qanastek/EMEA-V3 huggingface dataset:
INCRELEX 10 mg/ml solution for injection Mecasermin
Mecasermin
This medicine has been prescribed for you/your child.
Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek Din il- mediċina ġiet preskritta lilek jew għat- tifel/ tifla tiegħek.
It may harm them, even if their symptoms are the same.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell the doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m' humiex imsemmijin f' dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What INCRELEX is and what it is used for 2.
X' inhu INCRELEX u għalxiex jintuża 2.
Before you use INCRELEX 3.
Qabel ma tieħu INCRELEX 3.
How to use INCRELEX 4.
Kif għandek tieħu INCRELEX 4.
How to store INCRELEX 6.
Kif taħżen INCRELEX 6.
WHAT INCRELEX IS AND WHAT IT IS USED FOR
X' INHU INCRELEX U GĦALXIEX JINTUŻA
INCRELEX is a liquid that contains man-made insulin-like growth factor-1 (IGF-1), which is similar to the IGF-1 made by your body.
INCRELEX huwa likwidu magħmul mill- bniedem li fih fattur ta 'l- iżvilupp- 1 (IGF- 1) li jixbaħ l- insulina umana, li jixbaħ ħafna l- IGF- 1 magħmul f' ġismek.
INCRELEX is used to treat children or adolescents who are very short for their age because their bodies do not make enough IGF-1.
INCRELEX huwa użat biex jittratta lil tfal u adoloxxenti li baqgħu qosra ħafna għall- età tagħhom minħabba li ġisimhom ma jagħmilx biżżejjed IGF- 1.
This condition is called primary IGF-1 deficiency.
Din il- kundizzjoni tissejjaħ defiċjenza ta 'IGF- 1 primarja.
BEFORE YOU USE INCRELEX
QABEL MA TIEĦU INCRELEX
Do not use INCRELEX
Tieħux INCRELEX
if you/your child is allergic (hypersensitive) to mecasermin or any of the other ingredients of INCRELEX.
jekk inti jew it- tifel/ tifla tiegħek allerġiċi (tbati minn sensittività eċċessiva) għal mecasermin jew sustanzi oħra ta ’ INCRELEX.
if you/your child has cancer. by injecting directly into a vein.
jekk inti/ it- tifel/ tifla tiegħek għandek kanċer. billi tinjetta direttament ġo vina.
Benzyl alcohol must not be given to premature babies or neonates.
Benzyl alcohol m’ għandux jingħata lil trabi li twieldu qabel iż- żmien jew li għadhom kif twieldu
Take special care with INCRELEX
Oqgħod attent ħafna b' INCRELEX
if you/your child has a curved spine (scoliosis).
jekk inti jew it- tifel/ tifla tiegħek għandkom l- ispina dorsali mgħawġa (skoljosi).
They should be monitored for progression of their scoliosis.
Għandhom jiġu monitorati dwar il- progressjoni ta 'l- iskoljosi tagħhom.
if you/your child has enlarged tonsils (tonsillar hypertrophy).
jekk inti jew it- tifel/ tifla tiegħek għandkom tunsilli kbar (ipertrofija tat- tunsilli).
They should have examinations periodically.
Għandhom jiġu eżaminati perjodikament.
if you/your child has symptoms of increased pressure in the brain (intracranial hypertension), such as headache with vomiting, contact the doctor for advice.
jekk inti jew it- tifel/ tifla tiegħek għandkom sintomi ta 'pressjoni ogħla fil- moħħ (pressjoni għolja ġol kranju), bħal uġigħ ta' ras b' rimettar, ikkuntattja lit- tabib għal parir.
Call the doctor
jekk inti jew it- tifel/ tifla tiegħek għandkom reazzjoni allerġika ħafifa jew serja b' INCRELEX.
as soon as possible if you/your child get a rash or hives.
Sejjaħ it- tabib kemm jista 'jkun malajr jekk inti jew it- tifel/ tifla tiegħek jkollu raxx jew ħorriqija.
Get medical help immediately if you/your child have trouble breathing or goes into shock.
Sib għajnuna medika minnufih jekk inti jew it- tifel/ tifla tiegħek ikollhom problemi jieħdu n- nifs jew jidħlu f' xokk.
if you/your child has finished growing (the bone growth plates are closed). the use of INCRELEX has not been studied in children under 2 years of age and is therefore not recommended.
Jekk inti jew it- tifel tiegħek ma bqajtux tikbru (platti tal- għadam ta ’ żvilupp huma magħluqa).
Especially tell the doctor if you/your child takes insulin or other anti-diabetes medicines.
B’ mod speċjali għid lit- tabib jekk inti jew it- tifel/ tifla tiegħek qegħdin tieħdu l- insulina jew xi mediċini oħra kontra d- dijabete.
A dose adjustment may be needed for these medicines.
Jista ’ jkun hemm bżonn aġġustament tad- doża għal dawn il- mediċini.
Please tell the doctor or pharmacist if you/your child is taking or has recently taken any other medicines, including medicines obtained without a prescription, herbal medicines and vitamin supplements.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar jekk inti jew it- tifel/ tifla tiegħed qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, inklużi mediċini mingħajr riċetta, mediċini tal- ħxejjex u supplimenti tal - vitamini.
Taking INCRELEX with food and drink
Meta tieħu INCRELEX ma 'l- ikel u max- xorb
INCRELEX should be administered shortly before or after eating, because it may have insulin-like hypoglycaemic effects and so it may decrease blood sugar levels.
INCRELEX għandu jingħata ftit qabel jew wara l- ikel, minħabba li jista 'jkollu effetti ipogliċemiċi bħal ta' l- insulina u għalhekk jista 'jnaqqas il- livelli ta' zokkor fid- demm.
The doses should be withheld when a meal or snack is omitted.
Id- dożi għandhom jinżammu meta ikla jew snekk ma jitteħidtx.
The dose should never be increased to make up for one or more omitted doses.
Id- doża ta ’ mecasermin m’ għandha qatt tiġi miżjuda biex tpatti għal doża waħda jew aktar li ma jkunux ittieħdu.
INCRELEX therapy should be discontinued if pregnancy occurs.
It- terapija ta 'INCRELEX għandha titwaqqaf jekk ikun hemm tqala.
INCRELEX should not be administered to a breast-feeding mother.
INCRELEX m' għandux jingħata lil omm li qed tredda '.
No studies of the effects of INCRELEX on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti ta 'INCRELEX fuq il- ħila biex issuq jew tħaddem magni.
However, hypoglycaemia may impair the ability to drive and use machines.
Madankollu, l- ipogliċemija tista ’ ixxekkel l- abilità li wieħed isuq jew juża maġni.
Patients should avoid engaging in any high-risk activities (e.g., driving, etc.) within 2-3 hours after dosing, particularly at the initiation of INCRELEX treatment, until a dose of INCRELEX has been established without occurrence of significant treatment-related adverse events.
Il- pazjenti għandhom jevitaw li jagħmlu xi attivitajiet ta ’ riskju għoli fi żmien 2- 3 sigħat wara li jkunu ħadu d- doża, partikolarment fil- bidu ta ’ trattament b’ INCRELEX, sakemm doża li tkun ittollerata sew ta ’ INCRELEX tkun ġiet stabbilita mingħajr każijiet sinifikanti ta ’ effetti avversi relatati mat- trattament.
Important information about some of the ingredients of INCRELEX
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'INCRELEX
INCRELEX contains 9 mg per ml benzyl alcohol as a preservative.
INCRELEX fih 9 mg/ ml benzyl alkoħol bħala preservattiv.
3.
Benzyl alkoħol jista ’ jikkaġuna reazzjonijiet tossiċi u reazzjonijiet allerġiċi fit- trabi u tfal sa età ta 3 snin.
HOW TO USE INCRELEX
KIF GĦANDEK TIEĦU INCRELEX
Always use INCRELEX exactly as your/your child’s doctor has told you.
Dejjem għandek tieħu INCRELEX skond il- parir tat- tabib tiegħek jew tat- tifel/ tifla tiegħek.
You should check with your/your child’s doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jew tat- tifel/ tifla tiegħek jekk ikollok xi dubju.
The typical dose is 0.04 to 0.12 mg/kg of patient weight administered twice a day.
Id- doża li ssoltu tingħata hija ta '0. 04 sa 0. 12 mg/ kg ta' piż ta 'pazjent li tingħata darbtejn kuljum.
See the ‘Instructions for Use’ at the end of this leaflet.
Ara l - ‘ Istruzzjonijiet għal Użu ’ fi tmiem dan il- fuljett.
Inject INCRELEX just under your/your child’s skin shortly before or after a meal or snack.
Injetta INCRELEX eżatt taħt il- ġilda tiegħek jew tat- tifel/ tifla tiegħek ftit qabel jew wara ikla jew snekk.
Do not give you/your child’s dose of INCRELEX if you/your child cannot eat for any reason.
Tieħux id- doża tiegħek jew tagħtiex id- doża lit- tifel/ tifla tiegħek ta 'INCRELEX jekk għal xi raġuni l- ikel ma jistax jittiekel.
Do not make up the missed dose by giving two doses the next time.
Tpattiex għal doża li ma ħadtx billi darb' oħra tieħu żewġ dożi d- darba li jmiss.
Inject INCRELEX just below the skin in your/your child’s upper arm, upper leg (thigh), stomach area (abdomen), or buttocks.
Injetta INCRELEX eżatt taħt il- ġilda fin- naħa ta 'fuq tad- driegħ, in- naħa ta' fuq tar- riġel (koxxa), fl - erja ta 'l- istonku (żaqq) jew fil- patata.
Never inject it into a vein or muscle.
Qatt m' għandek tinjettah ġo vina jew f' muskolu.
Change the injection site for each injection.
Biddel is- sit mnejn jingħata għal kull injezzjoni.
25 Only use INCRELEX that is clear and colourless.
Uża biss INCRELEX li hu ċar u mingħajr kulur.
Treatment with INCRELEX is a long-term therapy.
It- trattament b' INCRELEX huwa terapija fuq perijodu ta 'żmien twil.
For further information ask the doctor.
Għal aktar tagħrif staqsi lit- tabib.
If you use more INCRELEX than you should
Jekk tieħu aktar INCRELEX milli suppost
If more INCRELEX than recommended was injected, please tell the doctor.
Jekk aktar INCRELEX milli dak irrakomandat ġie injettat, jekk jogħġbok għarraf lit- tabib tiegħek.
Acute overdosage could lead to hypoglycaemia (low blood sugar).
Doża eċċessiva akuta tista 'twassal għal ipogliċemija (livell baxx ta' zokkor).
Long-term overdose may result in enlargement of certain body parts (e.g., hands, feet, parts of the face) or excessive growth of the whole body.
Doża eċċessiva fuq perijodu ta 'żmien twil tista' twassal għal tkabbir ta 'ċertu partijiet tal- ġisem (eż. l- idejn, is- saqajn, partijiet mill- wiċċ) jew żvilupp eċċessiv tal- ġisem kollu.
Treatment of acute overdose of INCRELEX should be directed at reversing hypoglycaemia.
It- trattament ta 'doża eċċessiva akuta ta' INCRELEX għandu jiġi dirett biex jirriversja l- effetti ta 'ipogliċemija.
Sugar- containing fluids or food should be consumed.
Fluwidi jew ikel li fihom iz- zokkor għandhom jiġu konsmati.
If the patient is not awake or alert enough to drink sugar-containing fluids, an injection of glucagon into the muscle may be necessary to reverse the low blood sugar.
Jekk il- pazjent mhux imqajjem jew pront biex jixrob fluwidi li fihom iz- zokkor, għandu mnejn ikun meħtieġ li jingħata injezzjoni ta 'glucagon fil- muskolu biex jirriversja l- livell baxx ta' zokkor.
Your doctor or nurse will instruct you how to give the injection of glucagon.
It- tabib jew l- infermier tiegħek ser jagħtik struzzjonijiet dwar kif għandek tagħti l- injezzjoni ta 'glucagon.
If you forget to use INCRELEX
Jekk tinsa tieħu INCRELEX
If you stop using INCRELEX
Jekk tieqaf tieħu INCRELEX
A disruption or early ending of treatment with INCRELEX may impair the success of the growth therapy.
Sfaxxar jew tmiem bikri tat- trattament b' INCRELEX jista 'jimpedixxi s- suċċess tat- terapija ta' żvilupp.
Please ask the doctor for advice before stopping the treatment.
Jekk jogħġbok staqsi lit- tabib tiegħek għal parir qabel ma twaqqaf it- trattament.
If you have any further questions on the use of this product, ask the doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta 'dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, INCRELEX can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, INCRELEX jista ’ jkollu effetti kollaterali, għalkemm ma jseħħux fuq kulħadd.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell the doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti kollaterali li m' humiex imsemmijin f' dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
The very common side effects (likely to occur in more than 1 out of 10 patients) which occurred in clinical trials are listed below.
L- effetti sekondarji l- aktar komuni (li jistgħu jseħħu f’ aktar minn 1 minn kull 10) li seħħew fil- provi kliniċi huma elenkati hawn isfel.
Hypoglycaemia (Low Blood Sugar):
26 Ipogliċemija (Zokkor fid- Demm Baxx):
INCRELEX, like insulin, may lower blood sugar levels.
INCRELEX, bħal insulina, jista 'jbaxxi l- livelli ta' zokkor fid- demm.
Signs of low blood sugar are: dizziness, tiredness, restlessness, hunger, irritability, trouble concentrating, sweating, nausea and fast or irregular heartbeats.
Sinjali ta 'livelli ta' zokkor fid- demm baxx huma: sturdament, għejja, irrikwitezza, ġuħ, irritabilità, mhux faċli tikkonċentra, għaraq, nawsja u taħbit qawwi jew irregolari tal- qalb.
Severe hypoglycaemia may cause unconsciousness, seizures or death.
Ipogliċemija severa tista 'tikkaġuna telf mis- sensi, attakki ta' puplesija jew mewt.
If you/your child take INCRELEX, you/your child should avoid participating in high risk activities (such as vigorous physical activity) within 2 to 3 hours after INCRELEX injection, especially at the beginning of INCRELEX treatment.
Jekk int jew it- tifel jew tifla tiegħek qed tieħdu INCRELEX, int/ it- tifel jew it- tifla tiegħek għandkom tevitaw li tipparteċipaw f' attivitajiet ta 'riskju għoli (bħal attività fiżika vigoruża) fi żmien 2 sa 3 sigħat wara l - injezzjoni ta' INCRELEX, speċjalment fil- bidu ta 'trattament b' INCRELEX.
Before beginning treatment with INCRELEX the doctor or nurse will explain to you how to treat hypoglycaemia.
Qabel ma jinbeda t- trattament b' INCRELEX it- tabib jew l- infermier ser jispjegalek kif għandek tittratta l- ipogliċemija.
You/your child should always have a source of sugar such as orange juice, glucose gel, sweets, or milk available in case symptoms of hypoglycaemia occur.
Inti, jew it- tifel jew tifla tiegħek dejjem għandkom iżommu sors ta 'zokkor bħal meraq tal- frott tal- laring, ġel tal- glukows,, ħelu jew ħalib disponibbli f' każ li jseħħu s- sintomi ta' ipogliċemija.
For severe hypoglycaemia, if you/your child is not responsive and cannot drink sugar-containing fluids, you should give an injection of glucagon.
F' każ ta 'ipogliċemija severa, jekk inti/ it- tifel jew it- tifla tiegħek ma jweġbux u ma jistgħux jixorbu fluwidi li fihom iz- zokkor, għandek tagħti injezzjoni ta' glucagon.
The doctor or nurse will instruct you how to give the injection.
It- tabib jew l - infermier tiegħek ser jagħtik struzzjonijiet dwar kif għandek tagħti l- injezzjoni.
26 Glucagon raises the blood sugar when it is injected.
Glucagon jgħolli z - zokkor fid- demm meta jiġi injettat.
It is important that you/your child have a well- balanced diet including protein and fat such as meat and cheese in addition to sugar-containing foods.
Huwa importanti li inti/ it- tifel jew it- tifla tiegħek ikollkom dieta bilanċjata tajjeb li tinkludi proteini u grass bħal laħam u ġobon flimkien ma 'ikel li fih iz- zokkor.
Increased blood sugar has also been observed with INCRELEX treatment.
Żieda fil- livell ta ’ zokkor fid- demm ġie osservat ukoll bi trattament b’ INCRELEX.
Reactions at the Injection Site:
Reazzjonijiet fis- Sit ta 'l- Injezzjoni:
Injecting INCRELEX can cause local lipoatrophy (loss of fat), lipohypertrophy (increase of fat), or pain, redness or bruising at the injection site.
L- injezzjoni ta 'INCRELEX tista' toħloq lipoatrofija lokali (telf ta 'xaħam), lipoipertrofija (żieda fil- grass), jew uġigħ, ħmura jew tbenġil fil- sit ta' l- injezzjoni.
Injection site reactions can be avoided by changing the injection site at each injection (injection site rotation).
Reazzjonijiet fis- sit ta 'l- injezzjoni jistgħu jiġu evitati b' tibdil tas- sit għal kull injezzjoni (rotazzjoni tas- sit ta' l- injezzjoni).
Enlarged tonsils:
Tunsilli mkabbra:
INCRELEX may enlarge you/your child’s tonsils.
INCRELEX jista 'jkabbar it- tunsilli tiegħek jew tat- tifel jew tifla tiegħek.
Some signs of enlarged tonsils include: snoring, difficulty breathing or swallowing, sleep apnea (a condition where breathing stops briefly during sleep), or fluid in the middle ear, as well as infections of the ear.
Xi sinjali ta 'tunsilli mkabbra jinkludu: nħir, diffikultà biex tieħu n- nifs jew tibla', apnea ta 'l- irqad (kundizzjoni fejn ma jittiħidx nifs għal mumenti brevi waqt l- irqad), jew fluwidu fil- widna tan- nofs, kif ukoll infezzjonijiet fil- widna tan - nofs.
Sleep apnea can cause excessive daytime sleepiness.
L- apnea ta 'l- irqad tista' tikkaġuna ħedla eċċessiva waqt il- ġurnata.
Call the doctor should these symptoms bother you/your child.
Sejjaħ lit- tabib jekk dawn is - sintomi jdejqu lilek/ lit- tifel jew tifla tiegħek.
An infection of the tonsils has also been observed.
Ġiet osservata wkoll, infezzjoni fit- tunsilli.
The doctor should regularly examine your/your child’s tonsils.
It- tabib għandu jeżamina regolarment it- tunsilli tiegħek jew tat- tifel u t- tifla.
Swelling inside the nose, enlarged thymus and lymph nodes have been seen with INCRELEX treatment.
Nefħa fl- imnieħer, tijmu mkabbar u nodi linfatiċi mkabbrin dehru bi trattament b’ INCRELEX.
Hypoacusis (hearing loss) Tell the doctor if you/your child develop hearing problems.
Ipoakusi (telf ta ’ smiegħ) Għid lit- tabib tiegħek jekk inti jew it- tifel jew tifla tiegħek jiżviluppaw problemi ta ’ smiegħ.
The common side effects (likely to occur in fewer than 1 out of 10 patients) which occurred in clinical trials are listed below.
L- effetti kollaterali komuni (li x’ aktarx iseħħu f’ inqas minn 1 minn kull 10 pazjenti) li ġraw fil- provi kliniċi huma elenkati hawn isfel.
Heart abnormalities:
Abnormalitajiet tal- qalb:
In some patients treated with INCRELEX, an ultrasound examination of the heart (echocardiogram) showed an increased size of the heart muscle.
F’ xi pazjenti trattati b’ INCRELEX, eżami ultrasoniku tal- qalb (ekokardjogramma) wera żieda fid- daqs tal- muskolu tal- qalb.
Your doctor may perform an echocardiogram before, during and after INCRELEX treatment.
It- tabib tiegħek jista ’ jagħmel ekokardjogramma qabel, waqt u wara t- trattament b’ INCRELEX.
Also, a racing pulse and heart valve abnormalities have been reported with INCRELEX treatment.
Kif ukoll, polz iħabbat ħafna u abnormalitajiet fil- valv tal- qalb ġew irraportati bi trattament ta ’ INCRELEX.
Intracranial hypertension (increased pressure in the brain):
Pressjoni għolja ġol- kranju (pressjoni ogħla fil- moħħ):
INCRELEX, like growth hormone, can sometimes cause a temporary increase in pressure within the brain.
INCRELEX, bħal ormon ta 'l- iżvilupp, jista' xi kultant jikkaġuna żieda temporanja fil- pressjoni ġol- moħħ.
The symptoms of intracranial hypertension can include headache and nausea with vomiting.
Is- sintomi tal- pressjoni għolja ġol kranju jinkludu l- uġigħ ta 'ras u n- nawsja bir- rimettar.
Tell the doctor if you/your child has headache with vomiting.
Għid lit- tabib tiegħek jekk inti jew it- tifel / tifla tiegħek għandhom uġigħ ta 'ras bir- rimettar.
Your doctor can check to see if intracranial hypertension is present.
It- tabib tiegħek ser jiċċekkja biex jara jekk hemmx pressjoni għolja ġol kranju.
If it is present, your doctor may decide to temporarily reduce or discontinue INCRELEX therapy.
27 jista 'jiddeċiedi li temporanjament inaqqas jew iwaqqaf it- terapija b' INCRELEX.
INCRELEX may be started again after the episode is over.
INCRELEX jista 'jerġa jinbeda wara li jkun għadda l- episodju.
Vision disturbances have also been reported.
Disturbi viżivi ġew rapportati ukoll
Slipped capital femoral epiphysis:
Ċaqlieq ta ’ l- epifissi tar- ras tal- femora:
This is a situation where the top of the upper leg (femur) slips apart.
Din hi sitwazzjoni fejn in- naħa ta 'fuq tar- riġel ta' fuq (femur) jiċċaqlaq u jinqala.
Get medical attention for you/your child immediately if you/your child develops a limp or has hip or knee pain.
Fittex l- għajnuna medika għalik jew għat- tifel/ tifla tiegħek jekk inti jew it- tifel/ tifla tiegħek tibda zzappap jew ikun hemm uġigħ fil- ġnub jew l- irkoppa.
Worsened scoliosis (caused by rapid growth):
Skoljosi li taggrava (ikkawżata bi żvilupp mgħaġġel):
If you/your child has scoliosis, you/your child will need to be checked often for an increase in the curve of the spine.
Jekk int jew it- tifel/ tifla tiegħek għandkom l- iskoljosi, inti jew it- tifel jew it- tifla tiegħek hemm bżonn li tiġu ċċekkjati fil- kurva ta 'l- ispina dorsali.
Pain and stiffness in muscles or joints, as well as jaw malformations, have also been seen with INCRELEX treatment.
L- uġigħ u l- ebusija fil- muskoli jew il- ġogi, kif ukoll malformazzjonijiet tax- xedaq, ġew osservati ukoll bi trattament ta ’ INCRELEX.
Infections of the mouth, throat and the upper airways have been observed in children with Increlex treatment.
Infezzjonijiet Infezzjonijiet tal- ħalq, il- griżmejn u l- passaġġi ta ’ l- arja ta ’ fuq ġew osservati fi tfal fuq trattament b’ Increlex.
Such infections may be associated with fever.
Infezzjonijiet bħal dawn jistgħu jkunu assoċjati mad- deni.
Kidney stones have been reported, as well as associated pain and kidney swelling.
Disturbi fil- kliewi Ġebel fil- kliewi ġew irrapportati, kif ukoll uġigħ assoċjat u tinfiħ tal- kliewi.
Breast enlargement, as well as cysts in the ovaries, have been observed.
Sistema Riproduttiva Tkabbir tas- sider, kif ukoll ċisti fl- ovarji ġew osservati.
Stomach pain, difficulties swallowing, retching and vomiting have occurred with INCRELEX treatment.
Sistema diġestiva Uġigħ ta ’ l- istonku, diffikultà biex tibla ’, tqalligħ u rimettar seħħew bi trattament b’ INCRELEX.
Weight gain has also been reported, as have increases in blood fat and in liver enzyme values.
Kien hemm ukoll żieda fil- piż irrapportat, kif ukoll żieda fil- valuri ta ’ xaħam fid- demm u ta ’ enżimi tal- fwied.
Skin thickening, moles, skin tags, and abnormal hair texture have been seen with INCRELEX treatment.
Bidliet fil- gilda u fix- xagħar Ħxuna tal- ġilda, tbajja fuq il- ġilda, lametti tal- ġilda, ix- xagħar jinħass mhux normali dehru bi trattament b’ INCRELEX
Other reported adverse events include lack of energy, depression, nervousness, disorientation, chest discomfort, dizziness, trembling and restless legs.
Każijiet avversi oħra rrapportati jinkludu nuqqas ta ’ enerġija, depressjoni, nervożità, disorjentazzjoni, skonfort fis- sider, stordament, rogħda u riġlejn irrekwieti.
HOW TO STORE INCRELEX
KIF TAĦŻEN INCRELEX
Do not use INCRELEX after the expiry date which is stated on the label after EXP.
Tużax INCRELEX wara d- data ta ’ skadenza li tidher fuq it- tikketta wara "JIS".
The expiry date refers to the last day of the month.
Id- data ta 'skadenza tirreferi għall- aħħar ġurnata ta' dak ix- xahar.
Keep the vial in the outer carton in order to protect from light.
Żomm il- kunjett fil- kartuna ta 'barra sabiex tilqa' mid- dawl.
After first use, the vial may be stored for up to 30 days at 2 to 8ºC.
Wara li jintuża l- ewwel darba, il- kunjett tista 'tinżamm għal mhux aktar minn 30 jum f' temperatura ta' 2 sa 8ºC.
What INCRELEX contains
X' fih INCRELEX
One ml contains 10 mg of mecasermin.
Is- sustanza attiva hija mecasermin Kull ml fih 10 mg ta 'mecasermin.
The other ingredients are: benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate, and water for injections.
Sustanzi oħra huma: benzyl alcohol, sodium chloride, polysorbate 20, glacial acetic acid, sodium acetate u ilma għall- injezzjonijiet.
What INCRELEX looks like and contents of the pack
Id- Dehra ta 'INCRELEX u l- kontenuti tal- pakkett
INCRELEX is a clear and colourless solution for injection supplied in a glass vial closed with a stopper and a seal.
INCRELEX huwa soluzzjoni ċara u mingħajr kulur għall- injezzjoni li jiġi fi fjala tal- ħġieġ b' għatu u siġill.
The vial contains 4 ml of liquid.
Il- fjala fiha 4 ml ta 'likwidu.
INCRELEX is supplied as a pack containing one glass vial.
INCRELEX jiġi f' pakkett li fih fjala waħda tal- ħġieġ.
28 Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
Česká republika Beaufour Ipsen Pharma Evropská 136/810 CZ-160 00 Praha 6 Tel: + 420 220 612 125
2, Evropská 136/ 810 CZ- 160 00 Praha 6 Tel: + 420 220 612 125
2, LT-47183 Kaunas Tel. + 370 37 337854
LT- 47183 Kaunas Tel. + 370 37 337854
Danmark, Norge, Suomi/Finland, Sverige, Ísland Institut Produits Synthèse (IPSEN) AB Kista Science Tower Färögatan 33 SE - 164 51 Kista Sverige/Ruotsi/Svíþjóð Tel/Tlf/Puh/Sími: +46 8 588 370 70
Danmark, Norge, Suomi/ Finland, Sverige, Ísland Institut Produits Synthèse (IPSEN) AB Kista Science Tower Färögatan 33 SE - 164 51 Kista
This medicine has been authorised under “Exceptional Circumstances”.
Din il- mediċina kienet awtorizzata taħt ‘ ċirkustanzi ta ’ eċċezzjoni ’.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
L- Aġenzija Ewropeja dwar il- Mediċini (EMEA) ser tirrevedi l- informazzjoni l- ġdida dwar il - mediċina kull sena u dan il- fuljett ser jiġi aġġornat, skond il- bżonn.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/ There are also links to other websites about rare diseases and treatments.
30 Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu / Hemm ukoll links għall- websites oħra dwar mard rari u kura.
30 INSTRUCTIONS FOR USE
31 STRUZZJONIJIET GĦAL UŻU
INCRELEX should be administered using sterile disposable syringes and injection needles.
INCRELEX għandu jiġi mogħti permezz ta ’ siringi u labar ta ’ l- injezzjoni li jintremew wara l- użu.
The syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy.
Is- siringi għandhom ikunu ta ’ volum zgħir biżżejjed li d- doża miktuba mit- tabib tista ’ tkun miġbuda mill- fjala b’ eżattezza raġonevoli.
Preparing the Dose:
Kif tipprepara d- doża
Wash your hands before getting INCRELEX ready for your/your child’s injection.
Aħsel idejk qabel ma tlesti INCRELEX għall- injezzjoni tiegħek jew tat- tifel/ tifla tiegħek.
Use a new disposable needle and syringe every time you give a dose.
Uża labra u siringa ġdida li wara li tużha tarmiha kull darba li tagħti doża.
Use syringes and needles only once.
Uża s- siringi u l- labar darba biss.
Throw them away properly.
Armihom kif suppost.
Never share needles and syringes.
Qatt m' għandek taqsam labar u siringi ma 'oħrajn.
Check the liquid to make sure it is clear and colourless.
Iċċekkja li l- likwidu huwa ċar u mingħajr kulur.
Do not use after the expiry date or if it is cloudy or if you see particles.
Tużax wara d- data ta 'skadenza jew jekk tkun mdardra jew jekk tara l- frak.
If a vial freezes, dispose appropriately.
Jekk fjala tiffriża, armiha kif suppost.
If you are using a new vial, remove the protective cap.
Jekk qed tuża kunjett ġdid, neħħi l- għatu protettiv.
Do not remove the rubber stopper.
Tneħħiex it- tapp tal- lastku.
Wipe the rubber stopper of the vial with an alcohol swab to prevent contamination of the vial by germs that may be introduced by repeated needle insertions (see Figure 1).
Imsaħ it- tapp tal- lastku tal- fjala b' tajjar bl- alkoħol sabiex tiġi evitata l- kontaminazzjoni tal- fjala b' mikrobi li jistgħu jiġu introdotti b' inserzjonijiet ripetuti tal- labra (ara Figura 1).
Wipe top with alcohol
Imsaħ it- tapp bl- alkoħol
Before putting the needle into the vial, pull back on plunger to draw air into the syringe equal to the prescribed dose.
Qabel ma ddaħħal il- labra ġol- kunjett, iġbed lura l- planġer sabiex tiġbed arja fis- siringa daqs id- doża preskritta.
Put the needle through the rubber top of the vial and push the plunger to inject air into the vial (see Figure 2).
Poġġi l- labbra ġot- tapp tal- lastku tal- fjala u imbotta l- planġer biex tinjetta l - arja fil- fjala (ara Figure 2).
Inject air into vial
Injetta arja ġol- fjala
Leave the syringe in the vial and turn both upside down.
Ħalli s- siringa fil- fjala u eqleb it- tnejn rashom l- isfel.
Hold the syringe and vial firmly (see Figure 3).
Żomm is- siringa u l- fjala sew (ara Figura 3).
Prepare for extraction
Ipprepara biex testratta
Make sure the tip of the needle is in the liquid (see Figure 4).
Iżgura li t- tarf tal- labra tinsab ġol- likwidu (ara Figura 4).
Pull the plunger to withdraw the correct dose into the syringe (see Figure 5).
Iġbed il- planġer biex tieħu d- doża korretta fis- siringa (ara Figura 5).
Tip in liquid
It- tarf fil- likwidu
Extract correct dose
Estratta d- doża korretta
Before you take the needle out of the vial, check the syringe for air bubbles.
Qabel ma tneħħi l- labra minn ġol- kunjett, iċċekkja s- siringa għal bżieżaq ta 'l- arja.
If bubbles are in the syringe, hold the vial and syringe with needle straight up and tap the side of the syringe until the bubbles float to the top.
Jekk hemm bżieżaq fis- siringa, żomm il- kunjett u s- siringa bil- labra 'l fuq u taptap in- naħa tas- siringa sakemm il- bżieżaq jitilgħu fil- wiċċ.
Push the bubbles out with the plunger and draw liquid back in until you have the correct dose (see Figure 6).
Imbotta l- bżieżaq 'l barra mill- planġer u iġbed il- likwidu lura sakemm ikollok id- doża korretta (ara Figure 6).
Remove air bubbles and refill syringe
Neħħi l- bżieżaq u imla mill- ġdid is- siringa
Remove the needle from the vial.
Neħħi s- siringa minn mal- fjala.
Do not let the needle touch anything.
Tħalliex il- labra tmiss ma xi ħaġa.
You are now ready to inject (see Figure 7).
Inti issa lest biex tinjetta (ara Figura 7).
Ready to inject
Lest biex tinjetta
Injecting the Dose:
Meta Tinjetta d- doża:
Inject INCRELEX as instructed by the doctor.
Injetta INCRELEX kif qallek biex tagħmel it- tabib.
Do not give the injection if you/your child is unable to eat shortly before or after the injection.
M' għandekx tagħti l- injezzjoni jekk inti jew it- tifel/ tifla tiegħek ma setgħux jieklu qabel jew wara l - injezzjoni.
Decide on an injection area – upper arm, thigh, buttock, or abdomen (see below).
Iddeċiedi dwar erja fejn ser tinjetta – il- parti ta 'fuq tad- driegħ, koxxa, warrani, jew żaqq (ara isfel).
The injection site should be changed for each injection (rotate the injection site).
Is- sit ta 'l- injezzjoni għandu jitbiddel għal kull injezzjoni (dawwar is- sit ta' l- injezzjoni).
Upper arm
Driegħ ta 'fuq
Thigh
Koxxa
Buttock
Warrani
Abdomen
Żaqq
Use alcohol or soap and water to clean the skin where you are going to inject you/your child.
Uża l- alkoħol jew is- sapun u l- ilma u naddaf il- ġilda fejn ser tinjetta lilek / it- tifel jew it- tifla tiegħek.
The injection site should be dry before you inject.
Is- sit ta 'l- injezzjoni għandu jkun niexef qabel ma tinjetta.
Lightly pinch the skin.
Oqros il- ġilda bil- mod.
Insert the needle in the way the doctor showed you.
Daħħal il- labra kif qallek li għandek tagħmel it- tabib.
Release the skin (see Figure A).
Itlaq l- ġilda (ara Figura A).
Lightly pinch the skin and inject as instructed
Bil- mod oqros il- ġilda u injetta kif istruwit.
Slowly push in the plunger of the syringe all the way, making sure you have injected all the liquid.
Bil- mod imbotta l- planġer tas- siringa sa isfel, u agħmel żgur li injettajt il- likwidu kollu.
Pull the needle straight out and gently press on the spot where you injected you/your child with gauze or a cotton ball for a few seconds.
Iġbed il- labra 'l barra u agħfas bil- mod b' garża jew b' ballun tat- tajjar fil- post fejn injettajt lilek jew it - tifel jew tifla tiegħek għal ftit sekondi.
Do not rub the area (see Figure B).
Togħrokx l- erja (ara Figura B).
Press (don’t rub) with gauze or cotton
Agħfas (togħrokx) b' garża jew tajjara
Follow the doctor’s instructions for throwing away the needle and syringe.
Segwi l- istruzzjonijiet tat- tabib sabiex tarmi l- labra u s- siringa.
Do not recap the syringe.
Tqigħedx l- għatu fuq il- labra.
Used needle and syringe should be placed in a sharps container (such as a biohazard container), hard plastic container (such as a detergent bottle), or metal container (such as an empty coffee can).
Il- labra u s- siringa użati għandhom jitqegħdu fir- reċipjent ta 'l- ixfafar (bħal reċipjent tal- perikli bijoloġiċi), reċipjent tal- plastik iebes (bħal flixkun tad- deterġenti) jew kontenitur tal- metalli (bħal reċipjent vojt tal- kafe).
Such containers should be sealed and disposed of properly.
Reċipjenti bħal dawn għandhom jiġu ssiġilati u mormija kif suppost.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Jispjega kif il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l - istudji mwettqin, biex jissodisfa r- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (ukoll parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
What is InductOs?
X' inhu InductOs?
The kit consists of a powder containing the active substance, dibotermin alfa, a solvent and a matrix (collagen sponge).
InductOs huwa kitt għal impjant li jikkonsisti minn trab li fih is- sustanza attiva, dibotermina alfa (dibotermin alfa), solvent u matriċi (sponża tal- kollaġene).
What is InductOs used for?
Għal xiex jintuża InductOs?
InductOs is used to help new bone develop.
InductOs jintuża biex jgħin biex jikber l- għadam.
It can be used in the following situations: • lower back spine fusion surgery.
Jista 'jintuża f' dawn is- sitwazzjonijiet: • fl- interventi kirurġiċi ta' fużjoni spinali lombari (il- parti t' isfel tas- sinsla tad- dahar).
This is a type of surgery used to relieve back pain due to a damaged disc where the disc between two vertebrae (the bones in the spine) is removed and the vertebrae are fused (joined) together.
Dan huwa tip ta 'intervent kirurġiku li jsir biex itaffi l- uġigħ fid- dahar ikkawżat minn diska vertebrali bil- ħsara: id- diska bejn żewġ vertebri (l- għadam tas- sinsla tad- dahar) titneħħa u l- vertebri jiġu ġonġuti flimkien.
InductOs is used together with a special metal cage that corrects the position of the spine.
InductOs jintuża flimkien ma 'gaġġa metallika speċjali li sservi biex tikkoreġi l- qagħda tas- sinsla tad- dahar.
In this type of surgery, InductOs can be used instead of a bone graft (bone that is taken from another part of the same patient’ s body or from a bone donor) in adults who have been treated for at least six months for back pain due to a damaged disc but have not had an operation. • surgery to heal fractures (breaks) of the tibia (shin bone).
F' dan it- tip ta 'intervent, InductOs jista' jintuża minflok trapjant awtoġenu ta 'l- għadam (meta l- għadma titneħħa minn parti oħra tal- ġisem ta' l- istess pazjent jew minn donatur) f' adulti li ngħataw għal talanqas sitt xhur trattament għall- uġigħ fid- dahar minħabba diska bil - ħsara iżda li ma għamlux operazzjoni. • fl- interventi kirurġiċi biex ifejqu l- ksur tat- tibja (l- għadma tal- qasba tas- sieq).
InductOs is used in addition to standard treatment and care.
InductOs jintuża bħala żieda mat- trattament u l- kura standard.
It is only used when the nail to fix the bone does not need ‘ reaming’ (drilling to make room for nail placement).
Jintuża biss meta l- musmar biex ifejjaq l- għadma ma jeħtieġx 'reaming' (tħaffir ta 'toqba biex iwessa' l- ispazju għall- musmar).
How is InductOs used?
Kif jintuża InductOs?
InductOs should be used by a qualified surgeon.
InductOs għandu jintuża minn kirurgu kkwalifikat.
InductOs is made up into a solution before use, applied to the matrix and left for at least 15 minutes (but no more than two hours).
InductOs jissawwar f' soluzzjoni qabel l- użu, applikat mal- matriċi u jitħalla għal talanqas 15- il minuta (iżda mhux għal aktar minn sagħtejn).
The matrix is then cut, if needed, to the correct size before use.
Jekk ikun hemm bżonn, il- matriċi tinqata 'sad- daqs meħtieġ qabel l- użu.
Generally one kit is sufficient.
Ġeneralment, kitt wieħed huwa biżżejjed.
For lower back spine fusion, the damaged disc between the vertebrae is removed and replaced with two metal cages filled with InductOs.
Fl- intervent ta 'fużjoni spinali lombari, id- diska bil- ħsara bejn il- vertebri titneħħa u tiġi sostitwita b' żewġ gaġeġ metalliċi mimlijin b' InductOs.
The metal cages fix the position of the vertebrae, and InductOs encourages bone to grow between the two vertebrae to join them permanently in the correct position.
Il- gaġeġ metalliċi jiffissaw il- pożizzjoni tal - vertebri u InductOs jistimola l- għadam biex jikber bejn iż- żewġ vertebri biex jingħaqqdu b' mod permanenti f' qagħda korretta.
For a fractured tibia, InductOs is placed around the broken bone to aid healing.
Għal ksur tat- tibja, InductOs huwa applikat madwar l- għadma miksur biex jgħinha tfieq.
How does InductOs work?
Kif jaħdem InductOs?
The active substance in InductOs, dibotermin alfa, acts on the bone structure.
Is- sustanza attiva f' InductOs, dibotermina alfa, taġixxi fuq l- istruttura ta 'l- għadam.
The newly formed bone grows into the matrix, which then 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Din hija kopja ta 'proteina msejħa proteina- 2 morfoġenika ta' l- għadam (bone morphogenetic protein 2, BMP- 2) li hija 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. dissolves away.
Reproduction is authorised provided the source is acknowledged. prodotta b' mod naturali mill- ġisem u tgħin il- formazzjoni ta 'tessut ta' l- għadam ġdid.
Dibotermin alfa is produced by a method known as ‘ recombinant DNA technology’: it is made by cells that have received a gene (DNA) which makes them able to produce dibotermin alfa.
Id - dibotermina alfa hija prodotta b' metodu magħruf bħala 'teknoloġija tad- DNA rikombinanti': jiġifieri magħmula minn ċelluli li jkunu rċevew ġene (DNA), li jagħmilha kapaċi tipproduċi d- dibotermina alfa.
The replacement dibotermin alfa acts in same way as BMP-2 produced naturally by the body.
Id- dibotermina alfa ta 'sostituzzjoni taġixxi eżattament bħall- proteini BMP- 2 prodotti naturalment mill- ġisem.
How has InductOs been studied?
Kif ġie studjat InductOs?
InductOs has been studied in 279 patients having lower back spine fusion.
InductOs ġie studjat f' 279 pazjent li ġew sottoposti għal intervent ta 'fużjoni spinali lombari.
Spinal fusion using InductOs was compared with fusion using a bone graft removed from the hip during surgery.
Il- fużjoni spinali bl- użu ta 'InductOs tqabblet ma' fużjoni bl- użu ta 'trapjant ta' l- għadam li tneħħa mill- ġenbejn waqt intervent kirurġiku.
The main measure of effectiveness was fusion of the vertebrae confirmed by X-ray, and improvement in the pain and disability reported by the patient, measured two years after surgery.
Il- kejl ewlieni ta 'l- effikaċja kien il- fużjoni tal- vertebri aċċertata permezz ta' test radjoloġiku (raġġi X) u t- titjib fl- uġigħ u tad- diżabilità rrappurtat mill- pazjent, wara sentejn minn meta sar l- intervent.
InductOs has been studied in 450 patients with a fractured tibia.
InductOs ġie studjat f' 450 pazjent b' tibja miksura.
InductOs was compared with standard care.
InductOs tqabbel mal- kura standard.
The main measure of effectiveness was the number of patients who did not need further treatment for their fractured tibia (such as a bone graft or changes to the nail used to fix the bones together) in the year following surgery.
Il- kejl ewlieni ta 'l- effikaċja kien l- għadd ta' pazjenti li, wara sena, ma kellhomx bżonn trattament ulterjuri għat- tibja miksura tagħhom (bħal trapjant ta 'l- għadam jew il- bdil ta' l- imsiemer użat biex iġonġi l- għadam flimkien).
What benefit has InductOs shown during the studies?
X' benefiċċju wera InductOs waqt l- istudji li ġew mwettqa?
In spinal fusion, InductOs was as effective as bone grafts.
Fil- fużjoni spinali, InductOs wera l- istess effikaċja daqs it- trapjanti ta 'l- għadam.
After two years, 57% of the patients treated with InductOs (69 out of 122) had responded to treatment, compared with 59% of the patients treated with a bone graft (78 out of 133).
Wara sentejn, 57% tal- pazjenti ttrattati b' InductOs (69 minn 122) kienu rrispondew għat- trattament, meta mqabbla ma '59% tal- pazjenti li kellhom trapjant ta' l- għadam (78 minn 133).
In patients with a fractured tibia, using InductOs in addition to standard care was more effective than standard care alone in reducing the risk of treatment failure.
Fil- pazjenti b' tibja miksura, l- użu ta 'InductOs flimkien ma' kura standard kien aktar effikaċi mill- kura standard waħedha għat- tnaqqis tar- riskju ta 'falliment tat- trattament.
Of the patients in the standard care group, 46% needed a further intervention within a year to repair their fracture, while the proportion was 26% for those also receiving InductOs.
46% tal- pazjenti li ngħataw kura standard kellhom bżonn intervent ulterjuri fi żmien sena biex jitfejqilhom il- ksur, filwaqt li l - propozjon kien 26% għal dawk li ngħataw InductOs.
What is the risk associated with InductOs?
X' inhu r- riskju assoċjat ma 'InductOs?
When used in spinal fusion surgery, the most common side effects with InductOs (seen in more than 1 patient in 10) are accidental injury, neuralgia (nerve pain), back pain and bone disorders (such as delayed healing), but these were seen as frequently in patients receiving standard care.
Fl- intervent ta 'fużjoni spinali, l- effetti sekondarji l- aktar komuni b' InductOs (li dehru f' aktar minn pazjent 1 minn 10) huma feriti aċċidentali, newralġija (uġigħ fin- nervituri), uġigħ fid- dahar u disturbi fl- għadam (per eżempju, fejqan tard), madankollu dawn ġew osservati frekwentement ukoll fil - pazjenti li rċevew kura standard.
When used in tibia fracture surgery, the most common side effect with InductOs (seen in more than 1 patient in 10) is infection.
Fl- intervent għall- ksur tat- tibja, l- effett sekondarju l- aktar komuni b' InductOs (li deher f' iktar minn pazjent 1 minn 10) kien infezzjoni.
Infection is more common with InductOs than with standard care when the patient’ s bones are fixed together using reamed nails.
L- infezzjoni hija aktar komuni b' InductOs milli bil- kura standard meta l- għadmiet tal- pazjent huma mwaħħlin flimkien b' musmar mdaħħal f' toqba mwessa '(reamed).
For the full list of all side effects reported with InductOs, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati b' InductOs, ara l- Fuljett ta' Tagħrif.
InductOs should not be used in people who may be hypersensitive (allergic) to dibotermin alfa or any of the other ingredients.
InductOs ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għad- dibotermina alfa jew għal xi ingredjent ieħor tagħha.
InductOs should also not be used in the following situations: • patients who are still growing; • patients diagnosed with or being treated for cancer; • patients with an active infection at the surgery site; • patients with an inadequate blood supply at the fracture site; • treating a fracture that is related to a disease such as Paget’ s disease or cancer.
InductOs lanqas ma għandu jintuża f' dawn is- sitwazzjonijet: • pazjenti bi struttura skelettrika immatura (għadha qed tikber); • pazjenti li ġielhom dijanjostikat kanċer u li għaddejjin minn trattament antitumorali; • pazjenti b' infezzjoni attiva fil- punt ta 'l- intervent kirurġiku; • pazjenti li ż- żona tal- ksur tagħhom ma għandhiex kwantità biżżejjed ta' demm; • pazjenti bi ksur relatat ma 'mard bħall- marda ta' Paget jew kanċer.
Why has InductOs been approved?
Għaliex ġie approvat InductOs?
The Committee for Medicinal Products for Human Use (CHMP) decided that InductOs’ s benefits are greater than its risks for single-level (L4 - S1) anterior lumbar spine fusion as a substitute for autogenous bone graft and for the treatment of acute tibia fractures in adults, as an adjunct to standard care.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'InductOs huma ogħla mir- riskji tiegħu għall- fużjoni spinali lombari b' livell singolu (L4 - S1) bħala sostitut għat- trapjant awtoġenu ta' l- għadam u għat- trattament ta 'ksur akut tat- tibja f' adulti, użat bħala żieda mal- kura standard.
The Committee recommended that InductOs be given marketing authorisation.
Il- Kumitat irrakkomanda li InductOs jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about InductOs:
Aktar tagħrif dwar InductOs:
The European Commission granted a marketing authorisation valid throughout the European Union for InductOs to Wyeth Europa Ltd on 9 September 2002.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal InductOs lil Wyeth Europe fid- 9 ta 'Settembru 2002.
The marketing authorisation was renewed on 9 September 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fid- 9 ta 'Settembru 2007.
The full EPAR for InductOs is available here.
2/ 3 L- EPAR sħiħ għal InductOs jista 'jiġi kkonsultat hawn.
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT 1 ISEM TAL- PRODOTT MEDIĊINALI
InductOs 12 mg kit for implant
InductOs 12 mg kitt għall- impjant
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
2 GĦAMLA KWALITATTIVA U KWANTITATTIVA
One vial contains 12 mg dibotermin alfa*.
Kunjett wieħed fih 12 mg ta ’ dibotermin alfa *.
After reconstitution, InductOs contains 1.5 mg/ ml dibotermin alfa.
Wara r- rikostituzzjoni, InductOs ikun fih 1. 5 mg/ ml ta ’ dibotermin alfa.
*dibotermin alfa (recombinant human Bone Morphogenetic Protein-2; rhBMP-2) is a human protein derived from a recombinant Chinese Hamster Ovary (CHO) cell line.
* dibotermin alfa (Proteina- 2 Morfoġenika ta ’ l- Għadam umana rikombinanti; rhBMP- 2) hi proteina umana derivata minn razza ta ’ ċelluli rikombinanti ta ’ l- Ovarju tal- Ħamster Ċiniż (Chinese Hamster Ovary - CHO).
For a full list of excipients, see section 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi ara sezzjoni 6. 1.
3 PHARMACEUTICAL FORM
3 GĦAMLA FARMAĊEWTIKA
Kit for implant.
Kit għall- impjant
The kit consists of a white powder for solution, a clear colourless solvent and a white matrix.
Il- kitt jikkonsisti fi trab abjad għal soluzzjoni, solvent ċar u bla kulur, u matriċi bajda.
4 CLINICAL PARTICULARS
4 TAGĦRIF KLINIKU
InductOs is indicated for single-level (L4 – S1) anterior lumbar spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non- operative treatment for this condition.
InductOs hu indikat għall- fużjoni tas- sinsla tad- dahar lumbari anterjuri fuq livell wieħed (L4 – S1) bħala sostitut għal trapjanti ta ’ l- għadam awtoġenu f’ adulti li jkollhom mard deġenerattiv tad- disk, li kellhom mill- anqas 6 xhur ta ’ kura mhix kirurġika għal din il- kundizzjoni.
InductOs is indicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation.
InductOs hu indikat għall- kura ta ’ ksur akut fil- qasba tas- sieq fl- adulti, bħala żieda mal- kura standard billi tintuża operazzjoni tar- riduzzjoni tal- ksur u twaħħil permezz ta ’ msiemer unreamed intramedullari.
See section 5.1.
Ara sezzjoni 5. 1.
InductOs should be used by an appropriately qualified surgeon.
InductOs għandu jintuża minn kirurgu li jkun ikkwalifikat kif suppost.
The directions for preparation for each kit should be followed exactly using the appropriate amount of InductOs for the intended indication.
L- istruzzjonijiet għall- preparazzjoni ta ’ kull kitt għandhom ikunu segwiti eżattament billi tuża l - ammont adattat ta ’ InductOs għall- proċedura intenzjonata.
InductOs is prepared immediately prior to use from a kit containing all necessary components.
InductOs ikun ippreparat immedjatament qabel l- użu minn kitt li jkun fih il- komponenti neċessarji kollha.