natgillin/translations-raw huggingface dataset:
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimization) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
If you develop these symptoms, stop taking Bondronat and tell your doctor straight away (see sections 3 and 4).
Če se pojavijo ti simptomi, prenehajte z jemanjem zdravila Bondronat in takoj obvestite svojega zdravnika (glejte poglavji 3 in 4).
• you don't receive routine dental care or have not had a dental check up for a long time
• nimate redne zobozdravstvene oskrbe ali že dolgo niste bili na pregledu pri zobozdravniku;
The usual dose of Bondronat is one tablet each day.
Običajni odmerek zdravila Bondronat je ena tableta vsak dan.
Bondronat with food and drink
Zdravilo Bondronat skupaj s hrano in pijačo
**See further information below †Identified in post-marketing experience.
**Glejte nadaljne informacije spodaj † ugotovljeni po prihodu zdravila na trg
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRIDUCT
PRILOGA II A. IZDELOVALEC (IZDELOVALCI) ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
• rise in body temperature
• zvišanje telesne temperature,
In some cases, these events did not resolve until the ibandronic acid was discontinued.
V nekaterih primerih ti dogodki niso prenehali, dokler niso ibandronske kisline ukinili.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 June 1996
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 25. junij 1996 Datum zadnjega podaljšanja: 25. junij 2006
This leaflet was last revised in {MM/YYYY}
Navodilo je bilo nazadnje revidirano
Analgesic use *
uporaba analgezije *
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorsation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
• if you are allergic to any other bisphosphonates
• če ste alergični na druge difosfonate,
Do not take Bondronat:
Ne jemljite zdravila Bondronat:
Other medicines and Bondronat
Druga zdravila in zdravilo Bondronat
even if their signs of illness are the same as yours
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
What Bondronat is and what it is used for
Kaj je zdravilo Bondronat in za kaj ga uporabljamo
This belongs to a group of medicines called bisphosphonates.
Spada v skupino zdravil, imenovano difosfonati.
Products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk and food, are likely to interfere with absorption of Bondronat tablets.
Pripravki, ki vsebujejo kalcij in druge večvalentne katione (kot so aluminij, magnezij, železo), vključno z mlekom in hrano, lahko vplivajo na absorpcijo tablet Bondronat.
Before receiving treatment, tell your doctor/nurse (health care professional) if:
Pred zdravljenjem obvestite zdravnika/medicinsko sestro (zdravstvenega delavca), če:
• dry mouth, strange taste in your mouth or difficulty swallowing
• suha usta, čuden okus v ustih ali težave pri požiranju,
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Priloga I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
Children and adolescents Bondronat should not be used in children and adolescents below the age of 18 years.
Otroci in mladostniki Zdravilo Bondronat se ne sme uporabljati pri otrocih in mladostnikih, starih manj kot 18 let.
Water may be taken at any time during the course of Bondronat treatment (see section 4.5).
Vodo lahko med zdravljenjem z zdravilom Bondronat pijemo kadar koli (glejte poglavje 4.5).
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
Še posebej obvestite svojega zdravnika ali farmacevta, če jemljete katere koli izmen naslednjih zdravil:
• Bondronat is normally given by a doctor or other medical staff who have experience with the treatment of cancer
• Zdravilo Bondronat vam bo ponavadi dal zdravnik ali drugo zdravstveno osebje, ki ima izkušnje pri zdravljenju raka.
• you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)
• ste se že zdravili z difosfonati (ki se uporabljajo za zdravljenje ali preprečevanje bolezni kosti);
Bondronat tablets should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day.
Tablete Bondronat je treba vzeti po postu prek noči (najmanj 6 ur) pred prvim zaužitjem hrane ali pijače v dnevu.
Take Bondronat at least 6 hours after you last had anything to eat, drink or any other medicines or supplements (e.g. products containing calcium (milk), aluminium, magnesium and iron) except water.
Vzemite zdravilo Bondronat vsaj 6 ur po vašem zadnjem zaužitem obroku, pijači, katerem koli zdravilu ali dodatku (to so zdravila, ki vsebujejo kalcij (mleko), aluminij, magnezij in železo) razen vodi.
• It helps to prevent your bones from breaking (fractures)
• Pomaga preprečiti zlome (frakture) kosti.
Do not take Bondronat with food or any other drinks except water as Bondronat is less effective if it is taken with food or drink (see section 3).
Ne jemljite zdravila Bondronat s hrano ali katero koli drugo pijačo razen vodo, ker lahko jemanje zdravila s hrano ali pijačo povzroči, da je zdravilo Bondronat manj učinkovito (glejte poglavje 3).
• changes in your blood cells (‘anaemia')
• spremembe v številu krvnih celic (anemija),
• if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are listed in section 6
• če ste alergični na ibandronsko kislino ali katero koli drugo sestavino tega zdravila, navedeno v poglavju 6,
Taking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of Bondronat.
Jemanje zdravil, ki znižujejo količino kisline v želodcu, kot sta cimetidin in ranitidin, lahko rahlo povečajo učinek zdravila Bondronat.
• Take your tablet as soon as you get up for the day before having your first food, drink, any medicine or supplements
• vzamete tableto kmalu po tem, ko zjutraj vstanete, preden zaužijete prvo hrano, pijačo, katero koli zdravilo ali dodatek;
Irritation, inflammation or ulceration of the gullet/food pipe (oesophagus) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur, especially if you do not drink a full glass of water and/or if you lie down within an hour of taking Bondronat.
Lahko se pojavijo draženje, vnetje ali razjede v požiralniku (ezofagusu), pogosto s simptomi hude bolečine v prsih, hude bolečine po požiranju hrane in/ali pijače, hudo slabostjo in bruhanjem, še posebno, če ne popijete celega kozarca vode in/ali se uležete v eni uri po jemanju zdravila Bondronat.
The inhibition of endogenous bone resorption has also been documented by 45Ca kinetic studies and by the release of radioactive tetracycline previously incorporated into the skeleton.
Inhibicijo endogene resorpcije kosti so dokazali tudi s kinetičnimi raziskavami 45Ca in s sproščanjem radioaktivnega tetraciklina, predhodno vgrajenega v okostje.
Talk to a nurse or doctor if any effects become troublesome or last more than a couple of days
Posvetujte se z medicinsko sestro ali zdravnikom, če ti neželeni učinki postanejo hujši ali če trajajo več kot nekaj dni,
Gender Bioavailability and pharmacokinetics of ibandronic acid are similar in both men and women.
Spol Biološka uporabnost in farmakokinetika ibandronske kisline sta pri moških in ženskah podobni.
The safety and efficacy of Bondronat in children and adolescents below the age of 18 years have not been established.
Varnost in učinkovitost zdravila Bondronat pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
INFORMATION IN BRAILLE bondronat 50 mg
PODATKI V BRAILLOVI PISAVI bondronat 50 mg
In particular, tell your doctor or pharmacist if you are receiving a type of antibiotic injection called ‘aminoglycoside' such as gentamicin.
Še posebej obvestite svojega zdravnika ali farmacevta, če v obliki injekcije prejemate antibiotik iz skupine aminoglikozidov, kot je gentamicin.
• if you have heart problems and the doctor recommended to limit your daily fluid intake
• če imate težave s srcem in vam je zdravnik priporočil, da omejite dnevni vnos tekočin.
• changes in blood test results such as Gamma GT or creatinine
• spremembe v laboratorijskih vrednostih, kot sta gama GT ali kreatinin,
- Water is the only drink that should be taken with Bondronat.
- Voda je edina tekočina, ki jo lahko bolnik zaužije z zdravilom Bondronat.
White to off-white film-coated tablets, of oblong shape engraved “L2” on one side and “IT” on the other side.
Bele do sivo bele filmsko obložene tablete, podolgovate oblike z vgravirano oznako “L2” na eni strani in “IT” na drugi strani.
Therefore, Bondronat should not be used during pregnancy.
Zato se zdravila Bondronat med nosečnostjo ne sme uporabljati.
• you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
• jemljete zdravila, imenovana kortikosteroidi (kot sta prednizolon ali deksametazon);
• if you have high or low levels of vitamin D, calcium or any other minerals
• če imate visoke ali nizke koncentracije vitamina D, kalcija ali drugih mineralov,
You may be having a serious, potentially life threatening allergic reaction (see section 2)
Lahko imate resno, morda življenjsko ogrožujočo alergijsko reakcijo (glejte poglavje 2);
In a study in 130 patients with metastatic breast cancer the safety of Bondronat infused over 1 hour or 15 minutes was compared.
V študiji so pri 130 bolnikih z metastatskim rakom dojke primerjali varnost dajanja infuzije zdravila Bondronat v času več kot 1 uro z dajanjem v času 15 minut.
- Treatment of tumour-induced hypercalcaemia with or without metastases
- zdravljenje tumorsko povzročene hiperkalciemije z metastazami ali brez njih.
Frequency categories are defined using the following convention: very common (>1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Neželeni učinki so navedeni po organskih sistemih in pogostnosti po MedDRA. Glede na pogostnost so neželeni učinki opredeljeni kot zelo pogosti (≥1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
Total clearance of ibandronic acid was reduced to 44 ml/min in the subjects with severe renal impairment compared with 129 mL/min in subjects with normal renal function.
Celokupni očistek ibandronske kisline je bil pri bolnikih s hudo ledvično okvaro zmanjšan na 44 ml/min v primerjavi s 129 ml/min pri bolnikih z normalno ledvično funkcijo.
• you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction
• imate težave v ustih ali z zobmi, kot so slabo zdravstveno stanje zobovja, bolezni dlesni ali načrtujete izdrtje zoba;
If you are taking a tablet each day, skip the missed dose completely.
Če jemljete tablete vsak dan, izpustite pozabljeni odmerek.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
• acetylsalicylic acid and non-steroidal anti-inflammatory medicines called “NSAIDs”, such as ibuprofen or naproxen.
• acetilsalicilno kislino ali nesteroidna protivnetna zdravila, imenovana NSAID, kot so ibuprofen ali naproksen.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 1 viala
Less frequently, a decrease in serum calcium below normal range (hypocalcaemia) is reported.
Manj pogosto poročajo o znižanju serumskega kalcija pod spodnjo mejo normale (hipokalciemija).
Your doctor may ask you to undergo a dental examination before starting treatment with Bondronat.
Zdravnik vam bo morda svetoval, da pred začetkom zdravljenja z zdravilom Bondronat opravite zobozdravstveni pregled.
Temporary interruption of Bondronat treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Razmisliti je treba o začasni prekinitvi zdravljenja z zdravilom Bondronat, dokler se stanje ne popravi in zmanjša vpliv ostalih dejavnikov tveganja, če je to mogoče.
No data are available (see section 5.1 and section 5.2).
Podatki niso na voljo (glejte poglavji 5.1 in 5.2).
Table 2 Efficacy Results (Breast Cancer Patients with Metastatic Bone Disease) All Skeletal Related Events (SREs) Placebo n=158
Rezultati učinkovitosti (bolniki z rakom dojke in metastatično boleznijo kosti) Vsi z okostjem povezani dogodki (SREs) Placebo n = 158
LIST OF EXCIPIENTS The tablets also contain lactose monohydrate.
SEZNAM POMOŽNIH SNOVI Tablete vsebujejo tudi monohidrat laktoze.
Bondronat 50 mg film coated tablets are supplied in blisters (aluminium) containing 7 tablets, which are presented as packs containing 28 or 84 tablets.
Filmsko obložene tablete Bondronat 50 mg so pakirane v pretisnih omotih (aluminij) po 7 tablet, na voljo so v škatlah z 28 ali 84 tabletami.
In subjects with severe renal impairment (mean estimated CLcr = 21.2 mL/min), dose-adjusted mean AUC0-24h was increased by 110% compared to healthy volunteers.
Pri ljudeh s hudo ledvično okvaro (ocenjeno povprečje CLcr = 21,2 ml/min) se je povprečna vrednost AUC0-24 h glede na odmerek povečala za 110 % v primerjavi z zdravimi prostovoljci.
Burnt Mills Industrial Estate Basildon, SS13 1QF United Kingdom
Burnt Mills Industrial Estate Basildon, SS13 1QF Velika Britanija
5 How to store Bondronat Contents of the pack and other information
5 Shranjevanje zdravila Bondronat Vsebina pakiranja in dodatne informacije
You may be having a serious, potentially life threatening allergic reaction
Lahko imate resno, morda življenjsko ogrožujočo alergijsko reakcijo;
If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Bondronat.
Če vam zdravijo zobe ali boste imeli operacijo (npr. izdrtje zoba), o tem obvestite zdravnika, zobozdravniku pa povejte, da se zdravite z zdravilom Bondronat.
Take your tablet at least 6 hours after you last had anything to eat, drink or any other medicines or supplements except water.
Vzemite vašo tableto vsaj 6 ur po vašem zadnjem zaužitem obroku, pijači, katerem koli zdravilu ali dodatku razen vodi.
For these patients and dosages, the median time to achieve normocalcaemia was 4 to 7 days.
Za te bolnike je bil pri teh odmerkih mediana časa do normokalciemije 4 do 7 dni.
Bondronat contains less than 1 mmol sodium (23 mg) per vial, i.e. ‘essentially sodium free'.
Zdravilo Bondronat vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni "brez natrija".
Bondronat tablets contain lactose and should not be administered to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Tablete Bondronat vsebujejo laktozo, zato jih ne smemo dajati bolnikom z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze in galaktoze.
Medicinal product -Food Interactions
Medsebojno delovanje med zdravilom in hrano
SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago
• tablet coat: hypromellose, titanium dioxide (E 171), talc, macrogol 6,000
• obloga tablete: hipromeloza, titanov dioksid (E 171), smukec, makrogol 6000.
If you stop taking Bondronat
Če ste prenehali jemati zdravilo Bondronat
This is because Bondronat can affect the way some other medicines work.
Zdravilo Bondronat lahko vpliva na delovanje drugih zdravil.
Then you can have your first food and drink, and take any medicines or supplements
Nato lahko zaužijete prvo hrano, pijačo in druga zdravila ali dodatke.
Nevertheless, according to clinical assessment of the individual patient, it is recommended that renal function, serum calcium, phosphate and magnesium should be monitored in patients treated with Bondronat.
Glede na klinično oceno posameznega bolnika pa je ledvično funkcijo, serumske koncentracije kalcija, fosfata in magnezija pri bolnikih, ki se zdravijo z zdravilom Bondronat, priporočljivo spremljati.
Receiving this medicine
Prejemanje zdravila
All Skeletal Related Events (SREs) Placebo n=277
vsi z okostjem povezani dogodki (SREs) Placebo n = 277
• skin problems
• kožne težave,
The median time to relapse was 26 days with a dose of 6 mg.
Mediana časa do relapsa je pri odmerku 6 mg znašala 26 dni.
Paediatric population (see section 4.2 and section 5.2) The safety and efficacy of Bondronat in children and adolescents below the age of 18 years have not been established.
Pediatrična populacija (glejte poglavji 4.2 in 5.2) Varnost in učinkovitost zdravila Bondronat pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
≥50 CLcr<80 6 mg (6 ml of concentrate for solution for infusion)
≥50 CLcr < 80 6 mg (6 ml koncentrata za raztopino za infundiranje)
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih poškodba,
• sleep problems, feeling anxious, emotional instability, or mood swings
• težave s spanjem, občutek zaskrbljenosti, čustvena nestabilnost ali menjava razpoloženja,
The recommended dose is one 50 mg film-coated tablet daily.
Odmerjanje Priporočeni odmerek je ena 50 mg filmsko obložena tableta na dan.
While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to Bondronat administration.
Invazivne zobozdravstvene posege se lahko med zdravljenjem opravi le po temeljitem razmisleku, zlasti se jim je treba izogibati v času blizu termina prejema zdravila Bondronat.
METHOD AND ROUTE(S) OF ADMINISTRATION Do not suck, chew or crush tablets Read the package leaflet before use Oral use
POSTOPEK IN POT(I) UPORABE ZDRAVILA Tablet ne sesajte, žvečite ali drobite Pred uporabo preberite priloženo navodilo Peroralna uporaba
• if you have high or low blood levels of vitamin D or any other minerals
• če imate visoke ali nizke koncentracije vitamina D ali drugih mineralov v krvi,
If you forget to take Bondronat
Če ste pozabili vzeti zdravilo Bondronat
Also some other medicines can affect the way Bondronat works.
Prav tako lahko druga zdravila vplivajo na delovanje zdravila Bondronat.
Clinical studies have not shown any evidence of deterioration in renal function with long term Bondronat therapy.
Klinične študije niso pokazale, da bi pri dolgotrajnem zdravljenju z zdravilom Bondronat prišlo do poslabšanja ledvične funkcije.
Dosage: Treatment of Tumour-induced Hypercalcaemia Bondronat is usually administered in a hospital setting.
Odmerjanje: zdravljenje tumorsko povzročene hiperkalciemije Dajanje zdravila Bondronat običajno poteka v bolnišnici.
What Bondronat looks like and contents of the pack Bondronat is a colourless, clear solution.
Izgled zdravila Bondronat in vsebina pakiranja Zdravilo Bondronat je brezbarvna, bistra raztopina.
Bondronat should not be used during breast-feeding.
Zdravila Bondronat se ne sme uporabljati med dojenjem.
• weakness
• šibkost.
As no clinical data are available, dose recommendations cannot be given for patients with severe hepatic insufficiency (see section 4.2).
Ker za bolnike s težko insuficienco jeter klinični podatki niso na voljo, za to skupino bolnikov ne moremo dati priporočil o odmerjanju (glejte poglavje 4.2).
Milk or antacids should be given to bind Bondronat.
Za vezavo zdravila Bondronat je treba zaužiti mleko ali antacide.
Sodium acetate, sodium chloride, acetic acid and water for injections.
Natrijev acetat, natrijev klorid, ocetna kislina in voda za injekcije.
Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (158 patients) or 6 mg Bondronat (154 patients).
Bolnice z rakom dojke in radiološko potrjenimi metastazami v kosteh so prejemale placebo (158 bolnic) ali 6 mg zdravila Bondronat (154 bolnic).
Waymade PLC Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR United Kingdom
Waymade PLC Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR Velika Britanija
• a condition affecting the blood vessels in your brain called ‘cerebrovascular disorder' (stroke or brain bleeding)
• stanje, ki prizadene žile v možganih, imenovano cerebrovaskularna bolezen (kap ali krvavitev iz možganov),
Contains 88.1 mg lactose (as lactose monohydrate).
Pomožne snovi z znanim učinkom: vsebuje 88,1 mg laktoze (v obliki laktoze monohidrata).
Care must be taken not to administer Bondronat concentrate for solution for infusion via intra-arterial or paravenous administration, as this could lead to tissue damage.
Paziti je treba, da koncentrata za raztopino za infundiranje zdravila Bondronat ne dajemo intraarterijsko ali paravensko, ker lahko to vodi v poškodbo tkiva.
• Stay upright (sitting or standing) while taking your tablet and for the next hour (60 minutes).
• med jemanjem tablete in še naslednjo uro (60 minut) ostanete v pokončnem položaju (stoje ali sede).
Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (277 patients) or 50 mg Bondronat (287 patients).
Bolnice z rakom dojke in radiološko potrjenimi metastazami v kosteh so prejemale placebo (277 bolnic) ali 50 mg zdravila Bondronat (278 bolnic).
Urinary concentrations of the bone resorption marker CTx (C-terminal telopeptide released from Type I collagen) were significantly reduced in the Bondronat group compared to placebo.
Koncentracije označevalca resorpcije kosti CTx (C-terminalni telopeptid, ki se sprosti s kolagena tipa I) v seču so bile v skupini zdravljeni z zdravilom Bondronat v primerjavi s placebom značilno znižane.
• stomach problems such as ‘gastroenteritis” or ‘gastritis'
• težave z želodcem, kot sta gastroenteritis in gastritis,
Manufacturer Waymade PLC Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR United Kingdom
Izdelovalec Waymade PLC Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR Velika Britanija
• tablet core: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, purified stearic acid, colloidal anhydrous silica
• jedro tablete: monohidrat laktoze, povidon, mikrokristalna celuloza, krospovidon, prečiščena stearinska kislina, brezvoden koloidni silicijev dioksid;
On the basis of the pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that Bondronat has no or negligible influence on the ability to drive and use machines.
Glede na farmakodinamske in farmakokinetične lastnosti ter poročane neželene učinke pričakujemo, da zdravilo Bondronat nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.