qanastek/EMEA-V3 huggingface dataset:
Serum concentrations of alanine aminotransferase (ALT) and aspartate transaminase (AST) should be monitored at four to six week intervals for the first six months of treatment with SOMAVERT, or at any time in patients exhibiting symptoms suggestive of hepatitis.
Il- konċentrazzjonijiet ta ’ alanine aminotransferase (ALT) u aspartate transaminase (AST) fis- serum għandhom jiġu sorveljati f’ intervalli ta ’ bejn erba ’ u sitt ġimgħat matul l- ewwel sitt xhur ta ’ trattament b’ SOMAVERT, jew f’ kull ħin meta l- pazjenti jkunu qed juru sintomi li jindikaw l- preżenza ta ’ l - epatite.
Evidence of obstructive biliary tract disease should be ruled out in patients with elevations of ALT and AST or in patients with a prior history of treatment with any somatostatin analogue.
Il- preżenza ta ’ mard ostruttiv ta ’ l- apparat biljari għandha tiġi eliminata f’ dawk il- pazjenti b’ livelli għolja ta ’ ALT u AST jew f’ pazjenti li għandhom storja preċedenti ta ’ trattament b’ xi mediċina analoga għal somatostatin.
Administration of SOMAVERT should be discontinued if signs of liver disease persist.
L- għoti ta ’ SOMAVERT għandu jitwaqqaf jekk is- sinjali tal - mard fil- fwied jippersistu.
The study conducted with SOMAVERT in diabetic patients treated either by insulin or by oral hypoglycaemic medicinal products revealed the risk of hypoglycemia in this population.
L- istudju li sar b’ SOMAVERT f’ pazjenti dijabetiċi li kienu kkurati jew bl- insulina jew permezz ta ’ prodotti ipoglikemiċi orali kixef ir- riskju ta ’ ipogliċemija f’ dawn it- tip ta ’ pazjenti.
Therefore, in acromegalic patients with diabetes mellitus, doses of insulin or hypoglycaemic medicinal products may need to be decreased (see also section 4.5).
Għalhekk, f’ pazjenti akromegaliċi li jsofru mid- dijabete mellitus, jista ’ jagħti l- każ li d- dożi ta ’ l- insulina jew tal - prodotti mediċinali ipoglikemiċi jkollhom jiġu mnaqqsa (ara sezzjoni 4. 5).
The therapeutic benefits of a reduction in IGF-I concentration which results in improvement of the patient’ s clinical condition could potentially increase fertility in female patients.
Il- benefiċċji terapewtiċi ta ’ tnaqqis fil- konċentrazzjoni ta ’ IGF- I, li jirriżulta f’ titjib fil- kundizzjoni klinika tal- pazjent, jistgħu potenzjalment iżidu l- fertilità f’ pazjenti femminili.
Patients should be advised to use adequate contraception if necessary.
Il- pazjenti għandhom jingħataw parir biex jużaw kontraċezzjoni adegwata jekk ikun meħtieġ.
SOMAVERT is not recommended during pregnancy (see also section 4.6).
SOMAVERT ma huwiex rakkomandabbli waqt it- tqala (ara ukoll sezzjoni 4. 6).
It should be considered whether to continue treatment with somatostatin analogues.
Wieħed għandu jikkunsidra jekk għandux jitkompla t- trattament b’ analogi ta ’ somatostatin.
The use of SOMAVERT in combination with other medicinal products for the treatment of acromegaly has not been extensively investigated.
L- użu ta ’ SOMAVERT flimkien ma ’ prodotti mediċinali oħra għat- trattament ta ’ l- akromegalija ma ġiex investigat b’ mod estensiv.
Patients receiving insulin or oral hypoglycaemic medicinal products may require dose reduction of these active substances due to the effect of pegvisomant on insulin sensitivity (see section 4.4).
3 Il- pazjenti li jkunu qed jieħdu l- insulina jew prodotti mediċinali ipoglikemiċi orali jista ’ jkollhom bżonn ta ’ tnaqqis fid- doża ta ’ dawn is- sustanzi attivi minħabba l- effett ta ’ pegvisomant fuq is - sensittività ta ’ l- insulina (ara sezzjoni 4. 4).
SOMAVERT has significant structural similarity to growth hormone which causes it to cross-react in commercially available growth hormone assays.
SOMAVERT għandu xebh strutturali sinifikanti ma ’ l- ormoni tat- tkabbir, liema xebh jikkawża cross - reaction f’ assays ta ’ ormoni tat- tkabbir li jinsabu fis- suq.
SOMAVERT
Peress li l- konċentrazzjonijiet fis- serum ta ’ dożi ta ’ SOMAVERT li huma terapewtikament effettivi, huma ġeneralment minn 100 sa 1000 darba ogħla mill- konċentrazzjonijiet attwali ta ’ l- ormoni tat- tkabbir fis- serum kif jirriżultaw f’ akromegaliċi, f’ assays ta ’ ormoni tat- tkabbir li jinsabu fis- suq, il- kejl tal- konċentrazzjoni ta ’ l- ormoni tat- tkabbir jiġi rrappurtat b’ mod falz.
3 treatment should therefore not be monitored or adjusted based on serum growth hormone concentrations reported from these assays.
Għalhekk it- trattament b’ SOMAVERT ma għandux jiġi sorveljat u aġġustat abbażi tar- riżultati rrapportati minn dawn l- assays ta ’ konċentrazzjoni ta ’ ormoni tat- tkabbir fis- serum.
Pregnancy and lactation
4. 6 Tqala u treddigħ
For pegvisomant no clinical data on exposed pregnancies are available.
Għal pegvisomant m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Animal studies are insufficient with respect to effects on pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3). The potential risk for humans is unknown.
Mhux magħruf ir- riskju potenzjali fuq in- nies.
SOMAVERT should not be used during pregnancy unless clearly necessary (see also section 4.4).
SOMAVERT m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar (ara wkoll sezzjoni 4. 4).
The excretion of pegvisomant in breast milk has not been studied in animals.
Il- ħruġ ta ’ pegvisomant fil- ħalib ma ġiex studjat fl- annimali.
Clinical data are too limited (one reported case) to draw any conclusion on the excretion of pegvisomant in human breast milk.
It- tgħarif kliniku hu limitat wisq (hemm rapport wieħed biss) sabiex ikun hemm konklużjoni fuq il- ħruġ ta ’ pegvisomant fil- ħalib uman.
Therefore, SOMAVERT should not be used in breast-feeding women.
Għalhekk SOMAVERT ma għandux jintuża fuq nisa li qed ireddgħu.
However, breast-feeding may be continued if SOMAVERT is discontinued: this decision should take into account the benefit of SOMAVERT therapy to the mother and the benefit of breastfeeding to the child.
Din id- deċiżjoni għandha tittieħed billi jitqies l- benefiċċju tat- terapija b’ SOMAVERT għall- omm u il- benefiċċju tat- treddigħ għat- tarbija.
The list below contains adverse reactions seen in clinical trials.
Il- lista ta ’ hawn taħt turi reazzjonijiet avversi li rriżultaw waqt provi kliniċi.
In clinical studies, for patients treated with pegvisomant (n=160), the majority of adverse reactions to pegvisomant were of mild to moderate intensity, of limited duration and did not require discontinuation of treatment.
Fi studji kliniċi, għal dawk il- pazjenti ttrattati b’ pegvisomant (n=160), il- maġġoranza tar- reazzjonijiet avversi għal pegvisomant kienu ħfief għal moderati, ta ’ żmien limitat u li ma ħtiġux li jitwaqqaf it - trattament.
The most commonly reported adverse reactions considered related to SOMAVERT occurring in ≥ 5% of patients with acromegaly during the clinical trials were injection site reactions 11%, sweating 7%, headache 6% and asthenia 6%.
L- iktar reazzjonijiet avversi kkunsidrati bħala relatati ma ’ SOMAVERT li ġew irrappurtati l- aktar fi provi kliniċi u li rriżultaw f’ ≥5% tal- pazjenti b’ akromegalija, kienu reazzjonijiet fil- post ta ’ l - injezzjoni 11%, perspirazzjoni 7%, uġigħ ta ’ ras 6% u astenja 6%.
Adverse reactions are listed according to the following categories:
Ir- reazzjonijiet avversi huma mniżżla skond il- kategoriji segwenti:
Uncommon:
Komuni ħafna: ≥1/ 10 Komuni:
≥ 1/ 10 ≥ 1/ 100 to < 1/ 10 ≥ 1/ 1,000 to < 1/ 100
≥1/ 100 sa < 1/ 10
Uncommon:
Mhux komuni: ≥1/ 1, 000 sa < 1/ 100
thrombocytopenia, leukopenia, leukocytosis, bleeding tendency
Mhux komuni: tromboċitopenija, lewkopenja, lewkoċitozi, tendenza ta ’ fsada
Nervous system disorders:
4 Disturbi fis- sistema nervuża:
headache, dizziness, somnolence, tremor
uġigħ ta ’ ras, sturdament, ngħas, rogħda
hypoesthesia, dysgeusia, migraine, narcolepsy
ipoestesija, togħma ħażina, emigranja, narkolepsija
Uncommon:
Disturbi fl- għajnejn:
asthenopia, eye pain
Mhux komuni: astenopija, uġigħ fl- għajnejn
Uncommon:
Disturbi fil- widnejn u fis- sistema labirintika:
Meniere’ s disease
Mhux komuni: marda ta ’ Meniere
Uncommon:
Mhux komuni: dispnea
diarrhoea, constipation, nausea, vomiting, abdominal distension, dyspepsia, flatulence
dijarea, stitikezza, nawsja, rimettar, distensjoni taż- żaqq, dispepsja, gass fl- istonku
dry mouth, hemorrhoids, salivary hypersecretion, tooth disorder
ħalq xott, murliti, żieda fl- ammont ta ’ saliva, disturb dentali
Uncommon:
Disturbi fil- kliewi u fis- sistema urinarja:
heamaturia, proteinuria, polyuria, renal impairment
Mhux komuni: ħematurja, proteinurja, poliurja, indeboliment tal- kliewi
sweating, pruritis, rash
tixxarrab bl- għaraq, ħakk, raxx
face oedema, dry skin, contusion, tendency to bruise, night sweats
edema fil- wiċċ, ġilda xotta, kontużjoni, tendenza għal tbenġil, perspirazzjoni matul il- lejl
Musculoskeletal and connective tissue disorders:
Disturbi muskolu- skeltrali, tal- connective tissue:
arthralgia, myalgia, peripheral swelling
artralġja, uġigħ fil- muskoli, nefħa periferali
hypercholesterolemia, weight gain, hyperglycemia, hunger
iperkolesterolemija, żieda fil- piż, ipergliċemija, ġuħ
hypertriglyceridemia, hypoglycemia
ipertrigliċeridemija, ipogliċemija
General disorders Common:
Komuni:
and administration site conditions: influenza-like illness, fatigue, injection site bruising or bleeding, injection site reaction (including injection site hypersensitivity), injection site hypertrophy (e. g. lipohypertrophy)*
mard simili għall- influwenza, għeja, tbenġil jew telf ta ’ demm fis- sit ta ’ l - injezzjoni (inkluża reazzjoni ta ’ ipersensittivita fis- sit ta ’ l- injezzjoni), reazzjoni fis- sit ta ’ l- injezzjoni, ipertrofija fis- sit ta ’ l- injezzjoni (eż. lipoipertrofija) *
oedema lower limb, pyrexia, weakness, asthenia, feeling abnormal, impaired healing, peripheral oedema
edema fir- riġlejn, deni, telqa ta ’ l- għeja, astenja, sensazzjoni ta ’ anormalità, fejqan imfixkel, edema periferali
Common
Disturbi fil- fwied Komuni:
abnormal liver function tests (e. g. transaminase elevation) (see section 4.4)
u fil- marrara: testijiet abnormali tal- funzjoni tal- fwied (eż. żieda fit- transaminase) (ara sezzjoni 4. 4)
abnormal dreams, sleep disorder
ħolm abnormali, disturb fl- irqad
Uncommon:
5 Mhux komuni:
anger, apathy, confusion, increased libido, panic attack, short term memory loss
rabja, apatija, konfużjoni, żieda fil- libido, attakk ta ’ paniku, telf tal- memorja għal perjodu qasir
*see Additional Information below.
* ara Informazzjonji Oħra hawn taħt
Additional Information
Informazzjoni Oħra
Most injection site reactions characterised as localised erythemas and soreness, spontaneously resolved with local symptomatic treatment, while SOMAVERT therapy continued.
Ir- reazzjonijiet tas- siti ta ’ l- injezzjoni kienu l- aktar karatterizzati b’ eritema lokali u uġiegħ, u tfejqu bi trattament sintomatiku lokali, filwaqt li terapija bis- SOMAVERT tkompliet.
Occurrence of injection site hypertrophies has been observed, including lipohypertrophy.
Ġrajjiet ta ’ ipertrofiji fis - siti ta ’ l- injezzjoni ġew osservati, inkluża lipoipertrofija.
The development of isolated low-titre anti-growth hormone antibodies was observed in 16.9% of patients treated with SOMAVERT.
L- iżvilupp ta ’ antikorpi low- titre ta ’ kontra l- ormoni tat- tkabbir ġie nnutat f’ 16. 9% tal- pazjenti kkurati b’ SOMAVERT.
The clinical significance of these antibodies is unknown.
4. 9 Doża eċċessiva
There is limited experience of overdosage with SOMAVERT.
L- esperjenza ta ’ doża eċċessiva b’ SOMAVERT hija waħda limitata.
In the one reported incident of acute overdosage, where 80 mg/ day was administered for 7 days, the patient experienced a slight increase in fatigue and dry mouth.
F’ każ irrappurtat ta ’ doża eċċessiva akuta, fejn 80 mg kuljum ġew mogħtija għal 7 ijiem, il- pazjent kellu żieda żgħira fl- għeja u ħalq xott.
In the week following discontinuation of treatment the adverse reactions noted were: insomnia, increased fatigue, a trace of foot oedema, fine tremor, and weight gain.
Fil- ġimgħa ta ’ wara li twaqqaf it- trattament, ir- reazzjonijiet avversi nnutati kienu: insomnja, għeja akbar, traċċi ta ’ edema fis- sieq, rogħda ħafifa u żieda fil- piż.
Two weeks after stopping treatment, leukocytosis and moderate bleeding from injection and vein puncture sites was observed which were considered possibly related to SOMAVERT.
Ġimagħtejn wara li twaqqaf it - trattament, ġew innutati lewkoċitożi u telf moderat ta ’ demm fejn kien ġie injettat il- pazjent, inkluż mill- vini, liema effetti kienu konsiderati bħala possibbilment relatati ma ’ SOMAVERT.
In cases of overdose, administration of SOMAVERT should be discontinued and not resumed until IGF-I levels return to within or above the normal range.
F’ każ ta ’ doża eċċessiva, l- għoti ta ’ SOMAVERT għandu jitwaqqaf u ma jerġax jinbeda qabel ma l - livelli ta ’ IGF- I jirritornaw fil- medda normali jew ogħla.
Other anterior pituitary lobe hormones and analogues, ATC code:
Ormoni oħra tal- lobu pitwitarju anterjuri u analogi, Kodiċi ATC:
Pegvisomant is an analogue of human growth hormone that has been genetically modified to be a growth hormone receptor antagonist.
Pegvisomant huwa analogu ta ’ l- ormon tat- tkabbir uman, li ġie ġenetikament modifikat sabiex ikun antagonist għar- riċettur ta ’ l- ormoni tat- tkabbir.
Pegvisomant binds to growth hormone receptors on cell surfaces, where it blocks growth hormone binding, and thus interferes with intracellular growth hormone signal transduction.
Pegvisomant jeħel mar- riċetturi tal- ormon tat- tkabbir fuq il- wiċċ taċ- ċelluli, fejn jimblokka t- tqabbid ta ’ l- ormon tat- tkabbir u b’ hekk ifixkel is- sinjal trasduzzjonali fl- ormoni tat- tkabbir intraċellulari.
Pegvisomant is highly selective for the GH receptor, and does not cross-react with other cytokine receptors, including prolactin.
Pegvisomant huwa selettiv ħafna għar- riċettur GH u ma jagħmilx reazzjoni ma ’ riċetturi cytokine oħra, inkluż prolaktin.
Inhibition of growth hormone action with pegvisomant leads to decreased serum concentrations of insulin-like growth factor-I (IGF-I), as well as other growth hormone-responsive serum proteins such as free IGF-I, the acid-labile subunit of IGF-I (ALS), and insulin-like growth factor binding protein-3 (IGFBP-3).
L- inibizzjoni ta ’ l- azzjoni ta ’ l- ormoni tat- tkabbir permezz ta ’ pegvisomant tirriżulta fi tnaqqis tal- konċentrazzjonijiet fis- serum tal- fattur tat- tkabbir li jixbah lill- insulina – I (IGF - I), kif ukoll proteini oħra tas- serum risponsivi għall- ormoni tat- tkabbir bħall- IGF- I ħieles, is- subunit ta ’ l- acid- labile IGF- I (ALS) u l- proteina 3 li tgħin lill- fattur tat- tkabbir jaqbad mar- riċetturi (tixbah l - insulina) (IGFBP- 3).
Acromegalic patients (n=112) have been treated in a 12-week, randomised, double-blind, multicentre study comparing placebo and pegvisomant.
Pazjenti akromegaliċi (n=112) ġew trattati għal 12- il ġimgħa fi studju tat- tip double blind, multiċentri, magħmul b’ għażla każwali, fejn il- plaċebo ġie pparagunat ma ’ pegvisomant.
Dose-dependent, statistically significant reductions in mean IGF-I (p < 0.0001), free IGF-I (p < 0.05), IGFBP-3 (p < 0.05) and ALS (p < 0.05) were observed at all post-baseline visits in the pegvisomant treatment groups.
Ġie nnotat tnaqqis statistiku sinifikanti dipendenti fuq id- doża fl- IGF- I medju (p < 0. 0001), IGHF- I liberu (p < 0. 05), IGFBP- 3 (p < 0. 05) u ALS (p < 0. 05), f’ kull viżita sussegwenti għal dik inizjali, fil- gruppi kkurati b’ pegvisomant.
The serum IGF-1 was normalised at the end of the study (week 12) in 9.7%, 38.5%, 75% and 82% of subjects treated with placebo, 10 mg/ day, 15 mg/ day or 20 mg/ day SOMAVERT respectively.
L- IGF- I fis- serum ġie għan- normal fi tmiem l- istudju (it- 12- il ġimgħa) fi 9. 7%, 38. 5%, 75% u 82% tal- pazjenti ttrattati bil- plaċebo, 20 mg kuljum, 15 mg kuljum jew 20 mg kuljum SOMAVERT rispettivament.
Statistically significant differences from placebo (p < 0.05) were observed for improvements in the total signs and symptoms score for all dose groups compared to placebo.
Differenzi statistikament sinifikanti mill- plaċebo (p < 0. 05) ġew innutati għat- titjib fil- punteġġ totali tas- sinjali u s- sintomi għall- gruppi kollha li ħadu d- doża, kif imqabbla mal- plaċebo.
A cohort of 38 acromegalic subjects has been followed in a long-term, open-label, dose-titration study for at least 12 consecutive months of daily dosing with pegvisomant (mean = 55 weeks).
6 Ġemgħa ta ’ 38 pazjent akromegaliku ġew segwiti fi studju open label, fuq perjodu fit- tul, b’ titrazzjoni tad- doża, għal mill- anqas 12- il xahar konsekuttiv ta ’ dożaġġ kuljum b’ pegvisomant (medja = 55 ġimgħa).
The mean IGF-I concentration in this cohort fell from 917 ng/ ml to 299 ng/ ml on pegvisomant, with 92% achieving a normal (age-adjusted) IGF-I concentration.
Il- konċentrazzjoni medja ta ’ IGF- I f’ din il- ġemgħa niżlet minn 917 ng/ ml għal 299 ng/ ml fuq pegvisomant, bi 92% jirnexxilhom jiksbu konċentrazzjoni ta ’ IGF- I (aġġustata skond l- età) normali.
Absorption of pegvisomant following subcutaneous administration is slow and prolonged, and peak serum pegvisomant concentrations are not generally attained until 33-77 hours after administration.
L- assorbiment ta ’ pegvisomant wara l- għoti taħt il- ġilda huwa wieħed bil- mod u prolungat u l- ogħla konċentrazzjonijiet ta ’ pegvisomant fis- serum normalment ma jinkisbux qabel ma jgħaddu bejn 33 u 77 siegħa wara l- għoti.
The mean extent of absorption of a subcutaneous dose was 57% relative to an intravenous dose.
L- ammont medju ta ’ assorbiment ta ’ doża taħt il- ġilda kien ta ’ 57% relattiv għal doża fil- vini.
The apparent volume of distribution of pegvisomant is relatively small (7-12 l).
Il- volum apparenti ta ’ distribuzzjoni ta ’ pegvisomant huwa relattivament żgħir (7 – 12 1).
The mean total body systemic clearance of pegvisomant following multiple doses is estimated to be 28 ml/ h for subcutaneous doses ranging from 10 to 20 mg/ day.
Il- medja totali tat- tneħħija sistemika mill- ġisem ta ’ pegvisomant wara dożi multipli, hi stmata li hija ta ’ 28 ml fis- siegħa għal dożi ta ’ taħt il- ġilda ta ’ bejn 10 u 20 mg kuljum.
Pegvisomant is slowly eliminated from serum, with
It- tneħħija renali ta ’ pegvisomant hija negliġibbli u hija anqas minn 1% tat- tneħħija totali mill- ġisem.
6 mean estimates of half-life generally ranging from 74 to 172 hours following either single or multiple- doses.
Pegvisomant jiġi mneħħi bil- mod mis - serum, bl- istimi medji tal- half- life ġeneralment ivarjaw minn 74 sa 172 siegħa kemm wara doża waħdanija jew wara dożi multipli.
The metabolism of pegvisomant is not studied.
Il- metaboliżmu ta ’ pegvisomant ma huwiex studjat.
After single subcutaneous pegvisomant administration no linearity is observed with rising doses of 10, 15 or 20 mg.
Wara l- għoti ta ’ doża waħda taħt il- ġilda ta ’ pegvisomant, ma ġiet innutata l- ebda linearità fid- dożi mkabbra minn 10 għal 15 jew 20 mg.
Approximately linear pharmacokinetics is observed at steady state in the population pharmacokinetic studies.
Bejn wieħed u ieħor il- farmakokinetika lineari hija nnutata b’ mod stabbli fl- istudji ta ’ gruppi farmakokinetiċi.
The data from 145 patients in two long-term studies who received daily doses of 10, 15, or 20 mg, demonstrate pegvisomant mean serum concentrations (± SD) of approximately 8800 ± 6300, 13200 ± 8000 and 15600 ± 10300 ng/ ml, respectively.
Minn informazzjoni miksuba wara żewġ studji fit - tul, minn 145 pazjent li rċevew kuljum dożi ta ’ 10, 15 jew 20 mg, jintwerew konċentrazzjonijiet medji ta ’ pegvisomant fis- serum (±SD) ta ’ madwar 8800 ± 6300, 13200 ± 8000 u 15600 ± 10300 ng/ ml, rispettivament.
The pharmacokinetics of pegvisomant are similar in normal healthy volunteers and acromegaly patients, although heavier individuals tend to have a higher total body clearance of pegvisomant than lighter individuals, and may thus require greater doses of pegvisomant.
Il- farmakokinetika ta ’ pegvisomant hija simili fil- każ ta ’ voluntiera normali b’ saħħithom u pazjenti akromegaliċi, għalkemm individwi ta ’ piż akbar ikollhom it- tendenza ta ’ tneħħija totali akbar ta ’ pegvisomant mill- ġisem, minn individwi ta ’ piż inqas u għalhekk jista ’ jkollhom bżonn ta ’ dożi akbar ta ’ pegvisomant.
No pharmacokinetic data in special populations (children, populations with renal and hepatic impairment) are available.
L- ebda informazzjoni farmakokinetika fi gruppi speċjali (tfal, gruppi ta ’ persuni b’ indeboliment tal - fwied u tal- kliewi) ma hija disponibbli.
Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Non-clinical data revealed no special hazard for humans based on conventional studies of repeated dose toxicity in rat and monkey.
Informazzjoni ta ’ qabel l- użu kliniku, ibbażata fuq studji dwar l- effett tossiku minn dożi ripetuti fil- far u fix- xadina, ma turi l- ebda periklu speċjali għall- bnedmin.
However, due to the marked pharmacological response in monkey, systemic exposures higher than those achieved in patients at therapeutic doses have not been studied.
Madankollu minħabba r- rispons farmakoloġiku sinifikanti fix- xadina, esponimenti sistemiċi ogħla minn dawk miksuba f’ pazjenti b’ dożi terapewtiċi, ma ġewx studjati.
Except for one segment II test in the rabbit, no other reproductive toxicity studies were conducted.
Ħlief għal prova ta ’ segment II fil- fniek, ma saru l- ebda studji oħra dwar l- effett tossiku fuq is- sistema riproduttiva.
No data on carcinogenic potential are available.
L- ebda informazzjoni fuq il- potenzjal karċinoġeniku ma hija disponibbli.
Glycine Mannitol (E421) Sodium phosphate dibasic anhydrous Sodium phosphate monobasic monohydrate
Glycine Mannitol (E421) Sodium phosphate dibasic anyhydrous Sodium phosphate monobasic monohydrate
Solvent:
7 Solvent:
After reconstitution, the product should be used immediately.
Wara rikostituzzjoni, il- prodott għandu jintuża immedjatament.
Use immediately.
Uża mill- ewwel.
Powder in a vial (type I glass) with a rubber stopper (butyl) and 8 ml solvent in a vial (type I glass), with a stopper (rubber butyl).
Trab f’ kunjett (ħgieg ta ’ tip I) b’ tapp tal- gomma (butyl) u 8 ml solvent f’ kunjett (ħġieġ ta ’ tip I) b’ tapp (gomma butyl).
Pack size of 30.
Pakkett ta ’ 30.
Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Reconstitute using 1 ml solvent.
Irrikostitwixxi billi tuża 1 ml ta ’ solvent.
Add solvent to vial with powder for injection.
Żid is- solvent mal- kunjett bit- trab għal injezzjoni.
Gently dissolve the powder with a slow, swirling motion.
Ħoll bil- ħlewwa t- trab b’ moviment ċirkulari bil - mod.
Do not shake vigorously, as this might cause denaturation of the active ingredient.
Tħawwadx bis- saħħa għax dan jista ’ jbiddel in- natura tas- sustanza attiva.
After reconstitution, if the solution is cloudy or contains particulate matter, the product must be discarded.
Jekk wara r- rikostituzzjoni, is- soluzzjoni ma tkunx ċara jew ikollha xi frak, il- prodott għandu jintrema.
For single use only.
Għall- użu ta ’ darba biss.
Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom
Pfizer Limited Sandwich Kent CT 13 9 NJ Ir- Renju Unit
13/ 11/ 2002 Date of last renewal:
13/ 11/ 2002
SOMAVERT 15 mg powder and solvent for solution for injection.
SOMAVERT 15 mg trab u solvent għal soluzzjoni għal injezzjoni.
Each vial contains 15 mg of pegvisomant.
Kull kunjett fih 15 mg ta ’ pegvisomant.
After reconstitution, 1 ml of solution contains 15 mg pegvisomant.
Wara rikostituzzjoni, 1 ml ta ’ soluzzjoni jkollu 15 mg pegvisomant.
Following this, SOMAVERT 10 mg reconstituted in 1 ml of solvent should be administered once daily as a subcutaneous injection.
In segwitu, SOMAVERT 10 mg rikostitwit f’ 1 ml ta ’ solvent, għandu jingħata darba kuljum bħala injezzjoni taħt il- ġilda.
Serum IGF-I concentrations should be measured every four to six weeks and appropriate dose adjustments made in increments of 5 mg/ day in order to maintain the serum IGF-I concentration within the age-adjusted normal range and to maintain an optimal therapeutic response.
Il - konċentrazzjonijiet ta ’ IGF- I fis- serum għandhom jiġu mkejla kull erba ’ sa kull sitt ġimgħat u jsiru l - aġġustamenti xierqa fid- doża b’ żidiet ta ’ 5 mg kuljum sabiex il- konċentrazzjoni ta ’ IGF- I fis- serum tinżamm fil- medda normali aġġustata bl- età u sabiex jinżamm rispons terapewtiku ottimali.
Elderly patients
10 Pazjenti anzjani
No dose adjustment is required.
Ma hemmx bżonn ta ’ ebda aġġustament fid- doża.
9 Paediatric patients
Pazjenti pedjatriċi
A growth hormone deficient state may result from SOMAVERT administration, despite the presence of elevated serum growth hormone levels.
Minkejja l- preżenza f’ livell għoli ta ’ ormoni tat- tkabbir fis- serum, jista ’ jirriżulta stat ta ’ defiċjenza ta ’ l- ormoni tat- tkabbir, mill- għoti ta ’ SOMAVERT.
Serum concentrations of alanine aminotransferase (ALT) and aspartate transaminase (AST) should be monitored at four to six week intervals for the first six months of treatment with SOMAVERT, or at any time in patients exhibiting symptoms suggestive of hepatitis.
Il- konċentrazzjonijiet ta ’ alanine aminotransferase (ALT) u aspartate transaminase (AST) fis- serum għandhom jiġu sorveljati f’ intervalli ta ’ bejn erba ’ u sitt ġimgħat matul l- ewwel sitt xhur ta ’ trattament b’ SOMAVERT jew f’ kull ħin meta l- pazjenti jkunu qed juru sintomi li jindikaw l- preżenza ta ’ l - epatite.
Patients receiving insulin or oral hypoglycaemic medicinal products may require dose reduction of these active substances due to the effect of pegvisomant on insulin sensitivity (see section 4.4).
11 Il- pazjenti li jkunu qed jieħdu l- insulina jew prodotti mediċinali ipoglikemiċi orali jista ’ jkollhom bżonn ta ’ tnaqqis fid- doża ta ’ dawk is- sustanzi attivi minħabba l- effett ta ’ pegvisomant fuq is - sensittività ta ’ l- insulina (ara sezzjoni 4. 4).
10 treatment should therefore not be monitored or adjusted based on serum growth hormone concentrations reported from these assays.
Għalhekk it- trattament b’ SOMAVERT ma għandux jiġi sorveljat u aġġustat abbażi tar- riżultati rrapportati minn dawn l- assays ta ’ konċentrazzjoni ta ’ ormoni tat- tkabbir fis- serum.
For pegvisomant no clinical data on exposed pregnancies are available.
Għal Pegvisomant m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Animal studies are insufficient with respect to effects on pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Studji fuq bhejjem ma humiex biżżejjed rigward l- effetti fuq it- tqala, l- iżvilupp ta ’ l- embriju/ fetu, il - ħlas u l- iżvilupp wara t- twelid (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Mhux magħruf ir- riskju potenzjali fuq in- nies
and administration site conditions: influenza-like illness, fatigue, injection site bruising or bleeding, injection site reaction (including injection site hypersensitivity), injection site hypertrophy (e. g. lipohypertrophy)*
mard simili għall- influwenza, għeja, tbenġil jew telf ta ’ demm fis- sit ta ’ l- injezzjoni (inkluża reazzjoni ta ’ ipersensittivita fis- sit ta ’ l- injezzjoni), reazzjoni fis- sit ta ’ l - injezzjoni, ipertrofija fis- sit ta ’ l- injezzjoni (eż. lipoipertrofija) *
*see Additional Information below.
13 * ara Informazzjonji Oħra hawn taħt
Pegvisomant binds to growth hormone receptors on cell surfaces, where it blocks growth hormone binding, and thus interferes with intracellular growth hormone signal transduction.
Pegvisomant jeħel mar- riċetturi ta ’ l- ormon tat- tkabbir fuq il- wiċċ taċ- ċelluli, fejn jimblokka t- tqabbid ta ’ l- ormon tat- tkabbir u b’ hekk ifixkel is- sinjal trasduzzjonali fl- ormoni tat- tkabbir intraċellulari.
A cohort of 38 acromegalic subjects has been followed in a long-term, open-label, dose-titration study for at least 12 consecutive months of daily dosing with pegvisomant (mean = 55 weeks).
14 Ġemgħa ta ’ 38 pazjent akromegaliku ġew segwiti fi studju open- label, fuq perjodu fit- tul, b’ titrazzjoni tad- doża, għal mill- anqas 12- il xahar konsekuttiv ta ’ dożaġġ kuljum b’ pegvisomant (medja = 55 ġimgħa).
The mean IGF-I concentration in this cohort fell from 917 ng/ ml to 299 ng/ ml on pegvisomant, with 92% achieving a normal (age-adjusted) IGF-I concentration.
Il- konċentrazzjoni medja ta ’ IGF- I f’ din il- ġemgħa niżlet minn 917 ng/ ml għal 299 ng/ ml fuq pegvisomant, bi 92% jirnexxilhom jiksbu konċentrazzjoni IGF- I (aġġustata skond l- età) normali.
13 mean estimates of half-life generally ranging from 74 to 172 hours following either single or multiple- doses.
Pegvisomant jiġi mneħħi bil- mod mis - serum, bl- istimi medji tal- half- life ġeneralment ivarjaw minn 74 sa 172 siegħa kemm wara doża waħdanija jew wara dożi multipli.
Non-clinical data revealed no special hazard for humans based on conventional studies of repeated dose toxicity in rat and monkey.
L- informazzjoni ta ’ qabel l- użu kliniku, ibbażata fuq studji dwar l- effett tossiku minn dożi ripetuti fil - far u fix- xadina, ma turi l- ebda periklu speċjali għall- bnedmin.
Solvent:
15 Solvent:
After reconstitution, if the solution is cloudy or contains particulate matter, the product must be discarded.
Jekk wara r- rikostituzzjoni, is- soluzzjoni ma tkunx ċara jew ikollha xi frak, il- prodott għandu jiġi jintrema.
13/ 11/ 2002 Date of last renewal:
13/ 11/ 2002 Data ta ’ l- aħħar tiġdid:
SOMAVERT 20 mg powder and solvent for solution for injection.
SOMAVERT 20 mg trab u solvent għal soluzzjoni għal injezzjoni.
Each vial contains 20 mg of pegvisomant.
Kull kunjett fih 20 mg ta ’ pegvisomant.
After reconstitution, 1 ml of solution contains 20 mg pegvisomant.
Wara rikostituzzjoni, 1 ml ta ’ soluzzjoni jkollu 20 mg pegvisomant.
Elderly patients
18 Pazjenti anzjani
No dose adjustment is required.
Ma hemmx bżonn ta ’ aġġustament fid- doża.
16 Paediatric patients
Pazjenti pedjatriċi
Interaction with other medicinal products and other forms of interaction
L- użu ta ’ SOMAVERT flimkien ma ’ prodotti mediċinali oħra għall- kura ta ’ l- akromegalija ma ġiex investigat b’ mod estensiv.
It should be considered whether to continue treatment with somatostatin analogues.
L- użu ta ’
The use of SOMAVERT in combination with other medicinal products for the treatment of acromegaly has not been extensively investigated.
19 SOMAVERT flimkien ma ’ prodotti mediċinali oħra għat- trattament ta ’ l- akromegalija ma ġiex investigat b’ mod estensiv.
Patients receiving insulin or oral hypoglycaemic medicinal products may require dose reduction of these active substances due to the effect of pegvisomant on insulin sensitivity (see section 4.4).
Il- pazjenti li jkunu qed jieħdu l- insulina jew prodotti mediċinali ipoġlikemiċi orali jista ’ jkollhom bżonn ta ’ tnaqqis fid- doża ta ’ dawn is- sustanzi attivi, minħabba l- effett ta ’ pegvisomant fuq is - sensittività ta ’ l- insulina (ara sezzjoni 4. 4).
17 treatment should therefore not be monitored or adjusted based on serum growth hormone concentrations reported from these assays.
Għalhekk it- trattament b’ SOMAVERT ma għandux jiġi sorveljat u aġġustat abbażi tar- riżultati rrapportati minn dawn l- assays ta ’ konċentrazzjoni ta ’ ormoni tat- tkabbir fis- serum.
≥ 1/ 100 to < 1/ 10 ≥ 1/ 1,000 to < 1/ 100
≥1/ 100 sa < 1/ 10
Uncommon:
20 Mhux komuni:
*see Additional Information below.
21 * ara Informazzjonji Oħra hawn taħt
The serum IGF-1 was normalised at the end of the study (week 12) in 9.7%, 38.5%, 75% and 82% of subjects treated with placebo, 20 mg/ day, 15 mg/ day or 20 mg/ day SOMAVERT respectively.
L- IGF- I fis- serum ġie għan- normal fi tmiem l- istudju (it- 12- il ġimgħa) fi 9. 7%, 38. 5%, 75% u 82% tal- pazjenti ttrattati bil- plaċebo, 20 mg kuljum, 15 mg kuljum jew 20 mg kuljum SOMAVERT rispettivament.
A cohort of 38 acromegalic subjects has been followed in a long-term, open-label, dose-titration study for at least 12 consecutive months of daily dosing with pegvisomant (mean = 55 weeks).
Ġemgħa ta ’ 38 pazjent akromegaliku ġew segwiti fi studju open- label, fuq perjodu fit- tul, b’ titrazzjoni tad- doża, għal mill- anqas 12- il xahar konsekuttiv ta ’ dożaġġ kuljum b’ pegvisomant (medja = 55
20 mean estimates of half-life generally ranging from 74 to 172 hours following either single or multiple- doses.
Pegvisomant jiġi mneħħi bil- mod mis - serum, bl- istimi medji tal- half- life ġeneralment ivarjaw minn 74 sa 172 siegħa kemm wara doża waħdanija jew wara dożi multipli.
Incompatibilities
23 6. 2 Inkompatibilitajiet
Pack sizes of 1 or 30.
Pakketti ta ’ 1 jew 30 kunjett.
22 ANNEX II
25 ANNESS II
Box 13865, Research Triangle Park, North Carolina 27709-3865, USA
Box 13865, Research Triangle Park, North Carolina 27709- 3865, L- Istati Uniti
Pfizer Manufacturing Belgium NV Rijksweg 12, B-2870 Puurs, Belgium
Pfizer Manufacturing Belgium NV Rijksweg 12, B- 2870 Puurs, Il- Belġju
• OTHER CONDITIONS
Ma jgħoddx f’ dan il- każ.
The MAH will continue to submit yearly PSURs for the following three years, unless otherwise specified by the CHMP.
• KUNDIZZJONIJIET OĦRA Id- detentur ta ’ L- awtorizzazzjoni għat- tqegħid fis- suq għandu jibgħat PSURs kull sena, sakem ma jkunx speċifikat mod ieħor mis- CHMP.
24 ANNEX III
27 ANNESS III
26 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
29 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
SOMAVERT 10 mg powder and solvent for solution for injection Pegvisomant
SOMAVERT 10 mg trab u solvent għal soluzzjoni għal injezzjoni Pegvisomant
Each vial contains 10 mg pegvisomant
Kull kunjett fih 10 mg pegvisomant
30 vials of powder for solution for injection 30 vials of water for injections
30 kunjett ta ’ trab għal soluzzjoni għal injezzjoni 30 kunjett ta ’ ilma għall- injezzjonijiet
Use immediately after reconstitution.
Uża immedjatament wara rikostituzzjoni.
27 SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN
28 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
31 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SOMAVERT 10 mg powder for solution for injection Pegvisomant Subcutaneous use
SOMAVERT 10 mg trab għal soluzzjoni għal injezzjoni Pegvisomant Użu għal taħt il- ġilda
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
SOMAVERT 15 mg powder and solvent for solution for injection Pegvisomant
SOMAVERT 15 mg trab u solvent għal soluzzjoni għal injezzjoni Pegvisomant
Each vial contains 15 mg pegvisomant
Kull kunjett fih 15 mg pegvisomant
30 SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN
31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
34 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGHAR EWLENIN
SOMAVERT 15 mg powder for solution for injection Pegvisomant Subcutaneous use
SOMAVERT 15 mg trab għal soluzzjoni għal injezzjoni
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
35 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
SOMAVERT 20 mg powder and solvent for solution for injection Pegvisomant
SOMAVERT 20 mg trab u solvent għal soluzzjoni għal injezzjoni Pegvisomant
Each vial contains 20 mg pegvisomant
Kull kunjett fih 20 mg pegvisomant
33 SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
37 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
1 vial of powder for solution for injection 1 vial of water for injections
1 kunjett ta ’ trab għal soluzzjoni għal injezzjoni 1 kunjett ta ’ ilma għall- injezzjonijiet
For single use only.
Għall- uzu ta ’ darba biss.
35 SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN
36 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
39 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SOMAVERT 20 mg powder for solution for injection Pegvisomant Subcutaneous use
SOMAVERT 20 mg trab għal soluzzjoni għal injezzjoni Pegvisomant Użu għal taħt il- ġilda
37 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
40 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SOMAVERT powder for solution for injection Pegvisomant Subcutaneous use
SOMAVERT trab għal soluzzjoni għal injezzjoni Pegvisomant Użu għal taħt il- ġilda
8 ml water for injections
8 ml ilma għal injezzjonijiet
SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection Pegvisomant
SOMAVERT 10 mg trab u solvent għal soluzzjoni għal injezzjoni SOMAVERT 15 mg trab u solvent għal soluzzjoni għal injezzjoni SOMAVERT 20 mg trab u solvent għal soluzzjoni għal injezzjoni Pegvisomant
You may need to read it again
Jista ’ jkollok bżonn terġa ’ taqrah.
What SOMAVERT is and what it is used for 2.
X’ inhu SOMAVERT u għalxiex jintuża 2.
Before you use SOMAVERT 3.
Qabel ma tuża SOMAVERT 3.
How to use SOMAVERT 4.
Kif għandek tuża SOMAVERT 4.
How to store SOMAVERT 6.
Kif taħżen SOMAVERT 6.
WHAT SOMAVERT IS AND WHAT IT IS USED FOR
X’ INHU SOMAVERT U GĦALXIEX JINTUŻA
SOMAVERT is used for the treatment of acromegaly, a hormonal disorder resulting from the increased secretion of growth hormone (GH) and IGF-I (Insulin-like growth factors), which is characterised by overgrowth of bone, soft tissue swelling, heart disease and related disorders.
SOMAVERT jintuża għat- trattament ta ’ l- akromegalija, disturb ormonali li jirriżulta minn żieda fis - sekrezzjoni ta ’ l- ormon tat- tkabbir (GH) u IGF- I (fatturi tat- tkabbir li jixbhu lill- insulina), li huwa kkaratterizzat minn tkabbir eċċessiv ta ’ l- għadam, tinfiħ tat- tessuti rotob, mard tal- qalb u disturbi relatati.
SOMAVERT is a product of biotechnology.
SOMAVERT huwa prodott ta ’ bijoteknoloġija.
The active substance in SOMAVERT, pegvisomant is known as a growth hormone receptor antagonist.
Is- sustanza attiva f’ SOMAVERT, pegvisomant huwa magħruf bħala riċettur antagonista ta ’ l- ormon tat- tkabbir.
These substances decrease the action of GH and levels of IGF-I circulating in the blood.
Dawn is- sustanzi jnaqqsu l- effett tal- GH u l- livelli ta ’ IGF- I jiċċirkulaw fid- demm.
BEFORE YOU USE SOMAVERT
QABEL MA TUŻA SOMAVERT
Do not use SOMAVERT
Tużax SOMAVERT
• If you are allergic (hypersensitive) to pegvisomant or any of the other ingredients of SOMAVERT.
- jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal pegvisomant jew sustanzi oħra ta ’
- If you experience disturbed vision or headaches while using SOMAVERT you must contact
- Jekk ikollok disturbi fil- vista jew uġigħ ta ’ ras meta tuża SOMAVERT inti trid tikkuntattja lit -
your doctor immediately.
tabib tiegħek immedjatament.
- Your doctor or nurse will monitor the levels of IGF-I (Insulin-like growth factors) circulating in
- It- tabib jew in- ners tiegħek se jimmonitorja il- livelli ta ’ IGF- I (fatturi tat- tkabbir li jixbhu lill -
the blood and adjust the dose of SOMAVERT if necessary.
insulina) jiċċirkolaw fid- demm u jaġġusta d- doża ta ’ SOMAVERT jekk ikun hemm bżonn.
- Your doctor should also monitor your adenoma (benign tumour).
- It- tabib tiegħek għandu jimmonitorja wkoll l- adenoma tiegħek (tumur benin).
- Your doctor or nurse will monitor the level of liver enzymes in the blood every 4-6 weeks for
- It- tabib jew in- ners tiegħek se jimmonitorja l- livell ta ’ enzimi tal- fwied fid- demm kull 4- 6
the first six months of treatment with SOMAVERT.
ġimgħat għall- ewwel sitt xhur ta ’ trattament b’ SOMAVERT.
Administration of SOMAVERT should be discontinued if signs of liver disease persist.
L- għoti ta ’ SOMAVERT għandu jitwaqqaf jekk is- sinjali ta ’ mard tal- fwied jippersistu.
- If you are diabetic, your doctor may need to adjust the amount of insulin or other medicines you
- Jekk inti dijabetiku/ a, it- tabib tiegħek jista ’ jkollu bżonn jaġġusta l- ammont ta ’ insulina jew ta ’
are using.
mediċini oħra li tkun qed tieħu.
- Female patients should use adequate contraception as fertility may be increased.
- Pazjenti nisa għandhom jużaw kontraċezzjoni adegwata billi l- fertilità tista ’ tiżdied.
See also the
Ara wkoll
section about Pregnancy below.
is- sezzjoni dwar it- Tqala hawn isfel.
You must tell your doctor if you have previously used other medicines for the treatment of acromegaly or medicines for the treatment of diabetes.
Trid tgħid lit- tabib tiegħek jekk kont użajt qabel xi mediċini oħra għat- trattament ta ’ l- akromegalija jew mediċini għat- trattament tad- dijabete.
Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tuża jew użajt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
As part of your treatment you may be given other medicines.
Bħala parti mill- kura tiegħek inti tista ’ tingħata mediċini oħra.
It is important to keep using all your medicines as well as SOMAVERT unless you are told otherwise by your doctor or pharmacist.
Huwa importanti li tkompli tuża l - mediċini tiegħek kollha kif ukoll SOMAVERT sakemm it- tabib jew l- ispiżjar tiegħek ma jgħidulekx mod ieħor.
The effects of SOMAVERT in pregnant women are not known, and so the use of SOMAVERT in pregnant women is not recommended.
L- effetti ta ’ SOMAVERT waqt it- tqala mhumiex magħrufa, u għalhekk l- użu ta ’ SOMAVERT f’ nisa tqal mhuwiex rakkomandat.
You are advised to not become pregnant while taking SOMAVERT therapy.
Qed tingħata parir biex ma toħroġx tqila waqt li tkun qiegħda tieħu t - terapija b’ SOMAVERT.
In case you become pregnant, you must consult your doctor.
Jekk toħroġ tqila, inti trid tikkonsulta lit- tabib tiegħek.
It is not known if SOMAVERT passes into breast milk.
Mhux magħruf jekk SOMAVERT jgħaddix għal ġol- ħalib tas- sider.
You should not breast-feed while taking SOMAVERT unless your doctor has discussed this with you.
Inti m’ għandekx tredda ’ waqt li tkun qed tieħu SOMAVERT sakemm it- tabib ma jkunx iddiskuta dan miegħek.
Important information about some of the ingredients of SOMAVERT
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ SOMAVERT
This medicinal product contains less than 1 mmol sodium (23 mg) per 10 mg dose, less than 1 mmol sodium (23 mg) per 15 mg dose, or less than 1 mmol sodium (23 mg) per 20 mg dose i. e. essentially ‘ sodium-free’.
Dan il- prodott mediċinali fih anqas minn 1 mmol ta ’ sodju (23 mg) għal kull doża ta ’ 10 mg, inqas minn 1 mmol ta ’ sodju (23 mg) għal kull doża ta’ 15 mg, jew inqas minn 1 mmol ta ’ sodju (23 mg) għal kull doża ta ’ 20 mg, jiġifieri huwa prattikament ‘ bla sodju ’.
HOW TO USE SOMAVERT
KIF GĦANDEK TUŻA SOMAVERT
Always inject SOMAVERT exactly as your doctor has told you.
Dejjem għandek tinjetta SOMAVERT skond il- parir tat- tabib.
A starting dose of 80 mg of SOMAVERT will be given subcutaneously (just under the skin) by your doctor.
Doża inizjali ta ’ 80 mg SOMAVERT tingħata taħt il- ġilda (eżatt taħt il- ġilda) mit- tabib tiegħek.
Following this, the usual daily dose of SOMAVERT is 10 mg, which is given by subcutaneous injection (just under the skin).
Wara din ta ’ l- ewwel, id- doża ta ’ SOMAVERT li s- soltu tingħata hija ta ’ 10 mg kuljum mogħtija b’ injezzjoni taħt il- ġilda (eżatt taħt il- ġilda).
Every four to six weeks your doctor will make appropriate dose adjustments, made in increments of 5 mg pegvisomant/ day, based on your so-called serum IGF-I levels to maintain an optimal therapeutic response.
Kull erba ’ sa sitt ġimgħat it- tabib tiegħek jagħmel aġġustamenti xierqa fid- doża, b’ żidiet ta ’ 5 mg pegvisomant kuljum, ibbażati fuq l- hekk imsejħa livelli ta ’ IGF- I fis- serum tiegħek sabiex jinżamm rispons terapewtiku ottimali.
Method and route of administration
44 Mod ta ’ kif u mnejn jingħata
SOMAVERT is injected under the skin.
SOMAVERT huwa injettat taħt il- ġilda.
The injection can be self-administered or given by another person, for example your doctor or his/ her assistant.
L- injezzjoni tista ’ tingħata mill- persuna nnifisha jew minn xi ħadd ieħor, per eżempju t- tabib tiegħek jew l- assistent/ a tiegħu.
The detailed instructions on injection procedure
L- istruzzjonijiet dettaljati fuq il - proċedura ta ’ l- injezzjoni, li tista ’ ssibhom fl- aħħar ta ’ dan il- fuljett, iridu jiġu segwiti.
41 provided at the end of this leaflet must be followed.
SOMAVERT irid jinħall qabel l- użu.
You should continue to inject SOMAVERT for as long as instructed by your doctor.
L- injezzjoni ma tridx tiġi mħallta fl- istess siringa jew kunjett ta ’ xi mediċina oħra.
The injection must not be mixed in the same syringe or vial as any other medicine.
Jekk tħoss li l- effett ta ’ SOMAVERT huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew lill - spiżjar tiegħek.
Fatty tissue of the skin can build-up at the site of injection.
Tessut xaħmi jista jinġema fis- sit ta ’ l- injezzjoni.
To avoid this, use a slightly different place for your injection each time, as described in Step 2 of the ‘ Instructions for Preparing and Giving an Injection of Somavert’ section of this leaflet.
Sabiex dan ikun evitat, kull darba uża post ħarira differenti għall- injezzjoni, kif inhu spjegat f’ Parti 2 tas- sezzjoni ‘ Struzzjoniet sabiex tiġi ppreparata u mogħtija injezzjoni ta ’ Somavert ’ f’ dan il- fuljett.
This gives your skin and the area under your skin time to recover from one injection before it receives another one in the same place.
Dan jgħati ċans lill- ġilda u t- tessut ta ’ taħt il- ġilda biex jirkupra mill- injezzjoni, qabel ma tingħata oħra fl- istess post.
If you inject more SOMAVERT than you should
Jekk tinjetta SOMAVERT aktar milli suppost
If you accidentally inject more SOMAVERT than told to by your doctor it is unlikely to be serious, but you should contact your doctor or pharmacist immediately.
Jekk aċċidentalment tinjetta Somavert aktar milli qallek it- tabib, mhux probabbli li tkun xi ħaġa serja, iżda għandek tkellem lit- tabib jew lill- ispiżjar tiegħek immedjatament.
If you forget to use SOMAVERT
Jekk tinsa tuża SOMAVERT
If you forget to give yourself an injection you should inject the next dose as soon as you remember and then continue to inject SOMAVERT as prescribed by your doctor.
Jekk tinsa tagħti lilek innifsek injezzjoni, inti għandek tinjetta d- doża li jmiss malli tiftakar u mbagħad tkompli tinjetta SOMAVERT kif qallek it- tabib.
Do not inject a double dose to make up for forgotten individual doses.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Like all medicines, SOMAVERT can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, SOMAVERT jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common side effects (likely to occur in fewer than 1 in 10 patients) include:
Effetti sekondarji komuni (probabbli li jseħħu f’ anqas minn 1 minn kull 10 pazjenti) jinkludu:
Headache, dizziness, sleepiness, uncontrolled trembling.
Uġigħ ta ’ ras, sturdament, ngħas, rogħda mhux ikkontrollata.
Diarrhoea, constipation, feeling sick, being sick, feeling bloated, indigestion, gas.
Dijarea, stitikezza, sensazzjoni ta ’ dardir, dardir, sensazzjoni ta ’ nefħa, indiġestjoni, gass.
Sweating, itching, rash.
Għaraq, ħakk, raxx.
Joint pain, muscle pain, swelling of the extremities.
Uġigħ fil- ġogi, uġigħ fil- muskoli, nefħa ta ’ l- estremitajiet.
Increased blood cholesterol, weight gain, increased blood glucose, increased appetite.
Żieda fil- kolesterol fid- demm, żieda fil- piż, żieda fil- glucose fid- demm, żieda fl- aptit.
Increased blood pressure.
Żieda fil- pressjoni tad- demm.
Bruising or bleeding at injection site, soreness or swelling at injection site, build up of fat below the surface of the skin at injection site.
Tbenġil, fsada jew uġigħ fil- post ta ’ l- injezzjoni, uġiegħ u nefħa fil- post ta ’ l- injezzjoni, tiġmiħ ta ’ xaħam taħt il- ġilda fil- post ta ’ l- injezzjoni.
Flu-like illness, fatigue.
Mard jixbah lill- influwenza, għeja.
Increased levels of substances that measure the function of the liver.
Żieda fil- livelli tas- sustanzi li jkejlu l- funzjoni tal- fwied.
These can be seen in the results of blood tests.
Dawn jistgħu jidhru fir- riżultati tat - testijiet tad- demm.
Abnormal dreams, problems sleeping.
Ħolm abnormali, problemi fl- irqad.
Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include:
Effetti sekondarji mhux komuni (probabbli li jseħħu f’ anqas minn 1 minn kull 100 pazjenti) jinkludu: