qanastek/EMEA-V3 huggingface dataset:
As with all medicinal products, a small percentage of patients may develop antibodies to the protein somatropin.
Bħal kull prodott mediċinali, persentaġġ żgħir ta ’ pazjenti jistgħu jiżviluppaw antikorpi għall- proteina somatropin.
The binding capacity of growth hormone antibodies was lower than 2 mg/ l in NutropinAq subjects tested, which has not been associated with adversely affected growth rate.
Il- kapaċità ta ’ twaħħil ta ’ l- antikorpi ta ’ l- ormon tat- tkabbir kienet inqas minn 2 mg/ l fis - suġġetti b’ NutropinAq ittestjati, u ma kienetx assoċjata ma ’ effett negattiv fuq ir- rata ta ’ tkabbir.
Leukaemia has been reported in a small number of growth hormone deficient patients treated with growth hormone.
Lewkimja kienet irrappurtata f’ għadd żgħir ta ’ pazjenti b’ defiċjenza ta ’ l- ormon tat- tkabbir kkurati bl - ormon tat- tkabbir.
A causal relationship to somatropin therapy is unlikely.
Relazzjoni każwali mal- kura b’ somatropin mhux probabbli.
Patients with endocrinological disorders are more prone to develop an epiphysiolysis.
Pazjenti b’ mard endokrinoloġiku huma aktar probabbli li jiżviluppaw epifisiolisis.
Indication-specific adverse drug reactions from clinical trials
Effetti avversi speċifiċi għall- indikazzjoni minn provi kliniċi
Patients with growth failure due to inadequate growth hormone secretion Common: central nervous system neoplasm.
Pazjenti b’ falliment tat - tkabbir minħabba sekrezzjoni inadegwata ta ’ ormon ta ’ tkabbir Komuni: neoplażma fis- sistema nervuża ċentrali.
Patients with growth failure associated with Turner syndrome Common: menorrhagia.
Pazjenti b’ falliment tat - tkabbir assoċjat mas- sindromu ta ’ Turner Komuni: fsada qawwija aktar min- normal waqt il- mestrwazzjoni.
6 Patients with growth failure associated with chronic renal insufficiency Common: renal failure, peritonitis, osteonecrosis, blood creatinine increase.
6 Pazjenti b’ falliment tat - tkabbir assoċjat ma ’ insuffiċjenza kronika tal- kliewi Komuni: falliment tal- kliewi, peritonite, osteonecrosis, żieda tal- creatinina fid- demm.
Children with chronic renal insufficiency receiving NutropinAq are more likely to develop intracranial hypertension.
Tfal b’ insuffiċjenza kronika tal- kliewi li qed jirċievu NutropinAq huma aktar probabbli li jiżviluppaw ipertensjoni fil- kranju.
The greatest risk is at the beginning of treatment.
L- akbar riskju huwa fil- bidu tal- kura.
Adults with growth hormone deficiency Very common: paraesthesia.
Adulti b’ nuqqas ta ’ l- ormon tat- tkabbir Komuni ħafna: parasteżija.
Common: hyperglycaemia, hyperlipidaemia, insomnia, synovial disorder, arthrosis, muscular weakness, back pain, breast pain, gynaecomastia.
Komuni: ipergliċemija, iperlipidemija, insomnija, mard fil- fluwidu sinovjali, artrożi, djgħufija fil - muskoli, uġigħ fid- dahar, uġigħ fis- sider, żvilupp eċċessiv tas- sider fir- raġel.
Acute overdose could lead to hyperglycaemia.
Doża eċċessiva akuta tista ’ twasal għal ipergliċemija.
Long-term overdose could result in signs and symptoms of gigantism and/ or acromegaly consistent with the known effects of excess growth hormone.
Doża eċċessiva fit- tul tista ’ twassal għal sinjali u sintomi ta ’ ġigantiżmu u/ jew akromegalija konsistenti ma ’ l- effetti magħrufa ta ’ eċċess tal- ormon tat - tkabbir.
Somatropin and analogues, ATC Code:
Somatropin u analogi, Kodiċi ATC:
Somatropin stimulates growth rate and increases adult height in children who lack endogenous growth hormone.
Somatropin jistimola ir- rata ta ’ tkabbir u jżid it- tul adult fit- tfal li għandhom nuqqas tal- ormon tat - tkabbir endoġenu.
Treatment of growth hormone deficient adults with somatropin results in reduced fat mass, increased lean body mass and increased spine bone mineral density.
Kura ta ’ adulti li għandhom nuqqas tal- ormon tat- tkabbir b’ somatropin jirriżulta għal tnaqqis fil- massa tax- xaħam, żieda fil- massa bla xaħam tal- ġisem u żieda fid- densità tal- minerali ta ’ l- għadam fl- ispina.
Metabolic alterations in these patients include normalisation of IGF-1 serum levels.
Tibdliet metaboliċi f’ dawn il- pazjenti jikludu normaliżazzjoni tal- livelli ta ’ IGF- 1 fis- serum.
In vitro and in vivo preclinical and clinical tests have demonstrated that somatropin is therapeutically equivalent to human growth hormone of pituitary origin.
Testijiet prekliniċi u kliniċi in vitro u in vivo wrew li somatropin huwa ekwivalenti terapewtikament għall- ormon tat- tkabbir uman li ġej mill- glandola pitwitarja.
Actions that have been demonstrated for human growth hormone include:
Azzjonijiet ta ’ l- ormon tat- tkabbir li ġew dimostrati jinkludu:
Tissue Growth 1.
Tkabbir tat- Tessuti 1.
Skeletal growth: growth hormone and its mediator IGF-1 stimulate skeletal growth in growth hormone deficient children by an effect on the epiphyseal plates of long bones.
Tkabbir skeletali: l- ormon tat- tkabbir u l- medjatur tiegħu IGF- 1 jistimolaw tkabbir skeletali fi tfal b’ defiċjenza tal- ormon tat- tkabbir permezz ta ’ effett fuq il- plejt tal- epifisis tal- għadam it- twal.
This results in a measurable increase in body length until these growth plates fuse at the end of puberty.
Dan iwassal għal żieda fit- tul tal- ġisem li tista ’ titkejjel sakemm dawn il- postijiet ta ’ tkabbir jingħaqdu fl - aħħar tal- puberta.
Cell growth:
Tkabbir taċ- Ċelloli:
Treatment with somatropin results in an increase in both the number and size of skeletal muscle cells.
Kura b’ somatropin iwassal għal żieda kemm fil- għadd kif ukoll fid- daqs taċ - ċelloli tal- muskoli skeletali.
Organ growth:
Tkabbir ta ’ l- Organi:
Growth hormone increases the size of internal organs, including kidneys, and increases red blood cell mass.
L- ormon tat- tkabbir iżid id- daqs tal- organi interni, inkluż kliewi, u jżid il - massa ta ’ ċelloli ħomor tad- demm.
Protein metabolism Linear growth is facilitated in part by growth hormone-stimulated protein synthesis.
Metaboliżmu tal- proteina Tkabbir lineari huwa ffaċilitat parzjalment minn sintesi tal- proteini stimulati mill- ormon tat- tkabbir.
This is reflected by nitrogen retention as demonstrated by a decline in urinary nitrogen excretion and blood urea nitrogen during growth hormone therapy.
Dan huwa rifless minn żamma tan- nitroġenu hekk kif muri mit- tnaqqis fit- tneħħija tan- nitroġenu fl - awrina u tnaqqis fin- nitroġenu tal- urea fid- demm waqt terapija bl- ormon tat- tkabbir.
Carbohydrate metabolism Patients with inadequate growth hormone secretion sometimes experience fasting hypoglycaemia that is improved by treatment with somatropin.
7 Metaboliżmu tal- karboidrati Pazjenti b’ sekrezzjoni inadegwata tal- ormon tat- tkabbir xi kultant ikollhom ipogliċemija tas- sawm li titjieb bil- kura b’ somatropin.
Growth hormone therapy may decrease insulin sensitivity and impair glucose tolerance.
Terapija bl- ormon tat- tkabbir tista ’ tnaqqas is- sensitività tal- insulina u jnaqqas it- tolleranza għall- glukożju.
7 Somatropin induces retention of sodium, potassium and phosphorus.
Metaboliżmu tal- minerali Somatropin jinduċi żamma tas- sodju, potassju u fosforu.
Serum concentration of inorganic phosphorus are increased in patients with growth hormone deficiency after NutropinAq therapy due to metabolic activity associated with bone growth and increased tubular reabsorption in the kidney.
Konċentrazzjoni fis- serum tal- fosforu inorganiku tiżdied f’ pazjenti b’ defiċjenza tal- ormon tat- tkabbir wara terapija b’ NutropinAq minħabba attività metabolika assoċjata ma ’ tkabbir tal- għadam u żieda fir- riassorbiment tubolari fil- kliewi.
Serum calcium is not significantly altered by somatropin.
Kalċju fis- serum mhux mibdul b’ mod sinnifikanti minn somatropin.
Adults with growth hormone deficiency show low bone mineral density and in the childhood-onset patient, NutropinAq has been shown to increase spine bone mineral density in a dose-dependent manner.
Adulti b’ defiċjenza tal- ormon tat - tkabbir juru densità tal- minerali fl- għadam baxxa u f’ pazjent bi żvilupp fit- tfulija, NutropinAq intwera li jżid id- densità tal- minerali fl- għadam ta ’ l- ispina b’ mod li jiddependi mid- doża.
Connective tissue metabolism Somatropin stimulates the synthesis of chondroitin sulphate and collagen as well as the urinary excretion of hydroxyproline.
Metaboliżmu tal- connective tissue Somatropin jistimola is- sinteżi ta ’ chondroitin sulphate u collagen kif ukoll it- tneħħija fl- awrina ta ’ hydroxyproline.
Body composition Adult growth hormone deficient patients treated with somatropin at a mean dosage of 0.014 mg/ kg bodyweight daily demonstrate a decrease in fat mass and increase in lean body mass.
Kompożizzjoni tal- ġisem Pazjenti adulti b’ defiċjenza tal- ormon tat- tkabbir kkurati b’ somatropin b’ doża medja ta ’ 0. 014 mg/ kg piż tal- ġisem kuljum urew tnaqqis fil- massa tax- xaħam u żieda fil- massa bla xaħam tal- ġisem.
When these alterations are coupled with the increase in total body water and bone mass, the overall effect of somatropin therapy is to modify body composition, an effect that is maintained with continued treatment.
Meta dawn it- tibdiliet huma abbinati maż- żieda fl- ilma totali tal- ġisem u l- massa ta ’ l- għadam, l- effett globali ta ’ kura b’ somatropin huwa li jimmodifika l- kompożizzjoni tal- ġisem, effett li jinżamm b’ kura kontinwa.
General characteristics
Karatteristiċi ġenerali
The pharmacokinetic properties of NutropinAq have only been investigated in healthy adult males.
Il- kwalitajiet farmakokinetiċi ta ’ NutropinAq ġew investigati biss f’ irġiel adulti b’ saħħithom.
The absolute bioavailability of recombinant human growth hormone after subcutaneous administration is about 80%.
Il- bijodisponibilità assoluta ta ’ l- ormon tat- tkabbir uman rikombinat wara għotja taħt il - ġilda hija ta ’ madwar 80%.
Animal studies with somatropin showed that growth hormone localises to highly perfused organs, particularly the liver and kidney.
Studji fl- annimali b’ somatropin urew li l- ormon tat- tkabbir huwa lokalizzat fl- organi li għandhom perfużjoni għolja, speċjalment il- fwied u l- kliewi.
The volume of distribution at steady state for somatropin in healthy adult males is about 50 ml/ kg bodyweight, approximating the serum volume.
Il- volum ta ’ distribuzzjoni fi stat stabbli ta ’ somatropin f’ irġiel adulti b’ saħħithom huwa ta ’ madwar 50 ml/ kg piż tal- ġisem, ftit jew wisq il - volum tas- serum.
Both the liver and the kidney have been shown to be important protein catabolising organs for growth hormone.
Kemm il- fwied kif ukoll il- kilwa intwerew li huma organi importanti għall- katabolizmu ta ’ proteini għall- ormon tat- tkabbir.
Animal studies suggest that the kidney is the dominant organ of clearance.
Studji fl- annimali jissuġġerixxu li l - kilwa hija l- organu prinċipali għat- tneħħija.
Growth hormone is filtered at the glomerulus and reabsorbed in the proximal tubules.
L- ormon tat- tkabbir huwa ffiltrat fil- glomerulus u assorbit mil- ġdid fit- tubi prossimali.
It is then cleaved within renal cells into its constituent amino acids, which return to the systemic circulation.
Wara huwa maqsum ġewwa ċ- ċelloli tal- kliewi fl- amino aċidi kostitwenti, li jirritornaw fiċ - ċirkolazzjoni sistemika.
After subcutaneous bolus administration, the mean terminal half-life t½ of somatropin is about 2.3 hours.
Wara għotja waħda taħt il- ġilda, l- half- life t½ terminali medja ta ’ somatropin hija ta ’ madwar 2. 3 sigħat.
After intravenous bolus administration of somatropin, the mean terminal half-life t½β or t½ γ is about 20 minutes and the mean clearance is reported to be in the range of 116 - 174 ml/ h/ kg.
Wara għotja waħda ta ’ somatropin ġol- vina, l- half- life t½β jew t½γ terminali medja hija ta ’ madwar 20 minuta u t- tneħħija medja hija rrappurtata li hija fir- raġġ ta ’ 116 - 174 ml/ h/ kg.
Available literature data suggest that somatropin clearance is similar in adults and children.
Tagħrif ta ’ letteratura disponibbli jissuġġerixxi li t- tneħħija ta ’ somatropin hija simili fl- adulti u fit - tfal.
Characteristics in patients
8 Karatteristiċi fil- pazjenti
Clearance and mean terminal half-life t½ of somatropin in adult and paediatric growth hormone deficient patients are similar to those observed in healthy subjects.
It- tneħħija u l- half- life t½ terminali medja ta ’ somatropin fl- adulti u f’ pazjenti pedjatriċi b’ defiċjenza tal- ormon tat- tkabbir huma simili għal dawk osservati f’ soġġetti b’ saħħithom.
Children and adults with chronic renal failure and end-stage renal disease tend to have decreased clearance compared to normal subjects.
Hemm tendenza li tfal u adulti b’ falliment kroniku tal- kliewi u mard tal- kliewi ta ’ l- aħħar stadju jkollhom tneħħija mnaqqsa meta mqabbla ma ’ soġġetti normali.
Endogenous growth hormone production may also increase in some individuals with end-stage renal disease.
Produzzjoni ta ’ l- ormon tat- tkabbir endoġenu jista ’ wkoll jiżdied f’ ċertu individwi b’ mard tal- kliewi ta ’ l- aħħar stadju.
However, no somatropin accumulation has been reported in children with chronic renal failure or end-stage renal disease dosed with current regimens.
Iżda, ma ġiet irrappurtata l- ebda ’ akkumulazzjoni ta ’ somatropin fi tfal b’ falliment kroniku tal- kliewi jew mard tal - kliewi ta ’ l- aħħar stadju meta ngħataw dożi skond id- dożaġġi kurrenti.
Limited published data for exogenously-administered somatropin suggest absorption and elimination half-lives and time of maximum concentration tmax in Turner patients are similar to those observed in both normal and growth hormone deficient populations.
Tagħrif ippublikat limitat dwar somatropin mogħti b’ mod esoġenu jissuġġerixxi half- lives ta ’ assorbmient u eliminazzjoni u ħin sakemm tintlaħaq konċetrazzjoni massima tmax f’ pazjenti b’ Turner simili għal dawk osservati kemm f’ popolazzjoni normali kif ukoll f’ dik b’ defiċjenza tal- ormon tat- tkabbir.
8 In patients with severe liver dysfunction a reduction in somatropin clearance has been noted.
F’ pazjenti b’ funzjoni ħażina severa tal- fwied ġie nnutat tnaqqis fit- tneħħija ta ’ somatropin.
The clinical significance of this decrease is unknown.
Is - sinnifikat kliniku ta ’ dan it- tnaqqis mhux magħruf.
The toxicity of NutropinAq has been tested in rats and monkeys and no findings of toxicological relevance were revealed.
It- tossiċità ta ’ NutropinAq ġiet studjata fil- firien u xadini u ma kienx hemm sejbiet ta ’ rilevanza tossikoloġika.
Due to its hormonal activity, somatropin may exert a promotional effect on tumour growth in tumour- bearing subjects.
Minħabba l- attività ormonali tiegħu, somatropin jista ’ jkollu effetti li jippromovi t- tkabbir tat- tumur f’ soġġetti li għandhom tumur.
To date, this has not been confirmed in patients.
S’ issa, dan ma ġiex ikkonfermat f’ pazjenti.
Local tolerance studies with NutropinAq showed no substantial adverse local reactions.
Studji dwar it- tolleranza lokali b’ NutropinAq ma wrew l- ebda reazzjoni avversa lokali sostanzjali.
Studies in transgenic mice suggest a low antibody provoking potential of (aged) liquid Nutropin.
Studji fi ġrieden transġeniċi jissuġġerixxu potenzjal baxx ta ’ Nutropin likwidu (mkabbar) li jistimola antikorpi.
No common reproduction studies were performed.
Ma sarux studji komuni fuq ir- riproduzzjoni.
However, long-term treatment of monkeys during pregnancy and lactation and of newborn animals until adolescence, sexual maturity and reproduction did not indicate substantial disturbances of fertility, pregnancy, delivery, nursing or development of progeny.
Iżda kura fit- tul ta ’ xadini waqt tqala u treddigħ u ta ’ annimali li għadhom jitwieldu sal- adolexxenza, maturità sesswali u riproduzzjoni ma ndikaw l- ebda disturbi sostanzjali fil- fertilità, tqala, ħlas, treddigħ jew żvilupp tal- frieħ.
Sodium chloride Phenol Polysorbate 20 Sodium citrate and citric acid anhydrous Water for injections
Sodium chloride Phenol Polysorbate 20 Sodium citrate u citric acid anhydrous Ilma għall- injezzjoni
Chemical and physical in-use stability has been demonstrated for 28 days at 2°C - 8°C.
Stabbilità kimika u fiżika waqt l- użu ġiet murija għal 28 ġurnata f’ temperatura ta ’ 2°C - 8°C.
From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 2°C - 8°C.
9 Mikrobijoloġikament, ladarba jinfetaħ, il- prodott jista ’ jinħażen sa massimu ta ’ 28 ġurnata f’ temperatura ta ’ 2°C - 8°C.
NutropinAq is designed to withstand a nominal (one hour maximum) period of time outside of the refrigerator on a daily basis.
NutropinAq huwa maħsub sabiex jiflaħ perjodu ta ’ ħin kuljum (massimu ta ’ siegħa) barra mill- friġġ.
Keep the blister in the outer carton
Żomm il- folja fil- kartuna ta ’ barra.
For in-use storage conditions of the medicinal product, see section 6.3.
Għall- kundizzjonijiet ta ’ ħażna tal- prodott mediċinali waqt l- użu, ara sezzjoni 6. 3.
2 ml of solution in a cartridge (Type I glass) closed with a stopper (butyl rubber) and a seal (rubber).
2 ml ta ’ soluzzjoni fi skartoċċ (ħġieġ ta’ Tip I) magħluq b’ tapp (lasktu butyl) u siġill (lasktu).
Pack sizes of 1, 3 and 6 cartridges.
Daqs ta ’ pakketti ta ’ 1, 3 u 6 skrataċ.
Instructions for use and handling
Istruzzjonijiet għall- użu u mmaniġġjar
NutropinAq is supplied as a sterile solution with preservative for multiple use.
NutropinAq huwa pprovdut bħala soluzzjoni sterili li fiha preservattiv għall- użu multiplu.
The solution should be clear immediately after removal from the refrigerator.
Is - soluzzjoni trid tkun ċara hekk kif titneħħa mill- friġġ.
If the solution is cloudy, the content must not be injected.
Jekk is- soluzzjoni tkun imċajpra, il- kontenut m’ għandux jiġi injettat.
Gently swirl.
Ħawwad billi d- dawwar bil- mod.
Do not shake vigorously in order not to denature the protein.
Tħawwadx bis- saħħa sabiex ma tbiddilx in - natura tal- proteina.
NutropinAq is intended for use only with the NutropinAq Pen.
NutropinAq huwa maħsub sabiex jintuża biss mal- Pinna NutropinAq.
Wipe the rubber seal of the NutropinAq with rubbing alcohol or an antiseptic solution to prevent contamination of the contents by microorganisms that may be introduced by repeated needle insertions.
Imsaħ is- siġill tal- lasktu ta ’ NutropinAq bl- alkoħol jew soluzzjoni antisettika sabiex tipprevjeni kontaminazzjoni tal- kontenuti minn mikro- organiżmi li jistgħu jiddaħħlu minn inserzjoni ripetuta tal- labra.
It is recommended that NutropinAq be administered using sterile, disposable needles.
Huwa rakkomandat li NutropinAq jingħata permezz ta ’ labar sterili li jintużaw darba biss.
The NutropinAq Pen allows for administration of a minimum dose of 0.1 mg to a maximum dose of 4.0 mg, in 0.1 mg increments.
Il- Pinna NutropinAq tippermetti l- għotja ta ’ doża minima ta ’ 0. 1 mg sa doża massima ta ’ 4. 0 mg, f’ żiediet ta ’ 0. 1 mg.
A cartridge that is in the pen should not be removed during injections.
Skartoċċ li jkun fil- pinna, m’ għandux jitneħħa waqt injezzjonijiet.
190 Bath Road Slough, Berkshire SL1 3XE, United Kingdom
190 Bath Road Slough, Berkshire SL1 3XE, Renju Unit
Date of first authorisation:16 February 2001 Date of last renewal:
16 ta’ Frar 2001 Data ta ’ l- aħħar tiġdid:
16 February 2006
16 ta’ Frar 2006
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- mediċini (EMEA) http: // www. emea. europa. eu
11 A MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
11 ANNESS II
1 DNA Way South San Francisco CA 94080-4990 USA
1 DNA Way South San Francisco CA 94080- 4990 Stati Uniti
Ipsen Pharma Biotech SAS Parc d’ Activités du Plateau de Signes Chemin Départemental no 402 83870 Signes France
Ipsen Pharma Biotech SAS Parc d’ Activités du Plateau de Signes Chemin Départemental no 402 83870 Signes Franza
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING {CARTON - 1 CARTRIDGE}
15 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT
NutropinAq 10 mg/ 2 ml (30 IU), solution for injection Somatropin
NutropinAq 10 mg/ 2 ml (30 IU), soluzzjoni għall- injezzjoni Somatropin
2 ml of solution contains:
2 ml ta ’ soluzzjoni fiha:
10 mg (30 IU) of somatropin
10 mg (30 IU) ta ’ somatropin
Other ingredients: sodium chloride, phenol, polysorbate 20, sodium citrate, citric acid anhydrous and water for injections.
Ingredjenti oħra: sodium chloride, phenol, polysorbate 20, sodium citrate, citric acid anhydrous u ilma għall- injezzjoni.
1 cartridge containing 2 ml solution for injection
Skartoċċ wieħed fih 2 ml ta ’ soluzzjoni għall- injezzjoni
Subcutaneous use Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Store in a refrigerator.
Aħżen fi friġġ (2°C – 8°C).
Keep the blister in the outer carton.
Żomm il- folja fil- kartuna ta ’ barra.
Chemical and physical in-use stability has been demonstrated for 28 days at 2°C - 8°C.
16 Stabilita kimika u fiżika waqt l- użu ġiet demostrata għal 28 ġurnata f’ temperatura ta ’ 2°C - 8°C.
From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 2°C - 8°C.
Mikrobijoloġikament, ladarba jinfetaħ, il- prodott jista ’ jinħażen sa massimu ta ’ 28 ġurnata f’ temperatura ta ’ 2°C - 8°C.
Marketing Authorisation Holder:
Dententur ta ’ l- Awtorizazzjoni għat- Tqegħid fis- Suq:
IPSEN Ltd,190 Bath Road, Slough, Berkshire, SL1 3XE, UK
IPSEN Ltd, 190 Bath Road, Slough, Berkshire, SL1 3XE, Renju Unit
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING {CARTON - 3 CARTRIDGES}
{PAKKETT - 3 SKRATAĊ}
3 cartridges containing 2 ml solution for injection
3 skrataċ li fihom 2 ml ta ’ soluzzjoni għall- injezzjoni
Store in a refrigerator.
Aħżen fil- friġġ (2°C - 8°C).
Keep the blister in the outer carton.
Żomm il- folja fil- kaxxa ta ’ barra.
Chemical and physical in-use stability has been demonstrated for 28 days at 2°C - 8°C.
Stabilita kimika u fiżika waqt l- użu ġiet demostrata għal 28 ġurnata f’ temperatura ta ’ 2°C - 8°C.
IPSEN Ltd, 190 Bath Road, Slough, Berkshire, SL1 3XE, UK
IPSEN Ltd, 190 Bath Road, Slough, Berkshire, SL1 3XE, Renju Unit
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING {CARTON - 6 CARTRIDGES}
{PAKKETT - 6 SKRATAĊ}
NutropinAq 10 mg/ 2 ml (30IU), solution for injection Somatropin
NutropinAq 10 mg/ 2 ml (30 IU), soluzzjoni għall- injezzjoni Somatropin
6 cartridges containing 2 ml solution for injection
6 skrataċ li fihom 2 ml ta ’ soluzzjoni għall- injezzjoni
20 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {BLISTER}
21 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
NutropinAq 10 mg/ 2 ml (30IU) solution for injection Somatropin
NutropinAq 10 mg/ 2 ml (30 IU) soluzzjoni għall- injezzjoni Somatropin
Store in a refrigerator.
Aqra l- fuljett ta ’ tagħrif qabel l- użu Aħżen fil- friġġ.
21 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {CARTRIDGE}
22 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
NutropinAq 10 mg/ 2 ml (30 IU) solution for injection Somatropin
NutropinAq 10 mg/ 2 ml (30 IU) soluzzjoni għall- injezzjoni Somatropin
What NutropinAq is and what it is used for 2.
X’ inhu NutropinAq u għalxiex jintuża 2.
Before you use NutropinAq 3.
Qabel ma tuża NutropinAq 3.
How to use NutropinAq 4.
Kif għandek tuża NutropinAq 4.
How to store NutropinAq 6.
Kif taħżen NutropinAq 6.
WHAT NutropinAq IS AND WHAT IT IS USED FOR
X’ INHU NutropinAq U GĦALXIEX JINTUŻA
Somatropin has effects that are equivalent to human growth hormone of pituitary origin.
Somatropin għandu effetti li huma ekwivalenti għall- ormon uman tat- tkabbir ta ’ oriġini mill- glandola pitwitarja.
Growth hormone exerts significant effects directly on the production of other hormones, e. g.
L- ormon uman tat- tkabbir jeżerċita effetti sinifikanti direttament fuq il- produzzjoni ta ’ ormoni oħra, e. ż.
IGF-1, and on metabolic actions.
IGF- 1, u fuq azzjonijiet metaboliċi.
The anabolic and growth-promoting effects of somatropin are to some part indirect effects mediated by IGF-1.
L- effetti anaboliċi u li jippromwovu t- tkabbir ta ’ somatropin, huma sa ċertu punt effetti indiretti medjati minn IGF- 1.
NutropinAq is indicated for:
NutropinAq huwa indikat għal:
• Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion. • Long-term treatment of growth failure associated with Turner syndrome. • Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. • Replacement of growth hormone in adults with growth hormone deficiency originating in either childhood or adulthood.
• Kura fit- tul ta ’ tfal b’ falliment tat- tkabbir minħabba sekrezzjoni inadegwata ta ’ l- ormon ta ’ tkabbir endoġenu. • Kura fit- tul ta ’ falliment ta ’ tkabbir assoċjat mas- sindromu ta ’ Turner. • Kura ta ’ tfal qabel il- pubertà b’ falliment tat- tkabbir assoċjat ma ’ insuffiċjenza kronika tal- kliewi sa meta jkun iż- żmien għal trapjant tal- kliewi. • Sostituzzjoni ta ’ l- ormon tat- tkabbir f’ adulti b’ nuqqas ta ’ l- ormon tat- tkabbir li jibda ’ jew fit - tfulija jew f’ età adulta.
BEFORE YOU USE NutropinAq
QABEL MA TUŻA NutropinAq
Do not use NutropinAq
Tużax NutropinAq
• If you are allergic (hypersensitive) to somatropin or any of the other ingredients of NutropinAq. • For growth promotion if growing is already finished. • If an active tumour arises.
• Jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal somatropin jew sustanzi oħra ta ’ NutropinAq. • Għall- promozzjoni tat- tkabbir jekk it- tkabbir diġà spiċċa. • Jekk iseħħ tumur attiv.
Somatropin therapy should be discontinued if evidence of tumour growth develops. • During acute critical illness due to complications following open-heart or abdominal surgery, multiple accidental trauma, or in case of acute respiratory failure.
Terapija b’ somatropin għandha titwaqqaf jekk ikun hemm żvilupp ta ’ evidenza ta ’ tkabbir ta ’ tumur. • Waqt mard kritiku akut minħabba komplikazzjonijiet wara kirurġija fil- qalb open- heart jew fl - addome, korriment aċċidentali multiplu, jew f’ każ ta ’ falliment respiratorju akut.
24 Take special care with NutropinAq
25 Oqgħod attent ħafna b ’ NutropinAq
• In patients with previous malignant disease, the doctor should give special attention to signs and symptoms of relapse. • In patients with a history of brain lesions, the patient should be examined frequently for a progression or recurrence of the lesion. • Children with Prader-Willi syndrome should not be treated with NutropinAq unless they are also suffering from growth hormone failure. • In patients with acute critical illness in intensive care units, the doctor should carefully evaluate the safety of continuing somatropin treatment. • If during growing a limp or hip or knee pain develops, please ask the doctor for advice. • Scoliosis may progress in any child during rapid growth.
• F’ pazjenti b’ mard malinn minn qabel, it- tabib għandu jagħti attenzjoni speċjali għal sinjali u sintomi ta ’ rkadar. • F’ pazjenti b’ passat ta ’ leżjonijiet fil- moħħ, il- pazjent għandu jiġi eżaminat spiss għall - proggressjoni jew rikorrenza tal- leżjoni. • Tfal bis- sindromu ta ’ Prader- Willi m’ għandhomx jiġu kkurati b’ NutropinAq sakemm mhux qed isofru wkoll minn falliment ta ’ l- ormon tat- tkabbir. • F’ pazjenti b’ mard kritiku akut fit- taqsima ta ’ kura ntesiva, it- tabib għandu jivvaluta b’ attenzjoni s- sigurtà li titkompla l- kura b’ somatropin. • Jekk waqt it- tkabbir jiżviluppa mixi mzappap, jew uġigħ fl- irkoppa jew fil- ġembejn, jekk jogħġbok saqsi lit- tabib għall- parir. • Skoljożi tista ’ tiżviluppa f’ kull tifel/ a waqt żvilupp mgħaġġel.
Signs of scoliosis should be monitored during treatment. • In patients receiving NutropinAq, evidence of glucose intolerance should be monitored.
Sinjali ta ’ skoljożi għandhom jiġu sorveljati waqt il- kura. • F’ pazjenti li qed jirċievu NutropinAq, evidenza ta ’ ntolleranza għall- glukożju għandha tiġi sorveljata.
If the patient also has diabetes mellitus, please consult the doctor regularly during NutropinAq therapy.
Jekk il- pazjent għandu wkoll dijabete mellitus, jekk jogħġbok ikkonsulta t- tabib b’ mod regolari waqt terapija b’ NutropinAq.
The insulin dose may require adjustment after somatropin therapy is started. • This medicinal product contains 82 mg of sodium per cartridge.
Jista ’ jkun hemm bżonn ta ’ aġġustament fid- doża ta ’ l - insulina wara li tinbeda t- terapija b’ somatropin. • Dan il- prodott mediċinali fih 82 mg ta ’ sodju f’ kull skartoċċ.
To be taken in consideration by patients on a controlled sodium diet. • If symptoms like visual changes, headache, nausea and/ or vomiting occur, especially within the first eight weeks after starting somatropin therapy, please ask the doctor for advice. • In case of an untreated decrease of thyroid gland function (hypothyroidism), the optimal response to somatropin may be reduced.
Konsiderazzjoni ta ’ dan għandha tittiħed minn pazjenti fuq dieta b’ sodju kkontrollat. • Jekk iseħħu sintomi bħal tibdil fil- vista, uġigħ ta ’ ras, dardir u/ jew remettar, speċjalment fl- ewwel tmin ġimgħat wara li tinbeda terapija b’ somatropin, jekk jogħġbok saqsi lit- tabib għall- parir. • F’ każ ta ’ funzjoni mnaqqsa tal- glandola tat- tirojde (ipotirojdiżmu) mhux ikkurata, r- rispons ottimu għal somatropin jista ’ jkun mnaqqas.
Severe hypothyroidism has to be treated prior to start of NutropinAq therapy. • Since somatropin therapy following renal transplantation has not been adequately tested, growth hormone treatment should be terminated after that surgery. • Adrenocorticotrophic Hormone (ACTH) -deficient patients should consult the doctor regularly during growth hormone therapy.
Ipotirojdiżmu sever irid jiġi kkurat qabel ma tinbeda terapija b’ NutropinAq. • Minħabba li terapija b’ somatropin wara trapjant tal- kliewi ma ġietx studjata biżżejjed, kura bl - ormon tat- tkabbir għandha titwaqqaf wara dik il- kirurġija. • Pazjenti b’ defiċenza ta ’ l- Ormon Adrenokortikotrofiku (ACTH) għandhom jikkonsultaw lit- tabib b’ mod regolari waqt terapija bl- ormon tat- tkabbir.
The glucocorticoid replacement therapy may require adjustment after NutropinAq therapy has been started.
It- terapija ta ’ sostituzzjoni tal- glukokortikojdi għandu mnejn ikollha bżonn ta ’ aġġustament wara li tinbeda terapija b’ NutropinAq.
• Concomitant treatment with glucocorticoids may reduce the growth-promoting effect of somatropin. • Because somatropin may reduce insulin sensitivity, patients with diabetes mellitus may require adjustment of their antidiabetic therapy. • During concomitant administration of somatropin with corticosteroids, sex steroids, anticonvulsants or cyclosporin, please ask the doctor for advice.
• Kura flimkien ma ’ glukokortikojdi tista ’ tnaqqas l- effett li jistimula t- tkabbir ta ’ somatropin. • Minħabba li somatropin jista ’ jnaqqas is- sensittività għal l- insulina, pazjenti b’ dijabete mellitus jista ’ jkollhom bżonn ta ’ aġġustament fit- terapija tagħhom kontra d- dijabete. • Waqt l- użu ta ’ somatropin flimkien ma ’ kortikosterojdi, sterojdi sesswali, antikonvulsivi jew cyclosporin, jekk jogħġbok saqsi lit- tabib għall- parir.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
NutropinAq therapy should be discontinued if pregnancy occurs.
Terapija b’ NutropinAq għandha titwaqqaf jekk ikun hemm tqala.
It is not known whether somatropin is excreted in human milk.
Mhux magħruf jekk somatropin jintremiex fil- ħalib uman.
However, absorption of intact protein from the gastrointestinal tract of the infant is unlikely.
Madankollu, assorbiment tal- proteina ntatta mill- passaġġ gastro- intestinali tat- tarbija mhux probabbli.
Please ask your doctor or pharmacist for advice before taking any medicine.
Jekk jogħġbok itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
No studies on the effects of NutropinAq on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effett ta ’ NutropinAq fuq l- abilità biex issuq jew tuża magni.
Somatropin has no known effect on the ability to drive or to use machines.
Somatropin m’ għandu l- ebda effett magħruf fuq l- abilità biex issuq jew tuża magni.
HOW TO USE NutropinAq
KIF GĦANDEK TUŻA NutropinAq
The diagnosis and management of somatropin therapy should be initiated and monitored by adequately experienced physicians.
Id- dijanjożi u l- immaniġġjar ta ’ terapija b’ somatropin għandha tinbeda u tiġi sorveljata minn tobba b’ esperjenza xierqa.
The doctor will advise you about the individualised dose of NutropinAq.
It- tabib se jtik parir dwar id- doża individwalizzata ta ’ NutropinAq.
Please do not change the dosage without consulting the doctor or pharmacist.
Jekk jogħġbok tbiddilx id- dożaġġ mingħajr ma tkellem lit- tabib jew lill- ispiżjar.
In general, the dosage will be calculated according to the following rules:
Ġeneralment, id- dożaġġ jiġi kkalkulat skond dawn ir - regoli:
Growth failure in children due to inadequate growth hormone secretion:
Falliment tat- tkabbir fit- tfal minħabba sekrezzjoni insuffiċjenti ta ’ l- ormon tat- tkabbir:
0.025 - 0.035 mg/ kg bodyweight given as a daily subcutaneous injection.
0. 025 - 0. 035 mg/ kg piż tal- ġisem mogħti bħala injezzjoni taħt il- ġilda kuljum.
Up to 0.05 mg/ kg bodyweight given as a daily subcutaneous injection.
Sa 0. 05 mg/ kg piż tal- ġisem mogħti bħala injezzjoni taħt il- ġilda kuljum.
Growth failure associated with chronic renal insufficiency:
Falliment tat- tkabbir assoċjat ma ’ nsuffiċjenza kronika tal- kliewi:
Somatropin therapy may be continued up to the time of renal transplantation.
Kura b’ somatropin tista ’ titkompla sakemm isir trapjant tal- kliewi.
Growth hormone deficiency in adults:
Insuffiċjenza ta ’ l- ormon tat- tkabbir fl- adulti:
Low initial doses of 0.15 - 0.3 mg given as a daily subcutaneous injection.
Fil- bidu dożi baxxi ta ’ 0. 15 - 0. 3 mg bħala injezzjoni taħt il- ġilda darba kuljum.
The dose may be increased stepwise by the doctor according to the patient ’ s individual requirements.
Id- doża tista ’ tiġi miżjuda pass wara pass mit- tabib skond il- bżonnijiet individwali tal- pazjent.
The final dose seldom exceeds 1.0 mg/ day.
Id- doża finali rari taqbeż 1. 0 mg/ kuljum.
In general, the lowest efficacious dose should be received.
Ġeneralment, għandha tingħata l- anqas doża effikaċji.
For older or overweight patients lower doses may be necessary.
F’ pazjenti akbar jew b’ piż żejjed, jista ’ jkun hemm bżonn ta ’ dożi aktar baxxi.
NutropinAq is designed for use only with the NutropinAq Pen.
NutropinAq huwa maħsub biex jintuża biss flimkien ma ’ Pinna NutropinAq.
Please administer the prescribed dose of NutropinAq solution for injection subcutaneously each day and change the site of injection each time.
Jekk jogħġbok għati d - doża preskritta ta ’ NutropinAq soluzzjoni għall- injezzjoni taħt il- ġilda kuljum u biddel il- post ta ’ l - injezzjoni kull darba.
At the start of therapy it is recommended that a doctor or a nurse give the injection and train you with the appropriate NutropinAq Pen to use with your NutropinAq cartridge.
Fil- bidu tal- kura huwa rakkomandat li tabib jew ners jagħtu l- injezzjoni u jħarġuk bil- Pinna NutropinAq xierqa li tintuża ma ’ l- iskartoċċ NutropinAq tiegħek.
After training, the injection can be given by the patient or his/ her carer.
Wara t- taħriġ, l- injezzjoni tista ’ tingħata mill- pazjent jew minn min jieħu ħsiebu/ a.
The medicine is supplied in a cartridge as a sterile solution with preservative for multiple use.
Il- mediċina hija pprovduta fi skartoċċ bħala soluzzjoni sterili bil- preservattiv għall- użu ta ’ aktar minn darba.
For each single injection please use a new, sterile injection needle.
Għal kull injezzjoni, jekk jogħġbok uża labra ġdida sterili.
Do not use the solution unless it is clear and not cloudy.
Tużàx is- soluzzjoni jekk ma tkunx ċara u mhux imdardra.
Please see also the instructions for use (on reverse).
Jekk jogħġbok ara ukoll l- istruzzjonijiet għall- użu (fuq wara).
Treatment with somatropin is a long-term therapy.
Kura b’ somatropin hija terapija fit- tul.
For further information please ask the doctor.
Għall- aktar informazzjoni jekk jogħġbok saqsi lit- tabib.
If you use more NutropinAq than you should
Jekk tuża NutropinAq aktar milli suppost
If more NutropinAq than recommended was injected, please consult the doctor.
Jekk kien injettat aktar NutropinAq milli kien rakkomandat, jekk jogħġbok ikkonsulta lit- tabib.
Acute overdose could lead initially to a glucose decrease (hypoglycaemia) and subsequently to a glucose increase (hyperglycaemia).
Doża eċċessiva akuta fil- bidu tista ’ twassal għal tnaqqis ta ’ glukosju (ipogliċemija) u wara għal żieda fil- glukosju (ipergliċemija).
Long-term overdose may result in an enhanced growth of ears, nose, lips, tongue and cheekbone (gigantism and/ or acromegaly).
Doża eċċessiva fit- tul tista ’ twassal għal tkabbir żejjed tal- widnejn, imnieħer, xoftejn, ilsien u ħuġbejn (ġigantiżmu u/ jew akromegalija).
These signs are consistent with the known effects of excess in human growth hormone.
Dawn is- sintomi huma konsistenti ma ’ l- effetti magħrufa ta ’ livelli eċċessivi tal- ormon tat- tkabbir uman.
If you forget to take NutropinAq
Jekk tinsa tieħu NutropinAq
The prescribed dosage regimen should be continued.
Għandu jitkompla l- kors ta ’ dożaġġ preskritt.
If you stop using NutropinAq
27 Jekk tieqaf tieħu NutropinAq
A disruption or early ending of the treatment with somatropin may impair the success of the growth hormone therapy.
Interruzzjoni jew waqfien kmieni tal- kura b’ somatropin tista ’ ttellef is- suċċess tat- terapija bl- ormon tat- tkabbir.
Please ask the doctor for advice before stopping the treatment.
Jekk jogħġbok staqsi lit- tabib għall- parir qabel twaqqaf il- kura.
Like all medicines, NutropinAq can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, NutropinAq jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The common side effects reported were injection site reactions, headache, excessive tension of the muscles (hypertonia), subnormal activity of the thyroid gland (hypothyroidism), impaired glucose tolerance, loss of strength (asthenia) and development of antibodies to the protein somatropin.
L- effetti sekondarji komuni rrappurtati kienu reazzjonijiet fil- post ta ’ l- injezzjoni, uġigħ ta ’ ras, tensjoni eċċessiva tal- muskoli (ipertonija), attività taħt il- livell normali tal- glandola tat- tirojde (ipotajrojdiżmu), tollerranza għall- glukosju imdgħajfha, nuqqas ta ’ saħħa (astenja) u żvilupp ta ’ antikorpi għall- proteina somatropin.
An accumulation of fluids in the body with a mild transient swelling of the hands and feet (oedema), muscular pain (myalgia) and arthralgia (neuralgic pain in one or more joints) were seen very commonly in adult patients and commonly in children.
Akkumulazzjoni ta ’ fluwidi fil- ġisem b’ nefħa temporanja mhux severa ta ’ l- idejn u tas- saqajn (edema), uġigħ fil- muskoli (mijalġja) u artralġja (uġigħ newralġiku f’ ġok jew aktar) kienu komuni ħafna f’ pazjenti adulti u komuni fit- tfal.
In patients with Turner syndrome, abnormally heavy bleeding at menstruation was commonly reported.
F’ pazjenti bis- sindromu ta ’ Turner, kienet irrappurtata b’ mod komuni fsada qawwija aktar min- normal waqt il- mestrwazzjoni.
In patients with chronic renal insufficiency, renal failure, peritonitis, bone necrosis, increase of creatinine blood levels were commonly reported.
F’ pazjenti b’ insuffiċjenza kronika tal- kliewi, falliment tal- kliewi, peritonite, nekrożi tal- għadam, żieda fil- livelli tal- krejatinina fid- demm kienu rrapurtati b’ mod komuni.
Abnormal sensations (paraesthesia) were seen very commonly in adults with growth hormone deficiency.
Senzazzjonijiet mhux normali (parasteżija) dehru b’ mod komuni ħafna f’ adulti b’ insuffiċjenza ta ’ l - ormon tat- tkabbir.
These patients also reported the following common side effects: abnormally high levels of blood glucose, an excess of lipids in the blood, sleeplessness, joint disorders, arthrosis, muscular debility, back pain, breast pain and breast enlargement (gynaecomastia).
Dawn il- pazjenti irrappurtaw ukoll l- effetti sekondarji komuni li ġejjin: livelli għoljin ħafna tal- glukosju fid- demm, lipidi eċċessivi fid- demm, nuqqas ta ’ rqad, mard tal- ġogi, artrożi, debolizza tal- muskoli, uġigħ fid- dahar, uġigħ fis- sider u tkabbir tas- sider (ginekomastija).
Other less common side effects have been reported:
Kienu rrappurtati effetti sekondarji anqas komuni:
Those occurring at the injection site: injection site atrophy, injection site haemorrhage, injection site mass and hypertrophy.
Dawk li jseħħu fil- post ta ’ l- injezzjoni: atrofija fil- post ta ’ l- injezzjoni, emorraġġija fil- post ta ’ l - injezzjoni, massa u ipertrofija fil- post ta ’ l- injezzjoni.
Metabolic disorders: decrease in blood glucose, increase in phosphate levels in the blood.
Mard marbut mal- metaboliżmu: tnaqqis fil- glukosju tad- demm, żieda fil- livelli ta ’ fosfat fid- demm.
Nervous disorders: somnolence, rapid involuntary movements of the eyes (nystagmus), personality disorder, vertigo.
Mard tas- sistema nervuża: ħedla ta ’ ngħas, movimenti mgħaġġla mhux volontarji ta ’ l- għajnejn (nistagmus), disturbi fil- personalità, vertigo.
Those related to the heart: abnormally rapid heart rate (tachycardia), high blood pressure.
Dawk relatati mal- qalb: rata tat- taħbit tal- qalb mgħaġġla ħafna (takikardja), pressjoni tad- demm għolja.
Those related to the stomach: vomiting, abdominal pain, flatulence, feeling of sickness, and rarely diarrhoea.
Dawk relatati mal- istonku: remettar, uġigħ addominali, gass fl- istonku, dardir u rari dijarrea.
Those affecting the skin: lipodystrophy (disturbed fat metabolism), skin atrophy, exfoliative inflammation of the skin, urticaria (allergic disorder marked by raised oedematous patches of skin or mucus membrane), excessive growth of hair on the face and body (hirsutism), skin hypertrophy.
Dawk b’ effett fuq il- ġilda: lipodistrofija (disturbi fil- metaboliżmu tax- xaħijiet), atrofija tal- ġilda, infjammazzjoni bil- qxur tal- ġilda, urtikarja (marda allerġika ikkarratteriżżata b’ irqajja ’ minfuħa minħabba akkumulazzjoni ta ’ ilma, tal- ġilda jew tal- membrana mukuża), tkabbir eċċessiv ta ’ pil fuq il - wiċċ u l- ġisem (ħirsutiżmu), ipertrofija tal- ġilda.
Those related to the musculoskeletal system: decrease in muscle size (muscle atrophy), bone pain and carpal tunnel syndrome.
Dawk relatati mas- sistema muskolu- skeletrali: tnaqqis fid- daqs tal- muskoli (atrofija tal- muskoli), uġigħ fil- għadam u s- sindromu carpal tunnel.
Those affecting the urogenital system: urinary incontinence, discharge of mucus from the vagina (leukorrhoea), excessive secretion of urine, urine frequency, urine abnormality, urine haemorrhage.
28 Dawk b’ effett fuq is- sistema uro- ġenitali: inkontinenza ta ’ l- awrina, tnixxija ta ’ muku mill- vaġina (lewkorreja), tnixxija eċċessiva ta ’ awrina, awrina frekwenti, awrina mhux normali, emorraġġija fl - awrina.
Other possible side effects: neoplasm, anaemia, papilloedema, diplopia.
Effetti sekondarji possibbli oħra: neoplażma, anemija, papilledema, diplopja.
Increased growth of birthmarks or moles (pre-existing naevi) may occur.
Jista ’ jkun hemm żieda fid- daqs ta ’ marki tat- twelid jew tbajja tal- ġilda (naevi li kien hemm minn qabel).
The doctor should be consulted as soon as possible if any changed appearance of the skin is noticed.
It- tabib għandu jiġi kkonsultat malajr kemm jista ’ jkun jekk jiġi nnotat xi tibdil fid- dehra tal - ġilda.
As with all protein medicines, in a few patients antibodies may develop to the protein somatropin.
Bħal f’ kull mediċina mill- proteina, f’ xi pazjenti jista ’ jkun hemm żvilupp ta ’ antikorpi għall- proteina somatropin.
Growth hormone antibodies with very low binding capacity have not been associated with adversely affected growth rate.
Antikorpi għal l- ormon tat- tkabbir b’ kapaċità ta ’ twaħħil baxxa ħafna ma kienux assoċjati ma ’ effett neggattiv fuq ir- rata ta ’ tkabbir.
27 Leukaemia has been reported in a small number of growth hormone deficient patients treated with growth hormone.
Lewkimja kienet irrappurtata f’ numru żgħir ta ’ pazjenti b’ defiċjenza ta ’ l- ormon tat- tkabbir ikkurati bl - ormon tat- tkabbir.
A causal relationship to somatropin therapy is unlikely.
Relazzjoni kawżali għat- terapija b’ somatropin mhix probbabli.
Symptoms of benign increased brain pressure (benign intracranial hypertension), which are papilloedema, visual changes, headache, nausea and vomiting, may occur more often in children with chronic renal insufficiency receiving NutropinAq.
Sintomi ta ’ żieda bennina fil- pressjoni tal- moħħ (ipertensjoni fil- kranju bennina), li huma papilloedema, bidla fil- vista, uġigħ ta ’ ras, dardir u remettar, jistgħu jseħħu aktar ta ’ spiss fi tfal b’ insuffiċjenza kronika tal- kliewi li qed jieħdu NutropinAq.
Patients with endocrinological disorders are more prone to develop an epiphysiolysis.
Pazjenti b’ mard endokrinoloġiku għandhom tendenza akbar li jiżvilluppaw epifisjolisi.
HOW TO STORE NutropinAq
KIF TAĦŻEN NutropinAq.
Keep out of the reach and sight of children.
Żommu Aħżen
Store in a refrigerator (2°C - 8°C).
fejn ma jintlaħaqx u ma jidhirx mit- tfal. fi friġġ (2°C – 8°C).
After first use, the cartridge may be stored for up to 28 days at 2°C - 8°C.
Wara l- ewwel użu, l- iskartoċċ jista ’ jiġi maħżun għal mhux aktar minn 28 ġurnata f’ temperatura ta ’ 2°C - 8°C.
Do not remove the cartridge that is being used from the NutropinAq Pen between injections.
Bejn injezzjoni u oħra tneħħix l- iskartoċċ li qed jintuża mill- Pinna NutropinAq.
Do not use NutropinAq after the expiry date which is stated on the label of the cartridge and the carton after EXP.
Tużax NutropinAq wara d- data ta ’ skadenza li tidher fuq it- tikketta ta ’ l- iskartoċċ u l- kaxxa wara EXP.
Do not use NutropinAq if you notice that the solution is cloudy.
Tużax NutropinAq jekk tinnota li s- soluzzjoni hija mdardra.
What NutropinAq contains
NutropinAq:
− The active substance of NutropinAq is somatropin*. * human growth hormone produced in Escherichia coli cells by recombinant DNA technology.
* ormon tat- tkabbir uman proddott f’ ċelloli ta ’ Escherichia coli permezz ta ’ teknoloġija DNA rikombinata.
− The other ingredients are sodium chloride, phenol, polysorbate 20, sodium citrate, citric acid anhydrous and water for injections.
- Is- sustanzi l- oħra huma sodium chloride, phenol, polysorbate 20, sodium citrate, citric acid
What NutropinAq looks like and contents of the pack
29 Id- Dehra tal- prodott u l- kontenuti tal- pakkett:
NutropinAq is a solution for injection (in a cartridge (10 mg/ 2ml) - pack size of 1, 3 and 6).
NutropinAq huwa soluzzjoni għall- injezzjoni (fi skartoċċ (10 mg/ 2ml) – daqs tal- pakkett ta ’ 1, 3 u 6).
The solution for multidose use is clear, colourless and sterile.
Is- soluzzjoni għall- uża ta ’ aktar minn darba hija ċara, mingħajr kulur u sterili.
Not all pack sizes may be marketed.
Huwa possibli li mhux id- daqsijiet tal- pakketti kolla huma għall- użu kummerċjali.
28 Marketing Authorisation Holder:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
IPSEN PHARMA BIOTECH S. A. S., Parc d’ Activités du Plateau de Signes, CD no 402, 83870 Signes, France
IPSEN PHARMA BIOTECH S. A. S., Parc d’ Activités du Plateau de Signes, CD no 402, 83870 Signes, Franza
Eesti Polska ESTOBIIN OÜ Udeselja 4-4 EE-11913 Tallinn Tel: +372 51 55 810
30 Eesti Polska ESTOBIIN OÜ Udeselja 4- 4 EE- 11913 Tallinn Tel: +372 51 55 810
29 España Ipsen Pharma S. A.
România, България España Ipsen Pharma S. A.
România, България Beaufour Ipsen Pharma Aleea Alexandru, nr.10, Ap.1-3, Sct.1 Bucuresti, 011823 - RO Tel: + 40 21(0) 230 43 80
Beaufour Ipsen Pharma Aleea Alexandru, nr. 10, Ap. 1- 3, Sct. 1 Bucuresti, 011823 - RO Tel: + 40 21( 0) 230 43 80
Ireland Ipsen Pharmaceuticals Ltd.
Slovenská republika Ireland Ipsen Pharmaceuticals Ltd.
Figino, 16 I-20156 Milano Tel: + 39 - 02 - 39 22 41
Figino, 16 I -- 0156 Milano Tel: + 39 - 02 - 39 22 41
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. europa. eu