natgillin/translations-raw huggingface dataset:
All patients with PWS should be evaluated for sleep apnoea and monitored if sleep apnoea is suspected.Patients should be monitored for signs of respiratory infections, which should be diagnosed as early as possible and treated aggressively.
U bolesnika se moraju pratiti eventualni znakovi respiratornih infekcija, a infekcija se mora što prije dijagnosticirati i agresivno liječiti.
- a vial with solvent (liquid) for Omnitrope 1.3 mg/ml.
- bočicu s otapalom (tekućinom) za Omnitrope 1,3 mg/ml.
Store in the original pen in order to protect from light.
Čuvati u originalnoj brizgalici radi zaštite od svjetlosti.
How to inject Omnitrope
Kako injicirati Omnitrope
Pack size of 1.
Veličina pakovanja: 1.
Shelf life after first use
Rok valjanosti nakon prve primjene
Store and transport refrigerated (2°C - 8°C).
Čuvati i prevoziti na hladnom (2 °C - 8 °C).
Musculoskeletal stiffness*
mišićno-koštana ukočenost*
Rare side effects (likely to occur in fewer than 1 in 1,000 patients) include: In children
Rijetke nuspojave (vjerojatnost javljanja u manje od 1 na 1000 bolesnika) obuhvaćaju: U djece
Reconstituting Omnitrope - Remove the protective caps from the two vials in the box.
- Uklonite zaštitne zatvarače s dviju bočica iz kutije.
As kidneys lose their ability to function normally, this can affect growth.
Smanjenje normalne funkcije bubrega može utjecati na rast.
It has to be administered using sterile, disposable pen needles.
Mora se primjenjivati pomoću sterilnih jednokratnih igli za brizgalicu.
It also helps your fat and muscle tissues to develop in the right amounts.
Pospješuje i odgovarajući razvoj masnog i mišićnog tkiva.
Intracranial tumours must be inactive and anti-tumour therapy must be completed prior to starting GH therapy.
Prije započinjanja terapije hormonom rasta intrakranijalni tumori moraju biti neaktivni, a antitumorska terapija mora biti završena.
Patients and caregivers have to receive appropriate training and instruction on the proper use of the Omnitrope cartridges and the pen from the physician or other suitable qualified health professionals.
Bolesnici i osobe koje se brinu za bolesnike moraju biti odgovarajuće educirani i od strane liječnika ili drugog kvalificiranog zdravstvenog osoblja dobiti upute za pravilno korištenje Omnitrope uložaka i brizgalice.
Children with Prader-Willi syndrome
Djeca s Prader-Willijevim sindromom
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili ljekarniku ili medicinskoj sestri.
Clinical response and side effects may also be used as guidance for dose titration.
Za titraciju doze mogu se kao smjernice koristiti i klinički odgovor i nuspojave.
1 vial of 5 mg powder 1 cartridge of 1 ml solvent 5 vials of 5 mg powder 5 cartridges of 1 ml solvent
1 bočica s 5 mg praška 1 uložak s 1 ml otapala 5 bočica s 5 mg praška 5 uložaka s 1 ml otapala
Signs of scoliosis should be monitored during treatment.
Tijekom liječenja potrebno je pratiti pojavu znakova skolioze.
Children with Turner syndrome: 0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day.
Djeca s Turnerovim sindromom: 0,045-0,050 mg/kg tjelesne težine na dan ili 1,4 mg/m2 površine tijela na dan.
For instructions for use and handling see section 6.6.
Za uputu o primjeni i rukovanju, vidjeti dio 6.6. 4.3 Kontraindikacije
Higher doses may be needed if growth velocity is too low.
Ako je brzina rasta premala, mogu biti potrebne i veće doze.
The following instructions explain how to inject Omnitrope 1.3 mg/ml yourself.
U uputama u nastavku objašnjeno je kako ćete sami injicirati Omnitrope 1,3 mg/ml.
The following instructions explain how to inject Omnitrope 5 mg/ml yourself.
U uputama u nastavku objašnjeno je kako ćete sami injicirati Omnitrope 5 mg/ml.
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).
(aluminij) i zatvarač (ljubičasti polipropilenski „flip-off“), te 1 ml otapala u bočici (staklo tip I) s čepom (klorobutilni elastomer laminiran smolom fluora), dvoslojnica/strip (lakirani aluminij) i zatvarač (bijeli polipropilenski „flip-off“).
One vial contains 1.3 mg (corresponding to 4 IU) of somatropin after reconstitution with 1 ml solvent.
Jedna bočica sadrži 1,3 mg (što odgovara vrijednosti od 4 IU) somatropina nakon pripreme s 1 ml otapala.
Conversely, if a woman on somatropin discontinues oral oestrogen therapy, the dose of somatropin may need to be reduced to avoid excess of growth hormone and/or side effects (see section 4.5).
dozu lijeka somatropinom možda će biti potrebno sniziti kako bi se izbjegao višak hormona rasta i/ili nastanak nuspojava (vidjeti dio 4.5).
5 cartridges for SurePal 5 10 cartridges for SurePal 5
5 uložaka za SurePal 5 10 uložaka za SurePal 5
In general, administration of somatropin to growth hormone deficient patients results in reduction in serum LDL and apolipoprotein B. A reduction in serum total cholesterol may also be observed.
Primjena somatropina u bolesnika s deficitom hormona rasta općenito smanjuje LDL i apolipoprotein B u serumu.
Omnitrope 5 mg/1.5 ml solution for injection 2 years.
Omnitrope 5 mg/1,5 ml otopina za injekciju 2 godine.
STATEMENT OF ACTIVE SUBSTANCE Somatropin 10 mg (30 IU)/ml.
Somatropin 10 mg (30 IU)/ml.
The maintenance dose rarely exceeds 1.0 mg per day.
Dnevna doza održavanja rijetko prekoračuje 1,0 mg na dan.
Injecting Omnitrope - With a cleansing swab, disinfect the rubber membrane of the cartridge.
Injiciranje Omnitropea - Tupferom za čišćenje, dezinficirajte gumenu membranu uloška.
- Take the vial with solvent and the sterile, disposable syringe (e.g. 2 ml syringe) and needle (e.g. 0.33 mm x 12.7 mm).
Pomoću sterilne, jednokratne štrcaljke (npr. štrcaljke od 2 ml) i igle (npr. 0,33 mm x 12,7 mm)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS OMNITROPE CARTRIDGE LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE OZNAKA NA ULOŠKU LIJEKA OMNITROPE
Patients and caregivers have to receive appropriate training and instruction on the proper use of the Omnitrope vials, the cartridges with solvent, the transfer set and the pen from the physician or other suitable qualified health professionals.
Bolesnici i osobe koje se brinu za bolesnike moraju biti odgovarajuće educirani i od strane liječnika ili drugog kvalificiranog zdravstvenog osoblja dobiti upute za pravilno korištenje Omnitrope bočica, uložaka s otapalom, kompleta za prijenos i brizgalice.
Powder and solvent for solution for injection (powder in a vial (5 mg), solvent in a cartridge (1 ml)) Pack sizes of 1 and 5.
Prašak i otapalo za otopinu za injekciju (prašak u bočici (5 mg), otapalo u ulošku (1 ml)).
• Increased intracranial pressure (which causes symptoms such as strong headache, visual disturbances or vomiting)
• povišen intrakranijalni tlak (koji uzrokuje simptome kao što su jake glavobolje, poremećaji vida ili povraćanje)
• if you are seriously ill (for example, complications following open heart surgery, abdominal surgery, accidental trauma, acute respiratory failure, or similar conditions).
abdominalne operacije, slučajne povrede, akutno zatajenje disanja, ili slična stanja).
Omnitrope 10 mg/1.5 ml solution for injection 18 months.
Omnitrope 10 mg/1,5 ml otopina za injekciju 18 mjeseci.
• 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.
• Tijekom liječenja somatropinom, obavijestite svog liječnika ako primijetite znakove opstrukcije gornjih dišnih puteva (uključujući pojavu hrkanja ili pojačanje hrkanja).
Omnitrope 15 mg/1.5 ml solution for injection 18 months.
Omnitrope 15 mg/1,5 ml otopina za injekciju 18 mjeseci.
The contents must be clear and colourless.
Sadržaj mora biti bistar i bezbojan.
- Take the vial with the powder and push the needle through the rubber membrane of the vial.
- Uzmite bočicu s praškom i uvedite iglu kroz gumenu membranu na bočici.
• Increased intracranial pressure (which causes symptoms, such as strong headache, visual disturbances or vomiting)
• povišen intrakranijalni tlak (koji uzrokuje simptome, kao što su jake glavobolje, poremećaji vida ili povraćanje)
STATEMENT OF ACTIVE SUBSTANCE Somatropin 3.3 mg (10 IU)/ml.
Somatropin 3,3 mg (10 IU)/ml.
Injecting Omnitrope - Put the cartridge with the dissolved Omnitrope into the pen for injection.
Injiciranje Omnitropea - Uložak s otopljenim lijekom Omnitrope umetnite u brizgalicu.
• Your doctor will assess you for signs of upper airway obstruction, sleep apnoea (where your breathing is interrupted during sleep), or respiratory infection before you start treatment with somatropin.
• Liječnik će prije započinjanja liječenja somatropinom provjeriti postoje li znakovi opstrukcije gornjih dišnih puteva, apneje u snu (stanja u kojem se u snu prekida disanje) ili upale dišnih puteva.
Small for gestational age
Djeca koja su rođena mala za gestacijsku dob
‡ Clinical significance is unknown
‡ Nije poznata klinička značajnost.
Assemble the pen following the instructions for use.
Sastavite brizgalicu prema uputama za upotrebu.
Do not share your pen.
Nemojte brizgalicu dijeliti s drugima.
Transfer the solution back into the cartridge using the transfer set.
Vratite otopinu natrag u uložak pomoću kompleta za prijenos.
Based on available literature, higher doses of growth hormone are generally required during the initiation and maintenance phases of treatment in women with an intact hypothalamic-pituitarygonadal axis and on oral oestrogens.
Na temelju dostupne literature ustanovljeno je da su ženama koje imaju neoštećenu os hipotalamushipofiza-gonade i peroralno uzimaju estrogen, tijekom početne faze liječenja i faze održavanja uglavnom potrebne više doze hormona rasta.
Arthralgia* Myalgia* Musculoskeletal stiffness*
mialgija* mišićno-koštana ukočenost *
Each ml of solution contains 10 mg of somatropin (corresponding to 30 IU).
Jedan ml otopine sadrži 10 mg somatropina (što odgovara vrijednosti od 30 IU).
Very common side effects (likely to occur in more than 1 in 10 patients) include:
Vrlo česte nuspojave (vjerojatnost javljanja u više od 1 na 10 bolesnika) obuhvaćaju:
After reconstitution, one cartridge contains 5 mg somatropin (corresponding to 15 IU) per ml.
Nakon pripreme, jedan uložak sadrži 5 mg somatropina (što odgovara vrijednosti od 15 IU) u ml.
One cartridge contains 5 mg (corresponding to 15 IU) of somatropin after reconstitution with 1 ml solvent.
Jedan uložak sadrži 5 mg (što odgovara vrijednosti od 15 IU) somatropina nakon pripreme s 1 ml otapala.
• If you have chronic renal (kidney) insufficiency.
• Ako imate kroničnu insuficijenciju bubrega.
Bone metabolism
Metabolizam kostiju
Each vial must be reconstituted with the accompanying solvent only.
Svaka se bočica smije pripremiti samo s priloženim otapalom.
The solvent is clear and colourless.
Otopina je bistra i bezbojna.
- 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).
- Omnitrope Pen L, medicinski proizvod posebno izrađen za primjenu uz Omnitrope 5 mg/ml rekonstituiranu otopinu za injekciju (nije isporučeno u pakovanju; vidjeti upute za upotrebu kompleta za prijenos i injekcijskog uređaja).
Omnitrope 10 mg/1.5 ml is intended for multiple use.
Omnitrope 10 mg/1,5 ml je namijenjen za višekratnu upotrebu.
- Push the needle through the rubber stopper of the vial with the reconstituted solution.
- Uvedite iglu kroz gumeni čep bočice s rekonstituiranom otopinom.
After reconstitution, one vial contains 1.3 mg somatropin (corresponding to 4 IU) per ml.
Nakon pripreme, jedna bočica sadrži 1,3 mg somatropina (što odgovara vrijednosti od 4 IU) u ml.
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.
Supkutana doza od 5 mg Omnitrope praška i otapala za otopinu za injekciju u zdravih odraslih osoba rezultira plazmatskim vrijednostima Cmax od 71 ± 24 µg/l (srednja vrijednost ± SD), odnosno medijanom vrijednosti tmax od 4 sata (raspon 2 - 8 sati).
Turn the vial upside down and using another sterile, disposable syringe of appropriate size (e.g. 1 ml syringe) and injection needle (e.g. 0.25 mm x 8 mm) withdraw a bit more than the dose needed back into the syringe.
štrcaljke od 1 ml) i igle za injekciju (npr. 0,25 mm x 8 mm) izvucite nešto više otopine nego što je potrebno za dozu.
Omnitrope 5 mg/ml is intended for multiple use.
Omnitrope 5 mg/ml je namijenjen za višekratnu upotrebu.
• 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.
• Nakon prve injekcije, uložak mora ostati u brizgalici i mora se čuvati u hladnjaku (2 °C-8 °C) i iskoristiti tijekom najdulje 21 dan.
One cartridge contains 15 mg (corresponding to 45 IU) of somatropin in 1.5 ml.
Jedan uložak sadrži 15 mg (što odgovara vrijednosti od 45 IU) somatropina u 1,5 ml.
Remove any air bubbles from the syringe.
- Uklonite eventualne mjehuriće zraka.
1 cartridge for SurePal 15 5 cartridges for SurePal 15 10 cartridges for SurePal 15
5 uložaka za SurePal 15 10 uložaka za SurePal 15
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 otopina za injekciju Omnitrope 10 mg/1,5 ml otopina za injekciju Omnitrope 15 mg/1,5 ml otopina za injekciju
Use the transfer set for transferring the solvent from the cartridge into the vial.
Pomoću kompleta za prijenos prenesite otapalo iz uloška u bočicu.
Powder: glycine, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate Solvent: benzyl alcohol, water for injections
Prašak: glicin, dinatrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat dihidrat Otapalo: benzilni alkohol, voda za injekcije Sadrži benzilni alkohol.
Read package leaflet before use.
Prije uporabe pročitajte Uputu o lijeku.
Flip off the plastic protective caps from the vials.
Uklonite plastični zaštitni zatvarač s bočice.
• 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.
• Nakon prve injekcije, uložak mora ostati u brizgalici i mora se čuvati u hladnjaku (2 °C-8 °C) i iskoristiti tijekom najdulje 28 dana.
- Turn the vial with the solvent upside down and withdraw all the solvent from the vial.
- Okrenite prema dolje bočicu s otapalom i izvucite otapalo iz bočice.
- Take the needle off the pen using the outer needle cap, and discard the needle.
- Pomoću vanjskog zatvarača igle odvojite iglu od brizgalice i bacite je.
- a sterile, disposable syringe of appropriate size (e.g. 1 ml syringe)
- Uzmite sterilnu jednokratnu štrcaljku odgovarajuće veličine (npr.
INFORMATION IN BRAILLE Omnitrope 5 mg/ml
16. PODACI NA BRAILLEOVOM PISMU Omnitrope 5 mg/ml
Flip off the plastic protective cap from the vial.
Uklonite plastične zaštitne zatvarače s bočica.
However, after subcutaneous administration of Omnitrope 5 mg/ml powder and solvent for solution for injection, a half-life of 3 hours is achieved.
Međutim, nakon supkutane primjene Omnitrope 5 mg/ml praška i otapala za otopinu za injekciju postiže se poluvijek od 3 sata.
All patients with PWS should have effective weight control before and during growth hormone treatment.
Prije i tijekom liječenja hormonom rasta bolesnici s PWS-om moraju na učinkovit način kontrolirati tjelesnu težinu.
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.
Umetnite uložak u SurePal prema uputama za upotrebu priloženim uz brizgalicu.
You should check with your doctor or pharmacist if you are not sure.
Ako niste sigurni, provjerite s Vašim liječnikom ili ljekarnikom.
Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include:
Manje česte nuspojave (vjerojatnost javljanja u manje od 1 na 100 bolesnika) obuhvaćaju:
*In general, these adverse effects are mild to moderate, arise within the first months of treatment, and subside spontaneously or with dose-reduction.
* Te su nuspojave uglavnom blage do umjerene, javljaju se tijekom prvih mjeseci liječenja i nestaju spontano ili nakon smanjenja doze.
Powder: glycine, disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate Solvent: water for injections
Prašak: glicin, dinatrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat dihidrat Otapalo: voda za injekcije
Uncommon ≥ 1/1,000 to
Manje često ≥ 1/1000 i
Neoplasms Benign, Malignant and Unspecified (including cysts and polyps)
Dobroćudne, zloćudne i nespecificirane novotvorine
Powder: glycine disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate
Prašak: glicin dinatrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat
• Stiffness in the arms and legs, muscle pain
• bolovi u zglobovima
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 otopina za injekciju Jedan ml otopine sadrži 6,7 mg somatropina* (što odgovara vrijednosti od 20 IU).
Omnitrope 15 mg/1.5 ml solution for injection is for use in SurePal 15 only.
Omnitrope 15 mg/1,5 ml otopina za injekciju namijenjena je isključivo za upotrebu sa SurePal 15.
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.
Nakon prve primjene, uložak mora ostati u brizgalici te se mora čuvati u hladnjaku (2 °C - 8 °C) najdulje 28 dana.
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 otopina za injekciju je sterilna gotova otopina za supkutanu injekciju u staklenom ulošku.
Blood cortisol decreased‡
Pretrage snižen kortizol u krvi‡
Replacement therapy in adults with growth hormone deficiency System Organ
Nadomjesna terapija u odraslih s deficitom hormona rasta Klasifikacija organskog sustava
In general these adverse reactions are mild to moderate, arise within the first months of treatment and subside spontaneously or with dose-reduction.
Te su nuspojave uglavnom blage do umjerene, javljaju se tijekom prvih mjeseci liječenja i nestaju spontano ili nakon smanjenja doze.
Omnitrope 5 mg/1.5 ml solution for injection Omnitrope 10 mg/1.5 ml solution for injection
Omnitrope 5 mg/1,5 ml otopina za injekciju Omnitrope 10 mg/1,5 ml otopina za injekciju
Omnitrope 5 mg/1.5 ml is intended for multiple use.
Omnitrope 5 mg/1,5 ml je namijenjen za višekratnu upotrebu.
• medicine to treat diabetes,
• lijekove za liječenje dijabetesa, • hormone štitnjače,
- a sterile, disposable syringe (e.g. 2 ml syringe) and needle (e.g.
- sterilnu jednokratnu štrcaljku (npr. štrcaljku od 2 ml) i iglu (npr.
Treatment should be discontinued if there is evidence of tumour growth.
Liječenje se mora obustaviti ako je brzina rasta rasta u visinu
How to store Omnitrope
Kako čuvati Omnitrope
Other ingredients:
Simptomi:
0.025-0.035 mg/kg body weight per day or 0.7-1.0 mg/m2 body surface area per day.
0,025-0,035 mg/kg tjelesne težine na dan ili 0,7-1,0 mg/m2 površine tijela na dan.
Omnitrope 5 mg/1.5 ml solution for injection:
Omnitrope 5 mg/1,5 ml otopina za injekciju:
Type 2 diabetes mellitus
• dijabetes melitus tipa 2
Omnitrope 10 mg/1.5 ml in a cartridge for SurePal 10 is intended for multiple use.
Omnitrope 10 mg/1,5 ml u ulošku za SurePal 10 je namijenjen za višekratnu upotrebu.
- Use the transfer set for transferring all the solvent from the cartridge into the vial.
- Pomoću kompleta za prijenos prenesite cjelokupan sadržaj otopine natrag u uložak.
1 cartridge for SurePal 10 5 cartridges for SurePal 10 10 cartridges for SurePal 10
5 uložaka za SurePal 10 10 uložaka za SurePal 10
Excipient(s) with known effect: One ml contains 9 mg benzyl alcohol.
Jedan ml sadrži 9 mg benzilnog alkohola.
Shelf life after reconstitution
Rok valjanosti nakon pripreme
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 otopina za injekciju je sterilna gotova otopina za supkutanu injekciju u staklenom ulošku.
How to use Omnitrope
Kako primjenjivati Omnitrope
The maintenance dose seldom exceeds 0.5 mg per day.
Doza održavanja rijetko je kad viša od 0,5 mg na dan.
and injection needle (e.g. 0.25 mm x 8 mm) for subcutaneous injection (not supplied in the pack).
- sterilnu jednokratnu štrcaljku odgovarajuće veličine (npr. štrcaljku od 1 ml) i iglu za injekcije (npr. 0,25 mm x 8 mm) za potkožnu injekciju (nije isporučeno u pakovanju).
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.
Preporučuje se doza od 0,045 - 0,050 mg/kg tjelesne težine na dan ili 1,4 mg/m2 tjelesne površine na dan.
With a cleansing swab, disinfect the rubber membranes of both the powder-filled and the solvent-filled vial.
Tupferom za čišćenje, dezinficirajte gumene membrane na bočici s praškom i na bočici s otapalom.
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.
Kod pripreme Omnitrope 5 mg/ml praška za otopinu za injekciju, umetanja uloška, pričvršćivanja injekcijske igle i primjene nužno je pridržavanje uputa proizvođača za svaki pojedinačni komplet za prijenos i brizgalicu.
Replacement therapy in adults with growth hormone deficiency
Klinička ispitivanja u odraslih s deficitom hormona rasta
Tumours must be inactive and you must have finished your anti-tumour treatment before you start your treatment with Omnitrope.
Prije početka liječenja Omnitropeom tumori moraju biti neaktivni, a liječenje tumora mora biti završeno.
INFORMATION IN BRAILLE Omnitrope 1.3 mg/ml
16. PODACI NA BRAILLEOVOM PISMU Omnitrope 1,3 mg/ml
One cartridge contains 1.5 ml corresponding to 10 mg somatropin (30 IU).
Jedan uložak sadrži 1,5 ml što odgovara količini od 10 mg somatropina (30 IU).
Sandoz GmbH Biochemiestr.
Sandoz GmbH Biochemiestr. 10 A-6250 Kundl Austrija
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.
Smije se primjenjivati samo pomoću brizgalice Omnitrope Pen L, medicinskog proizvoda posebno izrađenog za primjenu uz Omnitrope 5 mg/ml prašak i otapalo za otopinu za injekciju.
Powder: glycine disodium hydrogen phosphate heptyhydrate sodium dihydrogen phosphate dihydrate
glicin dinatrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat
Omnitrope 15 mg/1.5 ml in a cartridge for SurePal 15 is intended for multiple use.
Omnitrope 15 mg/1,5 ml u ulošku za SurePal 15 je namijenjen za višekratnu upotrebu.
0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day.
0,035 mg/kg tjelesne težine na dan ili 1,0 mg/m2 površine tijela na dan.
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 tjelesne težine na dan ili 1,4 mg/m2 površine tijela na dan.
What Omnitrope 10 mg/1.5 ml contains
Što Omnitrope 10 mg/1,5 ml sadrži
• Leukaemia (This has been reported in a small number of growth hormone deficiency patients,
• leukemija (bila je prijavljena u malog broja bolesnika s nedostatkom hormona rasta, od kojih su neki bili liječeni somatropinom.