qanastek/EMEA-V3 huggingface dataset:
If you stop using Optisulin This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar).
Ja Jūs pārtraucat lietot Optisulin Tas var izraisīt smagu hiperglikēmiju (ļoti augstu glikozes līmeni asinīs) un ketoacidozi (skābes veidošanos asinīs, jo organismā tiek šķelti tauki cukura vietā).
Like all medicines, Optisulin can cause side effects, although not everybody gets them.
Tāpat kā citas zāles, arī Optisulin var izraisīt blakusparādības, kaut arī ne visiem tās izpaužas.
These could be symptoms of severe allergic reactions to insulins and may become life- threatening.
Ja Jums rodas šādi simptomi, nekavējoties sazinieties ar savu ārstu: dažādas ādas reakcijas, stipra ādas un gļotādu tūska (angioneirotiska tūska), aizdusa, asinsspiediena samazināšanās un asinsrites traucējumi Tie var būt smagas alerģiskas reakcijas simptomi pret insulīnu un var apdraudēt dzīvību.
51 Very common reported side effects (experienced in more than 1 in 10 patients) • Hypoglycaemia As with all insulin therapy, the most frequent side effect is hypoglycaemia.
Ļoti biežas blakusparādības (bijušas vairāk nekā 1 no 10 pacientiem) • Hipoglikēmija
Thickening of fatty tissue may occur in 1 to 2% of patients while shrinking may occur uncommonly.
Šādā vietā injicēts
Insulin that you inject in such a site may not work very well.
51 insulīns var nedarboties ļoti labi.
Paediatric patients In general, the side effects in patients of 18 years of age or less are similar to those seen in adults.
Parasti blakusparādības pacientiem līdz 18 gadu vecumam vai jaunākiem ir līdzīgas kā novēro pieaugušajiem.
Do not use Optisulin after the expiry date which is stated on the carton and on the label of the cartridge.
Nelietot Optisulin, ja beidzies uz kārbiņas un kārtridža etiķetes norādītais derīguma termiņš.
52 Unopened cartridges Store in a refrigerator (2°C-8°C).
Neiesākti kārtridži Uzglabāt ledusskapī (2ºC - 8oC).
In use cartridges Cartridges in use (in the insulin pen) may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
Iesākti kārtridži Kārtridžus, kuri tiek lietoti (insulīna pildspalvveida injektorā), var uzglabāt maksimāli 4 nedēļas temperatūrā līdz 25oC bez tiešas siltuma vai gaismas ietekmes.
The cartridge in use in the insulin pen must not be stored in a refrigerator.
Iesāktu kārtridžu insulīna pildspalvveida injektorā nedrīkst uzglabāt ledusskapī.
Do not use Optisulin if you notice particles in it.
52 Nelietojiet Optisulin, ja ievērojat tajā daļiņas.
- Other ingredients of Optisulin are: zinc chloride, m-cresol, glycerol, sodium hydroxide, hydrochloric
- Citas Optisulin sastāvdaļas: cinka hlorīds, m- krezols, glicerīns, nātrija hidroksīds, sālsskābe, un
acid and water for injections.
ūdens injekcijām.
What Optisulin looks like and contents of the pack
Optisulin ārējais izskats un iepakojums
Optisulin 100 Units/ ml solution for injection in a cartridge is a clear and colourless solution.
Optisulin 100 vienības/ ml šķīdums injekcijām flakonā ir dzidrs, bezkrāsains, līdzīgs ūdenim.
Optisulin comes in a special cartridge for use in an Insulin Pen such as OptiPen and other pens suitable for Optisulin cartridges.
Optisulin ir pildīts īpašos kārtridžos, kas paredzēti lietošanai insulīna pildspalvveida injektoros, piemēram, OptiPen sērijas ierīcēs un citos injektoros, kas ir piemēroti Optisulin kārtridžiem.
Each cartridge contains 3 ml solution (300 Units) and they are available in packs of 4, 5 and 10 cartridges.
Katrs kārtridžs satur 3 ml šķīduma (300 vienības), iepakojumā ir 4, 5 un 10 kārtridži.
This leaflet was last approved on Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Sīkāka informācija par šīm zālēm ir pieejama Eiropas zāļu aģentūras (EMEA) mājas lapā http: // www. emea. europa. eu /.
54 HYPERGLYCAEMIA AND HYPOGLYCAEMIA
54 HIPERGLIKĒMIJA UN HIPOGLIKĒMIJA
example through incorrect storage,
piemēram, nepareizas glabāšanas dēļ; Jūsu insulīna pildspalvveida injektors nedarbojas pareizi;
- you are doing less exercise than usual, you are under stress (emotional distress, excitement), or
samazinājusies Jūsu fiziskā slodze, Jums ir stress (emocionāls distress, satraukums), trauma,
Warning symptoms of hyperglycaemia Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat, and, glucose and ketone bodies in urine.
Brīdinoši hiperglikēmijas simptomi Slāpes, pastiprināta nepieciešamība urinēt, nogurums, sausa āda, sejas piesārtums, ēstgribas zudums, zems asinsspiediens, paātrināta sirdsdarbība un glikoze un ketonvielas urīnā.
- you are recovering from an illness or fromfever,
- Jūs atveseļojaties pēc slimības vai paaugstinātas ķermeņa temperatūras;
55 Hypoglycaemia is also more likely to occur if
Hipoglikēmija var būt arī šādos gadījumos:
from your previous basal insulin to Optisulin hypoglycaemia, if it occurs, may be more likely to occur in the morning than at night),
nomainot ar Optisulin, hipoglikēmija, ja tā rodas, biežāk var būt no rīta nevis naktī);
- your blood sugar levels are almost normal or are unstable,
- ja glikozes līmenis asinīs ir gandrīz normāls vai nestabils;
Warning symptoms of hypoglycaemia
55 Brīdinoši hipoglikēmijas simptomi
The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if
Pirmie simptomi, kas jūs brīdina par hipoglikēmiju (“ brīdinājuma simptomi ”), var mainīties, pavājināties vai vispār izzust, ja esat gados vecāks cilvēks, ja slimojat ar cukura diabētu ilgstoši vai ja Jums ir noteikta veida
- you have recently changed from an animal insulin to a human insulin such as Optisulin,
Jūs nesen esat pārgājuši no dzīvnieku (izcelsmes) insulīna uz cilvēka insulīna, piemēram,
What is Optruma?
Kas ir Optruma?
Optruma is a medicine containing the active substance raloxifene hydrochloride.
Optruma ir zāles, kas satur aktīvo vielu raloksifēna hidrohlorīdu.
What is Optruma used for?
Kāpēc lieto Optruma?
Optruma is used for the treatment and prevention of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Optruma lieto osteoporozes (kaulu trausluma) ārstēšanai un profilaksei sievietēm pēc menopauzes.
Optruma has been shown to significantly reduce vertebral fractures (breaks in the spine), but not hip fractures.
Optruma ievērojami samazina mugurkaula skriemeļu lūzumu, bet ne gūžas kaula lūzumu biežumu.
How is Optruma used?
Kā lietot Optruma?
Optruma is intended for long-term use.
Optruma ir paredzētas ilglaicīgai lietošanai.
How does Optruma work?
Kā Optruma darbojas?
The active substance in Optruma, raloxifene, is a selective oestrogen receptor modulator (SERM).
Optruma aktīvā viela raloksifēns ir selektīvs estrogēna receptoru modulators (SERM).
How has Optruma been studied?
Kā noritēja Optruma izpēte?
Optruma has been studied in the treatment and in the prevention of osteoporosis in four main studies.
Četros pamatpētījumos vērtēja Optruma izmantojamību osteoporozes ārstēšanai un profilaksei.
Three studies looked at the prevention of osteoporosis in 1,764 women, who took either Optruma or placebo (a dummy treatment) for two years.
Trīs osteoporozes profilakses pētījumi aptvēra 1764 sievietes, kas divus gadus saņēma Optruma vai placebo (zāļu imitāciju).
The fourth study compared the effects of Optruma with those of placebo in the treatment of osteoporosis in 7,705 women over four years.
Ceturtajā osteoporozes ārstēšanas pētījumā, kas ilga četrus gadus, salīdzināja Optruma un placebo iedarbīgumu 7705 sievietēm.
The main measure of effectiveness was how many women had vertebral (spine) fractures during the study.
Galvenais iedarbīguma rādītājs bija mugurkaula skriemeļu lūzumu skaits pētījuma laikā.
What benefit has Optruma shown during the studies?
Kāds ir Optruma iedarbīgums šajos pētījumos?
Optruma was more effective than placebo in preventing and treating osteoporosis.
Optruma bija iedarbīgākas par placebo osteoporozes ārstēšanai un profilaksei.
In the prevention of osteoporosis, women receiving Optruma had an increase in bone density in the hip or spine of 1.6% over two years, and those receiving placebo had a decrease of 0.8%.
Divu gadu laikā sievietēm, kas saņēma Optruma osteoporozes profilaksei, gūžas kaulu un mugurkaula kaulaudu blīvums bija palielinājies par 1, 6%, bet bija samazinājies par 0, 8% placebo saņēmēju grupā.
When used to treat osteoporosis, Optruma was more effective than placebo in reducing the number of vertebral fractures.
Osteoporozes ārstēšanā Optruma daudz efektīvāk nekā placebo samazināja mugurkaula skriemeļu lūzumu biežumu.
Over four years, in comparison with placebo, Optruma decreased the number of new vertebral fractures by 46% in women who had osteoporosis and by 32% in women who had osteoporosis and an existing fracture.
Salīdzinot ar placebo, Optruma četru gadu laikā par 46% samazināja jaunu mugurkaula skriemeļu lūzumu skaitu sievietēm ar osteoporozi un par 32% - sievietēm ar osteoporozi, kam jau ir kaulu lūzums.
There was no effect of Optruma on hip fractures.
Optruma nebija iedarbīgas pret gūžas kaula lūzumiem.
What is the risk associated with Optruma?
Kāds pastāv risks, lietojot Optruma?
The most common side effects with Optruma (seen in more than 1 patient in 10) are vasodilation (hot flushes) and flu-like symptoms.
Visbiežāk novērotās nevēlamās Optruma blakusparādības (vairāk nekā vienam pacientam no desmit) ir vazodilatācija (karstuma viļņi) un gripai līdzīgi simptomi.
For the full list of side effects reported with Optruma, see the Package Leaflet.
Pilns visu Optruma izraisīto nevēlamo blakusparādību apraksts ir atrodams zāļu lietošanas pamācībā.
Optruma should not be used in women who: • could become pregnant; • have or have had any blood clot disorders, including deep vein thrombosis and pulmonary embolism (a blood clot in the lungs); • have liver disease, severe kidney disease, unexplained bleeding from the womb or endometrial cancer (cancer of the lining of the womb).
Optruma nedrīkst lietot sieviets šādos gadījumos: • ja vēl var būt bērni; • ja ir vai ir bijuši asinsreces traucējumi, tostarp dziļo vēnu tromboze un plaušu embolija (asins trombs plaušās); • ja ir slimas aknas, smaga nieru slimība, neizskaidrojama asiņošana dzemdē vai endometrija vēzis (dzemdes sieniņas vēzis).
Optruma should not be used in people who may be hypersensitive (allergic) to raloxifene or any of the other ingredients.
Optruma nedrīkst lietot cilvēki ar paaugstinātu jutību (alerģiju) pret raloksifēnu vai kādu citu šo zāļu sastāvdaļu.
Why has Optruma been approved?
Kāpēc Optruma tika apstiprinātas?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Optruma had shown its effectiveness in preventing and treating osteoporosis, and had no effects on the breast or womb.
Cilvēkiem paredzēto zāļu komiteja (CHMP) secināja, ka Optruma ir efektīvas zāles osteoporozes profilaksei un ārstēšanai, un tās neiedarbojas uz krūts dziedzeru un dzemdes audiem.
The Committee decided that Optruma’ s benefits are greater than its risks for the treatment and prevention of osteoporosis in postmenopausal women.
Komiteja nolēma, ka pacienta ieguvums, sievietēm pēc menopauzes lietojot Optruma osteoporozes ārstēšanai un profilaksei, pārsniedz šo zāļu radīto risku.
The Committee recommended that Optruma be given marketing authorisation.
Komiteja ieteica izsniegt Optruma reģistrācijas apliecību.
Other information about Optruma:
Cita informācija par Optruma.
The European Commission granted a marketing authorisation valid throughout the European Union for Optruma to Eli Lilly Nederland B. V. on 5 August 1998.
Eiropas Komisija 1998. gada 5. augustā izsniedza Optruma reģistrācijas apliecību, kas derīga visā Eiropas Savienībā, uzņēmumam Eli Lilly Nederland B. V.
The full EPAR for Optruma is available here.
Pilns Optruma EPAR teksts ir atrodams šeit.
blister (PVC/ PE/ PCTFE). blister (PVC/ PE/ PCTFE). blister (PVC/ PE/ PCTFE). bottle (HDPE)
blisteris (PVH/ PE/ PCTFE). blisteris (PVH/ PE/ PCTFE). blisteris (PVH/ PE/ PCTFE). pudele (HDPE)
14 tablets 28 tablets 84 tablets 100 tablets
14 tabletes 28 tabletes 84 tabletes 100 tabletes
OPTRUMA 60 mg film coated tablets
OPTRUMA 60 mg apvalkot s tabletes
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base.
Katr apvalkot tablet ir 60 mg raloksif na hidrohlor da (Raloxifene hydrochloride), kas atbilst 56 mg raloksif na b zes.
Excipient: each tablet contains lactose (149.40 mg)
Pal gviela: katr tablet ir laktoze (149, 40 mg) Pilnu pal gvielu sarakstu skat t apakšpunkt 6. 1.
Film coated tablet.
Apvalkot tablete.
Elliptically shaped, white tablets imprinted with the code ’ 4165’.
Elipses formas, baltas tabletes, uz kur m uzdruk ts kods 4165.
OPTRUMA is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
OPTRUMA indic ts osteoporozes rst šanai un profilaksei sieviet m p cmenopauzes period.
A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.
Nov rota noz m ga skrieme u, bet ne g žas kaula l zumu biežuma samazin šan s.
When determining the choice of OPTRUMA or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Sievietei p cmenopauzes period izv loties starp OPTRUMA un citu terapiju, to vid estrog nu, j em v r menopauzes simptomi, ietekme uz dzemdes un kr ts dziedzera audiem, k ar kardiovaskul rais risks un ieguvums (skat t apakšpunktu 5. 1).
The recommended dose is one tablet daily by oral administration, which may be taken at any time of the day without regard to meals.
Ieteicam deva ir viena tablete dien iekš gi, lietojot jebkur dienas laik neatkar gi no dienreiz m.
No dose adjustment is necessary for the elderly.
Gados vec k m pacient m deva nav j piel go.
Due to the nature of this disease process, OPTRUMA is intended for long term use.
OPTRUMA paredz ta ilgstošai lietošanai, ko nosaka slim bas daba.
Generally calcium and vitamin D supplements are advised in women with a low dietary intake.
Sieviet m, kuras uztur lieto maz kalciju un D vitam nu saturošus produktus, ieteicams papildus lietot šos prepar tus.
Use in renal impairment:
Lietošana pacient m ar nieru darb bas trauc jumiem:
OPTRUMA should not be used in patients with severe renal impairment (see section 4.3).
EVISTA nedr kst lietot pacientes ar smagiem nieru darb bas trauc jumiem (skat t apakšpunktu 4. 3).
In patients with moderate and mild renal impairment, OPTRUMA should be used with caution.
Pacient m ar vid ji smagiem vai viegliem nieru darb bas trauc jumiem EVISTA j lieto piesardz gi.
Use in hepatic impairment:
Lietošana pacient m ar aknu darb bas trauc jumiem:
OPTRUMA should not be used in patients with hepatic impairment (see section 4.3).
EVISTA nedr kst lietot pacientes ar aknu darb bas trauc jumiem (skat t apakšpunktu 4. 3).
Hypersensitivity to the active substance or to any of the excipients.
Paaugstin ta jut ba pret akt vo vielu un/ vai jebkuru no pal gviel m.
Must not be used in women with child bearing potential.
Nelietot sieviet m reprodukt v vecum.
Active or past history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
Ak ta venoza trombembolija (VT) (ar anamn z), tostarp dzi o v nu tromboze, plaušu embolija un t klenes v nu tromboze.
2 Hepatic impairment including cholestasis.
2 Smagi nieru darb bas trauc jumi.
Unexplained uterine bleeding.
Neizskaidrojama dzemdes asi ošana.
OPTRUMA should not be used in patients with signs or symptoms of endometrial cancer as safety in this patient group has not been adequately studied.
OPTRUMA nedr kst lietot pacientes ar endometrija vai kr ts v ža paz m m vai simptomiem, jo lietošanas droš ba šais pacienšu grup s nav pietiekami izp t ta.
Raloxifene is associated with an increased risk for venous thromboembolic events that is similar to the reported risk associated with current use of hormone replacement therapy.
Raloksif na lietošana saist ta ar palielin tu venozo trombemboliju risku, kas ir t ds pats k lietojot pašreiz jo hormonu aizst jterapiju.
The risk-benefit balance should be considered in patients at risk of venous thromboembolic events of any aetiology.
Pacient m ar jebkuras cilmes venozas trombembolijas risku j apsver riska un ieguvuma attiec ba.
OPTRUMA should be discontinued in the event of an illness or a condition leading to a prolonged period of immobilisation.
OPTRUMA lietošana j p rtrauc visu slim bu vai st vok u gad jum, kas izraisa ilgstošu imobiliz ciju.
Therapy should not be restarted until the initiating condition has resolved and the patient is fully mobile.
Š das slim bas gad jum z u lietošana j p rtrauc p c iesp jas tr k vai ar tr s dienas pirms paredzam s imobiliz cijas. rst šanu dr kst ats kt tikai p c st vok a uzlabošan s, un kad paciente piln b atguvusi kust bu sp ju.
In a study of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, overall mortality, including overall cardiovascular mortality, or stroke, compared to placebo.
P t jum p cmenopauzes perioda sieviet m ar dokument tu koron ro sirds slim bu vai palielin tu koron ru notikumu risku raloksif ns neietekm ja miokarda infarkta sastopam bu, hospitaliz cijas biežumu ak ta koron ra sindroma d, kop jo mirst bu, tostarp kop jo kardiovaskul ro mirst bu vai insulta sastopam bu, sal dzinot ar placebo.
However, there was an increase in death due to stroke in women assigned to raloxifene.
Ta u palielin j s n ves biežums insulta d sieviet m, kuras lietoja raloksif nu.
The incidence of stroke mortality was 1.5 per 1000 women per year for placebo versus 2.2 per 1000 women per year for raloxifene.
Mirst bas biežums insulta d bija 1, 5 uz 1000 sieviet m gad placebo grup, sal dzinot ar 2, 2 gad jumiem uz 1000 sieviet m gad raloksif na grup.
This finding should be considered when prescribing raloxifene for postmenopausal women with a history of stroke or other significant stroke risk factors, such as transient ischemic attack or atrial fibrillation.
Tas j em v r, parakstot raloksif nu p cmenopauzes perioda sieviet m ar insultu anamn z vai citiem noz m giem insulta riska faktoriem, piem ram, tranzitorisku iš misku l kmi vai priekškambaru mirgošanu.
There is no evidence of endometrial proliferation.
Nav pier d jumu par endometrija prolifer ciju.
Any uterine bleeding during OPTRUMA therapy is unexpected and should be fully investigated by a specialist.
OPTRUMA terapijas laik nav paredzama dzemdes asi ošana, un, ja t da rodas, speci listam t r p gi j izmekl.
The two most frequent diagnoses associated with uterine bleeding during raloxifene treatment were endometrial atrophy and benign endometrial polyps.
Divas biež k s diagnozes, kas saist tas ar dzemdes asi ošanu raloksif na terapijas laik, bija endometrija atrofija un labdab gi endometrija polipi.
In postmenopausal women who received raloxifene treatment for 4 years, benign endometrial polyps were reported in 0.9% compared to 0.3% in women who received placebo treatment.
Sieviet m p cmenopauzes period, kuras tika rst tas ar raloksif nu 4 gadus, labdab gus endometrija polipus nov roja 0, 9% gad jumu, sal dzinot ar 0, 3% sieviešu, kuras sa ma placebo terapiju.
Raloxifene is metabolised primarily in the liver.
Raloksif ns tiek metaboliz ts galvenok rt akn s.
Single doses of raloxifene given to patients with cirrhosis and mild hepatic impairment (Child-Pugh class A) produced plasma concentrations of raloxifene which were approximately 2.5 times the controls.
Vienreiz jas raloksif na devas, ievad tas pacient m ar cirozi un viegli izteiktiem aknu darb bas trauc jumiem (A klase p c Child- Pugh klasifik cijas), rad ja aptuveni 2, 5 reizes augst ku raloksif na koncentr ciju plazm nek kontrolgrup.
The increase correlated with total bilirubin concentrations.
Koncentr cijas palielin šan s korel ja ar kop jo bilirub na koncentr ciju.
Serum total bilirubin, gamma-glutamyl transferase, alkaline phosphatase, ALT and AST should be closely monitored during treatment if elevated values are observed.
Kam r lietošanas droš ba un efektivit te pacient m ar aknu mazsp ju nav noskaidrota, šai pacienšu grupai OPTRUMA lietot nav ieteicams. rst šanas laik, ja konstat ti palielin ti raksturlielumi, r p gi j kontrol kop j bilirub na, gamma glutamiltransfer zes, s rmain s fosfat zes, AlAT un AsAT l menis serum.
Limited clinical data suggest that in patients with a history of oral oestrogen-induced hypertriglyceridemia (> 5.6 mmol/ l), raloxifene may be associated with a marked increase in serum triglycerides.
Ierobežoti kl niskie dati liecina, ka pacient m ar peror lo estrog nprepar tu izrais tu hipertriglicerid miju (> 5, 6 mmol/ l) anamn z raloksif na lietošana var izrais t noz m gu triglicer du l me a palielin šanos serum.
Patients with this medical history should have serum triglycerides monitored when taking raloxifene.
Pacient m ar š du medic nisku anamn zi raloksif na lietošanas laik j kontrol triglicer du l menis serum.
The safety of OPTRUMA in patients with breast cancer has not been adequately studied.
OPTRUMA lietošanas droš ba pacient m ar kr ts v zi nav pietiekami p t ta.
No data are available on the concomitant use of OPTRUMA and agents used in the treatment of early or advanced breast cancer.
Nav datu par OPTRUMA lietošanu vienlaikus ar z l m, ko lieto agr na vai progres joša kr ts v ža rst šanai.
Therefore, OPTRUMA should be used for osteoporosis treatment and prevention only after the treatment of breast cancer, including adjuvant therapy, has been completed.
T d OPTRUMA osteoporozes rst šanai un profilaksei dr kst lietot tikai p c kr ts v ža terapijas, k ar adjuvant s terapijas pabeigšanas.
As safety information regarding co-administration of raloxifene with systemic oestrogens is limited such use is not recommended
Inform cija par droš bu, lietojot raloksif nu vienlaikus ar sist miskiem estrog niem, ir neliela, t d š das kombin cijas lietošana nav ieteicama.
3 OPTRUMA is not effective in reducing vasodilatation (hot flushes), or other symptoms of the menopause associated with oestrogen deficiency.
OPTRUMA nemazina asinsvadu paplašin šanos (karstuma vi us) un citus menopauzes simptomus, kas saist ti ar estrog nu defic tu.
Optruma contains lactose.
OPTRUMA sast v ir laktoze.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Š s z les nevajadz tu lietot pacientiem ar retu iedzimtu galaktozes nepanes bu, Lapp lakt zes defic tu vai glikozes- galaktozes malabsorbciju.
4.5 Interaction with other medicinal products and other forms of interaction
3 4. 5 Mijiedarb ba ar cit m z l m un citi mijiedarb bas veidi
Concurrent administration of either calcium carbonate or aluminium and magnesium-hydroxide containing antacids do not affect the systemic exposure of raloxifene.
Ne kalcija karbon ta, ne alum nija un magnija hidroks du saturošu antac du l dzek u vienlaic ga lietošana neietekm raloksif na sist misko iedarb bu.
Co-administration of raloxifene and warfarin does not alter the pharmacokinetics of either compound.
Raloksif na un varfar na vienlaic ga lietošana nemaina farmakokin tiku nevienam no šiem savienojumiem.
However, modest decreases in the prothrombin time have been observed, and if raloxifene is given concurrently with warfarin or other coumarin derivatives, the prothrombin time should be monitored.
Tom r nov rota neliela protromb na laika samazin šan s, t p c, lietojot raloksif nu kop ar varfar nu vai citiem kumar na atvasin jumiem, j kontrol protromb na laiks.
Effects on prothrombin time may develop over several weeks if OPTRUMA treatment is started in patients who are already on coumarin anticoagulant therapy.
Ja OPTRUMA s k lietot pacient m, kuras jau sa em kumar nu antikoagulantu terapiju, ietekme uz protromb na laiku var att st ties vair ku ned u laik.
Raloxifene has no effect on the pharmacokinetics of methylprednisolone given as a single dose.
Raloksif ns neietekm vienreiz j dev lietota metilprednizolona farmakokin tiku.
Raloxifene does not affect the steady-state AUC of digoxin.
Raloksif ns neietekm digoks na AUC l dzsvara st vokl.
The Cmax of digoxin increased by less than 5%.
Digoks na Cmax palielin s maz k par 5%.
The influence of concomitant medication on raloxifene plasma concentrations was evaluated in the prevention and treatment trials.
Profilakses un terapijas p t jumos nov rt ja citu vienlaic gi lietotu z u ietekmi uz raloksif na koncentr ciju plazm.
Frequently co-administered medicinal products included: paracetamol, non-steroidal anti-inflammatory drugs (such as acetylsalicylic acid, ibuprofen, and naproxen), oral antibiotics, H1 antagonists, H2 antagonists, and benzodiazepines.
Biež k vienlaikus lietotie medikamenti: paracetamols, nestero die pretiekaisuma l dzek i (piem ram, acetilsalicilsk be, ibuprof ns un naproks ns), peror l s antibiotikas, H1 antagonisti, H2 antagonisti un benzodiazep ni.
No clinically relevant effects of the co-administration of the agents on raloxifene plasma concentrations were identified.
Nekonstat ja vienlaikus lietotu medikamentu kl niski noz m gu ietekmi uz raloksif na koncentr ciju plazm.
Concomitant use of vaginal oestrogen preparations was allowed in the clinical trial programme, if necessary to treat atrophic vaginal symptoms.
Kl nisko p t jumu programm bija at auta vienlaic ga vagin lo estrog nprepar tu lietošana, ja bija nepieciešama atrofisku vagin lu simptomu rst šana.
Compared to placebo there was no increased use in OPTRUMA treated patients.
Sal dzinot ar placebo, ar OPTRUMA rst t m pacient m šos prepar tus nelietoja biež k.
In vitro, raloxifene did not interact with the binding of warfarin, phenytoin, or tamoxifen.
In vitro netika nov rota raloksif na mijiedarb ba ar varfar nu, fenito nu vai tamoksif nu.
Raloxifene should not be co-administered with cholestyramine (or other anion exchange resins), which significantly reduces the absorption and enterohepatic cycling of raloxifene.
Raloksif nu nedr kst lietot vienlaikus ar holestiram nu (vai citiem anjonu apmai as sve iem), kas stipri mazina raloksif na uzs kšanos un enterohepatisko cirkul ciju.
Peak concentrations of raloxifene are reduced with co-administration with ampicillin.
Lietojot kop ar ampicil nu, pazemin s raloksif na maksim l koncentr cija.
However, since the overall extent of absorption and the elimination rate of raloxifene are not affected, raloxifene can be concurrently administered with ampicillin.
T k nemain s raloksif na kop jais uzs kšan s apjoms un elimin cijas trums, to var lietot vienlaikus ar ampicil nu.
Raloxifene modestly increases hormone-binding globulin concentrations, including sex steroid binding globulins (SHBG), thyroxine binding globulin (TBG), and corticosteroid binding globulin (CBG), with corresponding increases in total hormone concentrations.
Raloksif ns m reni paaugstina hormonus saistošo globul nu, tostarp dzimumhormonus saistošos globul nus (SHBG), tiroks nu saistošo globul nu (TBG) un kortikostero dus saistošo globul nu (CBG) koncentr ciju, attiec gi paaugstinoties kop jai hormonu koncentr cijai.
These changes do not affect concentrations of free hormones.
Š s p rmai as neietekm br vo hormonu koncentr ciju.
OPTRUMA is only for use in postmenopausal women.
OPTRUMA paredz ta lietošanai tikai sieviet m p cmenopauzes period.
OPTRUMA must not be taken by women of child bearing potential.
OPTRUMA nedr kst lietot sievietes reprodukt v vecum.
Raloxifene may cause foetal harm when administered to a pregnant woman.
Raloksif ns var izrais t aug a boj jumu, ja to lieto gr tniece.
If this medicinal product is used mistakenly during pregnancy or the patient becomes pregnant while taking it, the patient should be informed of the potential hazard to the foetus (see section 5.3).
Ja šo medikamentu k das d lieto gr tniec bas laik vai ja pacientei iest jas gr tniec ba šo z u lietošanas laik, paciente j inform par iesp jam m briesm m auglim (skat t apakšpunktu 5. 3).
4 It is not known whether raloxifene is excreted in human milk.
Nav zin ms, vai raloksif ns izdal s m tes pien.
Its clinical use, therefore, cannot be recommended in breast-feeding women.
T p c sieviet m b rna z d šanas period t kl niska lietošana nav ieteicama.
OPTRUMA may affect the development of the baby.
OPTRUMA var ietekm t z dai a att st bu.
Raloxifene has no known influence on the ability to drive and use machines.
Nav zin ms, ka raloksif ns ietekm tu sp ju vad t transportl dzek us un apkalpot meh nismus.
4.8 Undesirable effects
4 4. 8 Nev lam s blakuspar d bas
The duration of treatment in these studies ranged from 6 to 60 months.
Visas nev lam s blakuspar d bas tika fiks tas osteoporozes rst šanas un profilakses p t jumos ar vair k nek 13000 sieviet m p cmenopauzes period. rst šanas ilgums šajos p t jumos bija no 6 l dz 60 m nešiem.
The majority of adverse reactions have not usually required cessation of therapy.
Vairum gad jumu blakuspar d bu d rst šana nebija j p rtrauc.
In the prevention population discontinuations of therapy due to any adverse reaction occurred in 10.7% of 581 OPTRUMA treated patients and 11.1% of 584 placebo-treated patients.
Profilaktiskas lietošanas gad jum terapija blakuspar d bu d bija j p rtrauc 10, 7% no 581 ar OPTRUMA rst t m pacient m un 11, 1% no 584 ar placebo rst t m pacient m.
In the treatment population discontinuations of therapy due to any clinical adverse event occurred in 12.8% of 2,557 OPTRUMA treated patients and 11.1% of 2,576 placebo treated patients.
Terapeitiskas lietošanas grup terapija jebkuras kl niskas blakuspar d bas d bija j p rtrauc 12, 8% no 2557 ar OPTRUMA rst t m pacient m un 11, 1% no 2576 ar placebo rst t m pacient m.
The adverse reactions associated with the use of raloxifene in osteoporosis clinical trials are summarised in the table below.
Tabul apkopotas ar raloksif na lietošanu saist tas blakuspar d bas osteoporozes kl niskos p t jumos.
The following convention has been used for the classification of the adverse reactions: 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).
Blakuspar d bu klasific šanai ir izmantoti š di apz m jumi: oti bieži (> 1/ 10), bieži (> 1/ 100, < 1/ 10), ret k (> 1/ 1000, < 1/ 100), reti (> 1/ 10000, < 1/ 1000) oti reti (< 1/ 10000).
Vascular disorders Very common):
Ret k:
Venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, retinal vein thrombosis Superficial vein thrombophlebitis Musculoskeletal and connective tissue disorders Common:
Vazodilat cija (karstuma vi i) Venozi tromboemboliski notikumi, tostarp dzi o v nu tromboze, plaušu embolija, t klenes v nu tromboze, virspus jo v nu trombofleb ts
Leg cramps General disorders and administration site conditions Very common:
Bieži:
Flu syndrome Common:
Gripai l dz gs sindroms Perif r t ska
Peripheral oedema
Sal dzinot ar pacient
Compared with placebo-treated patients the occurrence of vasodilatation (hot flushes) was modestly increased in OPTRUMA patients (clinical trials for the prevention of osteoporosis, 2 to 8 years postmenopausal, 24.3% OPTRUMA and 18.2% placebo; clinical trials for the treatment of osteoporosis, mean age 66, 10.6% for OPTRUMA and 7.1% placebo).
vazodilat ciju (karstuma vi us) (kl niskie p t jumi par osteoporozes profilaksi, 2 – 8 gadi p c menopauzes, 24, 3% OPTRUMA un 18, 2% placebo lietot j m; kl niskie p t jumi par osteoporozes rst šanu, vid jais vecums 66 gadi, 10, 6% OPTRUMA un 7, 1% placebo lietot j m).
This adverse reaction was most common in the first 6 months of treatment, and seldom occurred de novo after that time.
Biež k šo nev lamo reakciju nov roja rst šanas pirmajos 6 m nešos, reti t pirmo reizi par d j s p c š perioda.
In a study of 10,101 postmenopausal women with documented coronary heart disease or at increased risk for coronary events (RUTH), the occurrence of vasodilatation (hot flushes) was 7.8% in the raloxifene-treated patients and 4.7% in the placebo-treated patients.
P t jum, kur piedal j s 10101 sieviete p cmenopauzes period ar dokument tu koron ro sirds slim bu vai palielin tu koron ro notikumu risku (RUTH), vazodilat cijas (karstuma vi u) biežums bija 7, 8% pacient m, kuras sa ma raloksif nu, un 4, 7% pacient m, kuras sa ma placebo.
Across all placebo-controlled clinical trials of raloxifene in osteoporosis, venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis occurred at a frequency of approximately 0.8% or 3.22 cases per 1,000 patient years.
Visos ar placebo kontrol tos kl niskos p t jumos par raloksif na lietošanu osteoporozes rst šanai venoza trombembolija, tostarp dzi o v nu tromboze, plaušu embolija un t klenes v nu tromboze rad s aptuveni 0, 8% jeb 3, 22 gad jumos uz 1000 pacientu gadiem.
A relative risk of 1.60 (CI 0.95, 2.71) was observed in OPTRUMA treated patients compared to placebo.
Ar OPTRUMA rst t m pacient m, sal dzinot ar placebo, relat vais risks bija 1, 60 (TI 0, 95, 2, 71).
The risk of a thromboembolic event was greatest in the first four months of therapy.
Trombemboliju risks liel ks bija pirmos etros terapijas m nešos.
Superficial vein thrombophlebitis occurred in a frequency of less than 1%.
Virspus jo v nu trombofleb ts rad s maz k nek 1%.
In the RUTH study, venous thromboembolic events occurred at a frequency of approximately 2.0% or 3.88 cases per 1000 patient-years in the raloxifene group and 1.4% or 2.70 cases per 1000 patient-years in the placebo group.
P t jum RUTH v nu trombemboliskus notikumus (VTN) nov roja aptuveni 2, 0% vai 3, 88 gad jumos uz 1000 pacientgadiem raloksif na grup un 1, 4% vai 2, 70 gad jumos uz 1000 pacientgadiem placebo grup.
5 HR = 1.44, (1.06 – 1.95).
Riska koeficients (HR) visiem VTN p t jum RUTH bija HR = 1, 44, (1, 06 – 1, 95).
Superficial vein thrombophlebitis occurred in a frequency of 1% in the raloxifene group and 0.6% in the placebo group.
Virspus jo v nu trombofleb tu nov roja 1% raloksif na grup un 0, 6% placebo grup.
Another adverse reaction observed was leg cramps (5.5% for OPTRUMA, 1.9% for placebo in the prevention population and 9.2% for OPTRUMA, 6.0% for placebo in the treatment population).
Cita nov rot nev lam reakcija bija krampji k j s (5, 5% OPTRUMA un 1, 9% placebo grup profilaktiskas lietošanas gad jum un 9, 2% OPTRUMA un 6, 0% placebo grup terapeitiskas lietošanas gad jum).
In the RUTH study, leg cramps were observed in 12.1% of raloxifene-treated patients and 8.3% of placebo-treated patients.
P t jum RUTH krampjus k j s nov roja 12, 1% pacienšu raloksif na grup un 8, 3% pacienšu placebo grup.
Flu syndrome was reported by 16.2% of OPTRUMA treated patients and 14.0% of placebo treated patients.
Par gripas sindromu zi oja 16, 2% ar OPTRUMA rst tu pacienšu un 14, 0% ar placebo rst tu pacienšu.
One further change was seen which was not statistically significant (p > 0.05), but which did show a significant dose trend.
Nov roja v l vienu p rmai u, kas nebija statistiski noz m ga (p < 0, 05), bet kura uzr d ja b tisku atkar bu no devas.
This was peripheral oedema, which occurred in the prevention population at an incidence of 3.1% for OPTRUMA and 1.9% for placebo; and in the treatment population occurred at an incidence of 7.1% for OPTRUMA and 6.1% for placebo.
T bija perif ra t ska, kas profilaktiskas lietošanas gad jum ar OPTRUMA rst t m pacient m rad s 3, 1% un ar placebo rst t m sieviet m 1, 9% gad jumu; terapeitiskas
In the RUTH study, peripheral oedema occurred in 14.1% of the raloxifene-treated patients and 11.7% of the placebo-treated patients, which was statistically significant.
P t jum RUTH perif ru t sku nov roja 14, 1% pacient m raloksif na grup un 11, 7% placebo grup, un tas bija statistiski noz m gi.
Slightly decreased (6-10%) platelet counts have been reported during raloxifene treatment in placebo- controlled clinical trials of raloxifene in osteoporosis.
Ar placebo kontrol tos p t jumos par raloksif na lietošanu osteoprozes rst šanai raloksif na terapijas laik nov roja nelielu (6 – 10%) tromboc tu skaita samazin šanos.
Rare cases of moderate increases in AST and/ or ALT have been reported where a causal relationship to raloxifene can not be excluded.
Zi ots par retiem AsAT un/ vai AlAT m renas paaugstin šan s gad jumiem, kad nevar izsl gt c lo sakar bu ar raloksif na lietošanu.
A similar frequency of increases was noted among placebo patients.
Pacient m, kuras sa ma placebo, tikpat bieži nov roja šo raksturlielumu paaugstin šanos.
In a study (RUTH) of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, an additional adverse reaction of cholelithiasis occurred in 3.3% of patients treated with raloxifene and 2.6% of patients treated with placebo.
P t jum (RUTH), kur piedal j s sievietes p cmenopauzes period ar dokument tu koron ro sirds slim bu vai palielin tu koron ro notikumu risku, 3, 3% pacienšu raloksif na grup un 2, 6% pacienšu placebo grup nov roja ar holeliti zi.
Cholecystectomy rates for raloxifene (2.3%) were not statistically significantly different from placebo (2.0%).
Nebija statistiski noz m gas atš ir bas holecistektomijas biežum raloksif na grup (2, 3%) un placebo grup (2, 0%).
OPTRUMA (n = 317) was compared with continuous combined (n = 110) hormone replacement therapy (HRT) or cyclic (n = 205) HRT patients in some clinical trials.
OPTRUMA (n=317) dažos kl niskos p t jumos sal dzin ja ar past v gu kombin tu (n=110) hormonu aizst jterapiju (HAT) vai ciklisku (n=205) HAT.
The incidence of breast symptoms and uterine bleeding in raloxifene treated women was significantly lower than in women treated with either form of HRT.
Ar kr ts dziedzeriem saist to simptomu un dzemdes asi ošanas biežums ar raloksif nu rst t m sieviet m nov rots daudz ret k nek sieviet m, kuras rst tas ar k du no HAT metod m.
The adverse reactions reported in post-marketing experience are presented in the table below.
Par blakuspar d b m ir zi ots p cre istr cijas period, un t s ir uzr d tas sekojošaj tabul.
Blood and lymphatic system disorders Very rare: thrombocytopenia Gastrointestinal disorders Very rare:
Ku a- zarnu trakta darb oti reti:
Gastrointestinal symptoms such as nausea, vomiting, abdominal pain, dyspepsia General disorders and administration site conditions Rare: peripheral oedema Investigations Very rare:
trombocitop nija bas trauc jumi gastrointestin li simptomi, piem ram, slikta d ša, vemšana, s pes v der, dispepsija
Increased blood pressure Nervous system disorders Very rare:
Visp r ji trauc jumi un reakcijas ievad šanas viet Reti: perif ra t ska Izmekl jumi oti reti:
Headache, including migraine Skin and subcutaneous tissue disorders Very rare:
Nervu sist mas darb bas trauc jumi oti reti:
Rash Reproductive system and breast disorders Very rare:
galvass pes, tostarp migr na
Mild breast symptoms such as pain, enlargement and tenderness.
Reprodukt v s sist mas oti reti:
Vascular disorders Rare: venous thromboembolic reaction Very rare: arterial thromboembolic reaction
Asinsvadu sist mas trauc jumi Reti: venoza trombemboliska reakcija oti reti:
6 4.9 Overdose
4. 9 P rdoz šana
In some clinical trials, daily doses were given up to 600 mg for 8 weeks and 120 mg, for 3 years.
Dažos kl niskajos p t jumos tika lietotas l dz 600 mg dienas lielas devas 8 ned as un 120 mg dienas devas 3 gadus.
No cases of raloxifene overdose were reported during clinical trials.
Kl niskajos p t jumos raloksif na p rdoz šana netika konstat ta.
In adults, symptoms of leg cramps and dizziness have been reported in patients who took more than 120 mg as a single ingestion.
Pieaugušiem pacientiem, kuri ie muši vair k nek 120 mg vien dev, rad s t di simptomi k k ju krampji un reibonis.
In accidental overdose in children younger than 2 years of age, the maximum reported dose has been 180 mg.
Nejauša p rdoz šana b rniem l dz 2 gadu vecumam notikusi, ie emot maksim li 180 mg.
In children, symptoms of accidental overdoseincluded ataxia, dizziness, vomiting, rash, diarrhea, tremor, and flushing, and elevation in alkaline phosphatase.
B rniem nov rotie nejaušas p rdoz šanas simptomi bija ataksija, reibonis, vemšana, izsitumi, caureja, tr ce un pietv kums un s rmain s fosfat zes l me a palielin šan s.
The highest overdose has been approximately 1.5 grams.
6 Liel k p rdoz šana ir bijusi apm ram 1, 5 grami.
No fatalities associated with overdose have been reported.
N ves gad jumi saist b ar p rdoz šanu nav konstat ti.
There is no specific antidote for raloxifene hydrochloride.
Raloksif na hidrohlor dam nav specifiska antidota.
Selective Oestrogen Receptor Modulator.
Farmakoterapeitisk grupa: selekt vs estrog nu receptoru modulators.
As a selective oestrogen receptor modulator (SERM), raloxifene has selective agonist or antagonist activities on tissues responsive to oestrogen.
K selekt vam estrog nu receptoru modulatoram (SERM) raloksif nam piem t selekt va agonista vai antagonista iedarb ba uz audiem, kas rea pret estrog niem.
It acts as an agonist on bone and partially on cholesterol metabolism (decrease in total and LDL-cholesterol), but not in the hypothalamus or in the uterine or breast tissues.
Tas darbojas k agonists uz kaulu un da ji uz holester na metabolismu (samazin s kop jais un ZBL holester ns), bet ne uz hipotal mu vai dzemdes un kr ts dziedzera audiem.
Raloxifene 'biological actions, like those of oestrogen, are mediated through high affinity binding to s oestrogen receptors and regulation of gene expression.
Raloksif na biolo isk darb ba, l dz gi estrog niem, realiz jas caur augstas afinit tes saist bu ar estrog nu receptoriem un g nu ekspresijas regul šanu.
This binding results in differential expression of multiple oestrogen-regulated genes in different tissues.
Š s saist šan s rezult t multiplie estrog nu regul tie g ni daž dos audos izpaužas daž di.
Recent data suggests that the oestrogen receptor can regulate gene expression by at least two distinct pathways which are ligand-, tissue-, and/ or gene-specific.
Jaun kie dati liecina, ka estrog nu receptori var regul t g nu ekspresiju vismaz divos atš ir gos veidos, kas ir ligandu, audu un/ vai g nu specifiska.
The decrease in oestrogen availability which occurs at menopause, leads to marked increases in bone resorption, bone loss and risk of fracture.
Estrog nu pieejam bas samazin šan s menopauzes laik stipri palielina kaulu rezorbciju, kaulaudu zudumu un l zumu rašan s risku.
Bone loss is particularly rapid for the first 10 years after menopause when the compensatory increase in bone formation is inadequate to keep up with resorptive losses.
Kaulaudu zudums paši strauji notiek pirmajos 10 gados p c menopauzes, kad kaulaudu veidošan s kompensator palielin šan s nav pietiekama, lai atsv rtu rezorbt vos zudumus.
Other risk factors which may lead to the development of osteoporosis include early menopause; osteopenia (at least 1 SD below peak bone mass); thin body build; Caucasian or Asian ethnic origin; and a family history of osteoporosis.
Citi riska faktori, kas var izrais t osteoporozes att st bu, ir agr na menopauze, osteop nija (vismaz 1 SD zem maksim l s kaulu masas), trausla erme a uzb ve, balt s rases vai azi tu etnisk pieder ba, osteoporoze imenes anamn z.
Replacement therapies generally reverse the excessive resorption of bone.
Aizst jterapijas visum nov rš p rm r gu kaulu rezorbciju.
In postmenopausal women with osteoporosis, OPTRUMA reduces the incidence of vertebral fractures, preserves bone mass and increases bone mineral density (BMD).
Sieviet m p cmenopauz ar osteoporozi OPTRUMA mazina skrieme u l zumu rašan s biežumu, saglab kaulu masu un palielina kaulaudu miner lvielu bl vumu (KMB).
Based on these risk factors, prevention of osteoporosis with OPTRUMA is indicated for women within ten years of menopause, with BMD of the spine between 1.0 and 2.5 SD below the mean value of a normal young population, taking into account their high lifetime risk for osteoporotic fractures.
Pamatojoties uz šiem riska faktoriem, osteoporozes profilakse ar OPTRUMA indic ta sieviet m desmit gadu period p c menopauzes, kur m mugurkaula KMB ir starp 1, 0 un 2, 5 SD zem vid j raksturlieluma veseliem jauniem indiv diem, emot v r lielo kop jo osteoporotisku l zumu risku dz ves laik š m sieviet m.
Likewise, OPTRUMA is indicated for the treatment of osteoporosis or established osteoporosis in women with BMD of the spine 2.5 SD below the mean value of a normal young population and/ or with vertebral fractures, irrespective of BMD.
OPTRUMA indic ts ar osteoporozes rst šanai sieviet m, kur m mugurkaula KMB ir 2, 5 SD zem vid j raksturlieluma veseliem jauniem indiv diem, un/ vai ar skrieme u l zumiem neatkar gi no KMB.
i) Incidence of fractures.
i) L zumu biežums.
Forty five women with osteoporosis or 15 women with
P t jum, kurš aptv ra 7705 sievietes p cmenopauz, vid ji 66 g. v., ar osteoporozi vai osteoporozi un l zumu, konstat ts, ka 3 gadu OPTRUMA terapija samazina skrieme u l zumu biežumu attiec gi par 47% (RR 0, 53, TI 0, 35, 0, 79; p < 0, 001) un 31% (RR 0, 69, TI 0, 56, 0, 86; p < 0, 001). etrdesmit piecas sievietes ar osteoporozi vai 15 sievietes ar osteoporozi un l zumu j rst ar OPTRUMA 3 gadus, lai nov rstu vienu vai vair kus skrieme u l zumus. rst šana ar OPTRUMA 4 gadus pacient m ar osteoporozi un pacient m ar osteoporozi un l zumu mazin ja mugurkaula skrieme u l zumu biežumu attiec gi par 46% (RR 0, 54, TI 0, 38, 0, 75) un par 32% (RR 0, 68, TI 0, 56, 0, 83).
In the 4th year alone, OPTRUMA reduced the new vertebral fracture risk by 39% (RR 0.61, CI 0.43, 0.88).
4. gad vien paš OPTRUMA samazin ja jaunu vertebr lo l zumu risku par 39% (RR 0, 61, TI 0, 43, 0, 88).
An effect on non-vertebral fractures has not been demonstrated.
Ietekme uz nevertebr liem l zumiem nav pier d ta.
From the 4th to the 8th year, patients were permitted the concomitant use of bisphosphonates, calcitonin and fluorides and all patients in this study received calcium and vitamin D supplementation.
No 4. l dz 8 gadam pacient m at va vienlaikus lietot bifosfon tus, kalciton nu un fluor dus, un visas pacientes šai p t jum sa ma papildus kalciju un D vitam nu.
In the RUTH study overall clinical fractures were collected as a secondary endpoint.
P t juma RUTH sekund rais m r a parametrs bija visp r g s inform cijas par kl niskiem l zumiem v kšana.
Optruma reduced the incidence of clinical vertebral fractures by 35% compared with placebo (HR 0.65, CI 0.47 0.89).
Sal dzinot ar placebo (HR 0, 65, CI 0, 47 0, 89), OPTRUMA samazin ja kl nisku vertebr lu l zumu skaitu par 35%.
These results may have been confounded by baseline differences in BMD and vertebral fractures.
Šos rezult tus var ietekm t s kotn j s atš ir bas starp BMD un vertebr liem l zumiem.
There was no difference between treatment groups in the incidence of new nonvertebral fractures.
P t juma grup s nebija atš ir bu nevertebr lo l zumu zi.
During the whole length of the study concomitant use of other bone-active medications was permitted.
Vis p t juma laik vienlaic gi bija at auts lietot citus rstniec bas l dzek us ar akt vu iedab bu uz kauliem.
ii) Bone Mineral Density (BMD):
7 ii) Kaulaudu miner lvielu bl vums (KMB).
The efficacy of OPTRUMA once daily in postmenopausal women aged up to 60 years and with or without a uterus was established over a two-year treatment period.
OPTRUMA efektivit ti l dz 60 gadus vec m sieviet m p cmenopauz ar vai bez dzemdes, lietojot vienreiz dien, noskaidroja divus gadus ilg rst šanas period.
The women were 2 to 8 years postmenopausal.
Sieviet m menopauze bija pirms 2 – 8 gadiem.
Three trials included 1,764 postmenopausal women who were treated with OPTRUMA and calcium or calcium supplemented placebo.
Trijos p t jumos piedal j s 1764 sievietes p cmenopauz, kuras tika rst tas ar OPTRUMA, kalciju vai placebo, kas papildin ts ar kalciju.
In one of these trials the women had previously undergone hysterectomy.
Vien no šiem p t jumiem sieviet m iepriekš bija veikta histerektomija.
OPTRUMA produced significant increases in bone density of hip and spine as well as total body mineral mass compared to placebo.
OPTRUMA b tiski palielin ja g žas kaula un mugurkaula kaulaudu bl vumu, k ar kop jo organisma miner lvielu masu, sal dzinot ar placebo.
This increase was generally a 2% increase in BMD compared to placebo.
Šo palielin jumu veidoja galvenok rt KMB palielin šan s par 2%, sal dzinot ar placebo.