natgillin/translations-raw huggingface dataset:
Patients and caregivers have to receive appropriate training and instruction on the proper use of the Omnitrope vials, the cartridges with solvent, the transfer set and the pen from the physician or other suitable qualified health professionals.
Zdravniki ali drugo ustrezno usposobljeno osebje morajo bolnike in negovalno osebje ustrezno poučiti o pravilni uporabi vial, vložkov s topilom, seta za prenos in peresa Omnitrope.
The manufacturer’ s instructions with each individual transfer set and pen must be followed for reconstituting Omnitrope 5 mg/ ml powder for solution for injection, loading the cartridge, attaching the injection needle and for the administration.
Izdelovalčeva navodila, ki so priložena vsakemu setu za prenos in peresu, je treba upoštevati pri pripravi zdravila Omnitrope 5 mg/ ml prašek za raztopino za injiciranje, pri polnjenju vložka, pritrditvi injekcijske igle in pri uporabi.
Use the transfer set for transferring the solvent from the cartridge into the vial.
Uporabite set za prenos topila iz vložka v vialo.
Assemble the pen following the instructions for use.
Pero sestavite tako, kot piše v navodilih za uporabo.
Remove the pen needle and dispose of it in accordance with local requirements.
Iglo peresa odstranite in zavrzite v skladu z lokalnimi predpisi.
Omnitrope 3.3 mg/ ml solution for injection
Omnitrope 3, 3 mg/ ml raztopina za injiciranje
Somatropin* 3.3 mg (corresponding to 10 IU)/ ml.
3, 3 mg somatropina * (ustreza 10 i. e.) / ml.
One cartridge contains 1.5 ml corresponding to 5 mg Somatropin* (15 IU).
En vložek vsebuje 1, 5 ml, kar ustreza 5 mg somatropina * (15 i. e.).
* produced in Escherichia coli by recombinant DNA technology.
* Izdelanega iz celic Escherichia coli s tehnologijo rekombinantne DNA.
Solution for injection The solution is clear and colourless.
Raztopina za injiciranje Raztopina je bistra in brezbarvna.
- 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 < – 1)
21 Growth disturbance due to insufficient secretion of growth hormone in paediatric patients:
20 Motnje rasti zaradi nezadostnega izločanja rastnega hormona pri pediatričnih bolnikih:
For instructions for use and handling see section 6.6.
Za navodila za pripravo in ravnanje z zdravilom glejte poglavje 6. 6.
Somatropin has been reported to reduce serum cortisol levels, possibly by affecting carrier proteins or by increasing hepatic clearance.
Poročali so, da somatropin zmanjša ravni kortizola v serumu, morda tako, da vpliva na prenašalne beljakovine ali poveča jetrni očistek.
Nevertheless, corticosteroid replacement therapy should be optimised before initiation of Omnitrope therapy.
Kljub temu je treba pred začetkom zdravljenja z zdravilom Omnitrope optimizirati kortikosteroidno nadomestno zdravljenje.
Patients with PWS should be evaluated for upper airway obstruction, sleep apnoea or respiratory infections before initiation of treatment with somatropin.
22 Pred začetkom zdravljenja s somatropinom je treba pri bolnikih s PWS preveriti, ali imajo obstrukcijo zgornjega dela dihal, apnejo v spanju ali okužbo dihal.
23 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.
Mortality was higher in patients
23 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.
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 P 450.
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 hude, 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
Pogostost pojava teh neželenih učinkov je
25 related to the age of patients at the onset of growth hormone deficiency.
24 odvisna od odmerka zdravila, bolnikove starosti in morda v obratnem sorazmerju z njegovo starostjo od pojavu pomanjkanja rastnega hormona.
Serum
Zvečuje serumske koncentracije IGF- I (insulinu podobnega
26 concentrations of IGF-I (Insulin-like Growth Factor-I) and IGFBP3 (Insulin-like Growth Factor Binding Protein 3) are increased by somatropin.
25 rastnega dejavnika- I) in IGFBP3 (vezavni protein 3 za insulinu podoben rastni dejavnik).
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 SSD (0, 033 mg/ kg telesne mase na dan) in +2, 19 SSD( 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 SSD.
A subcutaneous dose of 5 mg of Omnitrope 3.3 mg/ ml solution for injection in healthy adults results in plasma Cmax and tmax values of 72 ± 28 µg/ l and 4.0 ± 2.0 hours, respectively.
Po subkutani uporabi 5 mg zdravila Omnitrope 3, 3 mg/ ml raztopina za injiciranje pri zdravih odraslih je Cmax 72 ± 28 µg/ l, tmax pa 0 ± 2, 0 ure.
However, after subcutaneous administration of Omnitrope 3.3 mg/ ml solution for injection, a half-life of 3 hours is achieved.
Po subkutani uporabi zdravila Omnitrope 3, 3 mg/ ml raztopina za injiciranje traja razpolovna doba 3 ure.
27 5.3 Preclinical safety data
26 5. 3 Predklinični podatki o varnosti
Shelf life after first use:
Rok uporabnosti po prvi uporabi:
After 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 28 days.
Po prvi uporabi mora vložek ostati v peresu in shranjen v hladilniku (2 °C– 8 °C) največ 28 dni.
Store and transport refrigerated (2°C - 8°C).
Neodprti vložek: shranjujte in prevažajte na hladnem (2 °C - 8 °C).
1.5 ml of solution in a cartridge (colourless type I glass) with plunger on one side (siliconised bromobutyl), a disc (bromobutyl) and a cap (aluminium) on the other side.
1, 5 ml raztopine v vložku (brezbarvno steklo tipa I) z batom na eni strani (silikonizirani bromobutil), ploščico (brombutil) ter zaporko (aluminij) na drugi strani.
Omnitrope 3.3 mg/ ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge.
Omnitrope 3, 3 mg/ ml raztopina za injiciranje je sterilna pripravljena raztopina za subkutano injiciranje v steklenem vložku.
This presentation is intended for multiple use.
27 Ta oblika je namenjena za večkratno uporabo.
It should only be administered with the Omnitrope Pen 5, an injection device specifically developed for use with Omnitrope 3.3 mg/ ml solution for injection.
Uporablja se lahko samo v Omnitrope Pen 5, pripravi za injiciranje, narejeni posebej za uporabo raztopine za injiciranje zdravilo Omnitrope 3, 3 mg/ ml.
Patients and caregivers have to receive appropriate training and instruction on the proper use of the Omnitrope cartridges and the pen from the physician or other suitable qualified health professionals.
Zdravniki ali drugo ustrezno usposobljeno osebje morajo bolnike in negovalno osebje ustrezno poučiti o pravilni uporabi vložkov in peresa Omnitrope.
The manufacturer’ s instructions with each pen must be followed for loading the cartridge, attaching the injection needle and for the administration.
Izdelovalčeva navodila, ki so priložena peresu, je treba upoštevati pri polnjenju vložka, pritrditvi injekcijske igle in pri uporabi.
Insert the cartridge into the Omnitrope Pen 5 following the instructions for use provided with the pen.
Vložek vstavite v pero Omnitrope Pen 5 po priloženih navodilih za uporabo.
Administer the appropriate dose by subcutaneous injection using a sterile pen needle.
Odmerek injicirajte subkutano s sterilno iglo peresa.
Omnitrope 6.7 mg/ ml solution for injection
Omnitrope 6, 7 mg/ ml raztopina za injiciranje
Somatropin* 6.7 mg (corresponding to 20 IU)/ ml.
6, 7 mg somatropina * (ustreza 20 i. e.) / ml.
One cartridge contains 1.5 ml corresponding to 10 mg Somatropin* (30 IU).
En vložek vsebuje 1, 5 ml, kar ustreza 10 mg somatropina * (30 i. e.).
* produced in Escherichia coli by recombinant DNA technology.
* Izdelan iz celic Escherichia coli z metodo rekombinantne DNA.
Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with growth disorders.
Doagnozo in zdravljenje s somatropinom mora začeti in nadzirati zdravnik, ki je ustrezno usposobljen in ima izkušnje pri diagnosticiranju in obravnavanju bolnikov z motnjami rasti.
30 Growth disturbance due to insufficient secretion of growth hormone in paediatric patients:
Motnje rasti zaradi nezadostnega izločanja rastnega hormona pri pediatričnih bolnikih:
Prader-Willi syndrome, for improvement of growth and body composition in paediatric patients:
29 Prader- Willijev sindrom (PWS), za izboljšanje rasti in sestave telesa pri pediatričnih bolnikih:
Indication Growth hormone deficiency Prader-Willi syndrome Turner syndrome Chronic renal insufficiency Children/ adolescents born small for gestational age (SGA)
pomanjkanje rastnega hormona Prader- Willijev sindrom Turnerjev sindrom kronična ledvična insuficienca otroci/ mladostniki, ki so se za svojo
body surface dose per day 0.7 - 1.0 1.0 1.4 1.4 1.0
0, 035
32 In case of signs of upper airway obstruction, the problem should be solved by a specialist before starting treatment with somatropin.
31 Pri znakih obstrukcije zgornjega dela dihal naj to težavo odpravi specialist, preden se začne zdravljenje s somatropinom.
33 treated with 5.3 or 8 mg somatropin daily compared to patients receiving placebo, 42% vs.
32 odprtem srcu, abdominalnem kirurškem posegu, večkratnih poškodbah po nesreči ali akutni pljučni odpovedi.
34 Neoplasms benign, malignant and unspecified (incl cysts and polyps)
33 Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
In adults: paraesthesia In adults: carpal tunnel syndrome; In paediatric patients: paraesthesia Benign intracranial hypertension
parestezija pri odraslih pri odraslih: sindrom karpalnega kanala, pri pediatričnih bolnikih: parestezija benigna intrakranialna hipertenzija
35 Lipid metabolism:
34 Presnavljanje maščob:
A subcutaneous dose of 5 mg of Omnitrope 6.7 mg/ ml solution for injection in healthy adults results in plasma Cmax and tmax values of 74 ± 22 µg/ l and 3.9 ± 1.2 hours, respectively.
Po subkutani uporabi 5 mg zdravila Omnitrope 6, 7 mg/ ml raztopina za injiciranje pri zdravih odraslih je Cmax 74 ± 22 µg/ l, tmax pa 3, 9 ± 1, 2 ure.
However, after subcutaneous administration of Omnitrope 6.7 mg/ ml solution for injection, a half-life of 3 hours is achieved.
Po subkutani uporabi zdravila Omnitrope 6, 7 mg/ ml raztopina za injiciranje traja razpolovna doba 3 ure.
In studies with Omnitrope regarding subacute toxicity and local tolerance, no clinically relevant effects have been observed.
Pri preskušanjih subakutne toksičnosti in lokalne tolerance ni bilo opaziti klinično pomembnih učinkov.
36 In other studies with somatropin regarding general toxicity, local tolerance and reproduction toxicity no clinically relevant effects have been observed.
35 Tudi pri preskušanjih splošne toksičnosti somatropina, njegovi lokalni toleranci in vplivu na sposobnost razmnoževanja ni bilo opaziti klinično pomembnih učinkov.
With somatropins, in vitro and in vivo genotoxicity studies on gene mutations and induction of chromosome aberrations have been negative.
In vitro in in vivo genotoksična preskušanja genskih mutacij in indukcije aberacije kromosomov so bila negativna.
In another study with somatropin, no increase in chromosomal abnormalities was found in the lymphocytes of patients who had received long-term somatropin therapy.
V drugi študiji s somatropinom pa na limfocitih bolnikov, ki so se z njim zdravili dolgo časa, niso ugotovili zvečanja kromosomskih nepravilnosti.
disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol water for injections
natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat glicin poloksamer 188 fenol voda za injekcije
After 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 28 days.
Po prvi uporabi mora vložek ostati v peresu in shranjen v hladilniku (2 °C - 8 °C) največ 28 dni.
Store and transport refrigerated (2°C - 8°C).
Neodprt vložek: shranjujte in prevažajte na hladnem (2 °C - 8 °C).
1.5 ml of solution in a cartridge (colourless type I glass) with plunger on one side (siliconised bromobutyl), a disc (bromobutyl) and a cap (aluminium) on the other side.
1, 5 ml raztopine v vložku (brezbarvno steklo tipa I) z batom na eni strani (silikonizirani bromobutil), ploščico (bromobutil) ter zaporko (aluminij) na drugi strani.
Omnitrope 6.7 mg/ ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge.
Omnitrope 6, 7 mg/ ml raztopina za injiciranje je sterilna pripravljena raztopina za subkutano injiciranje v steklenem vložku.
37 This presentation is intended for multiple use.
Ta oblika je namenjena za večkratno uporabo.
It should only be administered with the Omnitrope Pen 10, an injection device specifically developed for use with Omnitrope 6.7 mg/ ml solution for injection.
Uporablja se lahko samo v Omnitrope Pen 10, pripomočku za injiciranje, narejeni posebej za uporabo raztopine za injiciranje zdravilo Omnitrope 6, 7 mg/ ml.
Patients and caregivers have to receive appropriate training and instruction on the proper use of the Omnitrope cartridges and the pen from the physician or other suitable qualified health professionals.
Zdravniki ali drugo 36 ustrezno usposobljeno osebje morajo bolnike in negovalno osebje ustrezno poučiti o pravilni uporabi vložkov in peresa Omnitrope.
Insert the cartridge into the Omnitrope Pen 10 following the instructions for use provided with the pen.
Vložek vstavite v pero Omnitrope Pen 10 po priloženih navodilih za uporabo.
38 ANNEX II
37 DODATEK II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVIN IN IMETNIKI DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
39 A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVIN IN IMETNIKI DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
Name and address of the manufacturer of the biological active substance
Ime in naslov izdelovalcev biološke zdravilne učinkovin
Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria
Sandoz GmbH Biochemiestrasse 10 A- 6250 Kundl Avstrija
The MAH must ensure that the system of pharmacovigilance, as described in version 4.3 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 4. 3, predstavljen v Modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 5.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 5. 0 načrta za obvladovanje tveganja (RMP), predstavljenem v Modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša CHMP.
In addition, an updated RMP should be submitted
Poleg tega je treba posodobljen PSUR/ RMP/ Načrt za obvladovane tveganja predložiti tudi:
Pharmacovigilance Plan or risk minimization activities
- na zahtevo Evropske agencije za zdravila (EMEA).
40
40 DODATEK III
- At the request of the EMEA
OZNAČEVANJE IN NAVODILO ZA UPORABO
LABELLING
42 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Omnitrope 1.3 mg/ ml powder and solvent for solution for injection Somatropin
Omnitrope 1, 3 mg/ ml prašek in vehikel za raztopino za injiciranje somatropin
Somatropin 1.3 mg (4 IU)/ ml in a vial.
1, 3 mg somatropina (4 i. e.) v viali.
After reconstitution, one vial contains 1.3 mg Somatropin (corresponding to 4 IU) per ml.
Po rekonstituciji ena viala vsebuje 1, 3 mg somatropina (ustreza 4 i. e.) na ml.
Powder and solvent for solution for injection (powder in a vial (1.3 mg) and solvent in a vial (1 ml)).
Prašek in vehikel za raztopino za injiciranje (prašek v viali (1, 3 mg) in vehikel v viali (1 ml)).
10 A-6250 Kundl Austria
Sandoz GmbH Biochemiestrasse 10 A- 6250 Kundl Avstrija
45 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
44 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL TEXT/ OMNITROPE POWDER
BESEDILO NA VIALI/ OMNITROPE PRAŠEK
Omnitrope 1.3 mg/ ml powder and solvent for solution for injection Somatropin Subcutaneous use
Omnitrope 1, 3 mg/ ml (4 i. e.) prašek in vehikel za raztopino za injiciranje somatropin Za subkutano uporabo.
1.3 mg somatropin
1, 3 mg somatropina
46 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
45 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL TEXT/ SOLVENT
BESEDILO NA VIALI/ VEHIKLU
Omnitrope 1.3 mg/ ml powder and solvent for solution for injection Somatropin Subcutaneous use
Omnitrope 1, 3 mg/ ml prašek in vehikel za raztopino za injiciranje. somatropin Za subkutano uporabo.
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
46 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Omnitrope 5 mg/ ml powder and solvent for solution for injection Somatropin
Omnitrope 5 mg/ ml prašek in vehikel za raztopino za injiciranje somatropin
Somatropin 5 mg (15 IU)/ ml in a vial.
Somatropin 5 mg (15 i. e.) / ml v viali.
After reconstitution, one cartridge contains 5 mg Somatropin (corresponding to 15 IU) per ml.
Po rekonstituciji en vložek vsebuje 5 mg somatropina (ustreza 15 i. e.) na ml.
Powder: glycine, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate Solvent: benzyl alcohol, water for injections Contains benzyl alcohol.
Prašek: glicin, natrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat dihidrat Vehikel: benzilalkohol, voda za injekcije Vsebuje benzilalkohol.
Powder and solvent for solution for injection (powder in a vial (5 mg) and solvent in a cartridge (1 ml)).
Prašek in vehikel za raztopino za injiciranje (prašek v viali (5 mg) in vehikel v vložku (1 ml)).
Pack sizes of 1 and 5.
Velikosti pakiranj po 1 in 5.
Use only with Omnitrope Pen L.
Uporabljajte samo s peresom Omnitrope Pen L.
Omnitrope 5 mg/ ml powder and solvent for solution for injection Somatropin Subcutaneous use
Omnitrope 5 mg/ ml prašek in vehikel za raztopino za injiciranje somatropin Za subkutano uporabo.
5 mg somatropin
5 mg somatropina
50 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
49 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
CARTRIDGE TEXT/ SOLVENT
BESEDILO NA VLOŽKU/ VEHIKLU
1 ml water for injections with 1.5% benzyl alcohol.
1 ml vode za injekcije z 1, 5- odstotnim benzilalkoholom
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
50 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Omnitrope 3.3 mg/ ml solution for injection Somatropin
Omnitrope 3, 3 mg/ ml raztopina za injiciranje somatropin
Somatropin 3.3 mg (10 IU)/ ml.
3, 3 mg somatropina (10 i. e.) / ml.
One cartridge contains 1.5 ml corresponding to 5 mg Somatropin (15 IU).
En vložek vsebuje 1, 5 ml, kar ustreza 5 mg somatropina (15 i. e.).
Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, mannitol, poloxamer 188, benzyl alcohol, water for injections Contains benzyl alcohol.
Pomožne snovi: natrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat dihidrat, manitol, poloksamer 188, benzilalkohol, voda za injekcije Vsebuje benzilalkohol.
Solution for injection in a cartridge (1.5 ml).
Raztopina za injiciranje v vložku (1, 5 ml).
Pack sizes of 1, 5 and 10.
Velikosti pakiranja po 5 in 10.
Use only with Omnitrope Pen 5.
Uporabljajte samo s peresom Omnitrope Pen 5.
53 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
52 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
CARTRIDGE TEXT
BESEDILO NA VLOŽKU
Omnitrope 3.3 mg/ ml solution for injection Somatropin Subcutaneous use
Omnitrope 3, 3 mg/ ml raztopina za injiciranje somatropin Za subkutano uporabo.
5 mg somatropin in 1.5 ml
5 mg somatropina v 1, 5 ml
54 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
53 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Omnitrope 6.7 mg/ ml solution for injection Somatropin
Omnitrope 6, 7 mg/ ml raztopina za injiciranje somatropin
Somatropin 6.7 mg (20 IU)/ ml.
6, 7 mg somatropina (20 i. e.) / ml.
One cartridge contains 1.5 ml corresponding to 10 mg Somatropin (30 IU).
En vložek vsebuje 1, 5 ml, kar ustreza 10 mg somatropina (30 i. e.).
Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, glycine, poloxamer 188, phenol, water for injections
Pomožne snovi: natrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat dihidrat, glicin, poloksamer 188, fenol, voda za injekcije
Pack sizes of 1, 5 and 10.
Velikosti pakiranj po 1, 5 in 10.
METHOD AND ROUTE OF ADMINISTRATION
POSTOPEK IN POTI UPORABE ZDRAVILA
Use only with Omnitrope Pen 10.
Uporabljajte samo s peresom Omnitrope Pen 10.
56 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
55 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Omnitrope 6.7 mg/ ml solution for injection Somatropin Subcutaneous use
Omnitrope 6, 7 mg/ ml raztopina za injiciranje somatropin Za subkutano uporabo.
10 mg somatropin in 1.5 ml
10 mg somatropina v 1, 5 ml
OTHER
56 B.
PACKAGE LEAFLET
57 NAVODILO ZA UPORABO
Somatropin
somatropin
Read all of this leaflet carefully before you start using this medicine.
Pred uporabo natančno preberite to navodilo!
What Omnitrope is and what it is used for 2.
Kaj je zdravilo Omnitrope in za kaj ga uporabljamo 2.
Before you use Omnitrope 3.
Kaj morate vedeti, preden boste uporabili zdravilo Omnitrope 3.
How to use Omnitrope 4.
Kako uporabljati zdravilo Omnitrope 4.
How to store Omnitrope 6.
Shranjevanje zdravila Omnitrope 6.
WHAT OMNITROPE IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO OMNITROPE IN ZA KAJ GA UPORABLJAMO
Omnitrope is a human growth hormone which is made by a method known as ‘ recombinant DNA technology using the bacterial microorganism E. coli.
Zdravilo Omnitrope je rastni hormon pri človeku, izdelan z metodo, imenovano tehnologija rekombinantne DNA z uporabo bakterije E. coli.