natgillin/translations-raw huggingface dataset:
70 Take special care with Imprida − if you have been sick (vomiting or diarrhoea). − if you are taking diuretics (a type of medicine also called “ water tablets” which increases the amount of urine you produce). − if you are taking other medicines or substances that increase the level of potassium in your blood (e. g. some types of diuretics, potassium supplements or salt substitutes containing potassium). − if you have liver or kidney problems. − if you have a condition affecting the renal glands called “ primary hyperaldosteronism”. − if you have had heart failure. − if your doctor has told you that you have a narrowing of the valves in your heart (called “ aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “ obstructive hypertrophic cardiomyopathy”).
73 Bodite posebno pozorni pri uporabi zdravila Imprida − če vam je bilo slabo (bruhanje ali driska). − če jemljete diuretike (zdravila, ki jim pravimo tudi “ zdravila za odvajanje vode ” in povečajo količino izločenega urina). − če jemljete druga zdravila ali učinkovine, ki zvišujejo koncentracijo kalija v krvi (npr. nekatere vrste diuretikov, dodatki kalija ali nadomestki soli, ki vsebujejo kalij). − če imate težave z jetri ali ledvicami. − če imate posebno bolezen nadledvičnih žlez, imenovano “ primarni hiperaldosteronizem ”. − če ste kdaj imeli srčno popuščanje. − če vam je zdravnik povedal, da imate zožene srčne zaklopke (t. i. aortno ali mitralno stenozo) ali nenormalno zadebeljeno srčno mišico (t. i. obstruktivno hipertrofično kardiomiopatijo).
71 Tell your doctor if you are breast-feeding.
74 Zdravniku morate povedati, če dojite.
Other possible side effects:
75 Drugi možni neželeni učinki:
What Imprida contains
Kaj vsebuje zdravilo Imprida − Zdravilni učinkovini v zdravilu Imprida sta amlodipin (v obliki amlodipinijevega besilata) in valsartan.
Each
Ena tableta vsebuje 5 mg amlodipina in 160 mg valsartana. − Pomožne snovi so mikrokristalna celuloza, krospovidon tipa A, brezvoden koloidni silicijev dioksid, magnezijev stearat, hipromeloza, makrogol 4000, smukec, titanov dioksid (E171), rumeni železov oksid (E172).
tablet contains 5 mg amlodipine and 160 mg valsartan.
Izgled zdravila Imprida in vsebina pakiranja Tablete Imprida 5 mg/ 160 mg so ovalne in temnorumene; na eni strani imajo oznako “ NVR ” in na drugi “ ECE ”.
76 Take special care with Imprida − if you have been sick (vomiting or diarrhoea). − if you are taking diuretics (a type of medicine also called “ water tablets” which increases the amount of urine you produce). − if you are taking other medicines or substances that increase the level of potassium in your blood (e. g. some types of diuretics, potassium supplements or salt substitutes containing potassium). − if you have liver or kidney problems. − if you have a condition affecting the renal glands called “ primary hyperaldosteronism”. − if you have had heart failure. − if your doctor has told you that you have a narrowing of the valves in your heart (called “ aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “ obstructive hypertrophic cardiomyopathy”).
79 Bodite posebno pozorni pri uporabi zdravila Imprida − če vam je bilo slabo (bruhanje ali driska). − če jemljete diuretike (zdravila, ki jim pravimo tudi “ zdravila za odvajanje vode ” in povečajo količino izločenega urina). − če jemljete druga zdravila ali učinkovine, ki zvišujejo koncentracijo kalija v krvi (npr. nekatere vrste diuretikov, dodatki kalija ali nadomestki soli, ki vsebujejo kalij). − če imate težave z jetri ali ledvicami. − če imate posebno bolezen nadledvičnih žlez, imenovano “ primarni hiperaldosteronizem ”. − če ste kdaj imeli srčno popuščanje. − če vam je zdravnik povedal, da imate zožene srčne zaklopke (t. i. aortno ali mitralno stenozo) ali nenormalno zadebeljeno srčno mišico (t. i. obstruktivno hipertrofično kardiomiopatijo).
77 Tell your doctor if you are breast-feeding.
80 Zdravniku morate povedati, če dojite.
Other possible side effects:
81 Drugi možni neželeni učinki:
Each tablet contains 10 mg amlodipine and 160 mg valsartan.
Kaj vsebuje zdravilo Imprida − Zdravilni učinkovini v zdravilu Imprida sta amlodipin (v obliki amlodipinijevega besilata) in valsartan.
79 − The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (E172).
Ena tableta vsebuje 10 mg amlodipina in 160 mg valsartana. − Pomožne snovi so mikrokristalna celuloza, krospovidon tipa A, brezvoden koloidni silicijev dioksid, magnezijev stearat, hipromeloza, makrogol 4000, smukec, titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172).
What Imprida looks like and contents of the pack Imprida 10 mg/ 160 mg tablets are oval and light yellow with “ NVR” on one side and “ UIC” on the other side.
Izgled zdravila Imprida in vsebina pakiranja Tablete Imprida 10 mg/ 160 mg so ovalne in svetlorumene; na eni strani imajo oznako “ NVR ” in na drugi “ UIC ”.
Danmark Novartis Healthcare A/ S Tlf: +45 39 16 84 00
83 Danmark Novartis Healthcare A/ S Tlf: +45 39 16 84 00
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO UVESTI DRŽAVE ČLANICE
1/ 3 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Države članice morajo zagotoviti izvajanje vseh pogojev in predpisov glede varne in učinkovite uporabe spodaj opisanih medicinskih izdelkov.
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Imetnik dovoljenja za promet mora zagotoviti, da imajo vsi zdravniki, od katerih se pričakuje predpisovanje zdravila INCRELEX, že na začetku na voljo » zdravnikov sveženj z informacijami «, ki vsebuje naslednje:
That at launch all physicians who are expected to prescribe INCRELEX are provided with a “ physician information pack” containing the following:
Informacije o zdravilu Informacije za zdravnika o zdravilu INCRELEX (informacijsko kartico, navodilo za odmerjanje in kalkulator za odmerjanje) Bolnikov sveženj z informacijami
Product information Physician information about INCRELEX (information card, dosing guide, and a dose calculator) Patient information pack
Zdravnikov sveženj z informacijami o zdravilu INCRELEX mora vsebovati naslednje ključne elemente:
The physician information about INCRELEX should contain the following key elements:
Poučiti starše o znakih, simptomih in zdravljenju hipoglikemije vključno z injiciranjem glukagona.
• To educate parents on the signs, symptoms and treatment of hypoglycaemia, including injection of glucagon. • That patients should have examinations of the ears, nose and throat periodically and at the occurrence of clinical symptoms to rule out such potential complications or to initiate appropriate treatment. • To perform a routine funduscopic examination prior to beginning treatment and periodically during treatment or at the occurrence of clinical symptoms. • INCRELEX is contraindicated in the presence of active or suspected neoplasia, and therapy should be discontinued if evidence of neoplasia develops. • Slipped capital femoral epiphysis and progression of scoliosis can occur in patients who experience rapid growth.
Pri bolnikih, ki začno hitro rasti, se lahko pojavita zdrs glavice stegnenice in napredovanje skolioze.
These conditions should be monitored during INCRELEX treatment. • To inform parents and patients that allergic reactions are possible and that if this occurs treatment should be interrupted and prompt medical attention should be sought. • Immunogenicity sampling information.
Informacije o vzorčenju imunogenih lastnosti
The patient information about INCRELEX should contain the following information:
Bolnikov sveženj z informacijami o zdravilu INCRELEX mora vsebovati naslednje informacije:
• That INCRELEX should be administered shortly before or after a meal or snack because it has insulin-like hypoglycaemic effects. • The signs and symptoms of hypoglycaemia.
Zdravilo INCRELEX je treba dati malo pred ali po obroku oziroma prigrizku, saj ima insulinu podobne hipoglikemične učinke Znaki in simptomi hipoglikemije.
Instructions on the administration of glucagon should severe hypoglycaemia occur. • INCRELEX should not be administered if the patient is unable to eat for any reason.
Odmerka zdravila INCRELEX ni dovoljeno podvojiti, če je bil en odmerek izpuščen.
The dose of INCRELEX should not be doubled to make up for one or more omitted doses. • To avoid engaging in any high-risk activities (such as vigorous physical activity) within 2 - 3 hours after dosing, particularly at the initiation of INCRELEX treatment, until a well-tolerated dose of INCRELEX has been established. • Instructions to change and rotate the site of injection for each injection to avoid the development of lipohypertrophy. • Instructions to report the onset or worsening of snoring that may indicate an increase in growth of tonsils and/ or adenoids following the beginning of treatment with INCRELEX. • To report the onset of severe headache blurred vision and associated nausea and vomiting to their physician. • To report any onset of a limp or complaint of hip or knee pain to their physician so it can be evaluated.
Navodila za poročanje zdravniku o pojavu šepanja ali bolečinah v kolku ali kolenu, da je mogoče stanje oceniti.
2/ 3 In addition there will be a dosing guide, and a dose calculator, for use by physician and patients to include information on the individualised dose escalation to minimise the risk of medication errors and hypoglycaemia.
Dodatno bodo na voljo navodila za odmerjanje in kalkulator za odmerjanje za zdravnike in bolnike, v katere bodo vključeni podatki o individualnem povečevanju odmerka, da bi tako zmanjšali tveganje napak pri zdravljenju in hipoglikemije.
What is INCRELEX?
Kaj je zdravilo INCRELEX?
INCRELEX is a solution for injection containing the active substance mecasermin (10 mg/ ml).
Zdravilo INCRELEX je raztopina za injiciranje, ki vsebuje zdravilno učinkovino mekasermin (10 mg/ ml).
What is INCRELEX used for?
Za kaj se zdravilo INCRELEX uporablja?
INCRELEX is used for the long-term treatment of growth failure in children and adolescents who have severe primary deficiency (low blood levels) of a hormone, insulin-like growth factor-1 (IGF-1), which is required for growth.
Zdravilo INCRELEX se uporablja za dolgotrajno zdravljenje zaostajanja v rasti pri otrocih in mladostnikih s hudim primarnim pomanjkanjem (nizko koncentracijo v krvi) insulinu podobnega rastnega faktorja- 1 (IGF- 1), t. j. hormona, ki je potreben za rast.
Patients with this disease produce growth hormone (GH) but their body does not respond to it, and they are short for their age.
Bolniki s to boleznijo tvorijo rastni hormon (GH), vendar se njihovo telo nanj ne odziva, zato so glede na svojo starost majhni.
It is a ‘ primary’ deficiency, meaning that there is no other identified cause for the low levels of IGF-1, such as malnutrition, low levels of thyroid hormone or the use of medicines called steroids to reduce or prevent inflammation.
Pri tem gre za primarno pomanjkanje, kar pomeni, da ni drugih znanih vzrokov za nizko koncentracijo IGF- 1, kot so podhranjenost, nizke ravni hormona ščitnice ali uporaba zdravil, imenovanih steroidi, za zmanjšanje ali preprečevanje vnetja.
Because the number of patients with primary IGF-1 deficiency is low, the disease is considered ‘ rare’, and INCRELEX was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 22 May 2006.
Ker je število bolnikov s primarnim pomanjkanjem IGF- 1 majhno, velja ta bolezen za redko, zato je bilo zdravilo INCRELEX 22. maja 2006 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja pri redkih boleznih).
How is INCRELEX used?
Kako se zdravilo INCRELEX uporablja?
Treatment with INCRELEX should be supervised by doctors who have experience in the diagnosis and treatment of patients with growth disorders.
Zdravljenje z zdravilom INCRELEX mora nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolnikov z motnjami rasti.
The recommended starting dose is 0.04 mg per kilogram body weight twice a day.
Priporočen začetni odmerek je 0, 04 mg na kilogram telesne mase dvakrat dnevno.
The dose should be tailored for each patient according to the speed of growth and certain side effects.
Odmerek je treba prilagoditi vsakemu posameznemu bolniku glede na hitrost rasti in določene neželene učinke.
The maximum dose is 0.12 mg per kilogram twice a day.
Največji odmerek je 0, 12 mg na kilogram dvakrat dnevno.
INCRELEX is given by injection under the skin, and the injection site should be changed with each injection.
Zdravilo INCRELEX se daje z injekcijo pod kožo, pri čemer je treba za vsako injekcijo izbrati drugo mesto injiciranja.
The injection should be carried out shortly before or after a meal or snack.
Injekcijo je treba dati neposredno pred ali po obroku oziroma prigrizku.
INCRELEX is not recommended for children below two years of age, due to a lack of data on safety and effectiveness in this group.
Zdravila INCRELEX pri otrocih, mlajših od dveh let, zaradi pomanjkanja podatkov o varnosti in učinkovitosti v tej skupini ni priporočljivo uporabljati.
For more information, see the Summary of Product Characteristics.
Več informacij najdete v Povzetku glavnih značilnosti zdravila.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Mecasermin is made using ‘ recombinant DNA technology’: it is made by bacteria that have received a gene that makes them able to produce IGF-1.
Mekasermin se proizvaja s „ tehnologijo rekombinantne DNK “: tvorijo ga bakterije, ki so prejele gen, ki jim omogoča tvorjenje IGF- 1.
How has INCRELEX been studied?
Kako je bilo zdravilo INCRELEX raziskano?
The effects of INCRELEX were first tested in experimental models before being studied in humans.
Učinki zdravila INCRELEX so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
INCRELEX has been studied in five studies involving a total of 76 children aged between 1 and 15 years with severe primary IGF-1 deficiency, nine of whom had received another type of recombinant IGF-1 before joining these studies.
Zdravilo INCRELEX so preučevali v petih študijah s skupno 76 otroki, starimi od 1 do 15 let, s hudim primarnim pomanjkanjem IGF- 1; devet jih je pred vključitvijo v te študije prejemalo drugo vrsto rekombinantnega IGF- 1.
One study compared INCRELEX to placebo (a dummy treatment) in eight patients, but the others did not compare INCRELEX to any other treatment.
V eni študiji so primerjali zdravilo INCRELEX s placebom (zdravilom brez zdravilne učinkovine) pri osmih bolnikih, v drugih študijah pa zdravila INCRELEX niso primerjali z nobenim drugim zdravilom.
The studies lasted between 15 months and eight years, and the main measure of effectiveness was the speed of growth.
Študije so trajale od 15 mesecev do osem let, glavno merilo učinkovitosti je bila hitrost rasti.
What benefit has INCRELEX shown during the studies?
Kakšne koristi je zdravilo INCRELEX izkazalo med raziskavami?
INCRELEX caused the speed of growth to increase significantly.
Zdravilo INCRELEX je bistveno povečalo hitrost rasti.
When the results of all four studies were taken together, the average growth rate was 2.8 cm per year before treatment.
Upoštevaje rezultate vseh štirih študij, je bila povprečna stopnja rasti pred zdravljenjem 2, 8 cm na leto.
This increased to 8.0 cm in the first year of treatment and 5.8 cm in the second.
Le- ta se je v prvem letu zdravljenja povečala na 8, 0 cm, v drugem letu pa na 5, 8 cm.
The growth rate stabilised at around 4.7 cm per year from the fourth year of treatment.
Od četrtega leta zdravljenja dalje se je stopnja rasti stabilizirala pri približno 4, 7 cm na leto.
Some of the studies had also included children who had defects in the gene for GH and who had developed antibodies (inhibitors) against GH, as INCRELEX could also be used to treat such patients.
V nekatere študije so bili vključeni tudi otroci z okvaro gena za GH ali ki so razvili protitelesa (zaviralce) proti GH, saj je zdravilo INCRELEX mogoče uporabljati tudi za zdravljenje takšnih bolnikov.
The company did apply for an authorisation to use INCRELEX in these children, but withdrew its application after the end of the medicine’ s assessment, as this disease is not listed in the medicine ’ s ‘ orphan’ designation.
Podjetje je zaprosilo za dovoljenje za uporabo zdravila INCRELEX pri teh otrocih, vendar je po zaključku ocenjevanja zdravila umaknilo vlogo, saj ta bolezen ni navedena v določitvi zdravila za zdravilo sirota.
What is the risk associated with INCRELEX?
Kakšna tveganja so povezana z zdravilom INCRELEX?
The most common side effects with INCRELEX (seen in more than 1 patient in 10) are hypoglycaemia (low blood sugar levels), thymus hypertrophy (growth of the thymus gland, a gland below the breastbone that is involved in producing infection-fighting cells), headache, hypoacusis (hearing loss), tonsillar hypertrophy (growth of the tonsils), snoring and injection site hypertrophy (lumps at the site of injection).
Najpogostejši neželeni učinki zdravila INCRELEX (opaženi pri več kot 1 bolniku izmed 10) so hipoglikemija (nizke ravni sladkorja v krvi), hipertrofija timusa (rast timusa, žleze pod prsnico, ki sodeluje pri tvorjenju celic za pomoč pri premagovanju okužb), glavobol, naglušnost, hipertrofija tonzil (povečanje tonzil), smrčanje in hipertrofija na mestu injiciranja (zatrdline na mestu injiciranja).
For the full list of all side effects reported with INCRELEX, see the Summary of Product Characteristics.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila INCRELEX, glejte Povzetek glavnih značilnosti zdravila.
INCRELEX should not be used in people who may be hypersensitive (allergic) to mecasermin or any of the other ingredients.
Zdravila INCRELEX ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) mekasermin ali katerokoli drugo sestavino zdravila.
It should also not be used in patients who have, or are thought to have active neoplasia (abnormal cell growth).
Prav tako ga ne smejo uporabljati bolniki, ki imajo ali utegnejo imeti aktivno neoplazijo (nenormalno rast celic).
Treatment with INCRELEX should be stopped if neoplasia develops.
Če se pojavi neoplazija, je treba zdravljenje z zdravilom INCRELEX ustaviti.
It should not be used in babies.
Zdravilo se ne sme uporabljati pri dojenčkih.
Why has INCRELEX been approved?
Zakaj je bilo zdravilo INCRELEX odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that INCRELEX’ s benefits are greater than its risks for the long-term treatment of growth failure in children and adolescents with severe primary IGF-1 deficiency.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila INCRELEX pri dolgotrajnem zdravljenju zaostajanja v rasti pri otrocih in mladostnikih s hudim pomanjkanjem primarnega IGF- 1 večje od z njim povezanih tveganj.
The Committee recommended that INCRELEX be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo INCRELEX odobri dovoljenje za promet.
INCRELEX has been authorised under “ Exceptional Circumstances”.
Zdravilo INCRELEX je bilo odobreno v „ izjemnih okoliščinah “.
This means that because the disease is rare, it has not been possible to obtain complete information about INCRELEX.
To pomeni, da zaradi dejstva, da je bolezen redka, še ni mogoče pridobiti celovitih informacij o zdravilu INCRELEX.
What information is still awaited for INCRELEX?
Katere informacije se še pričakujejo za zdravilo INCRELEX?
The company that makes INCRELEX will supply information packs for doctors and for patients explaining how the medicine is used and its side effects.
Podjetje, ki proizvaja zdravilo INCRELEX, bo izvedlo dolgoročno raziskavo o varnosti zdravila v primeru, ko se zdravljenje začne pri majhnih otrocih in nadaljuje v obdobje odraslosti.
The record of INCRELEX’ s designation as an orphan medicine is available here.
Kateri ukrepi so sprejeti za zagotavljanje varne uporabe zdravila INCRELEX?
The full EPAR for INCRELEX can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo INCRELEX je na voljo tukaj.
INCRELEX 10 mg/ ml solution for injection.
INCRELEX 10 mg/ ml raztopina za injiciranje
Each ml contains 10 mg of mecasermin.
En mililiter vsebuje 10 mg mekasermina.
Each vial contains 40 mg of mecasermin.
Ena viala vsebuje 40 mg mekasermina.
Mecasermin is a recombinant DNA-derived human insulin-like growth factor-1(IGF-1) produced in Escherichia coli.
Mekasermin je insulinu podoben rastni faktor- 1 (IGF- 1), pridobljen s tehnologijo rekombinantne DNA na kulturi celic Escherichia coli.
Aqueous, clear and colourless solution.
Bistra in brezbarvna vodna raztopina.
For the long-term treatment of growth failure in children and adolescents with severe primary insulin- like growth factor-1 deficiency (Primary IGFD).
Dolgotrajno zdravljenje zaostajanja v rasti pri otrocih in mladostnikih s hudim primarnim pomanjkanjem insulinu podobnega rastnega faktorja- 1 (primarno pomanjkanje IGF).
Severe Primary IGFD is defined by: • height standard deviation score ≤ – 3.0 and • basal IGF-1 levels below the 2.5th percentile for age and gender and • GH sufficiency. • Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.
Hudo primarno pomanjkanje IGF je definirano kot: • vrednost standardnega odklona (SDS) telesne višine ≤ - 3, 0 in • osnovna raven IGF- 1, manjša od 2, 5. percentila, glede na starost in spol in • zadostna količina GH. • Izključitev sekundarnih oblik pomanjkanja IGF- 1, kot so podhranjenost, hipotiroidizem ali kronično zdravljenje s farmakološkimi odmerki kortikosteroidov.
Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment.
Hudo primarno pomanjkanje IGF vključuje bolnike z mutacijami receptorjev za GH (GHR), post - GHR signalnih poti in okvar gena za IGF- 1; pri teh bolnikih ne gre za pomanjkanje GH in zato ne moremo pričakovati, da se bodo zadostno odzvali na zdravljenje z eksogenim GH.
It is recommended to confirm the diagnosis by conducting an IGF-1 generation test.
Diagnozo je priporočeno potrditi z izvedbo testa IGF- 1.
The recommended starting dose of mecasermin is 0.04 mg/ kg twice daily by subcutaneous injection.
Priporočeni začetni odmerek mekasermina je 0, 04 mg/ kg dvakrat na dan v obliki subkutane injekcije.
If no significant treatment-related adverse events occur for at least one week, the dose may be raised in increments of 0.04 mg/ kg to the maximum dose of 0.12 mg/ kg given twice daily.
Če vsaj en teden ne pride do resnih neželenih učinkov, povezanih z zdravljenjem, se lahko odmerek postopno povečuje za 0, 04 mg/ kg do največjega dovoljenega odmerka 0, 12 mg/ kg dvakrat na dan.
Doses greater than 0.12 mg/ kg given twice daily have not been evaluated in children with severe Primary IGFD.
Pri otrocih s hudim primarnim pomanjkanjem IGF ni zadostnih podatkov z odmerki, višjimi od 0, 12 mg/ kg dvakrat na dan.
2 If the recommended dose is not tolerated by the subject, treatment with a lower dose can be considered.
2 Če bolnik priporočenega odmerka ne prenaša, je potrebno presoditi o zdravljenju z nižjim odmerkom.
The lowest dose that was associated with substantial growth increases on an individual basis was 0.04 mg/ kg BID.
Najnižji odmerek, ki je povezan s pomembnim povečanjem rasti pri posameznem bolniku, je 0, 04 mg/ kg dvakrat na dan.