qanastek/EMEA-V3 huggingface dataset:
Driving and using machines The vaccine is unlikely to produce any effect on the ability to drive and use machines.
39 Sewqan u tħaddim ta 'magni Il- vaċċin mhux probabbli li jipproduċi xi effett fuq il- ħila biex issuq u tħaddem magni.
What Focetria contains
40 X' fih Focetria
39 Focetria does not contain live virus particles and so it cannot cause Pandemic influenza.
Focetria ma fihx partikoli tal- virus ħaj u għalhekk ma jistax jikkawża l- influwenza Pandemika.
It is provided in a vial containing a single dose (0.5 ml) for injection.
Huwa fornut: f' kunjett li fih doża waħda (0. 5 ml) għall- injezzjoni.
INFORMATION FOR THE USER
41 FULJETT TA 'TAGĦRIF:
Focetria suspension for injection in multidose container Pandemic Influenza Vaccine (surface antigen, inactivated, adjuvanted)
Vaċċin kontra l- Influwenza Pandemika (antiġen tal- wiċċ, inattivat, adjuvantat)
Possible side effects 7.
Effetti sekondarji li jista 'jkollu 7.
Driving and using machines The vaccine is unlikely to produce any effect on the ability to drive and use machines.
42 Sewqan u tħaddim ta 'magni Il- vaċċin mhux probabbli li jipproduċi xi effett fuq il- ħila biex issuq u tħaddem magni.
41 Important information about some of the ingredients of Focetria This medicinal product in multi-dose vial contains thiomersal as a preservative and it is possible that you may experience an allergic reaction.
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'Focetria Dan il- prodott mediċinali f' kunjett ta' ħafna dożi fih thiomersal bħala preservattiv u huwa possibbli li inti tista 'tesperjenza reazzjoni allerġika.
Tell your doctor if you have any known allergies.
Għid it- tabib tiegħek jekk għandek kwalunkwe allerġiji magħrufa.
Medicines should not be disposed of via wastewater or household waste.
43 Il- mediċini m' għandhomx jintremew ma 'l- ilma tad- dranaġġ jew ma' l- iskart domestiku.
42 What Focetria contains
X' fih Focetria
Focetria does not contain live virus particles and so it cannot cause Pandemic influenza.
Focetria ma fihx partikoli tal- virus ħaj u għalhekk ma jistax jikkawża l- influwenza Pandemika.
The other ingredients are: thiomersal, sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid and water for injections.
Is- sustanzi l- oħra huma: thiomersal, sodium chloride, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium citrate, citric acid u ilma għall- injezzjonijiet.
It is provided in a vial containing ten doses (0.5 ml each) for injection, Not all pack sizes may be marketed.
Huwa fornut: f' kunjett li fih għaxar dożi (0. 5 ml kull waħda) għall- injezzjoni.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek Jekk tixtieq aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Forsteo?
X' inhu Forsteo?
Forsteo is a prefilled pen that contains a solution for injection.
Forsteo huwa pinna mimlija għal- lest li fiha soluzzjoni għall- injezzjoni.
Forsteo contains the active substance teriparatide (one 2.4 ml prefilled pen contains 600 micrograms of teriparatide).
Forsteo fih is- sustanza attiva teriparatide (pinna mimlija għal- lest waħda ta '2. 4 ml fiha 600 mikrogramma ta' teriparatide).
What is Forsteo used for?
Għal xiex jintuża Forsteo?
Forsteo is used for the treatment of osteoporosis (a disease that makes bones fragile) in the following groups:  women who have been through the menopause.
Forsteo jintuża għat- trattament tal- osteoporożi (marda li tagħmel l- għadam fraġli) fil- gruppi li ġejjin:
In these patients, Forsteo has been shown to significantly reduce vertebral (spine) and non-vertebral fractures (broken bones), but not those of the hip;  men who are at an increased risk of fractures;  men and women who are at an increased risk of fractures due to long-term treatment with glucocorticoids (a type of steroid).
F' dawn il- pazjenti, Forsteo ntwera li jnaqqas b' mod sinjifikanti l- ksur vertebrali (spina) u l- ksur mhux vertebrali (għadam miksura), iżda mhux il- ksur tal- ġenbejn;  irġiel li għandhom riskju akbar ta 'ksur;  irġiel u nisa li għandhom riskju akbar ta ’ ksur minħabba trattament għal żmien twil bil - glukokortikojdi (tip ta ’ sterojd).
How is Forsteo used?
Kif jintuża Forsteo?
The recommended dose is 20 micrograms of Forsteo given once a day as an injection under the skin of the thigh or abdomen (tummy).
Id- doża rakkomandata hija 20 mikrogramm ta 'Forsteo mogħtija darba kuljum bħala injezzjoni taħt il - ġilda fil- koxxa jew fl- addome (żaqq).
Patients may inject themselves once they have been trained.
Il- pazjenti jistgħu jinjettaw lilhom infushom ladarba jkunu ġew imħarrġa.
A user manual is available for the pen.
Manwal għall- utent huwa disponibbli għall- pinna.
Patients should receive calcium and vitamin D supplements if they do not get enough from their diet.
Il- pazjenti għandhom jirċievu supplimenti tal- kalċju u tal- vitamina D jekk ma jeħduhomx biżżejjed mid- dieta tagħhom.
Forsteo can be used for up to two years.
Forsteo jista 'jintuża sa sentejn.
Only one two-year course of Forsteo should be given to a patient in their lifetime.
Kors wieħed biss ta ’ sentejn jista ’ jingħata lil pazjent matul ħajtu.
Forsteo must not be used in children or in young adults whose bones are not yet fully mature.
Forsteo ma għandux jintuża fi tfal jew f' żgħażagħ li l- għadam tagħhom ikun għadu mhux matur.
How does Forsteo work?
Kif jaħdem Forsteo?
Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
L- osteoporożi sseħħ meta ma jikbirx għadam ġdid biżżejjed biex jissostitwixxi l- għadam li jitkisser b' mod naturali.
Gradually, the bones become thin and fragile, and more likely to break.
Gradwalment, l- għadam isir irqiq u fraġli, u jsir iktar probabbli li jinqasam.
In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen fall.
Fin- nisa, l - osteoporożi hija aktar komuni wara l- menopawża, meta l- livelli tal- ormon tan- nisa, l- estroġenu, jaqgħu.
Osteoporosis can also occur in both sexes as a side effect of glucocorticoid treatment.
Osteoporożi tista ’ sseħħ ukoll fiż- żewġ sessi bħala effett sekondarju tat- trattament bil - glukokortikojd.
The active substance in Forsteo, teriparatide, is identical to part of the human parathyroid hormone.
Is- sustanza attiva f' Forsteo, teriparatide, hija identika għal parti minn ormon uman paratirojde.
It acts like the hormone to stimulate bone formation by acting on osteoblasts (bone-forming cells).
Taġixxi bħall- ormon biex tistimula l- formazzjoni tal- għadam billi taġixxi fuq osteoblasts (ċelloli li jiffurmaw l- għadam).
It
Iżżid ukoll l- assorbiment tal- kalċju mill- ikel u timpedixxi milli jintilef wisq kalċju mal - awrina.
Teriparatide is produced by a method known as ‘ recombinant DNA technology’: the hormone is made by a bacterium that has received a gene (DNA) that makes it able to produce the hormone.
Teriparatide jiġi prodott b' metodu magħruf bħala teknoloġija 'rikombinanti tad- DNA ’: l- ormon huwa magħmul minn batterju li jkun irċieva ġene (DNA) li jagħmilha possibbli li jipproduċi l- ormon.
Forsteo replaces the natural hormone.
Forsteo jissostitwixxi l- ormon naturali.
How has Forsteo been studied?
Kif ġie studjat Forsteo?
Forsteo has been studied in three main studies.
Forsteo ġie studjat fi tliet studji ewlenin.
The first study involved 1,637 women with osteoporosis who had been through the menopause (average age:
L- ewwel studju involva 1, 637 mara li kienu jbatu bl - osteoporożi u għaddew mill- menopawża (età medja:
69.5 years), in which Forsteo was compared with placebo (a dummy treatment) for an average of 19 months.
69. 5 sena), fejn Forsteo tqabbel ma 'plaċebo (trattament finta) għal medja ta ’ 19- il xahar.
The main measure of effectiveness was the number of new vertebral fractures at the end of the study, although the study also looked at non-vertebral fractures.
Il- kejl ewlieni tal- effikaċja kien in- numru ta 'ksur vertebrali ġdid fi tmiem l- istudju, għalkemm l- istudju ħares ukoll lejn il- ksur mhux vertebrali.
The patients were treated for up to 23 months.
Il - pazjenti ġew ikkurati għal 23 xahar.
The second study looked at the use of Forsteo in 437 men with osteoporosis, comparing its effect on the density of bones in the spine with that of placebo.
It- tieni studju ħares lejn l- użu ta ’ Forsteo f' 437 raġel b' osteoporożi, u qabbel l- effett tiegħu mad - densità tal- għadam fl- ispina ma 'dak ta' plaċebo.
The third study compared the effects of Forsteo and alendronate (another medicine used to treat osteoporosis) on spine bone density over three years.
It- tielet studju qabbel l- effetti ta ’ Forsteo u alendronate (mediċina oħra użata għat- trattament tal - osteoporożi) fuq id- densità tal- għadam tal- ispina tul tliet snin.
The study included 429 women and men who had osteoporosis and had been taking glucocorticoids for at least three months.
L- istudju inkluda 429 mara u raġel li kellhom l- osteoporożi u kienu ilhom jieħdu glukokortikojdi għal talanqas tliet xhur.
An additional study looked at the effects of Forsteo on bone density over two years in 234 women who had been through the menopause.
Studju ieħor addizzjonali iffoka fuq l- effetti ta ’ Forsteo fuq id- densità tal- għadam fuq perjodu ta ’ sentejn f’ 234 mara li kienu diġà qabżu l- menopawża.
What benefit has Forsteo shown during the studies?
X' benefiċċji ta 'Forsteo ntwerew f' dawn l- istudji?
Forsteo was more effective than placebo in reducing vertebral fractures:
Forsteo kien aktar effettiv minn plaċebo fit- tnaqqis tal- ksur vertebrali:
5% of the women who received Forsteo had a new fracture during the study, compared with 14% in the group who received placebo.
5% tan- nisa li rċevew Forsteo kellhom ksur ġdid waqt l- istudju, meta mqabbel ma '14. 3% fil- grupp li rċieva plaċebo.
Forsteo reduced the risk of developing a new vertebral fracture over 19 months by 65% compared with placebo.
Forsteo naqqas ir- riskju ta 'żvilupp ta' ksur vertebrali ġdid fuq id- 19- il xahar b' 65% meta mqabbel ma 'plaċebo.
It also reduced the risk of non-vertebral fractures by 62%, but did not reduce the risk of hip fractures.
Naqqas ukoll ir- riskju ta 'ksur mhux vertebrali bi 62%, iżda ma naqqasx ir- riskju tal- ksur tal- ġenbejn.
In the study in men, Forsteo increased bone density in the spine by about 6% after an average of almost 12 months.
Fl- istudju fl- irġiel, Forsteo żied id- densità tal- għadam fl- ispina b' madwar 6% wara medja ta 'kważi 12 - il xahar.
In the study of patients taking glucocorticoids, Forsteo was more effective than alendronate: after 18 months, patients receiving Forsteo had a 7% increase in bone density in the spine, compared with 3% in those receiving alendronate.
Fl- istudju tal- pazjenti li kienu qegħdin jieħdu glukokortikojdi, Forsteo kien iktar effikaċi mill - alendronate: wara tmintax- il xahar pazjenti li ngħataw Forsteo kellhom żieda ta ’ 7% fid- densità tal - għadam fl- ispina, meta mqabbel ma ’ 3% f’ dak li ngħataw alendronate.
The studies also showed that the benefits of Forsteo treatment continued to increase for up to two years, with further increases in bone density.
Dawn l- istudji wrew ukoll li l- benefiċċji tat- trattament b’ Forsteo komplew jiżdiedu sa sentejn wara, b’ żieda fid- densità tal- għadam.
What is the risk associated with Forsteo?
X' inhu r- riskju assoċjat ma 'Fortseo?
The most common side effect with Forsteo (seen in more than 1 patient in 10) is pain in the arms or legs.
L- iktar effett sekondarju komuni mat- teħid ta 'Forsteo (li deher f' iktar minn pazjent wieħed minn kull għaxra) hu uġigħ fid- dirgħajn jew fis- saqajn.
For the full list of all side effects reported with Forsteo, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati ma 'Forsteo, ara l- Fuljett ta' Tagħrif.
Forsteo should not be used in people who may be hypersensitive (allergic) to teriparatide or any of the other ingredients.
Forsteo ma għandux jintuża minn nies li jkunu ipersensittivi (allerġiċi) għat- teriparatide jew kwalunkwe mill- ingredjenti l- oħra.
It must not be used in patients who have other bone diseases such as Paget’ s disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme) or severe kidney disease.
Lanqas ma għandu jintuża f' pazjenti li għandhom mard ieħor tal - għadam bħall- marda tal- Paget, kanċer tal- għadam jew metastażi tal- għadam (kanċer li jkun infirex għall- għadam), pazjenti li kellhom terapija ta 'radjazzjoni tal- iskeletru, jew pazjenti b' iperkalċemija (livelli għoljin ta' kalċju fid- demm), b' livelli għoljin mingħajr raġuni ta 'alkaline phosphatase (enzim), jew mard serju tal- kliewi.
Forsteo must not be used in children or in young adults whose bones are not yet fully mature, or during pregnancy or breast- feeding.
Forsteo m' għandux jintuża fit- tfal jew fiż- żgħażagħ li l- għadam tagħhom ikun għadu ma mmaturax sewwa, matul it- tqala jew it- treddigħ.
Why has Forsteo been approved?
Għaliex ġie approvat Forsteo?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Forsteo’ s benefits are greater than its risks for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture, and for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li l- benefiċċji ta 'Forsteo huma akbar mir- riskji tiegħu għat- treatment ta' osteoporożi f' nisa ta 'wara l- menopawża u f' irġiel f' riskju akbar ta' ksur, u għat- trattament ta ’ osteoporożi assoċjat ma ’ terapija sistemika sostnuta tal- glukokortikojdi f’ nisa u irġiel b’ risku ogħla ta ’ ksur.
The Committee recommended that Forsteo be given marketing authorisation.
Il- Kumitat irrakkomanda li Forsteo jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Forsteo:
Tagħrif ieħor dwar Forsteo:
The European Commission granted a marketing authorisation valid throughout the European Union for Forsteo to Eli Lilly Nederland B. V. on 10 June 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Forsteo valida fl- Unjoni Ewropea kollha lil Eli Lilly Nederland B. V. nhar l- 10 ta 'Ġunju 2003.
The marketing authorisation was renewed on 10 June 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fl- 10 ta ’ Ġunju 2008.
2/ 3 The full EPAR for Forsteo is available here.
2/ 3 L- EPAR sħiħ għal Forsteo jista ’ jiġi kkonsultat hawn.
20 μ g/ 80 μ l
20µg/ 80µl
Pre-filled pen (glass)
Pinna mimlija għal - lest (ħġieġ)
1 pre-filled pen
Pinna 1 mimlija għal- lest
3 pre-filled pens
3 pinen mimlijin għal- lest
FORSTEO 20 micrograms/ 80 microliters solution for injection in pre-filled pen
FORSTEO 20 mikrogramma/ 80 mikrolitri soluzzjoni għall- injezzjoni f ’ pinna mimlija lesta.
One pre-filled pen of 2.4 ml contains 600 micrograms of teriparatide (corresponding to 250 micrograms per ml).
Kull doża fiha 20 mikrogramma ta ’ teriparatide Pinna mimlija lesta ta ’ 2. 4 ml fiha 600 mikrogramma ta ’ teriparatide (li tikkorrispondi għal 250 mikrogramma f ’ kull ml).
Teriparatide, rhPTH(1-34), produced in E. coli, using recombinant DNA technology, is identical to the 34 N-terminal amino acid sequence of endogenous human parathyroid hormone.
Teriparatide, rhPTH( 1- 34), magħmul f’ E. coli, permezz tat- teknoloġija rikombinanti tad- DNA, huwa identiku għas- sekwenza ta '34 N- terminal amino acid ta ’ l- ormon uman paratirodje endoġenu.
Solution for injection in a pre-filled pen.
Soluzzjoni għall- injezzjoni f’ pinna mimlija lesta
Colourless, clear solution.
Soluzzjoni ċara u bla kulur.
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1).
Kura ta ’ osteoporożi f’ nisa wara l- menopawża u fl- irġiel li qegħdin f’ riskju ogħla ta ’ ksur (ara sezzjoni 5. 1).
In postmenopausal women, a significant reduction in the incidence of vertebral and non- vertebral fractures but not hip fractures has been demonstrated.
F’ nisa wara l- menopawża, intwera tnaqqis sostanzjali fl- ammont ta ’ ksur vertebrali kif ukoll f’ dak mhux vertebrali iżda mhux fil- ksur ta ’ l- għadma tal- ġenbejn.
Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).
Kura ta ’ osteoporożi assoċjata ma ’ terapija b’ glukokortikojdi sistemiċi meħuda fit- tul, fin- nisa u fl - irġiel li qegħdin f’ riskju ogħla ta ’ ksur (ara sezzjoni 5. 1).
The recommended dose of FORSTEO is 20 micrograms administered once daily by subcutaneous injection in the thigh or abdomen.
Id- doża rakkmandata ta ’ FORSTEO hija 20 mikrogramma mogħtija darba kuljum b ’ injezzjoni subkutanja fil- koxxa jew fl- addome.
Patients must be trained to use the proper injection techniques (see section 6.6).
Il- pazjenti għandhom jiġu mħarrġa bil- metodi ta 'kif jittieħdu l- injezzjonijiet (ara sezzjoni 6. 6).
A User Manual is also available to instruct patients on the correct use of the pen.
Huwa disponibbli wkoll manwal għall- użu biex il- pazjenti jigtħallmu dwar l- użu korrett tal- pinna.
The maximum total duration of treatment with FORSTEO should be 24 months (see section 4.4).
Il- massimu ta ’ tul ta ’ żmien ta ’ kura b’ FORSTEO għandu jkun ta ’ 24 xahar (ara sezzjoni 4. 4).
The 24-month course of FORSTEO should not be repeated over a patient’ s lifetime.
Il- kors ta ’ 24 xahar ta ’ FORSTEO m’ għandux jiġi ripetut matul il- ħajja tal- pazjent.
Patients should receive supplemental Calcium and vitamin D supplements if dietary intake is inadequate.
Il- pazjenti għandhom jingħataw supplimenti ta ’ calcium u ta ’ vitamina D jekk l- ammont fid- dieta mhuwiex biżżejjed.
Following cessation of FORSTEO therapy, patients may be continued on other osteoporosis therapies.
Wara t- twaqqif tat- terapija b’ FORSTEO, il- pazjenti jistgħu jitkomplew fuq terapiji oħrajn ta ’ l - osteoporożi.
FORSTEO should not be used in patients with severe renal impairment (see 4.3.).
FORSTEO m ’ għandux jintuża f ’ pazjenti b’ indeboliment renali serju (ara 4. 3.).
In patients with moderate renal impairment, FORSTEO should be used with caution.
F ’ pazjenti b’ indeboliment renali moderat, FORSTEO għandu jintuża b ’ kawtela.
2 Use in hepatic impairment: no data are available in patients with impaired hepatic function (see section 5.3).
L- użu f’ indeboliment epatiku: m ’ hemmx informazzjoni dwar pazienti b’ indeboliment tal- fwied (ara sezzjoni 5. 3.).
There is no experience in paediatric patients (less than 18 years).
2 Populazzjoni pedjatrika u żgħażagħ b’ epifisi miftuħa:
FORSTEO should not be used in paediatric patients (less than 18 years), or young adults with open epiphyses.
M’ hemm ebda esperjenza f’ pazjenti pedjatriċi (inqas minn 18- il sena). FORSTEO m ’ għandux jintuża f ’ pazjenti pedjatrici (inqas minn 18- il sena), jew fiż - żgħażagħ b’ epifisi miftuħa.
Dosage adjustment based on age is not required (see section 5.2).
Pazjenti anzjani: bidla fid- doża bbażata fuq l- eta ’ mhux meħtieġa (ara sezzjoni 5. 2.).
• Hypersensitivity to the active substance or to any of the excipients. • Pregnancy and lactation (see section 4.4 and 4.6) • Pre-existing hypercalcemia • Severe renal impairment • Metabolic bone diseases other than primary osteoporosis (including hyperparathyroidism and Paget’ s disease of the bone) • Unexplained elevations of alkaline phosphatase • Prior external beam or implant radiation therapy to the skeleton • Patients with skeletal malignancies or bone metastases should be excluded from treatment with teriparatide.
• Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi. • Tqala u treddigħ (ara sezzjoni 4. 4 u 4. 6) • Iperkalċemija eżistenti minn qabel • Indeboliment renali serju • Mard metaboliku ta ’ l- għadam minbarra l- osteoporożi primarja (inkluża l- iperparatirojdiżmu u marda ta ’ l- għadam ta ’ Paget) • Livelli għoljin mhux spjegati ta ’ alkaline phosphatase • Terapija minn qabel bir- radjazzjoni għall- iskeletru • Pazjenti b’ tumuri malinni ta ’ l- iskeletru jew b’ metastasi fl- għadam m’ għandhomx ikunu kkurati b’ teriparatide
In normocalcemic patients, slight and transient elevations of serum calcium concentrations have been observed following teriparatide injection.
F ’ pazjenti normokalċemiċi, xi żidiet ħfief u traniżitorji fil- konċentrazzjonijiet ta ’ calcium fis- serum ġew osservati wara l- injezzjoni b’ teriparatide.
Serum calcium concentrations reach a maximum between 4 and 6 hours and return to baseline by 16 to 24 hours after each dose of teriparatide.
Il- konċentrazzjonijiet ta ’ calcium fis- serum jilħqu massimu bejn 4 u 6 sigħat u jirritornaw lura bħal qabel bejn 16 u 24 siegħa wara kull doża ta ’ teriparatide.
Routine calcium monitoring during therapy is not required.
Is- sorveljanza regolari ta ’ calcium matul it- terapija mhix meħtieġa.
Therefore if any blood samples are taken from a patient, this should be done at least 16 hours after the most recent FORSTEO injection.
Għalhekk, jekk jittieħdu kampjuni tad- demm minn pazjent, dan għandu jsir għall- inqas 16- il siegħa wara l- injezzjoni l- aktar riċenti ta ’ FORSTEO.
FORSTEO may cause small increases in urinary calcium excretion, but the incidence of hypercalciuria did not differ from that in the placebo-treated patients in clinical trials.
FORSTEO jista ’ jikkawża żidiet żgħar fl- eskrezzjoni ta ’ calcium fl- awrina, iżda l- inċidenza ta ’ ipercalciuria ma kinitx differenti minn dik fil- pazjenti kkurati bil- plaċebo f ’ provi kliniċi.
FORSTEO has not been studied in patients with active urolithiasis.
FORSTEO ma ġiex studjat f ’ pazjenti b ’ urolithiasis attiva.
FORSTEO should be used with caution in patients with active or recent urolithiasis because of the potential to exacerbate this condition.
FORSTEO għandu jintuża b ’ kawtela f ’ pazjenti b’ urolithiasis attiva jew riċenti minħabba l- potenzjal li din il- kundizzjoni tmur għall- agħar.
In short-term clinical studies with FORSTEO, isolated episodes of transient orthostatic hypotension were observed.
Fil- provi kliniċi qosra b ’ FORSTEO, episodji iżolati u tranżitorji ta ’ pressjoni tad- demm ortostatika baxxa ġew osservati.
Typically, an event began within 4 hours of dosing and spontaneously resolved within a few minutes to a few hours.
Tipikament, każ beda ’ 4 sigħat minn meta ngħatat id- doża u waqaf waħdu fi żmien ta ’ bejn ftit minuti u ftit sigħat.
When transient orthostatic hypotension occurred, it happened within the first several doses, was relieved by placing subjects in a reclining position, and did not preclude continued treatment.
Meta seħħet l- pressjoni tad- demm ortostatika baxxa temporanja, din ġrat fl- ewwel ftit dożi, u kienet ikkurata billi l- pazjenti tqiegħdu f ’ pożizzjoni mimduda u ma waqqfetx il- kontinwazzjoni tal- kura.
Caution should be exercised in patients with moderate renal impairment.
Għandha tintuża l- kawtela f ’ pazjenti b ’ indeboliment renali moderat.
Experience in the younger adult population, including premenopausal women, is limited (see section 5.1).
Hija limitata l- esperjenza fil- popolazzjoni ta ’ adulti żgħar li tinkludi n- nisa qabel il- menopawża (ara sezzjoni 5. 1).
Treatment should only be initiated if the benefit clearly outweighs risks in this population.
F’ din il- popolazzjoni l- kura għandha tinbeda biss jekk il- benefiċċju li wieħed jieħu jaqbeż bil- bosta r- riskji involuti.
Women of childbearing potential should use effective methods of contraception during use of FORSTEO.
Nisa li jistgħu joħorġu tqal għandhom jużaw metodi effettivi ta ’ kontraċezzjoni waqt l- użu ta ’ FORSTEO.
If pregnancy occurs, FORSTEO should be discontinued.
Jekk joħorġu tqal, FORSTEO għandu jitwaqqaf.
3 Studies in rats indicate an increased incidence of osteosarcoma with long-term administration of teriparatide (see section 5.3).
Studji fil- firien jindikaw inċidenza miżjuda ta ’ osteosarkoma b ’ għoti fit- tul ta ’ teriparatide (ara sezzjoni 5. 3).
Until further clinical data become available, the recommended treatment time of 24 months should not be exceeded.
Sakemm tkun disponibbli informazzjoni klinika ulterjuri, il- kura rrakkomandata ta ’ 24 xahar m ’ għandiex tinqabeż.
4.5 Interactions with other medicinal products and other forms of interaction
3 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
FORSTEO has been evaluated in pharmacodynamic interaction studies with hydrochlorothiazide.
FORSTEO ġie evalwat fi studji ta ’ interazzjoni farmakodinamika ma ’ hydrochlorothiazide.
No clinically significant interactions were noted.
Ma ġew innutati l- ebda interazzjonijiet klinikament sinjifikanti.
Co-administration of raloxifene or hormone replacement therapy with FORSTEO did not alter the effects of FORSTEO on serum or urine calcium or on clinical adverse events.
L- għotja ta ’ raloxifene jew terapija ta ’ sostituzzjoni ta 'l- ormoni flimkien ma ’ FORSTEO ma biddlitx l- effetti ta ’ FORSTEO fuq calcium fis- serum jew fl- awrina jew fuq episodji avversi kliniċi.
In a study of 15 healthy subjects administered digoxin daily to steady state, a single FORSTEO dose did not alter the cardiac effect of digoxin.
F ’ studju ta ’ 15- il voluntier b ’ saħħtu li ngħataw digoxin kuljum sa ammont fiss, doża waħda ta ’ FORSTEO ma biddlitx l- effett fuq il- qalb ta ’ digoxin.
However, sporadic case reports have suggested that hypercalcemia may predispose patients to digitalis toxicity.
Madankollu, rapporti ta ’ każijiet sporadiċi ssuġġerew li l- iperkalċemija tista ’ tippridisponi ‘ l- pazjenti għat- tossiċita ’ b’ digitalis.
Because FORSTEO transiently increases serum calcium, FORSTEO should be used with caution in patients taking digitalis.
Minħabba li FORSTEO iżid il- calcium fis- serum b ’ mod tranżitorju, għandu jintuża b ’ kawtela f ’ pazjenti li qed jieħdu digitalis.
General recommendation
Rakkomandazzjonijiet ġenerali
Studies in rabbits have shown reproductive toxicity (see section 5.3).
Studji fil- fniek urew tossiċità riproduttiva (ara sezzjoni 5. 3).
The effect of teriparatide on human foetal development has not been studied.
L- effett ta ’ teriparatide fuq l- iżvilupp ta ’ fetu uman ma ġiex studjat.
The potential risk for humans is unknown.
Ir- riskju potenzjali għall- umani m’ huwiex magħruf.
It is not known whether teriparatide is excreted in human milk.
M’ huwiex magħruf jekk teriparatide joħroġx fil- ħalib uman
FORSTEO is contraindicated for use during pregnancy or breast-feeding.
Waqt it- tqala jew it- treddigħ l- użu ta ’ FORSTEO huwa kontra- indikat.
Women of childbearing potential / Contraception in females
Nisa li jistgħu joħorġu tqal / Kontraċezzjoni fin- nisa
However, transient, orthostatic hypotension or dizziness was observed in some patients.
Iżda, pressjoni ortostatika baxxa tad- demm tranżitorja jew sturdament ġew osservati f’ xi pazienti.
These patients should refrain from driving or the use of machines until symptoms have subsided.
Dawn il- pazjenti m’ għandhomx isuqu jew iħaddmu magni sakemm is- sintomi jkunu għaddew.
Of patients in the teriparatide trials, 82.8% of the FORSTEO patients and 84.5% of the placebo patients reported at least 1 adverse event.
F ’ pazjenti fil- provi b’ teriparatide, 82. 8% tal- pazjenti li ħadu FORSTEO u 84. 5% mill- pazjenti li ħadu l- plaċebo rrappurtaw għall- inqas effett wieħed avvers.
The most commonly reported adverse reactions in patients treated with FORSTEO are nausea, pain in limb, headache and dizziness.
L- iktar reazzjonijiet avversi komuni li ġew irrappurtati f ’ pazjenti kkurati b ’ FORSTEO huma dardir, uġigħ fir- riġlejn jew fid- dirgħajn, uġigħ ta ’ ras u sturdament.
The undesirable reactions associated with the use of teriparatide in osteoporosis clinical trials are summarised in the table below.
Ir- reazzjonijiet mhux mixtieqa assoċjati ma ’ l- użu ta ’ teriparatide fi studji kliniċi dwar l- osteoporożi huma miġbura fil- qosor fit- tabella hawn taħt.
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).
Bħala klassifikazzjoni tar- reazzjonijiet avversi ġiet użata s- sistema li ġejja: komuni ħafna (≥ 1/ 10), komuni (≥ 1/ 100 sa < 1/ 10), mhux komuni (≥ 1/ 1, 000 sa < 1/ 100), rari( ≥ 1/ 10, 000 sa < 1/ 1, 000), rari ħafna (< 1/ 10, 000), mhux magħruf (ma tistax tittieħed stima mid- dejta disponibbli).
4 Investigations Uncommon:
4 Investigazzjonijiet Mhux komuni:
Weight increased, Cardiac murmur, alkaline phosphatase increase Cardiac disorders Common:
Żieda fil- piż, Ħoss fil- qalb, żieda fl- alkaline phosphatase Disturbi fil- qalb Komuni:
Palpitations Uncommon:
Palpitazzjonijiet Mhun komuni:
Tachycardia Blood and lymphatic system disorders Common:
Takikardija Disturbi tad- demm u tas- sistema limfatika Komuni:
Anaemia Nervous system disorders Common:
Anemija Disturbi fis- sistema nervuża Komuni:
Dizziness, Headache, Sciatica Ear and labyrinth disorders Common:
Sturdament, Uġigħ ta ’ ras, Xjatika Disturbi fil- widnejn u fis- sistema labirintika Komuni:
Vertigo Respiratory, thoracic and mediastinal disorders Common:
Vertigo Disturbi respiratorji, toraċiċi u medjastinali Komuni:
Dyspnoea Uncommon:
Qtugħ ta ’ nifs Mhux komuni:
Emphysema Gastrointestinal disorders Common:
Emfisema Disturbi gastro- intestinali Komuni:
Nausea, Vomiting, Hiatus hernia, Gastroesophageal reflux disease Uncommon:
Tqalligħ, Rimettar, Ħiatus hernia, Mard ta ’ rifluss gastro- esofagali Mhux komuni:
Haemorrhoids Renal and urinary disorders Uncommon:
Murliti Disturbi fil- kliewi u fis- sistema urinarja Mhux komuni:
Urinary incontinence, Polyuria, Micturition urgency Skin and subcutaneous tissue disorders Common:
Inkontinenza urinarja, Tgħaddi ammont eċċessiv ta ’ awrina, Urġenza biex tgħaddi l- awrina Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Komuni:
Sweating increased Musculoskeletal and connective tissue disorders Very common:
Żieda fl- ammont ta ’ għaraq Disturbi muskolu- skeltrali u tal- connective tissue Komuni ħafna:
Muscle cramps Uncommon:
Uġigħ fid- dirgħajn jew fir- riġlejn Komuni Bugħawwieġ fil- muskoli Mhux komuni:
Myalgia, Arthralgia Not known:
Mijalġja, Artralġja Mhux magħruf:
Back cramp/ pain* Metabolism and nutrition disorders Common:
Bugħawwieġ/ uġigħ fid- dahar * Disturbi fil- metaboliżmu u n- nutrizzjoni Komuni:
Hypercholesterolaemia Uncommon:
Livell għoli ta ’ kolesterol fid- demm Mhux komuni:
Hypercalcemia greater than 2.76 mmol/ L, Hyperuricemia Rare:
Livell għoli ta ’ kalċju fid- demm iżjed minn 2. 76 mmol/ L, Livell għoli ta ’ aċidu uriku fid- demm Rari:
Hypercalcemia greater than 3.25 mmol/ L Vascular disorders Common:
Livell għoli ta ’ kalċju fid- demm iżjed minn 3. 25 mmol/ L Disturbi vaskulari Komuni:
Hypotension General disorders and administration site conditions Common:
Pressjoni baxxa Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Komuni:
Fatigue, Chest pain, Asthenia, Mild and transient injection site events, including pain, swelling, erythema, localised bruising, pruritis and minor bleeding at injection site.
Għeja, Uġigħ fis- sider, Astenja, Avvenimenti ħfief u momentanji fis- sit ta ’ l- injezzjoni, li jinkludu wġigħ, nefħa, eritema, tbenġil lokalizzat, ħakk u xi ftit ta ’ fsada fis- sit ta ’ l- injezzjoni.
Injection site erythema, Injection site reaction Rare:
Eritema fis- sit ta ’ l- injezzjoni, Reazzjoni fis- sit ta ’ l- injezzjoni Rari:
Possible allergic events soon after injection: acute dyspnoea, oro/ facial oedema, generalised urticaria, chest pain, oedema (mainly peripheral).
Il- possibiltà ta ’ avvenimenti allerġiċi ftit wara l- injezzjoni: qtugħ ta ’ nifs akut, edima orali/ tal- wiċċ, urtikarja ġeneralizzata, uġigħ fis- sider, edima (l- iżjed periferali).
Psychiatric disorders Common:
Disturbi psikjatriċi Komuni:
Depression * Serious cases of back cramp or pain have been reported within minutes of the injection.
Dipressjoni * Ġew irrapportati każijiet serji ta ’ bugħawwieġ jew uġigħ fid- dahar ftit minuti biss wara l- injezzjoni
In clinical trials the following reactions were reported at a ≥ 1% difference in frequency from placebo: vertigo, nausea, pain in limb, dizziness, depression, dyspnoea.
Fi studji kliniċi, ġew irrapportati dawn ir- reazzjonijiet li ġejjin b’ differenza ta ’ frekwenza mill- plaċebo ta ’ ≥ 1%: vertigo, tqalligħ, uġigħ fid- dirgħajn u fir- riġlejn, dipressjoni, qtugħ ta ’ nifs.
FORSTEO increases serum uric acid concentrations.
FORSTEO jżid il- konċentrazzjonijiet ta ’ uric acid fis- serum.
In clinical trials, 2.8% of FORSTEO patients had serum uric acid concentrations above the upper limit of normal compared with 0.7% of placebo patients.
Fil- provi kliniċi, 2. 8% tal- pazjenti li ħadu FORSTEO kellhom konċentrazzjonijiet ta ’ uric acid fis- serum ogħla mill- limitu ta ’ fuq tan - normal meta mqabbel ma ’ 0. 7% ta ’ pazjenti li ġew ikkurati bil- plaċebo.
However, the hyperuricemia did not result in an increase in gout, arthralgia, or urolithiasis.
Madankollu, l- iperuriċemija ma rriżultatx f ’ żieda fil- gotta, artralġja jew urolithiasis.
In a large clinical trial, antibodies that cross-reacted with teriparatide were detected in 2.8% of women receiving FORSTEO.
F ’ prova klinika kbira, l- antikorpi li ġew cross- reacted ma ’ teriparatide instabu f ’ 2. 8% tan- nisa li ngħataw FORSTEO.
Generally, antibodies were first detected following 12 months of treatment and diminished after withdrawal of therapy.
Ġeneralment, l- antikorpi l- ewwel instabu wara 12- il xahar tal- kura u naqsu wara li twaqqfet it- terapija.
There was no evidence of hypersensitivity reactions, allergic reactions, effects on serum calcium, or effects on BMD response.
Ma kienx hemm evidenza ta ’ reazzjonijiet ta ’ sensittivita ’ eċċessiva, reazzjonijiet allerġiċi, effetti fuq calcium fis- serum, jew effetti fuq il- BMD.
5 Signs and symptoms No cases of overdose were reported during clinical trials.
Sinjali u sintomi L- ebda każi ta ’ doża eċċessiva ma ġew irrappurtati waqt il- provi kliniċi.
FORSTEO has been administered in single doses of up to 100 micrograms and in repeated doses of up to 60 micrograms/ day for 6 weeks.
FORSTEO ngħata f ’ dożi waħedhom sa 100 mikrogramma u f ’ dożi ripetuti sa 60 mikrogramma/ jum għal 6 ġimgħat.
The effects of overdose that might be expected include delayed hypercalcaemia and risk of orthostatic hypotension.
L- effetti ta ’ doża eċċessiva li jistgħu jkunu mistennija jinkludu iperkalċemija ttardjata u r- riskju ta ’ pressjoni baxxa ortostatika tad- demm.
Nausea, vomiting, dizziness, and headache can also occur.
Id- dardir, rimettar, sturdament u uġigħ ta ’ ras jistgħu jseħħu wkoll.
Overdose experience based on post-marketing spontaneous reports:
Esperjenza ta ’ doża eċċessiva bbażata fuq rapporti spontanji wara t- tqegħid fis- suq:
In post-marketing spontaneous reports, there have been cases of medication error where the entire contents (up to 800 µg) of the teriparatide pen have been administered as a single dose.
F’ rapporti spontanji wara t- tqegħid fis- suq, kien hemm każijiet ta ’ żbalji fil- medikazzjoni fejn il - kontenut kollu (sa 800 µg) tal- pinna ta ’ teriparatide ngħata f’ doża waħda.
Transient events reported have included nausea, weakness/ lethargy and hypotension.
L- avvenimenti tranżitorji rrapportati kienu jinkludi tqalligħ, debbulizza/ letarġija u pressjoni baxxa.
In some cases, no adverse events occurred as a result of the overdose.
F’ xi każijiet ma seħħ ebda avveniment avvers bħala konsegwenza tad- doża eċċessiva.
No fatalities associated with overdose have been reported.
Ma ġiet irrapportata ebda fatalità minħabba xi doża eċċessiva.
There is no specific antidote for FORSTEO.
Maniġġjar ta ’ dożi eċċessivi M ’ hemmx antidot speċifiku għal FORSTEO.
Treatment of suspected overdose should include transitory discontinuation of FORSTEO, monitoring of serum calcium, and implementation of appropriate supportive measures, such as hydration.
Kura ta ’ dożi eċċessivi suspettati għandha tinkludi twaqqif temporanju ta ’ FORSTEO, sorveljanza ta ’ calcium fis- serum, u implimentazzjoni ta ’ miżuri ta ’ appoġġ xieraq, bħall- idratazzjoni.
Pharmaco-therapeutic group: parathyroid hormones and analogues, ATC code:
Kategorija farmakoterapewtika: ormoni tal- paratirojde u analogi, Kodiċi ATC:
Mechanism of action:
Il- Mod ta 'kif jaħdem:
Endogenous 84-amino-acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney.
L- ormon endoġenu 84- amino- acid tal- paratirojde (PTH) huwa r- regulatur prinċipali tal- metaboliżmu ta ’ calcium u phosphate fl- għadam u fil- kliewi.
FORSTEO (rhPTH(1-34)) is the active fragment (1-34) of endogenous human parathyroid hormone.
FORSTEO (rhPTH( 1- 34)) hija l- parti attiva (1- 34) ta ’ l- ormon endoġenu uman tal- paratirojde.
Physiological actions of PTH include stimulation of bone formation by direct effects on bone forming cells (osteoblasts) indirectly increasing the intestinal absorption of calcium and increasing the tubular re-absorption of calcium and excretion of phosphate by the kidney.
L- azzjonijiet fiżjoloġiċi ta ’ PTH jikludu stimolu tal - formazzjoni ta ’ l- għadam permezz ta ’ effetti diretti fuq iċ- ċelloli li jiffurmaw l- għadam (osteoblasts) li jżidu indirettament l- assorbiment mill- intestin ta ’ calcium u li jżidu l- assorbiment mill- ġdid tubulari ta ’ calcium u l- eskrezzjoni ta ’ phosphate mill- kliewi.
Pharmacodynamic effects FORSTEO is a bone formation agent to treat osteoporosis.
Effett farmakodinamiku FORSTEO hija sustanza għal- formazzjoni ta ’ l- għadam fil- kura ta ’ l- osteoporożi.
The skeletal effects of FORSTEO depend upon the pattern of systemic exposure.
L- effetti skeletriċi ta 'FORSTEO jiddependu fuq il- mod ta ’ espożizzjoni sistemika.
Once-daily administration of FORSTEO increases apposition of new bone on trabecular and cortical bone surfaces by preferential stimulation of osteoblastic activity over osteoclastic activity.
L- għotja ta ’ FORSTEO darba kuljum iżżid il- formazzjoni ta ’ għadam ġdid fis- superfiċje ta ’ l- għadam trabekulari u kortikali, permezz ta ’ stimolu preferenzjali ta ’ attivita ’ osteoblastika fuq attivita ’ osteoklastika.
Clinical efficacy
Effikaċja klinika
Risk Factors
Fatturi ta ’ riskju
Independent risk factors, for example, low BMD, age, the existence of previous fracture, family history of hip fractures, high bone turnover and low body mass index should be considered in order to identify women and men at increased risk of osteoporotic fractures who could benefit from treatment.
Għandhom jiġu kkunsidrati l- fatturi ta ’ riskju indipendenti bħal per eżempju- BMD baxx, l- età, l - esiżtenza ta ’ ksur preċedenti, passat mediku fil- familja ta ’ ksur fl- għadam tal- ġenbejn, rata għolja fit - tibdil ta ’ l- għadam u indiċi tal- massa tal- ġisem baxx sabiex jiġu identifikati dawk in- nisa u irġiel li għandhom riskju ogħla ta ’ ksur osteoporotiku u li jistgħu jibbenefikaw mill- kura.
Premenopausal women with glucocorticoid-induced osteoporosis should be considered at high risk for fracture if they have a prevalent fracture or a combination of risk factors that place them at high risk for fracture (e. g., low bone density [e. g., T score ≤− 2], sustained high dose glucocorticoid therapy [e. g., ≥ 7.5 mg/ day for at least 6 months], high underlying disease activity, low sex steroid levels).
Nisa qabel il- menopawża b’ osteoporożi kkawżata minħabba t- teħid ta ’ glukokortikojdi għandhom jiġu kkunsidrati li għandhom riskju għoli ta ’ ksur jekk diġà għandhom xi ksur jew għandhom taħlita ta ’ fatturi ta ’ riskju li jpoġġuhom f’ riskju għoli li jkollhom xi ksur (eżempju densità ta ’ l- għadam baxx [eżempju valur T ≤ 2], terapija fit- tul ta ’ glukokortikojdi b’ dożi għoljin [eżempju. > 7. 5 mg/ jum
Postmenopausal osteoporosis:
Osteoporożi wara l- menopawża:
6 The pivotal study included 1637 postmenopausal women (mean age 69.5 years).
L- istudju prinċipali inkluda 1637 mara wara l- menopawża (eta ’ medja 69. 5 sena).
All patients were offered 1000 mg calcium per day and at least 400 IU vitamin D per day.
Fil- linja bażi disgħin fil- mija tal- pazjenti kellhom ksur vertebrali waħdani jew aktar. u bħala medja l- BMD vertebrali kien ta ’ 0. 82 g/ cm² (ekwivalenti għal T- score = - 2. 6) Il- pazjenti kollha ġew mogħtija 1000 mg calcium kuljum u mhux inqas minn 400 IU vitamina D kuljum.
Results from up to 24 months (median:
Ir- riżultati sa 24- il xahar (medja:
19 months) treatment with FORSTEO demonstrate statistically significant fracture reduction (Table 4).
19- il xahar) kura b ’ FORSTEO wrew tnaqqis ta ’ ksur statistikament sinjifikanti (Tabella 4).
To prevent one or more new vertebral fractures, 11 women had to be treated for a median of 19 months.
Biex jiġi evitat ksur waħdani jew aktar vertebrali ġdid, 11- il mara kellhom jiġu kkurati għal medja ta ’ 19- il xahar.
Fracture Incidence in Postmenopausal Women:
Każijiet ta ’ Ksur fin- Nisa Wara l- Menopawża
Relative risk
Riskju relativ
vs. placebo New vertebral
vs. plaċebo 5. 0 b
14.3
Ksur ġdid
5.0 b
14. 3
fracture (≥ 1) a
1. 1 b
(0.22, 0.55)
(0. 22, 055)
Multiple vertebral fractures (≥ 2) a
Ksur multiplu vertebrali( ≥2) a
1.1 b
0. 23 (0. 09, 0. 60)
0.23 (0.09, 0.60)
2. 6% c
Non-vertebral
Ksur ta ’ fraġilità
5.5%
5. 5%
2.6% d
0. 47
0.47
mhux vertebrali c
fragility fractures c
1. 5% c
(0.25, 0.87)
(0. 25, 0. 87)
Major non-vertebral fragility fracturesc (hip, radius, humerus, ribs and pelvis)
Ksur ta ’ fraġilità maġġuri mhux vertebrali c( ġenbejn, radjus, omeru, kustilji u pelvis)
3.9%
3. 9%
0.38 (0.17, 0.86)
0. 38 (0. 17, 0. 86)
Abbreviations:
Tqassir:
N = number of patients randomly assigned to each treatment group; CI = Confidence Interval.
N=numru ta ’ pazjenti li b’ mod arbitrarju ġew assenjati ma ’ kull grupp ta ’ kura.; CI= Intervall ta ’ Kunfidenza
a The incidence of vertebral fractures was assessed in 448 placebo and 444 Forsteo patients who had baseline and follow-up spine radiographs. b p≤ 0.001 compared with placebo c A significant reduction in the incidence of hip fractures has not been demonstrated d p≤ 0.025 compared with placebo.
a L- inċidenza ta ’ ksur vertebrali ġie evalwat f’ 448 pazjent li ħadu plaċebo u f’ 444 pazjent li ħadu Forsteo u li kellhom radjografi ta ’ l- ispina kemm bħala linja bażi kif ukoll ta ’ wara l- kura.. b p≤0. 001 meta mqabbel mal- plaċebo c p≤0. 025 meta mqabbel mal- plaċebo
After 19 months (median) treatment, bone mineral density (BMD) had increased in the lumbar spine and total hip, respectively, by 9% and 4% compared with placebo (p < 0.001).
Wara 19- il xahar (medja) ta ’ kura, id- densità minerali ta ’ l- għadam (BMD) kienet żdiedet fis- sinsla lumbari u fl- għadma tal- ġenbejn, b ’ 9% u 4% rispettivament meta mqabbla mal- plaċebo (p < 0. 001).
Post-treatment management:
L- immaniġġjar wara l- kura:
Following treatment with FORSTEO, 1262 postmenopausal women from the pivotal trial enrolled in a post-treatment follow-up study.
Wara l- kura b ’ FORSTEO, 1292 mara wara l- menopawża, mill- prova pivotali daħlu f ’ studju ta ’ wara l- kura.
The primary objective of the study was to collect safety data of FORSTEO.
L- għan ewlieni ta ’ l- istudju kien li tinġabar informazzjoni dwar is- sigurta ’ ta ’ FORSTEO.
During this observational period, other osteoporosis treatments were allowed and additional assessment of vertebral fractures was performed.
Matul dan il- perijodu ta ’ osservazzjoni, tħallew jintużaw kuri oħrajn ta ’ l - osteoporiżi u saret stima addizzjonali ta ’ ksur vertebrali.
During a median of 18 months following discontinuation of FORSTEO, there was a 41% reduction (p=0.004) compared with placebo in the number of patients with a minimum of one new vertebral fracture.
Matul medja ta ’ 18- il xahar wara l- waqfien tal- kura b ’ FORSTEO, kien hemm 41% tnaqqis (p=0. 004) meta mqabbel mal- plaċebo fin- numru ta ’ pazjenti b ’ minimu ta ’ ksur waħdani vertebrali ġdid.
In an open-label study, 503 postmenopausal women with severe osteoporosis and a fragility fracture within the previous 3 years (83% had received previous osteoporosis therapy) were treated with FORSTEO for up to 24 months.
F’ studju open- label, 503 nisa wara l- menopawża b’ osteoporożi severa u li kellhom ksur ta ’ fraġilità fl - aħħar 3 snin (83% kienu diġà rċevew kura għall- osteoporożi) ġew ikkurati b’ FORSTEO għal 24 xahar.
At 24 months, the mean increase from baseline in lumbar spine, total hip and femoral neck BMD was 10.5%, 2.6% and 3.9% respectively.
Iż- żieda medja mit- 18 sa 24 xahar
The mean increase in BMD from 18 to 24 months was 1.4%, 1.2%, and 1.6% at the lumbar spine, total hip and femoral neck, respectively.
7 fil- BMD tal- parti lumbari tas- sinsla, tat- total tal- ġenbejn u tal- għonq femorali kien rispettivament 1. 4%, 1. 2% u 1. 6%
7 Male osteoporosis:
Osteoporożi fl- irġiel:
437 patients (mean age 58.7 years) were enrolled in a clinical trial for men with hypogonadal (defined as low morning free testosterone or an elevated FSH or LH) or idiopathic osteoporosis.
437 pazjent (età medja 58. 7 snin) ġew irreġistrati fi studju kliniku għall- irġiel b’ osteoporożi tat- tip ipogonadali (definita bħala livell baxx tat- testosterone ħieles fid- demm ta ’ filgħodu jew livell għoli ta ’ FSH jew LH) jew idjopatika.
Baseline spinal and femoral neck bone mineral density mean T-scores were -2.2 and -2.1, respectively.
Bħala linja bażi, il- medja tat- T- scores tad- densità minerali ta ’ l- għadam tas- sinsla u ta ’ l- għonq tal- femorali kienu ta ’ - 2. 2 u ta ’ - 2. 1 rispettivament.
At baseline, 35% of patients had a vertebral fracture and 59% had a non-vertebral fracture.
Meta meħuda bħala linja bażi, 35% tal- pazjenti kellhom xi ksur tal- vertebra u 59% kellhom xi ksur mhux tal- vertebra.
All patients were offered 1000 mg calcium per day and at least 400 IU vitamin D per day.
Il- pazjenti kollha ġew mogħtija 1000 mg calcium kuljum u mhux inqas minn 400 IU vitamina D kuljum.
Lumbar spine BMD significantly increased by 3 months.
BMD tas- sinsla lumbari żdied b ’ mod sinjifikanti wara 3 xhur.
After 12 months, BMD had increased in the lumbar spine and total hip by 5% and 1%, respectively, compared with placebo.
Wara 12- il xahar, BMD kien żdied fil- għadma tal- ġenbejn b ’ 5% u 1% rispettivament meta mqabbel ma ’ plaċebo.
However, no significant effect on fracture rates was demonstrated.
Iżda ma ntwera l- ebda effett sinjifikanti fuq ir- rati tal- ksur.
Glucocorticoid-induced osteoporosis
Osteoporożi kkawżata minħabba t- teħid ta ’ glukokortikojdi
The efficacy of Forsteo in men and women (N=428) receiving sustained systemic glucocorticoid therapy (equivalent to 5 mg or greater of prednisone for at least 3 months) was demonstrated in the 18- month primary phase of a 36 month, randomised, double-blind, comparator-controlled study (alendronate 10 mg/ day).
L- effikaċja ta ’ Forsteo f’ irġiel u nisa (N=428) li kienu qed jirċievu terapija bil- glukokotikojdi b’ mod sistemiku fit- tul (ekwivalenti għal 5 mg jew iżjed ta ’ prednisone meħuda għallinqas għal 3 xhur) ġiet murija fl- ewwel fażi ta ’ 18- il xahar ta ’ studju double- blind, randomised, ikkontrollat b’ komparatur (alendronate 10 mg/ jum) u li dam 36 xahar.
Twenty-eight percent of patients had one or more radiographic vertebral fractures at baseline.
Fil- linja bażi, skond ir- radjografiji, tmienja u għoxrin fil - mija tal- pazjenti kellhom ksur ta ’ wieħed jew ta ’ aktar vertebra.
All patients were offered 1000 mg calcium per day and 800 IU vitamin D per day.
Il- pazjenti kollha ġew mogħtija 1000 mg ta ’ calcium kuljum u 800 UI ta ’ vitamina D kuljum.
This study included postmenopausal women (N=277), premenopausal women (N=67), and men (N=83).
Dan l- istudju kien jinkludi nisa wara l- menopawża (N=277), nisa qabel il- menopawża (N=67), u irġiel (N=83).