natgillin/translations-raw huggingface dataset:
In SCII, 656 patients were randomized 2:1 to RoActemra subcutaneous 162 mg every other week or placebo, in combination with non-biologic DMARD(s).
V SC-II so 656 bolnikov randomizirali v razmerju 2:1, da so prejeli 162 mg zdravila RoActemra subkutano vsak drugi teden ali placebo v kombinaciji z nebiološkimi imunomodulirajočimi antirevmatičnimi zdravili.
The frequency of ADRs in sJIA patients can be found in Table 2.
Pogostnost neželenih učinkov pri bolnikih s sJIA je prikazana v preglednici 2.
RoActemra subcutaneous weekly dose also showed a clinically meaningful decrease in the risk for flare compared to placebo plus 26 weeks prednisone in patients who entered the trial with relapsing GCA as well as those with new-onset disease (Table 4).
Subkutana uporaba zdravila RoActemra vsak teden je v primerjavi s placebom skupaj s 26-tedenskim prednizonom tudi klinično pomembno zmanjšala tveganje za poslabšanje tako pri bolnikih, ki so bili vključeni v preskušanje s ponovitvijo GCA kot pri tistih z novonastalo boleznijo (preglednica 4).
Children and adolescents RoActemra subcutaneous injection is not recommended for use in children under 18 years of age.
Zdravila RoActemra v podkožni injekciji ni priporočljivo uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
• cough, shortness of breath
• kašelj, oteženo dihanje,
• Package leaflet (with instructions for use for SC)
• navodilo za uporabo (z navodili za uporabo subkutane oblike), • opozorilno kartico za bolnika
• Then keep the syringe in position and let go of the pinch of skin.
• Nato napolnjeno injekcijsko brizgo držite in spustite kožno gubo.
0.9 mL solution in a pre-filled syringe (type I glass) with a staked-in needle containing 162 mg RoActemra assembled into a pre-filled pen.
0,9 ml raztopine za injiciranje v napolnjeni injekcijski brizgi (steklo tipa I) z vstavljeno iglo, ki vsebuje 162 mg zdravila RoActemra v napolnjenem injekcijskem peresniku.
Following 1 year of treatment with RoActemra plus MTX, 85% of patients(n=348) had no progression of structural joint damage, as defined by a change in the Total Sharp Score of zero or less, compared with 67% of placebo plus MTX-treated patients(n=290) (p ≤ 0.001).
Po 1 letu zdravljenja z zdravilom RoActemra in metotreksatom pri 85 % bolnikov (n = 348) ni bilo napredovanja strukturne okvare sklepov, opredeljene kot spremembe v celotni oceni po Sharpu 0 ali manj, v primerjavi s 67 % bolnikov, ki so prejemali placebo in metotreksat (n = 290) (p ≤ 0,001).
However, if you are worried, talk to your doctor or nurse.
A če vas skrbi, se posvetujte z zdravnikom ali medicinsko sestro.
Patients in study SC-I had a mean Disease Activity Score (DAS28) at baseline of 6.6 and 6.7 on the subcutaneous and intravenous arms, respectively.
Bolniki v študiji SC-I so imeli povprečno izhodiščno oceno aktivnosti bolezni DAS28 (Disease Activity Score) v subkutani skupini 6,6, v intravenski pa 6,7.
• high blood fat (triglycerides)
• zvišane maščobe v krvi (trigliceridi),
If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.
Če se simptomi tuberkuloze (vztrajen kašelj, izguba telesne mase, ravnodušnost, blago zvišana telesna temperatura) ali katerekoli druge okužbe pojavijo med zdravljenjem ali po njem, to nemudoma povejte svojemu zdravniku.
In the SC RoActemra study, the rate of infection in pJIA patients treated with SC RoActemra was comparable with pJIA patients treated with IV RoActemra.
V študiji s subkutano obliko zdravila RoActemra je bil delež okužb pri bolnikih s pJIA, zdravljenih z zdravilom RoActemra subkutano, primerljiv s tistim pri bolnikih s pJIA, zdravljenih z zdravilom RoActemra intravensko.
In the RoActemra subcutaneous weekly group, a total of 6% (6/100) patients reported an adverse reaction occurring at the site of a subcutaneous injection.
Reakcije na mestu injiciranja V skupini, zdravljeni z zdravilom RoActemra subkutano vsak teden je neželeni učinek na mestu subkutanega injiciranja navedlo skupno 6 % (6/100) bolnikov.
Clinically significant hypersensitivity reactions associated with RoActemra and requiring treatment discontinuation were reported in a total of 13 out of 3778 patients (0.3%) treated with RoActemra during the controlled and open label clinical studies.
Klinično pomembne preobčutljivostne reakcije, ki so bile povezane z uporabo zdravila RoActemra in so zahtevale prekinitev zdravljenja, so zabeležili pri skupaj 13 od 3778 bolnikov (0,3 %), ki so v kontroliranih in odprtih kliničnih študijah dobivali zdravilo RoActemra.
Upper Respiratory Tract Infections pJIA, sJIA
Občasni okužbe zgornjih dihal pJIA, sJIA
sJIA and pJIA Patients
Bolniki s sJIA in pJIA
Your doctor will have to decide if you can still be given RoActemra.
Zdravnik bo presodil, ali lahko dobite zdravilo RoActemra.
In the open-label extension of Study II the inhibition of progression of structural joint damage in RoActemra plus MTX-treated patients was maintained in the second year of treatment.
V odprti, podaljšani fazi študije II se je zaviranje strukturne okvare sklepov pri bolnikih, ki so prejemali zdravilo RoActemra in metotreksat, ohranilo v drugem letu zdravljenja.
Concentrate for solution for infusion 400 mg/20 mL
Koncentrat za raztopino za infundiranje 400 mg/20 ml
If you are using medicines containing any of the following active substances, tell your doctor:
Zdravniku morate povedati, če uporabljate zdravila, ki vsebujejo katero od naslednjih učinkovin:
Some side effects were seen more often: inflamed nose and throat, diarrhoea, lower white blood cell counts and higher liver enzymes.
Nekatere neželene učinke so opazili pogosteje: vnet nos in žrelo, drisko, majhno število belih krvnih celic in zvišanje jetrnih transaminaz.
What RoActemra contains
Kaj vsebuje zdravilo RoActemra
To mix the solution, gently invert the infusion bag to avoid foaming.
Za premešanje raztopine infuzijsko vrečko previdno obračajte, da boste preprečili penjenje.
A 52-week, open-label, multicenter, PK-PD and safety study was conducted in paediatric patients with pJIA, aged 1 to 17 years old, to determine the appropriate subcutaneous dose of RoActemra that achieved comparable PK/PD and safety profiles to the IV regimen.
Pri pediatričnih bolnikih s pJIA, starimi od 1 do 17 let, so izvedli 52-tedensko, odprto, multicentrično, študijo farmakokinetike/farmakodinamike in varnosti za določitev ustreznega subkutanega odmerka zdravila RoActemra, ki bi imel primerljiv farmakokinetični/farmakodinamični in varnostni profil v primerjavi z intravenskim režimom.
The types of adverse drug reactions in the tocilizumab arm were consistent with the known safety profile of tocilizumab and adverse drug reactions were reported at a similar frequency compared with Table 1.
Tipi neželenih učinkov v skupini s tocilizumabom so bili skladni z znanim varnostnim profilom tocilizumaba, o neželenih učinkih so poročali s podobno pogostnostjo v primerjavi s preglednico 1.
Cumulative glucocorticoid dose (mg) median at Week 52 (Tocilizumab groups vs Placebo+262) median at Week 52 (Tocilizumab groups vs Placebo +522)
Kumulativni odmerek glukokortikoida (mg) mediana po 52 tednih (skupini s tocilizumabom v primerjavi s placebom + 262)
Five patients (0.8%) developed positive anti-RoActemra antibodies; of these, all developed neutralizing anti-RoActemra antibodies.
Pri petih bolnikih (0,8 %) so se pojavila protitelesa proti zdravilu RoActemra, od teh pri vseh nevtralizacijska.
If an anaphylactic reaction or other serious hypersensitivity reaction occurs, administration of RoActemra should be stopped immediately, appropriate therapy initiated and RoActemra should be permanently discontinued.
Če pride do anafilaktične ali druge hude preobčutljivostne reakcije, je treba dajanje zdravila RoActemra nemudoma prekiniti, pričeti s primernim zdravljenjem in uporabo zdravila RoActemra trajno ukiniti.
RoActemra is supplied in a single use pre-filled syringe fitted into a needle safety device.
Zdravilo RoActemra je na voljo v napolnjeni injekcijski brizgi za enkratno uporabo z varnostnim pripomočkom za injekcijsko iglo.
The PK of RoActemra in GCA patients were determined using a population PK model from an analysis dataset composed of 149 GCA patients treated with 162 mg subcutaneous every week or 162 mg subcutaneous every other week.
Farmakokinetiko zdravila RoActemra so pri bolnikih z GCA ugotavljali z modelom populacijske farmakokinetike na podlagi podatkov za 149 bolnikov z GCA, zdravljenih s 162 mg subkutano vsak teden ali 162 mg subkutano vsak drugi teden.
Following 1 year of treatment with tocilizumab plus MTX, 85% of patients (n=348) had no progression of structural joint damage, as defined by a change in the Total Sharp Score of zero or less, compared with 67% of placebo plus MTX-treated patients (n=290) (p ≤ 0.001).
Po 1 letu zdravljenja s tocilizumabom in metotreksatom pri 85 % bolnikov (n = 348) ni bilo napredovanja strukturne okvare sklepov, opredeljene kot spremembe v celotni oceni po Sharpu 0 ali manj, v primerjavi s 67 % bolnikov, ki so prejemali placebo in metotreksat (n = 290) (p ≤ 0,001).
OTHER
oder
The safety and immunogenicity observed for RoActemra administered subcutaneous was consistent with the known safety profile of intravenous RoActemra and no new or unexpected adverse drug reactions were observed (see Table 1).
Varnost in imunogenost, opažena pri subkutano danem zdravilu RoActemra, je bila skladna z znanimi varnostnimi značilnostmi intravensko danega zdravila RoActemra, novih ali nepričakovanih neželenih učinkov niso opazili (glejte preglednico 1).
The efficacy of subcutaneous administered RoActemra in alleviating the signs and symptoms of RA and radiographic response, was assessed in two randomised, double-blind, controlled, multi-center studies.
Učinkovitost subkutano danega zdravila RoActemra za ublažitev znakov in simptomov revmatoidnega artritisa in radiološki odziv so ocenili v dveh randomiziranih, dvojno slepih, kontroliranih multicentričnih študijah.
Seven patients (1.6%) developed positive anti-RoActemra antibodies; of these, six (1.4%) developed neutralizing anti-RoActemra antibodies.
Pri sedmih bolnikih (1,6 %) so se pojavila protitelesa proti zdravilu RoActemra, od teh pri šestih (1,4 %) nevtralizacijska.
Table 6: Efficacy Results for Study VII (WA19926) on MTX-naïve, early RA patients
Rezultati učinkovitosti za študijo VII (WA19926) pri bolnikih z zgodnjim revmatoidnim artritisom, ki se še niso zdravili z metotreksatom
Study SC-I evaluated patients with moderate to severe active RA who had an inadequate clinical response to their existing rheumatologic therapy, including one or more DMARD(s) where approximately 20% had a history of inadequate response to at least one TNF inhibitor.
V študiji SC-I so ocenjevali bolnike z zmerno do hudo aktivnim revmatoidnim artritisom, ki se niso zadostno klinično odzvali na svoje obstoječe revmatološko zdravljenje, vključno z enim ali več imunomodulirajočimi antirevmatičnimi zdravili, pri čemer jih približno 20 % v preteklosti ni imelo zadostnega odziva na najmanj enega zaviralca TNF.
* p<0.01, tocilizumab vs. placebo
*p < 0,01, tocilizumab v primerjavi s placebom
Corticosteroid Tapering
Prilagoditev odmerka kortikosteroida
Healthcare professionals should exercise caution when considering the use of RoActemra in patients with a history of recurring or chronic infections or with underlying conditions (e.g. diverticulitis, diabetes and interstitial lung disease which may predispose patients to infections.
Zdravniki morajo biti previdni pri odločanju za uporabo zdravila RoActemra pri bolnikih z anamnezo ponavljajočih se ali kroničnih okužb ali z drugimi boleznimi (npr. divertikulitisom, sladkorno boleznijo in intersticijsko boleznijo pljuč), ki lahko povečajo nagnjenost k okužbam.
RoActemra monotherapy should not be used for the treatment of acute relapses (see 4.4).
Za zdravljenje akutnih relapsov se zdravila RoActemra samostojno ne sme uporabljati (glejte poglavje 4.4).
• phenytoin, used to treat convulsions
• fenitoin, ki se uporablja za zdravljenje epileptičnih napadov (konvulzij),
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.
Predklinični podatki na osnovi običajnih študij farmakologije varnosti, toksičnosti ponavljajočih se odmerkov, genotoksičnosti in toksičnosti za razmnoževanje in razvoj ne kažejo posebnega tveganja za človeka.
Therefore, tocilizumab doses exceeding 800 mg per infusion are not recommended (see section 4.2).
Odmerki tocilizumaba, večji od 800 mg na infuzijo, torej niso priporočljivi (glejte poglavje 4.2).
Viral reactivation
Reaktivacija virusov
Pharmacokinetic parameters of tocilizumab did not change with time.
Farmakokinetični parametri tocilizumaba se s časom niso spreminjali.
• Throw away the green cap in a sharps container.
• Zelen pokrovček odstranite v zabojnik za ostre predmete.
All ISRs reported were non-serious Grade 1 events, and none of the ISRs required patient withdrawal from treatment or dose interruption.
Vse reakcije na mestu injiciranja, o katerih so poročali, so bile zabeležene kot neresni dogodki 1. stopnje in nobena od njih ni zahtevala prenehanja zdravljenja ali prekinitve odmerjanja.
An increased frequency of these elevations was observed when potentially hepatotoxic drugs (e.g. MTX) were used in combination with RoActemra.
Zvišanje je bilo pogostejše med kombinirano uporabo zdravila RoActemra s potencialno hepatotoksičnimi zdravili (npr. z metotreksatom).
There are limited data available on overdose with RoActemra.
Podatkov o prevelikem odmerjanju zdravila RoActemra je malo.
Study V evaluated 499 patients who had an inadequate clinical response or were intolerant to one or more TNF antagonist therapies.
Študija V je ocenila 499 bolnikov, ki se niso dovolj odzvali na zdravljenje z enim ali več zaviralci TNF ali takšnega zdravljenja niso prenesli.
• If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or lightheadedness, swelling of the lips, tongue, face or skin itching, hives or rash during or after the injection, then tell your doctor immediately.
• Če se vam med injiciranjem ali po njem pojavi alergijska reakcija, npr. tiščanje v prsih, piskajoče dihanje, huda omotica ali vrtoglavost, otekanje ustnic, jezika, obraza ali srbenje kože, koprivnica ali kožni izpuščaj, morate to nemudoma povedati zdravniku.
The Physician Information pack should contain the following key elements:
Izobraževalno gradivo za zdravnike mora vključevati naslednje ključne elemente:
In general, the adverse drug reactions observed during or within 24 hours of an infusion were similar in nature to those seen in RA and sJIA patients, see section 4.8.
V splošnem so neželeni učinki, povezani z infundiranjem, opaženi med njim ali v 24 urah po njem, podobnega tipa kot tisti, opaženi pri bolnikih z revmatoidnim artritisom in sJIA (glejte poglavje 4.8).
Available data suggest that clinical improvement is observed within 12 weeks of initiation of treatment with RoActemra.
Razpoložljivi podatki kažejo, da je klinično izboljšanje opaženo v 12 tednih od začetka zdravljenja z zdravilom RoActemra.
You can press a cotton ball or gauze over the injection site.
Nanj lahko položite bombažno kroglico ali gazo.
RoActemra is used for children aged 2 years and over with active polyarticular juvenile idiopathic arthritis (pJIA), an inflammatory disease that causes pain and swelling in one or more joints.
Zdravilo RoActemra se uporablja tudi za zdravljenje otrok, starih 2 leti in več, ki imajo aktivni poliartikularni juvenilni idiopatski artritis (pJIA), vnetno bolezen, ki povzroči bolečino in otekanje enega ali več sklepov.
• If you weigh less than 30 kg: the dose is 12 mg for every kilogram of body weight
• Če tehtate manj kot 30 kg: odmerek je 12 mg na kg telesne mase.
(See Fig. G)
(glejte sliko G).
The addition of potentially hepatotoxic drugs (e.g. MTX) to tocilizumab monotherapy resulted in increased frequency of these elevations.
Če so monoterapiji s tocilizumabom dodali potencialno hepatotoksična zdravila (npr. metotreksat), se je pogostnost teh zvišanj povečala.
Peripheral oedema Hypersensitivity reaction, Injection site reaction
preobčutljivostna reakcija, reakcija na mestu injiciranja
PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled pen, ACTPen® 4 pre-filled pens
raztopina za injiciranje v napolnjenem injekcijskem peresniku, ACTPen® 4 napolnjeni injekcijski peresniki
• Always keep the puncture-resistant container out of the sight and reach of children.
• Vedno shranjujte zabojnik za ostre predmete nedosegljivo otrokom.
The overall clinical adverse event profile was similar between RoActemra and adalimumab.
Celokupne klinične značilnosti neželenih učinkov so bile pri zdravilu RoActemra in adalimumabu podoben.
• mouth ulceration, stomach pain
• razjeda v ustih, bolečine v trebuhu,
• Hold the pre-filled pen comfortably in 1 hand by the upper part, so that you can see the Window area of the pre-filled pen (See Figure F).
• Z eno roko držite zgornji del napolnjenega injekcijskega peresnika, tako da vidite območje okenca (glejte sliko F).
RoActemra has not been studied in patients with moderate to severe renal impairment (see section 5.2).
Uporaba zdravila RoActemra ni raziskana pri bolnikih z zmerno do hudo okvaro ledvic (glejte poglavje 5.2).
The rate of infection in sJIA patients treated with SC RoActemra was comparable to sJIA patients treated with IV RoActemra.
Delež okužb pri bolnikih s sJIA, zdravljenih s subkutano obliko zdravila RoActemra, je bil primerljiv s tistim pri bolnikih s sJIA, zdravljenih z intravensko obliko zdravila RoActemra.
There is no experience with the use of RoActemra with TNF antagonists or other biological treatments for RA, sJIA or pJIA patients.
Ni izkušenj z uporabo zdravila RoActemra z zaviralci TNF ali drugimi biološkimi zdravili za revmatoidni artritis, sJIA ali pJIA.
PBO + DMARD
placebo DMARD
FACIT-Fatigue change from baseline to week 52 scores were calculated for all groups.
Za vse skupine so izračunali spremembo ocene utrujenosti po FACIT-Fatigue od izhodišča do 52. tedna.
The addition of potentially hepatotoxic drugs (e.g. MTX) to RoActemra monotherapy resulted in increased frequency of these elevations.
Če so monoterapiji z zdravilom RoActemra dodali potencialno hepatotoksična zdravila (npr. metotreksat), se je pogostnost teh zvišanj povečala.
Always store the syringe in a refrigerator at a temperature of 2°C - 8°C.
Napolnjeno injekcijsko brizgo vedno shranjujte v hladilniku pri temperaturi 2 ºC - 8 ºC.
Side effects could occur 3 months or more after your last dose of RoActemra.
Neželeni učinki se lahko pojavijo tudi še 3 mesece ali več po zadnjem odmerku zdravila
Do not use the syringe if the expiration date has passed.
Ne uporabite injekcijske brizge, če je rok uporabnosti pretečen.
Important: Keep your unused pre-filled pens in the original carton and keep in the refrigerator at 2˚C
Pomembno: Neuporabljene napolnjene injekcijske peresnike shranjujte v originalni ovojnini (škatli) v hladilniku pri temperaturi od 2 °C in 8 °C (36 °F do 46 °F).
• adults with a disease of the arteries called giant cell arteritis (GCA), caused by inflammation of the body's largest arteries, especially those that supply blood to the head and neck.
Gre za vnetje največjih arterij v telesu, zlasti tistih, ki s krvjo oskrbujejo glavo in vrat.
Placebo + 52 weeks prednisone taper N=51
Placebo + 52 tednov zmanjševanja prednizona n = 51
Major clinical response
Pomembnejša klinična odzivnost
Reported serious infections were similar to those seen in RA patients with the addition of varicella and otitis media.
Resne okužbe, o katerih so poročali, so bile podobne opaženim pri bolnikih z revmatoidnim artritisom z dodatkom noric in vnetjem srednjega ušesa.
In addition to this leaflet, you will be given a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with RoActemra.
Na njej so zapisane pomembne informacije o varnosti, ki jih morate poznati pred zdravljenjem z zdravilom RoActemra in med zdravljenjem z njim.
RoActemra has not been studied in patients with severe renal impairment (see section 5.2).
Uporaba zdravila RoActemra ni raziskana pri bolnikih s hudo okvaro ledvic (glejte poglavje 5.2).
RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids.
Zdravilo RoActemra je indicirano za zdravljenje aktivnega sistemskega juvenilnega idiopatskega artritisa (sJIA) pri bolnikih, starih 1 leto ali več, ki se niso zadostno odzvali na predhodno zdravljenje z nesteroidnimi protivnetnimi zdravili ali sistemskimi kortikosteroidi.
In study I, superiority of RoActemra 8 mg/kg was demonstrated against the active comparator MTX.
V študiji I so dokazali superiornost 8 mg/kg zdravila RoActemra nad primerjalno učinkovino metotreksatom.
SF-36 (mean change in mental and physical component scores) was significantly greater with RoActemra subcutaneous group (6.5 and 5.3) versus placebo (3.8 and 2.9).
RoActemra (6,5 in 5,3) v primerjavi s placebom (3,8 in 2,9).
The mean LDL increase from baseline was 0.64 mmol/L (25 mg/dL) for patients in the tocilizumab arm and 0.19 mmol/L (7 mg/dL) for patients in the adalimumab arm.
0,64 mmol/l (25 mg/dl) pri bolnikih v skupini s tocilizumabom in 0,19 mmol/l (7 mg/dl) pri bolnikih v skupini z adalimumabom.
The types of adverse drug reactions in the RoActemra arm were consistent with the known safety profile of RoActemra and adverse drug reactions were reported at a similar frequency compared with Table 1.
Tipi neželenih učinkov v skupini z zdravilom RoActemra so bili skladni z znanimi varnostnimi značilnostmi zdravila RoActemra, o neželenih učinkih so poročali s podobno pogostnostjo v primerjavi s preglednico 1.
Other sources of information
DRUGI PODATKI
In clinical studies with RoActemra, rapid decreases in CRP, erythrocyte sedimentation rate (ESR), serum amyloid A (SAA) and fibrinogen were observed.
Farmakodinamični učinki V kliničnih študijah z zdravilom RoActemra so opažali hitro znižanje CRP, hitrosti sedimentacije eritrocitov (SR), serumskega amiloida A (SAA) in fibrinogena.
pJIA Patients
Bolniki s pJIA
• injection site reactions.
• reakcije na mestu injiciranja.
The concentrate is a clear to opalescent, colourless to pale yellow liquid.
Koncentrat je bistra do opalescentna, brezbarvna do bledorumena raztopina.
Population pharmacokinetic analyses did not detect any effect of MTX, non-steroidal antiinflammatory drugs (NSAIDs) or corticosteroids on tocilizumab clearance.
Analize populacijske farmakokinetike niso odkrile, da bi metotreksat, nesteroidna protivnetna zdravila ali kortikosteroidi vplivali na očistek tocilizumaba.
When compared to the adult RA population, patients with sJIA experienced a higher frequency of nasopharyngitis, decrease in neutrophil counts, hepatic transaminases increased, and diarrhea.
V primerjavi z odraslo populacijo z revmatoidnim artritisom so o naslednjih neželenih učinkih poročali pogosteje pri populaciji s sJIA: nazofaringitisu, zmanjšanem številu nevtrofilcev, zvišanju jetrnih transaminaz in diareji.
• The front of your thigh or your abdomen except for the 2-inch (5cm) area around your navel are the recommended injection sites (See Figure D).
• Priporočena mesta injiciranja so sprednji del stegna ali trebuha, razen območja okoli popka, ki meri približno 2 palca (5 cm) (glejte sliko D).
The solution is colourless to slightly yellowish.
Raztopina je brezbarvna do rahlo rumenkasta.
• If you weigh less than 30 kg: the dose is 10mg for every kilogram of body weight
• Če tehtate manj kot 30 kg: odmerek je 10 mg na kg telesne mase.