natgillin/translations-raw huggingface dataset:
Olanzapin Teva 15 mg filmovertrukne tabletter fås i kartoner med 28, 30, 35, 50, 56 eller 70 filmovertrukne tabletter.
Olanzapine Teva 15 mg film-coated tablets are available in cartons of 28, 30, 35, 50, 56or 70 film- coated tablets.
183 Olanzapin Teva 20 mg filmovertrukne tabletter fås i kartoner med 28, 30, 35, 56 eller 70 filmovertrukne tabletter.
Olanzapine Teva 20 mg film-coated tablets are available in cartons of 28, 30, 35, 56 or 70 film-coated tablets.
Indehaveren af markedsføringstilladelsen og fremstiller
181 Marketing Authorisation Holder and Manufacturer
Teva Pharma BV, Computerweg 10, 3542 DR Utrecht, Holland.
Teva Pharma BV, Computerweg 10, 3542 DR Utrecht, The Netherlands
Teva Pharmaceutical Works, Pallagi út 13, 4042 Debrecen, Ungarn Teva Pharmaceutical Works, Táncsics Mihály út 82, H- 2100 Gödöllo, Ungarn Teva Kutno S. A., Sienkiewicza 25 str, 99 300 Kutno, Polen Gry- Pharma GmbH, Kandelstr.
Teva Pharmaceutical Works, Pallagi út 13, 4042 Debrecen, Hungary Teva Pharmaceutical Works, Táncsics Mihály út 82, H-2 100 Gödöllo, Hungary Teva Kutno S.A., Sienkiewicza 25 str, 99 300 Kutno, Poland Gry-Pharma GmbH, Kandelstr.
10, 79199 Kirchzarten, Tyskland TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Storbritannien
10, 79199 Kirchzarten, Germany TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Hvis du vil have yderligere oplysninger om Olanzapin Teva, skal du henvende dig til den lokale repræsentant:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
184 België/ Belgique/ Belgien Teva Pharma Belgium N. V. / S. A. / AG Tél/ Tel: + (32) 38. 20. 73. 76 България Teva UK Limited Teл.: + (44) 1323 501 111.
182 België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Telephone:
Česká republika Teva Pharmaceuticals CR, s. r. o Tel: + (420) 606 763 892 Danmark Teva Sweden AB Tlf: + (46) 42 12 11 00 Deutschland Teva Generics GmbH Tel: + (49) 0 610597789 720 Eesti UAB “ Sicor Biotech ” Estonian Affiliate Tel: + 372 611 2407.
(46) 42 12 11 00 Deutschland Teva Generics GmbH Tel:
Ελλάδα Teva UK Limited Τηλ: + (44) 1323 501 111.
(44) 1323 501 111.
Tel: + (34) 91 535 91 80 / +( 34) 637 72 50 63 France Teva Classics S. A.
Telephone: +(34) 91 535 91 80 / +(34) 637 72 50 63 France Teva Classics S.A.
Tél: + (33) 1 55 91 7800 Ireland Teva UK Limited Tel: + (44) 1323 501 111.
(33) 1 55 91 7800 Ireland Teva UK Limited Telephone:
Ísland Teva UK Limited Sími: + (44) 1323 501 111.
Ísland Teva UK Limited Telephone:
Italia Teva Italia S. R. L.
Italia Teva Italia S.r.l.
Tel: + (39) 0289179807 Κύπρος Teva UK Limited Τηλ: + (44) 1323 501 111.
(44) 1323 501 111.
Latvija UAB “ Sicor Biotech ” Latvian Affiliate Tel: + 371 6714 25 63.
Latvija UAB “Sicor Biotech” Latvian Affiliate Telephone: +371 6714 25 63.
Lietuva UAB “ Sicor Biotech ” Tel: + 370 5 211 35 00.
Lietuva UAB “Sicor Biotech” Telephone: +370 5 211 35 00.
Luxembourg/ Luxemburg Teva Pharma Belgium N. V. / S. A. / AG Tél/ Tel: + (32) 38. 20. 73. 76 Magyarország Teva Gyógyszergyár Rt, Tel.: + (36) 52 515 095 Malta Teva UK Limited Tel: + (44) 1323 501 111.
(36) 1 288 6410 Malta Teva UK Limited Telephone:
Nederland Pharmachemie BV Tel: + (31) 235 147 147 Norge Teva Sweden AB Tlf: + (46) 42 12 11 00 Österreich Teva UK Limited Tel: + (44) 1323 501 111.
(46) 42 12 11 00 Österreich Teva UK Limited Telephone:
Polska Teva Pharmaceuticals Polska Sp. z o. o Tel: + (48) 22 345 93 00 Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel: + (351) 917 399 122 România Teva UK Limited Tel: + (44) 1323 501 111.
(351) 214 235 910 România Teva Pharmaceuticals S.R.L Telephone: +4021 212 08 90.
Slovenija Teva UK Limited Tel: + (44) 1323 501 111.
(44) 1323 501 111.
Tel: + (421) 2 5726 7974 Suomi/ Finland Teva Sweden AB Puh/ Tel: + (46) 42 12 11 00 Sverige Teva Sweden AB Tel: + (46) 42 12 11 00 United Kingdom Teva UK Limited Tel: + (44) 1323 501 111.
(44) 1323 501 111.
Denne indlægsseddel blev senest godkendt {MM/ ÅÅÅÅ}
183 This leaflet was last approved in {MM/YYYY}.
185 INDLÆGSSEDDEL:
184 PACKAGE LEAFLET:
Olanzapin Teva 5 mg smeltetabletter Olanzapin Teva 10 mg smeltetabletter Olanzapin Teva 15 mg smeltetabletter Olanzapin Teva 20 mg smeltetabletter Olanzapin
Olanzapine Teva 5 mg orodispersible tablets Olanzapine Teva 10 mg orodispersible tablets Olanzapine Teva 15 mg orodispersible tablets Olanzapine Teva 20 mg orodispersible tablets olanzapine
- Spørg lægen eller på apoteket, hvis der er mere du vil vide.
- If you have any further questions, ask your doctor or your pharmacist.
Olanzapin Teva VIRKNING OG HVAD SKAL BRUGE DET TIL
WHAT OLANZAPINE TEVA IS AND WHAT IT IS USED FOR
Olanzapin Teva anvendes til behandling af en lidelse med symptomer såsom, at man hører, ser og mærker ting, som ikke eksisterer, mistro, ualmindelig mistænksomhed og indesluttethed.
Olanzapine Teva is used to treat a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.
Olanzapin Teva bruges til at behandle en tilstand med symptomer såsom, at man føler sig ” høj ”, at man har usædvanlig meget energi og har behov for meget mindre søvn end normalt, at man taler meget hurtigt og hele tiden får nye idéer, og at man sommetider kan blive meget irriteret.
Olanzapine Teva is used to treat a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
Det er også en stemningsstabilisator, som forebygger yderligere optræden af de invaliderende høje og lave (depressive) stemningsekstremer, som er forbundet med denne tilstand.
It is also a mood stabiliser that prevents further occurrences of the disabling high and low (depressed) extremes of mood associated with this condition.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE Olanzapin Teva
BEFORE YOU TAKE Olanzapine Teva
Tag ikke Olanzapin Teva • Hvis du er allergisk (overfølsom) over for olanzapin eller et af de øvrige indholdsstoffer i Olanzapin Teva.
- If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of Olanzapine
Hvis du har oplevet dette, skal du fortælle det til lægen. • Hvis du tidligere har fået at vide, at du har en bestemt slags glaukom (grøn stær) med øget tryk i øjet.
- If you have been previously diagnosed with eye problems such as certain kinds of glaucoma
Vær ekstrasærlig forsigtig med at bruge Olanzapin Teva • Denne type medicin kan forårsage usædvanlige bevægelser af især ansigt eller tunge.
happens after you have been given Olanzapine Teva tell your doctor.
Hvis dette forekommer, når du har taget Olanzapin Teva, skal du fortælle det til lægen. • Yderst sjældent forårsager denne slags medicin en kombination af feber, hurtigere vejrtrækning, svedtendens, muskelstivhed og døsighed/ søvnighed.
- Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating,
186 • Det kan ikke anbefales at bruge Olanzapin Teva, hvis man er ældre og har demens, da det kan have alvorlige bivirkninger.
- The use of Olanzapine Teva in elderly patients with dementia is not recommended as it may
Hvis du lider af en af de følgende sygdomme, skal du fortælle det til din læge hurtigst muligt:
185 If you suffer from any of the following illnesses tell your doctor as soon as possible:
• Diabetes • Hjertesygdom • Lever - eller nyresygdom • Parkinsons sygdom • Epilepsi • Prostata problemer • Tarmslyng (paralytisk ileus) • Blodsygdomme • Slagtilfælde eller mindre forbigående slagtilfælde
• Diabetes • Heart disease • Liver or kidney disease • Parkinson’s disease • Epilepsy • Prostate problems • A blocked intestine (Paralytic ileus) • Blood disorders • Stroke or “mini” stroke (temporary symptoms of stroke)
Du bør fortælle det til din læge, hvis du tager fluvoxamin (et depressionsmiddel) eller ciprofloxacin (et bakteriedræbende middel), da det kan blive nødvendigt at ændre din Olanzapin Teva dosis.
You should tell your doctor if you are taking fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), as it may be necessary to change your Olanzapine Teva dose.
Det er specielt vigtigt at fortælle det til lægen, hvis du tager medicin for Parkinsons sygdom.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Fortæl det altid til lægen eller apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
Especially tell your doctor if you are taking medicines for Parkinson’s disease.
Vigtig information om nogle af de øvrige indholdsstoffer i Olanzapin Teva Olanzapin Teva indeholder også 1 mg D- glucose.
Important information about some of the ingredients of Olanzapine Teva Olanzapine Teva also contains 1 mg D-glucose.
Olanzapin Teva 5 mg indeholder 0, 4 mg tartrazin (E102) som kan medføre allergiske reaktioner.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product Olanzapine Teva 5 mg contains 0.4 mg tartrazine lake (E102) and may cause allergic reactions.
Olanzapin Teva 15 mg indeholser 0, 2 mg sunset yellow (E110) som kan medføre allergiske reaktioner.
Olanzapine Teva 15 mg contains 0.2 mg sunset yellow lake (E110) and may cause allergic reactions.
187 3.
3.
SÅDAN SKAL DU TAGE Olanzapin Teva
HOW TO TAKE Olanzapine Teva
Er du i tvivl, så spørg lægen eller apoteket.
You should check with your doctor 186 or pharmacist if you are not sure.
Olanzapin Teva er beregnet til at spise.
Olanzapine Teva orodispersible tablets are for oral use.
Olanzapin Teva tabletter knækker let, så du bør tage forsigtigt på tabletterne.
Olanzapine Teva tablets break easily, so you should handle the tablets carefully.
Rør rundt.
You can also place the tablet in a full glass or cup of water, orange juice, apple juice, milk or coffee, and stir.
Hurtig hjerterytme, ophidselse/ aggression, problemer med at tale, usædvanlige bevægelser (især af ansigt eller tunge) eller nedsat bevidsthedsniveau (døsighed).
If you take more Olanzapine Teva than you should Patients who have taken more Olanzapine Teva than they should, have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Hvis du holder op med at tage Olanzapin Teva Du må ikke ophøre med at tage tabletterne, fordi du føler dig bedre tilpas.
If you stop taking Olanzapine Teva Do not stop taking your tablets just because you feel better.
Det er vigtigt, at du fortsætter med at tage Olanzapin Teva, så længe din læge beder dig om det.
It is important that you carry on taking Olanzapine Teva for as long as your doctor tells you.
188 4.
4.
Meget almindelig (forekommer hos 1 af 10 patienter)
187 Very common side effects: affect 1 user in 10 • Weight gain. • Sleepiness. • Increases in the levels of prolactin in the blood.
Det vil sædvanligvis gå over af sig selv, men hvis det ikke gør, så fortæl det til lægen.
Common side effects: affect 1 to 10 users in 100 • Changes in the levels of some blood cells and circulating fats. • Increases in the level of sugars in the blood and urine. • Feeling more hungry. • Dizziness. • Restlessness. • Tremor. • Muscle stiffness or spasm (including eye movements). • Problems with speech. • Unusual movement (especially of the face or tongue). • Constipation. • Dry mouth. • Rash. • Loss of strength. • Extreme tiredness. • Water retention leading to swelling of the hands, ankles or feet. • In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position.
Krampeanfald, sædvanligvis forbundet med tidligere karmpeanfald (epilepsi).
Uncommon side effects: affect 1 to 10 users in 1,000 • Slow heart rate. • Make you sensitive to sunlight. • Hair loss.
189
Other possible side effects: frequency cannot be estimated from the available data. • Allergic reaction (e.g. swelling in the mouth and throat, itching, rash). • Diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma. • Lowering of normal body temperature. • Seizures, usually associated with a history of seizures (epilepsy). • Combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. • Spasms of the muscle of the eye causing rolling movement of the eye. • Abnormal rhythms of the heart. • Sudden unexplained death. • Blood clots such as deep venous thrombosis of the leg or blood clot on the lung. • Inflammation of the pancreas causing severe stomach pain, fever and sickness. • Liver disease appearing as yellowing of the skin and white parts of the eyes. • Muscle disease presenting as unexplained aches and pains. • Difficulty in passing urine. • Prolonged and/or painful erection.
I sjældne tilfælde har lægemidler af denne type efter langvarig anvendelse hos kvinder forårsaget, at mælken løber til, at menstruationen udebliver eller uregelmæssig menstruationen.
188 Rarely women taking medicines of this type for a long time have started to secrete milk and have missed periods or had irregular periods.
Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkinger, som ikke er nævnt her.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Hver Olanzapin Teva 5 mg smeltetablet indeholder 5 mg af det aktive stof.
Each Olanzapine Teva 5 mg orodispersible tablet contains 5 mg of the active substance.
Hver Olanzapin Teva 10 mg smeltetablet indeholder 10 mg af det aktive stof.
Each Olanzapine Teva 10 mg orodispersible tablet contains 10 mg of the active substance.
Hver Olanzapin Teva 15 mg smeltetablet indeholder 15 mg af det aktive stof.
Each Olanzapine Teva 15 mg orodispersible tablet contains 15 mg of the active substance.
Hver Olanzapin Teva 20 mg smeltetablet indeholder 20 mg af det aktive stof.
Each Olanzapine Teva 20 mg orodispersible tablet contains 20 mg of the active substance.
Mannitol (E421), natriumstivelsesglycolat, D- glucose og vanille smagsstof.
The other ingredients are Mannitol (E421), Sodium starch glycolate, D-glucose & vanilla flavouring.
Derudover indeholder Olanzapin Teva 5 mg smeltetablet tartrazin (E102), Olanzapin Teva 15 mg smeltetablet indeholder sunset yellow (E110) og Olanzapin Teva 20 mg smeltetablet indeholder indigocarmin (E132).
In addition, Olanzapine Teva 5 mg orodispersible tablet contains Tartrazine lake (E102), Olanzapine Teva 15 mg orodispersible tablet contains Sunset Yellow lake (E110) and Olanzapine Teva 20 mg orodispersible tablet contains Indigo carmine lake (E132).
Olanzapin Tevas udseende og pakningstørrelse Smeltetablet er det tekniske udtryk for en tablet, som straks bliver opløst i din mund, så du let kan sluge den.
What Olanzapine Teva looks like and contents of the pack Orodispersible tablet is the technical name for a tablet which dissolves directly in your mouth, so that it can be easily swallowed.
Olanzapin Teva 5 mg smeltetablet er en mørkegul, flad, rund tablet, glat på begge sider.
Olanzapine Teva 5 mg orodispersible tablet is a dark yellow, flat, round tablet, plain on both sides.
Olanzapin Teva 10 mg smeltetablet er en gul, flad, rund tablet, glat på begge sider.
Olanzapine Teva 10 mg orodispersible tablet is a yellow, flat, round tablet, plain on both sides.
Olanzapin Teva 15 mg smeltetablet er en marmoreret orange, flad, rund tablet, glat på begge sider.
Olanzapine Teva 15 mg orodispersible tablet is a mottled orange, flat, round tablet, plain on both sides.
Olanzapin Teva 20 mg smeltetablet er en grøn, flad, rund tablet, glat på begge sider.
Olanzapine Teva 20 mg orodispersible tablet is a green, flat, round tablet, plain on both sides.
190 Olanzapin Teva 5 mg, 10 mg og 15 mg smeltetabletter fås i kartoner med 28, 30, 35, 50, 56 eller 70 tabletter.
Olanzapine Teva 5 mg, 10 mg and 15 mg orodispersible tablets are available in cartons containing 28, 30, 35, 50, 56 or 70 tablets.
Olanzapin Teva 20 mg smeltetabletter fås i kartoner med 28, 30, 35, 56 eller 70 tabletter.
Olanzapine Teva 20 mg orodispersible tablets are available in cartons containing 28, 30, 35, 56 or 70 tablets.
Indehaveren af markedsføringstilladelsen og fremstiller
189 Marketing Authorisation Holder and Manufacturer
191 België/ Belgique/ Belgien Teva Pharma Belgium N. V. / S. A. / AG Telephone:
190 België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Telephone:
Det leveres som pulver og solvens, der blandes til injektionsvæske (1, 3 eller 5 mg/ ml), eller som færdigblandet opløsning i en cylinderampul (3, 3 eller 6, 7 mg/ ml).
It is available as a powder and solvent, which are made up into a solution for injection (1.3 or 5 mg/ ml), or as a ready-to-use solution in a cartridge (3.3 or 6.7 mg/ ml).
Omnitrope er et biosimilært lægemiddel.
Omnitrope is a ‘ biosimilar’ medicine.
Det vil sige, at Omnitrope svarer til et biologisk lægemiddel, der allerede er godkendt i Den Europæiske Union (EU) og indeholder det samme aktive stof (også kendt som referencelægemidlet).
This means that Omnitrope is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘ reference medicine’).
Omnitrope anvendes til behandling af børn: • som har problemer med væksten, fordi de mangler væksthormon • som har for lille kropshøjde, fordi deres nyrer ikke fungerer, som de skal (kronisk nyreinsufficiens) eller på grund af en defekt i generne, også kaldet Turners syndrom • som har for lille kropshøjde, fordi de ved fødslen var for små i forhold til fødselstidspunktet og ikke har indhentet dette inden fireårsalderen eller senere • som har en arvelig sygdom, der kaldes Prader- Willis syndrom.
Omnitrope is used to treat children: • who have trouble with their growth because they do not have enough growth hormone (GH), • when they are short because they have chronic renal insufficiency (malfunctioning kidneys) or a genetic disorder called Turner syndrome, • when they are short, because they were born small for their gestational age, and have not caught up by the age of four years or later, • when they have a genetic condition called Prader-Willi syndrome.
Omnitrope gives for at fremme væksten og forbedre kroppens sammensætning (forholdet mellem fedt - og muskelmasse).
Omnitrope is given to improve their growth and their body composition (relationship of fat and muscle mass).
Omnitrope i cylinderampuller bør kun indgives ved hjælp af den særlige Omnitrope- indsprøjtningsanordning.
The Omnitrope cartridges should only be used with the special Omnitrope injection device.
Det fremmer væksten i barndommen og ungdommen og har desuden betydning for protein -, fedtstof - og 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
It promotes growth during childhood and adolescence, and also acts on the way the body handles proteins, fat and 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Hormonet produceres af en bakterie, der har fået indsat et gen (DNA), som sætter den i stand til at producere dette hormon.
It is produced by a method known as ‘ recombinant DNA technology’: the hormone is made by a bacterium which has received a gene (DNA) that makes it able to produce it.
Efter ni måneder havde behandling med Omnitrope og Genotropin givet lige stor forøgelse i højde og væksthastighed (svarende til en forøgelse på 10, 7 cm/ år med begge lægemidler).
After nine months, treatment with Omnitrope and Genotropin gave similar increases in height and speed of growth (equivalent to an increase of 10.7 cm per year with both medicines).
Som for alle protein- lægemidler kan nogle patienter desuden danne antistoffer (proteiner, der produceres som reaktion på behandlingen med Omnitrope).
In addition, as with all protein medicines, some patients may develop antibodies (proteins that are produced in response to Omnitrope).
Omnitrope bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for somatropin eller andre af indholdsstofferne (den færdigblandede opløsning og opløsningsvæsken til Omnitrope 5 mg/ ml indeholder benzylalkohol).
Omnitrope should not be used in people who may be hypersensitive (allergic) to somatropin or any of the other ingredients (the ready-to-use solution and the solvent for Omnitrope 5 mg/ ml contain benzyl alcohol).
Somatropin kan gribe ind i kroppens udnyttelse af insulin.
Somatropin may interfere with the body’ s use of insulin.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Omnitrope i henhold til EU - kravene er påvist at have en kvalitet, sikkerhed og virkning, der er sammenlignelig med Genotropins.
The Committee for Medicinal products for Human Use (CHMP) considered that, in accordance with EU requirements, Omnitrope has been shown to have a comparable quality, safety and efficacy profile to Genotropin.
Det var derfor CHMP’ s opfattelse, at fordelene opvejer de identificerede risici som for Genotropin.
Therefore, the CHMP’ s view was that, as for Genotropin, the benefit outweighs the identified risk.
Det firma, der fremstiller Omnitrope, vil undersøge de mulige bivirkninger ved langtidsbehandling med lægemidlet i nærmere detaljer.
The measures taken to ensure the safe use of Omnitrope are linked to the reasons why the medicine is used.
Det gælder således eventuel risiko for udvikling af sukkersyge eller tilbagefald af visse kræftformer ved langtidsbehandling med somatropin, og hvilken betydning antistofdannelse vil få for stoffets virkning.
The company that makes Omnitrope will study in more detail potential long-term side effects of the medicine, such as the possible risk of developing diabetes or re-occurrence of some types of cancer when receiving long-term somatropin treatment, and implications of the development of antibodies on effectiveness.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Omnitrope til Sandoz GmbH den 12. april 2006.
The European Commission granted a marketing authorisation valid throughout the EU for Omnitrope to Sandoz GmbH on 12 April 2006.
Dette sammendrag blev sidst ajourført i 03- 2008
This summary was last updated in 03-2008.
EU- nummer EU/ 1/ 06/ 332/ 001
EU/ 1/ 06/ 332/ 001
Navn Omnitrope
Omnitrope
Styrke 1, 3 mg/ ml
1.3 mg/ ml
Emballage Pulver: hætteglas (glas) Solvens: hætteglas (glas)
powder: vial (glass); solvent: vial (glass)
1, 5 mg Solvens:
1.5 mg; solvent:
Paknings- størrelse 1 hætteglas + 1 hætteglas
1 vial + 1 vial
Pulver: hætteglas (glas) Solvens: patron (glas)
powder: vial (glass); solvent: cartridge (glass)
5, 8 mg, Solvens:
5.8 mg; solvent:
5, 8 mg Solvens:
5.8 mg; solvent:
Injektionsvæske, opløsning i en cylinderampul
Solution for injection in a cartridge
Omnitrope 1, 3 mg/ ml pulver og solvens til injektionsvæske, opløsning
Omnitrope 1.3 mg/ ml powder and solvent for solution for injection
Efter rekonstitution indeholder et hætteglas 1, 3 mg Somatropin * (svarende til 4 IU) pr. ml.
After reconstitution, one vial contains 1.3 mg Somatropin* (corresponding to 4 IU) per ml.
* fremstillet i Escherichia coli med rekombinant DNA- teknologi.
* produced in Escherichia coli by recombinant DNA technology.
Pulver og solvens til injektionsvæske, opløsning Pulveret er hvidt.
Powder and solvent for solution for injection The powder is white.
- Vækstforstyrrelse pga. utilstrækkelig sekretion af væksthormon (GH).
- Growth disturbance due to insufficient secretion of growth hormone (GH).
- Vækstforstyrrelse forbundet med kronisk nyreinsufficiens.
- Growth disturbance associated with chronic renal insufficiency.
- Vækstforstyrrelse (nuværende højde standard deviation score (SDS) < - 2, 5 og forældrejusteret
- Growth disturbance (current height standard deviation score (SDS) < -2.5 and parental adjusted