natgillin/translations-raw huggingface dataset:
Since patients with osteoporosis may not get enough vitamin D3 through exposure to sunlight, it is included in ADROVANCE.
Glede na to da utegnejo bolniki z osteoporozo z izpostavljanjem sončni svetlobi dobiti premalo vitamina D3, je ta vključen v zdravilo ADROVANCE.
How has ADROVANCE been studied?
Kako je bilo zdravilo ADROVANCE raziskano?
Because alendronate and vitamin D3 are already used separately in authorised medicines in the European Union, the company presented data obtained in earlier studies and from the published literature.
Ker se alendronat in vitamin D3 ločeno že uporabljata v zdravilih, odobrenih v Evropski uniji, je podjetje predložilo podatke iz starejših raziskav ter iz objavljene literature.
The company also carried out a study in 35 men and 682 post-menopausal women with osteoporosis to show ADROVANCE’ s effectiveness in increasing vitamin D levels.
Podjetje je izvedlo tudi raziskavo, v katero je bilo vključenih 35 moških in 682 žensk s pomenopavzalno osteoporozo, da bi tako dokazalo učinkovitost zdravila ADROVANCE pri zviševanju ravni vitamina D.
Patients received either ADROVANCE or alendronate only once a week.
Bolniki so enkrat tedensko prejemali bodisi zdravilo ADROVANCE bodisi le alendronat.
The main measure of effectiveness was the percentage of patients with low vitamin D levels.
Glavno merilo učinkovitosti je bil čim nižji delež bolnikov z nizko ravnjo vitamina D.
What benefit has ADROVANCE shown during the studies?
Kakšne koristi je zdravilo ADROVANCE izkazalo med raziskavami?
After 15 weeks of treatment, the proportion of patients with low vitamin D levels was lower among the patients treated with ADROVANCE (11%) than those taking alendronate only (32%).
Po 15 tednih zdravljenja je bil delež bolnikov z nizko ravnjo vitamina D med bolniki, zdravljenimi z zdravilom ADROVANCE, nižji (11%) kot pri tistih, ki so prejemali le alendronat (32%).
The company also presented evidence that the dose of alendronate included in ADROVANCE was the same as the dose needed to prevent bone loss.
Podjetje je predložilo tudi dokazila, da je odmerek alendronata, ki ga vsebuje zdravilo ADROVANCE, enak odmerku, potrebnemu za preprečevanje izgube kostne mase.
What is the risk associated with ADROVANCE?
Kakšna tveganja so povezana z zdravilom ADROVANCE?
The most common side effects (seen in between 1 and 10 patients in 100) are headache, musculoskeletal (bone, muscle or joint) pain and gastro-intestinal symptoms such as abdominal (tummy) pain, dyspepsia (indigestion), constipation, diarrhoea, flatulence (wind), oesophageal (gullet) ulcers, dysphagia (difficulty swallowing), abdominal distension (swollen tummy) and acid regurgitation.
Najpogostejši neželeni stranski učinki (opaženi pri 1 do 10 izmed 100 bolnikov) so glavobol, mišično - skeletne bolečine (v kosteh, mišicah ali sklepih) in prebavne težave, kot so bolečine v trebuhu, dispepsija (slaba prebava), zaprtje, driska, flatulenca (vetrovi), razjede požiralnika, disfagija (motnje pri požiranju), napet trebuh, gastroezofagalni refluks.
For the full list of all side effects reported with ADROVANCE, see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila ADROVANCE, najdete v Navodilih za uporabo.
ADROVANCE should not be used in people who may be hypersensitive (allergic) to alendronate, vitamin D3 or any of the other ingredients.
Zdravila ADROVANCE se ne sme uporabljati pri ljudeh, ki utegnejo biti preobčutljivi za (alergični na) alendronat, vitamin D3 ali katero drugo sestavino.
It should not be used where there are abnormalities of the oesophagus (gullet), in patients who have hypocalcaemia (low calcium levels), or in patients who cannot stand or sit upright for at least 30 minutes.
Ne sme se uporabljati v primeru nenormalnosti požiralnika, pri bolnikih s hipokalcemijo (nizko vrednostjo kalcija) ali pri bolnikih, ki ne morejo stati ali sedeti vzravnano vsaj 30 minut.
Why has ADROVANCE been approved?
Zakaj je bilo zdravilo ADROVANCE odobreno?
The Committee for Medicinal products for Human Use (CHMP) decided that ADROVANCE’ s benefits are greater than its risks for the treatment of osteoporosis in postmenopausal women at risk of vitamin D insufficiency.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila ADROVANCE pri zdravljenju in preprečevanju osteoporoze pri ženskah po menopavzi večje od z njim povezanih tveganj.
The Committee recommended that ADROVANCE be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo ADROVANCE podeli dovoljenje za promet.
Other information about ADROVANCE:
Druge informacije o zdravilu ADROVANCE:
The European Commission granted a marketing authorisation valid throughout the European Union for ADROVANCE to Merck Sharp & Dohme Ltd. on 4 January 2007.
Evropska komisija je dovoljenje za promet z zdravilom ADROVANCE, veljavno po vsej Evropski uniji, odobrila družbi Merck Sharp & Dohme Ltd dne 4 januarja 2007.
The full EPAR for ADROVANCE is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo ADROVANCE je na voljo tukaj.
This summary was last updated in 11-2006.
Ta povzetek je bil nazadnje posodobljen 11- 2006.
Invented name Adrovance Adrovance Adrovance Adrovance Adrovance Adrovance Adrovance Adrovance Adrovance
ADROVANCE ADROVANCE ADROVANCE ADROVANCE ADROVANCE ADROVANCE ADROVANCE ADROVANCE ADROVANCE
Strength 70 mg/ 2800 IU 70 mg/ 2800 IU 70 mg/ 2800 IU 70 mg/ 2800 IU 70 mg/ 2800 IU 70 mg/ 5600 IU 70 mg/ 5600 IU 70 mg/ 5600 IU 70 mg/ 5600 IU
70 mg/ 5. 600 i. e.
Pharmaceutical Form Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
tableta tableta tableta tableta tableta tableta tableta tableta tableta
Route of Administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba
Packaging blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu)
pretisni omot (alu/ alu) pretisni omot (alu/ alu) pretisni omot (alu/ alu) pretisni omot (alu/ alu) pretisni omot (alu/ alu) pretisni omot (alu/ alu) pretisni omot (alu/ alu) pretisni omot (alu/ alu) pretisni omot (alu/ alu)
Package size 2 tablets 4 tablets 6 tablets 12 tablets 40 tablets 2 tablets 4 tablets 12 tablets 40 tablets
2 tableti 4 tablete 6 tablet 12 tablet 40 tablet 2 tableti 4 tablete 12 tablet 40 tablet
ADROVANCE 70 mg/ 2800 IU tablets
ADROVANCE 70 mg/ 2. 800 i. e. tablete
Each tablet contains 70 mg alendronic acid as alendronate sodium trihydrate, and 70 micrograms (2800 IU) colecalciferol (vitamin D3).
Vsaka tableta vsebuje 70 mg alendronske kisline v obliki natrijevega alendronata trihidrata in 70 mikrogramov (2. 800 i. e.) holekalciferola (vitamina D3).
Each tablet contains 62 mg lactose anhydrous and 8 mg sucrose.
Ena tableta vsebuje 62 mg brezvodne laktoze in 8 mg saharoze.
Capsule-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and '710 'on the other.
Tablete v obliki kapsule, bele do skoraj bele barve, ki imajo na eni strani vtisnjen obris kosti, na drugi pa oznako '710'.
Treatment of postmenopausal osteoporosis in patients at risk of vitamin D insufficiency.
Zdravljenje pomenopavzalne osteoporoze pri bolnikih s tveganjem pomanjkanja vitamina D.
ADROVANCE reduces the risk of vertebral and hip fractures.
ADROVANCE zmanjša tveganje za vertebralne zlome in za zlome kolka.
The recommended dosage is one ADROVANCE tablet once weekly.
Priporočeni odmerek je ena FOSAVANCE tableta enkrat tedensko.
Due to the nature of the disease process in osteoporosis, ADROVANCE is intended for long-term use.
Zaradi narave bolezenskega procesa osteoporoze, je ADROVANCE namenjen za dolgotrajno uporabo.
To permit adequate absorption of alendronate:
Da bi omogočili zadostno absorpcijo alendronata:
ADROVANCE must be taken with water only (not mineral water) at least 30 minutes before the first food, beverage, or medicinal product (including antacids, calcium supplements and vitamins) of the day.
Moramo ADROVANCE vzeti izključno z navadno vodo (ne z mineralno vodo) najmanj pol ure pred prvim dnevnim obrokom hrane in pijače ali zaužitjem drugih zdravil (vključno z antacidi, pripravki kalcija in vitamini).
Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronate (see section 4.5).
Druge pijače (vključno z mineralno vodo), hrana in nekatera zdravila lahko zmanjšajo absorpcijo alendronata (glejte poglavje 4. 5).
The following instructions should be followed exactly in order to minimize the risk of oesophageal irritation and related adverse reactions (see section 4.4):
Naslednjim navodilom je potrebno dosledno slediti, da se zmanjša tveganje draženja požiralnika in s tem povezani neželeni učinki (glejte poglavje 4. 4):
• ADROVANCE should only be swallowed after getting up for the day with a full glass of water (not less than 200ml or 7fl. oz.).
• bolnik mora ADROVANCE pogoltniti zjutraj, ko vstane, s polnim kozarcem vode (ne manj kot 200 ml),
• Patients should not chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.
• bolnik tablete ne sme žvečiti ali je raztopiti v ustih, ker obstaja nevarnost razjede v ustih in žrelu,
• Patients should not lie down until after their first food of the day which should be at least 30 minutes after taking the tablet.
• bolnik se ne sme uleči, dokler ne zaužije prvega dnevnega obroka hrane, kar pa ne sme biti prej kot 30 minut po zaužitju tablete,
• Patients should not lie down for at least 30 minutes after taking ADROVANCE.
2 • bolnik se še vsaj 30 minut po zaužitju tablete ADROVANCE ne sme uleči,
2 • ADROVANCE should not be taken at bedtime or before arising for the day.
• bolnik zdravila ADROVANCE ne sme vzeti pred spanjem ali preden zjutraj vstane.
Patients should receive supplemental calcium if intake from diet is inadequate (see section 4.4).
V kolikor je vnos s hrano nezadosten, morajo bolniki prejemati nadomestni kalcij (glejte poglavje 4. 4).
Additional supplementation with vitamin D should be considered on an individual basis taking into account any vitamin D intake from vitamins and dietary supplements.
O še dodatnem jemanu vitamina D je treba presoditi pri vsakem bolniku posebej, pri tem pa upoštevati vnos vitamina D z vitamini in dodatki v prehrani.
The equivalence of intake of 2800 IU of vitamin D3 weekly in ADROVANCE to daily dosing of vitamin D 400 IU has not been studied.
Ekvivalent vnosa 2. 800 i. e. vitamina D3 tedensko v zdravilu ADROVANCE dnevnemu odmerjanju vitamina D 400 i. e. ni bil preučevan.
Use in the elderly:
Uporaba pri starejših:
In clinical studies there was no age-related difference in the efficacy or safety profiles of alendronate.
V kliničnih raziskavah ni bilo nobenih od starosti odvisnih razlik v učinkovitosti in varnosti alendronata.
Therefore no dosage adjustment is necessary for the elderly.
Zato pri starejših prilagajanje odmerkov ni potrebno.
Use in renal impairment:
Uporaba pri bolnikih z ledvično okvaro:
No dosage adjustment is necessary for patients with a glomerular filtration rate (GFR) greater than 35ml/ min.
Pri bolnikih, pri katerih je hitrost glomerulne filtracije večja od 35 ml/ min, prilagajanje odmerkov ni potrebno.
ADROVANCE is not recommended for patients with renal impairment where GFR is less than 35ml/ min, due to lack of experience.
Bolnikom, pri katerih je hitrost glomerulne filtracije pod 35 ml/ min, pa se zdravilo ADROVANCE zaradi pomanjkanja izkušenj ne priporoča.
ADROVANCE has not been studied in children and adolescents and therefore should not be given to them.
Zdravila ADROVANCE pri otrocih in mladostnikih niso preučevali, zato ga ne smejo jemati.
• Hypersensitivity to the active substances or to any of the excipients.
• Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
• Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia.
• Nenormalnosti požiralnika in drugi dejavniki, ki upočasnjujejo praznjenje požiralnika, kot sta zožitev ali ahalazija.
• Hypocalcaemia.
• Hipokalciemija.
Alendronate Alendronate can cause local irritation of the upper gastrointestinal mucosa.
Alendronat Alendronat lahko povzroči lokalno draženje sluznice zgornjega dela prebavil.
Because there is a potential for worsening of the underlying disease, caution should be used when alendronate is given to patients with active upper gastrointestinal problems, such as dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, or with a recent history (within the previous year) of major gastrointestinal disease such as peptic ulcer, or active gastrointestinal bleeding, or surgery of the upper gastrointestinal tract other than pyloroplasty (see section 4.3).
Previdnost je potrebna tudi pri bolnikih, ki so imeli v zadnjem obdobju (v preteklem letu) hujše bolezni prebavil, kot na primer peptično razjedo, aktivno krvavitev iz prebavil ali kirurški poseg (razen piloroplastike) v zgornjem delu prebavil (glejte poglavje 4. 3).
Oesophageal reactions (sometimes severe and requiring hospitalisation), such as oesophagitis, oesophageal ulcers and oesophageal erosions, rarely followed by oesophageal stricture, have been reported in patients receiving alendronate.
V nekaterih primerih so bili ti neželeni pojavi hujši in so zahtevali zdravljenje v bolnišnici.
Physicians should therefore be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue alendronate and seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing or retrosternal pain or new or worsening heartburn (see section 4.8).
Bolniku mora naročiti, naj v primeru simptomov draženja požiralnika, kot so disfagija, bolečine pri požiranju ali retrosternalna bolečina, pojav zgage ali poslabšanje le- te, prekine zdravljenje z alendronatom in poišče zdravniško pomoč (glejte poglavje 4. 8).
The risk of severe oesophageal adverse reactions appears to be greater in patients who fail to take alendronate properly and/ or who continue to take alendronate after developing symptoms suggestive of oesophageal irritation.
Kaže, da je tveganje za resne neželene učinke v požiralniku večje pri bolnikih, ki alendronata ne jemljejo pravilno in/ ali nadaljujejo z jemanjem tudi po pojavu simptomov, ki kažejo na razdraženost požiralnika.
It is very important that the full dosing instructions are provided to, and are understood by the patient (see section 4.2).
Zelo pomembno je, da se bolnika natančno pouči, kako naj jemlje alendronat, in da bolnik navodila tudi razume (glejte poglavje 4. 2).
3 While no increased risk was observed in extensive clinical trials with alendronate, there have been rare (post-marketing) reports of gastric and duodenal ulcers, some of which were severe and with complications (see section 4.8).
V obdobju trženja zdravila so redko poročali o razjedah v želodcu in dvanajstniku (nekatere so bile resne in s komplikacijami) (glejte poglavje 4. 8).
Osteonecrosis of the jaw, generally associated with tooth extraction and/ or local infection (including osteomyelitis) has been reported in patients with cancer who are receiving treatment regimens including primarily intravenously administered bisphosphonates.
O osteonekrozi čeljusti, navadno povezani z ekstrakcijo zoba in / ali lokalno okužbo (vključno z osteomielitisom), so poročali pri bolnikih z rakom, ki so kot del zdravljenja prejemali predvsem intravensko aplicirane bisfosfonate.
Many of these patients were also receiving chemotherapy and corticosteroids.
Veliko teh bolnikov je prejemalo tudi kemoterapijo in glukokortikoide.
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, periodontal disease).
Pred začetkom zdravljenja z bisfosfonati je pri bolnikih s spremljajočimi dejavniki tveganja (npr. rakom, kemoterapijo, radioterapijo, kortikosteroidi, slabo ustno higieno, težavami z dlesnimi) treba razmisliti o preventivnem zobozdravniškem pregledu.
Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/ risk assessment.
Lečeči zdravnik naj zdravljenje prilagodi vsakemu posameznemu bolniku glede na njegovo oceno razmerja koristi/ tveganja.
Bone, joint, and/ or muscle pain has been reported in patients taking bisphosphonates.
Pri bolnikih, ki so jemali bisfosfonate, so poročali o bolečinah v kosteh, sklepih in/ ali mišicah.
In post-marketing experience, these symptoms have rarely been severe and/ or incapacitating (see section 4.8).
Po izkušnjah s tržišča so bili ti simptomi le redko hudi in/ ali onesposabljajoči (glejte poglavje 4. 8).
The time to onset of symptoms varied from one day to several months after starting treatment.
Čas do začetka simptomov je bil od enega dneva do več mesecev po začetku zdravljenja.
They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.
Nadaljevati morajo z jemanjem ene tablete enkrat na teden na izbrani dan, tako kot so prvotno načrtovali.
ADROVANCE is not recommended for patients with renal impairment where GFR is less than 35ml/ min (see section 4.2).
Bolnikom, pri katerih je hitrost glomerulne filtracije manjša od 35 ml/ min, se zdravila ADROVANCE ne priporoča (glejte poglavje 4. 2).
Hypocalcaemia must be corrected before initiating therapy with ADROVANCE (see section 4.3).
Hipokalcemijo je treba korigirati pred začetkom zdravljenja z zdravilom ADROVANCE (glejte poglavje 4. 3).
Other disorders affecting mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) should also be effectively treated before starting ADROVANCE.
Pred začetkom jemanja zdravila ADROVANCE je treba učinkovito zdraviti tudi ostale bolezni, ki vplivajo na presnovo mineralov (kot npr. pomanjkanje vitamina D in hipoparatiroidizem).
The content of vitamin D in ADROVANCE is not suitable for correction of vitamin D deficiency.
Količina vitamina D v zdravilu ADROVANCE ne zadošča za odpravo pomanjkanja vitamina D.
In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with ADROVANCE.
Pri bolnikih s temi boleznimi je treba med zdravljenjem z zdravilom ADROVANCE spremljati serumski kalcij in simptome hipokalcemije.
Due to the positive effects of alendronate in increasing bone mineral, decreases in serum calcium and phosphate may occur.
Ker ima alendronat pozitiven vpliv na povečanje mineralov v kosteh, se lahko pojavijo znižanja serumskega kalcija in fosfata.
These are usually small and asymptomatic.
Običajno so majhna in asimptomatska.
However, there have been rare reports of symptomatic hypocalcaemia, which have occasionally been severe and often occurred in patients with predisposing conditions (e. g. hypoparathyroidism, vitamin D deficiency and calcium malabsorption) (see section 4.8).
Obstajajo pa redka poročila o simptomatski hipokalcemiji, ki je bila občasno huda in do katere je pogosto prišlo pri bolnikih s predisponirajočimi motnjami (npr. hipoparatiroidizem, pomanjkanje vitamina D in malabsorbcija kalcija) (glejte poglavje 4. 8).
Colecalciferol Vitamin D3 may increase the magnitude of hypercalcaemia and/ or hypercalciuria when administered to patients with disease associated with unregulated overproduction of calcitriol (e. g. leukaemia, lymphoma, sarcoidosis).
Holekalciferol Vitamin D3 lahko poveča hiperkalcemijo in/ ali hiperkalciurijo, če ga jemljejo bolniki z boleznimi, povezanimi z neuravnovešenim prekomernim izločanjem kalcitriola (npr. levkemija, limfom, sarkoidoza).
4 Excipients This medicinal product contains lactose and sucrose.
4 Pomožne snovi To zdravilo vsebuje laktozo in saharozo.
Patients with rare hereditary problems of fructose intolerance, galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Zdravila ne smejo jemati bolniki z naslednjimi redkimi dednimi boleznimi: intoleranca za fruktozo, intoleranca za galaktozo, laponska oblika zmanjšane aktivnosti laktaze, malabsorpcija glukoze/ galaktoze, nezadostno delovanje saharaze- izomaltaze.
Alendronate If taken at the same time, it is likely that food and beverages (including mineral water), calcium supplements, antacids, and some oral medicinal products will interfere with absorption of alendronate.
Alendronat Če jih bolnik vzame sočasno z alendronatom, lahko hrana in pijače (vključno z mineralno vodo), dodatki kalcija, antacidi in nekatera peroralna zdravila vplivajo na njegovo absorpcijo.
Therefore, patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product (see sections 4.2 and 5.2).
Zato morajo bolniki po zaužitju alendronata vsaj 30 minut počakati, preden peroralno vzamejo katerokoli drugo zdravilo (glejte poglavji 4. 2 in 5. 2).
No other clinically significant interactions with medicinal products are anticipated.
Drugih klinično pomembnih interakcij ni pričakovati.
A number of patients in the clinical trials received oestrogen (intravaginal, transdermal, or oral) while taking alendronate.
Številni bolniki so v kliničnih preskušanjih med jemanjem alendronata dobivali tudi estrogen (intravaginalno, transdermalno ali peroralno).
No adverse reactions attributable to their concomitant use were identified.
Ugotovili niso nobenih neželenih učinkov, ki bi bili posledica njune sočasne uporabe.
Although specific interaction studies were not performed, in clinical studies alendronate was used concomitantly with a wide range of commonly prescribed medicinal products without evidence of interactions of clinical relevance.
Čeprav specifičnih raziskav medsebojnega delovanja z drugimi zdravili niso izvedli, so v kliničnih raziskavah alendronat uporabljali sočasno z velikim številom pogosto predpisovanih zdravil, pri tem pa niso ugotovili nobenih klinično relevantnih interakcij.
Colecalciferol Olestra, mineral oils, orlistat, and bile acid sequestrants (e. g. cholestyramine, colestipol) may impair the absorption of vitamin D.
Holekalciferol Olestra, mineralna olja, orlistat in adsorbenti žolčnih kislin (npr. holestiramin, holestipol) lahko motijo absorpcijo vitamina D.
Anticonvulsants, cimetidine and thiazides may increase the catabolism of vitamin D.
Antikonvulzivi, cimetidin in tiazidi lahko povečajo razgradnjo vitamina D.
Additional vitamin D supplements may be considered on an individual basis.
O dodatnem jemanju vitamina D lahko razmislite pri vsakem posameznem bolniku.
ADROVANCE is only intended for use in postmenopausal women and therefore it should not be used during pregnancy or in breast-feeding women.
ADROVANCE je namenjen le ženskam po menopavi, zato se ga ne sme uporabljati v času nosečnosti ali dojenja.
There are no adequate data from the use of ADROVANCE in pregnant women.
Ni zadostnih podatkov o uporabi zdravila ADROVANCE pri nosečnicah.
Animal studies with alendronate do not indicate direct harmful effects with respect to pregnancy, embryonal/ foetal development, or postnatal development.
Raziskave alendronata na živalih ne kažejo na neposredne ali posredne škodljive vplive na nosečnost, razvoj zarodka/ plodu ali postnatalni razvoj.
Alendronate given during pregnancy in rats caused dystocia related to hypocalcaemia (see section 5.3).
Pri brejih podganah, ki so prejemale alendronat, je le- ta povzročil distocijo, povezano s hipokalcemijo (glejte poglavje 5. 3).
Studies in animals have shown hypercalcaemia and reproductive toxicity with high doses of vitamin D (see section 5.3).
Raziskave pri živalih so pri visokih odmerkih vitamina D pokazale hiperkalcemijo in reproduktivno toksičnost (glejte poglavje 5. 3).
It is not known whether alendronate is excreted into human breast milk.
Ni znano, če se pri ljudeh alendronat izloča v materino mleko.