne morete stati ali sedeti pokončno vsaj eno uro skupaj,
- If your kidneys are not functioning normally.
- če vaše ledvice ne delujejo normalno,
- If you have ever had problems with your oesophagus (the tube connecting your mouth to your
- če ste kdaj imeli težave s požiralnikom (to je cev, ki vaša usta povezuje z želodcem).
Problems in your oesophagus might give you symptoms including: severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting.
Težave s požiralnikom se lahko kažejo kot simptomi, ki vključujejo hudo bolečino v prsih, hudo bolečino pri požiranju hrane in/ ali pitju pijače, hudo slabost ali bruhanje.
If you develop these symptoms, speak to your doctor straight away.
Če se pri vas pojavijo ti simptomi, takoj poiščite pomoč zdravnika.
- If you are under dental treatment or will undergo dental surgery, tell your dentist that you are
- Pred zdravljenjem bolezni ali operacijo zob povejte svojemu zobozdravniku, da se zdravite z
being treated with Bondenza.
zdravilom Bondenza.
Especially:
Jemanje drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, še posebno:
influence the effects of Bondenza.
dodatke, ki vsebujejo kalcij, magnezij, železo ali aluminij, ker imajo lahko vpliv na − delovanje zdravila Bondenza.
ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine.
Aspirin in druga nesteroidna protivnetna zdravila (NSAID, ki vključujejo ibuprofen, − natrijev diklofenak in naproksen) lahko dražijo želodec in črevesje.
Bisphosphonates (like Bondenza) may also do so.
Bisfosfonati (kot zdravilo Bondenza) imajo lahko enak učinek.
So be especially careful if you take painkillers or anti-inflammatories while you’re taking Bondenza.
Če jemljete zdravila proti bolečini ali protivnetna zdravila med zdravljenjem z Bondenzo, bodite še posebno previdni.
After swallowing your monthly Bondenza tablet, wait for 1 hour before taking any other medication, including indigestion tablets, calcium supplements, or vitamins.
Vsak mesec, ko pogoltnete tableto Bondenze, počakajte 1 uro preden zaužijete katerokoli drugo zdravilo, vključno z zdravili proti slabi prebavi, kalcijevimi dodatki ali vitamini.
Do not take Bondenza with food.
Jemanje zdravila Bondenza skupaj s hrano in pijačo Ne jemljite zdravila Bondenza skupaj s hrano.
You can drink plain water but no other drinks (see 3.
Navadno vodo lahko pijete, drugih pijač pa ne (glejte 3.
HOW TO TAKE BONDENZA).
KAKO JEMATI ZDRAVILO BONDENZA).
Pregnancy and breast feeding Do not take Bondenza if you’re pregnant or breast feeding.
Nosečnost in dojenje Ne jemljite zdravila Bondenza, če ste noseči ali dojite.
Driving and using machines You can drive and use machines as it’s very unlikely that Bondenza will affect your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Lahko vozite in upravljate s stroji, ker je zelo malo verjetno, da bi zdravilo Bondenza vplivalo na vašo sposobnost za vožnjo in upravljanje s stroji.
41 Important information about some of the ingredients of Bondenza Bondenza contains an ingredient called lactose.
42 Pomembne informacije o nekaterih sestavinah zdravila Bondenza Zdravilo Bondenza vsebuje laktozo.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se z njim posvetujte, preden vzamete to zdravilo.
HOW TO TAKE BONDENZA
KAKO JEMATI ZDRAVILO BONDENZA
Always take Bondenza exactly as your doctor has told you.
Natančno upoštevajte zdravnikova navodila glede jemanja Bondenze.
If you’re not sure about anything, ask your doctor or pharmacist.
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
Taking your monthly tablet It’s important to follow these instructions carefully.
Mesečno jemanje vaše tablete Zelo pomembno je, da natančno upoštevate ta navodila.
- Choose one day of the month that will be easy to remember.
- Izberite si dan v mesecu, ki si ga boste lahko zapolnili.
You can choose either the same
1. v
date (such as the 1st of each month) or the same day (such as the first Sunday of each month) to take your Bondenza tablet.
mesecu) ali isti dan (npr. prvo nedeljo v mesecu) za jemanje tablet Bondenze.
- Take your Bondenza tablet at least 6 hours after you last had anything to eat or drink except
- Vzemite tableto Bondenze vsaj 6 ur po tem, ko ste zadnjič karkoli pojedli ali pili karkoli
plain water.
razen navadne vode.
- Take your Bondenza tablet
- Pogoltnite tableto Bondenza
after you first get up for the day, and before you have anything to eat or drink (on an empty stomach)
ko zjutraj vstanete in preden karkoli pojeste ali popijete (na prazen želodec).
- Swallow your tablet with a full glass of plain water (at least 180 ml).
- Tableto pogoltnite s polnim kozarcem navadne vode (ne manj kot 180 ml).
Do not take your tablet with mineral water, fruit juice or any other drinks.
Tablete ne vzemite z mineralno vodo, sadnim sokom ali katero koli drugo pijačo.
- Swallow your tablet whole — do not chew it, crush it or let it dissolve in your mouth.
- Tableto pogoltnite celo - ne žvečite in ne prelamljajte tablete ter ne pustite, da se raztopi v
- For the next hour (60 minutes) after you’ve taken your tablet
- Naslednjo uro (60 minut) potem, ko ste vzeli svojo tableto:
do not lie down; if you do not stay upright (standing or sitting), some of the medicine could leak back into your oesophagus
se ne ulezite; če ne ostanete v pokončnem položaju (stoje ali sede), lahko nekaj zdravila zaide nazaj v vaš požiralnik;
do not drink anything (except plain water if you need it) do not take any other medicines
ničesar ne pijte (razen navadne vode, če jo potrebujete); ne jemljite drugih zdravil.
- After you’ve waited for an hour, you can have your first food and drink of the day.
ko ste počakali eno uro, lahko zaužijete svoj prvi dnevni obrok.
Once you’ve
Ko ste se najedli, se
eaten, it’s OK to lie down if you wish, and to take any other medication you need.
lahko uležete, če želite, in vzamete druga zdravila, ki jih potrebujete.
42 Continuing to take Bondenza It’s important to keep taking Bondenza every month, as long as your doctor prescribes it for you.
43 Nadaljevanje jemanja zdravila Bondenza Pomembno je, da vzamete zdravilo Bondenza vsak mesec, dokler vam ga je predpisal zdravnik.
If you take too much Bondenza If you’ve taken more than one tablet by mistake, drink a full glass of milk and talk to your doctor straight away.
Če ste vzeli večji odmerek zdravila Bondenza, kot bi smeli Če ste po pomoti vzeli več kot eno tableto, popijte poln kozarec mleka in se takoj posvetujte s svojim zdravnikom.
If you forget a dose If you forget to take your tablet on the morning of your chosen day, do not take a tablet later in the day.
Če ste pozabili vzeti odmerek Če ste pozabili vzeti tableto na jutro izbranega dne, ne vzemite tablete pozneje v istem dnevu.
If your next scheduled dose is only 1 to 7 days away… You should wait until the next scheduled dose is due and take it as normal; then, continue taking one tablet once a month on the scheduled days you’ve marked on your calendar.
Če je do vašega načrtovanega odmerka le 1 do 7 dni … počakajte do naslednjega načrtovanega odmerka in ga vzemite kot običajno, nato jemanje tablet nadaljujte enkrat na mesec, na izbrane dni, ki ste si jih označili na koledarju.
If your next scheduled dose is more than 7 days away… You should take one tablet the next morning after the day you remember; then, continue taking one tablet once a month on the scheduled days you’ve marked on your calendar.
Če je vaš načrtovani odmerek čez več kot 7 dni … vzemite eno tableto naslednje jutro potem, ko se spomnite, nato jemanje tablet nadaljujte enkrat na mesec, na izbrane dni, ki ste si jih označili na koledarju.
Like all medicines, Bondenza can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Bondenza neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
These side effects may occur with certain frequencies, which are defined as follows:
Neželeni učinki se lahko pojavijo z določenimi pogostnostmi, ki so opredeljene takole:
- very common: affects more than 1 user in 10
- zelo pogosti: pojavijo se pri več kot 1 od 10 bolnikov,
- common: affects 1 to 10 users in 100
- pogosti: pojavijo se pri 1 do 10 od 100 bolnikov,