natgillin/translations-raw huggingface dataset:
Disodium hydrogen phosphate dihydrate, hydroxypropylcellulose, hydroxypropyl methylcellulose, lactose anhydrous, magnesium stearate, mannitol, methacrylic acid co-polymer, microcrystalline cellulose, macrogol (polyethylene glycol), sodium lauryl sulphate, iron oxide, titanium dioxide, gelatine, printing ink (containing shellac, ammonium hydroxide, potassium hydroxide and black iron oxide)
6.1 Seznam pomožnih snovi natrijev hidrogenfosfat dihidrat, hidroksipropilceluloza, hidroksipropilmetilceluloza, brezvodna laktoza, magnezijev stearat, manitol, kopolimer metakrilne kisline, mikrokristalna celuloza, makrogol (polietilenglikol), natrijev lavrilsulfat, železov oksid, titanov dioksid, želatina, barva za napis (vsebuje šelak, amonijev hidroksid, kalijev hidroksid in črni železov oksid).
10 mg: 7, 14, 15, 28, 30, 35, 50, 56, 84 capsules.
Aluminijski pretisni omot 10 mg: 7, 14, 15, 28, 30, 35, 50, 56, 84 kapsul.
Losec and associated names (see Annex I) 10 mg gastro-resistant tablets Losec and associated names (see Annex I) 20 mg gastro-resistant tablets Losec and associated names (see Annex I) 40 mg gastro-resistant tablets [See Annex I - To be completed nationally]
Losec in povezana imena (glejte Dodatek I) 10 mg gastrorezistentne tablete Losec in povezana imena (glejte Dodatek I) 20 mg gastrorezistentne tablete Losec in povezana imena (glejte Dodatek I) 40 mg gastrorezistentne tablete [Glejte Dodatek I - izpolni država članica]
Other active substances
Druge zdravilne učinkovine
The other ingredients are microcrystalline cellulose, glyceryl monostearate, hydroxypropylcellulose, hydroxypropyl methylcellulose, magnesium stearate, methacrylic acid copolymer, sugar spheres, paraffin, macrogol (polyethylene glycol), polysorbate, polyvinylpyrrolidone crosslinked, sodium hydroxide (for pH-adjustment), sodium stearyl fumarate, talc, triethyl citrate, iron oxide, titanium dioxide.
- Pomožne snovi so mikrokristalna celuloza, glicerilmonostearat, hidroksipropilceluloza, hidroksipropilmetilceluloza, magnezijev stearat, kopolimer metakrilne kisline, sladkorne kroglice, parafin, makrogol (polietilenglikol), polisorbat, premreženi polivinilpirolidon, natrijev hidroksid (za prilagoditev pH), natrijev stearilfumarat, smukec, trietilcitrat, železov oksid, titanov dioksid.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for reconstitution of Losec and associated names (see Annex I) solution for injection [See Annex I - To be completed nationally] iv
Vehikel za rekonstitucijo zdravila Losec in povezana imena (glejte Dodatek I) raztopina za injiciranje [Glejte Dodatek I - izpolni država članica] i.v.
With a syringe draw all of the solvent from the ampoule (10 ml).
OPOZORILO: Korake od 1 do 5 je treba opraviti neposredno enega za drugim: Z brizgo potegnite ves vehikel iz ampule (10 ml).
10 mg: 5, 7, 10, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 100 tablets; hospital pack of 560 tablets.
10 mg: 5, 7, 10, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 100 tablet, bolnišnično pakiranje 560 tablet.
Losec contains the active substance omeprazole.
Zdravilo Losec vsebuje zdravilno učinkovino omeprazol.
Disodium edetate, sodium hydroxide (for pH adjustment)
6.1 Seznam pomožnih snovi natrijev edetat, natrijev hidroksid (za prilagoditev pH).
Always take Losec exactly as your doctor has told you.
Pri jemanju zdravila Losec natančno upoštevajte zdravnikova navodila.
20 mg: 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 98, 100 tablets; hospital pack of, 560 tablets.
20 mg: 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 98, 100 tablet, bolnišnično pakiranje 560 tablet.
10 mg: 5, 7, 10, 14, 15, 28, 30, 50, 56, 60, 100 capsules; hospital packs of 140, 280 or 700 capsules.
10 mg: 5, 7, 10, 14, 15, 28, 30, 50, 56, 60, 100 kapsul, bolnišnična pakiranja s 140, 280 ali 700 kapsulami.
To treat ulcers in the stomach (gastric ulcer):
Za zdravljenje razjed v želodcu:
• 40 mg: o HDPE bottles of 7, 14, 15, 28, 30, 100 tablets.
o Plastenke iz HDPE s 7, 14, 15, 28, 30, 100 tabletami.
Losec and associated names (see Annex I) 10 mg hard capsules Losec and associated names (see Annex I) 20 mg hard capsules Losec and associated names (see Annex I) 40 mg hard capsules [See Annex I - To be completed nationally]
Losec in povezana imena (glejte Dodatek I) 10 mg trde kapsule Losec in povezana imena (glejte Dodatek I) 20 mg trde kapsule Losec in povezana imena (glejte Dodatek I) 40 mg trde kapsule [Glejte Dodatek I - izpolni država članica]
56 capsules (10 mg only) 60 capsules
50 kapsul (samo 10 mg in 20 mg) 56 kapsul (samo 10 mg) 60 kapsul
20 mg: 5, 7, 10, 14, 15, 28, 30, 50, 60, 100 capsules; hospital packs of 140, 280 or 700 capsules.
20 mg: 5, 7, 10, 14, 15, 28, 30, 50, 60, 100 kapsul, bolnišnična pakiranja s 140, 280 ali 700 kapsulami.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Losec and associated names (see Annex I) 40 mg powder for injection [See Annex I - To be completed nationally] omeprazole iv
IME ZDRAVILA IN POT(I) UPORABE Losec in povezana imena (glejte Dodatek I) 40 mg prašek za injekcijo [Glejte Dodatek I - izpolni država članica] omeprazol i.v.
• 40 mg: o HDPE bottles of 5, 7, 14, 15, 28, 30 or 60 capsules; hospital packs of 140, 280, or 700 capsules.
• 40 mg: o Plastenke iz HDPE s 5, 7, 14, 15, 28, 30 ali 60 kapsulami, bolnišnična pakiranja s 140, 280 ali 700 kapsulami.
OTC CARTON FOR BOTTLE CARTON FOR BLISTER WALLET
PODATKI NA ZUNANJI IN STIČNI OZ. PRIMARNI OVOJNINI BRp ŠKATLA ZA PLASTENKO ŠKATLA ZA PRETISNI OMOT ETUI
• 10 mg: o HDPE bottles of 5, 7, 10, 14, 15, 28, 30, 50, 56, 60 or 100 capsules; hospital packs of 140, 280 or 700 capsules.
• 10 mg: o Plastenke iz HDPE s 5, 7, 10, 14, 15, 28, 30, 50, 56, 60 ali 100 kapsulami, bolnišnična pakiranja s 140, 280 ali 700 kapsulami.
o Blisters of 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 100 tablets; hospital pack of 560 tablets.
o Pretisni omoti s 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 100 tabletami, bolnišnično pakiranje s 560 tabletami.
• 20 mg: o HDPE bottles of 5, 7, 10, 14, 15, 28, 30, 50, 60 or 100 capsules; hospital packs of 140, 280 , or 700 capsules.
• 20 mg: o Plastenke iz HDPE s 5, 7, 10, 14, 15, 28, 30, 50, 60 ali 100 kapsulami, bolnišnična pakiranja s 140, 280 ali 700 kapsulami.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Losec and associated names (see Annex I) 40 mg powder for infusion [See Annex I - To be completed nationally] omeprazole iv
IME ZDRAVILA IN POT(I) UPORABE Losec in povezana imena (glejte Dodatek I) 40 mg prašek za infuzijo [Glejte Dodatek I - izpolni država članica] omeprazol i.v.
Losec and associated names (see Annex I) 40 mg powder and solvent for solution for injection [See Annex I - To be completed nationally]
Losec in povezana imena (glejte Dodatek I) 40 mg prašek in vehikel za raztopino za injiciranje [Glejte Dodatek I - izpolni država članica]
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder for solution for injection contains omeprazole sodium 42.6 mg, equivalent to omeprazole 40 mg. After reconstitution, 1 ml contains omeprazole sodium 4.26 mg, equivalent to omeprazole 4 mg.
Ena viala praška za raztopino za injiciranje vsebuje 42,6 mg natrijevega omeprazolata, kar ustreza 40 mg omeprazola.
Losec and associated names (see Annex I) 40 mg powder for solution for infusion [See Annex I - To be completed nationally] Omeprazole
Losec in povezana imena (glejte Dodatek I) 40 mg prašek za raztopino za infundiranje [Glejte Dodatek I - izpolni država članica] omeprazol
The recommended dose in patients with an active duodenal ulcer is Losec 20 mg once daily.
Priporočeni odmerek za bolnike z aktivno razjedo na dvanajstniku je 20 mg zdravila Losec enkrat na dan. Ozdravitev se pri večini bolnikov pojavi v dveh tednih.
Inhibitors of CYP2C19 and/or CYP3A4
Učinki drugih zdravilnih učinkovin na farmakokinetiko omeprazola Zaviralci CYP2C19 in/ali CYP3A4
• They have had previous gastric ulcer or gastrointestinal surgery
• so kdaj imeli razjedo na želodcu ali operacijo na prebavilih
Losec and associated names (see Annex I) 10 mg gastro-resistant tablets Losec and associated names (see Annex I) 20 mg gastro-resistant tablets [See Annex I - To be completed nationally] Omeprazole
Losec in povezana imena (glejte Dodatek I) 10 mg gastrorezistentne tablete Losec in povezana imena (glejte Dodatek I) 20 mg gastrorezistentne tablete [Glejte Dodatek I - izpolni država članica] omeprazol
Vertigo
AMPULA
o Perforated unit dose blisters (hospital packs) of 25 x 1, 28 x 1, 50 x 1 tablets.
o Perforirani pretisni omoti za enkratni odmerek (bolnišnično pakiranje) s 25 x 1, 28 x
HOW TO STORE LOSEC
SHRANJEVANJE ZDRAVILA LOSEC
Microcrystalline cellulose, glyceryl monostearate, hydroxypropylcellulose, hydroxypropyl methylcellulose, magnesium stearate, methacrylic acid co-polymer, sugar spheres, paraffin, macrogol (polyethylene glycol), polysorbate, polyvinylpyrrolidone crosslinked, sodium hydroxide (for pH-adjustment), sodium stearyl fumarate,
6.1 Seznam pomožnih snovi mikrokristalna celuloza, glicerilmonostearat, hidroksipropilceluloza, hidroksipropilmetilceluloza, magnezijev stearat, kopolimer metakrilne kisline, sladkorne kroglice, parafin, makrogol (polietilenglikol), polisorbat, polivinilpirolidon, premreženi, natrijev hidroksid (za prilagoditev pH), natrijev stearilfumarat, smukec, trietilcitrat, železov oksid, titanov dioksid.
Treatment of symptomatic gastro-esophageal reflux disease The recommended dose is Losec 20 mg daily.
Zdravljenje simptomatske gastroezofagealne refluksne bolezni Priporočeni odmerek je 20 mg zdravila Losec na dan. Bolniki se lahko ustrezno odzovejo na odmerek 10 mg na dan, zato je treba odmerek prilagoditi individualno.
o Blisters of 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 98, 100 tablets; hospital pack of 560 tablets.
o Pretisni omoti s 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 98, 100 tabletami, bolnišnično pakiranje s 560 tabletami.
NAME OF THE MEDICINAL PRODUCT Losec and associated names (see Annex I) 40 mg powder for solution for infusion [See Annex I - To be completed nationally]
Losec in povezana imena (glejte Dodatek I) 40 mg prašek za raztopino za infundiranje [Glejte Dodatek I - izpolni država članica]
o Blisters of 5, 7, 10, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 100 tablets; hospital pack of 560 tablets.
o Pretisni omoti s 5, 7, 10, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 100 tabletami, bolnišnično pakiranje s 560 tabletami.
Interstitial nephritis
toksična epidermalna nekroliza)
• Treatment of NSAID-associated gastric and duodenal ulcers
• zdravljenje razjed na želodcu ali dvanajstniku, povezanih z uporabo nesteroidnih protivnetnih zdravil
• You continuously suffer from indigestion or heartburn for 4 or more weeks.
• Če imate 4 tedne ali več stalne težave z želodcem ali zgago.
Your doctor may tell you to take a dose of 40 mg for a further
Če se požiralnik še ni pozdravil, vam zdravnik lahko naroči, da jemljite odmerek 40 mg nadaljnjih 8 tednov.
• Do not use Losec after the expiry date which is stated on the outer and inner pack after EXP.
• Zdravila Losec ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji in notranji ovojnini poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Treatment of NSAID-associated gastric and duodenal ulcers
Zdravljenje razjed na želodcu ali dvanajstniku, povezanih z uporabo nesteroidnih protivnetnih zdravil (NSAID)
You must contact a doctor if your symptoms worsen or do not improve after 14 days.
- Če se znaki vaše bolezni ne izboljšajo v 14 dneh, se morate posvetovati z zdravnikom.
• Do not use Losec after the expiry date which is stated on the pack after EXP.
• Zdravila Losec ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pakiranju poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Annex I List of medicinal products and presentations
Priloga I Seznam zdravil in predstavitev
The Risk Management plan should be submitted by 9 May 2012.
Načrt za obvladovanje tveganja je treba predložiti do 9. maja 2012.
No special treatment is recommended.
Posebnega zdravljenja se ne priporoča.
This will vary according to your disease.
To se bo razlikovalo glede na vašo bolezen.
White or almost white powder.
Bel ali skoraj bel prašek.
Cmax was reached at 4 h and t½ was 3 h.
Vrednost Cmax je bila dosežena v 4 h, vrednost t½ pa je bila 3 h.
Collect the necessary items before you begin.
Pred začetkom zberite vse potrebne predmete.
Long-term studies for carcinogenicity have not been performed.
Dolgoročnih študij kancerogenosti niso opravili.
The minimum effective dose should be used.
Treba je uporabiti najmanjši učinkoviti odmerek.
Currently available data on renal insufficiency are described in section 4.4, but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki glede ledvične insuficience so opisani v poglavju 4.4, vendar priporočil o odmerjanju ni mogoče dati.
MARKETING AUTHORISATION NUMBER(S) EU/1/06/335/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/335/001
Your medicine is called Valtropin.
Vaše zdravilo se imenuje Valtropin.
In this leaflet the patient is addressed as ‘you'.
V tem navodilu bolnika naslavljamo kot "vi".
Your doctor may check the amount of sugar in your urine or blood.
Zdravnik bo morda pregledal količino sladkorja v urinu ali krvi.
However, individual doses may vary, and the doctor may change your dose based on your specific need.
Vendar se posamezni odmerki lahko razlikujejo, zdravnik pa lahko odmerek spremeni glede na vaše potrebe.
For use and handling
Za uporabo in ravnanje
In general the dosage will be calculated as described below.
Na splošno bo odmerjanje izračunano na naslednji način.
Valtropin - Occurrence of certain side effects') - and tell your doctor if you have an active tumour.
Valtropin - pojavnost določenih neželenih učinkov") - in povejte svojemu zdravniku, če imate aktivni tumor.
Do not use tap water.
Ne uporabljajte vode iz pipe.
Please read the instructions carefully and follow them step by step.
Pozorno preberite navodila in jih dosledno upoštevajte.
It has 191 amino acid residues and a molecular weight of 22,125 daltons.
Ima 191 aminokislinskih ostankov in molekulsko maso 22.125 daltonov.
The maximum recommended daily dose should not be exceeded (see section 4.2).
Največjega priporočenega dnevnega odmerka ni dovoljeno prekoračiti (glejte poglavje 4.2).
DO NOT aim it at the white powder at the bottom of the vial.
NE usmerite ga proti belem prašku na dnu viale.
This hurts less than pushing the needle in slowly.
To boli manj, kot če iglo vstavite počasi.
Animal data showed no effect on fertility parameters.
Podatki na živalih niso pokazali vpliva na parametre plodnosti.
When empty, discard the vial as well.
Kadar je prazna, tudi njo zavrzite.
It is not known whether somatropin is excreted in human milk.
Ni znano, ali se somatropin izloča v materino mleko.
It is very important that you vary the injection site each time you give the medicine.
Zelo pomembno je, da mesto injiciranja zamenjate vsakič, ko uporabite zdravilo.
Monitoring during treatment by your doctor - Valtropin may affect the way your body handles sugar from food and drink.
Zdravniško spremljanje med zdravljenjem - Zdravilo Valtropin lahko vpliva na to, kako vaše telo presnavlja sladkor, ki ga zaužijete s hrano in pijačo.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernico CHMP o sistemih za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen RMP predložen hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
Do not attempt to inject yourself unless you are sure you understand the procedure and requirements of self-injection.
Zdravila si ne poskusite injicirati, če niste prepričani, da razumete postopek in zahteve za injiciranje.
The clinical significance of this decrease is unknown.
Klinični pomen tega zmanjšanja ni znan.
Date of latest renewal 24.04.2011
Datum prve odobritve: 24.04.2006 Datum zadnjega podaljšanja: 24.04.2011
Animal studies are insufficient with respect to effects on pregnancy, embryofoetal development, parturition or postnatal development (see section 5.3).
Študije na živalih ne zadostujejo za oceno vpliva na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
Your doctor will always prescribe the minimum effective dose to be used.
Zdravnik vam bo vedno predpisal najmanjši učinkoviti odmerek.
Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data), including isolated reports
zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov), vključno s posameznimi poročili.
Caregivers administering Valtropin to their children should consider that ‘you' refers to the child.
Skrbniki, ki dajejo zdravilo Valtropin otrokom, morajo vedeti, da "vi" pomeni otroka.
It is a human growth hormone, also called somatropin.
Je humani rastni hormon, ki se imenuje tudi somatropin.
- Valtropin should not be used for growth promotion in children with closed epiphyses.
- Valtropin se ne sme uporabljati za spodbujanje rasti pri otrocih z zaprtimi epifizami.
During clinical studies 128 children (98 children with growth hormone deficiency and 30 with Turner syndrome) were exposed to Valtropin.
V kliničnih študijah je bilo 128 otrok (98 otrok s pomanjkanjem rastnega hormona in 30 s Turnerjevim sindromom) izpostavljeno zdravilu Valtropin.
The generation of such antibodies with low binding capacity is unlikely to be clinically relevant.
Ni verjetno, da bi bil nastanek teh protiteles z nizko sposobnostjo vezave klinično pomemben.
After first opening or following reconstitution with the solvent provided:
Po prvem odprtju ali po rekonstituciji s priloženim vehiklom:
Following use of the medicine for some time, it may be necessary to reduce the dose, particularly in men.
Po dolgotrajni uporabi bo morda treba odmerek zmanjšati, zlasti pri moških.
Storage conditions of the unopened medicine
Pogoji shranjevanja neodprtega zdravila
The safety profile of Valtropin observed in these clinical studies was consistent with that reported with the reference medicinal product used in these studies and other somatropin containing medicinal products.
Varnostni profil zdravila Valtropin v teh kliničnih študijah se je ujemal z varnostnim profilom, o katerem so poročali pri referenčnem zdravilu, uporabljenem v teh študijah in drugih zdravil, ki vsebujejo somatropin.
For children, the treatment should be continued until the end of the growth has been reached.
Pri otrocih je treba zdravljenje nadaljevati, dokler rast ni končana.
This dose should be gradually increased according to individual patient requirements based on the clinical response and serum IGF-1 concentrations.
Ta odmerek se postopno viša glede na zahteve posameznega bolnika, ki temeljijo na kliničnem odzivu in koncentraciji IGF-1 v serumu.
When it stimulates growth of cells in the long bones of the legs and spine, it causes an increase in height.
Kadar spodbuja rast celic v dolgih kosteh v nogah in v hrbtenici, povzroča rast v višino.
Please do not change the dosage without consulting your doctor.
Odmerjanja ne spreminjajte brez posveta z zdravnikom.
Your doctor may need to adjust the dose of Valtropin or of the other medicine.
Zdravnik vam bo morda prilagodil odmerek zdravila Valtropin ali drugega zdravila.
Insulin sensitivity
Občutljivost na insulin
Dosage in paediatric population
Odmerjanje pri pediatrični populaciji
The most prominent effect of somatropin is that it stimulates the growth plates of long bones.
Najbolj poudarjen učinek somatropina je, da stimulira rastne plošče dolgih kosti.
If the solution is cold, warm the syringe between your palms.
Če je raztopina hladna, pogrejte brizgo med dlanmi.
Before and after every injection, the septum of the vial should be wiped with alcohol to prevent contamination of the contents by repeated needle insertions.
Pred vsakim injiciranjem in po njem je treba septum viale obrisati z alkoholom ter tako preprečiti kontaminacijo vsebine zaradi večkratnega vstavljanja igle.
The binding capacity of these antibodies was low and there was no effect on growth rate.
Sposobnost teh protiteles za vezavo je bila majhna in niso vplivala na hitrost rasti.
- Treatment of short stature in children with Turner syndrome, confirmed by chromosome analysis.
- Zdravljenje nižje rasti pri otrocih s Turnerjevim sindromom, potrjenim s kromosomsko analizo.
It has the same structure as the growth hormone that the body produces in the pituitary glands (glands located at the base of the brain).
Ima enako zgradbo kot rastni hormon, ki ga telo proizvaja v hipofizi (žleza, ki se nahaja na dnu možganov).
Treatment after the end of growth in children
Zdravljenje pri otrocih po koncu rasti
Select the injection site according to the recommendation of your doctor.
Izberite mesto injiciranja po navodilih zdravnika.
There are no specific local tolerance studies in animals after subcutaneous injection of Valtropin.
Specifičnih študij lokalne tolerance pri živalih po subkutanem injiciranju zdravila Valtropin ni.
Experience of prolonged treatment (over 5 years) with somatropin in adults is limited.
Izkušnje s podaljšanim zdravljenjem (več kot 5 let) s somatropinom pri odraslih so skope.
Children with Turner syndrome
Otroci s Turnerjevim sindromom
- for growth promotion in children who have already stopped growing - if you have had a serious heart or abdominal operation - if you are being treated for more than one injury following a serious accident - if you have sudden serious breathing problems
- za spodbujanje rasti pri otrocih, ki so že prenehali rasti - če so vam opravili resni kirurški poseg na srcu ali trebuhu - če vas zdravijo zaradi več kot ene poškodbe, ki ste jo dobili v hudi nesreči - če imate nenadne resne težave pri dihanju
If the solution is discoloured, cloudy or contains particulate matter, the contents MUST NOT be injected.
Če je raztopina obarvana, motna ali vsebuje delce, vsebine NE SMETE injicirati.
Any unwanted reaction should be followed.
Vse neželene učinke je treba spremljati.
If not used immediately, in-use storage times and conditions prior to use would normally not be longer than 24 hours at 2°C - 8°C (refrigerator), unless reconstitution has taken place in controlled and validated aseptic conditions.
Če se ga ne uporabi takoj, čas shranjevanja navadno ne sme biti daljši od 24 ur pri temperaturi 2 °C - 8 °C (v hladilniku), razen če je bila raztopina rekonstituirana v nadzorovanih in preverjeno aseptičnih pogojih.
Continue with the prescribed dosage regimen.
Nadaljujte predpisano odmerjanje.
The resulting solution should be clear, without particles.
Nastala raztopina mora biti bistra in brez delcev.
Do not take a double dose to make up for forgotten doses.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
The efficacy and safety of Valtropin has been assessed in a randomised, double-blind, parallel, controlled Phase III study in children with growth hormone deficiency.
Varnost in učinkovitost zdravila Valtropin so ocenili v randomizirani, dvojno slepi, vzporedni, nadzorovani študiji faze III pri otrocih s pomanjkanjem rastnega hormona.
A double-blind, randomised, single dose, crossover study in 24 healthy volunteers showed that the pharmacokinetic profile of Valtropin was comparable to that of the reference medicinal product.
V dvojno slepi, randomizirani navzkrižni študiji posameznih odmerkov, ki so jo izvedli na 24 zdravih prostovoljcih, so pokazali, da je farmakokinetični profil zdravila Valtropin primerljiv s farmakokinetičnim profilom referenčnega zdravila.
There is no antidote for somatropin overdose.
Antidota za preveliko odmerjanje somatropina ni.
Subcutaneous administration of 0.073 mg/kg body weight of Valtropin resulted in a Cmax of 43.97 ng/ml and an AUC0-24 h of 369.90 ng·h/ml.
Po subkutanem odmerjanju 0,073 mg/kg telesne teže zdravila Valtropin je bila vrednost Cmax 43,97 ng/ml, vrednost AUC0-24 h pa 369,90 ng·h/ml.