qanastek/EMEA-V3 huggingface dataset:
Somatropin induces hepatic LDL cholesterol receptors, and affects the profile of serum lipids and lipoproteins.
Somatropin jikkaġuna r- riċetturi tal- kolesterol LDL tal- fwied u jaffettwa l- profil tal- lipidi tas- serum u tal- lipoproteini.
In general, administration of somatropin to growth hormone deficient patients results in reduction in serum LDL and apolipoprotein B.
B’ mod ġenerali, l- għoti ta ’ somatropin lill- pazjenti b’ defiċjenza ta ’ l- ormon tat- tkabbir jirriżulta fit- tnaqqis ta ’ l- LDL tas- serum u ta ’ apolipoprotein B.
A reduction in serum total cholesterol may also be observed.
Tnaqqis fil- kolesterol totali tas- serum jista ’ jkun osservat ukoll.
Carbohydrate metabolism:
Metaboliżmu tal- karboidrati:
Somatropin increases insulin but fasting blood glucose is commonly unchanged.
Somatropin iżid l- insulina iżda l- livell tal- glukows fid- demm fl- istat sajjem normalment ma jinbidilx.
Children with hypopituitarism may experience fasting hypoglycaemia.
It- tfal li jkollhom ipopitwitariżmu jista ’ jkollhom ipogliċemija fl- istat sajjem.
This condition is reversed by somatropin.
Din il- kundizzjoni tinqaleb permezz ta ’ somatropin.
Water and mineral metabolism:
Metaboliżmu ta ’ l- ilma u tal- minerali:
Growth hormone deficiency is associated with decreased plasma and extracellular volumes.
Id- defiċjenza ta ’ l- ormon tat- tkabbir hi assoċjata ma ’ volumi mnaqqsa tal- plażma u dawk ekstraċellulari.
Both are rapidly increased after treatment with somatropin.
It- tnejn jiżdiedu malajr wara l- kura b’ somatropin.
Somatropin induces the retention of sodium, potassium and phosphorus.
Somatropin jikkaġuna ż- żamma ta ’ sodium, potassium u phosphorus.
Bone metabolism:
Metaboliżmu ta ’ l- għadam:
Somatropin stimulates the turnover of skeletal bone.
Somatropin jistumula l- ammont ta ’ għadam skeletriku.
Long-term administration of somatropin to growth hormone deficient patients with osteopoenia results in an increase in bone mineral content and density at weight-bearing sites.
L- għoti fit- tul ta ’ somatropin lil pazjenti b’ defiċjenza ta ’ l- ormon tat- tkabbir li għandhom l- osteopenija, jirriżulta f’ żieda fil- kontenut minerali u fid- densità f’ siti fil- ġisem li jkunu qed jerfgħu l- piż.
Physical capacity:
Kapaċità fiżika:
Muscle strength and physical exercise capacity are improved after long-term treatment with somatropin.
Is- saħħa tal- muskoli u l- kapaċità ta ’ l- eżerċizzju fiżiku jittejbu wara l- kura fit- tul b’ somatropin.
Somatropin also increases cardiac output, but the mechanism has yet to be clarified.
Somatropin żied ukoll l- effiċjenza kardijaka, iżda l- mekkaniżmu għad irid jiġi ċċarat.
A decrease in peripheral vascular resistance may contribute to this effect.
Tnaqqis fir - reżistenza vaskulari periferali jista ’ jikkontribwixxi għal dan l- effett.
In clinical trials in short children/ adolescents born SGA doses of 0.033 and 0.067 mg somatropin/ kg body weight per day have been used for treatment until final height is reached.
Fi provi kliniċi fi tfal/ adolexxenti qosra li twieldu b’ SGA, dożi ta ’ 0. 033 u 0. 067 mg ta ’ somatropin kuljum għal kull kilogramm ta ’ piż tal- ġisem intużaw għall- kura sakemm jintlaħaq it- tul finali.
In 56 patients who are continuously treated and have reached (near) final height, the mean change from height at start of treatment was +1.90 SDS (0.033 mg/ kg body weight per day) and +2.19 SDS (0.067 mg/ kg body weight per day).
F’ 56 pazjent li kienu kkurati kontinwament u li laħqu t- tul (kważi) finali, il- medja tal- bidla mit- tul fil - bidu tal- kura kienet ta ’ +1. 90 SDS (0. 033 mg kuljum għal kull kilogramm ta ’ piż tal- ġisem) u +2. 19 SDS (0. 067 mg kuljum għal kull kilogramm ta ’ piż tal- ġisem).
Literature data from untreated SGA children/ adolescents without early spontaneous catch-up suggest a late growth of 0.5 SDS.
Informazzjoni mill- letteratura minn tfal/ adolexxenti b’ SGA mhux ikkurati, mingħajr ħluq spontanju, tissuġġerixxi dewmien fit - tkabbir ta ’ 0. 5 SDS.
Long-term safety data are still limited.
Informazzjoni dwar is- sigurtà fit- tul għadha limitata.
Absorption The bioavailability of subcutaneously administered somatropin is approximately 80% in both healthy subjects and growth hormone deficient patients.
Assorbiment Il- bijodisponibilità ta ’ somatropin li jingħata taħt il- ġilda hi ta ’ madwar 80%, kemm f’ persuni b’ saħħithom, u kemm f’ pazjenti b’ defiċjenza ta ’ l- ormon tat- tkabbir.
A subcutaneous dose of 5 mg of Omnitrope powder and solvent for solution for injection in healthy adults results in plasma Cmax values of 71 ± 24 µg/ l (mean ± SD) and median tmax value of 4 hours (range 2-8 hours), respectively.
8 tas- Cmax u tat- tmax tal- plażma ta ’ 71 ± 24 µg/ l (medja ± SD) u valur medjan ta ’ tmax ta ’ 4 sigħat (medda 2- 8 sigħat), rispettivament.
Elimination The mean terminal half-life of somatropin after intravenous administration in growth hormone deficient adults is about 0.4 hours.
Eliminazzjoni Il- medja tal- half- life terminali ta ’ somatropin wara l- għoti ġol- vina f’ adulti li kellhom defiċjenza ta ’ l - ormon tat- tkabbir hi ta ’ madwar 0. 4 ta ’ siegħa.
However, after subcutaneous administration of Omnitrope powder and solvent for solution for injection, a half-life of 3 hours is achieved.
Madankollu, wara l- għoti taħt il- ġilda ta ’ Omnitrope trab u solvent għal soluzzjoni għall- injezzjoni, tintlaħaq half- life ta ’ 3 sigħat.
The observed difference is likely due to slow absorption from the injection site following subcutaneous administration.
Id- differenza osservata hi x’ aktarx minħabba l- assorbiment bil- mod mis- sit ta ’ l- injezzjoni, wara l- għoti taħt il- ġilda.
Sub-populations The absolute bioavailability of somatropin seems to be similar in males and females following subcutaneous administration.
Sotto- popolazzjonijiet Il- bijodisponibilità assoluta ta ’ somatropin tidher li hi simili fl- irġiel u fin- nisa, wara l- għoti taħt il - ġilda.
Information about the pharmacokinetics of somatropin in geriatric and paediatric populations, in different races and in patients with renal, hepatic or cardiac insufficiency is either lacking or incomplete.
L- informazzjoni dwar il- farmakokinetiċi ta ’ somatropin f’ popolazzjonijiet ġerjatriċi u pedjatriċi, f’ razez differenti u f’ pazjenti b’ indeboliment tal- kliewi, tal- fwied jew insuffiċjenza kardijaka, ma teżistix jew hi inkompleta.
In studies with Omnitrope regarding subacute toxicity and local tolerance, no clinically relevant effects have been observed.
Fi studji b’ Omnitrope dwar it- tossiċità sotto- akuta u t- tolleranza lokali, l- ebda effetti klinikament rilevanti ma kienu osservati.
8 In other studies with somatropin regarding general toxicity, local tolerance and reproduction toxicity no clinically relevant effects have been observed.
Fi studji oħrajn b’ somatropin dwar it- tossiċità ġenerali, it- tolleranza lokali u t- tossiċità tar - riproduzzjoni, l- ebda effetti klinikament rilevanti ma kienu osservati.
With somatropins, in vitro and in vivo genotoxicity studies on gene mutations and induction of chromosome aberrations have been negative.
B’ somatropini, studji in vitro u in vivo dwar il- ġenotossiċità fuq mutazzjonijiet tal- ġeni u l- induzzjoni ta ’ aberrazzjonijiet tal- kromosomi kienu negattivi.
An increased chromosome fragility has been observed in one in vitro study on lymphocytes taken from patients after long term treatment with somatropin and following the addition of the radiomimetic medicinal product bleomycin.
Żieda fil- fraġilità tal- kromosomi kienet osservata fi studju in vitro fuq limfoċiti meħuda minn pazjenti wara kura fit- tul b’ somatropin u wara ż- żieda prodott mediċinali radjumimetiku bleomycin.
The clinical significance of this finding is unclear.
Ir - rilevanza klinika ta ’ din is- sejba mhijiex ċara.
In another study with somatropin, no increase in chromosomal abnormalities was found in the lymphocytes of patients who had received long-term somatropin therapy.
Fi studju ieħor b’ somatropin, ma nstabet l- ebda żieda fl- anormalitajiet tal- kromosomi fil- limfoċiti tal - pazjenti li kienu rċivew terapija fit- tul b’ somatropin.
Powder: glycine disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate
Trab: glycine disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate
Shelf life after reconstitution:
Iż- żmien kemm idum tajjeb il- prodott wara r- rikostituzzjoni:
After reconstitution, from a microbiological point of view, an immediate use is recommended.
Wara r- rikostituzzjoni, mill- aspett mikrobijoloġiku, l- użu immedjat hu rakkomandat.
However, the in-use stability has been demonstrated for up to 24 hours at 2°C - 8°C, in the original package.
Madankollu, l - istabbiltà matul l- użu ntweriet sa 24 siegħa f’ temperatura ta ’ 2°C - 8°C, fil- pakkett oriġinali.
Store and transport refrigerated (2°C - 8°C).
Żommu 9 kiesaħ waqt il- ħażna u l- ġarr (2°C - 8°C).
Unopened vial:
Il- kunjett mhux miftuħ:
Store and transport refrigerated (2°C - 8°C).
Żommu kiesaħ waqt il- ħażna u l- ġarr (2°C - 8°C).
For storage conditions of the in-use medicinal product, see section 6.3.
Għall- kundizzjonijiet tal- ħażna ta ’ dan il- prodott mediċiinali waqt l- użu, ara sezzjoni 6. 3.
Powder in a vial (type I glass) with a stopper (fluor-resin laminated butyl rubber), a strip (aluminium) and a cap (violet polypropylene flip-off), and 1 ml of solvent in a vial (type I glass) with a stopper (fluor-resin laminated chlorobutyl elastomer), a strip (lacquered aluminium) and a cap (white polypropylene flip-off).
Trab f’ kunjett (ħġieġ ta ’ tip I) b’ tapp (lastku fluor- resin laminated butyl), strixxa (aluminju) u għatu (vjola, polypropylene flip- off), u 1 ml ta ’ solvent f’ kunjett (ħġieġ ta ’ tip I) b’ tapp (fluor- resin laminated chlorobutyl elastomer), strixxa (aluminju lacquered) u għatu (abjad, polypropylene flip- off).
9 6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Omnitrope 1.3 mg/ ml is supplied in a vial containing the active substance as a powder and the solvent filled in a vial for single use.
Omnitrope 1. 3 mg/ ml hu fornut f’ kunjett li fih is- sustanza attiva bħala trab u s- solvent mimli f’ kunjett li jintuża darba biss.
Each vial must be reconstituted with the accompanying solvent only.
Kull kunjett għandu jkun rikostitwit bis- solvent li jakkompanjah biss.
The reconstituted solution should be administered using sterile, disposable syringes.
Is- soluzzjoni rikostitwita għandha tingħata billi jintużaw siringi sterili, li jintremew wara li jintużaw.
The following is a general description of the reconstitution and administration process.
Din li ġejja hi deskrizzjoni ġenerali tal- proċess tar- rikostituzzjoni u l- għoti.
Reconstitution should be performed in accordance with good practice rules, particularly in the respect of asepsis.
Ir- rikostituzzjoni għandha titwettaq b’ konformità mar- regoli ta ’ prattika tajba, partikularment fir- rigward ta ’ asepsis.
Hands should be washed.
L- idejn għandhom jinħaslu.
Flip off the plastic protective caps from the vials.
Neħħi l- għatu protettiv tal- plastik mill- kunjetti.
The top of the vials should be wiped with an antiseptic solution to prevent contamination of the contents.
In- naħa ta ’ fuq tal- kunjetti għandha tintmesaħ b’ soluzzjoni antisettika biex tiġi evitata l - kontaminazzjoni tal- kontenut.
2 ml syringe) and needle (e. g.
Uża siringa sterili, li tintrema wara li tintuża (eż. siringa ta ’ 2 ml) u labra (eż.
0.33 mm x 12.7 mm) to withdraw all the solvent from the vial.
0. 33 mm x 12. 7 mm) biex tiġbed is- solvent kollu minn ġol- kunjett.
Take the vial with the powder, push the needle through the rubber closure and inject the solvent slowly into the vial aiming the stream of liquid against the glass wall in order to avoid foam.
Ħu l- kunjett bit- trab, imbotta l- labra minn ġol- għeluq tal- lastku u injetta s- solvent bil- mod ġol - kunjett, billi timmira t- tnixxija tal- likwidu lejn il- ġenb tal- ħġieġ biex tevita r- ragħwa.
Gently swirl the vial a few times until the content is completely dissolved.
Dawwar il- kunjett bil- mod għal ftit drabi sakemm il- kontenut jinħall kollu.
Do not shake; this may cause denaturation of the active substance.
Iċċaqlaqx; dan jista ’ jibdel in- natura tas- sustanza attiva.
If the solution is cloudy or contains particulate matter, it should not be used.
Jekk is- soluzzjoni tkun imċajpra jew ikun fiha materjal f’ sura ta ’ partikuli, din ma tridx tintuża.
The content must be clear and colourless after reconstitution.
Il- kontenut għandu jkun ċar u bla kulur wara r- rikostituzzjoni.
1 ml syringe) and injection needle (e. g.
Dawwar il- kunjett ta ’ taħt fuq u billi tuża siringa oħra sterili, li tintrema wara li tintuża, tad- daqs adattat (eż. siringa ta ’ 1 ml) u labra ta ’ l- injezzjoni (eż.
0.25 mm x 8 mm) withdraw a bit more than the dose needed back into the syringe.
0. 25 mm x 8 mm), iġbed ftit ieħor mid - doża meħtieġa lura ġos- siringa.
Remove any air bubbles from the syringe.
Neħħi kwalunkwe bżieżaq ta ’ l- arja minn ġos- siringa.
Bring the syringe to the correct dose needed.
Ħalli d - doża korretta ġos- siringa.
Clean the injection site with an alcohol swab and administer Omnitrope by subcutaneous injection.
Naddaf is- sit ta ’ l- injezzjoni b’ biċċa li tnaddaf bl- alkoħol u agħti Omnitrope permezz ta ’
The solution is for single use only.
Is- soluzzjoni hi biex tintuża darba biss.
Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria
Sandoz GmbH Biochemiestrasse 10 A- 6250 Kundl Awstrija
12 April 2006
12 t’ April, 2006
Omnitrope 5 mg/ ml powder and solvent for solution for injection
Omnitrope 5 mg/ ml trab u solvent għal soluzzjoni għall- injezzjoni
After reconstitution, one vial contains 5 mg Somatropin* (corresponding to 15 IU) per ml.
Wara r- rikostituzzjoni, kunjett wieħed fih 5 mg ta ’ Somatropin * (li jikkorrispondi għal 15 IU) f’ kull ml.
After reconstitution, one ml contains 15 mg benzyl alcohol.
Wara r- rikostituzzjoni ml wieħed fih 15 mg ta ’ benzyl alcohol.
11 Growth disturbance due to insufficient secretion of growth hormone in paediatric patients:
Disturb tat- tkabbir minħabba tnixxija insuffiċjenti ta ’ l- ormon tat- tkabbir f’ pazjenti pedjatriċi:
Clinical response and undesirable effects may also be used as guidance for dose titration.
13 jintużaw ukoll bħala gwida għat- titrazzjoni tad- doża.
The injection should be given subcutaneously and the site varied to prevent lipoatrophy.
L- injezzjoni għandha tingħata taħt il- ġilda u s- sit ta ’ l- injezzjoni jinbidel biex tiġi evitata l- lipoatrofija.
- Hypersensitivity to somatropin or to any of the excipients.
- Sensittività eċċessiva għal somatropin jew għal xi sustanzi mhux attivi.
If papilloedema is confirmed, a diagnosis of benign intracranial hypertension should be considered and, if appropriate, the growth hormone treatment should be discontinued.
14 demm għolja intrakranjali beninna għandha tkun ikkunsidrata u, jekk ikun xieraq, il- kura bl- ormon tat - tkabbir għandha titwaqqaf.
Experience in patients above 60 years is limited.
L- esperjenza f’ pazjenti ta ’ iktar minn 60 sena hi limitata.
13 In case of signs of upper airway obstruction, the problem should be solved by a specialist before starting treatment with somatropin.
F’ każ ta ’ sinjali ta ’ ostruzzjoni fin- naħa ta ’ fuq tal- passaġġ tan- nifs, il- problema għandha tiġi solvuta minn speċjalista qabel ma tibda l- kura b’ somatropin.
Experience in initiating treatment in SGA patients near onset of puberty is limited.
15 L- esperjenza fil- bidu tal- kura f’ pazjenti b’ SGA li jkunu qrib il- bidu tal- pubertà hi limitata.
In chronic renal insufficiency, renal function should be below 50 percent of normal before institution of therapy.
F’ insuffiċjenza kronika tal- kliewi, il- funzjoni tal- kliewi għandha tkun taħt il- 50 fil- mija ta ’ dik normali qabel ma tinbeda t- terapija.
14 treated with 5.3 or 8 mg somatropin daily compared to patients receiving placebo, 42% vs.
Il- mortalità kienet ogħla f’ pazjenti kkurati b’ 5. 3 jew 8 mg ta ’ somatropin kuljum meta mqabbla ma ’ pazjenti li jkunu qed jirċievu l- plaċebo, 42% vs.
Because of the presence of benzyl alcohol the medicinal product must not be given to premature babies or neonates.
Minħabba l- preżenza ta ’ benzyl alcohol, il- prodott mediċinali m’ għandux jingħata lil trabi li jitwieldu qabel iż- żmien jew lil trabi tat- twelid.
It may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Jista ’ jikkawża reazzjonijiet tossiċi u reazzjonijiet anafilattojdi fit- trabi u fi tfal sa l- età ta ’ 3 snin.
It is not known if somatropin is excreted into breast milk, but absorption of intact protein from the gastrointestinal tract of the infant is extremely unlikely.
16 Mhux magħruf jekk somatropin jitneħħiex fil- ħalib tas- sider, iżda l- assorbiment ta ’ proteina intatta mill- apparat gastrointestinali tat- tarbija hu estremament mhux mistenni.
Within the organ system classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000).
Fil- kategoriji tas- sistemi ta ’ l- organi, ir- reazzjonijiet avversi huma elenkati taħt titli ta ’ frekwenza (numru ta ’ pazjenti li huma mistennija li jkollhom ir- reazzjoni), bl- użu tal- kategoriji li ġejjin: komuni ħafna (≥ 1/ 10); komuni (≥ 1/ 100, < 1/ 10); mhux komuni (≥ 1/ 1, 000, < 1/ 100); rari (≥ 1/ 10, 000, < 1/ 1, 000); rari ħafna (< 1/ 10, 000).
The incidence of these undesirable effects is related to the administered dose, the age of patients, and possibly inversely
L- inċidenza ta ’ dawn l- effetti mhux mixtieqa hi marbuta mad- doża li tingħata, l- età tal - pazjenti, u possibbilment hi marbuta b’ mod invers ma ’ l- età tal- pazjenti fil- bidu tad- defiċjenza ta ’ l - ormon tat- tkabbir.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
In adults: peripheral oedema; In paediatric patients: transient local skin reactions at the injection site
Fl- adulti: edema periferali; F’ pazjenti pedjatriċi: reazzjonijiet lokali tal- ġilda li Komuni: jgħaddu malajr fis- sit ta ’ l- injezzjoni Mhux komuni:
4.9 Overdose
17 4. 9 Doża eċċessiva
Long-term overdose could result in signs and symptoms consistent with the known effects of human growth hormone excess.
Doża eċċessiva fit- tul tista ’ tirriżulta f’ sinjali u f’ sintomi li huma konsistenti ma ’ l- effetti magħrufa ta ’ l- eċċess ta ’ l- ormon tat- tkabbir tal- bniedem.
Serum
Flimkien ma ’ lipolisi mtejba, somatropin inaqqas it- teħid tat- triglycerides għall- ħażna tax- xaħam fil - ġisem.
16 concentrations of IGF-I (Insulin-like Growth Factor-I) and IGFBP3 (Insulin-like Growth Factor Binding Protein 3) are increased by somatropin.
Il- konċentrazzjonijiet tas- serum ta ’ IGF- I (Fattur tat- tkabbir li jixbaħ lil insulina/ Insulin- like Growth Factor- I) u ta ’ IGFBP3 (Proteina li torbot 3 Fattur tat- tkabbir li jixbaħ lil insulina / Insulin- like Growth Factor Binding Protein 3) jiżdiedu b’ somatropin.
Lipid metabolism:
Metaboliżmu tal- lipidi:
In 56 patients who are continuously treated and have reached (near) final height, the mean change from height at start of treatment was +1.90 SDS (0.033 mg/ kg body weight per day) and +2.19 SDS (0.067 mg/ kg body weight per day).
F’ 56 pazjent li kienu kkurati kontinwament u li laħqu t- tul (kważi) finali, il- medja tal- bidla mit- tul fil - bidu tal- kura kienet ta ’ +1. 90 SDS (0. 033 mg kuljum għal kull kilogramm ta ’ piż tal- ġisem) u
A subcutaneous dose of 5 mg of Omnitrope powder and solvent for solution for injection in healthy adults results in plasma Cmax values of 71 ± 24 µg/ l (mean ± SD) and median tmax value of 4 hours (range 2-8 hours), respectively.
Doża ta ’ 5 mg ta ’ Omnitrope trab u solvent għal soluzzjoni għall- injezzjoni li tingħata taħt il- ġilda f’ adulti b’ saħħithom tirriżulta f’ valuri tas- Cmax u tat- tmax tal- plażma ta ’ 71 ± 24 µg/ l (medja ± SD) u l- valur medjan ta ’ tmax ta ’ 4 sigħat (medda 2- 8 sigħat), rispettivament.
However, after subcutaneous administration of Omnitrope 5 mg/ ml powder and solvent for solution for injection, a half-life of 3 hours is achieved.
Madankollu, wara l- għoti taħt il- ġilda ta ’ Omnitrope 5 mg/ ml trab u solvent għal soluzzjoni għall- injezzjoni, tintlaħaq half- life ta ’ 3 sigħat.
17 Information about the pharmacokinetics of somatropin in geriatric and paediatric populations, in different races and in patients with renal, hepatic or cardiac insufficiency is either lacking or incomplete.
L- informazzjoni dwar il- farmakokinetiċi ta ’ somatropin f’ popolazzjonijiet ġerjatriċi u pedjatriċi, f’ razez differenti u f’ pazjenti b’ indeboliment tal- kliewi, tal- fwied jew insuffiċjenza kardijaka, ma teżistix jew hi inkompleta.
In other studies with somatropin regarding general toxicity, local tolerance and reproduction toxicity no clinically relevant effects have been observed.
Fi studji oħrajn b’ somatropin dwar it- tossiċità ġenerali, it- tolleranza lokali u t- tossiċità tar - riproduzzjoni, l- ebda effetti klinikament rilevanti ma kienu osservati.
Solvent: water for injections benzyl alcohol
Solvent: ilma għall- injezzjonijiet benzyl alcohol
After reconstitution and the first use the cartridge should remain in the pen and has to be kept in a refrigerator (2°C - 8°C) for a maximum of 21 days.
Wara r- rikostituzzjoni u wara li jintuża għall- ewwel darba, l- iskartoċċ għandu jibqa ’ ġol- pinna u għandu jinżamm fi friġġ (2°C - 8°C) sa massimu ta ’ 21 jum.
Store in the original pen in order to protect from light.
Aħżen fil- pinna oriġinali sabiex tilqa ’ mid- dawl.
Store and transport refrigerated (2°C – 8°C).
Żommu kiesaħ waqt il- ħażna u l- ġarr (2°C - 8°C).
Powder in a vial (type I glass) with a stopper (fluor-resin laminated butyl rubber), a strip (aluminium) and a cap (green polypropylene flip-off), and 1 ml of solvent in a cartridge (type I glass) with a stopper (fluor-resin laminated chlorobutyl elastomer), a strip (lacquered aluminium) and a cap (white polypropylene flip-off).
Trab f’ kunjett (ħġieġ ta ’ tip I) b’ tapp (lastku fluor- resin laminated butyl), strixxa (aluminju) u għatu (aħdar, polypropylene flip- off), u 1 ml ta ’ solvent fi skartoċċ (ħġieġ ta ’ tip I) b’ tapp (fluor- resin laminated chlorobutyl elastomer), strixxa (aluminju lacquered) u għatu (abjad, polypropylene flip- off).
Pack sizes of 1 and 5.
Daqsijiet tal- pakkett ta ’ 1 u 5.
Omnitrope 5 mg/ ml is supplied in a vial containing the active substance as a powder and the solvent filled in a cartridge.
Omnitrope 5 mg/ ml hu fornut f’ kunjett li fih is- sustanza attiva bħala trab u s- solvent mimli fi skartoċċ.
It should be reconstituted with a transfer set as recommended in the information provided with the transfer set.
Għandu jkun rikostitwit bis- sett tat- trasferiment kif rakkomandati fl- informazzjoni pprovduta mas- sett tat- trasferiment.
This presentation is intended for multiple use.
Din il- preżentazzjoni hi maħsuba biex tintuża diversi drabi.
It should only be administered with the Omnitrope Pen L, an injection device specifically developed for use with Omnitrope 5 mg/ ml reconstituted solution for injection.
Għandha tingħata biss b’ Omnitrope Pen L, tagħmir ta ’ l- injezzjoni li kien żviluppat speċifikament għall- użu b’ Omnitrope 5 mg/ ml soluzzjoni rikostitwita għall- injezzjoni.
It has to be administered using sterile, disposable pen needles.
Trid tingħata billi jintużaw labar tal- pinna sterili, li jintremew wara li jintużaw.
Patients and caregivers have to receive appropriate training and instruction on the proper use of the Omnitrope vials, the cartridges with solvent, the transfer set and the pen from the physician or other suitable qualified health professionals.
Il- pazjenti u persuni li jieħdu ħsieb il- pazjenti, għandhom jirċievu taħriġ adattat u struzzjonijiet dwar l- użu kif suppost tal- kunjetti Omnitrope, l- iskartoċċi bis- solvent, is- sett tat - trasferiment u l- pinna, mit- tabib jew minn persuni oħrajn adattati professjonali fis- settur tas- saħħa li jkunu kkwalifikati.
The following is a general description of the reconstitution and administration process.
Din li ġejja hi deskrizzjoni ġenerali tal- proċess tar- rikostituzzjoni u għoti.
The manufacturer’ s instructions with each individual transfer set and pen must be followed for reconstituting Omnitrope 5 mg/ ml powder for solution for injection, loading the cartridge, attaching the injection needle and for the administration.
L- istruzzjonijiet tal - manifattur ma ’ kull sett tat- trasferiment u pinna individwali jridu jkunu segwiti għar- rikostituzzjoni ta ’ Omnitrope 5 mg/ ml trab għal soluzzjoni għall- injezzjoni, biex timla l- iskartoċċ, biex twaħħal il- labra ta ’ l- injezzjoni u biex tagħti l- mediċina.
Flip off the plastic protective cap from the vial.
Neħħi l- għatu protettiv tal- plastik mill- kunjett.
The top of the vial and of the cartridge should be wiped with an antiseptic solution in order to prevent contamination of the contents.
In- naħa ta ’ fuq tal- kunjett u ta ’ l- iskartoċċ għandha tintmesaħ b’ soluzzjoni antisettika biex tiġi evitata l- kontaminazzjoni tal- kontenut.
Use the transfer set for transferring the solvent from the cartridge into the vial.
Uża s- sett tat- trasferiment biex tittrasferixxi s- solvent mill- iskartoċċ għal ġol- kunjett.
Transfer the solution back into the cartridge using the transfer set.
Ittrasferixxi s- soluzzjoni kollha lura ġo l- iskartoċċ billi tuża s- sett tat- trasferiment.
Assemble the pen following the instructions for use.
Immonta l- pinna billi ssegwi l- istruzzjonijiet għall- użu li ġejjin.
Eliminate air bubbles if necessary.
Neħħi l- bżieżaq ta ’ l- arja jekk ikun hemm bżonn.
Clean the site of injection with an alcohol swab.
Naddaf is- sit ta ’ l- injezzjoni b’ biċċa li tnaddaf bl- alkoħol.
Administer the appropriate dose by subcutaneous injection using a sterile pen needle.
Agħti d- doża li suppost permezz ta ’ injezzjoni taħt il- ġilda billi tuża labra sterili tal- pinna.
Remove the pen needle and dispose of it in accordance with local requirements.
Neħħi l- labra tal- pinna u armiha skond il- liġijiet lokali.
Omnitrope 3.3 mg/ ml solution for injection
Omnitrope 3. 3 mg/ ml soluzzjoni għall- injezzjoni
One cartridge contains 1.5 ml corresponding to 5 mg Somatropin* (15 IU).
Somatropin * 3. 3 mg (li jikkorrispondi għal 10 IU) / ml Skartoċċ wieħed fih 1. 5 ml li jikkorrispondu għal 5 mg ta ’ Somatropin * (15 IU).
One ml contains 9 mg benzyl alcohol.
1 ml fih 9 mg ta ’ benzyl alcohol.
Solution for injection The solution is clear and colourless.
Soluzzjoni għall- injezzjoni Is- soluzzjoni hija ċara u mingħajr kulur.
SDS < -1) in short children/ adolescents born small for gestational age (SGA), with a birth weight and/ or length below -2 standard deviation (SD), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by 4 years of age or later.
deviation score (SDS) ta ’ < - 2. 5 u SDS aġġustat tal- ġenituri ta ’ < - 1) fi tfal qosra/ adolexxenti li twieldu żgħar għaż- żmien tat- tqala (small for gestational age - SGA), li jkollhom piż u/ jew tul taħt - 2 devjazzjonijiet standard/ standard deviations (SD), u li ma jkunx irnexxielhom juru tkabbir li laħaq (veloċita ’ tat- tul/ height velocity (HV) SDS < 0 matul l- aħħar sena) sa l- età ta ’ 4 snin jew iktar tard.
The posology and administration schedule should be individualised.
22 Il- pożoloġija u l- iskeda ta ’ l- għoti għandhom jiġu stabbiliti fuq bażi individwali.
21 Growth disturbance due to insufficient secretion of growth hormone in paediatric patients:
Disturb tat- tkabbir minħabba tnixxija insuffiċjenti ta ’ l- ormon tat- tkabbir f’ pazjenti pedjatriċi:
Generally a dose of 0.025 - 0.035 mg/ kg body weight per day or 0.7 - 1.0 mg/ m2 body surface area per day is recommended.
Ġeneralment doża ta ’ 0. 025- 0. 035 mg kuljum għal kull kilogramm ta ’ piż tal- ġisem jew 0. 7 - 1. 0 mg/ m2 ta ’ erja tas- superfiċje tal- ġisem kuljum hi rakkomandata.
Treatment should not be used in paediatric patients with a growth velocity less than 1 cm per year and near closure of epiphyses.
Il- kura m’ għandhiex tintuża f’ pazjenti pedjatriċi b’ rata tat- tkabbir ta ’ inqas minn 1 ċm kull sena u viċin għeluq ta ’ l- epifisi.
A dose of 0.045 - 0.050 mg/ kg body weight per day or 1.4 mg/ m2 body surface area per day is recommended.
Doża ta ’ 0. 045- 0. 050 mg kuljum għal kull kilogramm ta ’ piż tal- ġisem jew 1. 4 mg/ m2 ta ’ erja tas - superfiċje tal- ġisem kuljum hi rakkomandata.
Growth disturbance in short children/ adolescents born small for gestational age (SGA):
Disturb tat- tkabbir fi tfal qosra/ adolexxenti li twieldu żgħar għaż- żmien tat- tqala (small for gestational age - SGA):
Treatment should be discontinued after the first year of treatment if the height velocity SDS is below + 1.
Il- kura għandha titwaqqaf wara l- ewwel sena ta ’ kura jekk l- SDS tal- veloċita ’ tat- tul ikun taħt + 1.
Treatment should be discontinued if height velocity is< 2 cm/year and, if confirmation is required, bone age is > 14 years (girls) or > 16 years (boys), corresponding to epiphyseal closure.
Il- kura għandha titwaqqaf jekk ir- rata tat- tul hi ta ’ < 2 ċm/ sena u, jekk il- konferma tkun meħtieġa, l- età ta ’ għadam tkun ta ’ > 14- il sena (bniet) jew ta ’ > 16- il sena (subien), li tikkorrispondi għall- għeluq ta ’ l - epifisi.
Patients with normal IGF-I concentrations at the start of the treatment should be administered growth hormone up to an IGF-I level into the upper range of normal, not exceeding the 2 SDS.
Pazjenti b’ konċentrazzjonijiet normali ta ’ IGF- I fil- bidu tal- kura għandhom jingħataw l- ormon tat- tkabbir sa livell ta ’ IGF- I fil- medda tan - naħa ta ’ fuq tan- normal, li ma taqbiżx 2 SDS.
The accuracy of the growth hormone dose should therefore be controlled every 6 months.
Għalhekk, il- preċiżjoni tad- doża ta ’ l- ormon tat- tkabbir għandha tkun
- Hypersensitivity to somatropin or to any of the excipients.
− Sensittività eċċessiva għal somatropin jew għal xi sustanzi mhux attivi.
- Somatropin must not be used when there is any evidence of tumour activity and anti-tumour
− Somatropin ma jridx jintuża meta jkun hemm kwalunkwe evidenza ta ’ attività tat- tumur u t - terapija ta ’ kontra t- tumuri għandha titlesta qabel ma tibda t- terapija b’ somatropin.
- Somatropin must not be used for growth promotion in patients with closed epiphyses.
− Somatropin ma jridx jintuża biex jippromwovi it- tkabbir f’ pazjenti b’ għeluq ta ’ l- epifisi.
abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions must not be treated with somatropin.
− Pazjenti b’ mard kritiku akut li jbatu minn komplikazzjonijiet wara operazzjoni tal- qalb miftuħa, operazzjoni fiż- żaqq, trawma aċċidentali multipla, waqfien akut tan- nifs jew kundizzjonijiet simili, m’ għandhomx jiġu kkurati b’ somatropin.
With regard to patients undergoing substitution therapy, see section 4.4.
Fir- rigward ta ’ pazjenti li jkunu qed jirċievu terapija tas- sostituzzjoni, ara sezzjoni 4. 4).
However, clinical experience has shown that reinstitution of the therapy is often possible without recurrence of the intracranial hypertension.
Jekk il- kura bl- ormon tat -
If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary.
24 tkabbir tinbeda mill- ġdid, monitoraġġ bl- attenzjoni għal sintomi ta ’ pressjoni tad- demm għolja intrakranjali hu meħtieġ.
23 In case of signs of upper airway obstruction, the problem should be solved by a specialist before starting treatment with somatropin.
F’ każ ta ’ sinjali ta ’ ostruzzjoni fin- naħa ta ’ fuq tal- passaġġ tan- nifs, il- problema għandha tiġi solvuta minn speċjalista qabel ma tibda l- kura b’ somatropin.
In short children/ adolescents born SGA, other medical reasons or treatments that could explain growth disturbance should be ruled out before starting treatment.
Fi tfal qosra/ adolexxenti li jitwieldu b’ SGA, raġunijiet mediċi jew kuri oħrajn li jistgħu jispjegaw id - disturb tat- tkabbir għandhom jiġu esklużi qabel ma tibda l- kura.
In SGA children/ adolescents it is recommended to measure the IGF-I level before start of treatment and twice a year thereafter.
Fi tfal/ adolexxenti b’ SGA, hu rakkomandat li jitkejjel il- livell ta ’ l- IGF- I qabel il- bidu tal- kura u darbtejn fis- sena wara dan.
If on repeated measurements IGF-I levels exceed +2 SD compared to references for age and pubertal status, the IGF-I / IGFBP-3 ratio could be taken into account to consider dose adjustment.
Jekk, wara kejl ripetut, il- livelli ta ’ l- IGF- I livelli jaqbżu +2 SD meta mqabbla mal- livelli ta ’ referenza għall- età u l- istat tal- pubertà, il- proporzjon IGF- I / IGFBP- 3 jista ’ jiġi ikkunsidrat biex aġġustament fid- doża jkun ikkunsidrat.
Some of the height gain obtained with treating short children/ adolescents born SGA with growth hormone may be lost if treatment is stopped before final height is reached.
25 Ftit mit- tul li jinkiseb bil- kura ta ’ tfal/ adolexxenti qosra li jitwieldu b’ SGA bl- ormon tat- tkabbir, jista ’ jintilef jekk il- kura titwaqqaf qabel jintlaħaq it- tul finali.
24 treated with 5.3 or 8 mg somatropin daily compared to patients receiving placebo, 42% vs.
Il- mortalità kienet ogħla f’ pazjenti kkurati b’ 5. 3 jew 8 mg ta ’ somatropin kuljum meta mqabbla ma ’ pazjenti li jkunu qed jirċievu l- plaċebo, 42% vs.
Caution should be exercised when Omnitrope is administered to breast-feeding women.
26 Wieħed għandu joqgħod attent meta jikteb riċetta għal Omnitrope jingħata għal nisa li jkunu qed ireddgħu.
Within the organ system classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000).
Fil- kategoriji tas- sistemi ta ’ l- organi, ir- reazzjonijiet avversi huma elenkati taħt titli ta ’ frekwenza (numru ta ’ pazjenti li huma mistennija li jkollhom ir- reazzjoni), bl- użu tal- kategoriji li ġejjin: komuni ħafna (≥ 1/ 10); komuni (≥ 1/ 100, < 1/ 10); mhux komuni (≥ 1/ 1000, < 1/ 100); rari (≥ 1/ 10, 000, < 1/ 1000); rari ħafna (< 1/ 10, 000).
In adults: paraesthesia In adults: carpal tunnel syndrome; In paediatric patients: paraesthesia Benign intracranial hypertension
Fl- adulti: parestesija Fl- adulti: is- sindrome tal- carpal tunnel; F’ pazjenti pedatriċi: parestesija Pressjoni tad- demm għolja intrakranjali beninna
In adults: peripheral oedema; In paediatric patients: transient local skin reactions at the injection site
Fl- adulti: edema periferali; F’ pazjenti pedjatriċi: reazzjonijiet lokali tal- ġilda fis- sit ta ’ l- injezzjoni li jgħaddu malajr
Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia.
27 Doża eċċessiva akuta tista ’ twassal, inizjalment, għal ipogliċemija u, sussegwentement, għal ipergliċemija.
26 concentrations of IGF-I (Insulin-like Growth Factor-I) and IGFBP3 (Insulin-like Growth Factor Binding Protein 3) are increased by somatropin.
Il- konċentrazzjonijiet tas- serum ta ’ IGF- I (Fattur tat- tkabbir li jixbaħ lil insulina/ Insulin- like Growth Factor- I) u ta ’ IGFBP3 (Proteina li torbot 3 Fattur tat- tkabbir li jixbaħ lil insulina / Insulin- like Growth Factor Binding Protein 3) jiżdiedu b’ somatropin.
5.2 Pharmacokinetic properties
28 5. 2 Tagħrif farmakokinetiku
A subcutaneous dose of 5 mg of Omnitrope 3.3 mg/ ml solution for injection in healthy adults results in plasma Cmax and tmax values of 72 ± 28 µg/ l and 4.0 ± 2.0 hours, respectively.
Doża ta ’ 5 mg ta ’ Omnitrope 3. 3 mg/ ml soluzzjoni għall- injezzjoni f’ adulti b’ saħħithom tirriżulta f’ valuri tas- Cmax u tat- tmax tal - plażma ta ’ 72 ± 28 µg/ l u 4. 0 ± 2. 0 sigħat, rispettivament.
However, after subcutaneous administration of Omnitrope 3.3 mg/ ml solution for injection, a half-life of 3 hours is achieved.
Madankollu, wara l- għoti taħt il- ġilda ta ’ Omnitrope 3. 3 mg/ ml soluzzjoni għall- injezzjoni half- life ta ’ 3 sigħat.
An increased chromosome fragility has been observed in one in vitro study on lymphocytes taken from patients after long term treatment with somatropin and following the addition of the radiomimetic medicinal product bleomycin.
Żieda fil- fraġilità tal- kromosomi kienet osservata fi studju in vitro fuq limfoċiti meħuda minn pazjenti wara kura fit- tul b’ somatropin u wara ż- żieda tal- prodott mediċinali radjumimetiku bleomycin.
disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate mannitol poloxamer 188 benzyl alcohol water for injections
disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate mannitol poloxamer 188 benzyl alcohol ilma għall- injezzjonijiet
Shelf life after first use:
Iż- żmien kemm idum tajjeb il- prodott wara l- ewwel użu:
After first use the cartridge should remain in the pen and has to be kept in a refrigerator (2°C - 8°C) for a maximum of 28 days.
Wara l- ewwel użu, l- iskartoċċ għandu jibqa ’ ġol- pinna u għandu jinżamm fi friġġ (2°C - 8°C) sa massimu ta ’ 28 jum.
Store in the original pen in order to protect from light.
Aħżen fil - pinna oriġinali sabiex tilqa ’ mid- dawl.
Unopened cartridge:
Skartoċċ mhux miftuħ:
1.5 ml of solution in a cartridge (colourless type I glass) with plunger on one side (siliconised bromobutyl), a disc (bromobutyl) and a cap (aluminium) on the other side.
1. 5 ml ta ’ soluzzjoni fi skartoċċ (tal- ħġieġ ta ’ tip I, bla kulur), bi planġer fuq naħa waħda (siliconised bromobutyl), disk (bromobutyl) u għatu (aluminju) fuq in- naħa l- oħra.
Pack sizes of 1, 5 and 10.
Daqsijiet tal- pakkett ta ’ 1, 5 u 10.
Omnitrope 3.3 mg/ ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge.
Omnitrope 3. 3 mg/ ml soluzzjoni għall- injezzjoni hija soluzzjoni sterili, lesti għall- użu, biex tingħata taħt il- ġilda, mimlija fi skartoċċ tal- ħġieġ.
It should only be administered with the Omnitrope Pen 5, an injection device specifically developed for use with Omnitrope 3.3 mg/ ml solution for injection.
Għandha tingħata biss b’ Omnitrope Pen 5, tagħmir ta ’ l- injezzjoni li kien żviluppat speċifikament għall- użu b’ Omnitrope 3. 3 mg/ ml soluzzjoni għall- injezzjoni.
Patients and caregivers have to receive appropriate training and instruction on the proper use of the Omnitrope cartridges and the pen from the physician or other suitable qualified health professionals.
Il - pazjenti u persuni li jieħdu ħsieb il- pazjenti, għandhom jirċievu taħriġ adattat u struzzjonijiet dwar l - użu kif suppost ta ’ l- iskartoċċi Omnitrope u l- pinna, mit- tabib jew minn persuni oħrajn adattati professjonali fis- settur tas- saħħa li jkunu kkwalifikati.
The following is a general description of the administration process.
Din li ġejja hi deskrizzjoni ġenerali tal- proċess ta ’ l- għoti.
The manufacturer’ s instructions with each pen must be followed for loading the cartridge, attaching the injection needle and for the administration.
L- istruzzjonijiet tal- manifattur ma ’ kull pinna jridu jiġu segwiti biex timla l- iskartoċċ, biex twaħħal il- labra ta ’ l- injezzjoni u biex tagħti l - mediċina.
If the solution is cloudy or contains particulate matter, it should not be used.
Jekk is- soluzzjoni tkun imċajpra jew ikun fiha materjal f’ sura ta ’ partikuli, din m’ għandhiex tintuża.
The content must be clear and colourless.
Il- kontenut għandu jkun ċara u bla kulur.
Insert the cartridge into the Omnitrope Pen 5 following the instructions for use provided with the pen.
Daħħal l- iskartoċċ f’ Omnitrope Pen 5 billi ssegwi l- istruzzjonijiet għall- użu pprovduti mal - pinna.
Omnitrope 6.7 mg/ ml solution for injection
Omnitrope 6. 7 mg/ ml soluzzjoni għall- injezzjoni
Somatropin* 6.7 mg (corresponding to 20 IU)/ ml.
Somatropin * 6. 7 mg (li jikkorrispondi għal 20 IU).
One cartridge contains 1.5 ml corresponding to 10 mg Somatropin* (30 IU).
Skartoċċ wieħed fih 1. 5 ml li jikkorrispondu għal 10 mg ta ’ Somatropin * (30 IU).
30 Growth disturbance due to insufficient secretion of growth hormone in paediatric patients:
32 Disturb tat- tkabbir minħabba tnixxija insuffiċjenti ta ’ l- ormon tat- tkabbir f’ pazjenti pedjatriċi:
Dose recommendations for paediatric patients
kull kilogramm ta ’ piż tal - ġisem
Indication Growth hormone deficiency Prader-Willi syndrome Turner syndrome Chronic renal insufficiency Children/ adolescents born small for gestational age (SGA)
Defiċjenza ta ’ l- ormon tat- tkabbir Sindrome ta ’ Prader- Willi Sindrome ta ’ Turner Insuffiċjenza kronika tal- kliewi Tfal/ adolexxenti li twieldu żgħar għaż- żmien
mg/ kg body weight dose per day 0.025 - 0.035 0.035 0.045 - 0.050 0.045 - 0.050 0.035
0. 025 - 0. 035 0. 035 0. 045 - 0. 050 0. 045 - 0. 050
mg/ m² area
0. 7 - 1. 0 1. 0 1. 4 1. 4
body surface dose per day 0.7 - 1.0 1.0 1.4 1.4 1.0
tat- tqala (SGA)
The injection should be given subcutaneously and the site varied to prevent lipoatrophy.
33 L- injezzjoni għandha tingħata taħt il- ġilda u s- sit ta ’ l- injezzjoni jinbidel biex tiġi evitata l- lipoatrofija.
For instructions for use and handling see section 6.6.
Għal struzzjonijiet għall- użu u l- immaniġġjar ara sezzjoni 6. 6.
Experience in patients above 60 years is limited.
34 L- esperjenza f’ pazjenti ta ’ iktar minn 60 sena hi limitata.
32 In case of signs of upper airway obstruction, the problem should be solved by a specialist before starting treatment with somatropin.
F’ każ ta ’ sinjali ta ’ ostruzzjoni fin- naħa ta ’ fuq tal- passaġġ tan- nifs, il- problema għandha tiġi solvuta minn speċjalista qabel ma tibda l- kura b’ somatropin.
In chronic renal insufficiency, renal function should be below 50 percent of normal before institution of therapy.
35 F’ insuffiċjenza kronika tal- kliewi, il- funzjoni tal- kliewi għandha tkun taħt il- 50 fil- mija ta ’ dik normali qabel ma tinbeda t- terapija.
33 treated with 5.3 or 8 mg somatropin daily compared to patients receiving placebo, 42% vs.
Il- mortalità kienet ogħla f’ pazjenti kkurati b’ 5. 3 jew 8 mg ta ’ somatropin kuljum meta mqabbla ma ’ pazjenti li jkunu qed jirċievu l- plaċebo, 42% vs.
4.8 Undesirable effects
36 4. 8 Effetti mhux mixtieqa
34 Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
35 Lipid metabolism:
Metaboliżmu tal- lipidi:
A subcutaneous dose of 5 mg of Omnitrope 6.7 mg/ ml solution for injection in healthy adults results in plasma Cmax and tmax values of 74 ± 22 µg/ l and 3.9 ± 1.2 hours, respectively.
Doża ta ’ 5 mg ta ’ Omnitrope 6. 7 mg/ ml soluzzjoni għall- injezzjoni li tingħata taħt il- ġilda f’ adulti b’ saħħithom tirriżulta f’ valuri tas- Cmax u tat- tmax tal- plażma ta ’ 74 + 22 µg/ l u 3. 9 ± 1. 2 sigħat, rispettivament.
Elimination The mean terminal half-life of somatropin after intravenous administration in growth hormone deficient adults is about 0.4 hours.
38 Eliminazzjoni Il- medja tal- half- life terminali ta ’ somatropin wara l- għoti ġol- vina f’ adulti li kellhom defiċjenza ta ’ l - ormon tat- tkabbir hi ta ’ madwar 0. 4 ta ’ siegħa.
However, after subcutaneous administration of Omnitrope 6.7 mg/ ml solution for injection, a half-life of 3 hours is achieved.
Madankollu, wara l- għoti taħt il- ġilda ta ’ Omnitrope 6. 7 mg/ ml soluzzjoni għall- injezzjoni tintlaħaq half- life ta ’ 3 sigħat.
36 In other studies with somatropin regarding general toxicity, local tolerance and reproduction toxicity no clinically relevant effects have been observed.
Fi studji oħrajn b’ somatropin dwar it- tossiċità ġenerali, it- tolleranza lokali u t- tossiċità tar - riproduzzjoni, l- ebda effetti klinikament rilevanti ma kienu osservati.
disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol water for injections
disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol ilma għall- injezzjonijiet
6.4 Special precautions for storage
39 6. 4 Prekawzjonijiet speċjali għall- ħażna
Omnitrope 6.7 mg/ ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge.
Omnitrope 6. 7 mg/ ml soluzzjoni għall- injezzjoni hu soluzzjoni sterili, lesta għall- użu, biex tingħata taħt il- ġilda, mimlija fi skartoċċ tal- ħġieġ.
37 This presentation is intended for multiple use.
Din il- preżentazzjoni hi maħsuba biex tintuża diversi drabi.
It should only be administered with the Omnitrope Pen 10, an injection device specifically developed for use with Omnitrope 6.7 mg/ ml solution for injection.
Għandha tingħata biss b’ Omnitrope Pen 10, tagħmir ta ’ l- injezzjoni li kien żviluppat speċifikament għall- użu b’ Omnitrope 6. 7 mg/ ml soluzzjoni għall- injezzjoni.
Patients and caregivers have to receive appropriate training and instruction on the proper use of the Omnitrope cartridges and the pen from the physician or other suitable qualified health professionals.
Il- pazjenti u persuni li jieħdu ħsieb il- pazjenti, għandhom jirċievu taħriġ adattat u struzzjonijiet dwar l- użu kif suppost ta ’ l- iskartoċċi Omnitrope u l- pinna, mit- tabib jew minn persuni oħrajn adattati professjonali fis- settur tas- saħħa li jkunu kkwalifikati.
2.
L- idejn għandhom jinħaslu 2.
Disinfect the rubber membrane of the cartridge with a cleansing swab 4.
Iddiżinfetta l- membrana tal- lastku ta ’ l- iskartoċċ b’ biċċa li tnaddaf 4.
Insert the cartridge into the Omnitrope Pen 10 following the instructions for use provided with the pen.
Daħħal l- iskartoċċ fl- Omnitrope Pen 10 billi ssegwi l- istruzzjonijiet għall- użu pprovduti mal - pinna.
12 April 2006
12 t’ April 2006
38 ANNEX II
41 ANNESS II
39 A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria
Sandoz GmbH Biochemiestrasse 10 6250 Kundl Awstrija
The MAH must ensure that the system of pharmacovigilance, as described in version 4.3 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Id- Detentur ta ’ l- Awtorizzazzjoni tal- Manifattura jrid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 4. 3, ippreżentata f’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat - Tqegħid fis- Suq, tkun implimentata u taħdem qabel u waqt li l- prodott jibda jinbiegħ.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 5.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni tal- Manifattura jrid ikun obbligat li jwettaq l- istudji u attivitajiet addizzjonali ta ’ farmakoviġilanza deskritti fil- Pjan tal- Farmakoviġilanza, kif maqbul f’ verżjoni 5. 0 tal - Pjan dwar l- Immaniġġjar tar- Riskju (Risk Management Plan - RMP) ippreżentat f’ Modulu 1. 8. 2. ta ’ l - Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, u kwalunkwe aġġornamenti sussegwenti tal- RMP li kienu maqbula mis- CHMP.
In addition, an updated RMP should be submitted
Flimkien ma ’ dan, RMP aġġornat għandu jkun sottomess
- When new information is received that may impact on the current Safety Specification,
- Meta informazzjoni ġdida tkun irċevuta li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà
Pharmacovigilance Plan or risk minimization activities
kurrenti, fuq il- Pjan tal- Farmakoviġilanza jew fuq attivitajiet li jimminimizzaw ir- riskju
- Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
- Fi żmien 60 jum minn meta tintlaħaq milestone importanti (farmakoviġilanza jew
reached
minimizzazzjoni tar- riskju)
- At the request of the EMEA
- Fuq talba tal- EMEA
41 ANNEX III
44 ANNESS III
Omnitrope 1.3 mg/ ml powder and solvent for solution for injection Somatropin
Omnitrope 1. 3 mg/ ml trab u solvent għal soluzzjoni għall- injezzjoni Somatropin
Somatropin 1.3 mg (4 IU)/ ml in a vial.
Somatropin 1. 3 mg (4 IU) / ml f’ kunjett.