natgillin/translations-raw huggingface dataset:
Patients receiving tofacitinib 5 or 10 mg twice daily demonstrated significantly greater improvement from baseline in fatigue compared to placebo in all 5 studies.
V vseh 5 preskušanjih je bilo pri bolnikih, ki so prejemali 5 mg ali 10 mg tofacitiniba dvakrat na dan, izboljšanje utrujenosti glede na izhodišče pomembno večje v primerjavi s placebom.
Tofacitinib 10 mg Twice Daily + MTX N=309
tofacitinib 10 mg dvakrat na dan + MTX n = 309
Tofacitinib 5 mg Twice Daily Monotherapy N=241
Monoterapija s tofacitinibom 5 mg dvakrat na dan n = 241
ORAL Step: TNF Inhibitor Inadequate Responders N=118
ORAL Step: bolniki z nezadostnim odzivom na antagoniste TNF
In the controlled portion of the RA Phase 3 monotherapy study (0-3 months) (study I, see section 5.1), ALT elevations greater than 3x ULN were observed in 1.65%, 0.41%, and 0% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
V nadzorovanem delu preskušanja 3. faze z monoterapijo pri bolnikih z RA (0-3 meseci) (Preskušanje I, glejte poglavje 5.1) so zvečanja vrednosti ALT, večja od 3-kratne vrednosti ZMN, opazili pri 1,65 % bolnikov, ki so prejemali placebo, 0,41 % bolnikov, ki so prejemali 5 mg tofacitiniba dvakrat na dan, in 0 % bolnikov, ki so prejemali 10 mg tofacitiniba dvakrat na dan.
NA ORAL Standard: MTX Inadequate Responders
NA ORAL Standard: bolniki z nezadostnim odzivom na MTX
Tofacitinib 5 mg Twice Daily N=344 Mean (SD)a
a tofacitinib 5 mg dvakrat na dan n = 344 povprečje (SD)
GENERAL CLASSIFICATION FOR SUPPLY
Prilagajanje odmerka blaga
Tofacitinib 5 mg Twice Daily + MTX Mean Difference from Placebob (CI)
a tofacitinib 5 mg dvakrat na dan + MTX povprečna razlika glede na placebob
Patients who did not achieve clinical response in one of the induction studies (OCTAVE Induction 1 or OCTAVE Induction 2) after 8 weeks of tofacitinib 10 mg twice daily were allowed to enter an open-label extension study (OCTAVE Open).
Induction 2) po 8 tednih zdravljenja z 10 mg tofacitiniba dvakrat na dan niso dosegli kliničnega odziva, so lahko sodelovali v odprtem podaljšanem preskušanju (OCTAVE Open).
Patients receiving either 5 or 10 mg tofacitinib twice daily experienced significantly greater improvement from baseline compared to placebo in all 8 domains as well as the Physical Component Summary and Mental Component Summary scores at month 3 in ORAL Solo, ORAL Scan and ORAL Step.
V preskušanjih ORAL Solo, ORAL Scan in ORAL Step je bilo izboljšanje glede na izhodišče v 3. mesecu v primerjavi s placebom pomembno večje pri bolnikih, ki so prejemali 5 mg ali 10 mg tofacitiniba dvakrat na dan, v vseh 8 domenah, kot tudi pri rezultatih povzetka telesne komponente (Physical Component Summary) in povzetka duševne komponente (Mental Component Summary).
Normalization of endoscopic appearance of the mucosac
remisija a izboljšanje endoskopskega videza sluzniceb normalizacija endoskopskega videza sluznice c klinični odzivd
Tofacitinib 5 mg Twice Daily Monotherapy N=370
Monoterapija s tofacitinibom 5 mg dvakrat na dan n = 370
Tofacitinib 5 mg Twice Daily + MTX N=277 Mean (SD)a
a tofacitinib 5 mg dvakrat na dan + MTX n = 277 povprečje (SD)
Tofacitinib 10 mg Twice Daily + MTX N=134
tofacitinib 10 mg dvakrat na dan + MTX n = 134
Tofacitinib 5 mg Twice Daily + MTX N=316
tofacitinib 5 mg dvakrat na dan + MTX n = 316
Tel: +49 (0)30 550055-51000
Pfizer Pharma GmbH Tel: +49 (0)30 550055-51000
Tofacitinib 5 mg Twice Daily + MTX N=133
tofacitinib 5 mg dvakrat na dan + MTX n = 133
Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0)1 52 11 400
ORAL Standard: MTX Inadequate Responders
ORAL Standard: bolniki z nezadostnim odzivom na MTX
Pfizer Luxembourg SARL filialas Lietuvoje
Pfizer Luxembourg SARL filialas Lietuvoje Tel. +3705 2514000
Tofacitinib 5 mg Twice Daily + DMARD(s) N=312
tofacitinib 5 mg dvakrat na dan + DMARD**** n = 312
Table 14: Phase 3 Clinical Studies of Tofacitinib 5 and 10 mg Twice Daily Doses in Patients with UC
Preglednica 14: Klinična preskušanja 3. faze uporabe tofacitiniba v odmerkih 5 in 10 mg dvakrat na dan pri bolnikih z UK OCTAVE Induction 1 OCTAVE Induction 2 OCTAVE Sustain
Reduce Tofacitinib Dosea Reduce Tofacitinib Dosea May Decrease Efficacy
Zmanjšajte odmerek tofacitiniba a.
With prior TNF inhibitor failure Without prior TNF inhibitor failureb
brez predhodnega neučinkovitega zdravljenja z zaviralcem TNFb
Tofacitinib 5 mg Twice Daily Mean Difference from MTXd (CI)
a tofacitinib 5 mg dvakrat na dan povprečna razlika glede na MTXd
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/005 60 film-coated tablets EU/1/17/1178/006 180 film-coated tablets
EU/1/17/1178/005 60 filmsko obloženih tablet EU/1/17/1178/006 180 filmsko obloženih tablet
Tofacitinib 10 mg Twice Daily Monotherapy N=394
Monoterapija s tofacitinibom 10 mg dvakrat na dan n = 394
Vascular disorders Hypertension Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj dispneja, kongestija sinusov
Tofacitinib 10 mg Twice Daily Monotherapy N=243
Monoterapija s tofacitinibom 10 mg dvakrat na dan n = 243
Tofacitinib 5 or 10 mg twice daily-treated patients demonstrated significantly greater improvement in physical functioning compared to placebo as early as week 2 in ORAL Solo and ORAL Sync.
V preskušanjih ORAL Solo in ORAL Sync so pri bolnikih, ki so prejemali 5 mg ali 10 mg tofacitiniba dvakrat na dan, opazili pomembno izboljšanje telesne funkcije v primerjavi s placebom že po 2 tednih.
In both subgroups of patients with or without prior TNF inhibitor failure, a greater proportion of patients treated with either tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily achieved the following endpoints at week 52 of OCTAVE Sustain as compared to placebo: remission,
Tako v podskupini bolnikov s predhodnim neučinkovitim zdravljenjem z zaviralcem TNF kot v podskupini brez njega so po 52 tednih preskušanja OCTAVE Sustain pri pomembno večjem deležu bolnikov, ki so se zdravili s 5 mg tofacitiniba dvakrat na dan ali 10 mg tofacitiniba dvakrat na dan, kot v skupini s placebom potrdili naslednje opazovane dogodke: remisijo, izboljšanje endoskopskega videza sluznice ali ohranjeno remisijo brez jemanja kortikosteroidov po 24 in 52 tednih pri bolnikih, ki so bili ob izhodišču v remisiji (preglednica 18).
e. Sustained corticosteroid-free remission was defined as being in remission and not taking corticosteroids for at least
Ohranjena remisija brez jemanja kortikosteroidov je pomenila, da je bil bolnik v remisiji in ni jemal kortikosteroidov vsaj 4 tedne pred obiskom po 24 tednih in obiskom po 52 tednih.
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1178/001 60 film-coated tablets EU/1/17/1178/002 180 film-coated tablets
EU/1/17/1178/001 60 filmsko obloženih tablet EU/1/17/1178/002 180 filmsko obloženih tablet
Pfizer Luxembourg SARL
Luxembourg/Luxemburg Pfizer S.A.
MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS BLISTER FOR 10 MG TABLETS
NALEPKA ZA STIČNO OVOJNINO - PLASTENKO ZA 10 MG TABLETE
In the RA long-term safety population, confirmed decreases in ALC below 500 cells/mm occurred in
V populaciji z RA, pri kateri so preučevali dolgoročno varnost, so zmanjšanje ALC pod 500 celic/mm3 potrdili pri skupno 1,3 % bolnikov, zmanjšanje ALC med 500 in 750 celic/mm3 pa pri skupno 8,4 %
Improvement of endoscopic appearance of the mucosa
Pregled endoskopskih posnetkov na mestu kliničnega preskušanja
a. Primary endpoint: Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0. b. Key secondary endpoint: Improvement of endoscopic appearance of the mucosa was defined as Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern).
Ključni sekundarni opazovani dogodek: izboljšanje endoskopskega videza sluznice so opredelili kot endoskopska podocena Mayo 0 (normalen videz ali neaktivna bolezen) ali 1 (eritem, zmanjšan žilni vzorec).
Remissiona With prior TNF inhibitor failure Without prior TNF inhibitor failureb Improvement of endoscopic appearance of the mucosac With prior TNF inhibitor failure Without prior TNF inhibitor failureb OCTAVE Induction Study 2
remisija a predhodno neučinkovito zdravljenje z zaviralcem TNF 10/89 brez predhodnega neučinkovitega zdravljenja z zaviralcem TNFb izboljšanje endoskopskega videza sluznice c predhodno neučinkovito zdravljenje z zaviralcem TNF 11/89
MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS BLISTER FOR 5 MG TABLETS
NALEPKA ZA STIČNO OVOJNINO - PLASTENKO ZA 5 MG TABLETE
NAME OF THE MEDICINAL PRODUCT XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets
XELJANZ 5 mg filmsko obložene tablete XELJANZ 10 mg filmsko obložene tablete
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of tofacitinib (as tofacitinib citrate).
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 10 mg tofacitiniba (v obliki tofacitinibijevega citrata).
a. Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0. b. Included TNF Inhibitor naïve patients.
Remisijo so opredelili kot klinična remisija (ocena Mayo ≤ 2 brez posamezne podocene > 1) in podocena rektalnih krvavitev 0.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of tofacitinib (as tofacitinib citrate).
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 5 mg tofacitiniba (v obliki tofacitinibijevega citrata).
Placebo Tofacitinib 5 mg Twice Daily
placebo tofacitinib 5 mg dvakrat na dan n 3. mesec c,*
a. ≤3 weekly doses (MTX-naïve).
≤ 3-tedenski odmerki (bolniki, ki še niso prejemali MTX).
Placebo + DMARD(s) N=158
Opazovani dogodek Čas placebo + DMARD**** n = 158
It is not recommended to initiate or continue tofacitinib treatment in patients with a confirmed lymphocyte count less than 750 cells/mm3.
Pri bolnikih s potrjenim številom limfocitov, manjšim od 750 celic/mm3, uvedba ali nadaljevanje zdravljenja s tofacitinibom nista priporočljivi.
Patients randomised to tofacitinib received 5 mg twice daily or tofacitinib 10 mg twice daily for 6 months.
bolnikov za skupini, ki sta prejemali odmerke 5 mg dvakrat na dan in 10 mg dvakrat na dan.
Your doctor will test you for tuberculosis before starting XELJANZ and may retest during treatment - if you have any chronic lung disease - if you have liver problems - if you have or had hepatitis B or hepatitis C (viruses that affect the liver).
- če imate ali ste imeli hepatitis B ali hepatitis C (virusa, ki prizadeneta jetra).
Baseline Month 6
6. mesec placebo
Tofacitinib 10 mg Twice Daily + MTX
3. mesec tofacitinib 10 mg dvakrat na dan + MTX
Patients receiving tofacitinib 5 or 10 mg twice daily demonstrated significantly greater improvement from baseline in both scales compared to placebo in ORAL Sync, ORAL Standard and ORAL Scan.
V preskušanjih ORAL Sync, ORAL Standard in ORAL Scan je bilo pri bolnikih, ki so prejemali 5 mg ali 10 mg tofacitiniba dvakrat na dan, izboljšanje na obeh lestvicah glede na izhodišče pomembno večje v primerjavi s placebom.
Tuberculosis Diverticulitis Pyelonephritis Cellulitis Herpes simplex Gastroenteritis viral
Bolezni jeter, žolčnika in žolčevodov jetrna steatoza
• Once only.
• Samo enkrat.
Is this OK?
Je to vredu?
Note: This may take up to 5 minutes.
Opomba: To lahko traja do 5 minut.
Date of first authorization: 13 November 2002 Date of latest renewal: 20 September 2007
Datum prve odobritve: 13. november 2002 Datum zadnjega podaljšanja: 20. september 2007
Some patients required hospitalization.
Pri nekaterih bolnikih je bila potrebna hospitalizacija.
Before you start:
Preden začnete:
You will need a replacement syringe.
Potrebovali boste nadomestno brizgo.
What should I do if I have any doubts about my medicine?
Kaj naj storim, če imam pomisleke glede svojega zdravila?
See also the section about Pregnancy below.
Glejte tudi spodnje poglavje o nosečnosti.
The relevance of this response for humans is currently unknown.
Pomen takšnega odziva za ljudi trenutno ni znan.
There is also a risk you may lose some of the medicine.
Prav tako obstaja tveganje, da boste nekaj zdravila izgubili.
It may take more effort to snap off than you might expect.
Morda ga bo težje odlomiti, kot ste mislili.
- Your doctor should also monitor your adenoma (benign tumour).
Zdravnik mora prav tako spremljati vaš adenom (benigni tumor).
How many times can I safely insert the needle into the vial stopper?
Kolikokrat lahko iglo varno zabodem v zamašek viale?
As part of your treatment you may be given other medicines.
Kot del zdravljenja morda prejemate še druga zdravila.
The maximum dose should not exceed 30 mg/day.
Največji odmerek ne sme preseči 30 mg/dan.
Things you need
Kaj potrebujete
Adverse reactions are listed according to the following categories: Very common: 1/10
Neželeni učinki so našteti po naslednjih skupinah: Zelo pogosti:  1/10
The apparent volume of distribution of pegvisomant is relatively small (7-12 L).
Navidezni volumen porazdelitve pegvisomanta je razmeroma majhen (7-12 l).
Contact your doctor immediately if you develop any of these symptoms.
Nemudoma obvestite zdravnika, če se vam pojavi katerikoli od teh simptomov.
This can cause discomfort and increases risk of skin damage and infection.
To lahko povzroči neugodje in poveča tveganje za poškodbe kože in okužbe.
If these test results are not normal, your doctor will discuss treatment options with you.
Če rezultati teh testov ne bodo normalni, se bo zdravnik z vami posvetoval glede možnosti zdravljenja.
EU/1/02/240/001 10 mg 30 vials EU/1/02/240/002 15 mg 30 vials EU/1/02/240/004 20 mg 1 vial EU/1/02/240/003 20 mg 30 vials EU/1/02/240/009 25 mg 1 vial EU/1/02/240/010 25 mg 30 vials EU/1/02/240/011 30 mg 1 vial EU/1/02/240/012 30 mg 30 vials
EU/1/02/240/001 10 mg 30 vial EU/1/02/240/002 15 mg 30 vial EU/1/02/240/004 20 mg 1 viala EU/1/02/240/003 20 mg 30 vial EU/1/02/240/009 25 mg 1 viala EU/1/02/240/010 25 mg 30 vial EU/1/02/240/011 30 mg 1 viala EU/1/02/240/012 30 mg 30 vial
This will help you to draw off as much liquid as possible.
Tako boste lahko izvlekli kar največ tekočine.
Elderly No dose adjustment is required.
Starejši Prilagoditev odmerka ni potrebna.
• Blood in the urine.
• kri v urinu
The effects of SOMAVERT in pregnant women are not known, and so the use of this medicine in pregnant women is not recommended.
Učinki zdravila SOMAVERT na nosečnice niso znani in zato uporaba tega zdravila pri nosečnicah ni priporočljiva.
Why can't I get all of the medicine out of the vial?
Zakaj iz viale ne morem izvleči vsega zdravila?
• Do not use it-even if it looks undamaged.
• Ne uporabite je, čeprav se zdi nepoškodovana.
(angioedema)
(angioedem)
• Increased blood pressure.
• zvišan krvni tlak
The safety and efficacy of SOMAVERT in children aged 0 to 17 years have not been established.
Varnost in učinkovitost zdravila SOMAVERT pri otrocih, starih od 0 do 17 let, še nista bili dokazani.
The clinical significance of these antibodies is unknown.
Klinični pomen teh protiteles ni znan.
• If the decision is to treat, LTs and clinical symptoms should be monitored very closely.
• Če se odločite za zdravljenje, je treba zelo skrbno spremljati jetrne teste in klinične simptome.
- If you are diabetic, your doctor may need to adjust the amount of insulin or other medicines you are using.
Če imate sladkorno bolezen, bo zdravnik morda moral prilagoditi odmerek insulina ali drugih zdravil, ki jih jemljete.
• Abnormal dreams.
• nenormalne sanje
If you are unable to clean the stopper, do not use the vial.
Če zamaška ne morete očistiti, viale ne uporabite.
It is important that you do not try to give yourself or someone else an injection unless you have received training from your healthcare provider.
Pomembno je, da sebi ali drugim ne poskušate dajati injekcije, razen če vas je za to usposobil zdravstveni delavec.
However, breast-feeding may be continued if this medicine is discontinued: this decision should take into account the benefit of pegvisomant therapy to the mother and the benefit of breast-feeding to the child.
Dojenje se lahko nadaljuje, če se prekine zdravljenje s tem zdravilom: pri tem je treba upoštevati korist zdravljenja s pegvisomantom za mater in korist dojenja za otroka.
- Female patients should use adequate contraception as fertility may be increased.
Ženske bolnice morajo uporabljati ustrezno kontracepcijo, ker je plodnost lahko povečana.
Greater than 3 times ULN
Večje od 3-kratnika ZMN
The use of this medicine in combination with other medicinal products for the treatment of acromegaly has not been extensively investigated.
Uporaba tega zdravila v kombinaciji z drugimi zdravili za zdravljenje akromegalije ni podrobneje raziskana.
Renal clearance of pegvisomant is negligible and accounts for less than 1% of total body clearance.
Ledvični očistek pegvisomanta je zanemarljiv; na njegov račun gre manj kot 1 % celotnega telesnega očistka.
SOMAVERT should not be used during pregnancy unless clearly necessary (see section 4.4).
Zdravila SOMAVERT se ne sme uporabljati med nosečnostjo, razen če je nujno potrebno (glejte poglavje 4.4).
• The shape of the vial means that a very small amount of the medicine will be left behind in the vial.
• Zaradi oblike viale zelo majhna količina zdravila ostane v njej.
LT Levels and Clinical Signs/Symptoms
Vrednosti jetrnih testov in klinični znaki/simptomi
Dispose of the needle and syringe as instructed by your doctor, nurse or pharmacist and in accordance with local health and safety laws.
Iglo in brizgo zavrzite, kot vam je naročil zdravnik, medicinska sestra ali farmacevt in v skladu z lokalnimi predpisi o zdravju in varnosti.
This leaflet was last revised in <{MM/YYYY}>.
Navodilo je bilo nazadnje revidirano {MM/LLLL}
Use immediately after reconstitution.
Uporabite takoj po pripravi.
The detailed instructions on injection procedure provided at the end of this leaflet must be followed.
Podrobna navodila za injiciranje so navedena na koncu tega navodila.
You must tell your doctor if you have previously used other medicines for the treatment of acromegaly or medicines for the treatment of diabetes.
Zdravniku morate povedati, če ste že prej prejemali kakšna druga zdravila za zdravljenje akromegalije ali zdravila za zdravljenje sladkorne bolezni.
Tell your doctor or pharmacist if you are using or have recently used any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo.
The colour of the protective plastic cap is specific to the strength of the product.
Barva zaščitne plastične zaporke je specifična za jakost zdravila.
This technique will also reduce the swirling time and allow more of the medicine to be drawn off.
S to metodo boste prav tako skrajšali čas mešanja in izvlekli boste lahko več zdravila.
• Wash your hands with soap and water, and dry thoroughly.
• Roke si umijte z milom in vodo in jih dobro osušite.
Do not shake vigorously, as this might cause denaturation of the active substance.
Ne stresajte močno, ker to lahko povzroči denaturacijo učinkovine.
It must be clear and free of particles.
Zdravilo mora biti bistro in brez delcev.
About 17% of patients will develop antibodies to growth hormone during treatment.
Pri približno 17 % bolnikov se bodo med zdravljenjem razvila protitelesa proti rastnemu hormonu.
• Perform a comprehensive hepatic workup, including serial LTs, to determine if and when serum levels return to normal.
• Opravite celosten pregled jeter, vključno s serijskimi jetrnimi testi, da ugotovite, ali in kdaj se ravni v serumu povrnejo na normalne.
It is not known if pegvisomant passes into breast milk.
Ni znano, ali pegvisomant prehaja v materino mleko.
1 ml water for injections
1 ml vode za injekcije
Treatment should be initiated under the supervision of a physician experienced in the treatment of acromegaly.
Zdravljenje je treba začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem akromegalije.
How can I prevent the medicine from foaming?
Kako lahko preprečim, da bi se zdravilo spenilo?
Patients should be advised to use adequate contraception if necessary.
Če je potrebno, je treba bolnicam svetovati uporabo ustrezne kontracepcijske zaščite.
Pack sizes of 1 and/or 30.
Velikosti pakiranj po 1 in/ali30.
All patients with these tumours should be carefully monitored in order to avoid any eventual progression in tumour size under treatment.
Vse bolnike s takšnimi tumorji je treba skrbno spremljati, da bi se izognili morebitnemu večanju tumorja med zdravljenjem.
I can see some air in the syringe.
V injekcijski brizgi vidim nekaj zraka.
Clinical data are too limited (one reported case) to draw any conclusion on the excretion of pegvisomant in human breast milk.
Klinični podatki so preveč omejeni (en sam poročan primer), da bi na njihovi podlagi sklepali o izločanju pegvisomanta v materino mleko pri človeku.
Upon re-administration, symptoms did not re-occur in all patients.
Pri ponovni uporabi do vnovičnega pojava simptomov ni prišlo pri vseh bolnikih.
Treatment by pegvisomant does not reduce tumour size.
Zdravljenje s pegvisomantom ne zmanjša velikosti tumorjev.
The therapeutic benefits of a reduction in IGF-I concentration which results in improvement of the patient's clinical condition could potentially increase fertility in female patients.
Terapevtsko ugodno zmanjšanje koncentracije IGF-I, ki izboljša klinično stanje bolnikov, lahko pri bolnicah morda zveča plodnost.
Serum IGF-1 monitoring
Spremljanje serumske koncentracije IGF-1
SOMAVERT is injected under the skin.
Zdravilo SOMAVERT se injicira pod kožo.
Elevated, but less than or equal to 3 times ULN
Zvečane, vendar manjše ali enake 3-kratniku ZMN
The powder may take a few minutes to dissolve fully, so continue swirling the vial gently until the liquid is completely clear.
Da se prašek povsem raztopi, lahko traja nekaj minut, zato nadaljujte z nežnim mešanjem viale, dokler ni tekočina povsem bistra.
The pharmacokinetics of pegvisomant are similar in normal healthy volunteers and acromegaly patients, although heavier individuals tend to have a higher total body clearance of pegvisomant than lighter individuals, and may thus require greater doses of pegvisomant.
Farmakokinetika pegvisomanta je pri normalnih zdravih prostovoljcih in bolnikih z akromegalijo podobna, vendar imajo težji posamezniki praviloma večji celotni telesni očistek pegvisomanta kot lažji, zato utegnejo potrebovati večje odmerke pegvisomanta.
The antibodies do not seem to stop this medicine from working.
Kaže, da protitelesa ne preprečujejo učinka tega zdravila.
This gives your skin and the area under your skin time to recover from one injection before it receives another one in the same place.
Tako si bosta lahko koža in predel pod njo po injekciji opomogla, preden boste na isto mesto dali drugo injekcijo.
• May treat with SOMAVERT; however, monitor LTs monthly for at least 1 year after initiation of therapy and then bi-annually for the next year.
• Lahko zdravite z zdravilom SOMAVERT, vendar je treba vsaj 1 leto po uvedbi zdravljenja mesečno spremljati jetrne teste ter nato dvakrat letno v naslednjem letu.
The mean extent of absorption of a subcutaneous dose was 57% relative to an intravenous dose.
Povprečni delež absorpcije subkutanega odmerka v primerjavi z intravenskim je 57 %.
It should be considered whether to continue treatment with somatostatin analogues.
Razmisliti je treba o nadaljevanju zdravljenja z analogi somatostatina.
The list below contains adverse reactions seen in clinical trials or that were spontaneously reported, classified by system organ class and frequency.
V spodnji preglednici so navedeni neželeni učinki, ki so bili zabeleženi v kliničnih preskušanjih ali so o njih poročali spontano; razvrščeni so po organskih sistemih in pogostnosti.
What should I do with the syringe if it has been dropped?
Kaj naj storim z injekcijsko brizgo, če mi je padla na tla?
In cases of overdose, administration of this medicine should be discontinued and not resumed until IGF-I levels return to within or above the normal range.
V primeru prevelikega odmerjanja je treba uporabo pegvisomanta prekiniti in se ga ne sme znova uporabiti, dokler se raven IGF-I ne vrne v ali nad normalno območje.