natgillin/translations-raw huggingface dataset:
In studies with Omnitrope regarding subacute toxicity and local tolerance, no clinically relevant effects have been observed.
V preskušanjih o subakutni toksičnosti in lokalni toleranci ni bilo opaziti klinično relevantnih učinkov.
The daily dosage should not exceed 2.7 mg.
Dnevni odmerek ne sme preseči 2,7 mg.
• medicine to treat diabetes,
• zdravilo za zdravljenje sladkorne bolezni,
Growth hormone deficiency is associated with decreased plasma and extracellular volumes.
Pomanjkanje rastnega hormona je povezano z zmanjšano prostornino plazme in zunajceličnih tekočin.
Persons above 60 years should start with a dose of 0.1-0.2 mg per day which should be slowly increased according to individual requirements.
Osebe, stare več kot 60 let, morajo začeti z odmerkom 0,1-0,2 mg na dan, nato pa ga počasi povečevati glede na individualne potrebe.
Growth hormone decreases the conversion of cortisone to cortisol and may unmask previously undiscovered central hypoadrenalism or render low glucocorticoid replacement doses ineffective (see section 4.4).
Rastni hormon zmanjša pretvorbo kortizona v kortizol, pri čemer se lahko izrazi predhodno prikrit centralni hipoadrenalizem ali pa nizki nadomestni odmerki glukokortikoidov postanejo neučinkoviti (glejte poglavje 4.4).
The clinical significance of this finding is unclear.
Klinični pomen te ugotovitve ni jasen.
Omnitrope is a clear and colourless solution for injection.
Zdravilo Omnitrope je bistra in brezbarvna raztopina za injiciranje.
If during treatment with somatropin patients show signs of upper airway obstruction (including onset of or increased snoring), treatment should be interrupted, and a new ENT assessment performed.
Če imajo bolniki med zdravljenjem s somatropinom znake obstrukcije zgornjih dihal (vključno s pojavom smrčanja ali njegovega povečanja), je treba zdravljenje prekiniti in opraviti novo oceno ORL.
EXP After reconstitution, use within 21 days.
EXP Po rekonstituciji porabite v 21 dneh.
Injecting Omnitrope - Select the site of injection.
Injiciranje zdravila Omnitrope - Izberite mesto injiciranja.
Not Known (cannot be estimated from available data)
redki do zelo redki neznana (ni mogoče oceniti iz razpoložljivih podatkov)
Inject the solvent slowly.
Počasi injicirajte vehikel.
Somatropin increases insulin but fasting blood glucose is commonly unchanged.
Somatropin zveča vrednost insulina, vendar ostane navadno raven sladkorja v krvi na tešče nespremenjena.
Injection site reaction$
reakcija na mestu injiciranja$
The bioavailability of subcutaneously administered somatropin is approximately 80% in both healthy subjects and growth hormone deficient patients.
Biološka uporabnost somatropima po njegovi subkutani uporabi je tako pri zdravih ljudeh kot pri bolnikih s pomanjkanjem rastnega hormona približno 80-odstotna.
Omnitrope is a biosimilar medicinal product.
Omnitrope je biološko podobno zdravilo.
Read package leaflet before use.
Pred uporabo preberite priloženo navodilo!
However, the in-use stability has been demonstrated for up to 24 hours at 2°C
Vendar pa je bila stabilnost dokazana tudi med uporabo za obdobje do 24 ur pri temperaturi od
Somatropin stimulates the turnover of skeletal bone.
Somatropin spodbuja presnovo skeletne kosti.
Children with hypopituitarism may experience fasting hypoglycaemia.
Otroci s hipopituitarizmom imajo lahko hipoglikemijo na tešče.
In women on oral oestrogen replacement, a higher dose of growth hormone may be required to achieve the treatment goal (see section 4.4).
Pri ženskah na peroralnem estrogenskem nadomestnem zdravljenju bo za dosego cilja zdravljenja morda potreben večji odmerek rastnega hormona (glejte poglavje 4.4).
Your doctor should have already shown you how to use Omnitrope.
Vaš zdravnik bi vam moral že pokazati, kako se uporablja zdravilo Omnitrope.
Subcutaneous use after reconstitution
Za subkutano uporabo po rekonstituciji
Patients with diabetes, glucose intolerance, or additional risk factors for diabetes should be monitored closely during somatropin therapy.
Bolnike z že izraženo sladkorno boleznijo, intoleranco za glukozo ali dodatnimi dejavniki tveganja za sladkorno bolezen je treba med zdravljenjem s somatropinom skrbno spremljati.
In general, administration of somatropin to growth hormone deficient patients results in reduction in serum LDL and apolipoprotein B. A reduction in serum total cholesterol may also be observed.
Na splošno se pri bolnikih s pomanjkanjem rastnega hormona zaradi uporabe somatropina zmanjšata serumski koncentraciji LDL in apolipoproteina B. Zmanjša se lahko tudi serumska vrednost skupnega holesterola.
• Water retention (which shows as puffy fingers or swollen ankles)
• zastajanje vode (kar se kaže kot nabrekli prsti ali otekli gležnji)
Long-term overdose could result in signs and symptoms consistent with the known effects of human growth hormone excess.
Dolgotrajno preveliko odmerjanje povzroči pojav znakov in simptomov, ki so podobni tistim pri čezmernem izločanju rastnega hormona pri ljudeh.
Reconstituting Omnitrope - Remove the protective caps from the two vials in the box.
Priprava zdravila Omnitrope - Odstranite zaščitni zaporki z obeh vial v škatlici.
However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposing factors.)
Vendar pa ni dokazov, da je pogostnost levkemije povečana pri prejemnikih rastnega hormona brez predispozicijskih dejavnikov.)
In growth hormone deficiency, secondary to treatment of malignant disease, it is recommended to pay attention to signs of relapse of the malignancy.
Pri pomanjkanju rastnega hormona, ki je posledica zdravljenja maligne bolezni, je priporočljivo posvetiti pozornost znakom ponovitve maligne bolezni.
Sleep apnoea should be assessed before onset of growth hormone treatment by recognised methods such as polysomnography or overnight oxymetry, and monitored if sleep apnoea is suspected.
Apnejo v spanju je treba pred začetkom zdravljenja z rastnim hormonom oceniti s priznanimi metodami, kot sta polisomnografija ali nočna oksimetrija, bolnike pa je treba nadzorovati, če obstaja sum na apnejo v spanju.
In other studies with somatropin regarding general toxicity, local tolerance and reproduction toxicity no clinically relevant effects have been observed.
Tudi v preskušanjih o splošni toksičnosti somatropina, njegovi lokalni toleranci in reprodukcijski toksičnosti ni bilo opaziti klinično relevantnih učinkov.
Aim the stream of liquid against the glass wall in order to avoid foam.
Curek tekočine usmerite na stekleno steno, da preprečite penjenje.
Each vial must be reconstituted with the accompanying solvent only.
Vsebino viale je treba pripraviti le z vehiklom, ki je priložen.
In case of severe or recurrent headache, visual problems, nausea and/or vomiting, a fundoscopy for papilloedema is recommended.
Pri bolnikih s hudim ali ponavljajočim se glavobolom, motnjami vida, slabostjo in/ali bruhanjem se priporoča fundoskopija za odkrivanje edema papile.
Signs of scoliosis should be monitored during treatment.
Med zdravljenjem je treba spremljati znake skolioze.
• During treatment, if you develop a lung infection, tell your doctor so that he can treat the infection.
• Če se med zdravljenjem razvije okužba pljuč, to povejte zdravniku, da bo lahko okužbo zdravil.
However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposition factors.
Vendar pa ni dokazov, da je incidenca levkemije povečana pri prejemnikih rastnega hormona brez predispozicijskih dejavnikov.
• After starting somatropin treatment some patients may need to start thyroid hormone replacement.
• Po uvedbi zdravljenja s somatropinom potrebujejo nekateri bolniki nadomestno zdravljenje s ščitničnim hormonom.
Wash your hands before you continue with the next steps.
Preden postopek nadaljujete, si umijte roke.
• If you have chronic renal (kidney) insufficiency.
• če imate kronično renalno (ledvično) odpoved.
Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions must not be treated with somatropin (regarding patients undergoing substitution therapy, see section 4.4).
S somatropinom se ne sme zdraviti bolnikov z akutno kritično boleznijo, ki imajo zaplete po operaciji na odprtem srcu, v trebuhu, z večkratnimi nezgodnimi poškodbami, z akutno odpovedjo dihanja ali podobnimi stanji (o bolnikih, ki imajo nadomestno zdravljenje, glejte poglavje 4.4).
If during the evaluation of upper airway obstruction, pathological findings are observed, the child should be referred to an Ear, nose and throat (ENT) specialist for treatment and resolution of the respiratory disorder prior to initiating growth hormone treatment.
Če ocena obstrukcije zgornjega dela dihalnih poti pokaže patološke izsledke, je treba otroka pred začetkom zdravljenja z rastnim hormonom napotiti k specialistu za ušesa, nos in grlo (ORL) na zdravljenje in odpravo respiratorne težave.
If you continue Omnitrope after treatment during childhood you should start with 0.2-0.5 mg per day.
Če zdravljenje z zdravilom Omnitrope nadaljujete po uporabi v otroštvu, začnite z 0,2-0,5 mg na dan.
In patients with hypopituitarism on standard replacement therapy, the potential effect of growth hormone treatment on thyroid function must be closely monitored
Pri bolnikih s hipopituitarizmom s standardno nadomestno terapijo je treba skrbno nadzirati možne učinke zdravljenja z rastnim hormonom na delovanje ščitnice.
Long-term treatment and improvement of body composition of children with growth disturbance due to Prader-Willi syndrome
Dolgotrajno zdravljenje in izboljšanje telesne sestave otrok z motnjami v rasti zaradi PraderWillijevega sindroma
In clinical trials in short children/adolescents born SGA doses of 0.033 and 0.067 mg/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/kg telesne mase na dan, dokler ni bila dosežena končna višina.
• Increased intracranial pressure (which causes symptoms such as strong headache, visual disturbances or vomiting)
• zvišanje intrakranialnega tlaka (ki povzroča simptome kot so močan glavobol, motnje vida ali bruhanje)
$ Transient injection site reactions in children have been reported.
Poročali so o prehodnih reakcijah na mestu injiciranja pri otrocih.
Somatropin induces hepatic LDL cholesterol receptors, and affects the profile of serum lipids and lipoproteins.
Somatropin spodbuja jetrne receptorje za holesterol LDL in vpliva na lastnosti maščob ter lipoproteinov v serumu.
Pull back the plunger very slightly with one hand.
Z eno roko zelo narahlo povlecite bat nazaj.
• Pain or burning sensation in the hands or underarms (known as Carpal Tunnel syndrome) Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include: In children
• bolečina ali pekoč občutek v rokah ali podlahteh (znana kot sindrom karpalnega kanala) Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) vključujejo: Pri otrocih
If overt diabetes occurs, growth hormone should not be administered.
Če se pojavi izražen diabetes, se rastnega hormona ne daje.
Do not use Omnitrope if you notice that the solution is cloudy.
Ne uporabljajte zdravila Omnitrope, če opazite, da je raztopina motna.
Formation of antibodies to the injected growth hormone but these do not seem to stop the growth hormone from working.
Nastanek protiteles na injiciran rastni hormon, ki pa, kot kaže, ne ovirajo delovanja rastnega hormona.
Serum concentrations of IGF-I (Insulin-like Growth Factor-I) and IGFBP3 (Insulin-like Growth Factor Binding Protein 3) are increased by somatropin.
Povečuje serumske koncentracije IGF-I (insulinu podobnega rastnega dejavnika-I) in IGFBP3 (vezavni protein 3 za insulinu podoben rastni dejavnik).
Conversely, if a woman on somatropin discontinues oral oestrogen therapy, the dose of somatropin may need to be reduced to avoid excess of growth hormone and/or side effects (see section 4.5).
Nasprotno, če ženska, ki se zdravi s somatropinom, preneha z zdravljenjem s peroralnimi estrogeni, bo odmerek somatropina morda treba zmanjšati, da se prepreči presežek rastnega hormona in/ali pojav neželenih učinkov (glejte poglavje 4.5).
The maintenance dose in these patients seldom exceeds 0.5 mg per day.
Vzdrževalni odmerek pri teh bolnikih redko presega 0,5 mg na dan.
• If you have raised intracranial pressure (which causes symptoms, such as strong headache, visual disturbances or vomiting) you should inform your doctor about it.
• Če imate zvišan intrakranialni tlak (ki povzroča simptome, kot so močan glavobol, motnje vida ali bruhanje) to sporočite svojemu zdravniku.
It is also natural to have a higher level of growth hormone at night.
Med spanjem so višje ravni rastnega hormona naravne.
The powder is white and the solvent is a clear, colourless solution.
Prašek je bel, vehikel pa je bistra, brezbarvna raztopina.
In patients with a high likelihood for persistent GHD, i.e. a congenital cause or GHD secondary to a hypothalamic-pituitary disease or insult, an insulin-like growth factor-I (IGF-I) SDS < -2 off growth hormone treatment for at least 4 weeks should be considered sufficient evidence of profound GHD.
Pri bolnikih, pri katerih je možnost persistentnega PRH velika, tj. prirojeni vzrok ali PRH zaradi bolezni ali insultu hipofize/hipotalamusa, je SDS insulinu podobnega rastnega faktorja-I (IGF-I) < -2 po zdravljenju z rastnim hormonom, ki je trajalo vsaj 4 tedne, zadostni znak velikega PRH.
Patients with childhood onset GHD should be re-evaluated for growth hormone secretory capacity after completion of longitudinal growth.
Pri bolnikih z začetkom PRH v otroštvu je treba ponovno oceniti zmožnost izločanja rastnega hormona po zaključeni longitudinalni rasti.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVIN IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
In patients with endocrine disorders, including growth hormone deficiency, slipped epiphyses of the hip may occur more frequently than in the general population.
Pri bolnikih z motnjami pri delovanju žlez z notranjim izločanjem, tudi s pomanjkanjem rastnega hormona, lahko pogosteje kot pri splošni populaciji zdrsne epifiza stegnenične glavice.
To avoid this, use a slightly different place for your injection each time.
To preprečite tako, da si zdravilo vsakič injicirate na nekoliko drugo mesto.
• treat persons with pronounced growth hormone deficiency.
• zdravljenje oseb z izrazitim pomanjkanjem rastnega hormona.
• After reconstitution, from a microbiological point of view, the product should be used immediately.
• Po pripravi raztopine je zaradi mikrobioloških razlogov priporočena takojšnja uporaba zdravila.
After reconstitution, from a microbiological point of view, an immediate use is recommended.
Po pripravi raztopine je zaradi mikrobioloških razlogov priporočena takojšnja uporaba zdravila.
Slipped capital femoral epiphysis occurs more frequently in case of endocrine disorders and Legg-Calvé-Perthes is more frequent in case of short stature.
Zdrs epifize glavice stegnenice se pojavi pogosteje v primeru endokrinih motenj, Legg-Calvé-Perthesova bolezen pa je pogostejša pri manjši rasti.
Omnitrope (MAH: Sandoz), Zomacton and associated names (MAH: Ferring), Norditropin and associated names (MAH: Novo Nordisk), Genotropin and associated names (MAH: Pfizer)
Omnitrope (imetnik dovoljenja za promet z zdravilom: Sandoz), Zomacton in povezana imena (imetnik dovoljenja za promet z zdravilom: Ferring), Norditropin in povezana imena (imetnik dovoljenja za promet z zdravilom: Novo Nordisk), Genotropin in povezana imena (imetnik dovoljenja za promet z zdravilom: Pfizer)
- The residual solution, vials, and injection materials intended for single use must be discarded.
- Ostanke raztopine, vial in pribor za injiciranje, namenjen enkratni uporabi, morate zavreči.
Omnitrope is intended for subcutaneous use.
Zdravilo Omnitrope je namenjeno za subkutano uporabo.
Paediatric population The posology and administration schedule should be individualised.
Pediatrična populacija Odmerjanje in shema uporabe morata biti prilagojeni posamezniku.
Your other hand will be free to move the plunger.
Z drugo roko boste lahko premikali bat.
Before initiation of treatment with somatropin patients with PWS should be evaluated for upper airway obstruction, sleep apnoea or respiratory infections should be assessed.
Pred začetkom zdravljenja s somatropinom je treba pri bolnikih s PWS preveriti, ali imajo obstrukcijo zgornjega dela dihal in oceniti apnejo v spanju ali okužbo dihal.
• If you experience worsening abdominal pain you should inform your doctor.
• Če se vam pojavijo bolečine v trebuhu, ki postajajo čedalje hujše, morate obvestiti zdravnika.
Visceral adipose tissue is particularly responsive to somatropin.
Visceralno maščobno tkivo se na somatropin posebno rado odziva.
Pack sizes of 1, 5 or 10.
Velikosti pakiranj po 1, 5 ali 10.
Adults with growth hormone deficiency:
Odrasli s pomanjkanjem rastnega hormona:
Other medicines and Omnitrope
Druga zdravila in zdravilo Omnitrope
Somatropin is a potent metabolic hormone of importance for the metabolism of lipids, carbohydrates and proteins.
Somatropin je učinkovit presnovni hormon, ki je pomemben za presnovo maščob, ogljikovih hidratov in beljakovin.
If blood comes into the syringe, the needle has entered a blood vessel.
Če priteka v injekcijsko brizgo kri, je igla zadela v žilo.
In SGA children/adolescents it is recommended to measure fasting insulin and blood glucose before start of treatment and annually thereafter.
Pri otrocih/mladostnikih, ki so MGS, se priporoča merjenje vrednosti insulina in sladkorja v krvi na tešče pred začetkom zdravljenja in nato enkrat na leto.
‡ Clinical significance is unknown
‡ Klinični pomen ni znan.
Chronic renal insufficiency
Kronična ledvična insuficienca
• Stiffness in the arms and legs, muscle pain
• togost rok in nog, bolečine mišic
If your growth hormone deficiency starts during adult life you should start with 0.15-0.3 mg per day.
Če se pomanjkanje rastnega hormona pojavi v odrasli dobi, začnite z 0,15-0,3 mg na dan.
In addition to enhanced lipolysis, somatropin decreases the uptake of triglycerides into body fat stores.
Somatropin povečuje lipolizo in zmanjšuje vnos trigliceridov v maščobne zaloge telesa.
Type 2 diabetes mellitus
Presnovne in prehranske motnje diabetes mellitus tipa 2
In patients treated with somatropin, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required.
Pri bolnikih, ki se zdravijo s somatropinom, se lahko izrazi predhodno prikriti centralni (sekundarni) hipoadrenalizem, ki lahko zahteva nadomestno zdravljenje z glukokortikoidi.
- Before you make an injection, clean your skin well with an alcohol swab.
- Pred injiciranjem dobro očistite kožo z blazinico iz vate, namočeno v alkohol.
What Omnitrope looks like and contents of the pack
Izgled zdravila Omnitrope in vsebina pakiranja
Excipient(s) with known effect: One ml contains 9 mg benzyl alcohol.
Pomožne snovi z znanim učinkom: En ml vsebuje 9 mg benzilalkohola.
Experience in initiating treatment in SGA patients near onset of puberty is limited.
Izkušenj z začetkom zdravljenja otrok z MGS, pri katerih se bo kmalu začela puberteta, je malo.
- Turn the vial and the syringe upside down in one hand.
- Z eno roko obrnite vialo in injekcijsko brizgo navzdol tako, da oboje držite v eni roki.
This means that it is injected through a short injection needle into the fatty tissue just under your skin.
To pomeni, da se daje s kratko injekcijsko iglo v maščevje tik pod kožo.
† Reported in growth hormone deficient children treated with somatropin, but the incidence appears to be similar to that in children without growth hormone deficiency.
Poročila pri otrocih s pomanjkanjem rastnega hormona, zdravljenih s somatropinom, vendar pa kaže, da je pojavnost podobna pri otrocih brez pomanjkanja rastnega hormona.
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and subside spontaneously or with dose-reduction.
*Na splošno so bili ti neželeni učinki blagi do zmerni in so se pojavili v prvih mesecih zdravljenja, nato pa so spontano ali z zmanjšanjem odmerka izzveneli.
After injecting - After injection, press the injection site with a small bandage or sterile gauze for several seconds.
Po injiciranju - Po injiciranju pritiskajte na mesto injiciranja več sekund z majhnim povojem ali sterilno gazo.
• Temporary reddening, itchiness or pain at the injection site
• začasna pordečitev, srbenje ali bolečina na mestu injiciranja
Higher doses may be needed if growth velocity is too low.
Odmerek zdravila je lahko večji, če je rast prepočasna.
If the solution is cloudy or contains particulate matter, it should not be used.
Če je raztopina motna ali vsebuje delce, je ne smete uporabiti.
Clinical trials in children with Turner syndrome
Klinična preskušanja pri otrocih s Turnerjevim sindromom
Clinical trials in children with chronic renal insufficiency
Klinična preskušanja pri otrocih s kronično ledvično insuficienco
Somatropin has been reported to reduce serum cortisol levels, possibly by affecting carrier proteins or by increased hepatic clearance.
Poročali so, da somatropin niža ravni kortizola v serumu, morda z vplivom na nosilne beljakovine ali z zvečanjem jetrnega očistka.
Tumours must be inactive and you must have finished your anti-tumour treatment before you start your treatment with Omnitrope.
Tumorji morajo biti neaktivni, preden začnete zdravljenje z zdravilom Omnitrope, pa morate zaključiti zdravljenje tumorja.
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 kateri 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.
What Omnitrope is and what it is used for What you need to know before you use Omnitrope How to use Omnitrope
Kaj je zdravilo Omnitrope in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Omnitrope Kako uporabljati zdravilo Omnitrope Možni neželeni učinki
• Water retention (which shows as puffy fingers or swollen ankles) Common side effects (likely to occur in fewer than 1 in 10 patients) include: In children
• zastajanje vode (kar se kaže kot nabrekli prsti ali otekli gležnji) Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) vključujejo: Pri otrocih
There have been no clinical studies conducted with somatropin containing products in breast-feeding women.
Kliničnih študij s somatropinom, v katerih bi bile vključene ženske, ki dojijo, niso izvedli.
The top of the vials should be wiped with an antiseptic solution to prevent contamination of the contents.
Zgornji del viale obrišite z antiseptično raztopino, da preprečite kontaminacijo vsebine.
If you have been treated with Omnitrope for growth hormone deficiency during childhood, your growth hormone status will be retested after completion of growth.
Če ste se v otroštvu zdravili z zdravilom Omnitrope zaradi pomanjkanja rastnega hormona, se vaše stanje rastnega hormona ponovno preveri, ko prenehate rasti.
- the Omnitrope Pen , an injection device specifically developed for use with Omnitrope solution for injection (not supplied in the pack; see Instructions for Use provided with the Omnitrope Pen).
- injekcijski peresnik SurePal, pripravo za injiciranje, narejeno posebej za uporabo raztopine za injiciranje zdravila Omnitrope (ki je ni v ovojnini; glejte Navodila za uporabo, priložena napravi SurePal).
Solution for injection in a cartridge for SurePal 5, SurePal 10, SurePal 15.
Raztopina za injiciranje v vložku za injekcijski peresnik SurePal 5, Surepal 10, Surepal 15.