natgillin/translations-raw huggingface dataset:
INCRELEX should be administered shortly before or after a meal or snack.
Zdravilo INCRELEX je treba uporabljati neposredno pred ali po obroku oziroma prigrizku.
The dose of mecasermin should never be increased to make up for one or more omitted doses.
Odmerka mekasermina se ne sme nikoli zvišati, da bi se tako nadoknadil eden ali več izpuščenih odmerkov.
INCRELEX is not recommended for use in children below age 2 due to a lack of data on safety and efficacy (see section 5.1).
Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila INCRELEX pri otrocih, mlajših od 2 let, ni priporočljiva (glejte poglavje 5. 1).
Intravenous administration.
Intravenska uporaba.
Benzyl alcohol must not be given to premature babies or neonates.
Benzilalkohola se ne sme dajati nedonošenčkom ali novorojenčkom.
Patients should avoid engaging in any high-risk activities within 2-3 hours after dosing, particularly at the initiation of INCRELEX treatment, until a well tolerated dose of INCRELEX has been established.
Bolniki se morajo 2 do 3 ure po uporabi odmerka izogibati vseh visoko tveganih dejavnosti, še posebej na začetku zdravljenja z zdravilom INCRELEX, dokler se ne določi odmerek zdravila INCRELEX, ki ga bolnik dobro prenaša.
Doses of insulin and/ or other hypoglycaemic agents may need to be reduced for diabetic subjects using INCRELEX.
Pri osebah s sladkorno boleznijo bo med zdravljenjem z zdravilom INCRELEX morda treba zmanjšati odmerek insulina ali drugih antidiabetikov ali obojega.
Patients
3 Med uporabo zdravila INCRELEX so poročali o pojavu hipertrofije limfatičnega tkiva (npr. tonzilarnega) in zapletih povezanih s tem, kot so smrčanje, apneja v spanju in kronični izcedek iz srednjega ušesa.
3 should have examinations periodically and at the occurrence of clinical symptoms to rule out such potential complications or to initiate appropriate treatment.
Bolniki morajo redno hoditi na preglede in ob pojavu kliničnih simptomov je potrebno te zaplete preprečiti oziroma uvesti ustrezno zdravljenje.
Intracranial hypertension (IH) with papilloedema, visual changes, headache, nausea and/ or vomiting has been reported in patients treated with INCRELEX, as has been reported with therapeutic GH administration.
Pri bolnikih, ki so se zdravili z zdravilom INCRELEX, so poročali o intrakranialni hipertenziji (IH) s papiloedemom, motnjami vida, glavoboli, navzeo in/ ali bruhanjem, podobno kot pri zdravljenju z GH.
Slipped capital femoral epiphysis and progression of scoliosis can occur in patients who experience rapid growth.
Pri bolnikih s hitro rastjo lahko pride do zdrsa epifize glavice stegnenice in napredovanja skolioze.
As with any exogenous protein administration, local or systemic allergic reactions may occur.
Kot pri vsaki uporabi eksogenih proteinov se lahko pojavi lokalna ali sistemska alergijska reakcija.
Parents and patients should be informed that such reactions are possible and that if an allergic reaction occurs, treatment should be interrupted and prompt medical attention should be sought.
Starše in bolnike je treba opozoriti na možnost pojava tovrstnih reakcij in da morajo v primeru pojava alergijskih reakcij zdravljenje takoj opustiti ter nemudoma poiskati zdravniško pomoč.
Persons who have allergic reactions to injected IGF-1, who have unexpectedly high blood values of IGF-1 after injection, or who fail to show a growth response may be having an antibody response to injected IGF-1.
Pri osebah, pri katerih injiciranje IGF- 1 povzroči alergijske reakcije, ki imajo po vbrizganju IGF- 1 nepričakovano visoko raven IGF- 1 v krvi ali se ne odzovejo z rastjo, je morda ob vbrizganju IGF- 1 prišlo do odziva s protitelesi.
In such instances, follow the instructions for antibody testing.
V tovrstnih primerih sledite navodilom za testiranje protiteles.
INCRELEX contains 9 mg/ ml benzyl alcohol as a preservative.
Zdravilo INCRELEX vsebuje kot konzervans 9 mg/ ml benzilalkohola.
A negative pregnancy test and education about adequate contraception are recommended for all women of child bearing potential prior to treatment with INCRELEX.
Pred zdravljenjem z zdravilom INCRELEX je za vse ženske v rodni dobi priporočljiv negativen test nosečnosti in izobraževanje o ustrezni kontracepciji.
There are no adequate data for the use of mecasermin in pregnant women.
Ni zadostnih podatkov o uporabi mekasermina pri nosečnicah.
Animal studies are insufficient with respect to pregnancy (see section 5.3).
Študije na živalih ne zadostujejo za oceno vpliva na nosečnost (glejte poglavje 5. 3).
However, hypoglycaemia may impair the ability to drive or use machines.
Hipoglikemija lahko zmanjša sposobnost za vožnjo in upravljanje s stroji.
An integrated safety database from clinical studies contains 76 subjects with severe Primary IGFD treated for a mean duration of 4.4 years and representing 321 subject-years.
Integrirana podatkovna baza o varnosti iz kliničnih študij obsega podatke o 76 osebah s hudim primarnim pomanjkanjem IGF, ki so se v povprečju zdravile 4, 4 leta, kar predstavlja 321 bolnikov- let.
Hypoglycaemia is the most frequently reported adverse drug reaction.
Najpogostejši neželeni učinek, o katerem so poročali, je hipoglikemija.
The thirty-six subjects (47%) who had one or more episodes of hypoglycaemia included 4 subjects who had hypoglycaemic seizure on one or more occasion.
Pri 4 od teh 36 oseb so se enkrat ali večkrat pojavili epileptični napadi zaradi hipoglikemije.
Of the 36 subjects, 12 (33%) had a history of hypoglycaemia prior to beginning treatment.
12 od 36 oseb (33%) je imelo pred začetkom zdravljenja hipoglikemijo v anamnezi.
The frequency of hypoglycaemia was highest in the first month of treatment, and episodes were more frequent in younger children.
Hipoglikemija je bila najpogostejša med prvim mesecem zdravljenja, epizode pa so bile pogostejše pri mlajših otrocih.
Symptomatic hypoglycaemia was generally avoided when a meal or snack was consumed either shortly before or after the administration of INCRELEX.
Če je bolnik neposredno pred ali po uporabi zdravila INCRELEX zaužil hrano, se simptomatska hipoglikemija običajno ni pojavila.
Injection site hypertrophy occurred in 24 subjects (32%).
Hipertrofija na mestu injiciranja se je pojavila pri 24 osebah (32%).
This reaction was generally associated with lack of proper rotation of injections.
Ta neželeni učinek je bil običajno povezan z nepravilnim menjavanjem mesta injiciranja.
When injections were properly dispersed, the condition resolved.
Po pravilni menjavi mest injiciranja je prišlo do izboljšanja.
Tonsillar hypertrophy was noted in 12 (16%) subjects, particularly in the first 1 to 2 years of therapy with lesser tonsillar growth in subsequent years.
Kasneje je bilo povečanje tonzil manjše.
Snoring, generally beginning in the first year of treatment, was reported in 17 subjects (22%).
O smrčanju, ki se je običajno začelo med prvim letom zdravljenja, so poročali pri 17 osebah (22%).
Hypoacusis was reported in 15 subjects (20%).
O naglušnosti so poročali pri 15 osebah (20%).
Intracranial hypertension occurred in three subjects (4%).
Intrakranialna hipertenzija se je pojavila pri 3 osebah (4%).
In two subjects the events resolved without interruption of INCRELEX treatment.
Pri 2 osebah je minila brez prekinitve zdravljenja z zdravilom INCRELEX.
INCRELEX treatment was discontinued in the third subject and resumed later at a lower dose without recurrence.
Pri tretji osebi so zdravljenje z zdravilom INCRELEX prekinili in ga nato ponovno uvedli z nižjim odmerkom.
Fourteen subjects (18%) had headache considered related to study drug.
Pri 14 osebah (18%) so poročali o glavobolu, ki so ga pripisali zdravilu.
As with all protein pharmaceuticals, some patients may develop antibodies to INCRELEX.
Tako kot pri vseh zdravilih, ki vsebujejo proteine, se lahko pri nekaterih bolnikih pojavijo protitelesa proti zdravilu INCRELEX.
However, no clinical consequences of these antibodies were observed (e. g., allergic reactions or attenuation of growth).
Med prvim letom zdravljenja so protitelesa proti IGF- 1 opazili pri 11 od 23 otrok s hudim primarnim pomanjkanjem IGF, vendar pa kliničnih posledic teh protiteles (npr. alergijskih reakcij ali upočasnitve rasti) niso opazili.
Table 1 contains very common (≥ 1/ 10) and common (≥ 1/ 100 to < 1/ 10) adverse reactions for which there is at least a reasonable suspicion of a causal relationship to INCRELEX treatment which occurred in clinical trials.
V Preglednici 1 so navedeni zelo pogosti (≥ 1/ 10) in pogosti (≥ 1/ 100 do < 1/ 10) neželeni učinki, ki so se pojavili med kliničnim preskušanjem in bi lahko bili povezani z zdravilom INCRELEX.
5 Table 1:
5 Pregtlednica 1:
Adverse Drug Reactions in Clinical Trials
Neželeni učinki zdravila v kliničnih študijah
Adverse Reaction System Organ Class
Neželeni učinek Organski sistem
Investigations
Srčni šum,
Cardiac murmur, abnormal tympanometry, abnormal echocardiogram, increased alanine aminotransferase*, increased aspartate aminotransferase*, increased weight
timpanometrija, nenormalen ehokardiogram, povečana vrednost alanin - aminotransferaze *, povečana vrednost aspartat - aminotransferaze *, povečana telesna masa
Cardiomegaly, ventricular hypertrophy, atrial hypertrophy*, tachycardia, tachycardia paroxysmal*, mitral valve incompetence*, tricuspid valve incompetence*
Kardiomegalija, ventrikularna hipertrofija, atrijska hipertrofija *, tahikardija, paroksizmalna tahikardija *, insuficienca mitralne zaklopke *, insuficienca trikuspidalne zaklopke *
Congenital, Familial and Genetic Disorders
Prirojene in dedne genetske okvare
Congenital jaw malformation, pigmented naevus*
Prirojena malformacija čeljusti, pigmentirani nevus *
Thymus hypertrophy
Hipertrofija timusa
Lymphadenopathy*
Limfadenopatija *
Convulsions, febrile convulsion*, benign intracranial hypertension, loss of consciousness*, sleep apnoea syndrome, dizziness, tremor*, restless leg syndrome*
Konvulzije, febrilne konvulzije *, benigna intrakranialna hipertenzija, izguba zavesti *, sindrom apneje v spanju, omotičnost, tremor *, sindrom nemirnih nog *
Papilloedema, reduced visual acuity*, myopia*
Papiloedem, zmanjšanje ostrine vida *, miopija *
Hypoacusis
Naglušnost
Otorrhoea, ear disorder*, middle ear disorder*, tympanic membrane disorder*, ear pain, ear congestion*, fluid in middle ear
Otoreja, bolezen ušes *, bolezen srednjega ušesa *, bolezen membrane bobniča *, bolečina v ušesih, kongestija ušesa *, tekočina v srednjem ušesu
Tonsillar hypertrophy, snoring
Tonzilarna hipertrofija, smrčanje
Adenoidal hypertrophy, nasal turbinate hypertrophy*, dyspnoea*, nasal mucosal disorder*, obstructive airway disorder*, abnormal respiration*, nasal congestion, mouth breathing
Adenoidna hipertrofija, hipertrofija nosnih školjk *, dispneja *, bolezen nosne sluznice *, obstruktivna bolezen dihal *, neobičajno dihanje *, nosna kongestija, dihanje skozi usta
6 Adverse Reaction System Organ Class
6 Neželeni učinek Organski sistem
Vomiting, retching*, abdominal pain*, upper abdominal pain*, abdominal distension*, dysphagia*
Bruhanje, spahovanje *, abdominalna bolečina *, bolečina v zgornjem delu abdomna *, abdominalna distenzija *, disfagija *
Nephrolithiasis*, hydronephrosis*, renal colic*
Nefrolitiaza *, hidronefroza *, renalne kolike *
Skin hypertrophy, acrochordons*, abnormal hair texture*
Hipertrofija kože, akrohondroni *, nenormalna tekstura las *
Musculoskeletal and Connective Tissue Disorders
Bolezni mišično- skeletnega sistema in vezivnega tkiva
Arthralgia, pain in extremity, myalgia, scoliosis*, spinal deformity*, soft tissue disorder*, muscle cramp*, flank pain*, musculoskeletal stiffness*
Artralgija, bolečina v udih, mialgija, skolioza *, deformacija hrbtenice *, bolezni mehkih tkiv *, mišični krči *, bolečina v bokih *, otrdelost mišično- skeletnega sistema *
Hypoglycaemic seizure, hyperglycaemia, hyperlipidaemia*, obesity*
Hipoglikemični napad, hiperglikemija, hiperlipidemija *, debelost *
Febrile infection*, upper respiratory tract infection*, otitis media, otitis media serous, chronic otitis media serous *, otitis externa*, pharyngitis*, tonsillitis, ear infection, oral candidiasis*
Febrilna okužba *, okužba zgornjega dela dihal *, otitis media, serozni otitis media, kronični serozni otitis media *, vnetje zunanjega ušesa *, faringitis *, tonzilitis, vnetje ušesa, oralna kandidiaza *
Surgical and Medical Procedures
Kirurški in drugi medicinski posegi
Adenotonsillectomy*, adenoidectomy, ear tube insertion
Adenotonzilektomija *, adenoidektomija, inseriranje ušesne troblje
General Disorders and Administration Injection site hypertrophy Site Conditions
Splošne težave in spremembe na mestu aplikacije
Reproductive System and Breast Disorders
Hipertrofija na mestu injiciranja
Gynaecomastia, ovarian cyst*
Hiperplazija sluznične membrane, hipertrofija, bolečina na mestu injiciranja, modrica na mestu injiciranja, fibroza na mestu injiciranja *, reakcija na mestu injiciranja *, oteklina na mestu injiciranja *, zatrdlina na mestu injiciranja *, pigmentacijske spremembe na mestu injiciranja *, edem sluznice *, astenija *, letargija *, neugodje v prsnem košu *
7 Adverse Reaction System Organ Class
7 Neželeni učinek Organski sistem
Depression*, sleep terror, nervousness, abnormal behaviour*, disorientation*
Depresija *, strah med spanjem, živčnost, nenavadno obnašanje *, zmedenost *
* = occurred in only 1 subject (1%)
* = le pri 1 osebi (1%)
Treatment of acute overdose of mecasermin should be directed at alleviating any hypoglycaemic effects.
Zdravljenje akutnega prevelikega odmerjanja mekasermina mora biti usmerjeno k ublažitvi hipoglikemičnih učinkov.
Somatropin and agonists, ATC code:
Somatropin in sorodne učinkovine.
authorised under “ Exceptional Circumstances”.
Zdravilo je pridobilo dovoljenje za promet v “ izjemnih okoliščinah ”.
Mecasermin is a human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology.
Mekasermin je humani insulinu podoben rastni faktor- 1 (rhIGF- 1), pridobljen s tehnologijo rekombinantne DNA.
IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges and a molecular weight of 7649 daltons.
Njegova molekulska masa je 7. 649 daltonov.
The amino acid sequence of the product is identical to that of endogenous human IGF-1.
8 Aminokislinsko zaporedje zdravila je enako endogenemu humanemu IGF- 1.
The rhIGF-1 protein is synthesised in bacteria (E. coli) that have been modified by the addition of the gene for human IGF-1.
Sinteza proteina rhIGF- 1 poteka v bakterijah (E. coli), ki imajo vstavljen gen za humani IGF- 1.
Under normal circumstances, growth hormone (GH) binds to its receptor in the liver and other tissues, and stimulates the synthesis/ secretion of IGF-1.
V običajnih pogojih se rastni hormon (GH) veže na odgovarjajoče receptorje v jetrih in drugih tkivih ter spodbuja sintezo/ izločanje IGF- 1.
In target tissues the Type 1 IGF-1 receptor, which is homologous to the insulin receptor, is activated by IGF-1, leading to intracellular signaling which stimulates multiple processes leading to statural growth.
V ciljnem tkivu IGF- 1 aktivira receptor za IGF- 1 tipa 1, ki je homologen z receptorji za insulin, kar pripelje do znotrajceličnega signaliziranja, kar spodbudi številne procese, ki vodijo v telesno rast.
The metabolic actions of IGF-1 are in part directed at stimulating the uptake of glucose, fatty acids, and amino acids so that metabolism supports growing tissues.
Presnovno delovanje IGF- 1 je deloma usmerjeno k spodbujanju privzema glukoze, maščobnih kislin in aminokislin, tako da presnova oskrbuje rastoča tkiva.
The following actions have been demonstrated for endogenous human IGF-1:
Dokazani so bili naslednji učinki endogenega humanega IGF- 1:
8 Tissue Growth
Rast tkiva
• Skeletal growth is accomplished at the epiphyseal plates at the ends of a growing bone.
• Rast okostja, ki se odvija na področju epifiznih plošč na konceh rastoče kosti.
Growth and metabolism of epiphyseal plate cells are directly stimulated by GH and IGF-1. • Organ growth: treatment of IGF-1 deficient rats with rhIGF-1 results in whole body and organ growth. • Cell growth:
GH in IGF- 1 neposredno spodbujata rast in presnovo celic epifiznih plošč. • Rast organov: pri dajanju rhIGF- 1 podganam s pomanjkanjem IGF- 1 so zasledili rast tako celotnega telesa kot organov. • Celična rast: receptorji za IGF- 1 se nahajajo na večini vrst celic in v večini tkiv.
IGF-1 receptors are present on most types of cells and tissues.
IGF- 1 deluje mitogeno, kar vodi k povečanju števila celic v telesu.
IGF-1 suppresses hepatic glucose production, stimulates peripheral glucose utilization, and can reduce blood glucose and cause hypoglycaemia.
IGF- 1 zavira sintezo glukoze v jetrih in spodbuja porabo glukoze v perifernih tkivih ter lahko zmanjša koncentracijo glukoze v krvi in povzroči hipoglikemijo.
IGF-1 has inhibitory effects on insulin secretion.
IGF- 1 zavira izločanje insulina.
Bone/ Mineral Metabolism
Presnova kosti/ mineralov
Circulating IGF-1 plays an important role in the acquisition and maintenance of bone mass.
Cirkulirajoči IGF- 1 ima pomembno vlogo pri večanju in vzdrževanju kostne mase.
IGF-1 increases bone density.
IGF- 1 povečuje gostoto kosti.
Subcutaneous doses of mecasermin, generally ranging from 60 to 120 μ g/ kg given twice daily (BID), were administered to 76 paediatric subjects with severe Primary IGFD.
Odmerki so se v splošnem gibali od 60 do 120 μg/ kg dvakrat na dan.
Patients were enrolled in the studies on the basis of extreme short stature, slow growth rates, low IGF-1 serum concentrations, and normal GH secretion.
Bolniki so bili vključeni v študije na osnovi ekstremno nizke telesne višine, počasne rasti, nizkih koncentracij IGF- 1 v serumu in normalnega izločanja GH.
Baseline characteristics for the patients evaluated in the primary and secondary efficacy analyses from the combined studies were (mean ± SD): chronological age (years):
Izhodiščne lastnosti bolnikov, ki so jih vrednotili pri primarnih in sekundarnih analizah učinkovitosti kombiniranih študij so bile (povprečna vrednost ± SD): kronološka starost (leta):
6.8 ± 3.8; height (cm):
6, 8 ± 3, 8; telesna višina (cm):
85.0 ± 15.3; height standard deviation score (SDS): -6.7 ± 1.8; height velocity (cm/ yr):
85, 0 ± 15, 3; vrednost standardnega odklona (SDS - "standard deviation score") telesne višine: - 6, 7 ± 1, 8; hitrost rasti (cm/ leto):
2.8 ± 1.8; height velocity SDS: -3.3 ± 1.7; IGF-1 (ng/ ml):
2, 8 ± 1, 8; SDS hitrosti rasti: - 3, 3 ± 1, 7; IGF- 1 (ng/ ml):
21.9 ± 24.8; IGF-1 SDS: -4.4 ± 2.0; and bone age (years):
21, 9 ± 24, 8; SDS IGF- 1: - 4, 4 ± 2, 0; in zrelost kosti (leta):
Sixty-two subjects had at least one year of treatment.
62 oseb se je zdravilo vsaj eno leto.
Of these, 53 (85%) had Laron syndrome-like phenotype; 7 (11%) had GH gene deletion, and 1 (2%) had neutralizing antibodies to GH.
1 (2%) pa je imela nevtralizirajoča protitelesa proti GH.
Thirty-eight (61%) of the subjects were male; 49 (79%) were Caucasian.
38 oseb (61%) je bilo moškega spola; 49 oseb (79%) je bilo kavkazijskega porekla.
Fifty-six (90%) of the subjects were prepubertal at baseline.
56 oseb (90%) je bilo ob izhodišču v obdobju pred začetkom spolnega dozorevanja.
Annual results for height velocity, height velocity SDS, and height SDS are shown in Table 2.
Letni rezultati o hitrost rasti, SDS hitrosti rasti in SDS telesne višine so prikazani v Preglednici 2.
Pre- treatment height velocity data were available for 59 subjects.
Podatki o hitrosti rasti pred začetkom zdravljenja so bili na voljo za 59 oseb.
The height velocities at a given year of treatment were compared by paired t-tests to the pre-treatment height velocities of the same subjects completing that treatment year.
Pri osebah, ki so dokončale enoletno zdravljenje, so hitrost rasti v danem letu zdravljenja s parnim t- testom primerjali s hitrostjo rasti pred začetkom zdravljenja.
9 Table 2:
9
Height Velocity (cm/ yr)
Preglednica 2:
Pre-Tx
Letni rezultati telesne višine glede na število let zdravljenja z zdravilom INCRELEX
Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year
Pre- Tx Leto 1 Leto 2 Leto 3 Leto 4 Leto 5 Leto 6 Leto 7 Leto 8
7 Year 8
Hitrost rasti (cm/ leto)
Mean (SD) for
Povprečje (SD) za spremembo iz pre- Tx
+1.5
+5, 2 (2, 6)
+1.0
+3, 0 (2, 3)
+0.9
+2, 6 (2, 3)
change from pre-Tx
+1, 6 (2, 1)
(2.6)
+1, 5 (1, 8)
(2.3) (2.3)
+1, 5 (1, 7)
(2.1)
+1, 0 (2, 1)
(1.8)
+0, 9 (2, 4)
(1.7)
P- vrednost za
(2.1) (1.8) (1.7) (2.1)
< 0, 0001 < 0, 0001 < 0, 0001 < 0, 000 0, 0015 0, 0009 0, 0897 0, 2135
(2.4)
spremembo iz pre- Tx [1] SDS hitrosti rasti
P-value for change from pre-Tx [1] Height Velocity SDS
1
-0.7
- 0, 2
-0.6
- 0, 3
-0.3
- 0, 7
(2.9)
- 0, 6
(1.6)
- 0, 4 - 0, 4
(2.0)
- 0, 3
Mean (SD) for
(1, 4) (1, 9)
+5.1
(1, 8)
+3.2
Povprečje (SD) za spremembo iz pre- Tx
+3.1
+5, 1 (3, 1)
+2.5
+3, 2 (2, 2)
+2.5
+3, 1 (2, 4)
+2.7 +2.5
+2, 5 (2, 1)
+2.8
+2, 5 (2, 2)
change from pre-Tx
+2, 7 +2, 5 (1, 7) (2, 1)
(2.4)
+2, 8 (2, 7)
(2.1) (2.2)
P- vrednost za
(2.2) (2.4) (2.1) (2.2)
< 0, 0001 < 0, 0001 < 0, 0001 < 0, 000 0, 0001 < 0, 0001 0, 0003 0, 0041
(2.1) (2.2) (1.7) (2.1)
spremembo iz pre- Tx [1] SDS telesne višine
P-value for change from pre-Tx [1] Height SDS
1
Mean (SD)
- 6, 7 (1, 8)
-6.7 (1.8)
- 5, 9
-5.9 (1.7)
- 5, 6
-5.6 (1.8)
- 5, 3 - 5, 3
-5.3 -5.3 (1.8) (1.8)
- 5, 5
-5.5 (1.8)
- 5, 4
-5.4 (1.8)
- 5, 2
-5.2 (1.9)
(1, 9)
(SD) for
Povprečje (SD) za
+0.8
+0, 8
+1.1
+1, 1
+1.4 +1.4
+1, 4 +1, 4 +1, 4 +1, 4
+1.4
+1, 4
+1.4
+1, 6
+1.4
spremembo iz pre- Tx
+1.6
(0, 5)
change from pre-Tx
(0, 8)
(0.5)
(1, 0)
(0.8)
(1, 1)
(1.0)
(1, 3)
(1.1)
(1, 2)
(1.3)
(1, 1)
(1.2)
P- vrednost za
(1.1) (1.3) (1.2) (1.1)
spremembo
(1.1)
iz pre- Tx [1]
< 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 0.0001 < 0.0001
pred zdravljenjem, SD = standardna deviacija, SDS =
Pre-Tx = Pre-treatment; SD = Standard Deviation; SDS = Standard Deviation Score [1] P-values for comparison versus pre-Tx values were computed using paired t-tests.
[1] P- vrednosti za primerjanje z vrednostmi pre- Tx so bile izračunane s pomočjo parnega t- testa.
Forty-seven subjects were included in an analysis of the effects of INCRELEX on bone age advancement.
Analiza učinkov zdravila INCRELEX na razvoj kosti je bila izvedena pri 47 osebah.
The mean ± SD change in chronological age was 5.1 ± 3.0 years and the mean ± SD change in bone age was 5.8 ± 2.9 years.
Sprememba povprečne vrednosti ± SD po kronološki starosti je bila 5, 1 ± 3, 0 leta, sprememba povprečja ± SD po zrelosti kosti pa 5, 8 ± 2, 9 let.
For subjects receiving doses between 100 and 120 μ g/ kg BID, the mean first year height velocity was approximately 8.7 cm/ yr.
Pri osebah, ki so prejemale odmerke od 100 do 120 μg/ kg dvakrat na dan, je bila povprečna hitrost rasti v prvem letu približno 8, 7 cm/ leto.
GENERAL CHARACTERISTICS
SPLOŠNE LASTNOSTI
The absolute subcutaneous bioavailability of mecasermin in severe Primary IGFD subjects has not been determined.
Pri osebah s hudim primarnim pomanjkanjem IGF absolutna biološka uporabnost mekasermina po subkutanem injiciranju ni bila določena.
The bioavailability of mecasermin after subcutaneous administration in healthy subjects has been reported to be approximately 100%.
Biološka uporabnost mekasermina po subkutanem dajanju zdravim osebam je glede na poročila približno 100- odstotna.
10 Distribution
10 Porazdelitev
In blood, IGF-1 is bound to six IGF binding proteins (IGFBPs), with ~80% bound as a complex with IGFBP-3 and an acid-labile subunit.
Približno 80% IGF- 1 je vezanega v kompleksu z IGFBP- 3 in acidolabilno podenoto.
IGFBP-3 is reduced in subjects with severe Primary IGFD, resulting in increased clearance of IGF-1 in these subjects relative to healthy subjects.
Pri osebah s hudim primarnim pomanjkanjem IGF je koncentracija IGFBP- 3 manjša, posledično je pri njih očistek IGF- 1 večji kot pri zdravih osebah.
The total IGF-1 volume of distribution (mean ± SD) after subcutaneous administration of INCRELEX in 12 subjects with severe Primary IGFD is estimated to be 0.257 (± 0.073) l/ kg at a mecasermin dose of 0.045 mg/ kg, and is estimated to increase as the dose of mecasermin increases.
Ocenjeno je bilo, da se skupni volumen porazdelitve povečuje z zviševanjem odmerka mekasermina.