FrancophonIA/ELRC3.0 huggingface dataset:
English: Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, mannitol, poloxamer 188, benzyl alcohol, water for injections.
Lithuanian: Pagalbinės medžiagos: dinatrio vandenilio fosfato heptahidratas, natrio divandenilio fosfato dihidratas, manitolis, poloksameras 188, benzilo alkoholis, injekcinis vanduo.
English: The following instructions explain how to inject Omnitrope 1.3 mg/ml yourself.
Lithuanian: Toliau paaiškinama kaip pačiam susišvirkšti Omnitrope 1,3 mg/ml.
English: 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.
Lithuanian: Augimo sutrikimas, kurį sukelia lėtinis inkstų nepakankamumas Rekomenduojama paros dozė: 0,045 - 0,050 mg/kg kūno svorio (1,4 mg/m kūno paviršiaus). Jei augimo greitis pernelyg mažas, gali reikėti didesnių dozių.
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.
Lithuanian: Įdėkite užtaisą į Omnitrope Pen instrumentą poodiniam švirkštimui laikydamiesi nurodymų, pateiktų kartu su švirkštikliu.
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.
Lithuanian: Įdėkite užtaisą į SurePal instrumentą poodiniam švirkštimui laikydamiesi nurodymų, pateiktų kartu su švirkštikliu.
English: Long-term treatment of children with growth disturbance due to insufficient secretion of growth hormone
Lithuanian: Vaikų, kurių augimas sutrikęs, kai organizme išskiriama nepakankamai augimo hormono, ilgalaikis gydymas
English: What Omnitrope contains
Lithuanian: Omnitrope sudėtis
English: Omnitrope 10 mg/1.5 ml solution for injection
Lithuanian: Omnitrope 10 mg/1,5 ml injekcinis tirpalas
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
Lithuanian: Omnitrope 10 mg/1,5 ml injekcininis tirpalas dinatrio vandenilio fosfato heptahidratas natrio divandenilio fosfato dihidratas glicinas poloksameras 188 fenolis injekcinis vanduo
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.
Lithuanian: Omnitrope 15 mg/1,5 ml yra sterilus, leisti po oda paruoštas injekcinis tirpalas, pateikiamas supiltas į stiklo užtaisą.
English: METHOD AND ROUTE OF ADMINISTRATION Use only clear solution.
Lithuanian: VARTOJIMO METODAS IR BŪDAS Nevartoti, jei tirpalas neskaidrus.
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.
Lithuanian: Omnitrope 5 mg/1,5 ml yra sterilus, leisti po oda paruoštas injekcinis tirpalas, pateikiamas supiltas į stiklo užtaisą.
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
Lithuanian: Omnitrope 5 mg/1,5 ml injekcininis tirpalas dinatrio vandenilio fosfato heptahidratas natrio divandenilio fosfato dihidratas manitolis poloksameras 188 benzilo alkoholis injekcinis vanduo
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
Lithuanian: Omnitrope 15 mg/1,5 ml injekcininis tirpalas dinatrio vandenilio fosfato heptahidratas natrio divandenilio fosfato dihidratas natrio chloridas poloksameras 188 fenolis injekcinis vanduo
English: Omnitrope 15 mg/1.5 ml solution for injection is for use in SurePal 15 only.
Lithuanian: Omnitrope 15 mg/1,5 ml injekcini tirpalą, galima naudoti tik su SurePal 15.
English: For guidance on dosing see adult section below.
Lithuanian: Rekomendacijas dėl dozavimo žr. toliau, suaugusiųjų skyriuje.
English: - the Omnitrope Pen , an injection device specifically developed for use with Omnitrope solution for injection (not supplied in the pack; see Instructions for Use provided with the Omnitrope Pen).
Lithuanian: - SurePal - instrumentą įšvirkštimui, specialiai pritaikytą naudojimui su Omnitrope injekciniu tirpalu (instrumentas į rinkinį neįeina.
English: 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.
Lithuanian: Laikyti šaldytuve (2 °C - 8 °C) daugiausiai 28 dienas.
English: After reconstitution, one vial contains 1.3 mg somatropin (corresponding to 4 IU) per ml.
Lithuanian: Po atskiedimo, viename buteliuke yra 1,3 mg somatropino (atitinka 4 TV) mililitre.
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).
Lithuanian: Omnitrope 15 mg/1,5 ml injekcininis tirpalas Viename mililitre tirpalo yra 10 mg somatropino* (atitinka 30 TV).
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.
Lithuanian: Po oda suleistos 5 mg Omnitrope 15 mg/1,5 ml injekcinio tirpalo sudaro Cmax ir tmax 52 ± 19 μg/l plazmoje per 3,7 ± 1,2 valandas atitinkamai.
English: Omnitrope 1.3 mg/ml powder and solvent for solution for injection
Lithuanian: Omnitrope 1,3 mg/ml milteliai ir tirpiklis injekciniam tirpalui
English: INFORMATION IN BRAILLE Omnitrope 15 mg/1.5 ml
Lithuanian: INFORMACIJA BRAILIO RAŠTU Omnitrope 15 mg/1,5 ml
English: Uncommo n to <1/100
Lithuanian: Nedažni nuo iki < 1/100
English: Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, glycine, poloxamer 188, phenol, water for injections.
Lithuanian: Pagalbinės medžiagos: dinatrio vandenilio fosfato heptahidratas, natrio divandenilio fosfato dihidratas, glicinas, poloksameras 188, fenolis, injekcinis vanduo.
English: What Omnitrope 10 mg/1.5 ml contains
Lithuanian: Omnitrope 10 mg/1,5 ml sudėtis
English: Store in the original pen in order to protect from light.
Lithuanian: Laikyti gamintojo švirkštiklyje, kad preparatas būtų apsaugotas nuo šviesos.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 10 mg/1.5 ml Injection
Lithuanian: VAISTINIO PREPARATO PAVADINIMAS IR VARTOJIMO BŪDAS Omnitrope 10 mg/1,5 ml injekcija
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.
Lithuanian: Po oda suleistos 5 mg Omnitrope 5 mg/1,5 ml injekcinio tirpalo dozės sudaro Cmax ir tmax 72 ± 28μg/l plazmoje per 4,0 ± 2,0 valandas atitinkamai.
English: Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, poloxamer 188, phenol, water for injections.
Lithuanian: Pagalbinės medžiagos: dinatrio vandenilio fosfato heptahidratas, natrio divandenilio fosfato dihidratas, natrio chloridas, poloksameras 188, fenolis, injekcinis vanduo.
English: One cartridge contains 1.5 ml corresponding to 5 mg somatropin (15 IU).
Lithuanian: Viename užtaise yra 1,5 ml, kas atitinka 5 mg somatropino (15 TV).
English: - The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate sodium chloride poloxamer 188 phenol water for injections
Lithuanian: - Kitos pagalbinės medžiagos yra: dinatrio vandenilio fosfato heptahidratas natrio divandenilio fosfato dihidratas natrio chloridas poloksmeras 188 fenolis injekcinis vanduo
English: - The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol water for injections
Lithuanian: - Kitos pagalbinės medžiagos yra: dinatrio vandenilio fosfato heptahidratas natrio divandenilio fosfato dihidratas glicinas poloksmeras 188 fenolis injekcinis vanduo
English: Take the vial with the powder, push the needle through the rubber closure and inject the solvent slowly into the vial aiming the stream of liquid against the glass wall in order to avoid foam.
Lithuanian: Kad būtų išvengta putų susidarymo, nukreipkite tirpiklio srovę į stiklinę buteliuko sienelę.
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.
Lithuanian: Po oda suleistos 5 mg Omnitrope 10 mg/1,5 ml injekcinio tirpalo sudaro Cmax ir tmax 74 ± 22 μg/l plazmoje per 3,9 ± 1,2 valandas atitinkamai.
English: Omnitrope 5 mg/1.5 ml in a cartridge for SurePal 5 is intended for multiple use.
Lithuanian: Omnitrope 5 mg/1,5 ml užtaise, skirtame SurePal 5, skirtas daugkartiniam naudojimui.
English: One cartridge contains 1.5 ml corresponding to 15 mg somatropin (45 IU).
Lithuanian: Viename užtaise yra 1,5 ml, kas atitinka 15 mg somatropino (45 TV).
English: INFORMATION IN BRAILLE Omnitrope 10 mg/1.5 ml
Lithuanian: INFORMACIJA BRAILIO RAŠTU Omnitrope 10 mg/1,5 ml
English: After reconstitution, one cartridge contains 5 mg somatropin (corresponding to 15 IU) per ml.
Lithuanian: Po atskiedimo, viename užtaise yra 5 mg somatropino (atitinka 15 TV) mililitre.
English: - The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate mannitol poloxamer 188 benzyl alcohol water for injections
Lithuanian: - Pagalbinės medžiagos yra: dinatrio vandenilio fosfato heptahidratas natrio divandenilio fosfato dihidratas manitolis poloksmeras 188 benzilo alkoholis injekcinis vanduo
English: DATE OF REVISION OF THE TEXT
Lithuanian: Tinkamumo laikas atskiedus
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
Lithuanian: Prieš nutraukdami arba užbaigdami gydymą Omnitrope pasitarkite su gydytoju. Jeigu kiltų daugiau klausimų dėl šio vaisto vartojimo, kreipkitės į gydytoją, vaistininką arba slaugytoją.
English: INFORMATION IN BRAILLE Omnitrope 5 mg/1.5 ml
Lithuanian: INFORMACIJA BRAILIO RAŠTU Omnitrope 5 mg/1,5 ml
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 5 mg/ml powder for solution for injection Somatropin
Lithuanian: VAISTINIO PREPARATO PAVADINIMAS IR VARTOJIMO BŪDAS Omnitrope 5 mg/ml milteliai injekciniam tirpalui Somatropinas s.
English: In patients with endocrine disorders, including growth hormone deficiency, slipped epiphyses of the hip may occur more frequently than in the general population.
Lithuanian: Šlaunikaulio galvutės epifiziolizė daug dažniau pasitaiko pacientams, sergantiems endokrinine liga, įskaitant turintiems augimo hormono trūkumą. Jei gydant somatropinu pacientai šlubuoja, jie turėtų būti kliniškai tikrinami.
English: Omnitrope 15 mg/1.5 ml in a cartridge for SurePal 15 is intended for multiple use.
Lithuanian: Omnitrope 15 mg/1,5 ml užtaise, skirtame SurePal 15, skirtas daugkartiniam naudojimui.
English: Omnitrope 5 mg/1.5 ml solution for injection is for use in SurePal 5 only.
Lithuanian: Omnitrope 5 mg/1,5 ml injekcini tirpalą, galima naudoti tik su SurePal 5.
English: Omnitrope 10 mg/1.5 ml in a cartridge for SurePal 10 is intended for multiple use.
Lithuanian: Omnitrope 10 mg/1,5 ml užtaise, skirtame SurePal 10, skirtas daugkartiniam naudojimui.
English: Omnitrope 10 mg/1.5 ml solution for injection EU/1/06/332/007
Lithuanian: Omnitrope 10 mg/1,5 ml injekcininis tirpalas EU/1/06/332/007
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 5 mg/1.5 ml Injection
Lithuanian: VAISTINIO PREPARATO PAVADINIMAS IR VARTOJIMO BŪDAS Omnitrope 5 mg/1,5 ml injekcija
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 15 mg/1.5 ml Injection
Lithuanian: VAISTINIO PREPARATO PAVADINIMAS IR VARTOJIMO BŪDAS Omnitrope 15 mg/1,5 ml injekcija
English: Inject the solution by pushing the plunger all the way down gently.
Lithuanian: Sušvirkškite vaistą, švelniai stumdami švirkšto stūmoklį.
English: Injecting Omnitrope - Put the cartridge with the dissolved Omnitrope into the pen for injection.
Lithuanian: Omnitrope sušvirkštimas - Užtaisą su ištirpusiu Omnitrope įstatykite į instrumentą poodiniam įšvirkštimui.
English: - Change the injection sites to minimise the risk of local lipoatrophy (local reduction of fatty tissue under the skin).
Lithuanian: - Norėdamas išvengti vietinės lipoatrofijos (vietinio riebalinio audinio suplonėjimo po oda),
English: Omnitrope 5 mg/ml powder and solvent for solution for injection
Lithuanian: Omnitrope 5 mg/ml milteliai ir tirpiklis injekciniam tirpalui
English: Remove any air bubbles from the syringe.
Lithuanian: Pašalinkite visus švirkšte esančius oro burbuliukus. Švirkšte turi likti reikiama dozė.
English: Administer the appropriate dose by subcutaneous injection using a sterile pen needle.
Lithuanian: Injekcija atliekama naudojant sterilias, vienkartines švirkštiklio adatas.
English: Common side effects (likely to occur in fewer than 1 in 10 patients) include:
Lithuanian: Dažnas šalutinis poveikis (gali pasireikšti mažiau kaip 1 iš 10 pacientų):
English: Omnitrope 10 mg/1.5 ml solution for injection EU/1/06/332/016
Lithuanian: Omnitrope 10 mg/1,5 ml injekcininis tirpalas 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.
Lithuanian: Injekcija turi būti atliekama tik Omnitrope Pen 5 - instrumentu, specialiai pritaikytu naudojimui su Omnitrope 5 mg/1,5 ml injekciniu tirpalu.
English: Omnitrope 15 mg/1.5 ml solution for injection
Lithuanian: Omnitrope 15 mg/1,5 ml injekcinis tirpalas
English: - a sterile, disposable syringe (e.g. 2 ml syringe) and needle (e.g.
Lithuanian: , 2 ml) ir adatą (pvz.
English: 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.
Lithuanian: Laikyti šaldytuve (2 °C - 8 °C) daugiausiai 21 dieną.
English: Whereas the peripheral thyroid hormone levels have remained within the reference ranges for healthy subjects, hypothyroidism theoretically may develop in subjects with subclinical hypothyroidism.
Lithuanian: Tuo tarpu periferiniai sveikų pacientų skydliaukės hormono kiekiai išliko referenciniame intervale.
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.
Lithuanian: Injekcija turi būti atliekama tik Omnitrope Pen 10 - instrumentu, specialiai pritaikytu naudojimui su Omnitrope, 10 mg/1,5 ml injekciniu tirpalu.
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/013
Lithuanian: RINKODAROS TEISĖS NUMERIAI EU/1/06/332/013
English: The solvent is clear and colourless.
Lithuanian: Tirpiklis skaidrus ir bespalvis.
English: Omnitrope 15 mg/1.5 ml solution for injection EU/1/06/332/010
Lithuanian: Omnitrope 15 mg/1,5 ml injekcininis tirpalas EU/1/06/332/010
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL LABEL
Lithuanian: MINIMALI INFORMACIJA ANT MAŽŲ VIDINIŲ PAKUOČIŲ TIRPIKLIO UŽTAISO ETIKETĖ
English: Growth hormone deficient adult patients
Lithuanian: Suaugusieji, turintys augimo hormono trūkumą
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/007
Lithuanian: RINKODAROS TEISĖS NUMERIAI EU/1/06/332/007
English: However, after subcutaneous administration of Omnitrope powder and solvent for solution for injection, a half-life of 3 hours is achieved.
Lithuanian: Tačiau jei Omnitrope 5 mg/ml miltelių ir tirpiklio injekciniam tirpalui suleidžiamas po oda, pasiekiamas 3 valandų pusinės eliminacijos periodas.
English: If you get any side effects, talk to your doctor or pharmacist or nurse.
Lithuanian: Jeigu abejojate, kreipkitės į gydytoją, slaugytoją arba vaistininką.
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/016
Lithuanian: RINKODAROS TEISĖS NUMERIAI EU/1/06/332/016
English: Omnitrope 5 mg/1.5 ml solution for injection EU/1/06/332/004
Lithuanian: Omnitrope 5 mg/1,5 ml injekcininis tirpalas EU/1/06/332/004
English: What Omnitrope 5 mg/1.5 ml contains
Lithuanian: Omnitrope 5 mg/1,5 ml sudėtis
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 1.3 mg/ml powder for solution for injection Somatropin
Lithuanian: VAISTINIO PREPARATO PAVADINIMAS IR VARTOJIMO BŪDAS Omnitrope 1,3 mg/ml milteliai injekciniam tirpalui Somatropinas s.
English: Omnitrope 5 mg/1.5 ml solution for injection Omnitrope 10 mg/1.5 ml solution for injection
Lithuanian: VAISTINIO PREPARATO PAVADINIMAS Omnitrope 5 mg/1,5 ml injekcininis tirpalas Omnitrope 10 mg/1,5 ml injekcininis tirpalas
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/010
Lithuanian: RINKODAROS TEISĖS NUMERIAI EU/1/06/332/010
English: PHARMACEUTICAL FORM AND CONTENTS 1 vial of 1.3 mg powder
Lithuanian: FARMACINĖ FORMA IR KIEKIS PAKUOTĖJE 1 buteliuke yra 1,3 mg miltelių 1 buteliuke yra 1 ml tirpiklio Kiekis pakuotėje - 1
English: Rarely, an inflammation of the pancreas has been reported in patients treated with growth hormone.
Lithuanian: Augimo hormonu gydomiems pacientams retai nustatytas kasos uždegimas.
English: After reconstitution, one vial contains 1.3 mg somatropin* (corresponding to 4 IU) per ml.
Lithuanian: Praskiedus viename buteliuke yra 1,3 mg somatropino* (atitinka 4 TV) viename mililitre.
English: Omnitrope 5 mg/1.5 ml solution for injection EU/1/06/332/013
Lithuanian: Omnitrope 5 mg/1,5 ml injekcininis tirpalas EU/1/06/332/013
English: After reconstitution, one vial contains 5 mg somatropin* (corresponding to 15 IU) per ml.
Lithuanian: Praskiedus, viename buteliuke yra 5 mg somatropino* (atitinka 15 TV) viename mililitre.
English: In children with inadequate endogenous growth hormone, somatropin stimulates linear growth and increases growth rate.
Lithuanian: Somatropinas skatina ir spartina vaikų, turinčių nepakankamai endogeninio augimo hormono, augimą.
English: Do not use Omnitrope if you notice that the solution is cloudy.
Lithuanian: Nevartoti jei tirpalas neskaidrus.
English: Collect necessary items before you begin: - a vial with Omnitrope 5 mg/ml powder for solution for injection.
Lithuanian: Prieš pradėdamas surinkite visus reikalingus daiktus: - buteliuką su Omnitrope 5 mg/ml milteliais injekcijų tirpalui, - užtaisą su Omnitrope 5 mg/ml milteliams skirtu tirpikliu, - perkėlimo rinkinį, skirtą sumaišymui ir atskiesto tirpalo perkėlimui atgal į užtaisą (žr.
English: Myalgia* Musculoskel etal stiffness*
Lithuanian: Mialgija* Raumenų ir skeleto sustingimas*
English: What Omnitrope 15 mg/1.5 ml contains
Lithuanian: Omnitrope 15 mg/1,5 ml sudėtis
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/004
Lithuanian: RINKODAROS TEISĖS NUMERIAI EU/1/06/332/004
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/002
Lithuanian: RINKODAROS TEISĖS NUMERIAI EU/1/06/332/002
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.
Lithuanian: Injekcija turi būti atliekama SurePal 15 - instrumentu, specialiai pritaikytu naudojimui su Omnitrope 15 mg/1,5 ml injekciniu tirpalu.
English: Powder: glycine, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate Solvent: water for injections
Lithuanian: Milteliai: glicinas, dinatrio vandenilio fosfato heptahidratas, natrio divandenilio fosfato dihidratas.
English: - Take the vial with the powder and push the needle through the rubber membrane of the vial.
Lithuanian: - Paimkite buteliuką su milteliais ir adata pradurkite jo guminį kamštelį.
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.
Lithuanian: Injekcija turi būti atliekama tik SurePal 5 - instrumentu, specialiai pritaikytu naudojimui su Omnitrope 5 mg/1,5 ml injekciniu tirpalu.
English: - a sterile, disposable syringe of appropriate size (e.g. 1 ml syringe)
Lithuanian: , 1 ml) sterilų vienkartinį švirkštą ir injekcijoms skirtą adatą (pvz.
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.
Lithuanian: Injekcija turi būti atliekama tik SurePal 10 - instrumentu, specialiai pritaikytu naudojimui su Omnitrope, 10 mg/1,5 ml injekciniu tirpalu.
English: • Numbness/tingling
Lithuanian: • Tirpimas, dygčiojimas
English: Musculoskeleta l stiffness*
Lithuanian: Omnitrope švirkštimas
English: MARKETING AUTHORISATION NUMBER EU/1/06/332/001
Lithuanian: RINKODAROS TEISĖS NUMERIAI EU/1/06/332/001
English: Symptoms: Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia.
Lithuanian: Ūminis perdozavimas iš pradžių gali sukelti gliukozės koncentracijos kraujyje sumažėjimą, paskuipadidėjimą.
English: 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.
Lithuanian: Vaikams, kuriems trūksta augimo hormono: 0,025-0,035 mg/kg kūno svorio per parą arba 0,7-1,0 mg/m kūno paviršiaus ploto per parą.
English: A dose of 0.045 - 0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day is recommended.
Lithuanian: Paprastai rekomenduojama paros dozė: 0,025 - 0,035 mg/kg kūno svorio arba 0,7 - 1,0 mg/m kūno paviršiaus.
English: One cartridge contains 15 mg (corresponding to 45 IU) of somatropin in 1.5 ml.
Lithuanian: Viename 1,5 ml užtaise yra 15 mg somatropino (atitinka 45 TV).
English: Growth disturbance due to Turner syndrome
Lithuanian: Vaikams, sergantiems Turnerio sindromu:
English: Omnitrope 5 mg/1.5 ml solution for injection
Lithuanian: Omnitrope 5 mg/1,5 ml injekcinis tirpalas
English: - After reconstitution, Omnitrope is given as an injection under the skin.
Lithuanian: - Atskiedus, Omnitrope sušvirkščiamas po oda.
English: - Be sure that the tip of the syringe is in the Omnitrope reconstituted solution.
Lithuanian: - Švirkšto galiukas turi būti panardintas į Omnitrope atskiestą tirpalą.
English: - Take the needle off the pen using the outer needle cap, and discard the needle.
Lithuanian: - Nuo švirkštiklio nuimkite adatą naudodamiesi adatos išoriniu dangteliu.
English: • The Committee considered the referral under Article 29(4) of Directive 2001/83/EC,
Lithuanian: • komitetas apsvarstė kreipimąsi pagal Direktyvos 2001/83/EB 4 straipsnį;
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.
Lithuanian: • komitetas apsvarstė visus duomenis, kuriuos pareiškėjas pateikė dėl prieštaravimų, kurie buvo išreikšti dėl galimo rimto pavojaus visuomenės sveikatai.
English: Particularly the endpoint of main interest which is pain.
Lithuanian: Ypač vertinant svarbiausią vertinamąją baigtį - skausmą.
English: The difference in median VAS score was 8 mm at day 3-4 and 4.6mm at day 7-8.
Lithuanian: Vertinimo pagal VAS medianos skirtumas 3-4-ą dieną siekė 8 mm, o 7-8-ą dieną - 4,6 mm.
English: Numerically, the exposure of Spraygel is lower than Emulgel and its impact on efficacy cannot be ascertained accurately.
Lithuanian: Vertinant pagal skaičius, Spraygel ekspozicija yra mažesnė nei Emulgel ir jos poveikio veiksmingumui negalima tiksliai įvertinti.
English: Clinical Pharmacology
Lithuanian: Klinikinė farmakologija
English: 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.
Lithuanian: Vis dėlto, šio tyrimo duomenų negalima laikyti patvirtinančiais Spraygel veiksmingumą, nes pirminė vertinamoji baigtis nevaliduota, o statistinė analizė neatitinka teisės aktuose nustatytų reikalavimų.