natgillin/translations-raw huggingface dataset:
The safety and efficacy of Tolura in children and adolescents aged below 18 years have not been established.
Varnost in učinkovitost zdravila Tolura pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
Some people feel dizzy or tired when taking Tolura.
Vpliv na sposobnost upravljanja vozil in strojev Nekateri ljudje so med zdravljenjem z zdravilom Tolura omotični ali utrujeni.
These patients can be expected to have reduced hepatic clearance for telmisartan.
Pri bolnikih z naštetimi obolenji se lahko jetrni očistek telmisartana zmanjša.
Urinary tract infection including cystitis, upper respiratory tract infection including pharyngitis and sinusitis
okužba sečil, tudi cistitis,okužba zgornjih dihal, tudi faringitis in sinuzitis sepsa, tudi z usodnim izidom
Other medicines and Tolura
Shranjevanje zdravila Tolura
80 mg: white to almost white, biconvex, capsule shape tablets
80 mg: bele do skoraj bele, izbočene tablete v obliki kapsule.
Patients with renal impairment
Bolniki z ledvično okvar
Each tablet contains 40 mg telmisartan.
Ena tableta vsebuje 40 mg telmisartana.
Each tablet contains 20 mg telmisartan.
Ena tableta vsebuje 20 mg telmisartana.
In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with placebo.
Prevention Evaluation Study), v kateri so proučevali učinek ramiprila v primerjavi s placebom.
patients taking placebo (0,16 %) RR 2,07 (95 % confidence interval 1,14 - 3,76).
Pri bolnikih, ki so jemali telmisartan (0,33 %), se je v primerjavi s placebom (0,16 %) povečala pojavnost usodne sepse (RR 2,07 /95-odstotni interval zaupanja od 1,14 do 3,76/).
Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5 % CI 0.901.08), p (non-inferiority) = 0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo.
Telmisartan je bil podobno učinkovit kot ramipril pri vnaprej opredeljenem sekundarnem opazovanem dogodku, sestavljenem iz smrti zaradi srčnožilnega dogodka, neusodnega miokardnega infarkta in neusodne možganske kapi [0,99 (97,5-odstotni interval zaupanja 0,90 - 1,08), p (neinferiornost) = 0,0004], ki je bil primarni opazovani dogodek v referenčni študiji HOPE (The Heart Outcomes
Each tablet contains 80 mg telmisartan.
Ena tableta vsebuje 80 mg telmisartana.
However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Tolura may also be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Tolura.
Kadar s priporočenim odmerkom ne dosežemo želenega znižanja krvnega tlaka, lahko odmerek telmisartana povečamo do največ 80 mg enkrat na dan. Telmisartan lahko uporabljamo tudi v kombinaciji s tiazidnimi diuretiki, kot je npr. hidroklorotiazid, za katerega se je pokazalo, da ima v kombinaciji s telmisartanom aditivni učinek na znižanje krvnega tlaka.
What Tolura looks like and contents of the pack Tolura 40 mg tablets are white to almost white, biconvex, oval tablets.
Izgled zdravila Tolura in vsebina pakiranja Tolura 40 mg tablete so bele do skoraj bele, izbočene, ovalne tablete.
In the “Prevention Regimen For Effectively avoiding Second Strokes” (PRoFESS) trial in patients 50 years and older, who recently experienced stroke, an increased incidence of sepsis was noted for telmisartan compared with placebo, 0,70 % vs. 0,49 % RR 1,43 (95 % confidence interval 1,00
V preizkušanju PRoFESS (Prevention Regimen For Effectively avoiding Second Strokes) se je pri bolnikih, starih 50 let in več, ki so pred kratkim doživeli možgansko kap, med jemanjem telmisartana povečala pojavnost sepse, in sicer pri 0,70 % v primerjavi z 0,49 % pri zdravljenih s placebom (RR 1,43; 95-odstotni interval zaupanja od 1,00 do 2,06).
The overall incidence of adverse reactions reported with telmisartan was usually comparable to placebo (41.4 % vs 43.9 %) in controlled trials in patients treated for hypertension.
V s placebom nadzorovanih kliničnih preskušanjih pri bolnikih, ki so se zdravili zaradi hipertenzije, je bila skupna pogostost neželenih dogodkov podobna pri telmisartanu in placebu (41,4 % v primerjavi s 43,9 %).
At the beginning of the preventive therapy with Tolura 80 mg, blood pressure should be frequently monitored.
Za zmanjševanje srčnožilnih dogodkov je običajni odmerek zdravila Tolura ena tableta po 80 mg na dan. Na začetku preventivnega zdravljenja z zdravilom Tolura 80 mg je treba pogosto izmeriti krvni tlak.
No posology adjustment is required for patients with mild to moderate renal impairment.
Bolnikom z blago do zmerno ledvično okvaro odmerka ni treba prilagajati.
- Heart trouble.
- Huda jetrna okvara.
Tabulated summary of adverse reactions
Tabelarični pregled neželenih učinkov
Such conditions should be corrected before the administration of Tolura.
Taka stanja moramo uravnati pred zdravljenjem s telmisartanom.
Muscoloskeletal and connective tissue disorders Uncommon:
Bolezni mišično-skeletnega sistema in vezivnega tkiva Občasni:
What Tolura looks like and contents of the pack Tolura 80 mg tablets are white to almost white, biconvex, capsule shape tablets.
Izgled zdravila Tolura in vsebina pakiranja Tolura 80 mg tablete so bele do skoraj bele, izbočene tablete v obliki kapsule.
Treatment: Telmisartan is not removed by haemodialysis.
Telmisartan se s hemodializo ne odstrani.
Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may result in volume depletion and in a risk of hypotension when initiating therapy with telmisartan.
Ob uvedbi telmisartana sta možni posledici predhodnega zdravljenja z velikimi odmerki diuretikov, kot sta furosemid (diuretik zanke) in hidroklorotiazid (tiazidni diuretik), izguba zunajcelične tekočine in nevarnost hipotenzije.
Skin and subcutaneous tissue disorders Uncommon:
Bolezni kože in podkožja Občasni:
Telmisartan does not exhibit any partial agonist activity at the AT1receptor.
Na receptorju AT1 nima nikakršnega delnega agonističnega učinka.
Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
Ne zavira angiotenzinske konvertaze (kininaze II) - encima, ki razgrajuje bradikinin, zato predvidoma ne poveča neželenih učinkov, ki jih povzroča bradikinin.
Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics or antidepressants.
Alkohol, barbiturati, narkotiki ali antidepresivi še poslabšajo ortostatsko hipotenzijo.
The blood pressure lowering effect of telmisartan can be increased by concomitant use of other antihypertensive medicinal products.
Sočasno jemanje drugih antihipertenzivov lahko poveča antihipertenzivni učinek telmisartana.
Symptomatic hypotension, especially after the first dose of Tolura, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting.
Pri bolnikih z zmanjšanim volumnom krvi in/ali zmanjšano količino natrija zaradi intenzivnega diuretičnega zdravljenja, omejitve količine soli v hrani, driske ali bruhanja se zlasti po prvem odmerku telmisartana lahko pojavi simptomatska hipotenzija.
Tolura tablets contain sorbitol (E420).
To zdravilo vsebuje sorbitol (E420).
Respiratory, thoracic and mediastinal disorders Uncommon:
Bolezni dihal, prsnega koša in mediastinalnega prostora Občasni:
The binding is longlasting.
Vezava je dolgotrajna.
There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Pri bolnikih z obojestransko zožitvijo ledvične arterije ali zožitvijo arterije samo ene delujoče ledvice zdravljenje z zdravili, ki delujejo na reninsko-angiotenzinsko-aldosteronski sistem, poveča nevarnost hude hipotenzije in zmanjšanja ledvičnega delovanja.
In the elderly, in patients with renal insufficiency, in diabetic patients, in patients concomitantly treated with other medicinal products that may increase potassium levels, and/or in patients with intercurrent events, hyperkalaemia may be fatal.
Hiperkaliemija je lahko usodna za starejše bolnike in bolnike z ledvičnim odpovedovanjem ali s sladkorno boleznijo, za vse, ki se sočasno zdravijo z drugimi zdravili, ki lahko zvišajo raven kalija, ali za bolnike s sočasnimi dogodki.
General disorders and administration site conditions Uncommon:
Splošne težave in spremembe na mestu aplikacije Občasni:
The recommended dose is 80 mg once daily.
Običajni učinkovit odmerek je 40 mg enkrat na dan.
Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Pri bolnicah, ki načrtujejo nosečnost, je treba čim prej preiti na alternativno antihipertenzivno zdravljenje z zdravilom z uveljavljenim varnostnim profilom za uporabo v nosečnosti; razen če se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
Tolura contains lactose and sorbitol (E420).
Zdravilo Tolura vsebuje sorbitol (E420) in laktozo.
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor antagonists, including telmisartan.
Med sočasnim dajanjem litija in zaviralcev ACE ter antagonistov receptorjev angiotenzina II, vključno s telmisartanom, so poročali o reverzibilnem zvišanju ravni litija v serumu in toksičnih pojavih.
Metabolism and nutrition disorders Uncommon:
Presnovne in prehranske motnje Občasni:
Cardiovascular prevention:
Preprečevanje srčno-žilnih bolezni
High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness.
Posledice so lahko srčni napad, srčno popuščanje ali ledvična odpoved, možganska kap ali slepota.
Syncope Somnolence
sinkopa somnolenca
Cumulative urinary excretion is <1 % of dose.
S sečem se skupno izloči manj kot 1 % odmerka.
Hepatic impairment
Okvarjeno jetrno delovanje
The incidence of dry cough was significantly lower in patients treated with telmisartan than in those given angiotensin converting enzyme inhibitors in clinical trials directly comparing the two antihypertensive treatments.
Pogostost suhega kašlja je bila med bolniki, ki so se zdravili s telmisartanom, pomembno manjša kot pri tistih, ki so jemali zaviralce ACE.
There is an apparent trend to a dose relationship to a time to recovery of baseline systolic blood pressure (SBP).
Rezultati raziskav kažejo na povezanost med odmerkom in časom, v katerem se v telesu vzpostavijo začetne vrednosti sistoličnega krvnega tlaka.
Renal impairment and kidney transplantation
Ledvična okvara in ledvični presadek
Symptoms: The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia, dizziness, increase in serum creatinine, and acute renal failure have also been reported.
Poročali so tudi o bradikardiji, omotici, zvišani ravni kreatinina v serumu in akutni ledvični odpovedi.
- Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting.
ali pomanjkanje soli zaradi diuretičnega zdravljenja (jemanja tablet za odvajanje vode), diete z majhno vsebnostjo soli, driske ali bruhanja; - zvišano raven kalija v krvi, - sladkorno bolezen.
FRI
SRE
- Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
To velja zlasti za našteta zdravila, kadar jih jemljete sočasno z zdravilom Tolura: - zdravila z litijem za zdravljenje nekaterih oblik depresije; - zdravila, ki lahko povečajo raven kalija v krvi (npr. nadomestki soli s kalijem), diuretiki, ki zadržujejo kalij (nekatere tablete za odvajanje vode), zaviralci angiotenzinske konvertaze (ACE), angatonisti receptorjev angiotenzina II, nesteroidna protivnetna zdravila (npr. acetilsalicilna kislina ali ibuprofen), heparin, imunosupresivi (npr. ciklosporin ali takrolimus) in antibiotik trimetoprim; - diuretiki (tablete za odvajanje vode), zlasti če sočasno z zdravilom Tolura jemljete velike odmerke, ki lahko povzročijo preveliko izgubo vode iz telesa in znižajo krvni tlak (povzročijo hipotenzijo); - če jemljete zaviralec ACE ali aliskiren (glejte tudi informacije pod naslovoma "Ne jemljite zdravila Tolura" in "Opozorila in previdnostni ukrepi"); - digoksin.
There was evidence for a benefit of telmisartan compared to placebo in the pre-specified secondary composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.87 (95 % CI 0.76 - 1.00, p = 0.048)].
Podatki dokazujejo korist zdravljenja s telmisartanom v primerjavi s placebom glede na vnaprej opredeljeni sekundarni sestavljeni opazovani dogodek, in sicer smrt zaradi srčnožilnega dogodka, neusodni miokardni infarkt in neusodno možgansko kap [0,87 (95odstotni interval zaupanja 0,76 - 1,00, p = 0,048)], medtem ko korist pri srčno-žilni umrljivosti ni bila dokazana (razmerje tveganja 1,03, 95-odstotni interval zaupanja 0,85 - 1,24).
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Second and third trimester of pregnancy (see sections 4.4 and 4.6) - Biliary obstructive disorders - Severe hepatic impairment
- Drugo in tretje trimesečje nosečnosti (glejte poglavji 4.4 in 4.6).
- Liver disease.
- Obolenja z zaporo žolčevoda.
To be taken into account with concomitant use
za peroralno uporabo
Tolura should be used only with caution in patients with mild to moderate hepatic impairment.
Bolnikom z zmerno hudo do hudo jetrno okvaro je treba telmisartan dajati previdno.
Contains lactose monohydrate and sorbitol (E420).
Ena tableta vsebuje sorbitol (E420) in laktozo.
Ref. EMEA/166909/2008
EMEA/166894/2008
London, 21 February 2008 Doc.
London, 21. februar 2008 Sklic dok.
The main measure of effectiveness was the increase in adult height.
Glavno merilo učinkovitosti je bilo povečanje višine pri odraslih.
International non-proprietary name (INN): somatropin
Mednarodno nelastniško ime (INN): somatropin
This must be confirmed by chromosome analysis (DNA testing);
To mora biti potrjeno s kromosomsko analizo (analizo DNA);
In total, the children received the medicine for up to ten years.
Otroci so skupaj prejemali zdravilo do deset let.
In addition, a benefit of the medicine in improving the child's psychological or social wellbeing had not been shown.
Poleg tega ni bila dokazana korist zdravila z vidika izboljšanja otrokovega psihološkega ali socialnega počutja.
The company had requested a re-examination of the negative opinion, but this had not yet finished when the company withdrew.
Družba je zahtevala ponovno presojo negativnega mnenja, ki pa še ni bila zaključena, ko je družba podala zahtevek za umik.
NutropinAq is already used to treat children in the following situations:
Zdravilo NutropinAq se že uporablja za zdravljenje otrok v naslednjih primerih:
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 human growth hormone.
Proizvaja se z metodo, imenovano „tehnologija rekombinantne DNA“, pri kateri hormon izdela bakterija, ki je prejela gen (DNA), s katerim lahko tvori humani rastni hormon.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE APPLICATION FOR A CHANGE TO THE MARKETING AUTHORISATION for NUTROPINAQ
VPRAŠANJA IN ODGOVORI V ZVEZI Z UMIKOM VLOGE ZA SPREMEMBO DOVOLJENJA ZA PROMET z zdravilom NUTROPINAQ
There are no consequences on the use of NutropinAq in the authorised indications, for which the balance of benefits and risks remains unchanged.
Umik nima nobenih posledic za uporabo zdravila NutropinAq za odobrene indikacije, pri katerih ostaja razmerje med koristmi in tveganji nespremenjeno.
What were the major concerns of the CHMP?
Kateri so bili glavni zadržki CHMP?
• when they fail to grow because of a lack of growth hormone;
• pri motnjah v rasti zaradi pomanjkanja rastnega hormona;
• if they are short because of Turner syndrome (a rare genetic disorder affecting girls).
• če so premajhne rasti zaradi Turnerjevega sindroma (redka prirojena bolezen, ki prizadene dekleta).
The deficiency can have started in adulthood or childhood, and needs to be confirmed by testing before treatment begins.
Do pomanjkanja rastnega hormona lahko pride v odrasli dobi ali otroštvu, pred začetkom zdravljenja pa mora biti potrjeno s testi.
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using NutropinAq?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila NutropinAq?
On 24 January 2008, Ipsen Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for NutropinAq, for the long-term treatment of children with severe idiopathic short stature.
Družba Ipsen Ltd je dne 24. januarja 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za novo indikacijo za zdravilo NutropinAq, in sicer za dolgotrajno zdravljenje otrok s hudo idiopatsko nizko telesno višino.
The company presented the results of one main study looking at the effectiveness of NutropinAq in 118 children with short stature who did not have growth hormone deficiency or any other identifiable condition that could cause their growth impairment.
Družba je predložila rezultate glavne študije, v kateri so preučevali učinkovitost zdravila NutropinAq pri 118 otrocih z nizko telesno višino, ki niso izkazovali niti pomanjkanja rastnega hormona niti katerega koli drugega določljivega razloga, ki bi lahko povzročil motnjo v rasti.
It was to be used if all possible causes of the child's short height had been excluded, such as low growth hormone levels.
Zdravilo naj bi se uporabljalo le v primeru izključitve vseh možnih razlogov za otrokovo nizko telesno višino, npr. nizke ravni rastnega hormona.
For the first year, the study compared the effectiveness of NutropinAq given three times a week with that of no treatment.
Prvo leto so v okviru študije primerjali učinkovitost zdravila NutropinAq, dajanega trikrat tedensko, s stanjem brez zdravljenja.
The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes in Europe with NutropinAq in this indication.
Družba je obvestila CHMP, da trenutno v Evropi klinična preskušanja ali programi sočutne uporabe zdravila NutropinAq za to indikacijo ne potekajo.
It is given by injection under the skin, using the injection pen specially designed for the cartridge.
Daje se z injiciranjem pod kožo, in sicer z injekcijskim peresnikom, ki je posebej oblikovan za ta vložek.
The active ingredient in NutropinAq, somatropin, is identical to the human growth hormone.
Zdravilna učinkovina zdravila NutropinAq, somatropin, je identična humanemu rastnemu hormonu.
difference between the height that each child was predicted to reach based on their height and bone maturity before they started to receive NutropinAq, and their actual height when they had reached adulthood.
To je temeljilo na razliki med višino, ki naj bi jo posamezen otrok dosegel po napovedi na podlagi svoje višine in zrelosti kosti pred pričetkom prejemanja zdravila NutropinAq, ter njegovo dejansko višino, ko je dosegel odraslo dobo.
The Committee raised a concern that the use of NutropinAq for the long periods necessary to treat severe idiopathic short stature might increase the risk of the development of tumours or diabetes later in life.
Odbor je izrazil pomislek, da bi dolgotrajna uporaba zdravila NutropinAq za zdravljenje hude idiopatske nizke telesne višine utegnila povečati tveganje za razvoj tumorjev ali sladkorne bolezni kasneje v življenju.
What is happening for NutropinAq for treatment of failure to grow due to growth hormone deficiency, Turner syndrome or chronic renal insufficiency?
Kakšne so posledice za zdravilo NutropinAq, indicirano za zdravljenje zaustavitve rasti kot posledice pomanjkanja rastnega hormona, Turnerjevega sindroma ali kroničnega ledvičnega popuščanja?
Based on the review of the data and the company's response to the CHMP's list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend the approval of NutropinAq for the long-term treatment of children with severe idiopathic short stature.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil negativno mnenje in ni priporočil odobritve zdravila NutropinAq za dolgotrajno zdravljenje otrok s hudo idiopatsko nizko telesno višino.
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 tudi vpliva na presnovo beljakovin, maščob in ogljikovih hidratov v telesu.
• before puberty, when they fail to grow because of longstanding kidney disease (chronic renal insufficiency).
• pred puberteto v primeru zastoja rasti zaradi dolgotrajne bolezni ledvic (kroničnega ledvičnega popuščanja).
NutropinAq is also used to treat adults with growth hormone deficiency, as replacement therapy.
Zdravilo NutropinAq se uporablja tudi za zdravljenje odraslih s pomanjkanjem rastnega hormona, in sicer kot nadomestna terapija.
It was to be used as long-term treatment in children who were predicted to be short, in comparison with their parents' height, once they had reached adulthood.
Uporabljalo naj bi se za dolgotrajno zdravljenje pri otrocih, za katere se predvideva, da bodo v odrasli dobi, v primerjavi s svojimi starši, nizke rasti.
NutropinAq is a solution for injection in a cartridge, which contains the active substance somatropin.
Zdravilo NutropinAq je raztopina za injiciranje v vložku, ki vsebuje zdravilno učinkovino somatropin.
In the new indication, NutropinAq was expected to be used to treat children with ‘severe idiopathic short stature' (severe growth impairment with no identifiable cause).
Nova indikacija je predvidevala uporabo zdravila NutropinAq pri zdravljenju otrok s „hudo idiopatsko nizko telesno višino“ (hudo motnjo v rasti z nepojasnjenim razlogom).
The CHMP was concerned that only a modest benefit of NutropinAq in severe idiopathic short stature had been demonstrated, with an average gain in final adult height of around 6 to 7 cm in the main study.
CHMP je izrazil zadržek, da je bila v glavni študiji izkazana le zmerna korist zdravila NutropinAq pri hudi idiopatski nizki telesni višini, s povprečno 6- do7-centimetrskim povečanjem končne odrasle višine.
What was NutropinAq expected to be used for?
Za kaj naj bi se zdravilo NutropinAq uporabljalo?
Therefore, at the time of the withdrawal, the CHMP's view was that that the benefits of NutropinAq in the long-term treatment of children with severe idiopathic short stature did not outweigh its possible risks.
Posledično je CHMP v času umika menil, da koristi zdravila NutropinAq pri dolgotrajnem zdravljenju otrok s hudo idiopatsko nizko telesno težo ne odtehtajo z njim povezanih tveganj.
Growth hormone is a substance secreted by a gland located at the base of the brain called the pituitary gland.
Rastni hormon je snov, ki jo izloča žleza, ki se nahaja na možganskem dnu, imenovana hipofiza.
NutropinAq is used until the child receives a kidney transplant.
Zdravilo NutropinAq se uporablja do presaditve ledvice.