qanastek/EMEA-V3 huggingface dataset:
In phase III studies, as compared to placebo, biochemical markers of bone formation (bone-specific alkaline phosphatase and C-terminal propeptide of type I procollagen) increased and those of bone resorption (serum C-telopeptide and urinary N-telopeptide cross links) decreased from the third month of treatment up to 3 years.
Fi studji fażi III, meta mqabblin ma ’ plaċebo, il- markers biokimiċi tal- formazzjoni ta ’ l- għadam (alkaline phospatase speċifiku għall- għadam u C- terminal propeptide tat- tip I procollagen) żdiedu u dawk ta ’ ri- assorbiment ta ’ l- għadam (serum C- telopeptide u N- telopeptide mgħaqudin msallbin fl - awrina) naqqsu mit- tielet xahar tal- kura sat- tielet sena.
Secondary to the pharmacological effects of strontium ranelate, slight decreases in calcium and parathyroid hormone (PTH) serum concentrations, increases in blood phosphorus concentrations and in total alkaline phosphatase activity were observed, with no observed clinical consequences.
Minħabba l- effetti farmakoloġiċi ta ’ strontium ranelate, tnaqqis żgħir fil- konċentrazzjoni fis- serum ta ’ calcium u ta ’ l- ormoni parathyroid (PTH), żieda fil- konċentrazzjoni ta ’ phosphorus fid- demm u fit - total ta ’ l- attività ta ’ alkaline phosphatase kienu osservati, mingħajr ebda konsegwenzi kliniċi.
Clinical efficacy Osteoporosis is defined as BMD of the spine or hip 2.5 SD or more below the mean value of a normal young population.
Effikaċja klinika L- osteoporożi hija meqjusa bħala BMD ta ’ l- ispina jew tal- ġenb 2. 5 SD jew aktar taħt il- valur medju ta ’ popolazzjoni żagħżugħa normali.
A number of risk factors are associated with postmenopausal osteoporosis including low bone mass, low bone mineral density, early menopause, a history of smoking and a family history of osteoporosis.
Numru ta ’ fatturi ta ’ riskju huma assoċjati ma ’ l- osteoporożi menopawsali li jinkludu l- massa fl- għadam baxx, densità minerali baxxa, menopawsa kmieni, storja ta ’ tipjip u storja ta ’ l- osteoporożi fil- familja.
The clinical consequence of osteoporosis is fractures.
Il- konsegwenzi kliniċi ta ’ l- osteoporożi huwa l- ksur.
The risk of fractures is increased with the number of risk factors.
Ir - riskju tal- ksur jiżdied man- numru tal- fatturi tar- riskju.
Treatment of postmenopausal osteoporosis:
Kura ta ’ osteoporożi menopawsali:
The anti-fracture studies program of OSSEOR was made up of two placebo-controlled phase III studies:
Il- programm ta ’ studju fuq OSSEOR kontra l- ksur kien jikkonsisti minn żewġ studji fażi III ikkontrollati bi plaċebo:
SOTI study and TROPOS study.
Studju SOTI u studju TROPOS.
SOTI involved 1,649 postmenopausal women with established osteoporosis (low lumbar BMD and prevalent vertebral fracture) and a mean age of 70 years.
SOTI involva 1, 649 nisa wara l- menopawsa b’ osteoporożi stabbilit (BMD fil- lumbari baxx u prevelanza fi ksur tas- sinsla) u età medja ta ’ 70 sena.
TROPOS involved 5,091 postmenopausal women with osteoporosis (low femoral neck BMD and prevalent fracture in more than half of them) and a mean age of 77 years.
TROPOS involva 5, 091 nisa wara l- menopawsa b’ osteoporożi (BMD fl- għonq tal- femur baxx u ksur
Together, SOTI and TROPOS enrolled 1,556 patients over 80 years at inclusion (23.1% of the study population).
Flimkien f’ SOTI u TROPOS ħadu sehem 1, 556 pazjenti `l fuq minn 80 sena fil- bidu ta ’ l- istudju (23. 1% tal- popolazzjoni fl- istudju).
In addition to their treatment (2 g/ day strontium ranelate or placebo), the patients received adapted calcium and vitamin D supplements throughout both studies.
Flimkien mat- terapija (2 g/ jum strontium ranelate jew plaċebo), il- pazjenti, matul iż- żewġ studji, ngħataw supplimenti adattati ta ’ calcium u vitamina D.
OSSEOR reduced the relative risk of new vertebral fracture by 41% over 3 years in the SOTI study (table 1).
OSSEOR naqqas ir- riskju relattiv ta ’ ksur ġdid fis- sinsla b’ 41% tul tlett snin fl- istudju SOTI (tabella 1).
The effect was significant from the first year.
L- effett kien sinifikanti mill- ewwel sena.
Similar benefits were demonstrated in women with multiple fractures at baseline.
Benefiċċji simili ntwerew f’ nisa bi ksur multiptipliku fil - linja bażi.
With respect to clinical vertebral fractures (defined as fractures associated with back pain and/ or a body height loss of at least 1 cm), the relative risk was reduced by 38%.
Meta tħares lejn il- ksur kliniku tas- sinsla (iddefinit bħala ksur assoċjat ma ’ uġigħ fid- dahar u/ jew telf fit- tul tal- ġisem ta ’ mill- inqas 1 cm) ir- riskju relattiv naqas b’ 38%.
OSSEOR also decreased the number of patients with a body height loss of at least 1 cm as compared to placebo.
OSSEOR wera wkoll tnaqqis fin- numru ta ’ pazjenti b’ telf ta ’ tul tal - ġisem ta ’ mill- inqas 1 cm meta mqabbel ma ’ plaċebo.
Quality of life assessment on the QUALIOST specific scale as well as the General Health perception score of the SF-36 general scale indicated benefit of OSSEOR, compared with placebo.
Stima tal- kwalità tal- ħajja bbażata fuq l- iskala speċifika QUALIOST kif ukoll fuq il- punteġġ tal - perċezzjoni tas- Saħħa Ġenerali ta ’ l- iskala ġenerali SF- 36 indikat benefiċju bi OSSEOR, meta mqabbel ma ’ plaċebo.
6 Efficacy of OSSEOR to reduce the risk of new vertebral fracture was confirmed in the TROPOS study, including for osteoporotic patients without fragility fracture at baseline.
L- effikaċja ta ’ OSSEOR biex inaqqas ir- riskju tal- ksur ġdid tas- sinsla kien ikkonfermat fl- istudju TROPOS, li jinkludi l- pazjenti bl- osteoporożi mingħajr ksur fraġli fil- bidu ta ’ l- istudju.
Incidence of patients with vertebral fracture and relative risk reduction
Inċidenza ta ’ pazjenti bi ksur fis- sinsla u tnaqqis relattiv fir- riskju.
Relative Risk Reduction vs. placebo (95%CI), p value
Tnaqqis Relattiv fir- Riskju vs. plaċebo (95% CI), valur p
vertebral fracture over 3 years
Ksur ġdid tas- sinsla tul 3 snin
32.8%
32. 8%
20.9%
20. 9%
41% (27-52), p < 0.001
41% (27- 52), p < 0. 001
vertebral fracture
Ksur ġdid tas- sinsla tul l - ewwel sena
11.8%
11. 8%
6.1%
6. 1%
49% (26-64), p < 0.001
49% (26- 64), p < 0. 001
New clinical vertebral fracture over 3 years
Ksur kliniku ġdid tas- sinsla tul 3 snin
17.4%
17. 4%
11.3%
11. 3%
38% (17-53), p < 0.001
38% (17- 53), p < 0. 001
New
Ksur ġdid
vertebral fracture over 3 years
tas- sinsla tul 3 snin
20.0%
20. 0%
12.5%
12. 5%
39% (27-49), p < 0.001
39% (27- 49), p < 0. 001
In patients over 80 years of age at inclusion, a pooled analysis of SOTI and TROPOS studies showed that OSSEOR reduced the relative risk of experiencing new vertebral fractures by 32% over 3 years (incidence of 19.1% with strontium ranelate vs.
F’ pazjenti ’ l fuq minn 80 sena meta daħlu fl- istudju, analiżi miġbura flimkien ta ’ l- istudji SOTI u TROPOS uriet li OSSEOR naqqas ir- riskju relattiv li wieħed isofri minn ksur ġdid tas- sinsla b’ 32% fuq 3 snin (inċidenza ta ’ 19. 1% bi strontium ranelate vs.
26.5% with placebo).
26. 5% bi plaċebo).
12.0% with placebo).
F’ analiżi a- posteriori ta ’ pazjenti mill- istudji SOTI u TROPOS miġbura flimkien b’ bażi lumbari ta ’ l - ispina u/ jew ta ’ l- għonq tal- femur BMD fil- wisa ’ osteopenika u mingħajr ksur prevelanti iżda b’ mill - inqas fattur ta ’ riskju addizjonali għal ksur (N = 176), OSSEOR naqqas ir- riskju li jkun hemm l- ewwel ksur tas- sinsla b’ 72% tul 3 snin (inċidenza ta ’ ksur tas- sinsla 3. 6% bi strontium ranelate vs. 12. 0% bi plaċebo).
An a-posteriori analysis was performed on a subgroup of patients from the TROPOS study of particular medical interest and at high-risk of fracture [defined by a femoral neck BMD T-score ≤ - 3 SD (manufacturer’ s range corresponding to -2.4 SD using NHANES III) and an age ≥ 74 years (n=1,977, i. e.
Analiżi a- posteriori kien imwettaq fuq sottogrupp ta ’ pazjenti ta ’ interess mediku partikolari u b’ riskju għoli ta ’ ksur [definit bħala BMD ta ’ l- għonq tal- femur T- score ≤ - 3SD (il- wisa ’ tal- produttur tikkorispondi għal- 2. 4 SD meta tuża ’ NHANES III) u età ≥ 74 sena (n = 1, 977, i. e.
40% of the TROPOS study population)].
40% tal - popolazzjoni fil- istudju TROPOS)].
In this group, over 3 years of treatment, OSSEOR reduced the risk of hip fracture by 36% relative to the placebo group (table 2).
F’ dan il- grupp, tul 3 snin ta ’ kura, OSSEOR naqqas ir- riskju ta ’ ksur tal- ġenb b’ 36% relattivament mal- grupp bi plaċebo.
Incidence of patients with hip fracture and relative risk reduction in patients with BMD ≤ -2.4 SD (NHANES III) and age ≥ 74 years
Inċidenza ta ’ pazjenti bil- ksur tal- ġenb u tnaqqis fir- riskju relattiv tal- ksur f’ pazjenti b’ BMD ≤ - 2. 4 SD (NHANES III) u età ≥ 74 sena
Relative Risk Reduction vs. placebo (95%CI), p value
Tnaqqis fir- Riskju Relattiv vs. plaċebo (95% CI), valur p
Hip fracture over 3 years
Ksur tal- ġenb tul- 3 snin
6.4%
6. 4%
4.3%
4. 3%
36% (0-59), p=0.046
36% (0- 59), p = 0. 046
Strontium ranelate is made up of 2 atoms of stable strontium and 1 molecule of ranelic acid, the organic part permitting the best compromise in terms of molecular weight, pharmacokinetics and acceptability of the medicinal product.
Strontium ranelate hu magħmul minn 2 atomi ta ’ strontium stabbli u molekula waħda ta ’ ranelic acid, il- parti organika tippermetti l- aħjar kompromess bejn il- piz molekulari, il- farmakokinetika u l- aċċetabilità tal- prodott mediċinali.
The pharmacokinetics of strontium and ranelic acid have been assessed in healthy young men and healthy postmenopausal women, as well as during long-term exposure in postmenopausal osteoporotic women including elderly women.
Il- farmakokinetika ta ’ strontium u ranelic acid ġew studjati f’ żagħżagħ irġiel b’ saħħithom u nisa wara l- menopawsa b’ saħħithom, kif ukoll waqt espożizzjoni fit- tul f’ nisa wara lmenopawsa bl- osteoporożi, li jinkludu nisa anzjani.
Due to its high polarity, the absorption, distribution and binding to plasma proteins of ranelic acid are low.
Minħabba l- polarità għolja, l- assorbiment, id- distribuzzjoni u t- twaħħil mal- protejini tal- plażma ta ’ ranelic acid huma baxxi.
There is no accumulation of ranelic acid and no evidence of metabolism in animals and humans.
Ranelic acid ma jakkumulax u m’ hemm l- ebda evidenza ta ’ metaboliżmu fl- annimali u l- bnedmin.
Absorbed ranelic acid is rapidly eliminated unchanged via the kidneys.
Ranelic acid li jiġi assorbit jitneħħa malajr fi stat mhux mibdul mill- kliewi.
7 The absolute bioavailability of strontium is about 25% (range 19-27%) after an oral dose of 2 g strontium ranelate.
Assorbiment Il- biodisponibiltà assoluta ta ’ strontium hija ta ’ madwar 25% (bejn 19% u 27%) wara doża mill- ħalq ta ’ 2 g strontium ranelate.
Maximum plasma concentrations are reached 3-5 hours after a single dose of 2 g.
Il- konċentrazzjoni massima fil- plażma tintlaħaq 3- 5 sigħat wara doża waħda ta ’ 2 g.
Steady state is reached after 2 weeks of treatment.
Stat fiss jintlaħaq wara ġimgħatejn kura.
Intake of strontium ranelate with calcium or food reduces the bioavailability of strontium by approximately 60-70%, compared with administration 3 hours after a meal.
Jekk strontium ranelate jittieħed ma ’ calcium jew ma ’ l- ikel, dan inaqqas il- biodisponibiltà ta’ strontium bejn wieħed u ieħor 60% - 70% mqabbel ma ’ l- għoti 3 sigħat wara l- ikel.
Due to the relatively slow absorption of strontium, food and calcium intake should be avoided both before and after administration of OSSEOR.
Minħabba l- assorbiment relattivament bil- mod ta ’ strontium it- teħid ta ’ l- ikel u calcium għandu jiġi evitat kemm qabel kif ukoll wara l- għoti ta ’ OSSEOR.
Oral supplementation with vitamin D has no effect on strontium exposure.
Is- supplimentazzjoni mill- ħalq bil- Vitamina D ma għandu l- ebda effett fuq l- espożizzjoni għal strontium.
Distribution Strontium has a volume of distribution of about 1 l/ kg.
Distribuzzjoni Strontium għandu volum ta ’ distribuzzjoni ta ’ bejn wieħed u ieħor 1 l/ kg.
The binding of strontium to human plasma proteins is low (25%) and strontium has a high affinity for bone tissue.
It- twaħħilta ’ strontium mal- protejini tal- plażma tad- demm uman huwa baxx (25%) u strontium għandu affinità kbira għat - tessuti ta ’ l- għadam.
Measurement of strontium concentration in iliac crest bone biopsies from patients treated for up to 60 months with strontium ranelate 2 g/ day indicate that bone strontium concentrations may reach a plateau after about 3 years of treatment.
Il- kejl tal- konċentrazzjoni ta ’ strontium f’ biopsiji ta ’ l- għadam mill- krest ta ’ l- ilju ta ’ pazjenti trattati sa 60 xahar bi strontium ranelate 2 g/ jum jindikaw li l- konċentrazzjoni ta ’ strontium fl- għadam jistgħu jilħqu livell wara bejn wieħed u ieħor 3 snin ta ’ kura.
There are no data in patients to demonstrate elimination kinetics of strontium from bone off-therapy.
Mhemm l- ebda tagħrif f’ pazjenti biex turi l- kinetika ta ’ l- eliminazzjoni ta ’ l- istrontium mill- għadam, meta wieħed ma jibqax fuq it- terapija.
Biotransformation As a divalent cation, strontium is not metabolised.
Biotrasformazzjoni Bħala ketajin divalenti, strontium ma jiġix metaboliżżat.
Strontium ranelate does not inhibit cytochrome P450 enzymes.
Strontium ranelate ma jimpedixxix l- enżimi cytochrome P450.
Elimination The elimination of strontium is time and dose independent.
Eliminazzjoni L- eliminazzjoni ta ’ strontium hija indipendenti mill- ħin u mid- doża.
The effective half-life of strontium is about 60 hours.
Il- half- life ta ’ strontium hija ta ’ bejn wieħed u ieħor 60 siegħa.
Strontium excretion occurs via the kidneys and the gastrointestinal tract.
L- eskrezzjoni ta ’ strontium isseħħ mill- kliewi u mill- passaġġ gastro - intestinali.
Its plasma clearance is about 12 ml/ min (CV 22%) and its renal clearance about 7 ml/ min (CV 28%).
Il- clearance mill- plażma huwa ta ’ bejn wieħed u ieħor 12 ml/ min (CV 22%) u l- clearance renali huwa ta ’ bejn wieħed u ieħor 7 ml/ min (CV 28%).
Elderly Population pharmacokinetic data showed no relationship between age and apparent clearance of strontium in the target population.
Anzjani It- tagħrif farmakokinetiku fil- popolazzjoni ma wera l- ebda relazzjoni bejn l- età u l- clearance apparenti ta ’ strontium fil- popolazzjoni indikata.
Patients with renal impairment In patients with mild-to-moderate renal impairment (30-70 ml/ min creatinine clearance), strontium clearance decreases as creatinine clearance decreases (approximately 30% decrease over the creatinine clearance range 30 to 70 ml/ min) and thereby induces an increase in strontium plasma levels.
8 Pazjenti b’ indeboliment renali F’ pazjenti b’ indeboliment renali minn ħafif għal moderat (30- 70ml/ min clearance tal- krejatinina), il - clearance ta ’ strontium jonqos kif jonqos il- clearance tal- krejatinina (bejn wieħed u ieħor jonqos b’ 30% tul il- wisa ’ ta ’ clearance tal- krejatinina minn 30 sa 70 ml/ min) u għaldaqstant iwassal għal żieda fil- livelli ta ’ strontium fil- plażma.
In phase III studies, 85% of the patients had a creatinine clearance between 30 and 70 ml/ min and 6% below 30 ml/ min at inclusion, and the mean creatinine clearance was about 50 ml/ min.
Fi studji fażi III, 85% tal- pazjenti kellhom clearance tal - krejatinina ta ’ bejn 30 u 70 ml/ min u 6% b’ inqas minn 30 ml/ min fil- bidu ta ’ l- istudju u l- clearance medja tal- krejatinina kienet ta ’ bejn wieħed u ieħor 50 ml/ min.
No dosage adjustment is therefore required in patients with mild-to-moderate renal impairment.
Għalhekk mhux meħtieg ebda aġġustament fid- doża f’ pazjenti b’ indeboliment renali minn ftit sa moderat.
There is no pharmacokinetic data in patients with severe renal impairment (creatinine clearance below 30 ml/ min).
Mhemmx tagħrif farmakokinetiku f’ pazjenti b’ indeboliment renali severi (clearance tal- krejatinina inqas minn 30 ml/ min).
Patients with hepatic impairment There is no pharmacokinetic data in patients with hepatic impairment.
Pazjenti b’ indeboliment fil- fwied Mhemmx tagħrif farmakokinetiku f’ pazjenti b’ indeboliment fil- fwied.
Due to the pharmacokinetic properties of strontium, no effect is expected.
Minħabba l- karatterstiċi farmakokinetiċi ta ’ strontium ebda effett mhu mistenni.
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential.
Informazzjoni mhux klinika, ibbażata fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku fuq il- ġeni u riskju ta ’ kanċer, ma turi l- ebda periklu speċjali għall- bnedmin.
Chronic oral administration of strontium ranelate at high doses in rodents induced bone and tooth abnormalities, mainly consisting of spontaneous fractures and delayed mineralisation.
Għoti kroniku mill- ħalq ta ’ strontium ranelate lil firien f’ dożi għolja kkawżaw abnormalità fl- għadam u fis- snien, l- aktar ksur spontanju u mineralizzazzjoni ttardjata.
These effects were reported at bone strontium levels 2-3 times higher than long-term clinical bone strontium levels and were reversible after cessation of treatment.
Dawn l- effetti kienu rrapportati b’ livelli ta ’ strontium fl- għadam ta ’ 2- 3 darbiet ogħla minn livelli kliniċi fit- tul taż- żmien ta ’ strontium fl- għadam u kienu riversibbli wara li twaqqfet il- kura.
8 Developmental toxicity studies in rats and rabbits resulted in bone and tooth abnormalities (e. g. bent long bones and wavy ribs) in the offspring.
Studji tossici fuq l- iżvilupp f’ firien u fil- fniek irriżultaw f’ abnormalitajiet fl- għadam u fis- snien (p. e. tgħawwiġ fl- għadam it- twil u kustilji mxenglin) fil- wild.
In rats, these effects were reversible 8 weeks after cessation of treatment.
Fil- firien, dawn l- effetti kienu riversibbli 8 ġimgħat wara li twaqqfet il- kura.
Aspartame (E951) Maltodextrin Mannitol (E421)
Aspartame (E951) Maltodextrin Mannitol (E421)
Paper/ polyethylene/ aluminium/ polyethylene sachets.
Qartas tal- karti/ polyethylene/ aluminium/ polyethylene
Pack sizes Boxes containing 7, 14, 28, 56, 84 or 100 sachets.
9 Qisien tal- pakkett Kaxxi fihom 7, 14, 28, 56, 84, jew 100 qratas.
LES LABORATOIRES SERVIER 22, rue Garnier 92200 Neuilly-sur-Seine France
LES LABORATOIRES SERVIER 22, rue Garnier 92200 Neuilly- sur- Seine Franza
11 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Les Laboratoires Servier Industrie 905, route de Saran 45520 Gidy France
Les Laboratoires Servier Industrie 905, route de Saran 45520 Gidy Franza
Outer carton
Pakkett ta ’ barra
OSSEOR 2 g granules for oral suspension Strontium ranelate
OSSEOR 2 g granijiet għal suspensjoni orali Strontium ranelate
Each sachet contains 2 g strontium ranelate.
Kull qartas fih 2 g strontium ranelate.
Also contains aspartame (E 951).
Fih ukoll aspartame (E 951).
Granules for oral suspension.
Granijiet għal suspensjoni orali.
For oral use Read the package leaflet before use
Użu orali Aqra il- fuljett ta ’ tagħrif qabel l- użu.
Les Laboratoires Servier 22, rue Garnier 92200 Neuilly-sur-Seine France
Les Laboratoires Servier 22, rue Garnier 92200 Neuilly- sur- Seine Franza
For oral use Read the package leaflet before use
Aqra il- fuljett ta ’ tagħrif qabel l- użu.
56 sachets [84 sachets] [100 sachets]
56 qratas [84 qratas] [100 qratas]
EU/ 1/ 04/ 287/ 004 56 sachets EU/ 1/ 04/ 287/ 005/ 84 sachets EU/ 1/ 04/ 287/ 006 100 sachets
EU/ 1/ 04/ 287/ 004 56 qratas EU/ 1/ 04/ 287/ 005 84 qratas EU/ 1/ 04/ 287/ 006 100 qratas
22 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
22 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Sachet
Qartas
OSSEOR 2 g granules for oral suspension.
OSSEOR 2 g granijiet għal suspensjoni orali.
please tell your doctor or your pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What OSSEOR is and what it is used for 2.
X’ inhu OSSEOR u għalxiex jintuża 2.
Before you take OSSEOR 3.
Qabel ma tieħu OSSEOR 3.
How to take OSSEOR 4.
Kif għandek tieħu OSSEOR 4.
How to store OSSEOR 6.
Kif taħżen OSSEOR 6.
WHAT OSSEOR IS AND WHAT IT IS USED FOR
X’ INHU OSSEOR U GĦALXIEX JINTUŻA
OSSEOR is a non-hormonal medicine used to treat osteoporosis in postmenopausal women.
OSSEOR huwa mediċina li ma fihx ormoni li tintuża biex jikkura l- osteoporożi f’ nisa wara l- menopawsa.
OSSEOR reduces the risk of fracture at the spine and at the hip.
OSSEOR inaqqas ir- riskju ta ’ ksur ta ’ l- għadam fis- sinsla tad- dahar u fil- ġenb.
About osteoporosis Your body is constantly breaking down old bone and making new bone tissue.
Tagħrif dwar l- osteoporożi Il- ġisem tiegħek qiegħed il- ħin kollu jkisser l- għadam qadim u jiġġenera tessut ta ’ l- għadam ġdid.
If you have osteoporosis, your body breaks down more bone than it forms so that gradually bone loss occurs and your bones become thinner and fragile.
Jekk għandek l- osteoporożi, il- ġisem tiegħek jkisser aktar għadam milli jifforma sakhemm bil- mod il- mod jonqos l- għadam u l- għadam tiegħek jirqaq u ssir fraġli.
This is especially common in women after the menopause (change of life).
Dan hu l- aktar komuni f’ nisa wara l - menopawsa (meta l- mara ma tibqax tara l- pirjid).
Many people with osteoporosis have no symptoms and you may not even know that you have it.
Ħafna nies b’ osteoporożi ma jkollomx sintomi u inti tista lanqas biss tinduna li jkollok l- osteoporożi.
However, osteoporosis makes you more likely to have fractures (break bones), especially in your spine, hips and wrists.
Madankollu, l- osteoporożi tista żżidlek iċ- ċans li jkollok ksur (jinqassmu l- għadam), speċjalment ta ’ l- ispina, il- ġnub u l- polz.
How OSSEOR works OSSEOR belongs to a group of medicines used to treat bone diseases.
Kif jaħdem OSSEOR OSSEOR jappartjeni għall- grupp ta ’ mediċini li jintużaw għall- kura ta’ mard fl- għadam.
OSSEOR works by reducing bone breakdown and stimulating rebuilding of bone and therefore reduces the risk of fracture.
OSSEOR jaħdem billi jnaqqas il- ksur fl- għadam u jistimula l- bini ta ’ l- għadam mill- ġdid u għalhekk inaqqas ir- riskju ta ’ ksur.
The newly formed bone is of normal quality.
L- għadam iffurmat mill- ġdid huwa ta ’ kwalità normali.
BEFORE YOU TAKE OSSEOR
QABEL MA TIEĦU OSSEOR
Do not take OSSEOR:
Tieħux OSSEOR
- if you are allergic (hypersensitive) to strontium ranelate or any of the other ingredients of
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal strontium ranelate jew sustanzi oħra ta ’
Before taking OSSEOR talk to your doctor:
Oqgħod attent ħafna bi OSSEOR Qabel tieħu OSSEOR kellem lit- tabib tiegħek:
- if you have severe kidney disease.
- jekk tbati minn mard severi tal- kliewi.
- if you are being treated or have been treated for blood clots.
- jekk int qiegħed tieħu kura jew qatt ħadt kura għall - emboli fid- demm.
- if you are confined to bed or if you are to undergo an operation.
- jekk inti ma tistax tqum mis- sodda jew ser tagħmel operazzjoni.
The risk of vein thrombosis
Ir- riskju ta ’ trombożi fil- vini
(blood clots in the leg) may be increased in the event of lengthy immobilisation.
(emboli tad- demm fis- saqajn) jista ’ jiżdied jekk tagħmel żmien twil ma tiċċaqlaqx.
- OSSEOR is not intended for use in children and adolescents.
- OSSEOR mhux indikat għall- użu fit- tfal u fl- addoloxxenti.
25 During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must immediately stop taking OSSEOR and seek medical advice.
25 Waqt il- kura, jekk ikollok xi reazzjoni allerġika (bħal nefħa fil- wiċċ, ilsien jew fil- gerżuma, diffikultà biex tieħu in- nifs jew biex tibla ’, raxx fil - ġilda) għandek tieqaf immedjatament milli tieħu OSSEOR u għandek tfittex parir mediku.
If you have stopped treatment due to hypersensitivity reactions it should be permanent and you should not re-start therapy with OSSEOR.
Jekk tkun waqqaft il- kura minħabba reazzjonijiet ta ’ sensittività eċċessiva din għandha tkun permanenti u m’ għandekx terga ’ tibda kura b’ OSSEOR.
If you are taking medicines containing calcium, you should leave at least 2 hours before you take OSSEOR.
Jekk qed tieħu mediċini li fihom calcium, għandek tħalli ta ’ mill- inqas sagħtejn qabel ma tieħu OSSEOR.
If you take antacids (medicines to relieve heartburn) you should take them at least 2 hours after OSSEOR.
Jekk tieħu mediċini kontra l- aċidu fl- istonku (mediċini biex itaffu l- ħruq fl- istonku) għandek toħodhom mill- inqas 2 sigħat wara OSSEOR.
If this is not possible, it is acceptable to take the two medicines at the same time.
Jekk dan mhux possibli, huwa aċċettabli li - tieħu ż- żewġ mediċini fl- istess ħin.
You should stop taking OSSEOR if you have to take oral tetracyclines or quinolones (two types of antibiotics).
Għandek tieqaf mill tieħu OSSEOR jekk ikollok bżonn tieħu tetracyclines jew quinolones mil- ħalq (żewġ tipi ta ’ antibiotiċi).
You can take OSSEOR again when you have finished taking these antibiotics.
Tista terġa tibda tieħu OSSEOR meta tispiċċa tieħu dawn l- antibiotiċi.
If you are unsure about this ask your doctor or pharmacist.
Jekk ma tkunx ċert dwar dan staqsi lit- tabib jew lill- ispiżjar tiegħek.
Taking OSSEOR with food and drink:
Meta tieħu OSSEOR ma ’ l- ikel u max- xorb:
Food, milk and milk products reduce the absorption of strontium ranelate.
L- ikel, il- ħalib u prodotti magħmulin mill- ħalib inaqqsu l- assorbiment ta ’ strontium ranelate.
It is recommended that you take OSSEOR in-between meals, preferably at bedtime at least two hours after food, milk or milk products or calcium supplements.
Huwa rakkomandat li tieħu OSSEOR bejn l- ikel, prefibbilment qabel ir- raqda ta ’ bil- lejl mill- inqas sagħtejn wara l- ikel, il- ħalib jew prodotti magħmulin mill- ħalib u supplimenti ta ’ calcium.
OSSEOR is meant for use only in postmenopausal women.
OSSEOR huwa magħmul biss għall- użu f’ nisa wara l- menopawsa.
Therefore, OSSEOR should not be taken during pregnancy.
Għalhekk, OSSEOR m’ għandux jittieħed waqt it- tqala.
If you take it by accident during pregnancy, stop taking it straight away and talk to your doctor.
Jekk tieħdu biż- żball, waqt it- tqala, għandek tieqaf tieħdu mill- ewwel u tfittex il- parir tat- tabib tiegħek.
Therefore, breast-feeding women should not take this medicine.
Għalhekk, nisa li qegħdin ireddgħu m’ għandhomx jieħdu din il- mediċina.
If you take it by accident during breast-feeding, stop taking it straight away and talk to your doctor.
Jekk teħodha biż- żball u inti qegħda tredda ’, għandek tieqaf tieħdu mill- ewwel u tfittex il- parir tat- tabib tiegħek.
OSSEOR is not known to affect your ability to drive or use machines.
OSSEOR m’ għandu jkollu l- ebda effett fuq is- sewqan, l- użu minn għodda jew it- tħaddim ta’ magni.
Important information about some of the ingredients of OSSEOR:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ OSSEOR:
OSSEOR contains aspartame.
OSSEOR fih aspartame.
If you suffer from phenylketonuria (a rare, hereditary disorder of the metabolism) talk to your doctor before you start to take this medicine.
Jekk tbati minn phenylketonuria (marda rari tal- metaboliżmu, li tintiret) kellem lit- tabib tiegħek qabel ma tibda tieħu din il- mediċina.
HOW TO TAKE OSSEOR
KIF GĦANDEK TIEĦU OSSEOR
Always take OSSEOR exactly as your doctor has told you.
Dejjem għandek tieħu OSSEOR eżatt skond il- parir tat- tabib.
OSSEOR is for oral use.
OSSEOR huwa għal użu mill- ħalq.
The recommended dose is one 2g sachet a day.
Id- doża rakkomandata hija qartas wieħed ta ’ 2 g kuljum
It is recommended that you take OSSEOR at bedtime.
Huwa rakkomandat li tieħu OSSEOR qabel ir- raqda ta ’ bil- lejl.
You may lie down immediately after taking OSSEOR if you wish.
Tista ’ timtedd mill- ewwel wara li tieħu OSSEOR jekk tixtieq tagħmel dan.
Take the granules contained in the sachets as a suspension in a glass of water (see instructions below).
Ħallat il - granijiet ġol- qartas bħala suspensjoni ma ’ tazza ilma (ara struzzjonijiet hawn taħt).
OSSEOR can interact with milk and milk products, so it is important that you mix OSSEOR only with water to be sure it works properly.
OSSEOR jista ’ ma jaqbilx mal- ħalib jew prodotti magħmula mill- ħalib, għalhekk huwa importanti li tħawwad OSSEOR ma ’ l- ilma biss biex tkun ċert li jaħdem tajjeb.
26 Empty the granules from the sachet into a glass;
26 Żvojta il- granijiet mill- qartas ġo tazza;
Add water;
Żid l- ilma;
Stir until the granules are evenly dispersed in the water.
Ħawwad sakemm il- granijiet jitħalltu ugwalment fl- ilma.
Drink straight away.
Ixrob mill- ewwel.
If for some reason you do not drink the medicine straight away, make sure you stir it again before drinking.
Jekk għal xi raġuni ma tixrobx il- mediċina mill- ewwel, ara li terġa ’ tħawwadha qabel ma tixrobha.
You should not leave it more than 24 hours before you drink it.
M’ għandekx tħalliha iktar minn 24 siegħa qabel ma tixrobha.
Your doctor may advise you to take calcium and vitamin D supplements in addition to OSSEOR.
It- tabib tiegħek jista jirakkomandalek li tieħu supplimenti ta ’ calcium jew Vitamina D barra OSSEOR.
Do not take calcium supplements at bedtime, at the same time as OSSEOR.
Tieħux is- supplimenti ta’ calcium qabel ir- raqda ta ’ bil- lejl, fl- istess ħin ta ’ OSSEOR.
Your doctor will tell you how long you should continue to take OSSEOR.
It- tabib tieħek għandu jgħidlek kemm għandek iddum tieħu OSSEOR fit- tul.
Osteoporosis-therapy is usually required for a long period.
Il- kura għall- osteoporożi s- soltu tieħu fit- tul.
It is important that you continue taking OSSEOR for as long as your doctor prescribes the medicine.
Huwa importanti li tibqa ’ tieħu OSSEOR sakemm it- tabib jibqa ’ jiktiblek il- mediċina.
If you take more OSSEOR than you should:
Jekk tieħu OSSEOR aktar milli suppost:
If you take too many sachets of OSSEOR, tell your doctor or pharmacist.
Jekk tieħu aktar qratas ta ’ OSSEOR milli suppost, kellem lit- tabib jew l- ispiżjar tiegħek.
They may advise you to drink milk or take antacids to reduce the absorption of the active ingredient.
Jistgħu jagħtuk parir li tixrob il- ħalib jew tieħu mediċini ta ’ kontra l- aċidu fl- istonku biex tnaqqas l- assorbiment tal- mediċina.
If you forget to take OSSEOR:
Jekk tinsa tieħu OSSEOR:
Do not take a double dose to make up for forgotten individual doses.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża individwali li tkun insejt tieħu.
Just carry on with the next dose at the normal time.
Kompli billi tieħu d- doża li jmiss fil- ħin tas- soltu.
Like all medicines, OSSEOR can cause side effects, although not everybody gets them.
Bħall kull mediċina oħra, OSSEOR jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
During clinical trials, the most common side effects were nausea, diarrhoea, headache and skin irritation.
Waqt studji kliniċi, l- iżjed effetti sekondarji komuni kienu dardir, dijarea, uġigħ ta ’ ras u irritazzjoni fil- ġilda.
However, these effects were mild and short-lived and usually did not cause the patients to stop taking their treatment.
Iżda dawn l- effetti kienu ħfief u għal żmien qasir u s- soltu ma jikkanġunawx lill- pazjenti jwaqqfu l- kura.
Talk to your doctor if any effects become troublesome or persist.
Ħu l- parir tat- tabib tiegħek jekk xi effetti jikawżaw problemi jew jippersistu.
Other events less commonly reported included blood clots, fainting fit, memory troubles and, in rare cases, seizures.
Effetti oħrajn li kienu rraportati inqas komuni jinkludu emboli fid- demm, ħass ħażin, problemi fil - memorja u, f’ każi rari, attakki ta ’ puplesija.
The following side effects have also been reported by patients taking OSSEOR: vomiting, abdominal pain, oral irritation (such as mouth ulcers and gum inflammation), bone, muscle and/ or joint pain, muscle cramps, hypersensitivity syndromes (allergic reactions including rash and fever), itching, hives, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), swelling in limbs, feeling confused.
Dawn l- effetti mhux mixtieqa ġew irraportati ukoll minn pazjenti li ħadu OSSEOR: remettar, uġigħ addominali, irritazzjoni orali (bħal ulċeri fil - ħalq u infjammazjoni fil- ħanek), uġigħ fl- għadam, fil - muskoli u/ jew fil- ġogi, bugħawwieġ, sindromi ta ’ sensittività eċċessiva (reazzjonijiet allerġiċi li jinkludu raxx u deni), ħakk, urtikarja, anġjoedema (bħal nefħa fil- wiċċ, ilsien jew griżmejn, diffikulta` biex tieħu n- nifs jew biex tibla), nefha fl- idejn u s- saqajn, tħossok konfuż.
In some cases very serious hypersensitivity reactions have been reported.
F’ ċerti każijiet, reazzjonijiet serji ħafna ta ’ sensittivita` eċċessiva ġew irraportati.
Therefore you should immediately stop taking OSSEOR and see your doctor if you experience symptoms of angioedema or hypersensitivity syndrome.
Għalhekk għandek tieqaf tieħu OSSEOR immedjatament u għandek tara ’ t- tabib tiegħek jekk ikollok sintomi ta ’ anġjoedema jew sindromu ta ’ sensittività eċċessiva.
If you have stopped treatment due to hypersensitivity syndrome, it should be permanent and you should not re-start therapy with OSSEOR.
Jekk tkun waqqaft il- kura minħabba sindromu ta ’ sensittivita` aċċessiva, din għanda tkun għal dejjem u m’ għandekx terġa tibda l- kura bi OSSEOR.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
27 Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE OSSEOR
KIF TAĦŻEN OSSEOR
Do not use after the expiry date which is stated on the box and the sachet.
Tużax OSSEOR wara d- data ta ’ skadenza li tidher fuq il- kartuna u il- qartas
What OSSEOR contains
X’ fih OSSEOR
- The active substance is strontium ranelate.
- Is- sustanza attiva hi strontium ranelate.
- The other ingredients are aspartame (E 951), maltodextrin, mannitol (E 421).
- Is- sustanzi l- oħra huma aspartame (E951), maltodextrin, mannitol (E 421).
What OSSEOR looks like and contents of the pack OSSEOR is available in sachets containing yellow granules for oral suspension. OSSEOR is supplied in boxes of 7, 14, 28, 56, 84 or 100 sachets.
OSSEOR jinbiegħ f’ kaxxi ta ’ 7, 14, 28, 56, 84 jew 100 qartas.
Not all pack sizes may be marketed.
Jista jkun li mhux il- pakketti tad - daqsijiet kollha jkunu għall- skop kummerċjali.
Marketing Authorisation Holder Les Laboratoires Servier 22, rue Garnier 92200 Neuilly-sur-Seine France
Detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq Les Laboratoires Servier 22, rue Garnier 92200 Neuilly sur Seine Franza
Manufacturer Les Laboratoires Servier Industrie 905, route de Saran 45520 Gidy France
Manifattur Les Laboratoires Servier Industrie 905, route de Saran 45520 Gidy Franza
Lietuva UAB "SERVIER PHARMA" Tel: +370 (5) 2 63 86 28
Lietuva UAB “ SERVIER PHARMA ” Tel: +370 (5) 2 63 86 28
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Dan il- fuljett kien approvat l- aħħar f ’ 29 Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
Ovitrelle 250 micrograms powder and solvent for solution for injection
Ovitrelle 250 mikrogrammi trab u solvent għal taħlita likwida għall- injezzjoni.
To ensure delivery of a 250 microgram dose, each vial contains 285 micrograms of choriogonadotropin alfa.
Biex ikun assigurat li doża tkun ta ’ 250 mikrogrammi, kull fjala fiha 285 mikrogrammi ta ’ choriogonadotropin alfa.
Choriogonadotropin alfa is produced by recombinant DNA technology in Chinese Hamster Ovary cells.
Choriogonadotropin alfa hu prodott permezz ta ’ teknoloġija ta ’ DNA rikombinat f’ ċelloli ta ’ l- Ovarji tal- ħamster Ċiniż.
A dose of 250 micrograms is equivalent to approximately 6500 IU.
Doża ta ’ 250 mikrogrammi hi ekwivalenti għal madwar 6500 IU.
30 mg sucrose
30 mg sukrożju
Clear colourless solution
Dehra tat- trab: pellit bajda għal off- white Dehra tas- solvent: soluzzjoni mingħajr kulur
The pH of the reconstituted solution is 6.5 – 7.5
Il - pH tas- soluzzjoni rrikostitwita huwa 6. 5 - 7. 5.
Ovitrelle is indicated in the treatment of:
Ovitrelle hu indikat fil- kura ta ’
Women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF):
Nisa li għaddejjin minn ovulazzjoni mgħaġġla qabel l- użu ta ’ teknika ta ’ riproduzzjoni assistita bħall - fertilizzazzjoni in vitro (IVF):
Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth.
Ovitrelle jittieħed biex iħeġġeġ maturazzjoni follikulari finali u lutejniżżazzjoni wara l- istimulazzjoni tat- tkabbir follikulari.
Anovulatory or oligo-ovulatory women:
Nisa li ma jovulawx jew nisa li għandhom l- ovarji li jagħmlu anqas bajd min- normal:
Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory patients after stimulation of follicular growth
Ovitrelle jittieħed biex iħeġġeġ l- ovulazzjoni u lutejniżżazzjoni f’ pazjenti li ma jovulawx jew li għandhom l - ovarji li jagħmlu inqas bajd min- normal wara l- istimulazzjoni tat- tkabbir follikulari.
Ovitrelle is intended for subcutaneous administration.
Ovitrelle hu intiż biex jingħata għal taħt il- ġilda.
The powder should be reconstituted immediately prior to use with the solvent provided.
It- trab għandu jitħallat immedjatament qabel l- użu mas- solvent provdut.
Treatment with Ovitrelle should be performed under the supervision of a physician experienced in the treatment of fertility problems.
Il- kura b’ Ovitrelle għandha ssir taħt is- superviżjoni ta ’ tabib b’ esperjenza fil- kura ta ’ problemi ta ’ fertilità.
The following dosing regimen should be used:
Il- metodu tad- doża segwenti għandu jintuża:
Women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF):
2 Nisa li għaddejjin minn ovulazzjoni mgħaġġla qabel l- applikazzjoni ta ’ teknika ta ’ riproduzzjoni assistita bħall- fertiliżżazzjoni in vitro (IVF):
One vial of Ovitrelle (250 micrograms) is administered 24 to 48 hours after the last administration of an FSH- or hMG preparation, i. e. when optimal stimulation of follicular growth is achieved.
Fjala waħda ta ’ Ovitrelle (250 mikrogrammi) tingħata 24 sa 48 siegħa wara l- aħħar teħid ta ’ preparazzjoni ta ’ FSH - jew hMG, i. e. meta l- istimulazzjoni ottimali tat- tkabbir follikulari tkun inkisbet.
2 Anovulatory or oligo-ovulatory women:
Nisa li ma jovulawx jew li għandhom l- ovarji jagħmlu anqas bajd min- normal:
One vial of Ovitrelle (250 micrograms) is administered 24 to 48 hours after optimal stimulation of follicular growth is achieved.
Fjala waħda ta ’ Ovitrelle (250 mikrogrammi) tingħata 24 sa 48 siegħa wara li tinkiseb stimulazzjoni ottimali tat- tkabbir follikulari.
The patient is recommended to have coitus on the day of, and the day after, Ovitrelle injection.
Hu rakkomandat li l- pazjent ikollu kopulazzjoni fil- ġurnata ta ’, u fil - ġurnata ta ’ wara, l- injezzjoni ta ’ l- Ovitrelle.
Ovitrelle is contraindicated for safety reasons in case of: • Tumours of the hypothalamus and pituitary gland • Hypersensitivity to the active substance or to any of the excipients • Ovarian enlargement or cyst due to reasons other than polycystic ovarian disease • Gynaecological haemorrhages of unknown aetiology • Ovarian, uterine or mammary carcinoma • Extrauterine pregnancy in the previous 3 months • Active thrombo-embolic disorders
Ovitrelle m’ għandux jintuża għal raġunijiet ta ’ sigurtà fil- każ ta ’: • Tumuri fl- ipotalamu u l- glandola pitwitarja • Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi • Tkabbir ta ’ l- ovarji jew ċista minħabba raġunijiet oħra ħlief mard poliċistiku fl- ovarji • Emorraġija ginekoloġika ta ’ etjoloġija mhux magħrufa • Karċinoma fl- ovarji, fl- utru jew mammarja • Tqala barra mill- utru fi 3 xhur li għaddew • Problemi trombo- emboliċi attivi
Ovitrelle must not be used when an effective response cannot be obtained, for example: • Primary ovarian failure • Malformations of sexual organs incompatible with pregnancy • Fibroid tumours of the uterus incompatible with pregnancy • Postmenopausal women
Ovitrelle m’ għandux jintuża meta ma jistax jinkiseb riżultat effettiv, bħal per eżempju: • Falliment primarju ta ’ l- ovarji • Malformazzjoni ta ’ organi sesswali li ma jippermettux it- tqala • Tumuri fibrojdi fl- utru li ma jippermettux it- tqala • Nisa wara l- menopawża
4.4 Special warnings and precautions for use
4. 4 Twissjiet speċjali u prekawzjonijiet speċjali għall- użu
To date, there is no clinical experience with Ovitrelle in other indications commonly treated with urine derived human chorionic gonadotrophin.
Sal- lum, ma hemm l- ebda esperjenza klinika dwar l- użu ta ’ Ovitrelle f’ indikazzjonijiet oħra li normalment jingħataw kura permezz ta ’ human chorionic gonadotrophin derivata mill- urina.
Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
Qabel ma tingħata bidu għall- kura, l- infertilità tal- koppja għandha tkun eżaminata bħala xierqa u għandhom ikunu evalwati l- kontraindikazzjonijiet putattivi għat- tqala.
In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
B’ mod partikolari, il- pazjenti għandhom ikunu eżaminati għall- ipotirojdiżmu, defiċjenza adrenokortikali, iperprolaktinemija u tumuri pitwitarji jew ipotalamiċi, u għandha tingħata l- kura meħtieġa.
Special precautions should be taken before administering Ovitrelle to patients with clinically significant systemic disease where pregnancy could lead to a worsening of the condition.
Għandhom jittieħdu prekawzjonijiet speċjali qabel ma jingħata Ovitrelle lill- pazjenti b’ xi marda sistemika li hi klinikament sinifikanti fejn it- tqala tista ’ twassal biex il- kundizzjoni tmur għall- agħar.
Patients undergoing ovarian stimulation are at an increased risk of developing ovarian hyperstimulation syndrome (OHSS) due to multiple follicular development
Pazjenti li fuqhom qed titwettaq l- istimulazzjoni ta ’ l- ovarji jiltaqgħu ma ’ riskju akbar li jiżviluppaw is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji (OHSS) minħabba żvilupp follikulari multiplu.
Ovarian hyperstimulation syndrome may become a serious medical event characterised by large ovarian cysts which are prone to rupture and the presence of ascites within a clinical picture of circulatory dysfunction.
Is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji jista ’ jsir avveniment mediku serju karatterizzat minn ċisti kbar fl- ovarji, li jistgħu jinfaqgħu u il- preżenza ta ’ axxite fi ħdan sitwazzjoni klinika ta ’ funzjonament ċirkolatorju ħażin.
Ovarian hyperstimulation syndrome due to excessive ovarian response can be avoided by withholding hCG administration.
Is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji (OHSS) minħabba reazzjoni eċċessiva mill- ovarji jista ’ jiġi evitat billi jitwaqqaf it- teħid ta ’ hCG.
Patients should be advised to refrain from coitus or use barrier methods for at least 4 days.
Il- pazjenti għandhom ikunu infurmati biex jevitaw il- kopulazzjoni jew jużaw metodi protettivi għal mill- anqas erbat ijiem.
Careful monitoring of estradiol levels and ovarian response, based on ultrasound is recommended prior to and during stimulation therapy, for all patients.
Osservazzjoni attenta tal- livelli ta ’ estradiol u l- effett fuq l- ovarji, permezz ta ’ l- ultrasawnd, hu rakkomandat qabel u matul it- terapija ta ’ stimulazzjoni, għall- pazjenti kollha.
The risk of multiple pregnancy following assisted reproductive technologies is related to the number of embryos replaced.
3 Ir- riskju ta ’ tqala multipla wara l- użu ta ’ teknoloġiji ta ’ riproduzzjoni assistita hu marbut man- numru ta ’ embrijoni mibdula.
In patients undergoing induction of ovulation, the incidence of multiple pregnancies and births (mostly twins) is increased compared with natural conception.
Fil- pazjenti li għaddejjin minn induzzjoni ta ’ l- ovulazzjoni, in- numru ta ’ każi ta ’ tqala u twelid multiplu (l- aktar tewmin) jiżdied meta mqabbel mal- konċepiment naturali.
To minimise the risk of OHSS and of multiple pregnancy, ultrasound scans as well as estradiol measurements are recommended.
Biex jitnaqqas ir- riskju ta ’ OHSS u ta ’ tqala multipla, hu rakkomandat li jsiru scans permezz ta ’ l - ultrasawnd kif ukoll għandu jitkejjel il- livell ta ’ estradiol.
In anovulation, the risk of OHSS is increased by a serum estradiol level > 1500 pg/ ml (5400 pmol/ l) and more than 3 follicles of 14 mm or more in diameter.
Waqt ovulazzjoni, ir- riskju ta ’ OHSS jiżdied b’ livell ta ’ estradiol fis- serum ta ’ > 1500 picogramma / millilitru (5400 pikomol / litru) u aktar minn 3 follikuli ta ’ dijametru ta ’ 14 millimetru jew aktar.
When the estradiol level is
Fl- użu ta ’ teknika ta ’ riproduzzjoni assistita, jikber ir- riskju ta ’ OHSS b’ estradiol fis- serum ta ’ > 3000 pikogrammi / millilitru (11000 pikomol / litru) u 20 jew aktar follikuli ta ’ dijametru ta ’ 12 millimetru jew aktar.
3 > 5500 pg/ ml (20000 pmol/ l) and when there are 40 or more follicles in total, it may be necessary to withhold hCG administration.
Meta l- livell ta ’ estradajol hu ta ’ > 5500 pikogrammi / millilitru (20000 pikomol / litru) u fejn hemm 40 follikulu jew aktar b’ kollox, jista ’ jkun meħtieġ li jitwaqqaf it- teħid tal- hCG.
Severe ovarian hyperstimulation syndrome could be complicated in rare cases by haemoperitoneum, acute pulmonary distress, ovarian torsion, and thromboembolism.
Meta is- sindromu ta ’ stimulazzjoni eċċessiva ta ’ l- ovarji huwa severa, dan jsita ’ jkun ikkomplikat minn kazijiet rari ta ’ haemoperitoneum, acute pulmonary distress, torsjoni ta ’ l- ovarji u tromboemboliżmu.
Adherence to recommended Ovitrelle dosage, regimen of administration and careful monitoring of therapy will minimise the incidence of ovarian hyperstimulation and multiple pregnancy.
Ir- rispett tad- doża rakkomandata ta ’ Ovitrelle, ir- reġim ta ’ teħid tagħha u osservazzjoni attenta tat - terapija jnaqqsu l- possibilità li sseħħ l- istimulazzjoni eċċessiva ta ’ l- ovarji u tqala multipla.
The rate of miscarriage, in both anovulatory patients and women undergoing assisted reproductive techniques, is higher than that found in the normal population but comparable with the rates observed in women with other fertility problems.
Ir- rata ta ’ korriment, kemm f’ pazjenti li ma jovulawx u f’ nisa li fuqhom qed tintuża t- teknika ta ’ riproduzzjoni assistita, hi aktar għolja minn dik li tinstab fil- popolazzjoni normali iżda titqabbel mar - rati osservati fost nisa bi problemi oħra ta ’ fertilità.
During Ovitrelle therapy, a minor thyroid stimulation is possible, of which the clinical relevance is unknown.
Matul it- terapija permezz ta ’ Ovitrelle, hemm il- possibilità ta ’ stimulazzjoni żgħira fuq it- tirojde, iżda r- relevanza klinika ta ’ dan kollu mhuwiex magħruf.
Self-administration of Ovitrelle should only be performed by patients who are adequately trained and have access to expert advice.
Il- pazjenti jistgħu jieħdu Ovitrelle waħedhom biss meta huma mħarrġa b’ mod adegwat u għandhom aċċess għal konsulenza esperta.
No specific interaction studies with Ovitrelle and other medicines have been performed however no clinically significant drug interactions have been reported during hCG therapy.
Ma sarux studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku ta ’ Ovitrelle, iżda l- ebda interazzjonijiet klinikament sinifikanti ma ’ mediċini oħra ma kienu rrapurtati matul it - terapija bl- hCG.
Following administration, Ovitrelle may interfere for up to ten days with the immunological determination of serum / urinary hCG, leading to a false positive pregnancy test.
Wara t- teħid tagħha, Ovitrelle tista ’ tinterferixxi, sa massimu ta ’ għaxart ijiem, mad- determinazzjoni immunoloġika tal- hCG fis- serum / fl- urina, b’ mod li jwassal għal riżultat pożittiv li ma jkunx minnu f’ eżami tat- tqala.
Considering the indication, Ovitrelle should not be administered during pregnancy and lactation.
B’ kunsiderazzjoni ta ’ l- indikazzjoni, Ovitrelle m’ għandux jintuża waqt it- tqala u treddiegħ.
No clinical data on exposed pregnancies are available.
Għall - Ovitrelle ma teżistix informazzjoni klinika dwar tqala esposta għaliha.
No reproduction studies with choriogonadotropin alfa in animals were performed (see section 5.3).
Ma saru l- ebda studji dwar ir - riproduzzjoni permezz ta ’ choriogonadotrophin alfa fuq annimali (ara sezzjoni 5. 3).