natgillin/translations-raw huggingface dataset:
44 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
44 POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE ZDRAVILA, KI MORAJO BITI ZAGOTOVLJENI S STRANI DRŽAVE ČLANICE
Each cartridge contains 10 mg (corresponding to 30 IU) of the active substance somatropin.
Vsak vložek vsebuje 10 mg (kar ustreza 30 mednarodnim enotam) zdravilne učinkovine somatropin.
NutropinAq is used to treat children in the following situations: • children who fail to grow because of a lack of growth hormone. • children who are short because of Turner syndrome (a rare genetic disorder affecting girls), confirmed by chromosome analysis (DNA testing). • children before puberty, who fail to grow because of longstanding kidney disease, (chronic renal insufficiency) up to the time when they receive a kidney transplant.
NutropinAq se uporablja za zdravljenje otrok v naslednjih primerih: • otroci z motnjami v rasti zaradi pomanjkanja rastnega hormona, • otroci, ki so premajhne rasti zaradi Turnerjevega sindroma (redka prirojena bolezen, ki prizadene predvsem dekleta), ki ga je potrdila kromosomska analiza (DNA analiza), • otroci pred puberteto z zastojem v rasti zaradi dolgotrajne bolezni ledvic (kronično ledvično obolenje) do presaditve ledvice.
NutopinAq is used to treat adults in the following situation: • adult patients with growth hormone deficiency (replacement therapy).
NutropinAq se uporablja za zdravljenje odraslih v naslednjih primerih: • odrasli, ki jim primanjkuje rastnega hormona (nadomestna terapija).
The deficiency can have started in adulthood or childhood, and needs to be confirmed by testing before treatment.
Do pomanjkanja je lahko prišlo v odrasli dobi ali v otroštvu, mora pa biti potrjeno s testi pred pričetkom zdravljenja.
NutropinAq treatment should be started and supervised by a doctor experienced in the management of patients with growth disorders.
Zdravljenje z zdravilom NutropinAq lahko uvede in vzdržuje le zdravnik, ki ima izkušnje z zdravljenjem bolnikov z motnjami v rasti.
The medicine is given once a day by subcutaneous injection (under the skin), using the injection pen specially designed for the NutropinAq cartridge.
Zdravilo se daje enkrat na dan s subkutano (podkožno) injekcijo, pri čemer se uporabi injekcijsko pero, ki je oblikovano posebej za vložek zdravila NutropinAq.
The patient or caregiver can inject NutropinAq after training by a doctor or a nurse.
Bolnik ali negovalec lahko zdravilo NutropinAq vbrizgata sama pod pogojem, da ju medicinska sestra ali zdravnik za to ustrezno usposobita.
They should use a different injection site each day.
Zdravnik za vsakega bolnika posebej izračuna ustrezni odmerek glede na njegovo zdravstveno stanje.
The doctor calculates individually the dose for each patient depending on the condition, and this may need to be adjusted over time, depending on response, age and body weight.
Izračunani odmerek bo morda potrebno sčasoma prilagoditi glede na odziv, starost in spremembo telesne teže.
Growth hormone is a substance secreted by a gland located at the base of the brain (pituitary gland).
Rastni hormon je snov, ki jo izloča žleza, ki se nahaja na možganskem dnu (žleza hipofiza).
It promotes growth during childhood and adolescence, and also acts on the way the body handles proteins, fat and carbohydrates.
Ta hormon spodbuja rast v otroštvu in obdobju pubertete ter vpliva tudi na presnovo beljakovin, maščob in ogljikovih hidratov.
It is produced by a method known as ‘ recombinant DNA technology’: the hormone is made by a bacterium that has received a gene (DNA) that makes it able to produce it.
Proizvaja se po metodi, imenovani “ rekombinantna DNA tehnologija ”: hormon izdela bakterija, ki je prejela gen (DNA), s katerim postane sposobna tvoriti hormon.
NutropinAq replaces the natural hormone.
Zdravilo NutropinAq je nadomestilo za naravni hormon.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has NutropinAq been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo NutropinAq raziskano?
NutropinAq has been studied in children who had growth failure cause by lack of growth hormone (230), Turner syndrome (117), or kidney disease (195).
Zdravilo NutropinAq so preučevali pri otrocih z motnjami v rasti zaradi pomanjkanja rastnega hormona (230), Turnerjevega sindroma 8117) ali obolenja ledvic (195).
NutropinAq has also been studied in 171 adults with growth hormone deficiency.
NutropinAq so preučevali tudi pri 171 odraslih s pomanjkanjem rastnega hormona.
The studies were controlled (NutropinAq was compared with a placebo (a dummy treatment) or with a group of untreated patients) except for the studies in children with a lack of growth hormone where there was no comparison with another group.
Vse raziskave so bile kontrolirane (NutropinAq so primerjali s placebom (zdravilom brez zdravilne učinkovine) in s skupino nezdravljenih bolnikov), razen raziskav pri otrocih s pomanjkanjem rastnega hormona, kjer ni bilo primerjave z drugo skupino.
The main measures in the studies in children were height at the end of the study, and the speed of growth during the study.
Glavni merili v raziskavi pri otrocih je bila višina na koncu raziskave ter hitrost rasti med samo raziskavo.
The main measures in the adult study were lean body mass and decrease in total body fat.
Glavni merili v raziskavi pri odraslih sta bili mršava telesna masa in zmanjšanje skupnega telesnega maščevja.
What benefit has NutropinAq shown during the studies?
Kakšne koristi je zdravilo NutropinAq izkazalo med raziskavami?
NutropinAq produced significantly better growth in children than would have been expected without treatment.
Zdravilo NutropinAq je pri otrocih povzročilo pomembno večjo rast, kot bi jo bilo pričakovati brez zdravljenja.
In adults, NutropinAq increased lean body mass and reduced total body fat.
Pri odraslih je zdravilo NutropinAq povečalo mršavo telesno maso in zmanjšalo skupno telesno maščevje.
The most common side effects in adults are myalgia (muscle pain), arthralgia (joint pain) and oedema (swelling), and these are seen in more than 1 in 10 patients.
Najpogostejši neželeni stranski učinki pri odraslih so mialgija (bolečine v mišicah), artralgija (bolečine v sklepih) ter edem (otekanje), ki so bili opaženi pri več kot 1 od 10 bolnikov.
In children, the frequency is lower (between 1 and 10 in 100 patients).
Pri otrocih je pogostost manjša (med 1 in 10 od 100 bolnikov).
Other side effects seen at this lower frequency are reactions at the injection site, headache, hypertonia (muscle tension), hypothyroidism (under-activity of the thyroid gland), impaired glucose tolerance, asthenia (weakness) and development of antibodies (proteins that are produced in response to NutropinAq).
Drugi neželeni stranski učinki, opaženi manj pogosto, so reakcije na mestu injiciranja, glavobol, hipertonija (napetost v mišicah), hipotiroidizem (nezadostno delovanje ščitnice), motena toleranca za glukozo, astenija (izguba moči) ter razvoj protiteles (beljakovin, ki se pojavijo kot odziv na zdravilo NutropinAq).
For the full list of all side effects reported with NutropinAq, see the Package Leaflet.
Celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila NutropinAq, najdete v Navodilih za uporabo.
NutropinAq should not be used in people who may be hypersensitive (allergic) to somatropin or any of the other ingredients.
Zdravila NutropinAq ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) somatropin ali katero koli drugo sestavino.
NutropinAq should not be used when the patient suffers from an active tumour, or a life-threatening illness.
Zdravila NutropinAq ne smejo uporabljati bolniki, ki imajo aktiven tumor ali življenje ogrožujočo bolezen.
NutropinAq should not be used for growth promotion in children with closed epiphyses (the state of the large bones when they have finished growing).
Zdravila NutropinAq se ne sme uporabljati za spodbujanje rasti pri otrocih z zaprtimi epifizami (stanje večjih kosti po končani rasti).
Somatropin may interfere with the body’ s use of insulin.
Somatropin lahko ovira izrabo insulina.
Blood sugar levels will need to be checked during treatment, and treatment with insulin may sometimes need to be adjusted or started.
Med zdravljenjem je treba nadzorovati ravni sladkorja v krvi, včasih pa utegne biti potrebno zdravljenje z insulinom prilagoditi ali ga uvesti.
The Committee for Medicinal products for Human Use (CHMP) concluded that the effectiveness and safety of NutropinAq are generally comparable to that of other recombinant human growth hormone medicines.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da sta učinkovitost in varnost zdravila NutropinAq v splošnem primerljivi z učinkovitostjo in varnostjo drugih zdravil z rekombinantnim humanim rastnim hormonom.
They decided that NutropinAq’ s benefits are greater than its risks for the treatment of growth hormone deficiency in adults and children.
Odbor je odločil, da so koristi zdravila NutropinAq pri zdravljenju pomanjkanja rastnega hormona pri odraslih in otrocih večje od z njim povezanih tveganj.
They recommended that NutropinAq be given marketing authorisation.
Zato je priporočil odobritev dovoljenja za promet z zdravilom NutropinAq.
Other information about NutropinAq:
Druge informacije o zdravilu NutropinAq:
The European Commission granted a marketing authorisation valid throughout the European Union for NutropinAq to Ipsen Ltd on 16 February 2001.
Evropska komisija je dovoljenje za promet z zdravilom NutropinAq, veljavno po vsej Evropski uniji, odobrila družbi Ipsen Ltd dne 16. februarja 2001.
The Authorisation was renewed on 16 February 2006.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 16. februarja 2006.
The full EPAR for NutropinAq is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo NutropinAq je na voljo tukaj.
Solution for injection
Raztopina za injiciranje v vložku Za subkutano uporabo
cartridge (glass)
2 ml Raztopina za injiciranje v vložku Za subkutano uporabo vložek (steklo) 2 ml
cartridge (glass) 2 ml
2 ml Raztopina za injiciranje v vložku Za subkutano uporabo vložek (steklo) 2 ml
cartridge (glass) 2 ml
vložek (steklo) 2 ml
NutropinAq 10 mg/ 2 ml (30 IU) solution for injection
NutropinAq 10 mg/ 2 ml (30 i. e.) raztopina za injiciranje
One cartridge contains 10 mg (30 IU) of somatropin* * human growth hormone produced in Escherichia coli cells by recombinant DNA technology.
En vložek vsebuje 10 mg (30 i. e.) somatropina *. * humani rastni hormon, pridobljen iz celic Escherichie coli z genskim inženirstvom.
NutropinAq is a solution for subcutaneous use.
NutropinAq je raztopina za subkutano uporabo.
The clear, colourless, sterile solution for multidose use is contained in a glass cartridge, closed with a rubber stopper and a rubber seal.
Bistra, brezbarvna, sterilna raztopina za večkratno odmerjanje je pripravljena v steklenem vložku, zaprtem z gumijastim zamaškom in gumijasto zaporo.
- Long-term treatment of children with growth failure due to inadequate endogenous growth
- Dolgotrajno zdravljenje otrok z zaostankom v rasti zaradi nezadostnega endogenega sproščanja
hormone secretion.
rastnega hormona.
- Long-term treatment of growth failure associated with Turner syndrome.
- Dolgotrajno zdravljenje zaostanka v rasti, povezanega s Turnerjevim sindromom.
- Treatment of prepubertal children with growth failure associated with chronic renal
- Zdravljenje otrok pred puberteto, ki zaradi kronične odpovedi ledvic zaostajajo v rasti, do
insufficiency up to the time of renal transplantation.
presaditve ledvice.
- Replacement of endogenous growth hormone in adults with growth hormone deficiency of
- Nadomeščanje endogenega rastnega hormona pri odraslih s pomanjkanjem rastnega hormona, ki
either childhood or adult-onset etiology.
se začne v otroštvu ali odrasli dobi.
Growth hormone deficiency should be confirmed appropriately prior to treatment (see section 4.4).
Pomanjkanje rastnega hormona je treba pred zdravljenjem ustrezno potrditi (glejte poglavje 4. 4).
The NutropinAq dosage and administration schedule should be individualised for each patient.
Odmerjanje in urnik uporabe NutropinAq je treba določiti za vsakega bolnika posamezno.
Growth failure in children due to inadequate growth hormone secretion:
Zaostanek v rasti otrok zaradi nezadostnega izločanja rastnega hormona:
0.025 - 0.035 mg/ kg bodyweight given as a daily subcutaneous injection.
0, 025 - 0, 035 mg/ kg telesne mase v vsakodnevni subkutani injekciji.
Growth failure associated with Turner syndrome:
Zaostanek v rasti, povezan s Turnerjevim sindromom:
Up to 0.05 mg/ kg bodyweight given as a daily subcutaneous injection.
Do 0, 05 mg/ kg telesne mase v vsakodnevni subkutani injekciji.
Growth failure associated with chronic renal insufficiency:
Zaostanek v rasti, povezan s kronično odpovedjo ledvic:
2 At the start of somatropin therapy, low initial doses of 0.15 - 0.3 mg are recommended, given as a daily subcutaneous injection.
2 Pomanjkanje rastnega hormona pri odraslih:
The dose should be adjusted stepwise, controlled by serum Insulin-like Growth Factor-1 (IGF-1) values.
Odmerek je treba prilagajati postopoma in glede na vrednosti insulinu podobnega rastnega dejavnika I (IGF- I) v serumu.
The recommended final dose seldom exceeds 1.0 mg/ day.
Priporočeni končni odmerek redko presega 1, 0 mg/ dan.
The site of injection should be changed.
Mesto injciranja je treba menjati.
For instructions for use and handling, see section 6.6.
Za navodila za pripravo in ravnanje glejte poglavje 6. 6.
Growth hormone should not be used in patients with active neoplasm.
Rastnega hormona se ne sme uporabljati pri bolnikih z aktivnimi neoplazmami.
NutropinAq therapy should be discontinued if evidence of tumour growth develops.
Zdravljenje z NutropinAq je treba prekiniti, če se pojavijo znaki tumorske rasti.
Growth hormone should not be initiated to treat patients with acute critical illness due to complications following open-heart or abdominal surgery, multiple accidental traumas or to treat patients having acute respiratory failure.
Rastnega hormona se ne sme uvesti za zdravljenje bolnikov z akutno kritično boleznijo zaradi zapletov po operaciji na odprtem srcu ali v abdomnu, multiplih nezgodnih travmah ali akutno respiratorno insuficienco.
In adults with growth hormone deficiency the diagnosis should be established depending on the etiology:
Pri odraslih s pomanjkanjem rastnega hormona je treba diagnozo postaviti glede na etiologijo:
Adult-onset:
Začetek v odrasli dobi:
The patient must have growth hormone deficiency as a result of hypothalamic or pituitary disease, and at least one other hormone deficiency diagnosed (except for prolactin).
Bolnik mora imeti pomanjkanje rastnega hormona zaradi bolezni hipotalamusa ali hipofize ter diagnosticirano pomanjkanje vsaj še enega drugega hormona (razen prolaktina).
Test for growth hormone deficiency should not be performed until adequate replacement therapy for other hormone deficiencies have been instituted.
Preiskave pomanjkanja rastnega hormona se ne sme opraviti pred začetkom ustreznega nadomestnega zdravljenja drugih hormonskih pomanjkanj.
Childhood-onset:
Začetek v otroštvu:
Patients who have had growth hormone deficiency as a child should be retested to confirm growth hormone deficiency in adulthood before replacement therapy with NutropinAq is started.
Bolnike, ki so imeli pomanjkanje rastnega hormona kot otroci, je treba pred začetkom nadomestnega zdravljenja z NutropinAq znova preiskati za potrditev pomanjkanja rastnega hormona v odrasli dobi.
Patients with a history of an intracranial lesion should be examined frequently for progression or recurrence of the lesion.
Bolnike z anamnezo intrakranialne lezije je treba pogosto pregledati glede napredovanja ali ponovitve lezije.
NutropinAq is not indicated for the long-term treatment of paediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome, unless they also have a diagnosis of growth hormone deficiency.
NutropinAq ni indiciran za dolgotrajno zdravljenje pri pediatričnih bolnikih z zaostankom v rasti zaradi genetsko potrjenega Prader- Willijevega sindroma, razen če imajo ti bolniki tudi diagnozo pomanjkanja rastnega hormona.
There have been reports of sleep apnoea and sudden death after initiating therapy with growth hormone in paediatric 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.
Pri pediatričnih bolnikih s Prader- Willijevim sindromom, ki so imeli enega ali več od naslednjih rizičnih dejavnikov: prekomerno telesno težo, anamnezo obstrukcije zgornjih dihalnih poti ali apneje v spanju, ali neprepoznano respiratorno infekcijo, so poročali o smrtnih primerih po začetni terapiji z rastnim hormonom.
The effects of growth hormone on recovery were studied in two placebo-controlled clinical trials involving 522 adult patients who were critically ill due to complications following open-heart or abdominal surgery, multiple accidental traumas, or who were having acute respiratory failure.
Učinke rastnega hormona na okrevanje so proučevali v dveh s placebom kontroliranih kliničnih preskušanjih, ki sta zajeli 522 odraslih bolnikov, kritično bolnih zaradi zapletov po operaciji na odprtem srcu ali v abdomnu, multiplih nezgodnih travmah ali z akutno respiratorno insuficienco.
19.3%) among growth hormone treated patients (doses 5.3 - 8 mg/ day) compared to those receiving placebo.
3 Umrljivost je bila med bolniki, zdravljenimi z rastnim hormonom (v odmerkih od 5, 3 do 8 mg/ dan), večja kot pri prejemnikih placeba (41, 9% v primerjavi z 19, 3%).
The safety of continuing somatropin treatment in patients with acute critical illness in intensive care units due to complications following open-heart or abdominal surgery, multiple accidental trauma or acute respiratory failure receiving replacement doses for approved indications has not been established.
Varnost nadaljnjega somatropinskega zdravljenja v enoti za intenzivno nego pri bolnikih z akutno kritično boleznijo zaradi zapletov po operaciji na odprtem srcu ali v abdomnu, multiplih nezgodnih travmah ali akutno respiratorno insuficienco, ki dobivajo nadomestne odmerke za odobrene indikacije, ni ugotovljena.
However, growth hormone treatment has not been shown to increase the incidence or severity of scoliosis.
Čeprav zdravljenje z rastnim hormonom ni pokazalo zvečanje incidence ali poslabšanje skolioze, je potrebno med zdravljenjem spremljati znake skolioze.
For patients with diabetes mellitus, the insulin dose may require adjustment after NutropinAq therapy is instituted.
Pri bolnikih z diabetesom mellitusom utegne biti po uvedbi zdravljenja z NutropinAq potrebna prilagoditev odmerka insulina.
Patients with diabetes or glucose intolerance should be monitored closely during somatropin therapy.
Bolnike z diabetesom ali moteno toleranco za glukozo je treba med zdravljenjem s somatropinom natančno nadzirati.
Intracranial hypertension with papilloedema, visual changes, headache, nausea and/ or vomiting has been reported in a small number of patients treated with somatropin.
Pri majhnem številu bolnikov, zdravljenih s somatropinom, so poročali o intrakranialni hipertenziji s papiledemom, spremembami vida, glavobolom, navzeo in/ ali bruhanjem.
Symptoms usually occur within the first eight weeks of the initiation of NutropinAq therapy.
Simptomi se ponavadi pojavijo v prvih osmih tednih po začetku zdravljenja z NutropinAq.
Hypothyroidism may develop during treatment with somatropin, and untreated hypothyroidism may prevent optimal response to NutropinAq.
Med zdravljenjem s somatropinom se lahko pojavi hipotiroidizem; nezdravljen hipotiroidizem lahko prepreči optimalen odziv na NutropinAq.
Therefore, patients should have periodic thyroid function tests and should be treated with thyroid hormone when indicated.
Če je indicirano, morajo prejemati zdravljenje s ščitničnim hormonom.
Patients with severe hypothyroidism should be treated accordingly prior to the start of NutropinAq therapy.
Bolnike s hudim hipotiroidizmom je treba pred začetkom terapije z NutropinAq ustrezno zdraviti.
Since somatropin therapy following renal transplantation has not been adequately tested, NutropinAq treatment should be terminated after that surgery.
Zdravljenje s somatropinom po presaditvi ledvice ni dovolj preizkušeno, zato je treba zdravljenje z NutropinAq po takšni operaciji končati.
Concomitant treatment with glucocorticoids inhibits the growth-promoting effects of NutropinAq.
Sočasno zdravljenje z glukokortikoidi zavre rastne učinke NutropinAq.
Patients with ACTH deficiency should have their glucocorticoid replacement therapy carefully adjusted to avoid any inhibitory effect on growth.
Pri bolnikih s pomanjkanjem ACTH je treba nadomestno zdravljenje z glukokortikoidi skrbno prilagoditi, da bi preprečili inhibicijski učinek na rast.
The use of NutropinAq in patients with chronic renal insufficiency receiving glucocorticoid therapy has not been evaluated.
Uporaba NutropinAq pri bolnikih s kronično odpovedjo ledvic, ki dobivajo glukokortikoide, ni raziskana.
Monitoring is advisable when NutropinAq is administered in combination with medicinal products known to be metabolised by CYP450 liver enzymes, such as corticosteroids, sex steroids, anticonvulsants, and cyclosporin.
Med uporabo NutropinAq v kombinaciji z zdravili, za katera je znano, da se presnavljajo z jetrnimi encimi CYP450, kot na primer kortikosteroidi, spolni steroidi, antiepileptiki ali ciklosporin, je priporočljivo nadziranje.
For NutropinAq, no clinical data on exposed pregnancies are available.
Kliničnih podatkov o izpostavljenosti NutropinAq med nosečnostjo ni.
Although animal studies do not point to a potential risk during pregnancy, NutropinAq should be discontinued if pregnancy occurs.
Študije na živalih sicer ne kažejo potencialnih tveganj med nosečnostjo, toda če ženska zanosi, je treba uporabo NutropinAq kljub temu prekiniti.
During pregnancy, maternal somatropin will largely be replaced by placental growth hormone.
Med nosečnostjo placentni rastni hormon v glavnem nadomesti materin somatotropin.
It is not known whether somatropin is excreted in human milk, however, absorption of intact protein from the gastrointestinal tract of the infant is unlikely.
4 Ni znano, ali se somatropin izloča v materino mleko, vendar pa absorpcija nespremenjene beljakovine iz dojenčkovih prebavil ni verjetna.
No studies on the effects of NutropinAq on the ability to drive and use machines have been performed.
Študije o vplivu NutropinAq na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
Safety data from 9829 patients treated with Nutropin or NutropinAq - derived from a post-marketing surveillance survey in the United States - demonstrate that approximately 2% of patients have been shown to experience drug-related adverse reactions.
Podatki o varnosti iz študije pomarketinškega nadzora v ZDA pri 9829 bolnikih, ki so dobivali Nutropin ali NutropinAq, kažejo, da je mogoče z zdravilom povezane neželene reakcije pričakovati pri približno 2% bolnikov.
Most of these adverse drug reactions were reported in the “ general disorders and administration site conditions” system organ class.
Večina teh neželenih reakcij na zdravilo je bila zabeležena pri organskem sistemu "Splošne težave in spremembe na mestu aplikacije".
The adverse reactions are listed in the table below, based on experience from clinical trials and a post- marketing surveillance survey.
Neželene reakcije v spodnji tabeli so navedene na podlagi izkušenj iz kliničnih preskušanj in študije pomarketinškega nadzora.