natgillin/translations-raw huggingface dataset:
As there is no information available on the safety of growth hormone substitution therapy in acutely critically ill patients, the benefits of continued treatment in this situation should be weighed against the potential risks involved.
Ker ni na voljo podatkov o varnosti nadomestnega zdravljenja z rastnim hormonom pri akutnih kritičnih bolnikih, je treba pretehtati koristi nadaljnjega zdravljenja v primerjavi z morebitnim tveganjem.
This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i. e. essentially ‘ sodium- free’.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na ml, kar v bistvu pomeni » brez natrija «.
Data from an interaction study performed in growth hormone deficient adults suggests that somatropin administration may increase the clearance of compounds known to be metabolised by cytochrome P450 isoenzymes.
Podatki iz preskušanja o medsebojnem delovanju zdravil, v katerem so sodelovali odrasli s pomanjkanjem rastnega hormona, kažejo, da somatropin lahko zveča očistek učinkovin, za katere je znano, da se presnavljajo s pomočjo izoencimov citokroma P450.
The clearance of compounds metabolised by cytochrome P 450 3A4 (e. g. sex steroids, corticosteroids, anticonvulsants and ciclosporin) may be especially increased resulting in lower plasma levels of these compounds.
Očistek učinkovin, ki se presnavljajo s pomočjo citokroma P 450 3A4 (na primer spolni steroidi, kortikosteroidi, antikonvulzivi in ciklosporin), se lahko posebej zveča, zaradi česar se zmanjša njihova plazemska koncentracija.
Also see section 4.4 for statements regarding diabetes mellitus and thyroid disorder and section 4.2 for statement on oral oestrogen replacement therapy.
Glejte tudi poglavje 4. 4 o ugotovitvah, ki se nanašajo na diabetes mellitus in motnje delovanja ščitnice, ter poglavje 4. 2 o ugotovitvah, ki se nanašajo na peroralno estrogensko nadomestno zdravljenje.
For Omnitrope no clinical data on exposed pregnancies are available.
O uporabi zdravila Omnitrope pri nosečnicah ni kliničnih podatkov.
Animal experimental data on reproductive toxicity of Omnitrope are not available.
Tudi podatki o reprodukcijski toksičnosti zdravila Omnitrope pri živalih niso na voljo.
Treatment with Omnitrope should be interrupted if pregnancy occurs.
Če ženska zanosi, je treba zdravljenje z zdravilom Omnitrope prekiniti.
During normal pregnancy levels of pituitary growth hormone fall markedly after 20 gestation weeks, being replaced almost entirely by placental growth hormone by 30 weeks.
Med normalno nosečnostjo se raven hipofiznega rastnega hormona po 20 tednih nosečnosti izrazito zniža, skoraj popolnoma pa ga do 30. tedna nadomesti rastni hormon placente.
In view of this, it is unlikely that continued replacement therapy with somatropin would be necessary in growth hormone deficient women in the third trimester of pregnancy.
Glede na to je malo verjetno, da bi bilo v tretjem tromesečju nosečnosti pri ženskah s pomanjkanjem rastnega hormona še potrebno nadaljevanje nadomestnega zdravljenja s somatropinom.
Caution should be exercised when Omnitrope is administered to breast-feeding women.
Posebna previdnost je potrebna pri doječih materak, ki prejemajo zdravilo Omnitrope.
Within the organ system classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000).
V posameznih organskih sistemih so neželeni učinki navedeni po pogostnosti (število bolnikov, pri katerih se pričakuje reakcija), razvrščeni pa so v naslednje kategorije: zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100, < 1/ 10); občasni (≥ 1/ 1. 000, < 1/ 100); redki (≥ 1/ 10. 000, < 1/ 1. 000); zelo redki (< 1/ 10. 000).
When treatment with somatropin is started this deficit is rapidly corrected.
Kmalu po začetku zdravljenja s somatropinom se deficit hitro popravi.
In adult patients, adverse reactions related to fluid retention, such as peripheral oedema, stiffness in the extremities, arthralgia, myalgia and paraesthesia are common.
Neželeni učinki pri odraslih, ki so povezani z zastajanjem tekočin: periferni edem, okorelost okončin, artralgija, mialgija in parestezija se pojavijo pogosto.
In general these adverse reactions are mild to moderate, arise within the first months of treatment and subside spontaneously or with dose-reduction.
Ponavadi so blagi do zmerni, pojavijo se v prvih mesecih zdravljenja, izginejo pa same od sebe ali po zmanjšanju odmerka.
The incidence of these undesirable effects is related to the administered dose, the age of patients, and possibly inversely related to the age of patients at the onset of growth hormone deficiency.
Pogostost pojava teh neželenih učinkov je odvisna od odmerka zdravila, bolnikove starosti in morda v obratnem sorazmerju z njegovo starostjo od pojavu pomanjkanja rastnega hormona.
In paediatric patients such undesirable effects are uncommon.
Pri pediatričnih bolnikih se ti neželeni učinki pojavijo občasno.
6 Neoplasms benign, malignant and unspecified (incl cysts and polyps)
6 Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
Leukemia.
Levkemija.
Very rare cases of leukaemia have been reported in growth hormone deficient paediatric patients treated with somatropin, but the incidence appears to be similar to that in the paediatric subjects without growth hormone deficiency.
Pri pediatričnih bolnikih s pomanjkanjem rastnega hormona, ki so prejemali somatropin, so poročali o zelo redkih primerih levkemije, vendar je pogostnost enaka kot pri pediatričnih bolnikih brez pomanjkanja rastnega hormona.
Formation of antibodies.
Nastanek protiteles.
Somatropin has given rise to the formation of antibodies in approximately 1% of the patients.
Somatropin je pri približno 1% bolnikov povečal nastanek protiteles.
The binding capacity of these antibodies has been low and no clinical changes have been associated with their formation.
Njihova zmožnost vezave je majhna, z njihovim nastankom pa niso povezane nikakršne klinične spremembe.
Rare:
Redke:
Diabetes mellitus type II
diabetes mellitus tipa II.
In adults: paraesthesia In adults: carpal tunnel syndrome; In paediatric patients: paraesthesia Benign intracranial hypertension
pri odraslih: parestezija. pri odraslih: sindrom karpalnega kanala, pri pediatričnih bolnikih: parestezija. benigna intrakranialna hipertenzija.
In adults: stiffness in the extremities, arthralgia, myalgia In paediatric patients: stiffness in the extremities, arthralgia, myalgia
pri odraslih: okorelost okončin, artralgija in mialgija pri pediatričnih bolnikih: okorelost okončin, artralgija in mialgija
In adults: peripheral oedema; In paediatric patients: transient local skin reactions at the injection site
pri odraslih: periferni edem; pri pediatričnih bolnikih: prehodne lokalne kožne reakcije na mestu injiciranja
In paediatric patients: peripheral oedema
pri pediatričnih bolnikih: periferni edem
4.9 Overdose
4. 9 Preveliko
Pharmacotherapeutic group: anterior pituitary lobe hormones and analogues.
Farmakoterapevtska skupina: hormoni sprednjega dela hipofize in sorodne učinkovine.
In children with inadequate endogenous growth hormone, somatropin stimulates linear growth and increases growth rate.
Pri otrocih z nezadostno količino endogenega rastnega hormona pospešuje linearno rast in zvečuje hitrost rasti.
In adults as well as in children, somatropin maintains a normal body composition by increasing nitrogen retention and stimulation of skeletal muscle growth, and by mobilisation of body fat.
Pri odraslih in tudi pri otrocih vzdržuje normalno zgradbo organizma tako, da zvečuje retenco dušika in spodbuja rast skeletnih mišic, ter z mobilizacijo telesne maščobe.
In addition to enhanced lipolysis, somatropin decreases the uptake of triglycerides into body fat stores.
Somatropin zvečuje lipolizo in zmanjšuje vnos trigliceridov v maščobne zaloge telesa.
Serum concentrations of IGF-I (Insulin-like Growth Factor-I) and IGFBP3 (Insulin-like Growth Factor Binding Protein 3) are increased by somatropin.
Zvečuje serumske koncentracije IGF- I (insulinu podobnega rastnega dejavnika- I) in IGFBP3 (vezavni protein 3 za insulinu podoben rastni dejavnik).
7 Lipid metabolism:
7 Presnavljanje maščob:
In general, administration of somatropin to growth hormone deficient patients results in reduction in serum LDL and apolipoprotein B.
Na splošno se pri bolnikih s pomanjkanjem rastnega hormona zaradi uporabe somatropina zmanjšata serumski koncentraciji LDL in apolipoproteina B.
A reduction in serum total cholesterol may also be observed.
Zmanjša se lahko tudi serumska vrednost skupnega holesterola.
Carbohydrate metabolism:
Presnavljanje ogljikovih hidratov:
Water and mineral metabolism:
Presnavljanje vode in mineralov:
Bone metabolism:
Presnova kosti:
Long-term administration of somatropin to growth hormone deficient patients with osteopoenia results in an increase in bone mineral content and density at weight-bearing sites.
Dolgotrajna uporaba somatropina pri bolnikih z osteopenijo in pomanjkanjem rastnega hormona povzroči zvečanje mineralne gostote kosti ter gostote na mestih, ki nosijo telesno maso.
Physical capacity:
Telesna zmogljivost:
In clinical trials in short children/ adolescents born SGA doses of 0.033 and 0.067 mg somatropin/ kg body weight per day have been used for treatment until final height is reached.
V kliničnih preskušanjih pri otrocih/ mladostnikih z majhno telesno višino, ki so se rodili MGS, so za zdravljenje uporabili odmerke 0, 033 in 0, 067 mg somatropina/ kg telesne mase na dan, dokler ni bila dosežena končna višina.
In 56 patients who are continuously treated and have reached (near) final height, the mean change from height at start of treatment was +1.90 SDS (0.033 mg/ kg body weight per day) and +2.19 SDS (0.067 mg/ kg body weight per day).
Pri 56 bolnikih, ki so jih zdravili nepretrgano in so (skoraj) dosegli končno višino, je bila srednja vrednost spremembe višine na začetku zdravljenja +1, 90 SDS (0, 033 mg/ kg telesne mase na dan) in +2, 19 SDS (0, 067 mg/ kg telesne mase na dan).
Literature data from untreated SGA children/ adolescents without early spontaneous catch-up suggest a late growth of 0.5 SDS.
Podatki iz literature o nezdravljenih otrocih/ mladostnikih, ki se rodijo MGS, brez zgodnjega spontanega približevanja, kažejo pozno rast 0, 5 SDS.
Absorption The bioavailability of subcutaneously administered somatropin is approximately 80% in both healthy subjects and growth hormone deficient patients.
Absorpcija Biološka uporabnost somatropima po njegovi subkutani uporabi je tako pri zdravih ljudeh kot pri bolnikih s pomanjkanjem rastnega hormona približno 80- odstotna.
A subcutaneous dose of 5 mg of Omnitrope powder and solvent for solution for injection in healthy adults results in plasma Cmax values of 71 ± 24 µg/ l (mean ± SD) and median tmax value of 4 hours (range 2-8 hours), respectively.
Po subkutani uporabi 5 mg zdravila Omnitrope prašek in vehikel za raztopino za injiciranje pri zdravih odraslih je Cmax 71 ± 24 μg/ l (srednja vrednost ± SD) in mediana tmax 4 ure (razpon 2 – 8 ur).
Elimination The mean terminal half-life of somatropin after intravenous administration in growth hormone deficient adults is about 0.4 hours.
Izločanje Pri odraslih s pomanjkanjem rastnega hormona je po intravenski uporabi somatropina srednja končna razpolovna doba okoli 0, 4 ure.
Sub-populations The absolute bioavailability of somatropin seems to be similar in males and females following subcutaneous administration.
Podskupine Absolutna biološka uporabnost somatropina je videti po njegovi subkutani uporabi pri ženskah in moških podobna.
8 In other studies with somatropin regarding general toxicity, local tolerance and reproduction toxicity no clinically relevant effects have been observed.
8 Tudi v preskušanjih o splošni toksičnosti somatropina, njegovi lokalni toleranci in reprodukcijski toksičnosti ni bilo opaziti klinično relevantnih učinkov.
An increased chromosome fragility has been observed in one in vitro study on lymphocytes taken from patients after long term treatment with somatropin and following the addition of the radiomimetic medicinal product bleomycin.
V preskušanju in vitro na limfocitih, ki so jih odvzeli bolnikom, ki so se dolgo časa zdravili s somatropinom in poleg tega jemali radiomimetično zdravilo bleomicin, se je zvečala krhkost kromosomov.
Shelf life after reconstitution:
Rok uporabnosti po rekonstituciji:
However, the in-use stability has been demonstrated for up to 24 hours at 2°C - 8°C, in the original package.
Vendar pa je bila stabilnost dokazana tudi med uporabo za obdobje do 24 ur pri temperaturi od 2 °C do 8 °C v originalni ovojnini.
Store and transport refrigerated (2°C - 8°C).
Shranjujte in prevažajte na hladnem (2 ° - 8 °C).
Store and transport refrigerated (2°C - 8°C).
Neodprta viala: shranjujte in prevažajte na hladnem (2 °C - 8 °C).
For storage conditions of the in-use medicinal product, see section 6.3.
Za pogoje shranjevanja rekonstituiranega zdravila glejte poglavje 6. 3.
9 6.6 Special precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Omnitrope 1.3 mg/ ml is supplied in a vial containing the active substance as a powder and the solvent filled in a vial for single use.
Omnitrope 1, 3 mg/ ml je v viali za enkratno uporabo, ki vsebuje zdravilno učinkovino v obliki praška in topilo.
Each vial must be reconstituted with the accompanying solvent only.
Vsebino viale je treba pripraviti le s topilom, ki je priloženo.
The following is a general description of the reconstitution and administration process.
9 V nadaljevanju sledi splošni opis postopka rekonstitucije in uporabe.
Use a sterile, disposable syringe (e. g.
Uporabite sterilno injekcijsko brizgo za enkratno uporabo (npr.
2 ml syringe) and needle (e. g.
2- mililitrsko injekcijsko brizgo) in iglo (npr.
0.33 mm x 12.7 mm) to withdraw all the solvent from the vial.
0, 33 mm x 12, 7 mm), da odstranite vse topilo iz stekleničke.
Take the vial with the powder, push the needle through the rubber closure and inject the solvent slowly into the vial aiming the stream of liquid against the glass wall in order to avoid foam.
Vzemite vialo s praškom, potisnite iglo skozi gumijast zamašek in počasi injicirajte topilo v stekleničko tako, da usmerite curek tekočine na stekleno steno, in tako preprečite penjenje.
Turn the vial upside down and using another sterile, disposable syringe of appropriate size (e. g.
Zgornji del viale obrnite navzdol in s pomočjo druge sterilne injekcijske brizge za enkratno uporabo primerne velikosti (npr.
1 ml syringe) and injection needle (e. g.
1- mililitrske brizge) ter injekcijske igle (npr.
0.25 mm x 8 mm) withdraw a bit more than the dose needed back into the syringe.
0, 25 mm x 8 mm) prečrpajte nekoliko večjo količino, kot je odmerek, ki ga potrebujete, nazaj v brizgo.
Clean the injection site with an alcohol swab and administer Omnitrope by subcutaneous injection.
Mesto injiciranja očistite z blazinico iz vate, namočeno v alkohol, in injicirajte Omnitrope subkutano.
Omnitrope 5 mg/ ml powder and solvent for solution for injection
Omnitrope 5 mg/ ml prašek in vehikel za raztopino za injiciranje
After reconstitution, one vial contains 5 mg Somatropin* (corresponding to 15 IU) per ml.
Po rekonstituciji ena viala vsebuje 5 mg somatropina * (ustreza 15 i. e.) na ml.
* produced in Escherichia coli by recombinant DNA technology.
* izdelanega iz celic Escherichia coli s tehnologijo rekombinantne DNA.
Powder and solvent for solution for injection The powder is white.
Prašek in vehikel za raztopino za injiciranje Prašek je bel.
- Growth disturbance (current height standard deviation score (SDS) < -2.5 and parental adjusted
- Motnje rasti (srednja največja standardna deviacija (SSD) < – 2, 5 in izravnava s starši (SSD < –)
SDS < -1) in short children/ adolescents born small for gestational age (SGA), with a birth weight and/ or length below -2 standard deviation (SD), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by 4 years of age or later.
pri majhnih otrocih/ mladostnikih, ki so se za svojo gestacijsko starost rodili majhni (MGS) s porodno maso in/ ali dolžino manj kot – 2 standardni deviaciji (SD), ki manjkata za dosego rasti (hitrost rasti (HR) SSD < 0 v zadnjem letu) pri starosti 4 leta ali več.
11 Growth disturbance due to insufficient secretion of growth hormone in paediatric patients:
11 Motnje rasti zaradi nezadostnega izločanja rastnega hormona pri pediatričnih bolnikih:
Prader-Willi syndrome, for improvement of growth and body composition in paediatric patients:
Prader- Willijev sindrom (PWS), za izboljšanje rasti in sestave telesa pri pediatričnih bolnikih:
Indication
mg/ m2 telesne površine mg/ kg telesne mase Indikacija dnevni odmerek dnevni odmerek pomanjkanje rastnega hormona Prader- Willijev sindrom Turnerjev sindrom kronična ledvična insuficienca otroci/ mladostniki, ki so se za svojo
mg/ kg body weight dose
0, 025 – 0, 035 0, 035 0, 045 – 0, 050 0, 045 – 0, 050
body surface
0, 7 – 1, 0 1, 0 1, 4 1, 4
Growth hormone deficiency Prader-Willi syndrome Turner syndrome Chronic renal insufficiency Children/ adolescents born small for
gestacijsko starost rodili majhni (MGS)
per day 0.025 - 0.035 0.035 0.045 - 0.050 0.045 - 0.050
0, 035
area
1, 0
dose per day 0.7 - 1.0 1.0 1.4 1.4
Pomanjkanje rastnega hormona pri odraslih bolnikih:
gestational age (SGA)
Terapija se mora začeti z nizkim odmerkom – 0, 15 do 0, 3 mg
0.035
na dan.
1.0
v skladu z
The dose should be gradually increased according to individual patient requirements as determined by the IGF-I concentration.
bolnikovimi individualnimi potrebami, ki jih določa koncentracija IGF- I, zvečuje.
12
12 4. 3 Kontraindikacije
- Somatropin must not be used when there is any evidence of tumour activity and anti-tumour
- Somatropina se ne sme uporabljati, če obstajajo simptomi tumorske dejavnosti, zdravljenje
therapy must be completed prior to starting therapy.
tumorja pa se mora končati pred začetkom zdravljenja s tem zdravilom.
There have been reports of fatalities associated with the use of growth hormone in paediatric patients with PWS who had one or more of the following risk factors: severe obesity, history of respiratory impairment, sleep apnoea or unidentified respiratory infection.
Obstajajo poročila o smrtnih primerih, povezanih z uporabo rastnega hormona pri otrocih s PWS, ki so imeli enega ali več od naslednjih dejavnikov tveganja: čezmerna debelost, motnje dihanja v anamnezi,
13 In case of signs of upper airway obstruction, the problem should be solved by a specialist before starting treatment with somatropin.
Pri znakih obstrukcije zgornjega dela dihal naj to težavo odpravi specialist, preden se začne zdravljenje s somatropinom.
All patients with PWS should be monitored for signs of respiratory infections which should be diagnosed as early as possible and treated aggressively.
Pri vseh bolnikih s PWS je treba biti pozoren na morebitne znake okužbe dihal, jih čim prej diagnosticirati in agresivno zdraviti.
In short children/ adolescents born SGA, other medical reasons or treatments that could explain growth disturbance should be ruled out before starting treatment.
Pri otrocih/ mladostnikih, ki se rodijo MGS, je treba pred začetkom zdravljenja izključiti druge zdravstvene težave ali vrste zdravljenja, ki bi lahko pojasnile motnjo pri rasti.
To date, no data on final height in patients with chronic renal insufficiency treated with Omnitrope are available.
14 Podatkov o končni višini bolnikov s kronično ledvično insuficienco, ki so se zdravili z zdravilom Omnitrope, ni.
Mortality was higher in patients
Učinke somatropina na izboljšanje stanja so preučevali v dveh s placebom kontroliranih preskušanjih, v kateri je bilo vključenih 522 kritično bolnih odraslih bolnikov z zapleti po kirurškem posegu na odprtem srcu, abdominalnem kirurškem posegu, večkratnih poškodbah po nesreči ali akutni pljučni odpovedi.
19%.
Umrljivost je bila večja pri bolnikih, ki so se zdravili s 5, 3 mg ali 8 mg somatropina na dan, kot pri bolnikih, ki so dobivali placebo (42% proti 19%).
Within the organ system classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000).
V posameznih organskih sistemih so neželeni učinki navedeni po pogostnosti (število bolnikov, pri katerem se pričakuje reakcija), razvrščeni pa so v naslednje kategorije: zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100, < 1/ 10); občasni (≥ 1/ 1. 000, < 1/ 100); redki (≥ 1/ 10. 000, < 1/ 1. 000); zelo redki (< 1/ 10. 000).
In adult patients, adverse reactions related to fluid retention, such as peripheral oedema, stiffness in the extremities, arthralgia, myalgia and paraesthesia are common.
Neželeni učinki pri odraslih, ki
15 related to the age of patients at the onset of growth hormone deficiency.
15 so povezani z zastajanjem tekočin: periferni edem, okorelost okončin, artralgija, mialgija in parestezija se pojavijo pogosto.
Diabetes mellitus type II
diabetes mellitus tipa II
In adults: paraesthesia In adults: carpal tunnel syndrome; In paediatric patients: paraesthesia Benign intracranial hypertension
pri odraslih: parestezija pri odraslih: sindrom karpalnega kanala, pri pediatričnih bolnikih: parestezija benigna intrakranialna hipertenzija
In adults as well as in children, somatropin maintains a normal body composition by increasing nitrogen retention and stimulation of skeletal muscle growth, and by mobilisation of body fat.
16 zvečuje retenco dušika in spodbuja rast skeletnih mišic, ter z mobilizacijo telesne maščobe.
Serum
Somatropin zvečuje lipolizo in zmanjšuje vnos trigliceridov v maščobne zaloge telesa.
16 concentrations of IGF-I (Insulin-like Growth Factor-I) and IGFBP3 (Insulin-like Growth Factor Binding Protein 3) are increased by somatropin.
Zvečuje serumske koncentracije IGF- I (insulinu podobnega rastnega dejavnika- I) in IGFBP3 (vezavni protein 3 za insulinu podoben rastni dejavnik).
Lipid metabolism:
Presnavljanje maščob:
However, after subcutaneous administration of Omnitrope 5 mg/ ml powder and solvent for solution for injection, a half-life of 3 hours is achieved.
Po subkutani uporabi zdravila Omnitrope prašek in vehikel za raztopino za injiciranje traja razpolovna doba 3 ure.
17 Information about the pharmacokinetics of somatropin in geriatric and paediatric populations, in different races and in patients with renal, hepatic or cardiac insufficiency is either lacking or incomplete.
17 Podatkov o farmakokinetičnih lastnostih somatropina pri starejših ljudeh in otrocih, pri različnih rasah ter pri bolnikih z ledvično, jetrno ali srčno insuficienco bodisi ni bodisi so nepopolni.
After reconstitution and the first use the cartridge should remain in the pen and has to be kept in a refrigerator (2°C - 8°C) for a maximum of 21 days.
Po rekonstituciji in prvi uporabi mora vložek ostati v peresu in shranjen v hladilniku (2 °C - 8 °C) največ 21 dni.
Store and transport refrigerated (2°C – 8°C).
Neodprta viala: zdravilo shranjujte in prevažajte na hladnem (2 °C - 8 °C).
Pack sizes of 1 and 5.
18 Velikost pakiranja po 1 in 5.
Omnitrope 5 mg/ ml is supplied in a vial containing the active substance as a powder and the solvent filled in a cartridge.
Omnitrope 5 mg/ ml je v viali, ki vsebuje zdravilno učinkovino v obliki praška in topilo v vložku.
It should only be administered with the Omnitrope Pen L, an injection device specifically developed for use with Omnitrope 5 mg/ ml reconstituted solution for injection.
Uporablja se lahko samo v Omnitrope Pen L, pripravi za injiciranje, narejeni posebej za uporabo pripravljene raztopine za injiciranje zdravilo Omnitrope 5 mg/ ml.
It has to be administered using sterile, disposable pen needles.
Uporablja naj se s sterilnimi iglami za peresa za enkratno uporabo.