natgillin/translations-raw huggingface dataset:
Powder in a vial (type I glass) with a stopper (fluor-resin laminated butyl rubber), a strip (aluminium) and a cap (green polypropylene flip-off), and 1 ml of solvent in a cartridge (type I glass) with a stopper (fluor-resin laminated chlorobutyl elastomer), a strip (lacquered aluminium) and a cap (white polypropylene flip-off).
Prašek v viali (steklo tipa I) z zamaškom (butilkavčuk, laminiran s fluorovo smolo), trak (aluminij) in zaporko (zelena odtržna zaporka iz polipropilena) in 1 ml vehikla v vložku (steklo tipa I) z zamaškom (klorobutilelastomer, laminiran s fluorovo smolo), trakom (lakirani aluminij) ter zaporko (bela odtržna zaporka iz polipropilena).
Growth disturbance due to insufficient secretion of growth hormone in paediatric patients Generally a dose of 0.025 - 0.035 mg/kg body weight per day or 0.7 - 1.0 mg/m2 body surface area per day is recommended.
Motnje rasti zaradi nezadostnega izločanja rastnega hormona pri pediatričnih bolnikih Običajen priporočen odmerek je 0,025 do 0,035 mg/kg telesne mase na dan ali 0,7 do 1,0 mg/m telesne površine na dan.
The solvent is clear and colourless.
Raztopina je bistra in brezbarvna.
- The contents must be clear and colourless.
- Vsebina mora biti bistra in brezbarvna.
- Insert the cartridge into the pen for injection.
- Vložek vstavite v peresnik za injiciranje.
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 zdravilo Omnitrope subkutano.
Push the needle fitted to the syringe through the rubber membrane.
Iglo na injekcijski brizgi potisnite skozi gumijasto membrano.
Powder in a vial (type I glass) with a stopper (fluor-resin laminated butyl rubber), a strip (aluminium) and a cap (violet polypropylene flip-off), and 1 ml of solvent in a vial (type I glass) with a stopper (fluor-resin laminated chlorobutyl elastomer), a strip (lacquered aluminium) and a cap (white polypropylene flip-off).
Prašek v viali (steklo tipa I) z zamaškom (butilkavčuk, laminiran s fluorovo smolo), trakom (aluminij) in zaporko (vijoličasta odtržna zaporka iz polipropilena) in 1 ml vehikla v viali (steklo tipa I) z zamaškom (klorobutilelastomer, laminiran s fluorovo smolo), trakom (lakirani aluminij) ter zaporko (bela odtržna zaporka iz polipropilena).
Injecting Omnitrope
Injiciranje zdravila Omnitrope
For patients with diabetes mellitus, the insulin dose may require adjustment after somatropin therapy is instituted.
Pri bolnikih s sladkorno boleznijo bo morda treba po začetku zdravljenja s somatropinom prilagoditi odmerek insulina.
Clinical trials in adults with GHD
Klinična preskušanja pri odraslih s PRH
Rare side effects (likely to occur in fewer than 1 in 1,000 patients) include: In children
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) vključujejo: Pri otrocih
Children with Turner syndrome: 0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day.
Otroci s Turnerjevim sindromom: 0,045-0,050 mg/kg telesne mase na dan ali 1,4 mg/m telesne površine na dan.
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 vehikel.
Store in the original pen in order to protect from light.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
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 reakcije blage do zmerne, pojavijo se v prvih mesecih zdravljenja, izginejo pa sami od sebe ali po zmanjšanju odmerka.
The content must be clear and colourless.
Vsebina mora biti bistra in brezbarvna.
Omnitrope 10 mg/1.5 ml solution for injection 18 months.
Omnitrope 10 mg/1,5 ml raztopina za injiciranje 18 mesecev.
How to inject Omnitrope 1.3 mg/ml
Kako si je treba injicirati zdravilo Omnitrope 1,3 mg/ml
Omnitrope 15 mg/1.5 ml solution for injection 18 months.
Omnitrope 15 mg/1,5 ml raztopina za injiciranje 18 mesecev.
Growth disturbance in chronic renal insufficiency A dose of 0.045 - 0.050 mg/kg body weight per day (1.4 mg/m2 body surface area per day) is recommended.
Motnje rasti pri kronični ledvični insuficienci Priporočen odmerek je 0,045 do 0,05 mg/kg telesne mase na dan (1,4 mg/m telesne površine na dan).
Treatment should not be used in children who have almost stopped growing after puberty.
Otroci po puberteti, ki so skoraj nehali rasti, naj se ne zdravijo s tem zdravilom.
- Eliminate any air bubbles.
- Odstranite zračne mehurčke.
• Store and transport refrigerated (2°C-8°C).
• Zdravilo shranjujte in prevažajte na hladnem (2 °C-8 °C).
Eliminate air bubbles if necessary.
Odstranite morebitne zračne mehurčke.
Each ml of solution contains 10 mg of somatropin (corresponding to 30 IU).
En mililiter raztopine vsebuje 10 mg somatropina (kar ustreza 30 i.e.).
How to inject Omnitrope 5 mg/ml
Kako si je treba injicirati zdravilo Omnitrope, 5 mg/ml
- The solution should be clear after removal from the refrigerator.
- Po hranjenju raztopine v hladilniku mora biti ta bistra.
Children with chronic renal (kidney) insufficiency
Otroci s kronično renalno (ledvično) odpovedjo
Bring the syringe to the correct dose needed.
Preverite, da bo v injekcijski brizgi tolikšen odmerek, kot ga potrebujete.
Cases of leukaemia (rare or very rare) have been reported in growth hormone deficient children treated with somatropin and included in the post-marketing experience.
Pri otrocih s pomanjkanjem rastnega hormona, zdravljenih s somatropinom in vključenih v izkušnje v obdobju trženja, so poročali o primerih levkemije (redkih ali zelo redkih).
Transfer the solution back into the cartridge using the transfer set.
- Za prenos raztopine nazaj v vložek uporabite set za prenos.
Each ml of solution contains 3.3 mg of somatropin (corresponding to 10 IU) One cartridge contains 5.0 mg (corresponding to 15 IU) of somatropin in 1.5 ml.
En mililiter raztopine vsebuje 3,3 mg somatropina (ustreza 10 i.e.) En vložek vsebuje 5,0 mg (ustreza 15 i.e.) somatropina v 1,5 ml.
Omnitrope 5 mg/1.5 ml solution for injection 2 years.
Omnitrope 5 mg/1,5 ml raztopina za injiciranje 2 leti.
STATEMENT OF ACTIVE SUBSTANCE Somatropin 10 mg (30 IU)/ml.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 10 mg somatropina (30 i.e.)/ml.
STATEMENT OF ACTIVE SUBSTANCE Somatropin 3.3 mg (10 IU)/ml.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 3,3 mg somatropina (10 i.e.)/ml.
Therefore caution should be exercised when Omnitrope is administered to breast-feeding women.
Zato je pri doječih materah, ki prejemajo zdravilo Omnitrope, potrebna previdnost.
Omnitrope 5 mg/1.5 ml solution for injection Omnitrope 10 mg/1.5 ml solution for injection Omnitrope 15 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 15 mg/1,5 ml raztopina za injiciranje
Uncommo n ≥ 1/1,000 to < 1/100
Organski sistem zelo pogosti pogosti ≥ 1/100 do občasni do < 1/100
Blood cortisol decreased‡
Preiskave znižanje kortizola v krvi‡
How to inject Omnitrope
Kako si je treba injicirati zdravilo Omnitrope
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.
Use only with SurePal 15.
Uporabljajte samo z injekcijskim peresnikom SurePal 15.
Always use this medicine exactly as your doctor or pharmacist or nurse has told you.
Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika, farmacevta ali medicinske sestre.
The treatment should be discontinued at renal transplantation.
Po presaditvi ledvic je treba zdravljenje prekiniti.
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.
• During treatment with somatropin, tell your doctor if you show signs of upper airway obstruction (including starting to snore or worsening of snoring), your doctor will need to examine you and may interrupt treatment with somatropin.
• Povejte svojemu zdravniku, če imate med zdravljenjem s somatropinom znake zapore zgornjih dihalnih poti (vključno s tem, da ste začeli smrčati ali smrčite močneje).
Administer the appropriate dose by subcutaneous injection using a sterile pen needle.
Odmerek injicirajte subkutano s sterilno iglo peresnika.
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).
Growth disturbance in short children/adolescents born small for gestational age (SGA) A dose of 0.035 mg/kg body weight per day (1 mg/m2 body surface area per day) is usually recommended until final height is reached (see section 5.1).
Običajen priporočen odmerek je 0,035 mg/kg telesne mase na dan (1 mg/m telesne površine na dan), dokler se ne doseže končne višine (glejte poglavje 5.1).
Powder: glycine, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate Solvent: benzyl alcohol, water for injections
Prašek: glicin, natrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat dihidrat Vehikel: benzilalkohol, voda za injekcije
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 peresniku in shranjen v hladilniku (2 °C - 8 °C) največ 21 dni.
One cartridge contains 15 mg (corresponding to 45 IU) of somatropin in 1.5 ml.
En vložek vsebuje 15 mg (ustreza 45 i.e.) somatropina v 1,5 ml.
Collect necessary items before you begin: - a cartridge with Omnitrope solution for injection.
Preden začnete, si pripravite vse potrebno: - vložek z raztopino za injiciranje zdravila Omnitrope.
Arthralgia* Myalgia* Musculoskeletal stiffness*
mialgija* mišišnoskeletna okorelost*
What Omnitrope contains
Kaj vsebuje zdravilo Omnitrope
Omnitrope 10 mg/1.5 ml solution for injection Each ml of solution contains 6.7 mg of somatropin* (corresponding to 20 IU) One cartridge contains 1.5 ml corresponding to 10 mg somatropin* (30 IU).
Omnitrope 10 mg/1,5 ml raztopina za injiciranje En mililiter raztopine vsebuje 6,7 mg somatropina* (ustreza 20 i.e.).
Clean the site of injection with an alcohol swab.
Mesto injiciranja očistite z blazinico iz vate, namočeno v alkohol.
It may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Pri otrocih, starih do 3 let, lahko povzroči toksične in anafilaktoidne reakcije.
Ask for advice from your doctor before you stop using Omnitrope.
Preden prenehate uporabljati zdravilo Omnitrope, prosite zdravnika za nasvet.
Use only with SurePal 10.
Uporabljajte samo z injekcijskim peresnikom SurePal 10.
Omnitrope 10 mg/1.5 ml is intended for multiple use.
Zdravilo Omnitrope 10 mg/1,5 ml je namenjeno za večkratno uporabo.
Rare side effects (likely to occur in fewer than 1 in 1,000 patients) include:
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) vključujejo:
Very common side effects (likely to occur in more than 1 in 10 patients) include:
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) vključujejo:
- With one hand, pitch a fold of loose skin.
- Z eno roko stisnite kožo v gubo.
0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day.
0,035 mg/kg telesne mase na dan ali 1,0 mg/m2 telesne površine na dan.
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.