natgillin/translations-raw huggingface dataset:
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 peresniku in shranjen v hladilniku (2 °C - 8 °C) največ 28 dni.
Antibodies 
Protitelesa
• After the first injection, the cartridge should remain in the pen injector and has to be stored in a refrigerator (2°C-8°C) and only used for a maximum of 21 days. 
• Po prvem injiciranju mora vložek ostati v peresniku za injiciranje, ki ga je treba hraniti v hladilniku (2 °C-8 °C), uporabljati pa se sme največ 21 dni.
With a cleansing swab, disinfect both the rubber membrane of the vial with powder and the rubber membrane of the cartridge with solvent. 
Z blazinico iz vate razkužite gumijasto membrano viale, napolnjene s praškom, in vložka, napolnjenega z vehiklom.
Omnitrope solution for injection (not supplied in the pack; see 
Omnitrope (ki je ni v ovojnini; glejte Navodila za uporabo,
Omnitrope 5 mg/ml is intended for multiple use. 
Zdravilo Omnitrope 5 mg/ml je namenjeno za večkratno uporabo.
Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease have been reported in children treated with GH. 
Pri otrocih, zdravljenih z rastnim hormonom, so poročali o zdrsu epifize glavice stegnenice in o in Legg-Calvé-Perthesovi bolezni.
Omnitrope 5 mg/1.5 ml solution for injection Omnitrope 10 mg/1.5 ml solution for injection 
Omnitrope 5 mg/1,5 ml raztopina za injiciranje Omnitrope 10 mg/1,5 ml raztopina za injiciranje
- Omnitrope is given as an injection under the skin. 
Zdravilo Omnitrope se injicira pod kožo.
Fatty tissue of the skin can shrink at the site of injection. 
Na mestu injiciranja se lahko maščobno tkivo skrči.
Powder: glycine, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate Solvent: water for injections 
Prašek: glicin, natrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat dihidrat Vehikel: voda za injekcije
1 cartridge for SurePal 15 5 cartridges for SurePal 15 10 cartridges for SurePal 15 
raztopina za injiciranje 1 vložek za injekcijski peresnik SurePal 15 5 vložkov za injekcijski peresnik SurePal 15 10 vložkov za injekcijski peresnik SurePal 15
- Push the needle through the rubber stopper of the vial with the reconstituted solution. 
- Iglo potisnite skozi gumijast zamašek v viali s pripravljeno raztopino.
Somatropin 5 mg (15 IU)/ml in a vial. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Somatropin 5 mg (15 i.e.)/ml v viali.
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 drugem preskušanju o somatropinu pa na limfocitih bolnikov, ki so se z njim zdravili dolgo časa, niso ugotovili zvečanja kromosomskih nepravilnosti.
Myalgia* Musculoskel etal stiffness* 
mialgija* mišišno-skeletna okorelost*
- Take the needle off the pen using the outer needle cap, and discard the needle. 
- Iglo odstranite z injekcijskega peresnika z uporabo zunanje zaporke igle in jo zavrzite.
Omnitrope 5 mg/1.5 ml is intended for multiple use. 
Zdravilo Omnitrope 5 mg/1,5 ml je namenjeno za večkratno uporabo.
Clinical trials in children with SGA 
Klinična preskušanja pri otrocih z MGS
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.).
With a cleansing swab, disinfect the rubber membranes of both the powder-filled and the solvent-filled vial. 
Z blazinico iz vate razkužite gumijasto membrano viale, napolnjene s praškom, in viale, napolnjene z vehiklom.
Powder: glycine disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate 
Prašek: glicin natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihirat
Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include: 
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) vključujejo:
0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day. 
0,045-0,050 mg/kg telesne mase na dan ali 1,4 mg/m telesne površine na dan.
Omnitrope 15 mg/1.5 ml solution for injection disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate sodium chloride poloxamer 188 phenol water for injections 
Omnitrope 15 mg/1,5 ml raztopina za injiciranje natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat natrijev klorid poloksamer 188 fenol voda za injekcije
1 cartridge for SurePal 10 5 cartridges for SurePal 10 10 cartridges for SurePal 10 
raztopina za injiciranje 1 vložek za injekcijski peresnik SurePal 10 5 vložkov za injekcijski peresnik SurePal 10 10 vložkov za injekcijski peresnik SurePal 10
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL LABEL 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Omnitrope 5 mg/1.5 ml solution for injection disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate mannitol poloxamer 188 benzyl alcohol water for injections 
Omnitrope 5 mg/1,5 ml raztopina za injiciranje natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat manitol poloksamer 188 benzilalkohol voda za injekcije
Omnitrope 15 mg/1.5 ml solution for injection Each ml of solution contains 10 mg of somatropin* (corresponding to 30 IU) One cartridge contains 1.5 ml corresponding to 15 mg somatropin* (45 IU). 
Omnitrope 15 mg/1,5 ml raztopina za injiciranje En mililiter raztopine vsebuje 10 mg somatropina* (ustreza 30 i.e.).
A subcutaneous dose of 5 mg of Omnitrope 15 mg/1.5 ml solution for injection in healthy adults results in plasma Cmax and tmax values of 52 ± 19 µg/l and 3.7 ± 1.2 hours, respectively. 
Po subkutani uporabi 5 mg zdravila Omnitrope 15 mg/1,5 ml raztopina za injiciranje pri zdravih odraslih je Cmax 52 ± 19 µg/l, tmax pa 3,7 ± 1,2 ure.
Omnitrope 10 mg/1.5 ml solution for injection disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol water for injections 
Omnitrope 10 mg/1,5 ml raztopina za injiciranje natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat glicin poloksamer 188 fenol voda za injekcije
Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, mannitol, poloxamer 188, benzyl alcohol, water for injections. 
Pomožne snovi: natrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat dihidrat, manitol, poloksamer 188, benzilalkohol, voda za injekcije.
Treatment should be discontinued if there is evidence of tumour growth. 
Če obstajajo znaki rasti tumorja, je treba zdravljenje prekiniti.
Omnitrope 5 mg/1.5 ml solution for injection Each ml of solution contains 3.3 mg of somatropin* (corresponding to 10 IU) One cartridge contains 1.5 ml corresponding to 5 mg somatropin* (15 IU). 
Omnitrope 5 mg/1,5 ml raztopina za injiciranje En mililiter raztopine vsebuje 3,3 mg somatropina* (ustreza 10 i.e.).
A subcutaneous dose of 5 mg of Omnitrope 10 mg/1.5 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 10 mg/1,5 ml raztopina za injiciranje pri zdravih odraslih je Cmax 74 ± 22 µg/l, tmax pa 3,9 ± 1,2 ure.
NAME OF THE MEDICINAL PRODUCT Omnitrope 5 mg/ml powder and solvent for solution for injection Somatropin 
IME ZDRAVILA Omnitrope 5 mg/ml prašek in vehikel za raztopino za injiciranje
• After the first injection, the cartridge should remain in the pen injector and has to be stored in a refrigerator (2°C-8°C) and only used for a maximum of 28 days. 
• Po prvem injiciranju mora vložek ostati v peresniku za injiciranje, ki ga je treba hraniti v hladilniku pri temperaturi 2 °C-8 °C, uporabiti pa ga je treba v največ 28 dneh.
Omnitrope 10 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge. 
Omnitrope 10 mg/1,5 ml raztopina za injiciranje je sterilna pripravljena raztopina za subkutano injiciranje v steklenem vložku.
Omnitrope 10 mg/1.5 ml in a cartridge for SurePal 10 is intended for multiple use. 
Zdravilo Omnitrope 10 mg/1,5 ml v vložku za injekcijski peresnik SurePal 10 je namenjeno za večkratno uporabo.
Omnitrope 5 mg/1.5 ml solution for injection: 
Omnitrope 5 mg/1,5 ml raztopina za injiciranje:
- The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate mannitol poloxamer 188 benzyl alcohol water for injections 
- Druge sestavine zdravila so: natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat manitol poloksamer 188 benzilalkohol voda za injekcije
Paraesthesia* Carpal Tunnel Syndrome 
Bolezni živčevja parestezija* sindrom karpalnega kanala benigna intrakranialna hipertenzija
A subcutaneous dose of 5 mg of Omnitrope 5 mg/1.5 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 5 mg/1,5 ml raztopina za injiciranje pri zdravih odraslih je Cmax 72 ± 28 µg/l, tmax pa 4,0 ± 2,0 ure.
Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, poloxamer 188, phenol, water for injections. 
Pomožne snovi: natrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat dihidrat, natrijev klorid, poloksamer 188, fenol, voda za injekcije.
Clinical trials in children with GHD 
Klinična preskušanja pri otrocih s PRH
NAME OF THE MEDICINAL PRODUCT Omnitrope 1.3 mg/ml powder and solvent for solution for injection Somatropin 
IME ZDRAVILA Omnitrope 1,3 mg/ml prašek in vehikel za raztopino za injiciranje
Tabulated list of adverse reactions 
Neželene reakcije v obliki preglednice
Somatropin 1.3 mg (4 IU)/ml in a vial. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1,3 mg somatropina (4 i.e.)/ml v viali.
Disinfect the rubber membrane of the cartridge with a cleansing swab Insert the cartridge into the Omnitrope Pen following the instructions for use provided with the pen. 
Vložek vstavite v injekcijski peresnik Omnitrope Pen po priloženih navodilih za uporabo.
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.
Injecting Omnitrope - With a cleansing swab, disinfect the rubber membrane of the cartridge. 
Injiciranje zdravila Omnitrope - Gumijasto membrano vložka razkužite z blazinico za čiščenje.
- The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate sodium chloride poloxamer 188 phenol water for injections 
- Druge sestavine zdravila so: natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat natrijev klorid poloksamer 188 fenol voda za injekcije
- The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol water for injections 
- Druge sestavine zdravila so: natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat glicin poloksamer 188 fenol voda za injekcije
Omnitrope 15 mg/1.5 ml in a cartridge for SurePal 15 is intended for multiple use. 
Zdravilo Omnitrope 15 mg/1,5 ml v vložku za injekcijski peresnik SurePal 15 je namenjeno za večkratno uporabo.
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. 
5 mg/ml prašek za raztopino za injiciranje, pri polnjenju vložka, pritrditvi injekcijske igle in pri uporabi.
Omnitrope 15 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge. 
Omnitrope 15 mg/1,5 ml raztopina za injiciranje je sterilna pripravljena raztopina za subkutano injiciranje v steklenem vložku.
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.).
Omnitrope 5 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge. 
Omnitrope 5 mg/1,5 ml raztopina za injiciranje je sterilna pripravljena raztopina za subkutano injiciranje v steklenem vložku.
One cartridge contains 1.5 ml corresponding to 15 mg somatropin (45 IU). 
En vložek vsebuje 1,5 ml, kar ustreza 15 mg somatropina (45 i.e.).
What Omnitrope 10 mg/1.5 ml contains 
Omnitrope 10 mg/1,5 ml
Omnitrope 5 mg/1.5 ml in a cartridge for SurePal 5 is intended for multiple use. 
Zdravilo Omnitrope 5 mg/1,5 ml v vložku za injekcijski peresnik SurePal 5 je namenjeno za večkratno uporabo.
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 z Omnitrope Pen L, pripravi za injiciranje, narejeni posebej za uporabo pripravljene raztopine za injiciranje Omnitrope 5 mg/ml.
It should only be administered with the Omnitrope Pen L, an injection device specifically developed for use with Omnitrope 5 mg/ml powder and solvent for solution for injection. 
Dajati se sme samo z napravo za injiciranje zdravila Omnitrope Pen 5, narejeno posebej za uporabo z zdravilom Omnitrope 5 mg/ml prašek in vehikel za injiciranje.
Omnitrope 10 mg/1.5 ml solution for injection EU/1/06/332/007 
Omnitrope 10 mg/1,5 ml raztopina za injiciranje EU/1/06/332/007
Whereas the peripheral thyroid hormone levels have remained within the reference ranges for healthy subjects, hypothyroidism theoretically may develop in subjects with subclinical hypothyroidism. 
Pri tem so vrednosti perifernega hormona ščitnice ostale v priporočenih mejah za zdrave ljudi.
What Omnitrope 15 mg/1.5 ml contains 
Omnitrope 15 mg/1,5 ml
Use only clear solution. 
Uporabljajte samo bistro raztopino.
The content must be clear and colourless after reconstitution. 
Po pripravi mora biti vsebina bistra in brezbarvna.
In patients who continue growth hormone therapy after childhood GHD, the recommended dose to restart is 0.2 - 0.5 mg per day. 
Pomanjkanje rastnega hormona pri odraslih bolnikih Pri bolnikih, ki po PRH v otroštvu nadaljujejo zdravljenje z rastnim hormonom, je priporočeni odmerek za ponovno jemanje 0,2 - 0,5 mg na dan. Odmerek je treba postopoma večati ali manjšati v skladu z individualnimi potrebami bolnika, ki jih določa koncentracija IGF-I.
The reconstituted solution should be administered using sterile, disposable syringes. 
Pripravljeno raztopino je treba dajati s pomočjo sterilne injekcijske brizge za enkratno uporabo.
Talk to your doctor before using Omnitrope. 
Pred začetkom uporabe zdravila Omnitrope se posvetujte z zdravnikom.
NAME OF THE MEDICINAL PRODUCT Omnitrope 10 mg/1.5 ml solution for injection Somatropin 
Omnitrope 10 mg/1,5 ml raztopina za injiciranje somatropin
Omnitrope 10 mg/1.5 ml solution for injection is for use in SurePal 10 only. 
Zdravilo Omnitrope 10 mg/1,5 raztopina za injiciranje se uporablja samo z napolnjenim injekcijskim peresnikom SurePal 10.
MARKETING AUTHORISATION NUMBERS EU/1/06/332/016 
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/06/332/016
Omnitrope 10 mg/1.5 ml solution for injection EU/1/06/332/016 
Omnitrope 10 mg/1,5 ml raztopina za injiciranje EU/1/06/332/016
• Joint pain 
• bolečine mišic
What Omnitrope 5 mg/1.5 ml contains 
Omnitrope 5 mg/1,5 ml
MARKETING AUTHORISATION NUMBERS EU/1/06/332/013 
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/06/332/013
It has to be administered using sterile, disposable pen needles. 
Uporablja naj se s sterilnimi iglami za enkratno uporabo, ki so namenjene za injekcijske peresnike.
Omnitrope 5 mg/1.5 ml solution for injection EU/1/06/332/004 
Omnitrope 5 mg/1,5 ml raztopina za injiciranje EU/1/06/332/004
Omnitrope 10 mg/1.5 ml solution for injection 
Omnitrope 10 mg/1,5 ml raztopina za injiciranje
How to store Omnitrope 
Shranjevanje zdravila Omnitrope
MARKETING AUTHORISATION NUMBERS EU/1/06/332/010 
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/06/332/010
NAME OF THE MEDICINAL PRODUCT Omnitrope 15 mg/1.5 ml solution for injection Somatropin 
Omnitrope 15 mg/1,5 ml raztopina za injiciranje somatropin
It should only be administered with the Omnitrope Pen 5, an injection device specifically developed for use with Omnitrope 5 mg/1.5 ml solution for injection. 
Uporablja se lahko samo z Omnitrope Pen 5, pripomočku za injiciranje, narejeni posebej za uporabo raztopine za injiciranje Omnitrope 5 mg/1,5 ml.
Omnitrope 5 mg/1.5 ml solution for injection is for use in SurePal 5 only. 
Zdravilo Omnitrope 5 mg/1,5 raztopina za injiciranje se uporablja samo z napolnjenim injekcijskim peresnikom SurePal 5.
Omnitrope 15 mg/1.5 ml solution for injection EU/1/06/332/010 
Omnitrope 15 mg/1,5 ml raztopina za injiciranje EU/1/06/332/010
MARKETING AUTHORISATION NUMBERS EU/1/06/332/007 
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/06/332/007
It should only be administered with SurePal 10, an injection device specifically developed for use with Omnitrope 10 mg/1.5 ml solution for injection. 
Dajati se sme samo s peresnikom SurePal 10, pripomočkom za injiciranje, narejenim posebej za uporabo z zdravilom Omnitrope 10 mg/1,5 ml raztopina za injiciranje.
Omnitrope 15 mg/1.5 ml solution for injection is for use in SurePal 15 only. 
Zdravilo Omnitrope 15 mg/1,5 raztopina za injiciranje se uporablja samo z napolnjenim injekcijskim peresnikom SurePal 15.
It should only be administered with SurePal 15, an injection device specifically developed for use with Omnitrope 15 mg/1.5 ml solution for injection. 
Dajati se sme samo s peresnikom SurePal 15, pripomočkom za injiciranje, narejenim posebej za uporabo z zdravilom Omnitrope 15 mg/1,5 ml raztopina za injiciranje.
Omnitrope 5 mg/1.5 ml solution for injection EU/1/06/332/013 
Omnitrope 5 mg/1,5 ml raztopina za injiciranje EU/1/06/332/013
It should only be administered with the Omnitrope Pen 10, an injection device specifically developed for use with Omnitrope 10 mg/1.5 ml solution for injection. 
Uporablja se lahko samo z Omnitrope Pen 10, pripomočku za injiciranje, narejeni posebej za uporabo raztopine za injiciranje Omnitrope 10 mg/1,5 ml.
NAME OF THE MEDICINAL PRODUCT Omnitrope 5 mg/1.5 ml solution for injection Somatropin 
Omnitrope 5 mg/1,5 ml raztopina za injiciranje somatropin
MARKETING AUTHORISATION NUMBER EU/1/06/332/001 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/06/332/001
Collect necessary items before you begin: - a vial with Omnitrope 5 mg/ml powder for solution for injection. 
Preden začnete, si pripravite vse potrebno: - vialo s praškom za raztopino za injiciranje zdravila Omnitrope
SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2°C - 8°C). 
Zdravilo shranjujte in prevažajte na hladnem (2 C - 8 C).
MARKETING AUTHORISATION NUMBERS EU/1/06/332/004 
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/06/332/004
MARKETING AUTHORISATION NUMBERS EU/1/06/332/002 
ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/06/332/002
It should only be administered with SurePal 5, an injection device specifically developed for use with Omnitrope 5 mg/1.5 ml solution for injection. 
Dajati se sme samo s peresnikom SurePal 5, pripomočkom za injiciranje, narejenem posebej za uporabo z zdravilom Omnitrope 5 mg/1,5 ml raztopina za injiciranje.
Musculoskeletal , Connective Tissue and Bone Disorders 
Bolezni mišičnoskeletnega sistema in vezivnega tkiva artralgija*
Omnitrope 5 mg/1.5 ml solution for injection 
Omnitrope 5 mg/1,5 ml raztopina za injiciranje
The dose should be gradually increased or decreased according to individual patient requirements as determined by the IGF-I concentration. 
Pri bolnikih z začetkom PRH v odrasli dobi je treba zdravljenje začeti z majhnim odmerkom - 0,15 do 0,3 mg na dan. Nato se ga postopno, v skladu z bolnikovimi individualnimi potrebami, ki jih določa koncentracija IGF-I, povečuje.
Dose recommendations in paediatric patients Indication mg/kg body weight dose per day mg/m² body surface area dose per day 
Indikacija mg/kg telesne mase dnevni odmerek mg/m telesne površine dnevni odmerek pomanjkanje rastnega hormona Prader-Willijev sindrom Turnerjev sindrom kronična ledvična insuficienca otroci/mladostniki, ki so se za svojo gestacijsko starost rodili majhni (MGS)
Common side effects (likely to occur in fewer than 1 in 10 patients) include: 
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) vključujejo:
Always inject Omnitrope exactly as your doctor has told you. 
Pri injiciranju zdravila Omnitrope natančno upoštevajte zdravnikova navodila.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON LABEL 
OZNAKA NA ZUNANJI OVOJNINI
Disinfect the rubber membrane of the cartridge with a cleansing swab Insert the cartridge into SurePal following the instructions for use provided with the pen. 
Vložek vstavite v injekcijski peresnik SurePal po priloženih navodilih za uporabo.
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 5 mg/ml powder for solution for injection Somatropin 
Omnitrope 5 mg/ml prašek in vehikel za raztopino za injiciranje somatropin
• The Committee considered the referral under Article 29(4) of Directive 2001/83/EC, 
• odbor je obravnaval napotitev v skladu s členom 29(4) Direktive 2001/83/ES,
Particularly the endpoint of main interest which is pain. 
Končna točka v središču zanimanja je bolečina.
The product information remains as per the final version achieved during the Coordination group procedure as mentioned in Annex III of the CHMP opinion. 
Informacije o zdravilu ostajajo take, kot so v končni različici, doseženi v postopku skupine za usklajevanje, kakor je navedeno v Prilogi III k mnenju odbora CHMP.
The study was designed and powered to demonstrate superiority with a significant level of 5% one-sided, but the current requirement is now that a significance level of 2.5% one-sided, which the study could not reach. 
Študija je bila zasnovana in oblikovana za prikaz superiornosti s stopnjo značilnosti 5 % enostransko, vendar se trenutno zahteva stopnja značilnosti 2,5 % enostransko, česar pa v študiji ni bilo mogoče doseči.
An effect was seen on the critical secondary endpoint of spontaneous pain visual analogue scale (VAS). 
Učinek je bil opažen na kritični sekundarni končni točki spontane bolečine glede na vizualno analogno lestvico (VAS).
However, this study cannot be considered to provide confirmatory evidence on efficacy of Spraygel as the primary endpoint is not validated and statistical analysis does not meet regulatory requirements. 
Vendar pa ta študija ne more z gotovostjo potrditi učinkovitosti gela v pršilu, saj primarna končna točka ni potrjena, statistična analiza pa ne izpolnjuje regulativnih zahtev.
Numerically, the exposure of Spraygel is lower than Emulgel and its impact on efficacy cannot be ascertained accurately. 
Izpostavljenost gela v pršilu je številčno nižja kot pri emulgelu, njenega vpliva na učinkovitost pa ni mogoče natančno ugotoviti.
MIKA Pharma GmbH requested that the marketing authorisation for Diclofenac Sodium Spray Gel 4% granted by the UK in 2001, and subsequently granted by Austria, Estonia, Hungary, Ireland, Latvia, Lithuania and Slovenia, be also recognised in Germany, Italy and Spain as part of a “second wave” Mutual recognition procedure (MRP). 
Podjetje MIKA Pharma GmbH je zahtevalo, da se dovoljenje za promet z zdravilom Diclofenac Sodium Spray Gel 4 %, ki ga je leta 2001 izdalo Združeno kraljestvo, pozneje pa tudi Avstrija, Estonija, Madžarska, Irska, Latvija, Litva in Slovenija, prizna tudi v Nemčiji, Italiji in Španiji kot del „drugega vala“ postopka z medsebojnim priznavanjem (MRP).
Clinical Pharmacology 
Klinična farmakologija
The applicant included a review of the Predel 2013 study [previously pre-publication known as Study 9702SUV] on the efficacy of Spraygel in acute ankle injury. 
Predlagatelj je vključil pregled študije Predel 2013 (prej predhodna objava, imenovana Študija 9702SUV) o učinkovitosti gela v pršilu pri akutni poškodbi gležnja.