natgillin/translations-raw huggingface dataset:
In adults: carpal tunnel syndrome Endocrine disorders
mladostnikih: motnje pri zaznavanju
Diabetes mellitus
pri odraslih: sindrom karpalnega kanala
Disorders of the immune system Benign and malignant neoplasms
bolezni endokrinega sistema
Development of antibodies
sladkorna bolezen
Leukemia
pojav protiteles
General disorders and
levkemija
reactions at the injection site
63 Splošne težave in reakcije na mestu injiciranja
- Temporary local reactions at the injection site, such as pain, numbness, reddening, and swelling
- Začasne lokalne reakcije na mestu injiciranja, npr. bolečine, otrplost, rdečina in oteklina, so
are common side effects.
pogosti neželeni učinki.
In isolated cases, subcutaneous administration of somatropin can lead to loss of fatty tissue at the injection site.
V posameznih primerih se lahko zaradi podkožne uporabe somatropina zmanjša maščobno tkivo na mestu injiciranja.
This side effect is a
- Pojavi se lahko blaga oteklina (nabiranje vode v tkivih), ki je posledica motenj ravnotežja
consequence of disturbances in fluid balance and occurs only at the start of treatment with somatropin and is dose-dependent.
tekočin, in to le na začetku zdravljenja s somatropinom, odvisna pa je od odmerka.
It is common in adult patients, but uncommon in infants, children and adolescents.
Pogosta je pri odraslih bolnikih ter redka pri dojenčkih, otrocih in mladostnikih.
64 Musculoskeletal system, connective tissues, and bones
Skeletne mišice, vezivno tkivo in kosti
- Joint and muscle pain (especially in the hip or knee) and stiffness of the limbs have been
- Pojavijo se lahko bolečine v sklepih in mišicah (zlasti v kolkih ali kolenih) ter okorelost
observed.
okončin.
These side effects occur only at the start of treatment with somatropin and are dose- dependent.
Ti neželeni učinki se pojavijo le na začetku zdravljenja s somatropinom in so odvisni od velikosti odmerka.
They are common in adult patients, but uncommon in infants, children and adolescents.
Pogosti so pri odraslih bolnikih in občasni pri dojenčkih, otrocih in mladostnikih.
- Sensory disturbances, such as numbness and tingling, have been observed.
- Pojavijo se lahko motnje zaznavanja, na primer odrevenelost in mravljinčenje.
These usually occur
Po navadi se
at the start of treatment with somatropin and are dose-dependent.
pojavijo na začetku zdravljenja s somatropinom in so odvisne od odmerka.
They are common in adult patients, but uncommon in infants, children and adolescents.
Pogoste so pri odraslih bolnikih in redke pri dojenčkih, otrocih in mladostnikih.
- Muscular atrophy (reduction of muscular tissue) of the ball of the thumb and sensory
- Mišična atrofija (zmanjšanje mišične mase) blazinice palca ter motnje zaznavanja v prstih rok in
disturbances in the fingers and palm of the hand are uncommon side effects.
na dlaneh so redki neželeni učinki.
They are consequences of carpal tunnel syndrome (constriction of the nerve supplying part of the palm of the hand), which has been observed mainly in adults.
So posledica sindroma karpalnega kanala (pritiska na živec, ki oskrbuje del dlani roke), ki se pojavi predvsem pri odraslih.
- Visual disturbances, headaches, nausea, and vomiting have been observed.
- Pojavijo se lahko motnje vida, glavobol, slabost in bruhanje.
These symptoms
Ti simptomi utegnejo biti znak
could indicate benign intracranial hypertension (increased brain pressure), which is a rare side effect of treatment with somatropin.
benigne intrakranialne hipertenzije (zvišanega krvnega tlaka v možganih), ki je redek neželeni učinek zdravljenja s somatropinom.
- Diabetes has been observed as a rare side effect.
- Redek neželeni učinek, ki se lahko pojavi, je sladkorna bolezen.
Disorders of the immune system
Motnje imunskega sistema
- As with all protein based medicines, some patients may develop antibodies to the protein.
- Kot pri vseh zdravilih, ki vsebujejo beljakovino, se lahko pri nekaterih bolnikih pojavijo
However, these have not been found to have growth-inhibiting effects.
Vendar pa ni dokazano, da bi ta negativno vplivala na rast.
This is a common side effect.
To je pogost neželeni učinek.
Benign and malignant neoplasms
Benigne in maligne novotvorbe
- Very rare cases of leukemia have been reported in growth-hormone deficient children treated
- Poročali so o zelo redkih primerih levkemije pri otrocih s pomanjkanjem rastnega hormona, ki
with somatropin.
so jih zdravili s somatropinom.
A causal relationship to somatropin therapy is unlikely.
Verjetnost vzročne povezave z zdravljenjem s somatropinom je majhna.
HOW TO STORE OMNITROPE
SHRANJEVANJE ZDRAVILA OMNITROPE
Do not use after the expiry date which is stated on the label and carton.
Zdravila Omnitrope ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
- Store and transport refrigerated (2°C - 8°C).
- Zdravilo shranjujte in prevažajte na hladnem (2 °C– 8 °C).
- Store in the original package in order to protect from light.
- Shranjujte v originalni ovojnini, da zaščitite pred svetlobo.
- After reconstitution, from a microbiological point of view, the product should be used
- Po pripravi raztopine je zaradi mikrobioloških razlogov priporočena takojšnja uporaba zdravila.
Do not use Omnitrope if it was frozen or subject to high temperatures.
Zdravila Omnitrope ne smete uporabljati, če je bilo zamrznjeno ali izpostavljeno visokim temperaturam.
Do not use Omnitrope if you notice that the solution is cloudy.
Zdravila Omnitrope ne uporabljajte, če opazite, da je raztopina motna.
The active substance of Omnitrope is somatropin (1.3 mg) in a vial.
Zdravilna učinkovina v zdravilu Omnitrope je somatropin (1, 3 mg) v viali.
One vial contains 1.3 mg (corresponding to 4 IU) of somatropin after reconstitution with 1 ml solvent.
Po rekonstituciji z 1 ml vehikla, ena viala vsebuje 1, 3 mg (ustreza 4 i. e.) somatropina.
Powder: glycine disodium hydrogen phosphate heptyhydrate sodium dihydrogen phosphate dihydrate
Prašek: glicin natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat
Powder and solvent for solution for injection (powder in a vial (1.3 mg), solvent in a vial (1 ml)).
Prašek in vehikel za raztopino za injiciranje (prašek v viali (1, 3 mg), vehikel v viali (1 ml)).
10 A-6250 Kundl Austria Tel: + 43-(0)5338 2000
10 A- 6250 Kundl Austria
Osa Mayor, 4 E-28023 Aravaca (Madrid) Tel: + 34 91 740 12 80
Osa Mayor, 4 2o andar – Escritório 15 E- 28023 Aravaca (Madrid) Tel: + 34 91 740 12 80
Italia Sandoz S. p. A.
66 Suomi/ Finland Italia Sandoz Oy Ab Sandoz S. p. A.
Κύπρος Sandoz GmbH Biochemiestr.
Sverige Κύπρος Sandoz AB Sandoz GmbH Berga Allé 1E Biochemiestr.
10
10 S- 254 52 Helsingborg A- 6250 Kundl Tel: + 46 42 152065 Austria Tel: + 43 - (0) 5338 2000
starting therapy.
zdravljenje tumorja.
- To stimulate growth if growing is already finished (closed epiphyses).
- za spodbujanje rasti, če je ta že končana (zaprte epifize).
Take special care with Omnitrope
68 Bodite posebno pozorni pri uporabi zdravila Omnitrope
- All patients with PWS should have effective weight control before and during treatment with
- Pri vseh bolnikih s PWS je treba učinkovito nadzorovati telesno maso pred začetkom
somatropin.
zdravljenja s somatropinom in med njim.
Patients born SGA
Bolniki, ki se rodijo majhni za svojo gestacijsko starost
- Some of the height gain obtained with treating short children/ adolescents born SGA with
- Nekaj pridobljenih centimetrov telesne višine pri otrocih, ki so se rodili majhni za svojo
somatropin may be lost if treatment is stopped before final height is reached.
gestacijsko starost, s pomočjo zdravljenja s somatropinom, se lahko izgubi, če zdravljenje ustavimo, preden se doseže končna telesna višina.
May cause toxic reactions and allergic reactions in infants and children up to 3 years old.
Pri otrocih, starih do 3 let, lahko povzroči toksične in alergijske reakcije.
Omnitrope 5 mg/ ml is intended for multiple use.
Zdravilo Omnitrope 5 mg/ ml je namenjeno za večkratno uporabo.
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.
Dajati se sme samo z napravo za injiciranje zdravilo Omnitrope Pen 5, narejeno posebej za uporabo z zdravilom Omnitrope 5 mg/ ml prašek in vehikel za injiciranje.
Omnitrope is given through a short injection needle into the fatty tissue just under your skin.
Zdravilo Omnitrope se daje s kratko injekcijsko iglo v maščevje tik pod kožo.
71 How much and how often to use Omnitrope
Koliko zdravila Omnitrope uporabiti in kako pogosto
Dose adjustments may be required over time, depending on your increase in body weight and response.
70 Sčasoma bo morda potrebna prilagoditev odmerkov, kar je odvisno od zvečanja telesne mase in odziva.
How to inject Omnitrope 5 mg/ ml
Kako si je treba injicirati zdravilo Omnitrope, 5 mg/ ml
The following instructions explain how to inject Omnitrope 5 mg/ ml yourself.
Navodila v nadaljevanju pojasnjujejo, kako si lahko sami injicirate zdravilo Omnitrope, 5 mg/ ml.
- a vial with Omnitrope 5 mg/ ml powder for solution for injection.
- vialo s praškom za raztopino za injiciranje zdravila Omnitrope
- a cartridge with solvent for Omnitrope 5 mg/ ml.
- vložek z vehiklom Omnitrope 5 mg/ ml
- a transfer set for mixing and transferring the reconstituted solution
- set za prenos za mešanje in prenos pripravljene raztopine nazaj v
back into the cartridge (see Instructions for Use of the pen injector).
vložek (glejte navodila za uporabo peresnika za injiciranje)
- the Omnitrope Pen L, an injection device specifically developed for
- napravo za injiciranje Omnitrope Pen L, narejeno posebej za
use with Omnitrope 5 mg/ ml reconstituted solution for injection (not supplied in the pack; see Instructions for Use of the transfer set and of the injection device).
uporabo pripravljene raztopine za injiciranje zdravila Omnitrope, 5 mg/ ml (ki je ni v ovojnini; glejte Navodila za uporabo seta za prenos in priprave za injiciranje)
- a pen needle for subcutaneous injection.
- igla za pero za subkutano injiciranje
- Remove the protective cap from the vial.
- Odstranite zaščitno zaporko z viale.
With a cleansing swab,
Z blazinico iz vate razkužite
disinfect both the rubber membrane of the vial with powder and the rubber membrane of the cartridge with solvent.
gumijasto membrano viale, napolnjene s praškom, in vložka, napolnjenega z vehiklom.
- Use the transfer set for transferring all the solvent from the
- Vzemite set za prenos, da boste prenesli ves vehikel iz vložka v
cartridge into the vial.
vialo.
- Gently swirl the reconstituted vial until the content is completely
- Pripravljeno vsebino viale narahlo vrtite, dokler se vsebina
- If the solution is cloudy (and the cloudiness does not disappear
- Če je raztopina motna ali vsebuje delce, je ne smete uporabiti.
- Transfer all of the dissolved solution back into the cartridge using
- Za prenos raztopine nazaj v vložek uporabite set za prenos.
the transfer set.
Injiciranje zdravila Omnitrope
Injecting Omnitrope
71
- Put the cartridge with the dissolved Omnitrope into the pen for
- Vložek z raztopljenim zdravilom Omnitrope vstavite v pero za
injection.
injiciranje.
Follow the Instructions for Use of the pen injector.
Upoštevajte navodila za uporabo peresa za injiciranje.
To setup the pen dial the dose.
Nastavite odmerek na peresu.
- Make sure you inject at least 1 cm from your last injection site and
- Bodite pozorni na to, da si zdravilo injicirate najmanj 1 cm stran
that you change the places where you inject, as you have been taught.
od mesta zadnjega injiciranja in da zamenjate mesto injiciranja, kot so vas naučili.
- Before you make an injection, clean your skin well with an alcohol
- Pred injiciranjem dobro očistite kožo z blazinico iz vate,
swab.
namočeno v alkohol.
- Insert the needle into the skin in the way your doctor has taught
- Iglo zapičite v kožo tako, kot vam je pokazal zdravnik.
sterile gauze for several seconds.
Po injiciranju • Iglo odstranite s peresa z uporabo zunanje zaporke igle in jo zavrzite.
Do not massage the injection site.
Tako bo raztopina Omnitrope ostala sterilna in ne bo odtekala.
It will also stop air going back into the pen and the needle clogging up.
To bo tudi preprečilo vstop zraka nazaj v pero in zamašitev igle.
Do
Svojega peresa ne dajajte drugim. • Vložek pustite v peresu, ga zaprite z zaporko in shranite v hladilniku. • Vložek pustite v peresu, ga zaprite z zaporko in shranite v hladilniku. • Po hranjenju raztopine v hladilniku mora biti ta bistra.
not use if the solution is cloudy or contains particles.
Raztopine ne uporabljajte, če je motna ali vsebuje delce.
73 General disorders and reactions at the injection site
injiciranja
Common (occurring in at least 1 of 100 but less than 1 of 10 patients) In infants/ children/ adolescents: transient local skin reactions
mladostnikih: prehodne lokalne reakcije na koži
Uncommon (occurring in at least 1 of 1,000 but less than 1 of 100 patients) In infants/ children/ adolescents: mild oedema
pri odraslih: blagi edem
Rare (occurring in at least 1 of 10,000 but less than 1 of 1,000 patients)
pri
Very Rare (occurring in less than 1 of 10,000 patients)
skeletne mišice,
Nervous system
živčevje
In adults: carpal tunnel syndrome Endocrine disorders
zaznavanju
Diabetes mellitus
mladostnikih: motnje pri zaznavanju
Disorders of the immune system Benign and malignant neoplasms
pri odraslih: sindrom karpalnega kanala sladkorna bolezen bolezni endokrinega sistema motnje imunskega sistema benigne in maligne novotvorbe
Development of antibodies
pojav protiteles
Leukemia
levkemija
General disorders and
Splošne težave in reakcije na mestu injiciranja
Musculoskeletal system, connective tissues, and bones
Skeletne mišice, vezivno tkivo in kosti
74 Nervous system
73 Živčevje
These usually occur
Ponavadi se
- After the first injection, the cartridge should remain in the pen injector and has to be stored in a
- Po prvem injiciranju mora vložek ostati v peresu za injiciranje, ki ga je treba hraniti v hladilniku
refrigerator (2°C - 8°C) and only used for a maximum of 21 days.
(2 °C do 8 °C), uporabljati pa se sme največ 21 dni.
The active substance of Omnitrope is somatropin (5 mg/ ml) in a vial.
Zdravilna učinkovina v zdravilu Omnitrope je somatropin (5 mg/ ml) v viali.
One cartridge contains 5 mg (corresponding to 15 IU) of somatropin after reconstitution with 1 ml solvent.
Po rekonstrukciji z 1 ml vehikla, en vložek vsebuje 5 mg (ustreza 15 i. e.) somatropina.
Powder: glycine
Prašek: glicin natrijev hidrogenfosfat heptahidrat
75 disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate
74 natrijev dihidrogenfosfat dihidrat
11 D-83607 Holzkirchen Tel: + 49 (0)8024 902 40 00 E-Mail: info@sandoz. de
11 D- 83607 Holzkirchen Tel: + 49( 0) 8024 902 40 00 E- Mail: info@ sandoz. de
76 Eesti Österreich Sandoz d. d.
75 Österreich Eesti Sandoz GmbH Sandoz d. d.
Sandoz GmbH Biochemiestr.
Eesti filiaal Biochemiestr.
10 A-6250 Kundl Tel: + 43-(0)5338 2000
10 Pärnu mnt 105 A- 6250 Kundl EE - 11312 Tallinn Tel: + 43 - (0) 5338 2000 Tel: +372 665 2400
Alameda da Beloura, Edifício 1 2o andar – Escritório 15 P-2710-693 Sintra Tel: + 351 21 000 86 00
15 P- 2710- 693 Sintra Tel: + 351 21 000 86 00
77 Latvija Sandoz d. d.
76 United Kingdom Latvija Sandoz Limited Sandoz d. d.
Representative office Meza str.
Representative office 37, Woolmer Way Meza str.
4 Riga, LV-1048 Tel: + 371 7 892 006
4 Bordon, Hants GU35 9QE – UK Riga, LV- 1048 Tel: + 44 1420 478 301 Tel: + 371 7 892 006
Omnitrope is a human growth hormone which is made by a method known as ‘ recombinant DNA technology using the bacterial microorganism E. coli.
Zdravilo Omnitrope je rastni hormon pri človeku, izdelan z metodo, znano kot tehnologija rekombinantne DNK, z uporabo bakterije E. coli.
Take special care with Omnitrope
78 Bodite posebno pozorni pri uporabi zdravila Omnitrope
- Please tell your doctor or pharmacist if you are taking or have recently taken any other
- Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli
Omnitrope 3.3 mg/ ml is intended for multiple use.
Zdravilo Omnitrope 3, 3 mg/ ml je namenjeno za večkratno uporabo.
It should only be administered with the Omnitrope Pen 5, an injection device specifically developed for use with Omnitrope 3.3 mg/ ml solution for injection.
Dajati se sme samo z napravo Omnitrope Pen 5, pripravo za injiciranje, narejeno posebej za uporabo z zdravilom Omnitrope 3, 3 mg/ ml raztopina za injiciranje.
81 How much and how often to use Omnitrope
Koliko zdravila Omnitrope uporabljati in kako pogosto
Dose adjustments may be required over time, depending on your increase in body weight and response.
80 Sčasoma bo morda potrebna prilagoditev odmerkov, kar je odvisno od zvečanja telesne mase in odziva.
If you use more Omnitrope than you should
Če ste vzeli večji odmerek zdravila Omnitrope, kot bi smeli
How to inject Omnitrope 3.3 mg/ ml
Kako si je treba injicirati zdravilo Omnitrope 3, 3 mg/ ml
The following instructions explain how to inject Omnitrope 3.3 mg/ ml yourself.
Navodila v nadaljevanju pojasnjujejo, kako si lahko sami injicirate zdravilo Omnitrope 3, 3 mg/ ml.
- Omnitrope is given as an injection under the skin.
- Zdravilo Omnitrope se injicira pod kožo.
- a cartridge with Omnitrope 3.3 mg/ ml solution for injection.
- vložek z raztopino za injiciranje zdravila Omnitrope 3, 3 mg/ ml
- the Omnitrope Pen 5, an injection device specifically developed for
- Omnitrope Pen 5, pripravo za injiciranje, narejeno posebej za
use with Omnitrope 3.3 mg/ ml solution for injection (not supplied in the pack; see Instructions for Use provided with the Omnitrope Pen 5).
uporabo raztopine za injiciranje zdravila Omnitrope 3, 3 mg/ ml (ki je ni v ovojnini; glejte Navodila za uporabo, priložena napravi Omnitrope Pen 5).
- With a cleansing swab, disinfect the rubber membrane of the
- Gumijasto membrano vložka razkužite z blazinico za čiščenje.
- Insert the cartridge into the pen for injection.
- Vložek vstavite v pero za injiciranje.
Follow the
Upoštevajte navodila za
Instructions for Use of the pen injector.
uporabo peresa za injiciranje.
After injecting
81 Po injiciranju
- After injection, press the injection site with a small bandage or
- Po injiciranju pritiskajte na mesto injiciranja več sekund z
sterile gauze for several seconds.
majhnim povojem ali sterilno gazo.
- Take the needle off the pen using the outer needle cap, and discard
- Iglo odstranite s peresa z uporabo zunanje zaporke igle in jo
the needle.
zavrzite.
Do not share your pen.
Svojega peresa ne dajajte drugim.
- Leave the cartridge in the pen, put the cap on the pen, and store it
- Vložek pustite v peresu, ga zaprite z zaporko in shranite v
in the refrigerator.
hladilniku.
Do
Raztopine
not use if the solution is cloudy or contains particles.
ne uporabljajte, če je motna ali vsebuje delce.
83 General disorders and reactions at the injection site
82 zelo redko redko občasno pogosto (pojavljajo se pri (pojavljajo se pri (pojavljajo se pri (pojavljajo se pri manj kot vsaj 1 bolniku od vsaj 1 bolniku od vsaj 1 bolniku od 1 bolniku od 10. 000, vendar 1. 000, vendar 100, vendar manj 10. 000) manj kot pri 1 od manj kot pri 1 od kot pri 1 od 10) 1. 000) 100) pri splošne težave in
Common (occurring in at least 1 of 100 but less than 1 of 10 patients) In infants/ children/ adolescents: transient local skin reactions
pri
Uncommon (occurring in at least 1 of 1,000 but less than 1 of 100 patients) In infants/ children/ adolescents: mild oedema
dojenčkih/ otrocih /
Rare (occurring in at least 1 of 10,000 but less than 1 of 1,000 patients)
dojenčkih/ otrocih /
In adults: mild oedema
pri odraslih: blagi edem
Musculoskeletal system, connective tissues, bones
skeletne mišice, vezivno tkivo in kosti
In adults: stiffness of the limbs, joint and muscle pain
pri odraslih: okorelost okončin, sklepov in bolečine v mišicah
In infants/ children/ adolescents: stiffness of the limbs, joint and muscle pain
pri dojenčkih/ otrocih / mladostnikih: okorelost okončin, sklepov in bolečine v mišicah
In adults: sensory disturbances
pri odraslih:
In infants/ children/ adolescents: sensory disturbances
motnje pri
Benign intracranial hypertension
dojenčkih/ otrocih /
In adults: carpal tunnel syndrome Endocrine disorders
hipertenzija
Disorders of the immune system Benign and malignant neoplasms
pri odraslih: sindrom karpalnega kanala sladkorna bolezen bolezni endokrinega sistema pojav protiteles motnje imunskega sistema benigne in maligne novotvorbe
General disorders and reactions at the injection site
Splošne težave in reakcije na mestu injiciranja
- Mild oedema (accumulation of water in the tissues) has been observed.
- Opazili so blagi edem (kopičenje vode v tkivih).
This side effect is a
Ta neželeni učinek je posledica motenj
consequence of disturbances in fluid balance and occurs only at the start of treatment with somatropin and is dose-dependent.
ravnovesja tekočin, pojavlja pa se samo ob začetku zdravljenja s somatropinom in je odvisen od odmerka.
It is common in adult patients, but uncommon in infants, children and adolescents.
Pogost je pri odraslih bolnikih, pri dojenčkih, otrocih in mladostnikih pa se pojavlja občasno.
84 Nervous system
83 Živčevje
These usually occur
Pojavijo se
at the start of treatment with somatropin and are dose-dependent.
ponavadi na začetku zdravljenja s somatropinom in so odvisne od odmerka.
- Muscular atrophy (reduction of muscular tissue) of the ball of the thumb and sensory
- Mišična atrofija (zmanjšanje mišičnega tkiva) blazinice palca ter motnje zaznavanja v prstih rok
disturbances in the fingers and palm of the hand are uncommon side effects.
in na dlaneh so redki neželeni učinki.
Do not use after the expiry date which is stated on the label and carton.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in škatli.
refrigerator (2°C - 8°C) and only used for a maximum of 28 days.
pri temperaturi 2 °C do 8 °C, uporabiti pa ga je treba v največ 28 dneh.
The active substance of Omnitrope is somatropin (3.3 mg/ ml) in a cartridge.
Zdravilna učinkovina v zdravilu Omnitrope je somatropin (3, 3 mg/ ml) v vložku.
One cartridge contains 5.0 mg (corresponding to 15 IU) of somatropin in 1.5 ml.
En vložek vsebuje 5, 0 mg (ustreza 10 i. e.) somatropina v 1, 5 ml.
The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate mannitol
Pomožne snovi so: natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat manitol
85 poloxamer 188 benzyl alcohol water for injections.
84 poloksamer 188 benzilalkohol voda za injekcije
Omnitrope is presented as a solution for injection.
Zdravilo Omnitrope je na voljo kot raztopina za injiciranje.
Omnitrope is a clear and colourless solution.
Zdravilo Omnitrope je bistra in brezbarvna raztopina.
Norge Sandoz AS Jernbaneveien 4 N-1400 Ski Tlf: + 47 64 91 30 00
Norge Sandoz AS Jernbaneveien 4 N- 1400 Ski Tlf: + +47 64 91 30 00
86 Eesti Österreich Sandoz d. d.
85 Österreich Eesti Sandoz GmbH Sandoz d. d.
Domaniewska 50 C PL – 02 672 Warszawa Tel.: + 48-22 549 15 00
Domaniewska 50 C PL – 02 672 Warszawa Poland Tel: + 48- 22 549 15 00
Livezeni, Nr 7A Târgu Mureş 540472 – RO Tel: + 40 265 208 120
Livezeni, Nr 7A Târgu Mureş 540472 – RO Tel: +. +40 265 208 120
87 Latvija Sandoz d. d.
86 United Kingdom Latvija Sandoz Limited Sandoz d. d.
INFORMATION FOR THE USER
87 NAVODILO ZA UPORABO
Take special care with Omnitrope
88 Bodite posebno pozorni pri uporabi zdravila Omnitrope
Omnitrope 6.7 mg/ ml is intended for multiple use.
Zdravilo Omnitrope 6, 7 mg/ ml je namenjeno za večkratno uporabo.
It should only be administered with the Omnitrope Pen 10, an injection device specifically developed for use with Omnitrope 6.7 mg/ ml solution for injection.
Dajati se sme samo z napravo Omnitrope Pen 10, pripravo za injiciranje, narejeno posebej za uporabo z zdravilom Omnitrope 6, 7 mg/ ml raztopina za injiciranje.
How much and how often to use Omnitrope
Koliko zdravila Omnitrope uporabljati in kako pogosto
91 Dose adjustments may be required over time, depending on your increase in body weight and response.
Sčasoma bo morda potrebna prilagoditev odmerkov, kar je odvisno od zvečanja telesne mase in odziva.