natgillin/translations-raw huggingface dataset:
beverage, or other medication of the day.
drugo zdravilo v tem dnevu.
- You should remain in an upright (sitting or standing) position while taking Bondronat tablets
Po
and remain upright for 60 minutes after taking your tablet
zaužitju tablete ostanite v pokončnem položaju še 60 minut.
- It is important to continue taking Bondronat for as long as your doctor prescribes the medicine.
- Pomembno je, da nadaljujete z jemanjem zdravila Bondronat tako dolgo, kot vam je predpisal
Bondronat can help with your condition only if you continue to take the tablets.
Zdravilo Bondronat vam lahko pomaga pri vaši bolezni le, če nadaljujete z jemanjem tablet.
If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately.
Če ste vzeli večji odmerek zdravila Bondronat, kot bi smeli Če ste pomotoma vzeli večji odmerek, popijte poln kozarec mleka in takoj obvestite svojega zdravnika.
Do not make yourself vomit, and do not lie down.
Ne izzovite bruhanja in ne lezite.
Do not take a double dose to make up for a forgotten dose.
Če ste pozabili vzeti zdravilo Bondronat Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Return to taking one tablet per day the following day, as usual.
Naslednji dan vzemite eno tableto na dan kot običajno.
Common side effects include indigestion, nausea, abdominal pain, oesophagitis, tiredness, and low calcium levels in the blood.
Pogosti neželeni učinki so slaba prebava, slabost, bolečina v trebuhu, vnetje požiralnika, utrujenost in nizka koncentracija kalcija v krvi.
Symptoms reported uncommonly include strange taste, tingling sensation (paraesthesia), dry mouth, bleeding gastrointestinal ulcer, difficulty swallowing, gastritis, itching, chest pain, flu-like symptoms, feeling unwell, and pain.
Simptomi, o katerih so poročali občasno, so nenavaden okus, občutek zbadanja (parestezija), suha usta, gastrointestinalni ulkus s krvavenjem, težave s požiranjem, vnetje želodca, srbenje, bolečina v prsih, gripi podobni simptomi, slabo počutje in bolečina.
Uncommonly, low hemoglobin, high levels of urea and high levels of parathyroid hormone have been reported from blood tests.
Občasno so poročali o nizkem hemoglobinu, visoki koncentraciji sečnine in visoki koncentraciji hormona obščitnice v krvnih preiskavah.
Keep blister in the outer carton.
Pretisne omote shranjujte v zunanji ovojnini.
Do not use Bondronat after the expiry date which is stated on the blister and carton.
Zdravila Bondronat ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli.
- Each film-coated tablet contains 56.25 mg of ibandronic acid, monosodium salt, monohydrate,
- Vsaka filmsko obložena tableta vsebuje 56, 25 mg ibandronske kisline v obliki monohidrata
equivalent to 50 mg of ibandronic acid.
natrijeve soli, kar ustreza 50 mg ibandronske kisline.
- tablet core: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, purified
- jedro tablet: monohidrat laktoze, povidon, mikrokristalna celuloza, krospovidon, prečiščena
stearic acid, colloidal anhydrous silica.
stearinska kislina, brezvoden koloidni silicijev dioksid;
- tablet coat: hypromellose, titanium dioxide, talc, macrogol 6,000.
- obloga tablet: hipromeloza, titanov dioksid, smukec, makrogol 6. 000.
The film-coated tablets are of oblong shape and white to off-white in colour, engraved L2/ IT.
Filmsko obložene tablete so podolgovate oblike in bele do sivo bele barve z oznako L2/ IT.
Manufacturer Roche Pharma AG Emil-Barell-Str.
Izdelovalec Roche Pharma AG Emil- Barell- Str.
Deutschland Roche Pharma AG Tel: +49 (0) 7624 140
65 Deutschland Roche Pharma AG Tel: +49 (0) 7624 140
66 PACKAGE LEAFLET INFORMATION FOR THE USER
66 NAVODILO ZA UPORABO
Before you use Bondronat 3.
Kaj morate vedeti, preden boste uporabili zdravilo Bondronat 3.
tumours
tumorjev
of surgery) in patients with breast cancer and bone metastases..
potrebno obsevanje ali kirurški poseg) pri bolnikih z rakom dojke in z metastazami v kosteh.
If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Bondronat.
Pred zdravljenjem bolezni ali operacijo zob povejte svojemu zobozdravniku, da se zdravite z zdravilom Bondronat.
Take special care with Bondronat: if you know or believe that you may have:
Bodite posebno pozorni pri uporabi zdravila Bondronat Če veste ali mislite, da:
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription
Uporaba drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
You will be given Bondronat as an infusion. Your doctor will determine how much Bondronat you will be given depending on your illness.
Glede na vašo bolezen vam bo zdravnik določil, koliko zdravila Bondronat boste prejeli.
Like all medicines, Bondronat can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Bondronat neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
In rare cases, patients have reported the following: gastroenteritis, oral thrush, vaginitis, benign skin growth, sleep disturbance, anxiety, affect lability, memory loss, numbness round the mouth (paraesthesia circumoral), hyperaesthesia, hypertonia, nerve root lesion, neuralgia, migraine, cerebrovascular disorder, parosmia, deafness, heart and circulatory problems (including palpitations, myocardial ischaemia, hypertension, varicose veins), lymphoedema, lung oedema, stridor, gastritis,
V redkih primerih so bolniki poročali naslednje: gastroenteritis, ustni oprh, vaginitis, benigna rast kože, motnje spanja, zaskrbljenost, vpliv na čustveno labilnost, izguba spomina, mravljinčenje okoli ust (parestezija okoli ust), hiperastezija, hipertonija, lezija živčnih korenov, nevralgija, migrena, cerebrovaskularna bolezen, parozmija, gluhost, težave s srcem in obtočili (vključno s palpitacijami, srčnomišična ishemija, povišan krvni tlak, krčne žile), limfni edem, pljučni edem, stridor, gastritis,
68 cheilitis, difficulty swallowing (dysphagia), mouth ulceration, gall stones cholelithiasis, rash, hair loss, cystitis, renal cyst, urinary retention, pelvic pain, injection site pain, weight loss, and hypothermia.
68 heilitis, težko požiranje (disfagija), ulceracija ust, žolčni kamni (holelitiaza), osip, izguba las, vnetje mehurja, ledvična cista, zastajanje seča, bolečina v medenici, bolečina na mestu injiciranja, izguba telesne mase in hipotermija.
Bondronat may also cause changes in laboratory tests carried out by your doctor, these include; low calcium (metal), low phosphate (mineral), raised liver enzyme and raised creatinine, parathyroid disorder (hormone) in the blood, low hemoglobin (and rarely blood dyscrasia).
Zdravilo Bondronat lahko povzroči tudi spremembe v laboratorijskih testih, ki vam jih odredi vaš zdravnik: nizek kalcij (kovina), nizek fosfat (mineral), povišan jetrni encim in povišan kreatinin, motnja obščitnice (hormon v krvi), nizek hemoglobin in redko diskrazija krvi).
The shelf-life of Bondronat 6 mg is 5 years.
Rok uporabnosti vial Bondronat 6 mg je 5 let.
After dilution the infusion solution is stable for 24 hours at 2-8 °C (in a refrigerator).
Po razredčitvi je infuzijska raztopina stabilna 24 ur pri temperaturi med 2 °C in 8 °C (v hladilniku).
- One vial with 6 ml of a concentrate for solution for infusion contains 6 mg ibandronic acid (as
- Ena viala s 6 ml koncentrata za raztopino za infundiranje vsebuje 6 mg ibandronske kisline (kot
6.75 mg ibandronic acid, monosodium salt, monohydrate).
6, 75 mg ibandronske kisline v obliki monohidrata natrijeve soli.
Bondronat is supplied as packs containing 1, 5 and 10 vials (6 ml type I glass vial).
Zdravilo Bondronat je na voljo v pakiranju po 1, 5 in 10 vial (6 ml viala iz stekla tipa I).
Marketing Authorisation Holder 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Imetnik dovoljenja za promet z zdravilom Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW Velika Britanija
Manufacturer Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim Germany
Izdelovalec Roche Diagnostics GmbH Sandhofer Strasse 116 D- 68305 Mannheim
69 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
71
71 * Opomba: koncentracije korigiranega kalcija v serumu izračunamo po naslednjih formulah:
Overdose Up to now there is no experience of acute poisoning with Bondronat concentrate for solution for infusion.
72 Ni poročil o primerih akutnega prevelikega odmerjanja s koncentratom za raztopino za infundiranje Bondronat.
72 Clinically relevant hypocalcaemia (very low serum calcium levels) should be corrected by intravenous administration of calcium gluconate.
Klinično pomembno hipokalciemijo (zelo nizke koncentracije kalcija v serumu) je treba popraviti z intravenskim dajanjem kalcijevega glukonata.
It is available as white, oblong tablets (150 mg) or as a solution for injection (3 mg).
Na voljo je v belih tabletah podolgovate oblike (150 mg) in kot raztopina za injiciranje (3 mg).
Bonviva 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 Bonviva se uporablja za zdravljenje osteoporoze (bolezni, pri kateri postanejo kosti krhke) pri ženskah v obdobju po menopavzi, pri katerih obstaja tveganje za zlome kosti.
Bonviva can be given either by mouth as a tablet or as an injection into a vein.
Zdravilo Bonviva se daje bodisi peroralno s tabletami ali z injiciranjem v veno.
The tablet must always be taken after an overnight fast, one hour before any food of 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.
Patients taking Bonviva should also take vitamin D and calcium supplements if they do not get enough from their diet.
Bolnice, ki jemljejo zdravilo Bonviva, bi morale jemati tudi dodatke vitamina D in kalcija, če jih ne dobivajo v zadostni količini s prehrano.
Bonviva is not recommended for patients who have severe kidney problems.
Zdravilo Bonviva ni priporočljivo za bolnike s hudimi ledvičnimi obolenji.
The active substance in Bonviva, ibandronic acid, is a bisphosphonate.
Zdravilna učinkovina v zdravilu Bonviva, ibandronska kislina, je bisfosfonat.
Bonviva was studied in three main studies involving women with osteoporosis.
Zdravilo Bonviva so proučevali v treh glavnih študijah, v katere so bile vključene ženske z osteoporozo.
The first study compared Bonviva 2.5 mg tablets taken once a day with placebo (a dummy treatment) in almost 3,000 women and looked at how many new spine fractures were seen in the patients over three years.
V prvi študiji so primerjali 2, 5- miligramske tablete zdravila Bonviva, ki so jih bolnice
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. 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 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 drugih dveh študijah so primerjali 150- miligramske mesečne tablete (pri 1 609 bolnicah) in injiciranje (1 395 bolnic) z 2, 5- miligramskimi tabletami, ki se jemljejo enkrat dnevno.
Note that the 2.5 mg once-daily tablets 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 Bonviva 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 Bonviva zmanjšalo tveganje za nove zlome hrbtenice za 62% v primerjavi s placebom.
The most common side effects with Bonviva 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 Bonviva (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.
For the full list of all side effects reported with Bonviva, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Bonviva, glejte navodilo za uporabo.
Bonviva should not be used in people who may be hypersensitive (allergic) to ibandronic acid or any of the other ingredients.
Zdravila Bonviva ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) ibandronsko kislino ali katero koli drugo sestavino zdravila.
Bonviva treatment may be linked to osteonecrosis of the jaw (collapse of bone tissue in the jaw).
Zdravljenje z zdravilom Bonviva je morda povezano z osteonekrozo čeljusti (odmiranje kostnega tkiva v čeljusti).
The Committee for Medicinal Products for Human Use (CHMP) decided that Bonviva’ 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 Bonviva 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 Bonviva be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Bonviva odobri dovoljenje za promet.
Other information about Bonviva:
Druge informacije o zdravilu Bonviva:
The European Commission granted a marketing authorisation valid throughout the European Union for Bonviva to Roche Registration Limited on 23 February 2004.
Evropska komisija je dovoljenje za promet z zdravilom Bonviva, veljavno po vsej Evropski uniji, odobrila družbi Roche Registration Limited dne 23. februarja 2004.
The full EPAR for Bonviva can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Bonviva je na voljo tukaj.
Blister (PVC/ PVDC) Blister (PVC/ PVDC)
Filmsko Obložena Tableta Peroralna Uporaba Pretisni Omot (PVC/ PVDC) Filmsko Obložena Tableta Peroralna Uporaba Pretisni Omot (PVC/ PVDC)
1 tablet 3 tablets
1 tableta 3 tablete
Solution for injection
Raztopina Za Injiciranje
Pre-filled syringe (glass)
Napolnjena Injekcijska Brizga (Steklo)
Posology:
Za peroralno uporabo.
The recommended dose is one 150 mg film-coated tablet once a month.
Priporočeni odmerek je ena 150 mg filmsko obložena tableta na mesec.
Bonviva 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 Bonviva 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 Bonviva 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 Bonvive naslednje jutro potem, ko se spomni, razen če je do naslednjega načrtovanega odmerka manj kot 7 dni.
Patients should receive supplemental calcium and / or vitamin D if dietary intake is inadequate (see section 4.4 and section 4.5).
2 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.
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.
Bonviva 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).
Bonviva pri bolnikih s kreatininskim očistkom pod 30 ml/ min zaradi omejenih kliničnih izkušenj ni priporočljiva (glejte poglavje 4. 4 in poglavje 5. 2).
Patients should not lie down for 1 hour after taking Bonviva.
Otroci in mladostniki Izkušenj pri otrocih ni.
Gastrointestinal Disorders Bisphosphonates have been associated with dysphagia, oesophagitis and oesophageal or gastric ulcers.
Hipokalcemijo je treba popraviti pred začetkom zdravljenja z Bonvivo.
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).
Zadosten vnos kalcija in vitamina D je pomemben za vse bolnike.
Physicians should be alert to signs or symptoms signalling a possible oesophageal reaction during therapy, and patients should be instructed to discontinue Bonviva and seek medical attention if they develop symptoms of oesophageal irritation such as new or worsening dysphagia, pain on swallowing, retrosternal pain, or heartburn.
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).
Since Nonsteroidal Anti-Inflamatory Drugs and bisphosphonates are both associated with gastrointestinal irritation, caution should be taken during concomitant administration.
Zdravniki morajo biti pozorni na znake ali simptome, ki opozarjajo na možno reakcijo v požiralniku med zdravljenjem.
Adequate intake of calcium and vitamin D is important in all patients.
Ker nesteroidna protivnetna zdravila in bisfosfonate povezujejo z gastrointestinalnim draženjem, je pri sočasnem peroralnem jemanju teh zdravil potrebna previdnost.
Renal impairment Due to limited clinical experience, Bonviva is not recommended for patients with a creatinine clearance below 30 ml/ min (see section 5.2).
Zaradi omejenih kliničnih izkušenj Bonvive ne priporočamo bolnikom, ki imajo kreatininski očistek manjši kot 30 ml/ min (glejte poglavje 4. 2 in 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.
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.
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).
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 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
Galactose intolerance Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicinal product.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze ne smejo jemati tega zdravila.
Oral bioavailability of ibandronic acid is generally reduced in the presence of food.
Interakcije zdravila s hrano Peroralna biološka uporabnost ibandronske kisline je v prisotnosti hrane večinoma zmanjšana.
In particular, products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk, are likely to interfere with absorption of Bonviva, 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 Bonvive, kar je v skladu z ugotovitvami študij na živalih.
Therefore, patients should fast overnight (at least 6 hours) before taking Bonviva and continue fasting for 1 hour following intake of Bonviva (see section 4.2).
Zato morajo bolniki jemati Bonvivo zjutraj na prazen želodec (vsaj 6 ur brez obroka), po zaužitju Bonvive pa morajo biti še 1 uro tešči.
Calcium supplements, antacids and some oral medicinal products containing multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with the absorption of Bonviva.
Farmakokinetične študije medsebojnega delovanja pri ženskah v postmenopavzi so pokazale, da s tamoksifenom ali hormonskim nadomestnim zdravljenjem (estrogenom) ne prihaja do medsebojnega delovanja.
Therefore, patients should not take other oral medicinal products for at least 6 hours before taking Bonviva and for 1 hour following intake of Bonviva.
Ker je to zvečanje v mejah normalne variabilnosti biološke uporabnosti ibandronske kisline, pri sočasnem jemanju Bonvive s H2- antagonisti ali drugimi zdravili, ki zvečajo pH želodca, prilagajanje odmerkov ni potrebno.
Among these patients, the incidence of upper gastrointestinal events in the patients treated with Bonviva 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 Bonviva 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.
Študije na podganah so pokazale določen vpliv na sposobnost razmnoževanja (glejte poglavje 5. 3).
However, since this increase is within the normal variability of the bioavailability of ibandronic acid, no dose adjustment is considered necessary when Bonviva is administered with H2- antagonists or other active substances which increase gastric pH.
Zdravilo Bonviva se med nosečnostjo ne sme uporabljati.
Pharmacokinetic interaction studies in postmenopausal women have demonstrated the absence of any interaction potential with tamoxifen or hormone replacement therapy (oestrogen).
Ni znano, ali se ibandronska kislina izloča v materino mleko.
No interaction was observed when co-administered with melphalan/ prednisolone in patients with multiple myeloma.
Študije pri podganah v laktaciji so pokazale, da je po intravenskem dajanju v mleku prisotna majhna količina ibandronske kisline.
4 4.6 Pregnancy and lactation
4 Zdravilo Bonviva se med dojenjem ne sme uporabljati.
In a two-year study in postmenopausal women with osteoporosis (BM 16549) the overall safety of Bonviva 150 mg once monthly and ibandronic acid 2.5 mg daily was similar.
V dveletni študiji pri ženskah z osteoporozo v postmenopavzi (BM 16549) je bila celokupna varnost Bonvive 150 mg enkrat na mesec in ibandronske kisline 2, 5 mg enkrat na dan podobna.