qanastek/EMEA-V3 huggingface dataset:
You should not take Valdoxan together with certain medicines (see also under “ Do not take Valdoxan ” in section 2): fluvoxamine (another medicine used in the treatment of depression), ciprofloxacin (an antibiotic).
M’ għandekx tieħu Valdoxan flimkien ma` ċertu mediċini (ara taħt ‘ Tieħux Valdoxan ’ f’ sezzjoni 2): ’ fluvoxamine (mediċina oħra użata biex tikkura id- dipressjoni), ciprofloxacin (antibijotiku).
Taking Valdoxan with food and drink Valdoxan can be taken with or without food.
Meta tieħu Valdoxan ma ’ l- ikel u max- xorb Valdoxan jista ’ jittieħed ma ’ l- ikel jew mingħajru.
It is not advisable to drink alcohol while you are being treated with Valdoxan.
Mhuwiex irrakkomandat li tixrob l- alkoħol meta int qed tiġi kkurat b’ Valdoxan.
Pregnancy Talk to your doctor if you become pregnant (or plan to become pregnant) while you are taking Valdoxan.
Tqala Tkellem mat- tabib tiegħek jekk toħrog tqila (jew qed tipjanja biex tinqabad tqila) waqt li tkun qed tieħu Valdoxan.
Breast-feeding Talk to your doctor if you are breast-feeding or intending to breast-feed as breastfeeding should be discontinued if you take Valdoxan.
Treddigħ Tkellem mat- tabib tiegħek jekk int qed tredda` jew intenzjonata li tredda` minħabba li treddigħ għandu jitwaqqaf jekk int qed tieħu Valdoxan.
Important information about some of the ingredients of Valdoxan
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Valdoxan Din il- mediċina fiha lactose.
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking Valdoxan.
Jekk inti ġejt mgħarraf mit- tabib tiegħek li inti għandek intolleranza għal xi zokkor, kellem lit- tabib tiegħek qabel tieħu Valdoxan.
HOW TO TAKE VALDOXAN
KIF GĦANDEK TIEĦU VALDOXAN
Always take Valdoxan exactly as your doctor has told you.
Dejjem għandek tieħu Valdoxan skond il- parir eżatt tat- tabib.
The recommended dose of Valdoxan is one tablet (25 mg) at bedtime.
Id- doża li ssoltu tingħata hija pillola kuljum (25 mg) qabel l- irqad.
Valdoxan starts to act on symptoms of depression in most depressed people within two weeks of starting treatment.
20 Valdoxan jibda jaħdem fuq is- sintomi tad- dipressjoni f’ ħafna min- nies bid- dipressjoni fi żmien ġimgħatejn minn meta tibda l- kura.
Your doctor may continue to give you Valdoxan when you are feeling better to prevent your depression from returning.
It- tabib tiegħek jista jibqa` itik Valdoxan meta inti tħossok aħjar biex jipprevjeni d- dipressjoni milli terġa` lura.
Valdoxan is for oral use.
Valdoxan huwa għall- użu orali.
Valdoxan can be taken with or without food.
Valdoxan jista jittiehed ma ’ l- ikel jew mingħajru.
You must not use Valdoxan if your liver does not work properly.
M’ għandekx tuża Valdoxan jekk il- fwied mhux qed jaħdem sew.
If you have trouble with your kidneys, your doctor will make an individual evaluation of whether it is safe for you to take Valdoxan.
Jekk inti għandek il- problemi fil- kliewi, it- tabib tiegħek jagħmel evalwazzjoni individwali għas - sigurta` tiegħek meta tieħu Valdoxan.
If you take more Valdoxan than you should If you have taken more Valdoxan than you should, or if for example a child has taken medicine by accident, contact your doctor immediately.
Jekk tieħu Valdoxan aktar milli suppost Jekk inti ħadt aktar Valdoxan aktar milli suppost, jew jekk per eżempju tifel/ tifla ħadu l- mediċina aċċidentalment, għarraf lit- tabib tiegħek mill- ewwel.
The experience of overdoses with Valdoxan is limited but reported symptoms include pain in the upper part of the stomach and drowsiness.
L- esperjenza ta ’ dozi eċċessivi b’ Valdoxan hija limitata imma sintomi rapportati jinkludu ugigħ fil - parti ta ’ fuq ta ’ l- istonku u sturdament.
Just carry on with the next dose at the usual time.
Jekk tinsa tieħu Valdoxan M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
The calendar printed on the blister containing the tablets should help you remembering when you last took a tablet of Valdoxan.
Il- kalendarju li jkun stampat fuq il- folji li jkun fihom il- pilloli għandu jgħinek meta ħadt l- aħħar pillola ta ’ Valdoxan.
Like all medicines, Valdoxan can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Valdoxan jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
HOW TO STORE VALDOXAN
KIF TAĦŻEN VALDOXAN
Do not use Valdoxan after the expiry date which is stated on the carton and blister.
Tużax Valdoxan wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja.
What Valdoxan contains
X’ fih Valdoxan
What Valdoxan looks like and contents of the pack Valdoxan 25 mg film-coated tablets are oblong, orange-yellow with a blue imprint of ‘ company logo ’ on one side.
Id- Dehra ta ’ Valdoxan u l- kontenuti tal- pakkett Valdoxan 25 mg pilloli miksija b’ rita huma rettangolari, oranġjo fl- isfar bil- logo tal- kumpanija imnaqqax bil- blu fuq naħa minnhom.
Valdoxan 25 mg film-coated tablets are available in calendar blisters.
Valdoxan 25 mg pilloli miksija b’ rita huma disponibbli f’ folji b’ kalendarju.
Packs of 100 film-coated tablets are also available for hospital use.
Pakketti ta ’ 100 pillola miksija b’ rita huma disponibbli għall- użu ta ’ l- isptar biss.
Marketing Authorisation Holder Les Laboratoires Servier 22, rue Garnier 92200 Neuilly sur Seine - France
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Les Laboratoires Servier 22, rue Garnier 92200 Neuilly sur Seine - Franza
Valtropin 5 mg/ 1.5 ml powder and solvent for solution for injection
Valtropin 5 mg/ 1. 5 ml trab u solvent għal soluzzjoni għall- injezzjoni
One vial of powder contains 5 mg somatropin (corresponding to 15 IU).
Kunjett wieħed tat- trab fih 5 mg somatropin (li jikkorrispondi għal 15 IU).
After reconstitution with 1.5 ml solvent, 1 ml contains: somatropin* 3.33 mg (corresponding to 10 IU) * produced in Saccharomyces cerevisiae cells by recombinant DNA technology.
Wara rikostituzzjoni b' 1. 5 ml solvent, 1 ml ikun fih: somatropin * 3. 33 mg (li jikkorrispondu għal 10 IU) * magħmul f' ċelloli Saccharomyces cerevisiae permezz ta 'teknoloġija tad- DNA rikombinanti.
1.5 ml of solvent contains 4.5 mg metacresol.
1. 5 ml ta 'solvent fih 4. 5 mg metacresol.
White or almost white powder.
Trab abjad jew kważi abjad.
The solvent is a clear solution.
Is- solvent huwa soluzzjoni ċara.
After reconstitution with the solvent provided Valtropin has a pH of approximately 7.5 and an osmolality of approximately 320 mOsm/ kg.
Wara li jiġi rikostitwit bis- solvent ipprovdut Valtropin ikollu pH ta 'madwar 7. 5 u osmolalità ta' madwar 320 mOsm/ kg.
- Long-term treatment of children with growth failure due to an inadequate secretion of normal
- Kura fuq perijodu fit- tul ta 'tfal b' nuqqas ta' tkabbir minħabba tnixxija inadegwata ta 'l- ormon
endogenous growth hormone.
endoġenu normali tat- tkabbir.
- Treatment of short stature in children with Turner syndrome, confirmed by chromosome
- Kura ta 'l- istatura qasira fi tfal bis- sindrome ta' Turner, ikkonfermata b' analiżi tal- kromosomi.
- Treatment of growth retardation in pre-pubertal children with chronic renal insufficiency.
- Kura ta ’ dewmien fit- tkabbir fi tfal ta 'qabel il- pubertà li jkollhom insuffiċjenza renali kronika.
Adult patients
Pazjenti adulti
- Replacement therapy in adults with pronounced growth hormone deficiency of either childhood-
- Terapija ta 'sostituzzjoni f' persuni adulti b' defiċjenza evidenti ta' l- ormon tat- tkabbir li bdiet
or adult-onset aetiology.
fit- tfulija jew f' età adulta.
Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone not being prolactin.
Pazjenti b' defiċjenza severa ta 'l- ormon tat- tkabbir f' età adulta huma definiti bħala pazjenti b' patoloġija ipotalamika- pitwitarja magħrufa u mill- anqas b’ defiċjenza oħra magħrufa ta' ormon pitwitarju li ma jkunx prolactin.
These patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency.
Dawn il- pazjenti jridu jagħmlu test dinamiku wieħed sabiex tiġi ddijanjostikata jew eskluża defiċjenza ta 'l- ormon tat- tkabbir.
In patients with childhood-onset isolated growth hormone deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like growth factor-1 (IGF-1) concentrations (< 2 standard deviation score (SDS)), who may be considered for one test.
F' pazjenti b' defiċjenza iżolata ta 'l- ormon tat- tkabbir li bdiet fit- tfulija (ebda evidenza ta' mard ipotalamiku- pitwitarju jew ta 'radjazzjoni fil- kranju), għandhom jiġu rakkomandati żewġ testijiet dinamiċi, ħlief għal dawk li jkollhom konċentrazzjonijiet baxxi tal- fattur- 1 tat- tkabbir (IGF- 1) li jixbah lill- insulina (< 2 punteġġ ta' devjazzjoni standard (SDS)), li jistgħu jiġu kkunsidrati għal test wieħed.
The cut-off point of the dynamic test should be strict.
Il- punt ta 'qtugħ il- linja tat - test dinamiku għandu jkun strett.
Therapy with Valtropin should be initiated and monitored by physicians adequately experienced in the diagnosis and management of patients with growth hormone deficiency.
2 It- terapija b' Valtropin għandha tinbeda u tiġi mmonitorjata minn tobba li jkollhom esperjenza adegwata fid- dijanjosi u l- immaniġġar ta 'pazjenti b' defiċjenza ta' l- ormon tat- tkabbir.
2 The dosage and administration schedule should be individualised for each patient.
L- iskeda tad- dożaġġ u ta 'kif jingħata għandhom jiġu individwalizzati għal kull pazjent.
Dosage in paediatric patients
Dożaġġ f' pazjenti pedjatriċi
Growth hormone deficiency in children The recommended dosage is 0.025 - 0.035 mg/ kg body weight per day, given as a subcutaneous injection.
Defiċjenza ta 'l- ormon tat- tkabbir fit- tfal Id- dożaġġ rakkomandat huwa 0. 025 - 0. 035 mg/ kg ta' piż tal- ġisem kuljum, mogħti bħala injezzjoni taħt ġilda.
Children with Turner syndrome The recommended dosage is 0.045 - 0.050 mg/ kg body weight per day, given as a subcutaneous injection.
Tfal bis- sindrome ta 'Turner Id- dożaġġ rakkomandat huwa 0. 045 - 0. 050 mg/ kg ta' piż tal- ġisem kuljum, mogħti bħala injezzjoni taħt ġilda.
Pre-pubertal children with chronic renal insufficiency The recommended dosage is 0.045 - 0.050 mg/ kg body weight per day, given as a subcutaneous injection.
Tfal ta 'qabel il- pubertà b' insuffiċjenza renali kronika Id- dożaġġ rakkomandat huwa 0. 045 - 0. 050 mg/ kg ta' piż tal- ġisem kuljum, mogħti bħala injezzjoni taħt ġilda.
Dosage in adult patients
Dożaġġ f' pazjenti adulti
Growth hormone deficiency in adults The recommended starting dose is 0.15 - 0.30 mg/ day, given as a subcutaneous injection.
Defiċjenza ta 'l- ormon tat- tkabbir fl- adulti Id- doża inizjali rakkomandata hija 0. 15 - 0. 30 mg/ kuljum, mogħtija bħala injezzjoni taħt ġilda.
A lower starting dose may be necessary in older and obese patients.
Tista 'tkun meħtieġa doża inizjali aktar baxxa f' pazjenti akbar fl- età u obeżi.
This dose should be gradually increased according to individual patient requirements based on the clinical response and serum IGF-1 concentrations.
Din id- doża għandha tiżdied b' mod gradwali skond il- ħtiġijiet individwali tal- pazjent fuq il- bażi tar- reazzjoni klinika u l- konċentrazzjonijiet ta 'IGF- 1 fis- serum.
Total daily dose usually does not exceed 1 mg.
Id- doża totali ta 'kuljum ġeneralment ma taqbiżx 1 mg.
IGF-1 concentrations should be maintained below the upper limit of the age-specific normal range.
Il- konċentrazzjonijiet ta 'IGF- 1 għandhom jinżammu taħt il- limitu ta' fuq tal- medda normali speċifika għall- età.
The minimum effective dose should be used, and dose requirements may decline with increasing age.
Għandha tintuża d- doża minima effettiva, u l- bżonn tad- doża jista ’ jonqos ma 'l- età.
The dosage of somatropin should be decreased in cases of persistent oedema or severe paraesthesia, in order to avoid the development of carpal tunnel syndrome.
Id- dożaġġ ta 'somatropin għandu jitnaqqas f' każijiet ta' edima persistenti jew parasteżija severa, sabiex jiġi evitat l- iżvilupp tas- sindrome tal- carpal tunnel.
Valtropin is administered by subcutaneous injection.
Valtropin jingħata b' injezzjoni taħt ġilda.
The injection sites should be varied in order to avoid lipo-atrophy.
Il- postijiet ta 'l- injezzjoni għandhom jitbiddlu sabiex tiġi evitata lipoatrofija.
For further information on reconstitution and administration see section 6.6.
Għal aktar informazzjoni dwar ir- rikostituzzjoni u kif jingħata ara sezzjoni 6. 6.
- Hypersensitivity to the active substance or to any of the excipients (e. g. metacresol) (see
4. 3 Kontra- indikazzjonijiet
section 4.4).
sezzjoni 4. 4).
- Any evidence of activity of a tumour.
- Kwalunkwe evidenza ta 'l- attività ta' tumur.
Intracranial lesions must be inactive and anti-tumour
Il- feriti ġol- kranju jridu jkunu inattivi u t- terapija
therapy complete prior to the institution of growth hormone therapy.
kontra t- tumuri għandha tkun mitmuma qabel ma tinbeda t- terapija bl- ormon tat- tkabbir.
Valtropin should be discontinued if there is evidence of tumour growth.
Valtropin għandu jitwaqqaf jekk ikun hemm evidenza ta 'żvilupp ta' tumur.
- Valtropin should not be used for growth promotion in children with closed epiphyses.
- Valtropin m' għandux jintuża biex jippromwovi t- tkabbir fi tfal b' epiphyses magħluqa.
- Patients with acute critical illness due to complications following open heart or abdominal
- Pazjenti b' mard kritiku akut minħabba kumplikazzjonijiet wara kirurġija miftuħa tal- qalb jew
surgery, multiple accidental trauma, or patients having acute respiratory failure.
addominali, trawmi aċċidentali multipli, jew pazjenti li jkollhom difett respiratorju akut.
There is no evidence to suspect that growth hormone replacement influences the recurrence rate or regrowth of intracranial neoplasms, but standard clinical practice requires regular pituitary imaging in
M' hemmx evidenza biex wieħed jissuspetta li s- sostituzzjoni ta 'l- ormon tat- tkabbir tinfluwenza r- rata ta' rikorrenza jew l- iżvilupp mill- ġdid ta 'neoplażmi ġol- kranju, iżda prattika klinika standard titlob immaġni pitwitarja regolari f' pazjenti bi storja ta' patoloġija pitwitarja.
A baseline scan is recommended in these patients before instituting growth hormone replacement therapy.
Huwa rakkomandat skan tal- linja bażi f' dawn il- pazjenti qabel ma tinbeda terapija ta 'sostituzzjoni ta ’ l- ormon tat- tkabbir.
In cases of severe or recurrent headache, visual problems, nausea, and/ or vomiting, a fundoscopy for papilloedema is recommended.
F' każijiet ta 'uġigħ ta' ras qawwi jew rikorrenti, problemi viżwali, nawsja, u/ jew rimettar, hija rakkomandata fundoskopija għal papilloedima.
If papilloedema is confirmed, a diagnosis of benign intracranial hypertension should be considered and, if appropriate, the growth hormone treatment should be discontinued.
Jekk tkun ikkonfermata papilloedima, għandha tiġi kkunsidrata dijanjosi ta 'pressjoni għolja beninnja ġol- kranju u, jekk ikun xieraq, il- kura bl- ormon tat- tkabbir għandha titwaqqaf.
At present, there is insufficient evidence to guide clinical decision making in patients with resolved intracranial hypertension.
Attwalment, m' hemmx evidenza biżżejjed biex tiggwida t- teħid ta 'deċiżjonijiet kliniċi f' pazjenti bi pressjoni għolja ġol- kranju riżolta.
If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary.
Jekk terġa 'tinbeda l- kura bl- ormon tat- tkabbir, ikun meħtieġ monitoraġġ attent għal sintomi ta' pressjoni għolja ġol- kranju.
Because human growth hormone may induce a state of insulin resistance, patients treated with somatropin should be monitored for evidence of glucose intolerance.
Billi l- ormon tat- tkabbir uman jista 'jikkawża stat ta' reżistenza għall- insulina, pazjenti kkurati b' somatropin għandhom jiġu mmonitorjati għal evidenza ta 'intolleranza għall- glukose
Growth hormone increases the extrathyroidal conversion of T4 to T3 and may, as such, unmask incipient hypothyroidism.
L- ormon tat- tkabbir iżid il- bidla ekstratirojdali ta 'T4 għal T3 u jista', b' hekk, jikxef bidu ta 'ipotirojdiżmu.
Monitoring of thyroid function should therefore be conducted in all patients.
Għalhekk għandu jsir monitoraġġ tal- funzjoni tat- tirojde fil- pazjenti kollha.
In patients with hypopituitarism, standard replacement therapy must be closely monitored when somatropin therapy is administered.
F' pazjenti li jkollhom ipopitwitariżmu, it- terapija standard ta 'sostituzzjoni trid tiġi mmonitorjata mill- qrib meta tingħata terapija b' somatropin.
Patients with endocrine disorders, including growth hormone deficiency, may develop slipped capital epiphyses more frequently.
Pazjenti b' mard endokrinali, fosthom defiċjenza ta 'l- ormon tat- tkabbir, jistgħu jiżviluppaw epiphyses kapitali mqabbża aktar ta' spiss.
Any child with the onset of a limp during growth hormone therapy should be evaluated.
Kwalunkwe tifel/ tifla li jkollhom bidu ta 'mixi mzappap waqt terapija bl- ormon tat- tkabbir għandhom jiġu evalwati.
Subjects who had been treated with growth hormone during childhood, until final height was attained, should be re-evaluated for growth hormone deficiency after epiphyseal closure before replacement therapy is commenced at the doses recommended for adults.
Individwi li jkunu ġew ikkurati bl- ormon tat- tkabbir fit- tfulija, sakemm inkiseb it- tul finali, għandhom jiġu evalwati mill- ġdid għal defiċjenza ta 'l- ormon tat- tkabbir wara għeluq epiphyseal qabel ma tinbeda t- terapija ta' sostituzzjoni bid- dożi rakkomandati għall- adulti.
For children, the treatment should be continued until the end of the growth has been reached.
Fil- każ tat- tfal, il- kura għandha titkompla sakemm jintlaħaq it- tmiem tat- tkabbir.
It is advisable not to exceed the recommended dosage in view of the potential risks of acromegaly, hyperglycaemia, and glucosuria.
Huwa rakkomandabbli li ma jinqabiżx id- dożaġġ rakkomandat minħabba r- riskji potenzjali ta 'akromegalija, ipergliċemija, u glukosurja.
Valtropin is not indicated for the treatment of patients with growth failure due to Prader-Willi syndrome unless they also have a diagnosis of growth hormone deficiency.
Valtropin mhuwiex indikat għall- kura ta ’ pazjenti b’ insuffiċjenza tat- tkabbir minħabba s- sindrome ta ’ Prader- Willi ħlief jekk ikollhom ukoll dijanjosi ta ’ defiċjenza ta ’ l- ormon tat- tkabbir.
There have been reports of sleep apnoea and sudden death after initiating growth hormone therapy in patients with Prader-Willi syndrome, who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.
Kien hemm rapporti ta ’ apnea waqt l- irqad u mewt għal għarrieda wara l- bidu tat- terapija bl- ormon tat- tkabbir f’ pazjenti bis- sindrome ta ’ Prader- Willi, li kellhom wieħed jew iktar mill- fatturi ta ’ riskju li ġejjin: obesita ’ severa, storja medika ta ’ ostruzzjoni fin- naħa ta ’ fuq tal- pajp tan- nifs jew apnea waqt l- irqad, jew infezzjoni respiratorja mhux identifikata.
Before instituting treatment with somatropin for growth retardation secondary to chronic renal insufficiency, children should have been followed for one year to verify growth disturbance.
Qabel ma tinbeda kura b' somatropin għal dewmien fit- tkabbir b' konsegwenza ta 'insuffiċjenza renali kronika, it- tfal iridu jkunu ġew segwiti għal sena sabiex jiġi vverifikat id- disturb tat- tkabbir.
Conservative treatment for renal insufficiency (which includes control of acidosis, hyperparathyroidism, and nutritional status for one year prior to the treatment) should have been established and should be maintained during treatment.
Għandha tkun ġiet stabbilita kura konservattiva għal insuffiċjenza renali (li tinkludi kontroll ta 'l- aċidożi, iperparatirojdiżmu, u status nutrittiv għal sena qabel il- kura) u għandha tinżamm waqt il- kura.
Treatment with somatropin should be discontinued at the time of renal transplantation.
Il- kura b' somatropin m' għandhiex tissokta fiż- żmien tat- trapjant renali.
In order to reach the defined treatment goal, men may need lower growth hormone doses than women.
Sabiex tintlaħaq il- mira definita tal- kura, l- irġiel jistgħu jeħtieġu dożi aktar baxxi ta 'l- ormon tat- tkabbir min- nisa.
Oral oestrogen administration increases the dose requirements in women.
L- għoti orali ta 'estroġenu jżid id- doża meħtieġa fin- nisa.
An increasing sensitivity to growth hormone (expressed as change in IGF-1 per growth hormone dose) over time may be observed, particularly in men.
Maż- żmien tista 'tkun osservata sensittività akbar għall- ormon tat- tkabbir (espressa bħala bidla fil- IGF- 1 għal kull doża ta' ormon tat- tkabbir), b' mod partikolari fl- irġiel.
The accuracy of the growth hormone dose should therefore be controlled every 6 months.
L- eżattezza tad- doża ta 'l- ormon tat- tkabbir għalhekk għandha tiġi kkontrollata kull 6 xhur.
Valtropin should not be reconstituted with the supplied solvent for patients with a known sensitivity to metacresol.
4 Valtropin m' għandux jiġi rikostitwit bis- solvent pprovdut fil- każ ta 'pazjenti b' sensittività magħrufa għal metacresol.
If sensitivity to the accompanying solvent occurs, the vials should be reconstituted with water for injections and used as a single use vial (see section 6.3).
Jekk tinstab sensittività għas- solvent li jakkumpanja, il- kunjetti għandhom jiġu rikostitwiti bl- ilma għall- injezzjonijiet u jintużaw bħala kunjett ta 'użu waħdieni (ara sezzjoni 6. 3).
Patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear or hearing disorders.
Pazjenti bis- sindrome ta 'Turner għandhom jiġu evalwati bir- reqqa għal otite tal- parti tan- nofs tal- widna u disturbi oħra mard fil- widnejn billi dawn il- pazjenti għandhom riskju akbar ta' mard tal- widnejn jew tas- smigħ.
4 After accidental intramuscular injection, hypoglycaemia may appear.
Wara injezzjoni aċċidentali fil- muskoli, tista 'titfaċċa ipergliċemija.
Experience of somatropin treatment in patients above 60 years of age is limited.
L- esperjenza ta 'kura b' somatropin f' pazjenti li għandhom' il fuq minn 60 sena hija limitata.
Experience of prolonged treatment (over 5 years) with somatropin in adults is limited.
L- esperjenza ta 'kura prolungata (iżjed minn 5 snin) b' somatropin fl- adulti hija limitata.
Excessive glucocorticoid therapy will inhibit the growth-promoting effect of human growth hormone.
Terapija bi glukokortikojdi eċċessiva timpedixxi l- effett ta 'promozzjoni ta' l- iżvilupp ta 'l- ormon tat- tkabbir uman.
Patients with co-existing adrenocorticotropic hormone (ACTH) deficiency should have their glucocorticoid replacement dose carefully adjusted to avoid an inhibitory effect on growth.
Il- pazjenti li jbatu ukoll b' defiċjenza ta 'l- ormon andrenokortikotropiku (ACTH) irid ikollhom id- doża ta' sostituzzjoni ta ’ glukokortikojdi tagħhom aġġustata bir- reqqa sabiex jiġi evitat effett inibitorju fuq it- tkabbir.
In women taking oral oestrogens, a higher dose of somatropin may be required to achieve the treatment goal.
Fil- każ ta 'nisa li jieħdu estroġeni orali, tista' tkun meħtieġa doża aktar għolja ta 'somatropin biex tinkiseb il- mira tal- kura.
Patients taking insulin for diabetes mellitus should be carefully monitored during treatment with somatropin.
Il- pazjenti li jieħdu l- insulina għad- dijabete mellitus għandhom jiġu mmonitorjati bir- reqqa waqt kura b' somatropin.
An adjustment of the insulin dose may be required.
Jista 'jkun meħtieġ aġġustament tad- doża ta' l- insulina.
Data from an interaction study performed in growth hormone deficient adults, suggests that somatropin administration may increase the clearance of compounds known to be metabolised by cytochrome P450 isoenzymes.
Tagħrif minn studju ta 'l- interazzjoni mwettaq f' persuni adulti b' defiċjenza ta' l- ormon tat- tkabbir, jissuġġerixxi li l- għoti ta 'somatropin jista' jżid it- tneħħija ta 'komposti magħrufa li jiġu metabolizzati minn isoenzimi taċ- ċitokromu P450.
The clearance of compounds metabolised by cytochrome P 450 3A4 (e. g. sex steroids, corticosteroids, anticonvulsants and cyclosporine) may be especially increased resulting in lower plasma levels of these compounds.
It- tneħħija ta 'komposti metabolizzati miċ- ċitokromu P450 3A4 (pereżempju sterojdi tas- sess, kortikosterojdi, antikonvulsivi u cyclosporine) tista' tiżdied b' mod partikolari li jwassal għal livelli aktar baxxi ta 'dawn il- komposti fil- plażma.
The clinical significance of this is unknown.
L- importanza klinika ta 'dan mhix magħrufa.
For Valtropin no clinical data on exposed pregnancies are available.
Għal Valtropin m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Animal studies are insufficient with respect to effects on pregnancy, embryofoetal development, parturition or postnatal development (see section 5.3).
Studji fuq bhejjem m’ humiex biżżejjed rigward l- effetti fuq it- tqala, fuq l - iżvilupp ta ’ l- embriju/ fetu, fuq il- ħlas, jew fuq l- żvilupp wara t- twelid (ara sezzjoni 5. 3).
Therefore Valtropin should not be used during pregnancy unless clearly necessary.
Għalhekk Valtropin m’ għandux jintuża waqt it- tqala ħlief meta hemm bżonn speċifiku.
There have been no clinical studies conducted with Valtropin in breast-feeding women.
Ma sarux studji kliniċi b' Valtropin f' nisa li jreddgħu.
It is not known whether somatropin is excreted in human milk.
Mhux magħruf jekk somatropin joħroġx fil- ħalib uman.
Therefore caution should be exercised when Valtropin is administered to breast-feeding women.
Għalhekk, wieħed għandu joqgħod attent meta jagħti Valtropin lil nisa tqal.
Valtropin has no or negligible influence on the ability to drive and use machines.
Valtropin m' għandu l- ebda effett jew effett żgħir jew moderat fuq il- ħila ta ’ sewqan u l- użu ta ’ magni.
During clinical studies 128 children (98 children with growth hormone deficiency and 30 with Turner syndrome) were exposed to Valtropin.
Waqt studji kliniċi 128 tifel/ tifla (98 tifel/ tifla b' defiċjenza ta 'l- ormon tat- tkabbir u 30 bis- sindrome ta' Turner) kienu esposti għal Valtropin.
The safety profile of Valtropin observed in these clinical studies was consistent with that reported with the reference product used in these studies and other somatropin containing products.
5 kien konsistenti ma 'dak irrapportat bil- prodott ta' referenza użat f' dawn l- istudji kliniċi u prodotti oħra li fihom somatropin.
The following adverse reactions and their frequencies have been observed under treatment with somatropin based on published information:
Ir- reazzjonijiet avversi li ġejjin u l- frekwenzi tagħhom kienu osservati b’ kura b' somatropin fuq il- bażi ta 'informazzjoni ppubblikata:
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) including isolated reports
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) inkluż rapporti iżolati
Endocrine disorders Hypothyroidism: common
Disturbi fis- sistema endokrinarja Ipotirojdiżmu: komuni
Metabolism and nutrition disorders Mild hyperglycaemia: common (1% in children; 1% - 10% in adults)
Disturbi fil- metaboliżmu u n- nutrizzjoni Ipergliċemija ħafifa: komuni (1% fit- tfal; 1% - 10% fl- adulti) Reżistenza għall- insulina
Nervous system disorders Benign intracranial hypertension: rare Headache: very common in adults Insomnia: very rare in children; common in adults Paraesthesia: rare in children; very common in adults
Disturbi fis- sistema nervuża Pressjoni għolja beninnja ġol- kranju: rari Uġigħ ta 'ras: komuni ħafna fl- adulti Nuqqas ta' rqad: rari ħafna fit- tfal; komuni fl- adulti Parasteżija: rari fit- tfal; komuni ħafna fl- adulti
Vascular disorders Hypertension: rare in children; common in adults
Disturbi vaskulari Pressjoni għolja: rari fit- tfal; komuni fl- adulti
Musculoskeletal and connective tissue disorders Localised muscle pain (myalgia): common in adults Joint pain and disorder (arthralgia): very common in adults
Disturbi muskolu- skeltrali u tal- connective tissue Uġigħ lokalizzat fil- muskoli (majalġja): komuni fl- adulti Uġigħ u mard tal- ġogi (artralġja): komuni ħafna fl- adulti
Reproductive system and breast disorders Gynaecomastia: very rare in children; uncommon in adults
Disturbi fis- sistema riproduttiva u fis- sider Ginekomastja: rari ħafna fit- tfal; mhux komuni fl- adulti
General disorders and administration site conditions Weakness: uncommon Injection site pain (reaction): common Oedema (local or generalised): common (1% - 10% in children; 10% in adults)
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Indeboliment: mhux komuni Uġigħ fil- post ta' l- injezzjoni (reazzjoni): komuni Edima (lokali jew ġeneralizzata: komuni (1% - 10% fit- tfal; 10% fl- adulti)
As with all somatropin containing medicinal products a small percentage of patients may develop antibodies to somatropin.
L- istess bħal fil- każ tal- prodotti mediċinali l- oħra kollha li fihom somatropin, perċentwal żgħir ta 'pazjenti jistgħu jiżviluppaw antikorpi għal somatropin.
In a clinical study with Valtropin, 3% of children with growth hormone deficiency developed such antibodies.
Fi studju kliniku b' Valtropin, 3% tat- tfal b' defiċjenza ta 'l- ormon tat- tkabbir żviluppaw antikorpi bħal dawn.
The binding capacity of these antibodies was low and there was no effect on growth rate.
Il- kapaċità ta 'rbit ta' dawn l- antikorpi kienet baxxa u ma kienx hemm effett fuq ir- rata tat- tkabbir.
Testing for antibodies to somatropin should be carried out in any patient who fails to respond to therapy.
Għandu jsir ittestjar għall- antikorpi għal somatropin f' kull pazjent li jonqos milli jirrispondi għat- terapija.
Anti-host cell protein (anti-S. cerevisiae) antibodies were uncommon in patients treated with Valtropin.
L- anti- host cell protein (anti- S cerevisiae) antibodies ma kinux komuni f' pazjenti kkurati b' Valtropin.
The generation of such antibodies with low binding capacity is unlikely to be clinically relevant.
Il- produzzjoni ta 'antikorpi bħal dawn b' kapaċità ta' rbit baxxa mhix probabbli li tkun klinikament rilevanti.
In contrast to bacteria (E. coli), yeast has not been described to elicit adjuvant effects modifying the immunological response.
B' kuntrast mal- batterji (E. coli), il- ħmira ma ġietx deskritta li tislet effetti oħra li jimmodifikaw ir- reazzjoni immunoloġika.
There was one case (< 1%) of acute hypersensitivity involving urticaria and pruritus in a patient administered Valtropin.
Kien hemm każ wieħed (< 1%) ta 'sensittività eċċessiva akuta li kien jinvolvi urtikarja u ħakk f' pazjent li ngħata Valtropin.
Paediatric patients Mild and transient oedema was observed early during the course of treatment with somatropin.
6 Pazjenti pedjatriċi Kienet osservata edima ħafifa u temporanja kmieni matul il- kors tal- kura b' somatropin.
Leukaemia has been reported in a small number of children who have been treated with somatropin.
Kienet irrapportata lewkimja f' numru żgħir ta 'tfal li ġew ikkurati b' somatropin.
However, there is no evidence that leukaemia incidence is increased in somatropin recipients without predisposing factors.
Madankollu, m' hemmx evidenza li l- inċidenza tal- lewkimja tiżdied f’ dawk li jirċievu somatropin mingħajr fatturi ta 'predisposizzjoni.
Adult patients In general, in patients with adult-onset growth hormone deficiency, oedema, muscle pain, joint pain and disorders were reported early in therapy and tended to be transient.
Pazjenti adulti B' mod ġenerali, f' pazjenti b' defiċjenza ta 'l- ormon tat- tkabbir li bdiet f' età adulta, edima, uġigħ fil- muskoli, uġigħ u mard tal- ġogi kienu rrapportati kmieni fit- terapija u kellhom tendenza li jkunu temporanji.
Adult patients treated with somatropin, following diagnosis of growth hormone deficiency in childhood, reported undesirable effects less frequently than those with adult-onset growth hormone deficiency.
Pazjenti adulti kkurati b' somatropin, wara dijanjosi ta 'defiċjenza ta' l- ormon tat- tkabbir fit - tfulija, irrapportaw effetti mhux mixtieqa b' mod anqas frekwenti minn dawk b' defiċjenza ta 'l- ormon tat- tkabbir li bdiet f' età adulta.
Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia.
Doża eċċessiva akuta tista 'għall- ewwel twassal għal ipogliċemija u wara għal ipergliċemija.
Long-term overdose could result in signs and symptoms of acromegaly consistent with the known effects of excess human growth hormone.
Doża eċċessiva fuq perijodu fit- tul tista 'tirriżulta f' sinjali u sintomi ta' akromegalija konsistenti ma 'l- effetti magħrufa ta' eċċess ta ’ ormoni tat- tkabbir uman.
Somatropin and analogues; ATC code:
Somatropin u analogi; Kodiċi ATC:
Somatropin is a polypeptide hormone of recombinant DNA origin.
Somatropin huwa ormon polipeptide ta 'oriġini ta ’ DNA rikombinanti.
It has 191 amino acid residues and a molecular weight of 22,125 daltons.
Huwa għandu 191 residwu ta 'aċidu amminiku u piż molekulari ta' 22, 125 daltons.
The amino acid sequence of the product is identical to that of human growth hormone of pituitary origin.
Is- sekwenza ta 'l- aċidu amminiku tal- prodott hija identika għal dik ta' l- ormon tat- tkabbir uman ta 'oriġini pitwitarja.
Valtropin is synthesised in yeast cells (Saccharomyces cerevisiae).
Valtropin huwa sintetizzat f' ċelloli tal- ħmira (Saccharomyces cerevisiae).
The biological effects of somatropin are equivalent to those of human growth hormone of pituitary origin.
L- effetti bijoloġiċi ta 'somatropin huma ekwivalenti għal dawk ta' l- ormon tat- tkabbir uman ta 'oriġini pitwitarja.
The most prominent effect of somatropin is that it stimulates the growth plates of long bones.
L- aktar effett prominenti ta 'somatropin huwa li jistimula l- folji tat- tkabbir ta' l- għadam twil.
Additionally, it promotes cellular protein synthesis and nitrogen retention.
Barra minn hekk, huwa jippromwovi s- sintesi ċellulari tal- proteini u ż- żamma ta ’ nitrogen.
Somatropin stimulates lipid metabolism; it increases plasma fatty acids and high-density lipoprotein (HDL)-cholesterols, and decreases total plasma cholesterol.
Somatropin jistimula l- metaboliżmu tal- lipidi; huwa jżid l- aċidi grassi tal- plasma u l- kolesteroli tal- lipoproteini b' densità għolja (HLD) u jnaqqas il- kolesterol totali fil- plasma.
Somatropin therapy has a beneficial effect on body composition in growth hormone-deficient patients, in that body fat stores are reduced and lean body mass is increased.
It- terapija b' somatropin għandha effett benefiku fuq il- kompożizzjoni tal- ġisem f' defiċjenza ta 'l- ormon tat- tkabbir, billi l- ħażniet tax- xaħam jitnaqqsu u l- massa tal- ġisem bla xaħam tiżdied.
Long-term therapy in growth hormone-deficient patients increases bone mineral density.
Terapija fuq perijodu fit- tul f' pazjenti b' defiċjenza ta 'l- ormon tat- tkabbir iżżid id- densità tal- minerali fl- għadam.
Somatropin may induce insulin resistance.
Somatropin jista 'jikkawża reżistenza għall- insulina.
Large doses of somatropin may impair glucose tolerance.
Dożi kbar ta 'somatropin jistgħu jdgħajjfu t- tolleranza tal- glukows.
The efficacy and safety of Valtropin has been assessed in a randomised, double-blind, parallel, controlled Phase III study in children with growth hormone deficiency.
L- effikaċja u sigurtà ta 'Valtropin ġew evalwati fi studju parallel, ikkontrollat, b' għażla każwali, double- blind tal- Fażi III fi tfal b' defiċjenza ta' l- ormon tat- tkabbir.
There were no relevant differences between Valtropin and the reference product with regard to height velocity and height velocity SDS.
Ma kienx hemm differenzi rilevanti bejn Valtropin u l- prodott ta 'referenza fir- rigward tal- veloċità tat- tul u l- SDS tal- veloċità tat- tul.
An open single-arm Phase III study investigating the efficacy and safety of treatment with Valtropin in girls with short stature associated with Turner syndrome showed a significant effect of study treatment on height velocity.
7 Studju open single- arm tal- Fażi III li eżamina l- effikaċja u s- sigurtà ta 'kura b' Valtropin fi bniet bi statura qasira assoċjata mas- sindrome ta' Turner wera effett sinifikanti tal- kura ttestjata fuq il- veloċità tat- tul.
A double-blind, randomised, single dose, crossover study in 24 healthy volunteers showed that the pharmacokinetic profile of Valtropin was comparable to that of the reference product.
Studju tat- tip cross- over ta 'doża waħda, double blind, fejn 24 voluntiera b’ saħħithom ntgħażlu b' mod każwali wera li l- profil farmakokinetiku ta' Valtropin kien komparabbli ma 'dak tal- prodott ta' referenza.
Subcutaneous administration of 0.073 mg/ kg body weight of Valtropin resulted in a Cmax of 43.97 ng/ ml and an AUC0-24 h of 369.90 ng·h/ ml.
L- għoti taħt ġilda ta '0. 073 mg/ kg tal- piż tal- ġisem ta' Valtropin irriżulta f' Cmax ta '43. 97 ng/ ml u AUC0- 24 h ta' 369. 90 ng h/ ml.
Cmax was reached at 4 h and t½ was 3 h.
Cmax intlaħaq wara 4 sigħat u t- t½ kien 3 sigħat.
Non-clinical data reveal no special hazard for humans based on conventional studies with Valtropin of repeated dose toxicity, genotoxicity and reproductive toxicity studies.
Informazzjoni li mhijiex klinika ma tikxef ebda periklu speċjali għan- nies fuq il- bażi ta 'studji konvenzjonali b’ Valtropin dwar it- tossiċità b' doża ripetuta, l- effett tossiku fuq il- ġeni u l- effett tossiku fuq is- sistema riproduttiva.
Animal studies with Valtropin are not sufficient to assess the reproductive toxicity potential.
L- istudji fuq l- annimali b' Valtropin mhumiex suffiċjenti biex jiġi evalwat il- potenzjal tat- tossiċità riproduttiva.
From reproductive toxicity studies performed with other somatropin products there is no evidence of an increased risk of adverse reactions for the embryo or foetus.
Minn studji dwar it- tossiċità riproduttiva li saru bi prodotti oħra ta 'somatropin, m' hemmx evidenza ta' riskju akbar ta 'reazzjonijiet avversi għall- embriju jew il- fetu.
Long-term studies for carcinogenicity have not been performed.
Ma sarux studji fuq perijodu fit- tul dwar il- karċinoġeniċità.
There are no specific local tolerance studies in animals after subcutaneous injection of Valtropin.
M' hemmx studji speċifiċi dwar it- tolleranza lokali fl- annimali wara injezzjoni taħt ġilda ta 'Valtropin.
However, in single and repeat-dose general toxicity studies no adverse reactions at the injection sites were reported.
Madankollu, fi studji ġenerali dwar it- tossiċità b' doża waħda jew doża ripetuta ma kienu rrapportati ebda reazzjonijiet avversi fil- postijiet ta 'l- injezzjoni.
7 6.
8 6.
Glycine Mannitol Sodium phosphate monobasic Sodium phosphate dibasic Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment).
Glycine Mannitol Sodium phosphate monobasic Sodium phosphate dibasic Sodium hydroxide (għal aġġustament tal- pH) Hydrochloric acid (għal aġġustament tal- pH).
Metacresol Water for injections.
Metacresol Ilma għall- injezzjonijiet.
36 months
36 xahar
After first opening or following reconstitution with the solvent provided:
Wara li jinfetaħ l- ewwel darba jew wara rikostituzzjoni bis- solvent ipprovdut:
After reconstitution with the solvent provided, chemical and physical in-use stability has been demonstrated for 21 days at 2°C - 8°C (refrigerator).
Wara rikostituzzjoni bis- solvent ipprovdut, stabbiltà kimika u fiżika waqt li jkun qed jintuża ntweriet għal 21 ġurnata f' temperatura ta '2°C - 8°C (friġġ).
From a microbiological point of view, once opened, the product may be stored for a maximum of 21 days at 2°C - 8°C (refrigerator).
Minn perspettiva mikrobijoloġika, ladarba jinfetaħ, il- prodott jista 'jinħażen sa massimu ta' 21 ġurnata f' temperatura ta '2°C - 8°C (friġġ).
Following reconstitution with water for injections:
Wara rikostituzzjoni b' ilma għall- injezzjonijiet:
After reconstitution with water for injections, the product must be used immediately and must be used as a single use vial.
Wara rikostituzzjoni b' ilma għall- injezzjonijiet, il- prodott irid jintuża immedjatament u jrid jintuża bħala kunjett li jintuża darba biss.
If not used immediately, in-use storage times and conditions prior to use would normally not be longer than 24 hours at 2°C - 8°C (refrigerator), unless reconstitution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax immedjatament, iż- żminijiet u l- kondizzjonijiet ta 'ħażna qabel l- użu ġeneralment ma jkunux itwal minn 24 siegħa f' temperatura ta' 2°C - 8°C (friġġ), sakemm ir- rikostituzzjoni ma tkunx saret f' kondizzjonijiet asettiċi kkontrollati u validati.
For the purpose of transport and/ or ambulatory use the non-reconstituted product can be kept at room temperature (not above 25°C) for one single period of up to 4 weeks.
Għall- iskop ta 'trasport u/ jew użu ambulatorju l- prodott mhux rikostitwit jista' jinżamm f' temperatura tal- kamra (mhux ogħla minn 25°C) għal perijodu wieħed li ma jaqbiżx l- 4 ġimgħat.
Patients may keep the non-reconstituted product at room temperature for one single period of up to 4 weeks before use.
Il- pazjenti jistgħu jżommu l- prodott mhux rikostitwit f' temperatura tal- kamra għal perijodu wieħed li ma jaqbiżx l- 4 ġimgħat qabel l- użu.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Għall- kundizzjonijiet ta 'ħażna tal- prodott mediċinali rikostitwit, ara sezzjoni 6. 3.
5 mg of powder in a vial (Type I glass) closed with a stopper (butyl rubber) and a flip-off cap (aluminium plastic).
5 mg ta 'trab f' kunjett (ħġieġ tat- Tip I) magħluq b' tapp (gomma tal- butyl) u għatu li jinfetaħ b’ daqqa ta ’ saba ’ (aluminju u plastik).
1.5 ml of solvent in a pre-filled syringe (Type I glass) closed with a tip cap (FluroTec coated butyl rubber)
1. 5 ml ta 'solvent f' siringa mimlija għal- lest (ħġieġ tat- Tip I) magħluqa b' għatu għall- ponta (gomma tal- butyl miksija bi FluroTec)
8 Pack size of 1 vial and 1 pre-filled syringe.
Daqs tal- pakkett ta 'kunjett wieħed u siringa waħda mimlija għal- lest.
For use and handling Valtropin should not be reconstituted with the supplied solvent for patients with a known sensitivity to metacresol (see section 4.3).
Dwar l- użu u l- immaniġġar Valtropin m' għandux jiġi rikostitwit bis- solvent ipprovdut fil- każ ta 'pazjenti b' sensittività magħrufa għal metacresol (ara sezzjoni 4. 3).
If sensitivity to the accompanying solvent occurs, the vials should be reconstituted with water for injections and used as a single use vial.
Jekk titfaċċa sensittività eċċessiva għas- solvent li jakkumpanjah, il- kunjetti għandhom jiġu rikostitwiti bl- ilma għall- injezzjonijiet u jintużaw bħala kunjett li jintuża darba.
Reconstitution with the solvent provided Each vial of Valtropin should be reconstituted using the accompanying solvent.
Rikostituzzjoni bis- solvent ipprovdut Kull kunjett ta 'Valtropin għandu jiġi rikostitwit billi jintuża s- solvent ipprovdut.
The solvent should not be used if it is discoloured or cloudy.
Is- solvent m' għandux jintuża jekk ikollu lewn mitfi jew imdardar.
The solvent should be injected into the vial by aiming the stream of liquid against the glass wall.
Is- solvent għandu jiġi injettat fil- kunjett billi l- fluss tal - likwidu jiġi mmirat għal mall- ħajt tal- ħġieġ.
Following reconstitution, the vial should be swirled with a GENTLE rotary motion until the contents are completely dissolved.
Wara r- rikostituzzjoni, il- kunjett għandu jiġi mdawwar b' moviment ĠENTILI fit- tond sakemm il- kontenut jinħall għal kollox.
The resulting solution should be clear, without particulate matter.
Is- soluzzjoni li tirriżulta għandha tkun ċara, mingħajr materjal frak.
If the solution is discoloured, cloudy or contains particulate matter, the contents MUST NOT be injected.
Jekk is- soluzzjoni jkollha lewn mitfi, tkun imdardra jew ikun xi frak, il- kontenut M' GĦANDUX jiġi injettat.
Before and after every injection, the septum of the vial should be wiped with alcohol to prevent contamination of the contents by repeated needle insertions.
Qabel u wara kull injezzjoni, is- septum tal- kunjett għandu jintmesaħ bl- alkoħol sabiex jiġi evitat it- tniġġis tal- kontenut bl- inserzjoni ripetuta tal- labra.
If reconstituted with the solvent, then the solution is for multidose use (see section 6.3).
Jekk tiġi rikostitwita bis- solvent, f' dak il- każ is- soluzzjoni tkun għal aktar minn doża waħda (ara sezzjoni 6. 3).
Reconstitution with water for injections After reconstitution with water for injections the product must be used immediately (see section 6.3) and the solution is for single use only.
Rikostituzzjoni b' ilma għall- injezzjonijiet Wara rikostituzzjoni b' ilma għall- injezzjonijiet il- prodott irid jintuża immedjatament (ara sezzjoni 6. 3) u s- soluzzjoni tkun għal użu wieħed biss.
Administration Sterile disposable syringes and needles should be used for administration of Valtropin.
Kif jingħata Għandhom jintużaw siringi u labar sterilizzati li jintremew wara l- użu biex jingħata Valtropin.
The volume of the syringe should be small enough so that the prescribed dose can be withdrawn from the vial with reasonable accuracy.
Il- volum tas- siringa għandu jkun żgħir biżżejjed sabiex id- doża preskritta tkun tista 'tinġibed mill- kunjett bi preċiżjoni raġonevoli.
BioPartners GmbH Eisenstrasse 3 D-65428 Rüsselsheim Germany
BioPartners GmbH Eisenstrasse 3 D- 65428 Rüsselsheim Il- Ġermanja
9 ANNEX II
11 ANNESS II
LG Life Sciences Ltd., Iksan Plant, 601 Yongje-dong, Iksan-si, Jeonbuk-do 570-350, South Korea
LG Life Sciences Ltd., Iksan Plant, 601 Yongje- dong, Iksan- si, Jeonbuk- do 570- 350, Korea t' Isfel
BioPartners GmbH, Eisenstrasse 3, D-65428 Rüsselsheim, Germany
BioPartners GmbH, Eisenstrasse 3, D- 65428 Rüsselsheim, il- Ġermanja
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Sistema ta 'farmakoviġilanza Il- MAH għandu jiżgura li s- sistema ta' farmakoviġilanza tkun fis- seħħ u li din tkun qegħda taħdem qabel ma l- prodott jitpoġġa fis- suq u għal sakemm il- prodott li qiegħed jitpoġġa fuq is- suq jibqa 'jintuża.
Risk Management plan The MAH commits to performing additional pharmacovigilance activities as detailed in the Pharmacovigilance Plan.
Pjan ta 'l- immaniġġar tar- Riskju Il- MAH jikkommetti ruħu li jwettaq attivitajiet addizzjonali ta' farmakoviġilanza kif dettaljati fil- Pjan ta 'Farmakoviġilanza.
11 ANNEX III
13 ANNESS III
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
15 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Valtropin 5 mg/ 1.5 ml powder and solvent for solution for injection Somatropin
Valtropin 5 mg/ 1. 5 ml trab u solvent għal soluzzjoni għall- injezzjoni Somatropin
1 vial of powder contains 5 mg (15 IU) somatropin (3.33 mg/ ml somatropin after reconstitution with 1.5 ml solvent).
Kunjett 1 ta 'trab fih 5 mg (15 IU) somatropin (3. 33 mg/ ml somatropin wara rikostituzzjoni b' 1. 5 ml solvent).
Powder: glycine, mannitol, sodium phosphate monobasic, sodium phosphate dibasic. pH adjustment: sodium hydroxide and hydrochloric acid.
Trab: glycine, mannitol, sodium phosphate monobasic, sodium phosphate dibasic. aġġustament tal- pH: sodium hydroxide u hydrochloric acid.
Solvent: metacresol (see leaflet for further information) and water for injections.
Solvent: metacresol (ara l- fuljett għal aktar informazzjoni) u ilma għall- injezzjonijiet.
Powder and solvent for solution for injection 1 vial (powder) and 1 pre-filled syringe (1.5 ml solvent).
Trab u solvent għal soluzzjoni għall- injezzjoni Kunjett 1 (trab) u siringa 1 mimlija għal- lest (1. 5 ml solvent).
Subcutaneous use For information on reconstitution and use read the package leaflet.
Użu għal taħt il- ġilda Għal informazzjoni dwar ir- rikostituzzjoni u l- użu aqra l- fuljett ta 'tagħrif.
After reconstitution with the solvent provided: can be stored for 21 days in a refrigerator.
Wara rikostituzzjoni bis- solvent provdut: jista 'jinħażen għal 21 jum fi friġġ.
After reconstitution with water for injections: must be used immediately.
16 Wara rikostituzzjoni bl- ilma għall- injezzjonijiet: għandu jintuża minnufih.
Valtropin 5 mg/ 1.5 ml
Valtropin 5 mg/ 1. 5 ml
Valtropin 5 mg/ 1.5 ml Powder for solution for injection Somatropin
Valtropin 5 mg/ 1. 5 ml Trab għal soluzzjoni għall- injezzjoni Somatropin
16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
18 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN