FrancophonIA/ELRC3.0 huggingface dataset:
English: Omnitrope 10 mg/1.5 ml is intended for multiple use.
Danish: Omnitrope 10 mg/1,5 ml er beregnet til flergangsbrug.
English: Rare side effects (likely to occur in fewer than 1 in 1,000 patients) include:
Danish: Sjældne bivirkninger (sandsynlige hos færre end 1 ud af 1.000 patienter) omfatter:
English: Chronic renal insufficiency Children/adolescents born small for gestational age (SGA)
Danish: Prader-Willis syndrom Turners syndrom Kronisk nedsat nyrefunktion Børn/unge født små i forhold til deres gestationsalder (SGA)
English: Omnitrope 5 mg/ml powder and solvent for solution for injection
Danish: Omnitrope 5 mg/ml pulver og solvens til injektionsvæske, opløsning
English: With a cleansing swab, disinfect both the rubber membrane of the vial with powder and the rubber membrane of the cartridge with solvent.
Danish: Desinficer gummimembranen på hætteglasset indeholdende det hvide pulver og gummimembranen på patronen med solvens med en desinficerende serviet.
English: Injecting Omnitrope - With a cleansing swab, disinfect the rubber membrane of the cartridge.
Danish: Injektion af Omnitrope - Desinficer cylinderampullens gummimembran med en renseserviet.
English: Omnitrope 5 mg/ml is intended for multiple use.
Danish: Omnitrope 5 mg/ml er beregnet til flergangsbrug.
English: • Leukaemia (This has been reported in a small number of growth hormone deficiency patients,
Danish: • Leukæmi (rapporteret hos et lille antal patienter med væksthormonmangel, hvoraf nogle er blevet behandlet med somatropin.
English: One cartridge contains 15 mg (corresponding to 45 IU) of somatropin in 1.5 ml.
Danish: En cylinderampul indeholder 15 mg (svarende til 45 IE) somatropin i 1,5 ml.
English: - Gently swirl the reconstituted vial until the content is completely dissolved.
Danish: Roter forsigtigt blandingen, til der fremkommer en fuldstændig klar opløsning.
English: - Pull back on the plunger slowly and withdraw just a bit more than the dose prescribed by your doctor into the syringe.
Danish: Træk langsomt stemplet tilbage og udtræk en lille smule mere i injektionssprøjten, end foreskrevet af lægen Hold injektionssprøjten med nålen i hætteglasset med spidsen opad og fjern injektionssprøjten fra hætteglasset.
English: Clean the site of injection with an alcohol swab.
Danish: Rens injektionsstedet med en desinficerende serviet.
English: Long-term treatment of children with growth disturbance due to chronic renal insufficiency System Organ
Danish: Langvarig behandling af børn med vækstforstyrrelse pga. kronisk nedsat nyrefunktion Systemorgan klasse
English: - Transfer all of the dissolved solution back into the cartridge using the transfer set.
Danish: Overfør hele opløsningen til patronen ved brug af overførselssættet.
English: Omnitrope 5 mg/1.5 ml solution for injection is for use in SurePal 5 only.
Danish: Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning er kun til brug med SurePal 5.
English: Omnitrope 10 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge.
Danish: Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning er en steril, brugsklar opløsning til subkutan injektion i en cylinderampul af glas.
English: Omnitrope 5 mg/1.5 ml is intended for multiple use.
Danish: Omnitrope 5 mg/1,5 ml er beregnet til flergangsbrug.
English: Omnitrope 1.3 mg/ml powder and solvent for solution for injection
Danish: Omnitrope 1,3 mg/ml pulver og solvens til injektionsvæske, opløsning
English: After reconstitution, one vial contains 1.3 mg somatropin* (corresponding to 4 IU) per ml.
Danish: Efter rekonstitution indeholder et hætteglas 1,3 mg somatropin* (svarende til 4 IE) pr. ml.
English: 0.025-0.035 mg/kg body weight per day or 0.7-1.0 mg/m2 body surface area per day.
Danish: 0,025-0,035 mg/kg legemsvægt dagligt eller 0,7-1,0 mg/m2 legemsoverfladeareal dagligt.
English: 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).
Danish: Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning Hver ml opløsning indeholder 6,7 mg somatropin* (svarende til 20 IE).
English: After reconstitution, one vial contains 1.3 mg somatropin (corresponding to 4 IU) per ml.
Danish: Efter rekonstitution indeholder et hætteglas 1,3 mg somatropin (svarende til 4 IE) pr. ml.
English: 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
Danish: Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning Omnitrope 15 mg/1,5 ml injektionsvæske, opløsning
English: 0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day.
Danish: 0,035 mg/kg legemsvægt dagligt eller 1,0 mg/m2 legemsoverfladeareal dagligt.
English: - Push the needle through the rubber stopper of the vial with the reconstituted solution.
Danish: Skub nålen gennem gummiproppen på hætteglasset med den tilberedte opløsning.
English: and injection needle (e.g. 0.25 mm x 8 mm) for subcutaneous injection (not supplied in the pack).
Danish: Steril engangsinjektionssprøjte i passende størrelse (f.eks. 1 ml injektionssprøjte) og injektionsnål (f.eks. 0,25 mm x 8 mm) til subkutan injektion (medfølger ikke i pakken) 2 desinficerende servietter (medfølger ikke i pakken).
English: INFORMATION IN BRAILLE Omnitrope 5 mg/ml
Danish: INFORMATION I BRAILLESKRIFT Omnitrope 5 mg/ml
English: Chronic renal insufficiency
Danish: Kronisk nedsat nyrefunktion
English: 0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day.
Danish: 0,045-0,050 mg/kg legemsvægt dagligt eller 1,4 mg/m2 legemsoverfladeareal dagligt.
English: 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.
Danish: Sæt cylinderampullen i SurePal ifølge den medfølgende brugsanvisning.
English: After reconstitution, one cartridge contains 5 mg somatropin (corresponding to 15 IU) per ml.
Danish: Efter rekonstitution indeholder en cylinderampul 5 mg somatropin (svarende til 15 IE) pr. ml.
English: Omnitrope 15 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge.
Danish: Omnitrope 15 mg/1,5 ml injektionsvæske, opløsning er en steril, brugsklar opløsning til subkutan injektion i en cylinderampul af glas.
English: 1 cartridge for SurePal 15 5 cartridges for SurePal 15 10 cartridges for SurePal 15
Danish: 5 cylinderampuller for SurePal 15 10 cylinderampuller for SurePal 15
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 5 mg/1.5 ml Injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Omnitrope 5 mg/1,5 ml Injektionsvæske
English: Omnitrope 5 mg/1.5 ml solution for injection Omnitrope 10 mg/1.5 ml solution for injection
Danish: Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning
English: After reconstitution, one vial contains 5 mg somatropin* (corresponding to 15 IU) per ml.
Danish: Efter rekonstitution indeholder et hætteglas 5 mg somatropin* (svarende til 15 IE).pr.
English: Omnitrope 10 mg/1.5 ml in a cartridge for SurePal 10 is intended for multiple use.
Danish: Omnitrope 10 mg/1,5 ml i en cylinderampul til SurePal 10 er beregnet til flergangsbrug.
English: 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).
Danish: Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning Hver ml opløsning indeholder 3,3 mg somatropin* (svarende til 10 IE).
English: Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include:
Danish: Ikke almindelige bivirkninger (sandsynlige hos færre end 1 ud af 100 patienter) omfatter:
English: Omnitrope 15 mg/1.5 ml in a cartridge for SurePal 15 is intended for multiple use.
Danish: Omnitrope 15 mg/1,5 ml i en cylinderampul til SurePal 15 er beregnet til flergangsbrug.
English: Children with chronic renal (kidney) insufficiency:
Danish: Børn med kronisk nedsat nyrefunktion:
English: INFORMATION IN BRAILLE Omnitrope 1.3 mg/ml
Danish: INFORMATION I BRAILLESKRIFT Omnitrope 1,3 mg/ml
English: 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.
Danish: Det bør kun gives med Omnitrope Pen L, en injektionsanordning som er specifikt udviklet til brug sammen med Omnitrope 5 mg/ml pulver og injektionsvæske, opløsning.
English: Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, mannitol, poloxamer 188, benzyl alcohol, water for injections.
Danish: Andre indholdsstoffer: dinatriumhydrogenphosphatheptahydrat og natriumdihydrogenphosphatdihydrat, mannitol, poloxamer 188, benzylalkohol, vand til injektionsvæsker.
English: 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.
Danish: En subkutan dosis på 5 mg Omnitrope 15 mg/1,5 ml injektionsvæske, opløsning, til raske voksne resulterer i Cmax- og tmax-værdier i plasma på henholdsvis 52 ± 19 µg/l og 3,7 ± 1,2 timer.
English: Common side effects (likely to occur in fewer than 1 in 10 patients) include:
Danish: Almindelige bivirkninger (sandsynlige hos færre end 1 ud af 10 patienter) omfatter:
English: 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
Danish: Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning dinatriumhydrogenphosphatheptahydrat natriumdihydrogenphosphatdihydrat mannitol poloxamer 188 benzylalkohol vand til injektionsvæsker
English: 1 cartridge for SurePal 10 5 cartridges for SurePal 10 10 cartridges for SurePal 10
Danish: 5 cylinderampuller for SurePal 10 10 cylinderampuller for SurePal 10
English: One cartridge contains 1.5 ml corresponding to 10 mg somatropin (30 IU).
Danish: En cylinderampul indeholder 1,5 ml svarende til 10 mg somatropin (30 IE).
English: Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, glycine, poloxamer 188, phenol, water for injections.
Danish: Andre indholdsstoffer: dinatriumhydrogenphosphatheptahydrat og natriumdihydrogenphosphatdihydrat, glycin, poloxamer 188, phenol, vand til injektionsvæsker.
English: 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.
Danish: En subkutan dosis på 5 mg Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning, til raske voksne resulterer i Cmax- og tmax-værdier i plasma på henholdsvis 72 ± 28 µg/l og 4,0 ± 2,0 timer.
English: What Omnitrope is and what it is used for What you need to know before you use Omnitrope How to use Omnitrope
Danish: Det skal du vide, før du begynder at bruge Omnitrope Sådan skal du bruge Omnitrope Bivirkninger
English: 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.
Danish: En subkutan dosis på 5 mg Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning, til raske voksne resulterer i Cmax- og tmax-værdier i plasma på henholdsvis 74 ± 22 µg/l og 3,9 ± 1,2 timer.
English: 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
Danish: Omnitrope 15 mg/1,5 ml injektionsvæske, opløsning dinatriumhydrogenphosphatheptahydrat natriumdihydrogenphosphatdihydrat natriumchlorid poloxamer 188 phenol vand til injektionsvæsker
English: Omnitrope 10 mg/1.5 ml solution for injection disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol water for injections
Danish: Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning dinatriumhydrogenphosphatheptahydrat natriumdihydrogenphosphatdihydrat glycin poloxamer 188 phenol vand til injektionsvæsker
English: 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).
Danish: Omnitrope 15 mg/1,5 ml injektionsvæske, opløsning Hver ml opløsning indeholder 10 mg somatropin* (svarende til 30 IE).
English: How to use Omnitrope
Danish: Sådan skal du bruge Omnitrope
English: Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, poloxamer 188, phenol, water for injections.
Danish: Andre indholdsstoffer: dinatriumhydrogenphosphatheptahydrat og natriumdihydrogenphosphatdihydrat, natriumchlorid, poloxamer 188, phenol, vand til injektionsvæsker.
English: The active substance of Omnitrope is somatropin.
Danish: Aktivt stof: somatropin
English: Omnitrope 5 mg/1.5 ml in a cartridge for SurePal 5 is intended for multiple use.
Danish: Omnitrope 5 mg/1,5 ml i en cylinderampul til SurePal 5 er beregnet til flergangsbrug.
English: Musculoskeletal, Connective Tissue and Bone Disorders
Danish: Knogler, led, muskler og bindevæv
English: - a transfer set for mixing and transferring the reconstituted solution back into the cartridge (see Instructions for Use of the pen injector).
Danish: En patron med solvens til Omnitrope 5 mg/ml Et overførselssæt til blanding og overførsel af den tilberedte opløsning til patronen (se instruktion for brug af Pen injektor).
English: - The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate mannitol poloxamer 188 benzyl alcohol water for injections
Danish: - Øvrige indholdsstoffer: dinatriumhydrogenphosphatheptahydrat natriumdihydrogenphosphatdihydrat mannitol poloxamer 188 benzylalkohol vand til injektionsvæsker
English: Growth hormone deficiency Prader-Willi syndrome Turner syndrome
Danish: Væksthormonmangel Prader-Willis syndrom Turners syndrom Kronisk nedsat nyrefunktion Børn/unge født små i forhold til deres gestationsalder (SGA)
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 1.3 mg/ml powder and solvent for solution for injection Somatropin
Danish: Omnitrope 1,3 mg/ml pulver og solvens til injektionsvæske, opløsning Somatropin
English: What Omnitrope 15 mg/1.5 ml contains
Danish: Omnitrope 15 mg/1,5 ml indeholder:
English: What Omnitrope 10 mg/1.5 ml contains
Danish: Omnitrope 10 mg/1,5 ml indeholder:
English: 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.
Danish: Sæt cylinderampullen i Omnitrope Pen ifølge den medfølgende brugsanvisning.
English: Omnitrope 5 mg/1.5 ml solution for injection:
Danish: Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning:
English: - The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol water for injections
Danish: - Øvrige indholdsstoffer: dinatriumhydrogenphosphatheptahydrat natriumdihydrogenphosphatdihydrat glycin poloxamer 188 phenol vand til injektionsvæsker
English: Omnitrope 5 mg/1.5 ml solution for injection is a sterile, ready-to-use solution for subcutaneous injection filled in a glass cartridge.
Danish: Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning er en steril, brugsklar injektionsvæske, opløsning til subkutan injektion i en cylinderampul af glas.
English: • Joint pain
Danish: • Ledsmerter
English: - The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate sodium chloride poloxamer 188 phenol water for injections
Danish: - Øvrige indholdsstoffer: dinatriumhydrogenphosphatheptahydrat natriumdihydrogenphosphatdihydrat natriumchlorid poloxamer 188 phenol vand til injektionsvæsker
English: 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.
Danish: Det må kun anvendes med Omnitrope Pen L, en injektionsanordning udviklet specielt til brug af Omnitrope 5 mg/ml rekonstitueret injektionsvæske, opløsning.
English: Omnitrope 10 mg/1.5 ml solution for injection
Danish: Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 10 mg/1.5 ml solution for injection Somatropin
Danish: LÆGEMIDLETS NAVN Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning Somatropin
English: INFORMATION IN BRAILLE Omnitrope 15 mg/1.5 ml
Danish: INFORMATION I BRAILLESKRIFT Omnitrope 15 mg/1,5 ml
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 15 mg/1.5 ml solution for injection Somatropin
Danish: LÆGEMIDLETS NAVN Omnitrope 15 mg/1,5 ml injektionsvæske, opløsning Somatropin
English: some of whom have been treated with somatropin.
Danish: I andre studier med somatropin vedr.
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 5 mg/1.5 ml solution for injection Somatropin
Danish: LÆGEMIDLETS NAVN Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning Somatropin
English: What Omnitrope 5 mg/1.5 ml contains
Danish: Omnitrope 5 mg/1,5 ml indeholder:
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 5 mg/ml powder and solvent for solution for injection Somatropin
Danish: Omnitrope 5 mg/ml pulver og solvens til injektionsvæske, opløsning Somatropin
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT CARTRIDGE LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS MED SOLVENS ETIKET
English: Omnitrope 10 mg/1.5 ml solution for injection EU/1/06/332/007
Danish: Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning EU/1/06/332/007
English: Omnitrope 15 mg/1.5 ml solution for injection
Danish: Omnitrope 15 mg/1,5 ml injektionsvæske, opløsning
English: One cartridge contains 1.5 ml corresponding to 15 mg somatropin (45 IU).
Danish: En cylinderampul indeholder 1,5 ml svarende til 15 mg somatropin (45 IE).
English: One cartridge contains 1.5 ml corresponding to 5 mg somatropin (15 IU).
Danish: En cylinderampul indeholder 1,5 ml svarende til 5 mg somatropin (15 IE).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER SOLVENS CYLINDERAMPUL ETIKET
English: INFORMATION IN BRAILLE Omnitrope 10 mg/1.5 ml
Danish: INFORMATION I BRAILLESKRIFT Omnitrope 10 mg/1,5 ml
English: 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.
Danish: Det bør kun gives med Omnitrope Pen 10, en injektionsanordning som er specifikt udviklet til brug sammen med Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning.
English: INFORMATION IN BRAILLE Omnitrope 5 mg/1.5 ml
Danish: INFORMATION I BRAILLESKRIFT Omnitrope 5 mg/1,5 ml
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/013
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/06/332/013
English: Omnitrope 10 mg/1.5 ml solution for injection EU/1/06/332/016
Danish: Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning EU/1/06/332/016
English: 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.
Danish: Det bør kun gives med Omnitrope Pen 5, en injektionsanordning som er specifikt udviklet til brug sammen med Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning.
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/016
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/06/332/016
English: Unopened cartridge
Danish: Uåbnet cylinderampul
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/010
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/06/332/010
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/007
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/06/332/007
English: 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.
Danish: Det bør kun gives med SurePal 10, en injektionsanordning som er specifikt udviklet til brug sammen med Omnitrope 10 mg/1,5 ml injektionsvæske, opløsning.
English: Omnitrope 5 mg/1.5 ml solution for injection EU/1/06/332/004
Danish: Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning EU/1/06/332/004
English: How to store Omnitrope
Danish: Tilberedning af Omnitrope
English: Omnitrope 15 mg/1.5 ml solution for injection EU/1/06/332/010
Danish: Omnitrope 15 mg/1,5 ml injektionsvæske, opløsning EU/1/06/332/010
English: • Numbness/tingling
Danish: • Følelsesløshed/prikkende fornemmelse
English: Children with chronic renal (kidney) insufficiency
Danish: Børn med kronisk nedsat nyrefunktion
English: Omnitrope 5 mg/1.5 ml solution for injection
Danish: Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning
English: Omnitrope 5 mg/1.5 ml solution for injection EU/1/06/332/013
Danish: Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning EU/1/06/332/013
English: Testing for antibodies to somatropin should be carried out in any patient with otherwise unexplained lack of response.
Danish: Alle patienter, som af ukendt årsag ikke responderer, bør testes for antistoffer mod somatropin.
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/004
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/06/332/004
English: 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.
Danish: Det bør kun gives med SurePal 15, en injektionsanordning som er specifikt udviklet til brug sammen med Omnitrope 15 mg/1,5 ml injektionsvæske, opløsning.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 10 mg/1.5 ml Injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Omnitrope 10 mg/1,5 ml Injektionsvæske Somatropin s.c.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 15 mg/1.5 ml Injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Omnitrope 15 mg/1,5 ml Injektionsvæske Somatropin s.c.
English: MARKETING AUTHORISATION NUMBER EU/1/06/332/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/06/332/001
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/002
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/06/332/002
English: 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.
Danish: Det bør kun gives med SurePal 5, en injektionsanordning som er specifikt udviklet til brug sammen med Omnitrope 5 mg/1,5 ml injektionsvæske, opløsning.
English: Paraesthesia
Danish: Amning
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 5 mg/ml powder for solution for injection Somatropin
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Omnitrope 5 mg/ml pulver til injektionsvæske, opløsning.
English: Shelf life after reconstitution
Danish: Opbevaringstid efter rekonstitution
English: Each ml of solution contains 6.7 mg of somatropin (corresponding to 20 IU) One cartridge contains 10.0 mg (corresponding to 30 IU) of somatropin in 1.5 ml.
Danish: En cylinderampul indeholder 10,0 mg (svarende til 30 IE) somatropin i 1,5 ml.
English: • The Committee considered the referral under Article 29(4) of Directive 2001/83/EC,
Danish: • Udvalget behandlede indbringelsen i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF.
English: Quality
Danish: Kvalitet
English: • The Committee considered the totality of the data submitted by the applicant in relation to the objections raised as a potential serious risk to public health.
Danish: • Udvalget vurderede alle de data, som ansøgeren havde fremsendt, i forhold til indvendingerne vedrørende en mulig alvorlig risiko for folkesundheden.
English: The difference in median VAS score was 8 mm at day 3-4 and 4.6mm at day 7-8.
Danish: Forskel i median VAS-score: 8 mm på dag 3-4 og 4,6 mm på dag 7-8.