qanastek/EMEA-V3 huggingface dataset:
At baseline, the postmenopausal women had a mean age of 61 years, mean lumbar spine BMD T score of − 2.7, median prednisone equivalent dose of 7.5 mg/ day, and 34% had one or more radiographic vertebral fractures; premenopausal women had a mean age of 37 years, mean lumbar spine BMD T score of − 2.5, median prednisone equivalent dose of 10 mg/ day, and 9% had one or more radiographic vertebral fractures; and men had a mean age of 57 years, mean lumbar spine BMD T score of − 2.2, median prednisone equivalent dose of 10 mg/ day, and 24% had one or more radiographic vertebral fractures.
Fil- linja bażi, in- nisa wara l- menopawża kellhom età medja ta ’ 61 sena, medja ta ’ BMD fil - parti lumbari ta ’ l- ispina b’ valur T ta ’ - 2. 7, doża medja ekwivalenti għal 7. 5 mg/ jum ta ’ prednisone u 34%, skond ir- radjografiji, kellhom ksur ta ’ wieħed jew ta ’ aktar vertebra; in- nisa qabel il- menopawża kellhom età medja ta ’ 37 sena, medja ta ’ BMD fil- parti lumbari ta ’ l- ispina b’ valur T ta ’ - 2. 5, doża medja ekwivalenti għal 10 mg/ jum ta ’ prednisone u 9%, skond ir- radjografiji, kellhom ksur ta ’ wieħed jew ta ’ aktar vertebra; u l- irġiel kellhom età medja ta ’ 57 sena, medja ta ’ BMD fil- parti lumbari ta ’ l- ispina b’ valur T ta ’ - 2. 2, doża medja ekwivalenti għal 10 mg/ jum ta ’ prednisone u 24%, skond ir- radjografiji, kellhom ksur ta ’ wieħed jew ta ’ aktar vertebra.
Sixty-nine percent of patients completed the 18-month primary phase.
Disgħa u sittin fil- mija tal- pazjenti spiċċaw l- ewwel fażi ta ’ 18- il xahar.
At the 18 month endpoint, FORSTEO significantly increased lumbar spine BMD (7.2%) compared with alendronate (3.4%) (p < 0.001).
Fit- tmiem tat- 18- il xahar, FORSTEO żied b’ mod sinifikanti l- BMD fil- parti lumbari ta ’ l- ispina (7. 2%) meta mqabbel ma ’ alendronate (3. 4%) (p < 0. 001).
FORSTEO increased BMD at the total hip (3.6%) compared with alendronate (2.2%) (p < 0.01), as well as at the femoral neck (3.7%) compared with alendronate (2.1%) (p < 0.05).
FORSTEO żied il- BMD tal- ġenbejn kollu (3. 6%) meta mqabbel ma ’ alendronate (2. 2%) (p < 0. 01) kif ukoll fl- għonq ta ’ l- għadma tal- koxxa (3. 7%) meta mqabbel ma ’ alendronate (2. 1%) (p < 0. 05).
In patients treated with teriparatide, lumbar spine, total hip and femoral neck BMD increased between 18 and 24 months by an additional 1.7%, 0.9%, and 0.4%, respectively.
Bejn it- 18 u l- 24 xahar, fil- pazjenti kkurati b’ teriparatide, il- BMD tal - parti lumbari tas- sinsla, tat- total tal- ġenbejn u tal- għonq femorali żdied b’ 1. 7%, b’ 0. 9% u b’ 0. 4% ieħor rispettivament.
At 36 months, analysis of spinal X-rays from 169 alendronate patients and 173 FORSTEO patients showed that 13 patients in the alendronate group (7.7%) had experienced a new vertebral fracture compared with 3 patients in the FORSTEO group (1.7%) (p=0.01).
Wara 36 xahar, analiżi tal- X- rays tas- sinsla minn 169 pazjent fuq alendronate u minn 173 pazjent fuq FORSTEO wrew li 13- il pazjent fil- grupp ta ’ alendronate (7. 7%) kellhom ksur wieħed vertebrali ġdid meta mqabbel ma ’ 3 pazjenti fil- grupp ta ’ FORSTEO (1. 7%) (p=0. 01).
In addition, 15 of 214 patients in the alendronate group (7.0%) had experienced a nonvertebral fracture compared with 16 of 214 patients in the FORSTEO group (7.5%) (p=0.84).
Barra minn hekk, 15 minn 214 il- pazjent fil- grupp ta ’ alendronate kellhom ksur wieħed mhux tal- vertebra meta mqabbel ma ’ 16 minn 214- il pazjent fil- grupp ta ’ FORSTEO (7. 5%) (p=0. 84).
In premenopausal women, the increase in BMD from baseline to 18 month endpoint was significantly greater in the FORSTEO group compared with the alendronate group at the lumbar spine (4.2% versus − 1.9%; p < 0.001) and total hip (3.8% versus 0.9%; p=0.005).
Fin- nisa qabel il- menopawża, iż- żieda fil- BMD mil- linja bażi sar- riżultat finali wara 18- il xahar kien iżjed, b’ mod sinifikanti, fil- grupp ta ’ FORSTEO meta mqabbel mal- grupp ta ’ alendronate fil- parti lumbari ta ’ l- ispina (4. 2% kontra - 1. 9%; p < 0. 001) u mal- ġenbejn kollu (3. 8% kontra 0. 9%; p=0. 005).
However, no significant effect on fracture rates was demonstrated.
Madankollu, ma ġiex muri effett sinifikanti fuq ir- rata ta ’ ksur.
FORSTEO is eliminated through hepatic and extra-hepatic clearance (approximately 62 l/ hr in women and 94 l/ hr in men).
FORSTEO jiġi eliminat permezz ta 'tneħħija mill- fwied u barra mill- fwied (madwar 62 l/ hr fin- nisa u 94 l/ hr fl- irġiel).
The volume of distribution is approximately 1.7 l/ kg.
Il- volum tad- distribuzzjoni huwa madwar 1. 7 l/ kg.
The half-life of FORSTEO is approximately 1 hour when administered subcutaneously, which reflects the time required for absorption from the injection site.
Il- half- life ta ’ FORSTEO huwa ta ’ madwar siegħa meta jingħata taħt il- ġilda, li jirrifletti ż- żmien meħtieġ għall- assorbiment mill- post ta ’ l- injezzjoni.
No metabolism or excretion studies have been performed with FORSTEO but the peripheral metabolism of parathyroid hormone is believed to occur predominantly in liver and kidney.
L- ebda studji dwar il- metaboliżmu jew l- eskrezzjoni b 'FORSTEO ma ’ saru iżda l - metaboliżmu periferali ta ’ l- ormon paratirojde huwa maħsub li jseħħ l- aktar fil- fwied u fil- kliewi.
8 Patient characteristics:
Karatteristiċi tal- pazjent:
Geriatrics No differences in FORSTEO pharmacokinetics were detected with regard to age (range 31 to 85 years).
Anzjani L- ebda differenza ma dehret fil- farmakokinetiċita ’ ta ’ FORSTEO rigward l- eta '(medda 31 sa 85 sena).
Dosage adjustment based on age is not required.
L- aġġustament tad- doża a bażi ta ’ l- eta mhuwiex meħtieġ.
Teriparatide was not genotoxic in a standard battery of tests.
Teriparatide ma kienx ġenotossiku f ’ sensiela ta ’ testijiet standardizzati.
There were no important effects observed in pregnant rats or mice administered teriparatide at daily doses of 30 to 1000 µg/ kg.
Ma pproduċa l- ebda effetti teratoġeniċi fil- firien, fil- ġrieden jew fil- fniek. Ma dehru ebda effetti importanti fil- firien u ġrieden tqal li ngħataw teriparatide f’ dożi ta ’ 30 sa 1000 µg/ kg kuljum.
However, fetal resorption and reduced litter size occurred in pregnant rabbits administered daily doses of 3 to 100 µg/ kg.
Madankollu, fil- fniek tqal kien hemm assorbiment tal- fetu u tnaqqis fl- ammont ta ’ frieħ meta ngħataw dożi ta ’ 3 sa 100 µg/ kg kuljum.
The embryotoxicity observed in rabbits may be related to their much greater sensitivity to the effects of PTH on blood ionised calcium compared with rodents.
Dan l - effett tossiku fuq l- embriju fil- fniek jista ’ jkun minħabba li għandhom ħafna iżjed sensittività għall - effetti ta ’ PTH fuq il- kalċju jonizzat fid- demm meta mqabbla ma ’ l- annimali gerriema.
Rats treated with near-life time daily injections had dose-dependent exaggerated bone formation and increased incidence of osteosarcoma most probably due to an epigenetic mechanism.
Il- firien li ġew ikkurati b ’ injezzjonijiet qrib it- tmiem tal- ħajja kellhom formazzjoni esaġerata ta ’ l - għadam dipendenti fuq id- doża u incidenza ogħla ta ’ osteosarkoma li x ’ aktarx kienet minħabba mekkaniżmu epiġenetiku.
Teriparatide did not increase the incidence of any other type of neoplasia in rats.
Teriparatide ma żiedx in- numru ta ’ xi tip ieħor ta ’ tumur fil- firien.
Due to the differences in bone physiology in rats and humans, the clinical relevance of these findings is probably minor.
Minħabba d- differenzi fil- fiżjoloġija ta ’ l- għadam fil- firien u fil- bniedem, ir- rilevanza klinika ta ’ dawn is- sejbiet hija x ’ aktarx minuri.
No bone tumours were observed in ovariectomised monkeys treated for 18 months or during a 3-year follow-up period after treatment cessation.
L- ebda tumuri fl- għadam ma ġew osservati f’ xadini li kellhom l- ovarji mneħħija u kkurati għal 18- il xahar u lanqas waqt perjodu ta ’ studju ta ’ 3 snin minn meta kienet twaqqfet il- kura.
In addition, no osteosarcomas have been observed in clinical trials or during the post treatment follow-up study.
Minbarra dan, l- ebda osteosarkoma ma ġiet osservata f ’ provi kliniċi jew l- istudju ta ’ wara l- kura.
Animal studies have shown that severely reduced hepatic blood flow decreases exposure of PTH to the principal cleavage system (Kupffer cells) and consequently clearance of PTH(1-84).
L- istudji fl- annimali wrew li ċ- ċirkolazzjoni mnaqqsa ħafna tad- demm fil- fwied inaqqas l- espożizzjoni ta ’ PTH għas- sistema prinċipali ta ’ cleavage (ċelluli ta ’ Kupffer) u konsegwentement it- tneħħija ta ’ PTH( 1- 84).
Glacial acetic acid Sodium acetate (anhydrous) Mannitol Metacresol Hydrochloric acid Sodium hydroxide Water for injections
Glacial acetic acid Sodium acetate (anhydrous) Mannitol Metacresol Hydrochloric acid Sodium hydroxide Ilma għall- injezzjoni
Hydrochloric acid and/ or sodium hydroxide solution may be added to adjust pH.
Tista ’ tiġi miżjuda soluzzjoni ta ’ hydrochloric acid u/ jew sodium hydroxide biex il- pH jiġi aġġustat.
Chemical, physical and microbiological in-use stability has been demonstrated for 28 days at 2-8°C.
Stabilita ’ kimika, fiżika u mikrobioloġika waqt l- użu ntweriet għal 28 jum f ’ temperatura ta ’ bejn 2 u 8°C.
Once opened, the product may be stored for a maximum of 28 days at 2°C to 8°C.
Ladarba nfetaħ, il- prodott jista ’ jinħażen għal massimu ta ’ 28 jum f ’ temperatura ta ’ bejn 2°C u 8°C.
Other in-use storage times and conditions are the responsibility of the user.
Ħinijiet u kundizzjonijiet oħrajn tal- ħażna waqt l- użu huma r- responsabbilta ’ ta ’ min qiegħed juża l- prodott.
9 Store in a refrigerator (2°C – 8°C) at all times.
Aħżen fi friġġ (2°C – 8°C) f ’ kull ħin.
The pen should be returned to the refrigerator immediately after use.
Il- pinna għandha tiġi rritornata fil- friġġ minnufih wara l- użu.
Do not store the injection device with the needle attached.
Taħżinx it- tagħmir ta ’ l- injezzjoni bil- labra mwaħħla.
2.4 ml solution in cartridge (siliconised Type I glass) with a plunger (halobutyl rubber), disc seal (polyisoprene/ bromobutyl rubber laminate)/ aluminium assembled into a disposable pen.
2. 4 ml soluzzjoni f ’ stoċċ (ħġieġ silikoniżżat tat- Tip I) bi planġer (halobutyl rubber), siġill fil- forma ta ’ diska (polyisoprene/ bromobutyl rubber laminate) / aluminium magħqudin f ’ pinna li tintrema wara li tintuża.
FORSTEO is available in pack sizes of 1 or 3 pens.
FORSTEO huwa disponibbli f’ pakketti ta ’ pinna waħda jew ta '3 pinen.
Each pen contains 28 doses of 20 micrograms (per 80 microliters).
Kull pinna fiha 28 doża ta ’ 20 mikrogramma (għal kull 80 mikrolitru).
FORSTEO is supplied in a pre-filled pen.
FORSTEO issibu f‘ pinna mimlija lesta.
Each pen should be used by only one patient.
Kull pinna għandha tintuża minn pazjent wieħed biss.
A new, sterile needle must be used for every injection.
Għandha tintuża labra sterili ġdida għal kull injezzjoni.
Each FORSTEO pack is provided with a user manual that fully describes the use of the pen.
Kull pakkett ta ’ FORSTEO jiġi provdut b ’ manwal għal pazjent li jiddeskrivi kif tuża l- pinna.
No needles are supplied with the product.
L- ebda labar ma jiġu pprovduti mal- prodott.
The device can be used with insulin pen injection needles.
It - tagħmir jista ’ jintuża mal- labar tal- pinen ta ’ l- injezzjoni ta ’ l- insulina (Becton Dickinson).
After each injection, the FORSTEO pen should be returned to the refrigerator.
Wara kull injezzjoni, il- pinna ta ’ FORSTEO għandha tiġi rritornata fil- friġġ.
FORSTEO should not be used if the solution is cloudy, coloured or contains particles.
FORSTEO m ’ għandux jintuża jekk is- soluzzjoni hija mdardra, ikkulurita jew fiha l- frak.
Please also refer to the User Manual for instructions on how to use the pen.
Irreferi wkoll għall- Manwal tal- pazjent dwar istruzzjonijiet fuq kif tuża l- pinna.
Eli Lilly Nederland B. V, Grootslag 1-5, NL-3991 RA Houten, The Netherlands
Eli Lilly Nederland B. V, Grootslag 1- 5, NL- 3991 RA Houten, L- Olanda
10 June 2003.
10 ta ’ Ġunju 2003 Data ta ’ l- aħħar tiġdid:
Date of last renewal 10 June 2008
10 ta ’ Ġunju 2008
10 ANNEX II
11 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTURI TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTURI TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
Eli Lilly and Company, Lilly Technology Center, Indianapolis, Indiana 46285, United States of America
Eli Lilly and Company, Lilly Technology Center, Indianapolis, Indiana 46285, Stati Uniti ta ’ l- Amerika
Lilly France S. A. S., rue du colonel Lilly, 67640 Fegersheim, France
Lilly France S. A. S., rue du colonel Lilly, 67640 Fegersheim, Franza
Lilly S. A., Avda de la Industria 30, 28108 Alcobendas (Madrid), Spain
Lilly S. A., Avda de la Industria 30, 28108 Alcobendas (Madrid), Spanja
Medicinal product subject to medical prescription.
Prodott mediċinali jingħata bir- riċetta tat- tabib. >
The Marketing Authorisation Holder will submit PSURs annually.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq se jissottometti il- PSURs kull sena
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the version n.
Pjan dwar l- Immaniġġar tar- Riskju L- MAH jintrabat li jagħmel l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza mniżżlin fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni n. 2. 5 tas- 17 ta’ Jannar 2008 tal- Pjan dwar l - Immaniġġar tar- Riskju (RMP) ippreżentat fit- Taqsima 1. 8. 2 ta ’ l- Awtorizzazzjoni għat- Tqegħid fis - Suq u f’ kull aġġornament ta ’ l- RMP li jista ’ jkun hemm u li jkun qabel miegħu is- CHMP.
2.5 dated 17 January 2008 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Kif hemm fil- Linji Gwida tas- CHMP dwar is- Sistemi ta ’ l- Immaniġġar tar- Riskju għal prodotti mediċinali għall- użu fil- bniedem, l- RMP aġġornat għandu jiġi ppreżentat fl- istess żmien mar- Rapport ta ’ Aġġornament Perjodiku dwar is- Sigurtà (PSUR) li jkun imiss.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Meta jkun hemm informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjonijiet tas - Sigurtà, fuq il- Pjan ta ’ Farmakoviġilanza jew fuq l- attivitajiet li jnaqqsu ir- riskju li jkunu jgħoddu f’ dak il- mument.
In addition, an updated RMP should be submitted: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Fi żmien 60 ġurnata minn meta jkun deċiż xi avveniment importanti (ta ’ farmakoviġilanza jew tat- tnaqqis tar- riskju)
12 ANNEX III
•
LABELLING AND PACKAGE LEAFLET
Fuq talba ta ’ l- EMEA
13 A.
13 ANNESS III
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
OUTER CARTON TEXT
KITBA TA ’ FUQ IL- KAXXA TA ’ BARRA
FORSTEO 20 micrograms/ 80 microliters solution for injection in pre-filled pen Teriparatide
FORSTEO 20 mikrogramma/ 80 mikrolitri soluzzjoni għall- injezzjoni f ’ pinna mimlija lesta Teriparatide
Each ml contains 250 micrograms of teriparatide.
Kull millilitru fih 250 mikrogramma ta ’ teriparatide
Glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol 3.0 mg/ ml (preservative), water for injections.
Glacial acetic acid, Sodium acetate (anhydrous), mannitol, metacresol (preservattiv) hydrochloric acid, sodium hydroxide, ilma għall- injezzjoni.
Hydrochloric acid solution and/ or sodium hydroxide solution (as appropriate).
Soluzzjoni ta ’ hydrochloric acid u/ jew soluzzjoni ta ’ sodium hydroxide (kif xieraq).
1 pen of 2.4 ml solution.
Pinna ta ’ soluzzjoni ta ’ 2. 4 ml.
3 pens of 2.4 ml solution each.
3 pinen ta ’ soluzzjoni ta ’ 2. 4 ml kull wieħed
Subcutaneous use READ THE PACKAGE LEAFLET BEFORE USE
Użu subkutanju AQRA L- FULJETT TA ’ TAGĦRIF QABEL L- UŻU
This is a new pen design please read the user manual before injecting
Din hija għamla ġdida ta ’ pinna, jekk jogħġbok aqra ’ l- manwal qabel ma tinjetta l- injezzjoni
EXP {MM/ YYYY} The pen should be discarded 28 days after the first use.
JIS [XX/ SSSS] Il- pinna għandha tintrema 28- il jum wara li tintuża għall- ewwel darba.
Date of first use:
Data ta ’ l- ewwel użu:
Do not freeze.
Aħżen fi friġġ Tagħmlux fil- friża.
Grootslag 1-5, NL-3991 RA Houten The Netherlands
Grootslag 1- 5, NL- 3991 RA Houten L- Olanda
EU/ 1/ 03/ 247/ 001 Or EU/ 1/ 03/ 247/ 002
EU/ 1/ 03/ 247/ 001 Jew EU/ 1/ 03/ 247/ 002
16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL TEXT
17 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
FORSTEO 20 micrograms/ 80 microliters, solution for injection in pre-filled pen Teriparatide Subcutaneous use
FORSTEO 20 mikrogramma/ 80 mikrolitri, soluzzjoni għall- injezzjoni f ’ pinna mimlija lesta Teriparatide Użu subkutanju
17 B.
18 B.
18 PACKAGE LEAFLET:
19 FULJETT TA ’ TAGĦRIF:
FORSTEO 20 micrograms/ 80 microliters solution for injection in pre-filled pen Teriparatide
FORSTEO 20 microgramma/ 80 mikrolitri soluzzjoni għall- injezzjoni ġo pinna mimlija lesta Teriparatide
What FORSTEO is and what it is used for 2.
X’ inhu FORSTEO u għalxiex jintuża 2.
Before you use FORSTEO 3.
Qabel ma tuża FORSTEO 3.
How to use FORSTEO 4.
Kif għandek tuża FORSTEO 4.
Possible side effects 5 How to store FORSTEO 6.
Kif taħżen FORSTEO 6.
WHAT FORSTEO IS AND WHAT IT IS USED FOR FORSTEO is used to make the bones stronger, and to reduce the risk of fractures (bone-formation agent).
X’ INHU FORSTEO U GĦALXIEX JINTUŻA FORSTEO jintuża biex issaħħaħ l- għadam u biex inaqqas ir- riskju ta ’ ksur (sustanza għall - formazzjoni ta ’ l- għadam)
This product is used to treat osteoporosis.
Dan il- prodott jintuża għall- kura ta ’ l- osteoporożi.
Osteoporosis is a disease that causes your bones to become thin and fragile.
L- osteoporożi hija marda li ġġiegħel lill- għadam tiegħek jirqaqu u jiddgħajjfu.
This disease is especially common in women after the menopause, but it can also occur in men.
Din il- marda hija speċjalment komuni fin- nisa wara l- menopawża iżda tista ’ sseħħ ukoll fl- irġiel.
Osteoporosis is also common in patients receiving corticosteroids.
L- osteoporożi hija wkoll komuni f’ pazjenti li qegħdin jingħataw il - kortikosterojdi.
BEFORE YOU USE FORSTEO
QABEL MA TUŻA FORSTEO
Do not use FORSTEO • if you are allergic (hypersensitive) to teriparatide or any of the other ingredients of FORSTEO. • if you suffer from high calcium level (pre-existing hypercalcaemia). • if you suffer from serious kidney problems. • If you have ever been diagnosed with bone cancer or other cancers that have spread (metastasised) to your bones. • If you have certain bone diseases.
Tużax FORSTEO: • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal teriparatide jew sustanzi oħra ta ’ FORSTEO • jekk tbati minn livell għoli ta ’ calcium (iperkalċemija pre- eżistenti). • jekk tbati minn problemi serji fil- kliewi. • jekk qatt kont dijanjostikat b’ kanċer ta ’ l- għadam jew b’ xi kanċer ieħor li nfirixlek (immetastatizza) fl- għadam • jekk għandek xi tip ta ’ mard ta ’ l- għadam.
If you have a bone disease, tell your doctor. • If you have unexplained high levels of alkaline phosphatase in your blood, which means you might have Paget’ s disease.
Jekk għandek xi marda fl- għadam, għid lit- tabib. • jekk għandek livelli għoljin ta ’ alkaline phosphatase fid- demm mingħajr ma taf għaliex, li tfisser li jista ’ jkun li għandek il- marda ta ’ Paget.
If you are not sure, ask your doctor. • if you have had radiation therapy involving your bones. • if you are pregnant or breast-feeding.
Jekk m’ intix ċert staqsi lit- tabib. • jekk kellek terapija bir- radjazzjoni fejn kienu involuti l- għadam. • jekk int tqila jew qed tredda ’.
FORSTEO should not be used in children (less than 18 years) or in growing adults.
FORSTEO m ’ għandux jintuża fit- tfal (inqas minn 18- il sena) jew f’ adulti li qegħdin jikbru.
Take special care with FORSTEO
20 Oqgħod attent ħafna b’ FORSTEO
FORSTEO may cause an increase in the amount of calcium in your blood.
FORSTEO jista ’ jikkawża żieda fl- ammont ta ’ calcium fid- demm.
Tell your doctor if you have continuing nausea, vomiting, constipation, low energy, or muscle weakness.
Għid lit- tabib jekk b’ mod kontinwu għandek it- tqalligħ, ir- rimettar jew l- istitikezza jew tħossok bla saħħa jew għandek il - muskoli dgħajfin.
These may be signs there is too much calcium in your blood.
Dawn jista ’ jkunu sinjali li għandek wisq calcium fid- demm.
FORSTEO may cause an increase in the amount of calcium in your urine.
FORSTEO jista ’ jikkawża żieda fl- ammont ta ’ calcium fl- awrina.
You should tell your doctor if you suffer from kidney stones or have a history of kidney stones.
Għandek tgħid lit- tabib jekk tbati minn ġebel fil- kliewi jew għandek xi passat mediku ta ’ ġebel fil- kliewi
You should tell your doctor if you suffer from kidney problems (moderate renal impairment).
Għandek tgħid lit- tabib jekk tbati minn xi problemi tal- kliewi (indeboliment tal- kliewi moderat)
For the first doses, inject FORSTEO where you can sit or lie down right away if you get dizzy.
Wara l- ewwel ftit dożi xi pazjenti jħossuhom sturduti jew ikollhom il- qalb li tibda tħabbat b’ mod mgħaġġel.
The recommended treatment time of 24 month should not be exceeded.
Għall- ewwel dożi, FORSTEO għandu jiġi injettat fejn, jekk tħoss li ġej xi sturdament, tkun tista ’ mal- ewwel toqgħod bilqiegħda jew timtedd M’ għandekx taqbeż iż- żmien rakkomandat ta ’ kura ta ’ 24 xahar.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, because occasionally they may interact (e. g. digoxin/ digitalis, a medicine used to treat heart disease).
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta għax kultant jistgħu jirreaġixxu ma ’ xulxin (eż, digoxin/ digitalis, mediċina għall- kura tal- mard fil- qalb).
Using FORSTEO with food and drink Forsteo can be given with or without food.
Meta tuża FORSTEO ma ’ l- ikel u max- xorb Forsteo jista ’ jingħata kemm ma ’ l- ikel kif ukoll fuq stonku vojt.
Pregnancy and breast-feeding Do not use FORSTEO if you are pregnant or breast-feeding.
Tqala u treddigħ Tużax FORSTEO jekk int tqila jew qed tredda ’.
Women of child-bearing 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.
Driving and using machines Some patients may feel dizzy after injecting FORSTEO.
Xi pazjenti jistgħu jħossu sturdament wara li jingħataw FORSTEO.
If you feel dizzy you should not drive or use machines until you feel better.
Jekk tħossok sturdut m ’ għandekx issuq jew tħaddem magni sakemm tkun tħossok aħjar.
Important information about some of the ingredients of FORSTEO:
Tagħrif importanti dwar xi wħud mill- ingredjenti ta ’ FORSTEO:
This medicinal product contains less than 1 mmol sodium (23 mg) per dose.
Dan il- prodott mediċinali fih inqas minn mmol 1 ta ’ sodium (23 mg) għal kull doża.
This means that it is essentially “ sodium-free”.
Dan ifisser li tista ’ tgħid li huwa “ ħieles mis- sodium ”
HOW TO USE FORSTEO
KIF GĦANDEK TUŻA FORSTEO
Always use FORSTEO exactly as your doctor has told you to.
Dejjem għandek tuża FORSTEO skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Għandek taċċerta ruħek mat- tabib jew ma ’ l - ispiżjar tiegħek jekk ikollok xi dubju.
Never share your FORSTEO pen with others
Qatt taqsam il- pinna ta ’ FORSTEO tiegħek ma ’ ħaddieħor.
The recommended dose of FORSTEO is 20 microgram given once daily by injection under the skin (subcutaneous injection) in the thigh or abdomen.
Id- doża rrakkmandata ta ’ FORSTEO hija 20 mikrogramma mogħtija darba kuljum b ’ injezzjoni taħt il- ġilda (injezzoni subkutanja) fil- koxxa jew fl- addome.
To help you remember to take FORSTEO, inject it at about the same time each day.
Biex jgħinek tiftakar tuża FORSTEO, uża madwar fl- istess ħin kuljum.
Inject FORSTEO each day for as long as your doctor prescribes it for you.
Uża FORSTEO kuljum għal kemm qallek it- tabib tiegħek.
The total duration of treatment with FORSTEO should not exceed 24 months.
It- tul totali tal- kura b’ FORSTEO m ’ għandux ikun aktar minn 24 xahar.
You should not receive more than one treatment course of 24 months over your lifetime.
M’ għandekx tirċievi iżjed minn kors wieħed ta ’ kura ta ’ 24 xahar tul il- ħajja kollha tiegħek.
FORSTEO can be injected at meal times.
FORSTEO jista ’ jingħata waqt il- ħin ta ’ l- ikel.
Read the user manual booklet, which is included in the carton for instructions on how to use the FORSTEO pen.
Aqra l- ktejjeb li huwa l- Manwal tal- Pazjent, li jinstab fil- kaxxa għal tagħrif dwar kif tuża l- pinna FORSTEO.
Injection needles are not included with the pen.
21 Il- labar ta ’ l- injezzjoni mhumiex inklużi mal- pinna.
You can use Becton Dickinson and Company’ s insulin pen injection needles.
Tista ’ tuża l- labar tal- pinna ta ’ l- injezzjoni ta ’ l - insulina ta ’ Becton Dickinson and Company.
You should take your FORSTEO injection shortly after you take the pen out of the refrigerator as described in the user manual.
Għandek tieħu l- injezzjoni tiegħek ta ’ FORSTEO ftit wara li toħroġ il- pinna mill- friġġ kif mniżżel fil - manwal tal- pazjent.
Put the pen back into the refrigerator immediately after you have used it.
Qiegħed il- pinna lura fil- friġġ mill- ewwel wara li tkun użajtha.
Use a new injection needle for each injection and dispose of it after each use.
Uża labra ta ’ l- injezzjoni ġdida għal kull injezzjoni u armiha wara kull użu.
Never store your pen with the needle attached.
Qatt taħżen il- pinna bil - labra mwaħħla.
Your doctor may advise you to take FORSTEO with calcium and vitamin D.
It- tabib jista ’ jagħtik parir li tuża FORSTEO b’ calcium u vitamina D.
Your doctor will tell you how much you should take each day.
It- tabib tiegħek jgħidlek kemm għandek tieħu kuljum.
If you use more FORSTEO than you should If, by mistake, you have used more FORSTEO than you should, contact your doctor or pharmacist.
Jekk tuża aktar FORSTEO milli suppost Jekk, bi żball, tuża aktar FORSTEO milli suppost, ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
20 The effects of overdose that might be expected include nausea, vomiting, dizziness, and headache.
L- effetti li tista ’ tistenna minħabba doża eċċessiva jinkludu tqalligħ, rimettar, sturdament u wġigħ ta ’ ras
If you forget or cannot take FORSTEO at your usual time, take it as soon as possible on that day.
Jekk tinsa jew ma tistax tieħu FORSTEO fil- ħin tas- soltu, ħudu malajr kemm jista ’ jkun f’ dik il - ġurnata.
Do not take more than one injection in the same day.
Fl- istess ġurnata tieħux iżjed minn injezzjoni waħda.
Do not try to make up for a missed dose.
Tipprovax tagħmel tajjeb għal doża li ma tkunx ħadt.
Like all medicines, FORSTEO can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, FORSTEO jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The most common side effects (affects more than 1 user in 10) are: • feeling sick, • headache • dizziness and • pain in limb.
L- aktar effetti sekondarji komuni (jolqtu aktar minn pazjent 1 minn kull 10) huma: • tħossok imdardar, • uġigħ ta ’ ras • sturdament u • uġigħ fid- dirgħajn u fir- riġlejn.
Common side effects (1 to 10 users in 100) are: • increase in blood cholesterol levels • depression • neuralgic pain in the leg • feeling faint • irregular heart beats • breathlessness • increased sweating • muscle cramps • loss of energy • tiredness • chest pain.
Effetti sekondarji komuni (jolqtu minn 1 sa 10 pazjenti minn kull 100) huma: • żieda fil- livell tal- kolesterol fid- demm • depressjoni • uġigħ newraliġiku fir- riġlejn • ħass ħażin • taħbit irregolari tal- qalb • qtugħ ta ’ nifs • żieda fl- għaraq • bugħawwieġ fil- muskoli • nuqqas ta ’ enerġija • għeja u • uġigħ fis- sider.
Uncommon side effects (affects 1 to 10 users in 1000) are: • increased heart rate, • low blood pressure, • shortness of breath, • heartburn (painful or burning sensation just below the breast bone), • haemorrhoids (piles), • accidental loss or leakage of urine, • increased need to pass water, • weight increase.
Effetti sekondarji mhux komuni (jolqtu minn 1 sa 10 pazjenti minn kull 1000) huma: • taħbit aktar mgħaġġel tal- qalb • pressjoni baxxa tad- demm • qtuġħ ta ’ nifs • ħruq ta ’ stonku (sensazzjoni ta ’ uġigħ jew ħruq eżatt taħt l- għadma ta ’ nofs is- sider • emorrojdi (murliti) • telf aċċidentali jew • ċarċir ta ’ l- awrina • żieda fil- bżonn li tgħaddi l- awrina • żieda fil- piż.
Other uncommon side effects reported include pain in the muscles and pain in the joints.
22 Effetti sekondarji oħrajn li m’ humiex komuni u li ġew irrapportati jinkludu uġigħ fil- muskoli u uġigħ fil- ġogi.
Some people may experience discomfort such as redness of the skin, pain, swelling, itching, bruising or minor bleeding around the area of the injection.
Xi nies jistgħu jħossu xi skumdita ’ bħal ħmura fil- ġilda, uġigħ, nefħa, ħakk, tbenġil jew xi telf minimu ta ’ demm madwar il- post ta ’ l- injezzjoni.
This should clear up in a few days or weeks.
Dan għandu jgħaddi fi ftit jiem jew ġimgħat.
Otherwise tell your doctor as soon as possible.
Inkella għid lit - tabib tiegħek malajr kemm jista ’ jkun.
If you become dizzy (light-headed) after your injection, you should sit or lie down until you feel better.
Jekk tħossok sturdut (tħoss rasek iddur)) wara l- injezzjoni, għandek tpoġġi jew timtedd sakemm tħossok aħjar.
If you do not feel better, you should call a doctor before you continue treatment.
Jekk ma tħossokx aħjar, għandek issejjaħ lit- tabib tiegħek qabel ma tkompli l- kura.
Some patients treated with FORSTEO have had an increase in their blood calcium level.
Xi pazjenti li ġew ikkurati b’ FORSTEO kellhom żieda fil- livell tal- kalċju fid- demm.
Rare side effects (affects 1 to 10 users in 10,000): some patients have experienced allergic reactions soon after injection, consisting of breathlessness, swelling of the face, rash and chest pain.
Effetti sekondarji rari (jolqtu minn 1 sa 10 pazjenti minn kull 10, 000): xi pazjenti kellhom reazzjonijiet allerġiċi ftit ħin wara l- injezzjoni, li kienu jikkonsistu f’ qtugħ ta ’ nifs, nefħa tal- wiċċ, raxx u uġigħ fis - sider.
21 Other rare side effects include swelling, mainly in the hands, feet and legs.
Effetti sekondarji rari oħra jinkludu nefħa l- iżjed fl- idejn, fis- saqajn u fir- riġlejn.
Some patients have experienced severe back cramps or pain, which led to hospitalisation.
Xi pazjenti kellhom bugħawwieġ jew uġigħ sever fid- dahar, li wassal biex kellhom jidħlu l- isptar.
FORSTEO may also cause an increase in an enzyme called alkaline phosphatase
FORSTEO jista ’ wkoll jikkawża żieda f’ enzima msejħa alkaline phosphatase.
HOW TO STORE FORSTEO
KIF TAĦŻEN FORSTEO
Do not use FORSTEO after the expiry date which is stated on the carton and pen.
Tużax FORSTEO wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- pinna
FORSTEO should be stored in a refrigerator (2°C and 8°C) at all times.
FORSTEO għandu jinħażen fi friġġ (2°C – 8°C) f ’ kull ħin.
You can use FORSTEO for up to 28 days after the first injection, as long as the pen is stored in a refrigerator (2°C to 8°C).
Tista ’ tuża l- FORSTEO sa 28- il jum wara l- ewwel injezzjoni sakemm il- pinna tinħażen fi friġġ (2°C – 8°C).
Do not freeze FORSTEO.
Tiffriżax FORSTEO.
Avoid placing the pens close to the ice compartment of the refrigerator to prevent freezing.
Evita li tqiegħed il- pinen qrib tal- kompartiment tas- silġ fil- friġġ biex ma tiffriżax.
Do not use FORSTEO if it is, or has been, frozen.
Tużax FORSTEO jekk huwa, jew ġie, iffriżat.
Each pen should be properly disposed of after 28 days, even if it is not completely empty.
Kull pinna għandha tintrema kif jixraq wara 28- il jum, ukoll jekk mhix kompletament vojta.
FORSTEO contains a clear and colourless solution.
FORSTEO fih soluzzjoni ċara u mingħajr kulur.
Do not use FORSTEO if solid particles appear or if the solution is cloudy or coloured.
Tużax FORSTEO jekk jidhru frak jew jekk is - soluzzjoni hija mdardra jew ikkulurita.
What FORSTEO contains
X’ fih FORSTEO:
- The active substance is teriparatide.
- Is- sustanza attiva hija teriparatide.
Each millilitre of the solution for injection contains 250
Kull millilitru ta ’ soluzzjoni għall- injezzjoni fih 250
microgram of teriparatide.
mikrogramma teriparatide.
- The other ingredients are glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol
- L- ingredjenti l- oħrajn huma: glacial acetic acid, sodium acetate (anidrat), mannitol, metacresol
3.0 mg/ ml (preservative), and water for injections.
3. 0 mg/ ml (preservattiv), u ilma għall- injezzjoni.
In addition, hydrochloric acid and/ or sodium hydroxide solution may have been added to adjust the acidity.
Minbarra dan, setgħu ġew miżjuda hydrochloric acid u/ jew soluzzjoni ta ’ sodium hydroxide biex tiġi aġġustata l- aċidita ’.
What FORSTEO looks like and contents of the pack FORSTEO is a colourless and clear solution for injection under the skin (subcutaneous use).
FORSTEO huwa soluzzjoni għall- injezzjoni għal taħt il- ġilda (użu subkutanju) bla kulur u ċara.
It is supplied in a cartridge contained in a prefilled disposable pen.
Issibu ġo stoċċ li jkun ġo pinna li tintrema u li hija mimlija lesta.
Each pen contains 2.4 ml of solution enough for 28 dosages.
Kull pinna fiha 2. 4 ml ta ’ soluzzjoni li 23 huma biżżejjed għal 28 doża.
The pens are available in cartons containing one or three pens.
Il- pinen issibhom f’ kaxxi tal- kartun li fihom waħda jew tliet pinen.
Not all pack sizes may be available.
Jista ’ jkun li ma jkunux disponibbli l- pakketti tad- daqsijiet kollha.
Eli Lilly Nederland B. V., Grootslag 1-5, NL-3991 RA Houten, The Netherlands Manufacturer:
Eli Lilly Netherland B. V., Grootslag 1- 5, NL- 3991 RA Houten, L- Olanda.
Lilly France S. A. S, Rue du Colonel Lilly, F-67640 Fegersheim, France, or Lilly S. A., Avda de la Industria 30, 28108 Alcobendas (Madrid), Spain
Lilly France S. A. S, Rue du Colonel Lilly, F- 67640 Fegersheim, Franza jew Lilly S. A., Avda de la Industria 30, 28108 Alcobendas (Madrid), Spanja Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Eesti Eli Lilly Holdings Limited Eesti filiaal Tel: + 3726817280
Danmark Eli Lilly Danmark A/ S Tlf: + 45 45 26 60 00 Deutschland Lilly Deutschland GmbH Tel. + 49 - (0) 6172 273 2222 Eesti Eli Lilly Holdings Limited Eesti filiaal Tel: + 3726817280 Ελλάδα ΦΑΡΜΑΣΕΡΒ- ΛΙΛΛΥ Α. Ε. Β. Ε.
Τηλ: + 30 210 629 4600
Τηλ: + 30 210 629 4600 España Elanco Valquímica S. A.
France Lilly France SAS.
Tel: + 34- 91 623- 1732 France Lilly France SAS.
Tél: + 33-(0) 1 55 49 34 34
Tél: + 33 - (0) 1 55 49 34 34 Ireland Eli Lilly and Company (Ireland) Limited.
România Eli Lilly România S. R. L.
Nederland Eli Lilly Nederland B. V.
Tel: + 40 21 4023000
Tel: + 31 - (0) 30 60 25 800 Norge Eli Lilly Norge A. S.
Ireland Eli Lilly and Company (Ireland) Limited.
Tlf: + 47 22 88 18 00 Österreich Eli Lilly Ges. m. b. H.
Tel: + 353-(0) 1 661 4377
Tel: + 43 - (0) 1 711 780 Polska Eli Lilly Polska Sp. z o. o.
Slovenija Eli Lilly farmacevtska druž ba, d. o. o Tel: +386 (0)1 580 00 10
Tel: + 40 21 4023000 Slovenija Eli Lilly farmacevtska družba, d. o. o Tel: +386 (0) 1 580 00 10
Sverige Eli Lilly Sweden AB Tel: + 46-(0) 8 7378800
Slovenská republika Eli Lilly Slovakia, s. r. o Tel: + 421 - 220 663 111 Suomi/ Finland Oy Eli Lilly Finland Ab Puh/ Tel: + 358 - (0) 9 85 45 250 Sverige Eli Lilly Sweden AB Tel: + 46 - (0) 8 7378800
Latvija Eli Lilly Holdings Limited pā rstā vniecī ba Latvijā Tel: + 371 67364000
Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā Eli Tel: + 371 67364000 Lietuva Eli Lilly Holdings Limited atstovybė Tel. + 370 (5) 2649600 24 Dan il- fuljett kien approvat l- aħħar f ’ [XX/ SSSS]
United Kingdom Eli Lilly and Company Limited Tel: + 44-(0) 1256 315999
United Kingdom Lilly and Company Limited Tel: + 44 - (0) 1256 315999
24 PEN USER MANUAL
25 MANWAL GĦAL MIN QED JAGĦMEL UŻU MILL- PINNA
Forsteo FORSTEO, 20 microgram (µg) 80 microlitres solution for injection, in pre-filled pen
Forsteo™ FORSTEO, 20 mikrogramma (µg) soluzzjoni għall- injezzjoni ta '80 mikrolitru, f' pinna mimlija għal- lest
Before you use your new FORSTEO, please read the section Instructions for Use completely.
Struzzjonijiet għall- Użu Qabel ma tuża pinna ġdida FORSTEO, jekk jogħġbok aqra s- sezzjoni Struzzjonijiet għall- Użu kollha.
Follow the directions carefully when using the FORSTEO.
Segwi l- istruzzjonijiet bir- reqqa meta tuża l- pinna FORSTEO.
Also read the package leaflet provided.
Aqra wkoll il- fuljett ta 'tagħrif ipprovdut.
Your FORSTEO contains 28 days of medication.
Il- pinna FORSTEO fiha medikazzjoni għal 28 ġurnata.
Forsteo Parts*
Partijiet tal- pinna Forsteo * Xaft Isfar Buttuna ta 'l - Injezzjoni Sewda
Yellow Shaft Black Injection button
Faxx Aħmar
Red Stripe
Korp Blu
Blue Body Medicine Cartridge White Cap
Skartoċċ tal- Mediċina
Paper Tab Needle
Kappa Bajda
Large Needle Cover
* Labar mhux inklużi.
* Needles not included.
Siġill protettiv
Becton, Dickinson and Company pen needles 29 to
Labra
Small Needle Protector
Għatu tal- Labra Kbir
31 gauge (diameter 0.25- 0.33mm) and 12.7, 8 or 5mm length can be used.
jintużaw labar tal- pinna ta 'Becton, Dickinson and Company gejġ ta ’ minn 29 sa 31 (dijametru 0. 25 - 0. 33mm) u 12. 7, 8 jew 5mm tul.
Ask your healthcare professional which needle gauge and length are best for you.
Għatu protettiv tal- Labra Żgħir Saqsi lill- professjonist tal- kura tas - saħħa tiegħek liema gejġ u tul ta 'labra huma l- aħjar għalik.
Always wash your hands before every injection.
Dejjem aħsel idejk qabel kull injezzjoni.
Prepare the injection site as directed by your healthcare professional.
Ipprepara s- sit għall- injezzjoni skond kif qallek il- professjonist tal- kura tas- saħħa tiegħek.
1 Pull off white cap
1 Iġbed u aqla 'l- kappa bajda Għatu tal- labra kbir 2 Waħħal labra ġdida
2 Attach new needle
Iġbed u aqla 's - siġill protettiv.
Pull off paper tab.
Imbotta l- labra dritta fl- iskartoċċ tal - mediċina.
Push needle straight onto medicine cartridge.
Dawwar il- labra sakemm tissikkaha sew.
Screw on needle until firmly attached.
Iġbed u aqla 'l - għatu tal- labra l - kbir u erfgħu.
Pull off large needle cover and save it.
26 Strixxa ħamra 3 Issettja d- doża
25 3 Red Set stripe dose Small needle protecto r
Għatu protettiv tal- labra żgħir
Pull out black injection button until it stops.
Iġbed il- buttuna ta 'l- injezzjoni sewda sakemm tieqaf.
If you cannot pull out the black injection button see Troubleshooting, Problem E.
Iċċekkja li tkun tidher l- istrixxa l - ħamra
Check to make sure red stripe shows.
Iġbed u aqla 'l - għatu protettiv tal - labra ż- żgħir u armih.
Pull off small needle protector and throw away.
Jekk ma tistax tiġbed il- buttuna s- sewda ta 'l - injezzjoni ara Problemi li jista ’ jkollok, Problema E.
4
4 Injetta d- doża
Gently hold a fold of skin from thigh or abdomen and insert needle straight into skin.
Bil- mod għolli ftit il- ġilda tal- koxxa jew taż - żaqq u daħħal il- labra dritta fil- ġilda.
Push in black injection button until it stops.
Agħfas il- buttuna s- sewda ta 'l- injezzjoni sakemm tieqaf.
Hold it in and count to 5 s-l-o-w-l-y.
Ibqa 'agħfasha u għodd b- i- l- m- o- d sa 5.
Then pull the needle from skin.
Imbagħad iġbed il- labra mill- ġilda.
After completing the injection:
IMPORTANTI Wara li tinjetta
Once the needle is removed from the skin, check to make sure the black injection button is all the way in.
Kif toħroġ il - labra mill- ġilda, iċċekkja li l - buttuna s - sewda ta 'l - injezzjoni tkun magħfusa sa ġewwa.
If the yellow shaft does not show, you have completed the injection steps correctly.
Jekk ma jidhirx ix - xaft isfar, tkun segwejt il- passi ta 'l- injezzjoni korrettament.
If you do and have already injected, do not inject yourself a second time on the same day.
tarah u tkun diġà injettajt l- injezzjoni, tinjettax injezzjoni oħra dak in - nhar.
Instead, you MUST reset FORSTEO (see Troubleshooting Problem A).
Minflok, TRID terġa 'tissettja l- pinna FORSTEO (ara Problemi li jista ’ jkollok Problema A).
26 6 Remove needle
6 Għatu tal - labra kbir Neħħi l - labra
Put large needle cover on needle.
Iġbed u aqla 'l- labra u armiha skond l -
Unscrew the needle all the way by giving the large needle cover 3 to 5 complete turns.
labra l- kbir minn 3 sa 5 dawriet sħaħ.
Pull off needle and throw away as directed by your healthcare professional.
professjonist tal- kura tas- saħħa tiegħek.
Place FORSTEO in the refrigerator immediately after use.
friġġ minnufih wara l - użu.
Forsteo FORSTEO, 20 microgram (µg) 80 microlitres solution for injection, in pre-filled pen
27 Forsteo™ FORSTEO, 20 mikrogramma (µg) soluzzjoni għall - injezzjoni ta '80 mikrolitru, f' pinna mimlija għal- lest
Troubleshooting Problem A.
Problemi li Jista ’ Jkollok Problema A.
The yellow shaft is still showing after I push in the black injection button.
Ix- xaft isfar baqa 'jidher wara li għafast il - buttuna s- sewda ta' l - injezzjoni.
How do I reset my FORSTEO?
Kif nerġa 'nissettja l- pinna FORSTEO?
Solution To reset the FORSTEO, follow the steps below.
Soluzzjoni Biex terġa 'tissettja l- pinna FORSTEO, segwi l- passi ta' hawn taħt.
1) If you have already injected, DO NOT inject yourself a second time on the same day.
1) Jekk diġà injettajt l- injezzjoni, TINJETTAX injezzjoni oħra dak in- nhar.
2) Remove the needle.
2) Neħħi l- labra.
3) Attach a new needle, pull off the large needle cover and save it.
3) Waħħal labra ġdida, iġbed u aqla 'l- għatu tal - labra l- kbir u erfgħu.
4) Pull out the black injection button until it stops.
4) Iġbed il- buttuna s- sewda ta 'l- injezzjoni sakemm tieqaf.
Check to make sure the red stripe shows.
Iċċekkja li tkun tidher l - istrixxa ħamra.
5) Pull off the small needle protector and throw away.
5) Iġbed u aqla 'l- għatu protettiv tal- labra ż- żgħir u armih.
6) Point the needle down into an empty container.
6) Ipponta l- labra l- isfel ġo reċipjent vojt.
Push in the black injection button until it stops.
Agħfas il- buttuna s- sewda ta 'l- injezzjoni sakemm tieqaf.
Hold it in and count to 5 s-l-o- w-l-y.
Ibqa 'agħfasha u għodd b- i- l- m- o- d sa 5.
You may see a small stream or drop of fluid.
Tista 'tara nixxiegħa żgħira jew qatra ta' fluwidu.
When you have finished, the black injection button should be all the way in.
Meta tlesti, il- buttuna s- sewda ta 'l- injezzjoni għandha tkun magħfusa sa ġewwa.
7) If you still see the yellow shaft showing, please contact your healthcare professional 8) Put the large needle cover on needle.
7) Jekk xorta jibqa 'jidher ix- xaft isfar, jekk jogħġbok kellem lill- professjonist tal- kura tas - saħħa tiegħek.
Unscrew the needle all the way by giving the needle cover 3 to 5 complete turns.
Ħoll il- labra kompletament billi ddawwar l - għatu tal- labra l- kbir minn 3 sa 5 dawriet sħaħ.
Pull off needle cover and throw away as directed by your health care professional.
Iġbed u aqla 'l- labra u armiha skond l - istruzzjonjiet tal- professjonist tal- kura tas - saħħa tiegħek.
Push the white cap back on, and place FORSTEO in the refrigerator.
Erġa 'agħlaq bil- kappa bajda, u poġġi l- pinna FORSTEO fil- friġġ.
You can prevent this problem by always using a NEW needle for each injection, and by pushing the black injection button all the way in and counting to 5 s-l-o-w-l-y.
Tista 'tippreveni din il- problema billi dejjem tuża labra ġdida għal kull injezzjoni, u billi tagħfas il - buttuna s- sewda ta' l- injezzjoni ġewwa u tgħodd b- i- l- m- o- d sa 5.
How can I tell if my FORSTEO works?
Il- pinna FORSTEO hija ddisenjata biex tinjetta d- doża B.
The FORSTEO is designed to inject the full dose every time it is used according to the directions in the section Instructions for Use.
Kif inkun naf li l - kollha kull darba li tintuża skond l- istruzzjonijiet fis - pinna FORSTEO sezzjoni Struzzjonijiet għall- Użu.
The black injection button will be all the way in to show that the full dose
Il- buttuna s- sewda taħdem? ta 'l- injezzjoni tkun imdaħħla sa ġewwa sabiex turi li d- doża kollha ġiet injettata mill- pinna FORSTEO.
Remember to use a new needle every time you inject to be sure your FORSTEO will work properly.
Ftakar li trid tuża labra ġdida kull darba li tagħmel injezzjoni sabiex tkun żgur li l- pinna FORSTEO taħdem kif suppost.
I see an air bubble in my FORSTEO.
Bużżieqa ta 'l- arja żgħira mhix ser taffettwa d- doża li C.
A small air bubble will not affect your dose nor will it harm you.
Fil- pinna FORSTEO tieħu u lanqas ma hi ser tagħmillek ħsara.
You can continue to take your dose as usual.
Tista 'qiegħed nara bużżieqa tkompli tieħu d- doża tiegħek bħas- soltu. ta' l- arja.
1) Put the large needle cover on the needle.
1) Qiegħed l- għatu tal- labra l- kbir fuq il- labra.
2) Use the large needle cover to unscrew the needle.
Ma nistax naqla 'l - 2) Uża l- għatu tal- labra l- kbir biex tħoll il- labra. labra.
3) Unscrew the needle all the way by giving the large needle cover 3 to 5 complete turns.
28 għatu tal- labra l- kbir minn 3 sa 5 dawriet sħaħ.
4) If you still cannot get the needle off, ask someone to help you.
4) Jekk xorta ma tkunx tista 'taqla' l- labra, għid lil xi ħadd biex jgħinek.
What should I do if I cannot pull out the black injection button?
Imsaħ il- pinna FORSTEO minn barra b' ċarruta niedja.
Change to a new FORSTEO to take your dose as directed by your healthcare professional.
Poġġi l- pinna FORSTEO fil- friġġ minnufih wara kull użu.
This indicates that you have now used all the medication that can be injected accurately even though you may still see some medication left in the medicine cartridge.
Aqra u segwi l- istruzzjonijiet fil- Fuljett ta 'Tagħrif għall- Pazjent dwar kif taħżen il- medikazzjoni.
Cleaning and Storage Cleaning Your FORSTEO • Wipe the outside of the FORSTEO with a damp cloth. • Do not place the FORSTEO in water, or wash or clean it with any liquid.
Taħżinx il- pinna FORSTEO bil- labra mwaħħla għaliex tista 'tikkawża l- formazzjoni ta' bżieżaq ta 'l- arja fl- iskartoċċ tal- mediċina.
Storing Your FORSTEO • Refrigerate the FORSTEO immediately after every use.
Tagħmel qatt il- pinna FORSTEO fil- friża.
Read and follow the instructions in the Information for the Patient leaflet on how to store medication. • Do not store the FORSTEO with a needle attached as this may cause air bubbles to form in the medicine cartridge. • Store the FORSTEO with the white cap on. • Never store the FORSTEO in the freezer. • If the medication has been frozen, throw the device away and use a new FORSTEO. • If the FORSTEO has been left out of the refrigerator, do not throw the pen away.
Jekk ħallejt il- pinna FORSTEO barra l- friġġ, tarmihiex.
Place the pen back in the refrigerator and contact your healthcare professional.
Erġa 'daħħal il- pinna fil- friġġ u kellem lill- professjonist tal- kura tas- saħħa tiegħek.
Disposal of Pen Needles and Device Disposal of Pen Needles and FORSTEO Device • Before disposing of the FORSTEO device, be sure to remove the pen needle. • Dispose of your FORSTEO and used needles as directed by your healthcare professional. • Dispose of the device 28 days after first use.
Armi l- pinna FORSTEO u l- labar użati skond l- istruzzjonijiet tal- professjonist tal- kura tas - saħħa tiegħek.
Other Important Notes • The FORSTEO contains 28 days of medication. • Do not transfer the medication into a syringe.
Armi l- apparat 28 ġurnata wara l- ewwel użu.
28 • Write down your first injection date on a calendar. • Read and follow the instructions in the Information for the Patient leaflet for using medication. • Check the FORSTEO label to make sure you have the correct medication and that it has not expired. • Contact your healthcare professional if you notice any of the following:
Iċċekkja t- tiketta tal- pinna FORSTEO biex tkun ċert li għandek il- medikazzjoni korretta u li ma skadietx.
- The FORSTEO appears damaged
•