natgillin/translations-raw huggingface dataset:
Warm the solvent vial to room temperature by gently rolling it between your hands.
Vialo vehikla ogrejte na sobno temperaturo z nežnim valjanjem med dlanmi.
The powder should be homogenously suspended in the injection vehicle prior to administration.
Prašek mora biti homogeno suspendiran v vehiklu injekcije, preden jo uporabite.
When adverse reactions occurred, they tended to be transient and severity was generally mild to moderate.
Če so se pojavile neželene reakcije, so bile te prehodne, njihova resnost pa je bila v glavnem blaga do zmerna.
Important information about some of the ingredients of Somatropin Biopartners This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free'.
Pomembne informacije o nekaterih sestavinah zdravila Somatropin Biopartners To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni »brez natrija«.
The recommended dose is 0.5 mg of somatropin per kilogram of body weight injected once a week.
Priporočeni odmerek je 0,5 mg somatropina na kilogram telesne mase, injiciranega enkrat na teden.
In a randomized, parallel-group, multicentre Phase III study, 178 children between 3 and 12 years of age with organic and/or idiopathic GHD were randomised to receive either weekly administered Somatropin Biopartners (0.5 mg/kg/week) or daily administered recombinant hGH (0.03 mg/kg/day) for 12 months.
V randomizirani, vzporedni, multicentrični študiji faze III je bilo randomiziranih 178 otrok, starih 3 do 12 let z organskim in/ali idiopatičnim pomanjkanjem rastnega hormona, da so 12 mesecev tedensko prejemali zdravilo Somatropin Biopartners (0,5 mg/kg/teden) ali dnevno rekombinantni hGH (0,03 mg/kg/dan).
The patient or carer should receive training to ensure understanding of the administration procedure before being allowed to (self-) inject.
Bolnika ali negovalca je treba poučiti, kako naj (si) zdravilo (samo)injicirajo, in s tem zagotoviti, da razumejo postopek uporabe.
Non-clinical pharmacokinetic and pharmacodynamic studies in dogs and juvenile monkeys showed that Somatropin Biopartners released recombinant hGH in a prolonged manner and increased serum IGF-I for an extended period up to 5-6 days.
Predklinične farmakokinetične in farmakodinamične študije pri psih in mladih opicah so pokazale, da je zdravilo Somatropin Biopartners sproščalo rekombinantni hGH na podaljšan način in povečalo serumski IGF-I za podaljšano obdobje, ki je trajalo do 5-6 dni.
Withdraw the syringe and discard it.
Injekcijsko brizgo izvlecite in jo zavrzite.
Special populations
Posebne populacije Starejši ljudje
Side effects very commonly reported (may affect more than 1 in 10 people) were injection site swelling and development of substances (antibodies) in the blood that bind to growth hormone.
Neželeni učinki, o katerih so zelo pogosto poročali (pojavijo se lahko pri več kot 1 od 10 bolnikov), so oteklost na mestu injiciranja in razvoj snovi (protiteles) v krvi, ki vežejo rastni hormon.
The active substance is somatropin.
Zdravilna učinkovina je somatropin.
3 mg (9 IU)
3 mg (9 i.e.)
2 mg (6 IU)
2 mg (6 i.e.)
Common: Hypercortisolism (7.7%), hypothyroidism (2.2%), adrenal cortical insufficiency (3.3%), hypothyreosis secondary to TSH deficiency (2.6%), decreased free thyroxine (4.4%), increased blood TSH (2.2%)
Bolezni endokrinega sistema pogosti: hiperkortizolizem (7,7 %), hipotiroidizem (2,2 %), adrenalnokortikalna insuficienca (3,3 %), hipotireoza kot posledica pomanjkanja TSH (2,6 %), zmanjšanje vrednosti prostega tiroksina (4,4 %), povečanje vrednosti TSH v krvi (2,2 %)
None or -0.5 mg (all patients)
kliničnega statusa brez ali -0,5 mg (vsi bolniki)
The recommended starting dose is 2 mg of somatropin injected once a week.
Priporočeni začetni odmerek je 2 mg somatropina, injiciranega enkrat na teden.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
For children heavier than 40 kg, two vials (a 10 mg and a 20 mg vial or two vials of 20 mg) can be used according to the body weight as indicated in the table below.
Za otroke s telesno maso več kot 40 kg lahko uporabite dve viali (vialo z 10 mg in vialo z 20 mg ali dve viali z 20 mg) v skladu s telesno maso, kot je razvidno v spodnji preglednici.
The maximum injection volume per injection site should not exceed 1 mL.
Največja količina injiciranega zdravila na mesto injiciranja ne sme preseči 1 ml.
After accidental intramuscular injection, hypoglycaemia may occur.
Po nehotnem intramuskularnem injiciranju se lahko pojavi hipoglikemija.
It is therefore crucial to assess baseline and stress doses of glucocorticoids which may need to be adjusted when growth hormone therapy is initiated.
Zato je ključnega pomena, da se ocenijo izhodiščni in stresni odmerki glukokortikoidov, ki jih bo morda treba po uvedbi zdravljenja z rastnim hormonom prilagoditi.
Somatropin Biopartners has given rise to the formation of antibodies in approximately 4% of adult patients.
Zdravilo Somatropin Biopartners je povzročilo razvoj protiteles pri približno 4 % odraslih bolnikov.
Long-term therapy in growth hormone-deficient patients increases bone mineral density.
Dolgotrajno zdravljenje pri bolnikih s pomanjkanjem rastnega hormona zveča mineralno gostoto kosti.
The somatropin in this medicinal product is a polypeptide hormone of recombinant DNA origin.
Somatropin v tem zdravilu je polipeptidni hormon, pridelan z metodo rekombinantne DNA.
Somatropin therapy has a beneficial effect on body composition in patients with -GHD, in that body fat stores are reduced and lean body mass is increased.
Zdravljenje s somatropinom ima koristen učinek na zgradbo telesa pri bolnikih z GHD, in sicer tako, da se zmanjšajo zaloge maščob v telesu, zveča pa se delež puste telesne mase.
• Somatropin treatment must not be started in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or to patients having acute respiratory failure or similar conditions.
• S Somatropinom se ne sme zdraviti bolnikov z akutno kritično boleznijo, nastalo zaradi zapletov po operaciji na odprtem srcu ali v trebuhu, bolnikov z večkratnimi nezgodnimi poškodbami ter bolnikov z akutno odpovedjo dihanja ali podobnimi stanji.
After reconstitution the injection should be administered immediately.
Po rekonstituciji je treba injekcijo dati takoj.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni »brez natrija«.
Thyroid function should therefore be closely monitored in all patients.
Zato je treba pri vseh bolnikih natančno spremljati delovanje ščitnice.
What Somatropin Biopartners is and what it is used for What you need to know before you use Somatropin Biopartners
Kaj je zdravilo Somatropin Biopartners in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Somatropin Biopartners Kako uporabljati zdravilo Somatropin Biopartners
Somatropin has no or negligible influence on the ability to drive and use machines.
Somatropin nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Patients with diabetes, glucose intolerance, or additional risk factors for diabetes should be monitored closely during somatropin therapy.
Bolnike s sladkorno boleznijo, neprenašanjem glukoze ali dodatnimi dejavniki tveganja za sladkorno bolezen je treba med zdravljenjem s somatropinom skrbno spremljati.
Once a normal peak bone mass is attained patients should be switched to Somatropin Biopartners for adults, if clinically indicated, and the dosing recommendation for adults should be followed.
Ko je dosežena največja kostna masa, mora bolnik preiti na zdravljenje z zdravilom Somatropin Biopartners za odrasle, če je to klinično indicirano, upoštevati pa je treba smernice glede odmerjanja pri odraslih.
The most frequently reported adverse reactions in children were injection site related reactions, most of them being mild to moderate in intensity.
Neželeni učinki, ki so jih pri otrocih najpogosteje poročali, so bili reakcije na mestu injiciranja, ki so bile večinoma blage do zmerne.
Female (not on oral oestrogen)
Ženske (ki ne dobivajo peroralnega estrogena)
Patients taking insulin for diabetes mellitus should be carefully monitored during treatment with somatropin.
Bolnike, ki uporabljajo insulin za sladkorno bolezen, je treba med zdravljenjem s somatropinom skrbno spremljati.
Your doctor may need to adjust the dose of Somatropin Biopartners or of the other medicines: - corticosteroids, such as cortisone or prednisolone: medicines to reduce inflammation or immune system activity, to prevent organ transplant rejection or to treat asthma - thyroxine: a medicine to treat reduced thyroid gland function - insulin: a medicine to lower blood sugar levels
Vaš zdravnik bo morda moral prilagoditi odmerek zdravila Somatropin Biopartners ali drugih zdravil: - kortikosteroidi, kot sta kortizon ali prednizolon: zdravila za zmanjševanje vnetja ali aktivnosti imunskega sistema, za preprečevanje zavrnitve presajenega organa ali za zdravljenje astme - tiroksin: zdravilo za zdravljenje zmanjšanega delovanja žleze ščitnice - insulin: zdravilo za nižanje ravni sladkorja v krvi
Inject the suspension over a period of 5 seconds by gently pushing the plunger until the syringe is empty.
Suspenzijo injicirajte 5 sekund z nežnim pritiskanjem na bat, da se injekcijska brizga izprazni.
Hold the syringe firmly by the finger grip.
Injekcijsko brizgo čvrsto držite s prsti.
Diagnosis and therapy with this medicinal product should be initiated and monitored by physicians adequately experienced in the diagnosis and management of patients with growth hormone deficiency (GHD).
Diagnozo in zdravljenje s tem zdravilom morajo začeti in spremljati zdravniki, ki imajo ustrezne izkušnje pri diagnosticiranju in zdravljenju bolnikov s pomanjkanjem rastnega hormona (GHD,
After reconstitution the medicinal product should be used immediately before the suspension settles.
Po rekonstituciji morate zdravilo uporabiti takoj, preden se suspenzija usede.
Continue to fill the syringe with the correct volume of the solvent for injection, as described in the text of figure 4 above.
Injekcijsko brizgo napolnite s pravilno količino vehikla za injiciranje, kot je opisano v besedilu ob sliki 4 zgoraj.
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 visoke gostote (HDL, High-Density Lipoprotein) ter zniža skupno koncentracijo plazemskega holesterola.
Dosage reductions may be necessary: - in patients above 60 years of age - in patients who develop long lasting tissue swelling caused by fluid retention or who develop abnormal sensations such as prickling, tingling and itchiness - to avoid the development of carpal tunnel syndrome, where the nerve running through the wrist
Odmerek bo morda treba zmanjšati: - pri bolnikih, starejših od 60 let - pri bolnikih, pri katerih se razvije dolgo trajajoča oteklost tkiva zaradi zastajanja tekočine ali pri katerih se pojavijo nenormalni občutki, kot so ščemenje, zbadanje in srbenje - za preprečitev razvoja sindroma karpalnega kanala, kjer se živec, ki poteka skozi zapestje
The biological effects of somatropin are equivalent to those of hGH of pituitary origin.
Biološki učinki somatropina so enakovredni hGH hipofiznega izvora.
Growth hormone decreases the conversion of cortisone to cortisol and may unmask previously undiscovered central hypoadrenalism or render low glucocorticoid replacement doses ineffective.
Rastni hormon zmanjšuje pretvorbo kortizona v kortizol in lahko razkrije predhodno neodkrito centralni hipoadrenalizem ali povzroči neučinkovitost nizkih nadomestnih odmerkov glukokortikoidov.
Dose requirements may decline with increasing age.
Morda je treba z višjo starostjo odmerek zmanjšati.
Excessive glucocorticoid therapy will inhibit the growth-promoting effect of hGH.
Čezmerno zdravljenje z glukokortikoidi bo zavrlo rast spodbujajoči učinek hGH.
From reproductive toxicity studies performed with other somatropin products there is no evidence of an increased risk of adverse reactions to the embryo or foetus.
Iz študij vpliva na sposobnost razmnoževanja, opravljenih z drugimi zdravili s somatropinom, ni dokazov o povečanem tveganju za neželene učinke za zarodek ali plod.
Very rare, may affect up to 1 in 1,000 people - sleeplessness - enlargement of the male breast
Zelo redki; pojavijo se lahko pri največ 1 od 1.000 bolnikov - nespečnost - povečanje moških prsi
Vascular disorders Common: Hypertension,increased blood pressure
Žilne bolezni pogosti: hipertenzija, povečan krvi tlak
Therefore, if you weigh more than 40 kg the overall injection volume must be divided into equal parts between two injection sites, as more than 1 mL of suspension is required.
Če imate več kot 40 kg, morate celotno količino injekcije razdeliti na dva enaka dela in ju injicirati na dve mesti, saj je potrebna količina večja kot 1 ml suspenzije.
Childhood-onset: In patients with childhood-onset isolated GHD (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like growth factor-I (IGF-I) concentrations (< -2 standard deviation score (SDS)), who may be considered for one test.
Začetek v otroštvu: Pri bolnikih z izoliranim GHD od otroštva dalje (brez dokazov bolezni osi hipotalamus-hipofiza ali obsevanja glave) je treba priporočiti dva dinamična testa, razen pri tistih z nizkimi koncentracijami insulinu podobnega rastnega dejavnika I (IGF-I, Insulin-Like Growth FactorI) (<-2 standardna odklona (SDS, Standard Deviation Score)), pri katerih zadošča en test. Mejna točka dinamičnega testa mora biti strogo določena.
Leukaemia
Levkemija
If you use more Somatropin Biopartners than you should, you should consult your doctor.
Če ste uporabili več zdravila Somatropin Biopartners, se posvetujte s svojim zdravnikom.
In cases of severe or recurrent headache, visual problems, nausea, and/or vomiting, a fundoscopy for papilloedema is recommended.
Pri bolnikih s hudim ali ponavljajočim se glavobolom, motnjami vida, slabostjo in/ali bruhanjem se priporoča fundoskopija za odkrivanje edema papile.
Safely dispose of all used injection needles and syringes after a single use.
Vse uporabljene igle in injekcijske brizge po enkratni uporabi zavrzite.
In general, Cmax and AUC increased approximately proportionally with dose over a dose range of 0.2 to 0.7 mg/kg in prepubertal children with GHD.
Na splošno sta Cmax in AUC pri otrocih pred puberteto s pomanjkanjem rastnega hormona naraščala približno sorazmerno z odmerkom v razponu odmerka 0,2 do 0,7 mg/kg.
Oral oestrogen administration increases the dose requirements in women.
Peroralno dajanje estrogenov pri ženskah poveča potrebni odmerek.
This pivotal phase III study comprised 151 adult patients with GHD of adult- or childhood-onset and lasted 6 months.
Ta osrednja študija faze III je zajela 151 bolnikov s pomanjkanjem rastnega hormona, ki se je začelo v odrasli dobi ali v otroštvu, in je trajala 6 mesecev.
1 vial of 1.5 mL solvent
1 viale z 1,5 ml vehikla
Insert the needle straight through the centre of the vial's rubber stopper into the suspension.
Iglo vstavite neposredno skozi sredino gumijastega zamaška viale v suspenzijo.
With regard to antibodies against host cell proteins, low anti-S. cerevisiae protein antibody titres similar to levels in the normal untreated population were found in some patients treated with this medicinal product.
Pri nekaterih bolnikih, zdravljenih s tem zdravilom, so opazili nizke titre protiteles proti beljakovinam gostiteljskih celic (anti-S. cerevisiae), ki so bile podobne kot pri normalni nezdravljeni populaciji.
For the treatment of children and adolescents aged 2 to 18 years the 10 mg and 20 mg vials of this medicinal product should be used.
Za zdravljenje otrok in mladostnikov, starih 2 do 18 let, je treba uporabiti viale z 10 mg in 20 mg zdravila.
Very common: Formation of antibodies against growth hormone (33%), see section “Descriptions of selected adverse reactions”, under “Immunogenicity”.
Bolezni imunskega sistema zelo pogosti: nastanek protiteles proti rastnemu hormonu (33 %), glejte »Imunogenost« v poglavju »Opis izbranih neželenih učinkov«.
Patients receiving concomitant glucocorticoid therapy should have their dose carefully adjusted to avoid an inhibitory effect on growth.
Pri bolnikih, ki se sočasno zdravijo z glukokortikoidi, je treba odmerek skrbno prilagoditi, da se prepreči zaviralni učinek na rast.
In patients with hypopituitarism receiving thyroxin replacement therapy, hyperpituitarism may develop.
Pri bolnikih s hipotiroidizmom, ki prejemajo nadomestno zdravljenje s tiroksinom, se lahko pojavi blag hiperpituitarizem.
Clean the rubber stopper again with an unused alcohol swab.
Gumijasti zamašek ponovno očistite z nerabljeno alkoholno blazinico.
IGF-I SDS greater than +2
SDS IGF-I večji kot +2
Do not use this medicine after the expiry date which is stated on the label and the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake Uporabno do. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Any remaining solvent should not be used for a second preparation.
Morebitnega preostanka vehikla ne hranite za drugo pripravo.
Apply gentle pressure to the plunger until a small drop of suspension appears at the end of the needle.
Na bat nežno pritiskajte, dokler se na koncu igle ne pojavi majhna kapljica suspenzije.
Metabolism and nutrition disorders Common: Mild hyperglycaemia* Not known: Insulin resistance*
Presnovne in prehranske motnje pogosti: blaga hiperglikemija* neznana: odpornost na insulin*
- disposal box for used syringes and needles
- posodo za uporabljene injekcijske brizge in igle
Tel: +49 (0)7121 948 7756 Fax: +49 (0)7121 346 255 e-mail: info@biopartners.de
Tel.: +49 (0)7121 948 7756 Faks: +49 (0)7121 346 255 e-pošta: info@biopartners.de
Patients with prior malignancies should be examined routinely for progression or recurrence.
Pri bolnikih z obstoječimi malignostmi je treba z rutinskimi pregledi ugotavljati znake napredovanja ali ponovnega pojava bolezni.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Storage conditions of the unopened product
Pogoji shranjevanja neodprtega zdravila
Because it is a thick mixture, the syringe might fill slowly.
Mešanica je gosta, zato se bo morda injekcijska brizga polnila počasi.
Intracranial tumours must be inactive and antitumour therapy must be completed prior to the initiation of growth hormone therapy.
Intrakranialni tumorji morajo biti nedejavni, zdravljenje tumorja pa je treba zaključiti pred začetkom zdravljenja z rastnim hormonom.
An increasing sensitivity to growth hormone (expressed as change in IGF-I per growth hormone dose) over time may be observed, particularly in men.
Zlasti pri moških je mogoče sčasoma opaziti povečano občutljivost na rastni hormon (izraženo kot spremembo v IGF-I na odmerek rastnega hormona).
Collect the following items before you begin: - supplied in the pack - Somatropin Biopartners vial containing active substance - Somatropin Biopartners vial containing 1.5 mL solvent for suspension for injection - not supplied in the pack - one sterile injection syringe with 19 (19G) or wider Gauge needle to withdraw the solvent - one sterile injection syringe with 26 Gauge (26G) needle for the injection
Pred začetkom zberite naslednje: - priloženo pakiranju - vialo z zdravilom Somatropin Biopartners, ki vsebuje zdravilno učinkovino - vialo zdravila Somatropin Biopartners, ki vsebuje 1,5 ml vehikla za suspenzijo za injiciranje - ni priloženo pakiranju - eno sterilno injekcijsko brizgo z iglo velikosti 19 G ali večjo, da izvlečete vehikel - eno sterilno injekcijsko brizgo z iglo velikosti 26 G za injiciranje
Side effects very commonly reported in adults (may affect more than 1 in 10 people) were tissue swelling due to fluid retention, mild increase in blood sugar and headache.
Neželeni učinki, o katerih so zelo pogosto poročali pri odraslih (pojavijo se lahko pri več kot 1 od 10 bolnikov), so oteklost tkiva zaradi zastajanja tekočine, blago zvišanje ravni krvnega sladkorja in glavobol.
Because human growth hormone (hGH) may induce a state of insulin resistance and hyperglycaemia, patients treated with this medicinal product should be monitored for evidence of glucose intolerance.
Ker lahko humani rastni hormon (hGH, human growth hormone) pri nekaterih bolnikih povzroči odpornost proti insulinu in hiperglikemijo, je treba biti pri teh bolnikih pozoren na morebiten pojav znakov neprenašanja glukoze.
Somatropin administration may increase the clearance of compounds known to be metabolised by cytochrome P450 isoenzymes.
Uporaba somatropina lahko poveča očistek spojin, ki jih presnavljajo izoencimi citokroma P450.
What you need to know before you use Somatropin Biopartners
Kaj morate vedeti, preden boste uporabili zdravilo Somatropin Biopartners
For the treatment of children and adolescents aged 2 to 18 years vials with 10 mg and 20 mg somatropin should be used.
Za zdravljenje otrok in mladostnikov, starih 2 do 18 let, je treba uporabiti viale z 10 mg in 20 mg somatropina.
Somatropin Biopartners has given rise to the formation of antibodies in approximately 33% of the paediatric patients.
Zdravilo Somatropin Biopartners je povzročilo razvoj protiteles pri približno 33 % pediatričnih bolnikov.
Vascular disorders Rare: hypertension*
Žilne bolezni redki: hipertenzija*
Tap and shake the vial of powder to make sure the powder is moving freely.
Na vialo s praškom potrkajte in jo stresite, da zagotovite, da se prašek prosto premika.
Conversion from required dose to injection volume and vial strength Somatropin dose vials and solvent required for preparation of
Pretvorba iz potrebnega odmerka v volumen injekcije in jakost viale viale in vehikel, potrebni za pripravo enega
Common: injection site pain (9.9%), injection site discolouration (8.8%), injection site erythema (7.7%), injection site nodule (4.4%), injection site reaction (1.1%), injection site warmth (1.1%), pyrexia (2.6%), oedema (local and generalised)*
Splošne težave in spremembe na mestu aplikacije zelo pogosti: oteklina na mestu injiciranja (30,8 %) pogosti: bolečina na mestu injiciranja (9,9 %), obarvanje na mestu injiciranja (8,8 %), eritem na mestu injiciranja (7,7 %), vozliček na mestu injiciranja (4,4 %), reakcija na mestu injiciranja (1,1 %), toplota na mestu injiciranja (1,1 %), pireksija (2,6 %), edem (lokalni in generaliziran)*
Because somatropin increases growth rate, patients with a history of scoliosis who are treated with somatropin should be monitored for progression of scoliosis.
Ker somatropin pospešuje hitrost rasti, je treba pri bolnikih s skoliozo v anamnezi spremljati napredovanje skolioze.
What Somatropin Biopartners is and what it is used for
Kaj je zdravilo Somatropin Biopartners in za kaj ga uporabljamo
Clean the injection site with an unused alcohol swab.
Mesto injiciranja očistite z nerabljeno alkoholno blazinico.
The metabolic fate of hGH involves classical protein catabolism in both the liver and kidney.
Presnova hGH poteka v obliki klasične razgradnje beljakovin v jetrih in ledvicah.
Tel: +49 (0) 7121 948 7756 Fax:+49 (0) 7121 346 255 e-mail: info@biopartners.de
Tel. +49 (0) 7121 948 7756 Faks +49 (0) 7121 346 255 e-pošta: info@biopartners.de
The adverse reactions most commonly reported were injection site related reactions, peripheral oedema, headache, myalgia, arthralgia, paraesthesia, hypothyroidism and decreased free thyroxine.
Neželeni učinki, o katerih so najpogosteje poročali, so reakcije, povezane z mestom injiciranja, periferni edem, glavobol, mialgija, artralgija, parestezija, hipotiroidizem in zmanjšanje prostega tiroksina.