natgillin/translations-raw huggingface dataset:
- a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can
- vsebnik, odporen na vbode (plastičen vsebnik, ki ga dobite v bolnišnici ali lekarni), tako da
dispose of used syringes safely.
boste lahko varno odlagali uporabljene brizge.
Push the plunger up to the number (ml) on the syringe that matches the dose of Biograstim that your doctor prescribed.
Bat potisnite navzgor do številke (ml), ki se sklada z odmerkom zdravila Biograstim, ki vam ga je predpisal vaš zdravnik.
Where should I give my injection?
59 Kam naj si dam injekcijo?
- the top of your thighs; and
- zgornji del stegen; in
- the abdomen, except for the area around the navel (see picture 3).
- trebuh, razen predela okrog popka (glejte sliko 3).
59 6
60 6
Remember If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Ne pozabite Če imate kakršnekoli težave, naj vas ne bo strah poprositi svojega zdravnika ali medicinske sestre za pomoč in nasvet.
sight of children.
- Poln vsebnik odvrzite v skladu z navodili, ki ste jih dobili pri vašem zdravniku ali farmacevtu.
- Dispose of the full puncture-proof container as instructed by your doctor, nurse or pharmacist.
- Uporabljenih brizg nikoli ne odložite v koš, ki ga uporabljate za odlaganje ostalih gospodinjskih
- Never put the syringes that you have used into your normal household rubbish bin.
odpadkov.
Only clear solutions without particles should be used.
Pri bolnikih, ki prejemajo filgrastim v koncentraciji, ki je nižja od 1, 5 x 106 i. e.
For patients treated with filgrastim diluted to concentrations below 1.5 MIU (15 μ g) per ml, human serum albumin (HSA) should be added to a final concentration of 2 mg/ ml.
(15 μg) na ml, morate končni koncentraciji 2 mg/ ml dodati še raztopino humanega albumina.
Example:
Primer: v injekciji s končnim volumnom 20 ml morate k celotnemu odmerku filgrastima z manj kot 30 x 106 i. e.
BONDENZA (previously known as Ibandronic Acid Roche)
(prej znano kot Ibandronic Acid Roche)
Bondenza is medicine that contains the active substance ibandronic acid.
Bondenza je zdravilo, ki vsebuje zdravilno učinkovino ibandronska kislina.
It is available as white, oblong tablets (150 mg) and as a solution for injection (3 mg).
Na voljo je v belih tabletah podolgovate oblike (150 mg) in kot raztopina za injiciranje (3 mg).
Bondenza is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of developing bone fractures (breaks).
Zdravilo Bondenza se uporablja za zdravljenje osteoporoze (bolezni, pri kateri postanejo kosti krhke) pri ženskah v obdobju po menopavzi, pri katerih obstaja tveganje za zlome kosti.
Its effect in reducing the risk of vertebral (spine) fractures has been shown in studies, but its effect on the risk of fractures of the neck of the femur (the top of the thighbone) has not been established.
V študijah so dokazali učinek zdravila pri zmanjševanju tveganja za zlome vretenc (hrbtenice), njegov vpliv na tveganje za zlom stegneničnega vratu (vrha stegnenice) pa ni bil dokazan.
Bondenza can be given either by mouth as a tablet or as an injection into a vein.
Zdravilo Bondenza se daje bodisi peroralno s tabletami ali z injiciranjem v veno.
If the tablet is used, the dose is one tablet every month.
Pri uporabi tablet znaša odmerek eno tableto mesečno.
The tablet must always be taken after an overnight fast, one hour before any food or drink except for water, and with a full glass of plain water.
Tableto je treba vedno vzeti po celonočnem postu, eno uro pred zaužitjem hrane ali pijače, razen vode.
The patient must not lie down for one hour after taking the tablet.
Vzeti jo je treba s polnim kozarcem navadne vode.
The dose by injection is 3 mg once every three months.
Bolnica ne sme leči vsaj eno uro potem, ko je vzela tableto.
Patients taking Bondenza should also take vitamin D and calcium supplements if they do not get enough from their diet.
V primeru injiciranja se daje en 3- miligramski odmerek vsake tri mesece.
Bondenza is not recommended for patients who have severe kidney problems.
Bolnice, ki jemljejo zdravilo Bondenza, bi morale jemati tudi dodatke vitamina D in kalcija, če jih ne dobivajo v zadostni količini s prehrano.
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall.
Osteoporoza je pogostejša pri ženskah v obdobju po menopavzi, ko raven ženskega hormona estrogena pade.
The active substance in Bondenza, ibandronic acid, is a bisphosphonate.
Zdravilna učinkovina v zdravilu Bondenza, ibandronska kislina, je bisfosfonat.
The other two studies compared the 150 mg monthly tablets (1,609 patients) and the injections (1,395 patients) with the 2.5 mg once-daily tablets.
V prvi študiji so primerjali 2, 5- miligramske tablete zdravila Bondenza, ki so jih bolnice jemale enkrat dnevno, s placebom (zdravilom brez zdravilne učinkovine) pri skoraj 3 000 ženskah in spremljali, koliko novih zlomov hrbtenice se je pri bolnicah pojavilo v treh letih.
The studies looked at the change in the density of the bones in the spine and the hip over two years.
Študije so proučevale spremembo gostote kosti v hrbtenici in kolkih v dveh letih.
Note that the 2.5 mg once-daily tablets used in the studies are no longer authorised.
Treba je opozoriti, da 2, 5- miligramske dnevne tablete, ki so jih uporabljali v študijah, niso več odobrene.
In the first study, daily treatment with Bondenza 2.5 mg tablets reduced the risk of new spine fractures by 62% in comparison with placebo.
V prvi študiji je dnevno zdravljenje z 2, 5- miligramskimi tabletami zdravila Bondenza zmanjšalo tveganje za nove zlome hrbtenice za 62% v primerjavi s placebom.
The other two studies showed that the 150 mg monthly tablets and the injections were more effective than the 2.5 mg once-daily tablets at increasing bone density in the spine and the hip.
Drugi dve študiji sta pokazali, da so 150- miligramske tablete in injekcije enkrat mesečno učinkovitejše kot 2, 5- miligramske tablete enkrat dnevno pri povečevanju kostne gostote hrbtenice in kolkov.
Over two years, bone density in the spine increased by 7% with the monthly tablets and by 6% with the injections, compared with 5% with the daily tablets.
V dveh letih se je kostna gostota hrbtenice povečala za 7% z mesečnimi tabletami in za 6% z injekcijami v primerjavi s 5- odstotnim povečanjem, doseženim z dnevnimi tabletami.
In the hip, bone density increased by 4% with the monthly tablets and by 3% with the injections, compared with 2% with the daily tablets.
Kostna gostota kolka se je z mesečnimi tabletami povečala za 4% in za 3% z injekcijami, z dnevnimi tabletami pa samo 2%.
The most common side effects with Bondenza tablets (seen in between 1 and 10 patients in 100) are gastritis (inflammation of the stomach), diarrhoea, abdominal pain (stomach ache), dyspepsia (indigestion), nausea (feeling sick), influenza-like illness, fatigue (tiredness), musculoskeletal pain (pain in the muscles and bones), arthralgia (joint pain), myalgia (muscle pain) and musculoskeletal stiffness.
Najpogostejši neželeni učinki pri tabletah Bondenza (opaženi pri 1 do 10 bolnicah od 100) so gastritis (vnetje želodca), driska, bolečine v trebuhu, dispepsija (slaba prebava), slabost, gripi podobni simptomi, utrujenost, bolečine v mišicah in kosteh, artralgija (bolečine v sklepih), mialgija (bolečine v mišicah) ter otrdelost mišic in sklepov.
With the injection, constipation, headache and back pain are also seen in between 1 and 10 patients in 100.
Pri injiciranju so bili pri več kot 1 do 10 bolnicah od 100 opaženi tudi zaprtje, glavobol in bolečine v hrbtu.
For the full list of all side effects reported with Bondenza, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Bondenza, glejte navodilo za uporabo.
Bondenza should not be used in people who may be hypersensitive (allergic) to ibandronic acid or any of the other ingredients.
Zdravila Bondenza ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) ibandronsko kislino ali katero koli drugo sestavino zdravila.
It must not be used in patients who have hypocalcaemia (low blood calcium levels).
Ne smejo ga uporabljati bolnice s hipokalcemijo (nizko ravnjo kalcija v krvi).
Bondenza treatment may be linked to osteonecrosis of the jaw (collapse of bone tissue in the jaw).
Zdravljenje z zdravilom Bondenza je morda povezano z osteonekrozo čeljusti (odmiranje kostnega tkiva v čeljusti).
Care is needed in patients who receive the medicine and are having dental treatment.
Pri bolnicah, ki prejemajo zdravilo in prestajajo zobozdravstveno zdravljenje, je potrebna posebna previdnost.
The Committee for Medicinal Products for Human Use (CHMP) decided that Bondenza’ 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 odločil, da so koristi zdravila Bondenza pri zdravljenju in preprečevanju osteoporoze pri ženskah v obdobju po menopavzi, pri katerih je povečano tveganje za zlome, večje od z njim povezanih tveganj.
The Committee recommended that Bondenza be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Bondenza odobri dovoljenje za promet.
Other information about Bondenza:
Druge informacije o zdravilu Bondenza:
The European Commission granted a marketing authorisation valid throughout the European Union for Ibandronic Acid Roche to Roche Registration Limited on 23 February 2004.
Evropska komisija je dovoljenje za promet z zdravilom Ibandronic Acid Roche, veljavno po vsej Evropski uniji, odobrila družbi Roche Registration Limited dne 23. februarja 2004.
The name of the medicine was changed to Bondenza on 18 August 2004.
Ime zdravila je bilo dne 18. avgusta 2004 spremenjeno v Bondenza.
The marketing authorisation was renewed on 23 February 2009.
Dovoljenje za promet je bilo obnovljeno dne 23. februarja 2009.
The full EPAR for Bondenza can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Bondenza je na voljo tukaj.
This summary was last updated in 02-2009.
Povzetek je bil nazadnje posodobljen 02- 2009.
Invented name
Izmišljeno Ime Jakost
Pharmaceutical Form
Farmacevtska Oblika
Content
Vsebina (Koncentracija)
EU/ 1/ 03/ 266/ 003 EU/ 1/ 03/ 266/ 004
EU/ 1/ 03/ 266/ 003 Bondenza EU/ 1/ 03/ 266/ 004 Bondenza EU/ 1/ 03/ 266/ 005 Bondenza
150 mg 150 mg
150 mg 150 mg 3 mg
Blister (PVC/ PVDC) Blister (PVC/ PVDC)
Filmsko Obložena Tableta Filmsko Obložena Tableta Raztopina Za Injiciranje
1 tablet 3 tablets
Peroralna Uporaba Pretisni Omot (PVC/ PVDC) Peroralna Uporaba Pretisni Omot (PVC/ PVDC) Intravenska Napolnjena Injekcijska Brizga 3 ml (1 mg/ ml) (Steklo)
1 pre-filled syringe
1 tableta 3 tablete 1 napolnjena injekcijska brizga
EU/ 1/ 03/ 266/ 006
EU/ 1/ 03/ 266/ 006 Bondenza
Pre-filled syringe (glass)
Raztopina Za Injiciranje
3 ml (1 mg/ ml)
Intravenska Napolnjena Injekcijska Brizga 3 ml (1 mg/ ml) (Steklo)
Each film-coated tablet contains 150 mg ibandronic acid (as ibandronic sodium monohydrate).
Vsaka filmsko obložena tableta vsebuje 150 mg ibandronske kisline (v obliki natrijevega ibandronata monohidrata).
Each film-coated tablet contains 162.75 mg lactose monohydrate.
Vsaka filmsko obložena tableta vsebuje 162, 75 mg laktoze monohidrata.
Film-coated tablet White to off white film-coated tablets, of oblong shape marked “ BNVA” on one side, and “ 150” on the other side.
Filmsko obložene tablete so bele do sivo bele barve, podolgovate oblike z oznako “ BNVA ” na eni strani in “ 150 ” na drugi strani.
Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1).
Zdravljenje osteoporoze pri postmenopavznih ženskah s povečanim tveganjem za zlome (glejte poglavje 5. 1).
The recommended dose is one 150 mg film-coated tablet once a month.
Odmerjanje Priporočeni odmerek je ena 150- mg filmsko obložena tableta na mesec.
Bondenza should be taken after an overnight fast (at least 6 hours) and 1 hour before the first food or drink (other than water) of the day (see section 4.5) or any other oral medicinal products or supplementation (including calcium).
Zdravilo Bondenza je treba vzeti zjutraj na prazen želodec (najmanj 6 ur brez obroka) in 1 uro pred prvim dnevnim obrokom hrane ali pijače, ki ni voda (glejte poglavje 4. 5) ali zaužitjem drugih peroralnih zdravil ali dodatkov (vključno s kalcijem).
In case a dose is missed, patients should be instructed to take one Bondenza 150 mg tablet the morning after the tablet is remembered, unless the time to the next scheduled dose is within 7 days.
Če bolnik odmerek izpusti, mu je treba svetovati, naj vzame eno 150- mg tableto Bondenze naslednje jutro potem, ko se spomni, razen če je do naslednjega načrtovanega odmerka manj kot 7 dni.
If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one tablet once a month as originally scheduled.
Če je naslednji načrtovani odmerek v manj kot 7 dneh, naj bolnik počaka do tega odmerka in nadaljuje jemanje ene tablete enkrat na mesec po prvotnem načrtu.
Patients should receive supplemental calcium and / or vitamin D if dietary intake is inadequate (see section 4.4 and section 4.5).
Če vnos s hrano ni zadosten, morajo bolniki prejemati dodatke kalcija, vitamina D ali obojega (glejte poglavje 4. 4 in poglavje 4. 5).
Special Populations Patients with renal impairment No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal or greater than 30 ml/ min.
Posebne skupine bolnikov Bolniki z ledvično okvaro Pri bolnikih z blago do zmerno ledvično okvaro, ki imajo očistek kreatinina enak ali večji kot 30 ml/ min, prilagajanje odmerkov ni potrebno.
Bondenza is not recommended for patients with a creatinine clearance below 30 ml/ min due to limited clinical experience (see section 4.4 and section 5.2).
2 Bondenza pri bolnikih s kreatininskim očistkom pod 30 ml/ min zaradi malo kliničnih izkušenj ni priporočljiva (glejte poglavje 4. 4 in poglavje 5. 2).
2 Patients with hepatic impairment No dose adjustment is required (see section 5.2).
Bolniki z jetrno okvaro Prilagajanje odmerkov ni potrebno (glejte poglavje 5. 2).
Elderly Population No dose adjustment is required (see section 5.2).
Starejši bolniki Prilagajanje odmerkov ni potrebno (glejte poglavje 5. 2).
Paediatric Population There is no relevant use of Bondenza in children, and Bondenza was not studied in the paediatric population.
Zdravila Bondenza pri pediatričnih bolnikih niso proučevali.
Tablets should be swallowed whole with a glass of plain water (180 to 240 ml) while the patient is sitting or standing in an upright position.
Tablete je treba pogoltniti cele s kozarcem navadne vode (180 do 240 ml), bolnik mora pri tem stati ali pokončno sedeti.
Patients should not lie down for 1 hour after taking Bondenza.
Po zaužitju Bondenze bolniki 1 uro ne smejo leči.
Plain water is the only drink that should be taken with Bondenza.
Navadna voda je edina tekočina, ki jo lahko bolnik zaužije z Bondenzo.
Please note that some mineral waters may have a higher concentration of calcium and therefore, should not be used.
Prosimo upoštevajte, da lahko nekatere mineralne vode vsebujejo višje koncentracije kalcija in jih zato ne smemo uporabljati.
- Hypocalcaemia (see section 4.4)
- Hipokalcemija (glejte poglavje 4. 4)
- Hypersensitivity to ibandronic acid or to any of the excipients.
- Preobčutljivost za ibandronsko kislino ali katerokoli pomožno snov
Gastrointestinal Disorders Bisphosphonates have been associated with dysphagia, oesophagitis and oesophageal or gastric ulcers.
Bolezni prebavil Bisfosfonate so povezovali z disfagijo, ezofagitisom, ulceroznim ezofagitisom in želodčno razjedo.
Therefore patients, especially those with a history of prolonged oesophageal transit time, should pay particular attention to and be able to comply with the dosing instructions (see section 4.2).
Bolniki, še posebno tisti, ki so v preteklosti imeli podaljšan čas prehoda skozi požiralnik, morajo skrbno prebrati in upoštevati navodila za odmerjanje (glejte poglavje 4. 2).
Physicians should be alert to signs or symptoms signalling a possible oesophageal reaction during therapy, and patients should be instructed to discontinue Bondenza and seek medical attention if they develop symptoms of oesophageal irritation such as new or worsening dysphagia, pain on swallowing, retrosternal pain, or heartburn.
Če se pri bolnikih med zdravljenjem z Bondenzo pojavijo simptomi ezofagealnega draženja, kot je pojav ali poslabšanje disfagije, bolečina pri požiranju, retrosternalna bolečina ali zgaga, morajo zdravljenje z Bondenzo prekiniti in poiskati zdravniško pomoč.
Since Nonsteroidal Anti-Inflamatory Drugs and bisphosphonates are both associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Ker nesteroidna protivnetna zdravila in bisfosfonate povezujejo z gastrointestinalnim draženjem, je pri sočasnem peroralnem jemanju teh zdravil potrebna previdnost.
Hypocalcaemia Existing hypocalcaemia must be corrected before starting Bondenza therapy.
Hipokalcemija Obstoječo hipokalcemijo je treba popraviti pred začetkom zdravljenja z Bondenzo.
Renal impairment Due to limited clinical experience, Bondenza is not recommended for patients with a creatinine clearance below 30 ml/ min (see section 5.2).
Ledvična okvara Zaradi malo kliničnih izkušenj Bondenze ne priporočamo bolnikom, ki imajo kreatininski očistek manjši kot 30 ml/ min (glejte poglavje 5. 2).
Osteonecrosis of the Jaw Osteonecrosis of the jaw, generally associated with tooth extraction and/ or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphosphonates.
Osteonekroza čeljusti Pri bolnikih z rakom, ki so prejemali zdravljenje, ki je prvenstveno vključevalo bisfosfonate, dane intravensko, so poročali o osteonekrozi čeljusti, po navadi povezani z izdrtjem zoba ali lokalno okužbo (vključno z osteomielitisom) ali obojim.
Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
O osteonekrozi čeljusti so poročali tudi pri bolnikih z osteoporozo, ki so bisfosfonate prejemali peroralno.
3 A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e. g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
3 Pri bolnikih s sočasnimi dejavniki tveganja (npr. rak, kemoterapija, radioterapija, kortikosteroidi, slaba ustna higiena) je treba pred začetkom zdravljenja z bisfosfonati razmisliti o pregledu zobovja in primernih preventivnih zobozdravstvenih posegih.
For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Pri bolnikih, pri katerih se med zdravljenjem z bisfosfonati pojavi osteonekroza čeljusti, lahko zobne operacije stanje poslabšajo.
For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Za bolnike, pri katerih je potreben zobozdravstveni poseg, ni na voljo podatkov o tem, ali prekinitev zdravljenja z bisfosfonati zmanjša tveganje za osteonekrozo čeljusti.
Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/ risk assessment.
Glede na klinično presojo zdravnika, ki oceni razmerje med tveganjem in koristjo za vsakega bolnika posebej, je treba osnovati načrt ravnanja.
Galactose intolerance Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicinal product.
Intoleranca za galaktozo Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze ne smejo jemati tega zdravila.
In particular, products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk, are likely to interfere with absorption of Bondenza, which is consistent with findings in animal studies.
Posebno pripravki, ki vsebujejo kalcij in druge večvalentne katione (kot so aluminij, magnezij, železo), vključno z mlekom, lahko vplivajo na absorpcijo Bondenze, kar je v skladu z ugotovitvami študij na živalih.
Therefore, patients should fast overnight (at least 6 hours) before taking Bondenza and continue fasting for 1 hour following intake of Bondenza (see section 4.2).
Zato morajo bolniki jemati Bondenzo zjutraj na prazen želodec (vsaj 6 ur brez obroka), po zaužitju Bondenze pa morajo biti še 1 uro tešči (glejte poglavje 4. 2).
Therefore, patients should not take other oral medicinal products for at least 6 hours before taking Bondenza and for 1 hour following intake of Bondenza.
Dodatki kalcija, antacidi in nekatera peroralna zdravila, ki vsebujejo večvalentne katione (kot so aluminij, magnezij, železo), lahko vplivajo na absorpcijo Bondenze, zato bolniki najmanj 6 ur pred zaužitjem Bondenze ter še 1 uro po ne smejo jemati drugih peroralnih zdravil.
Metabolic interactions are not considered likely, since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and has been shown not to induce the hepatic cytochrome P450 system in rats.
Ibandronska kislina pri ljudeh ne zavira glavnih jetrnih izoencimov P450, pri podganah pa ne spodbuja jetrnega citokroma P450, zato presnovna medsebojna delovanja niso verjetna.
Furthermore, plasma protein binding is approximately 85% - 87% (determined in vitro at therapeutic concentrations), and thus there is a low potential for interaction with other medicinal products due to displacement.
Vezava ibandronske kisline na beljakovine v plazmi je približno 85 - do 87 -% (določeno in vitro pri terapevtskih koncentracijah učinkovine), zato obstaja majhna možnost za medsebojno delovanje z drugimi zdravili zaradi izpodrivanja.
In a two-year study in postmenopausal women with osteoporosis (BM 16549), the incidence of upper gastrointestinal events in patients concomitantly taking aspirin or NSAIDs was similar in patients taking ibandronic acid 2.5 mg daily or 150 mg once monthly after one and two years.
V dveletni študiji pri ženskah z osteoporozo v postmenopavzi (BM 16549), ki so sočasno jemale acetilsalicilno kislino ali nesteroidna protivnetna zdravila, je bila incidenca neželenih učinkov v zgornjem delu prebavil podobna pri tistih, ki so jemale ibandronsko kislino 2, 5 mg vsak dan ali 150 mg enkrat na mesec eno ali dve leti.
Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14% and 18% of patients used histamine (H2) blockers or proton pump inhibitors after one and two years, respectively.
Od več kot 1500 bolnikov, vključenih v študijo BM 16549, ki je primerjala mesečno jemanje ibandronske kisline z dnevnim, je po enem letu 14% bolnikov uporabljalo antagoniste histaminskih receptorjev H2 ali zaviralce protonske črpalke, po dveh letih pa 18% bolnikov.
Among these patients, the incidence of upper gastrointestinal events in the patients treated with Bondenza 150 mg once monthly was similar to that in patients treated with ibandronic acid 2.5 mg daily.
Pri teh bolnikih je bila incidenca neželenih učinkov v zgornjem delu prebavil podobna pri tistih, ki so se zdravili z zdravilom Bondenza 150 mg enkrat na mesec ali ibandronsko kislino 2, 5 mg vsak dan.
In healthy male volunteers and postmenopausal women, intravenous administration of ranitidine caused an increase in ibandronic acid bioavailability of about 20%, probably as a result of reduced gastric acidity.
Pri zdravih moških prostovoljcih in ženskah v postmenopavzi je intravensko apliciran ranitidin zvečal biološko uporabnost ibandronske kisline za približno 20%, kar je verjetno posledica zmanjšane kislosti želodca.