natgillin/translations-raw huggingface dataset:
surgery, multiple accidental trauma, or patients having acute respiratory failure.
trebuha, bolniki z mnogovrstnimi nezgodnimi poškodbami ali bolniki z akutno respiratorno odpovedjo.
There is no evidence to suspect that growth hormone replacement influences the recurrence rate or regrowth of intracranial neoplasms, but standard clinical practice requires regular pituitary imaging in
Ni dokazov, zaradi katerih bi lahko sumili, da nadomeščanje rastnega hormona vpliva na stopnjo ponovitve ali ponovne rasti intrakranialnih novotvorb, vendar standardna klinična praksa pri bolnikih s patologijo hipofize v anamnezi zahteva redno slikanje hipofize.
3 patients with a history of pituitary pathology.
V primerih hudega ali ponavljajočega se glavobola, motenj vida, slabosti in/ ali bruhanja je priporočena fundoskopija zaradi možnosti edema papile.
A baseline scan is recommended in these patients before instituting growth hormone replacement therapy.
Če je edem papile potrjen, je treba upoštevati
If papilloedema is confirmed, a diagnosis of benign intracranial hypertension should be considered and, if appropriate, the growth hormone treatment should be discontinued.
3 tudi možnost diagnoze benigne intrakranialne hipertenzije in po potrebi prekiniti zdravljenje z rastnim hormonom.
Valtropin is not indicated for the treatment of patients with growth failure due to Prader-Willi syndrome unless they also have a diagnosis of growth hormone deficiency.
Zdravilo Valtropin ni indicirano za zdravljenje bolnikov z zastojem v rasti zaradi Prader- Willijevega sindroma, razen če imajo ti bolniki tudi diagnozo pomanjkanja rastnega hormona.
There have been reports of sleep apnoea and sudden death after initiating growth hormone therapy in patients with Prader-Willi syndrome, who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.
Poročali so o apneji med spanjem in nenadni smrti po uvedbi zdravljenja z rastnim hormonom pri bolnikih s Prader - Willijevim sindromom, ki so imeli enega ali več od naslednjih dejavnikov tveganja: zelo veliko prekomerno telesno težo, anamnezo obstrukcije zgornjih dihalnih poti ali apnejo med spanjem ter neopredeljeno okužbo dihal.
Treatment with somatropin should be discontinued at the time of renal transplantation.
Zdravljenje s somatropinom je treba v času presaditve ledvic ukiniti.
An increasing sensitivity to growth hormone (expressed as change in IGF-1 per growth hormone dose) over time may be observed, particularly in men.
Sčasoma lahko opazimo povečano občutljivost za rastni hormon (izraženo kot sprememba koncentracije IGF- 1 v serumu na odmerek rastnega hormona), zlasti pri moških.
Valtropin should not be reconstituted with the supplied solvent for patients with a known sensitivity to metacresol.
Pri bolnikih z znano preobčutljivostjo za metakrezol, zdravila Valtropin ne smemo rekonstituirati s priloženim vehiklom.
If sensitivity to the accompanying solvent occurs, the vials should be reconstituted with water for injections and used as a single use vial (see section 6.3).
Če se pojavi občutljivost na priloženi vehikel, je treba vialo rekonstituirati z vodo za injekcije in uporabiti kot vialo za enkratno uporabo (glejte poglavje 6. 3).
4 After accidental intramuscular injection, hypoglycaemia may appear.
Po nenamernem intramuskularnem injiciranju se lahko pojavi hipoglikemija.
Experience of somatropin treatment in patients above 60 years of age is limited.
Izkušnje z zdravljenjem bolnikov, starejših od 60 let, s somatropinom so pomanjkljive.
Experience of prolonged treatment (over 5 years) with somatropin in adults is limited.
Izkušnje s podaljšanim zdravljenjem (več kot 5 let) odraslih s somatropinom so pomanjkljive.
The clearance of compounds metabolised by cytochrome P 450 3A4 (e. g. sex steroids, corticosteroids, anticonvulsants and cyclosporine) may be especially increased resulting in lower plasma levels of these compounds.
Očistek spojin, ki jih presnavlja citokrom P450 3A4 (npr. spolni steroidi, kortikosteroidi, antikonvulzivi in ciklosporin), se lahko poveča, kar povzroči manjše koncentracije teh spojin v plazmi.
For Valtropin no clinical data on exposed pregnancies are available.
Za zdravilo Valtropin ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
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).
The safety profile of Valtropin observed in these clinical studies was consistent with that reported with the reference product used in these studies and other somatropin containing 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.
Very common (> 1/ 10), common (> 1/ 100 ,< 1/10), uncommon (> 1/ 1,000 ,< 1/100), rare (> 1/ 10,000, < 1/ 1,000), very rare (< 1/ 10,000) including isolated reports
zelo pogosti (> 1/ 10), pogosti (> 1/ 100, < 1/ 10), občasni (> 1/ 1. 000, < 1/ 100), redki (> 1/ 10. 000, < 1/ 1. 000), zelo redki (< 1/ 10. 000), vključno s posameznimi poročili.
Endocrine disorders Hypothyroidism: common
Bolezni endokrinega sistema Hipertiroidizem: pogosto.
Metabolism and nutrition disorders Mild hyperglycaemia: common (1% in children; 1% - 10% in adults)
Odpornost na insulin.
5 Insulin resistance
5 Parestezija: redko pri otrocih, zelo pogosto pri odraslih.
Nervous system disorders Benign intracranial hypertension: rare Headache: very common in adults Insomnia: very rare in children; common in adults Paraesthesia: rare in children; very common in adults
Žilne bolezni Hipertenzija: redko pri otrocih, pogosto pri odraslih.
Vascular disorders Hypertension: rare in children; common in adults
Bolečine v sklepih in okvare sklepov (artralgija): zelo pogosto pri odraslih.
Musculoskeletal and connective tissue disorders Localised muscle pain (myalgia): common in adults Joint pain and disorder (arthralgia): very common in adults
Motnje reprodukcije in dojk Ginekomastija: zelo redko pri otrocih, občasno pri odraslih.
Reproductive system and breast disorders Gynaecomastia: very rare in children; uncommon in adults
Bolečina (reakcije) na mestu injiciranja: pogosto.
General disorders and administration site conditions Weakness: uncommon Injection site pain (reaction): common Oedema (local or generalised): common (1% - 10% in children; 10% in adults)
Edem (lokaliziran ali splošni): pogosto (1 - 10% pri otrocih; 10% pri odraslih).
As with all somatropin containing medicinal products a small percentage of patients may develop antibodies to somatropin.
Kot pri vseh zdravilih, ki vsebujejo somatropin, se pri majhnem odstotku bolnikov razvijejo protitelesa proti somatropinu.
In a clinical study with Valtropin, 3% of children with growth hormone deficiency developed such antibodies.
V klinični študiji z zdravilom Valtropin so se taka protitelesa razvila pri 3% otrok s pomanjkanjem rastnega hormona.
Anti-host cell protein (anti-S. cerevisiae) antibodies were uncommon in patients treated with Valtropin.
Protitelesa proti beljakovinam gostiteljskih celic (anti- S. cerevisiae) so bila občasna pri bolnikih, zdravljenih z zdravilom Valtropin.
In contrast to bacteria (E. coli), yeast has not been described to elicit adjuvant effects modifying the immunological response.
V nasprotju z bakterijami (E. coli) pri glivicah niso opazili dodatnih učinkov, ki bi spremenili imunski odziv.
There was one case (< 1%) of acute hypersensitivity involving urticaria and pruritus in a patient administered Valtropin.
Pri enem bolniku (< 1%), ki je prejemal zdravilo Valtropin, je prišlo do akutne preobčutljivostne reakcije vključno z urtikarijo in pruritusom.
Paediatric patients Mild and transient oedema was observed early during the course of treatment with somatropin.
Pediatrični bolniki V zgodnji fazi zdravljenja s somatropinom so opazili blag in prehoden edem.
Leukaemia has been reported in a small number of children who have been treated with somatropin.
Pri manjšem številu otrok, zdravljenih s somatropinom, so poročali o levkemiji.
However, there is no evidence that leukaemia incidence is increased in somatropin recipients without predisposing factors.
Vendar pa ni nobenih dokazov za večjo pogostost levkemije pri prejemnikih somatropina brez dejavnikov predispozicije.
Adult patients In general, in patients with adult-onset growth hormone deficiency, oedema, muscle pain, joint pain and disorders were reported early in therapy and tended to be transient.
Odrasli bolniki Pri bolnikih s pomanjkanjem rastnega hormona, nastalim v odrasli dobi, so zgodaj v poteku zdravljenja poročali o edemu, bolečinah v mišicah in sklepih ter o obolenjih sklepov, ki so bili navadno prehodni.
Adult patients treated with somatropin, following diagnosis of growth hormone deficiency in childhood, reported undesirable effects less frequently than those with adult-onset growth hormone deficiency.
Odrasli bolniki, ki so jih zdravili s somatropinom po diagnozi pomanjkanja rastnega hormona v otroštvu, so poročali o neželenih učinkih manj pogosto kot tisti s pomanjkanjem rastnega hormona, nastalim v odrasli dobi.
Somatropin and analogues; ATC code:
Farmakoterapevtska skupina: somatropin in sorodne učinkovine; oznaka ATC:
Somatropin is a polypeptide hormone of recombinant DNA origin.
6 Somatropin je polipeptidni hormon, pridelan z metodo rekombinantne DNA.
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 amino acid sequence of the product is identical to that of human growth hormone of pituitary origin.
Aminokislinsko zaporedje zdravila je identično aminokislinskemu zaporedju humanega rastnega hormona hipofiznega izvora.
Somatropin stimulates lipid metabolism; it increases plasma fatty acids and high-density lipoprotein (HDL)-cholesterols, and decreases total plasma cholesterol.
Somatropin stimulira presnovo maščob, zviša raven plazemskih maščobnih kislin in holesterola lipoproteinov nizke gostote (HDL, High- Density Lipoprotein) ter zniža skupno koncentracijo plazemskega holesterola.
Somatropin therapy has a beneficial effect on body composition in growth hormone-deficient patients, in that body fat stores are reduced and lean body mass is increased.
Zdravljenje s somatropinom ima koristen učinek na zgradbo telesa pri bolnikih s pomanjkanjem rastnega hormona, in sicer tako, da se zmanjšajo zaloge maščob v telesu, zveča pa se delež mase brez maščob.
There were no relevant differences between Valtropin and the reference product with regard to height velocity and height velocity SDS.
Pri hitrosti rasti in vrednosti SDS hitrosti rasti, med zdravilom Valtropin in referenčnim zdravilom ni bilo pomembnih razlik.
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 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.
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.
Non-clinical data reveal no special hazard for humans based on conventional studies with Valtropin of repeated dose toxicity, genotoxicity and reproductive toxicity studies.
Predklinični podatki na osnovi običajnih študij, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in reproduktivne toksičnosti zdravila Valtropin. ne kažejo posebnega tveganja za človeka.
Animal studies with Valtropin are not sufficient to assess the reproductive toxicity potential.
Študije na živalih niso zadostne za oceno potenciala reproduktivne toksičnosti zdravila Valtropin.
From reproductive toxicity studies performed with other somatropin products there is no evidence of an increased risk of adverse reactions for the embryo or foetus.
Na osnovi študij reproduktivne toksičnosti, opravljenih z drugimi zdravili, ki vsebujejo somatropin, ni dokazov o povečanem tveganju za neželene učinke na plod.
However, in single and repeat-dose general toxicity studies no adverse reactions at the injection sites were reported.
Vendar v študijah splošne toksičnosti pri posameznih in ponavljajočih se odmerkih niso poročali o neželenih reakcijah na mestu injiciranja.
Glycine Mannitol Sodium phosphate monobasic Sodium phosphate dibasic Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment).
Prašek: glicin manitol mononatrijev fosfat dinatrijev fosfat natrijev hidroksid (za uravnavanje pH) klorovodikova kislina (za uravnavanje pH).
36 months
36 mesecev.
From a microbiological point of view, once opened, the product may be stored for a maximum of 21 days at 2°C - 8°C (refrigerator).
Iz mikrobiološkega stališča se lahko zdravilo po odprtju shranjuje največ 21 dni pri 2 °C - 8 °C (v hladilniku).
After reconstitution with water for injections, the product must be used immediately and must be used as a single use vial.
Po rekonstituciji z vodo za injekcije je treba zdravilo uporabiti takoj in kot vialo za enkratno uporabo.
For the purpose of transport and/ or ambulatory use the non-reconstituted product can be kept at room temperature (not above 25°C) for one single period of up to 4 weeks.
Za prevoz in/ ali ambulantno uporabo se lahko nerekonstituirano zdravilo hrani pri sobni temperaturi (do 25 °C) za eno samo obdobje do štirih tednov.
Patients may keep the non-reconstituted product at room temperature for one single period of up to 4 weeks before use.
Bolniki lahko nerekonstituirano zdravilo hranijo pri sobni temperaturi za eno samo obdobje do štirih tednov pred uporabo.
5 mg of powder in a vial (Type I glass) closed with a stopper (butyl rubber) and a flip-off cap (aluminium plastic).
6. 5 Vrsta ovojnine in vsebina
1.5 ml of solvent in a pre-filled syringe (Type I glass) closed with a tip cap (FluroTec coated butyl rubber)
5 mg praška v viali (steklo vrste I) z zamaškom (butilna guma) in zaporko "flip- off" (aluminij, plastika).
8 Pack size of 1 vial and 1 pre-filled syringe.
Velikost pakiranja – 1 viala in 1 napolnjena injekcijska brizga.
For use and handling Valtropin should not be reconstituted with the supplied solvent for patients with a known sensitivity to metacresol (see section 4.3).
Za uporabo in ravnanje Pri bolnikih z znano preobčutljivostjo za metakrezol zdravila Valtropin ne smemo rekonstituirati s priloženim vehiklom (glejte poglavje 4. 3).
If sensitivity to the accompanying solvent occurs, the vials should be reconstituted with water for injections and used as a single use vial.
Če se pojavi občutljivost za priloženi vehikel, je treba vialo rekonstituirati z vodo za injekcije in uporabiti kot vialo za enkratno uporabo.
Reconstitution with the solvent provided Each vial of Valtropin should be reconstituted using the accompanying solvent.
Rekonstitucija s priloženim vehiklom Vsako vialo zdravila Valtropin je treba rekonstituirati s priloženim vehiklom.
The solvent should not be used if it is discoloured or cloudy.
Vehikla ne smete uporabljajti, če je razbarvan ali moten.
If the solution is discoloured, cloudy or contains particulate matter, the contents MUST NOT be injected.
Če je raztopina razbarvana, motna ali vsebuje delce, vsebine NE SMETE injicirati.
If reconstituted with the solvent, then the solution is for multidose use (see section 6.3).
Če raztopino rekonstituirate z vehiklom, jo lahko uporabljate za večkratno odmerjanje (glejte poglavje 6. 3).
Reconstitution with water for injections After reconstitution with water for injections the product must be used immediately (see section 6.3) and the solution is for single use only.
Rekonstitucija z vodo za injekcije Po rekonstituciji z vodo za injekcije je treba zdravilo uporabiti takoj (glejte poglavje 6. 3), raztopina pa je le za enkratno uporabo.
Administration Sterile disposable syringes and needles should be used for administration of Valtropin.
Uporaba Za dajanje zdravila Valtropin je treba uporabljati sterilne brizge in igle za enkratno uporabo.
BioPartners GmbH Eisenstrasse 3 D-65428 Rüsselsheim Germany
BioPartners GmbH Eisenstrasse 3 D- 65428 Rüsselsheim Nemčija
LG Life Sciences Ltd., Iksan Plant, 601 Yongje-dong, Iksan-si, Jeonbuk-do 570-350, South Korea
LG Life Sciences Ltd., Iksan Plant, 601 Yongje- dong, Iksan- si, Jeonbuk- do 570- 350, Južna Koreja
BioPartners GmbH, Eisenstrasse 3, D-65428 Rüsselsheim, Germany
BioPartners GmbH, Eisenstrasse 3, D- 65428 Rüsselsheim, Nemčija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance postavljen in da deluje, preden da zdravilo v promet in dokler zdravilo, ki ga trži, ostane v rabi.
Risk Management plan The MAH commits to performing additional pharmacovigilance activities as detailed in the Pharmacovigilance Plan.
Načrt obvladovanja tveganja Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil dodatne dejavnosti farmakovigilance, opisane v načrtu farmakovigilance.
Valtropin 5 mg/ 1.5 ml powder and solvent for solution for injection Somatropin
Valtropin 5 mg/ 1, 5 ml prašek in vehikel za raztopino za injiciranje Somatropin
1 vial of powder contains 5 mg (15 IU) somatropin (3.33 mg/ ml somatropin after reconstitution with 1.5 ml solvent).
1 viala praška vsebuje 5 mg (15 i. e.) somatropina (3, 33 mg/ ml somatropina po rekonstituciji z 1, 5 ml vehikla).
Powder: glycine, mannitol, sodium phosphate monobasic, sodium phosphate dibasic. pH adjustment: sodium hydroxide and hydrochloric acid.
Uravnavanje pH: natrijev hidroksid in klorovodikova kislina.
Powder and solvent for solution for injection 1 vial (powder) and 1 pre-filled syringe (1.5 ml solvent).
1 viala (prašek) in 1 napolnjena injekcijska brizga (1, 5 ml vehikla).
Subcutaneous use For information on reconstitution and use read the package leaflet.
Pred uporabo preberite priloženo navodilo.
Valtropin 5 mg/ 1.5 ml Powder for solution for injection Somatropin
Valtropin 5 mg/ 1, 5 ml Prašek za raztopino za injiciranje Somatropin
5 mg (15 IU) somatropin
5 mg (15 i. e.) somatropina
PRE-FILLED SYRINGE OF SOLVENT
NAPOLNJENA INJEKCJSKA BRIZGA Z VEHIKLOM
Valtropin 5 mg/ 1.5 ml Solvent for solution for injection
Valtropin 5 mg/ 1, 5 ml Vehikel za raztopino za injiciranje
1.5 ml (water for injections with metacresol)
1, 5 ml (voda za injekcije z metakrezolom)
Contains 4.5 mg metacresol.
Vsebuje 4, 5 mg metakrezola.
What Valtropin is and what it is used for 2.
Kaj je zdravilo Valtropin in za kaj ga uporabljamo 2.
Before you use Valtropin 3.
Kaj morate vedeti, preden boste uporabili zdravilo Valtropin 3.
How to use Valtropin 4.
Kako uporabljati zdravilo Valtropin 4.
How to store Valtropin 6.
Shranjevanje zdravila Valtropin 6.
It is a brand of human growth hormone, also called somatropin.
Je blagovna znamka humanega rastnega hormona, ki se imenuje tudi somatropin.
Valtropin is made in the laboratory by a special process known as a ‘ recombinant DNA technology’ process in yeast cells (Saccharomyces cerevisiae).
Valtropin se prideluje v laboratoriju iz celic kvasovk (Saccharomyces cerevisiae) po postopku, ki je znan kot "tehnologija rekombinantne DNA".
It has the same structure as the growth hormone that the body produces in the pituitary glands.
Ima enako zgradbo kot rastni hormon, ki ga telo proizvaja v hipofizi.
Valtropin is used
Zdravilo Valtropin se uporablja:
- to treat children who do not develop to their normal height because of poor bone growth caused
- za zdravljenje otrok, ki se niso razvili do normalne višine zaradi slabe rasti kosti, ki jo je
by growth hormone deficiency (relative lack of growth hormone), Turner syndrome, or ‘ chronic renal insufficiency’ (a condition in which the kidneys gradually lose their ability to perform their normal functions, such as the removal of wastes and extra fluid from the body).
povzročilo pomanjkanje rastnega hormona (relativno pomanjkanje rastnega hormona), Turnerjev sindrom ali "kronična ledvična insuficienca" (bolezen, pri kateri ledvice postopno zgubljajo sposobnost normalnega delovanja, kot je odstranjevanje odpadnih snovi in odvečne tekočine iz telesa);
- to treat adults with severe growth hormone deficiency who already had growth hormone
- za zdravljenje odraslih s hudim pomanjkanjem rastnega hormona, ki so to pomanjkanje imeli že
deficiency when they were children or who do not have enough growth hormone during their adult years for some other reason.
v otroštvu ali ki v odrasli dobi nimajo dovolj rastnega hormona.
In this leaflet the patient is addressed as ‘ you’.
V tem navodilu bolnika naslavljamo kot "vi".
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.
⊗ Do not use Valtropin:
⊗ Ne uporabljajte zdravila Valtropin:
- if you are allergic (hypersensitive) to somatropin or any of the other ingredients of the
- če ste alergični na (preobčutljivi za) somatropin ali katerokoli sestavino praška ali vehikla
powder or solvent of Valtropin, e. g. metacresol (see section 2, ‘ Take special care with Valtropin – Occurrence of certain side effects’)
Valtropin, npr. metakrezol (glejte poglavje 2, "Bodite posebej pozorni pri uporabi zdravila Valtropin – pojavnost določenih neželenih učinkov")
- to promote growth if you have already stopped growing
- za spodbujanje rasti, če se je vaša rast že končala
- if you have had a serious heart or abdominal operation
- če so vam opravili resni kirurški poseg na srcu ali trebuhu
- if you are being treated for more than one injury following a serious accident
- če vas zdravijo zaradi več kot ene poškodbe, ki ste jo dobili v hudi nesreči
- if you have sudden serious breathing problems
- če imate aktivni tumor na možganih ali drugi tumor (rak), ker bo rastni hormon bolezen
19
19 zdravljenje mora biti končano.
- if you have an active brain tumour or any other tumour (cancer), since growth hormone will
Če obstajajo dokazi tumorske rasti, je treba zdravljenje z zdravilom Valtropin prekiniti.
If there is evidence of tumour growth, treatment with Valtropin should be discontinued.
/!\ Bodite posebno pozorni pri uporabi zdravila Valtropin:
/!\ Take special care with Valtropin Examinations before starting treatment:
Pregledi pred začetkom zdravljenja:
- A specialist doctor trained in hormone disorders must examine you to decide if it is safe to use
- Zdravnik specialist, usposobljen za zdravljenje hormonskih motenj, vas mora pregledati in
Valtropin.
ugotoviti, ali je uporaba zdravila Valtropin varna.
- If adults have been treated with growth hormone during childhood, they should be re-evaluated
- Če so odrasle osebe v otroštvu jemale rastne hormone, je treba pred začetkom kakršnegakoli
for growth hormone deficiency before starting any further treatment with growth hormones.
zdravljenja z rastnimi hormoni ponovno oceniti pomanjkanje rastnih hormonov.
- Patients with Prader-Willi syndrome should not be treated with Valtropin unless they are also
- Bolnikov s Prader- Willijevim sindromom naj se ne zdravi z zdravilom Valtropin, razen če
suffering from growth hormone failure.
imajohkrati pomanjkanje rastnega hormona.
During or after serious illness:
Med resno boleznijo ali po njej:
- If you have had a brain tumour, you should be re-examined frequently to make sure that the
- Če ste imeli tumor na možganih, vas bo moral zdravnik pogosto pregledati, da bi zagotovil, da
tumour has not come back.
se tumor ni povrnil.