natgillin/translations-raw huggingface dataset:
The rate of pregnancies ending with at least one live born infant with a major birth defect was 6/69 (8.7%) in the adalimumab-treated women with RA and 5/74 (6.8%) in the untreated women with RA (unadjusted OR 1.31, 95% CI 0.38-4.52) and 16/152 (10.5%) in the adalimumab-treated women with CD and 3/32 (9.4%) in the untreated women with CD (unadjusted OR 1.14, 95% CI 0.31-4.16).
Razmerje nosečnosti, ki so se končale vsaj z enim živorojenim otrokom z večjim defektom ob rojstvu, je bilo 6/69 (8,7 %) pri nosečnicah z RA, zdravljenih z adalimumabom, in 5/74 (6,8 %) pri nezdravljenih nosečnicah z RA (neprilagojeno razmerje obetov 1,31; 95 % interval zaupanja 0,38-4,52), ter 16/152 (10,5 %) pri nosečnicah, zdravljenih z adalimumabom s CB, in 3/32 (9,4 %) pri nezdravljenih nosečnicah s CB (neprilagojeno razmerje obetov 1,14; 95 % interval zaupanja 0,31-4,16).
1.6 Place the remaining pre-filled pen(s) in its (their) original box back in the refrigerator (Figure E).
1.6 Drug injekcijski peresnik (druge injekcijske peresnike) položite nazaj v hladilnik v originalni ovojnini (Slika E).
• Idacio is a pre-filled syringe for single use only.
• Zdravilo Idacio je napolnjena injekcijska brizga za zgolj enkratno uporabo.
In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of adalimumab and azathioprine/6-mercaptopurine compared with adalimumab alone.
V študijah Crohnove bolezni pri odraslih so pri sočasni uporabi adalimumaba in azatioprina/6merkaptopurina opazili večjo incidenco malignih in resnih z okužbo povezanih neželenih dogodkov kot pri zdravljenju samo z adalimumabom.
Syringe plunger final position
Končni položaj bata
6.5 If there is blood or liquid on the injection site, gently press a cotton ball or gauze on the skin (Figure T).
6.5 Če je na mestu injiciranja kri ali tekočina, nanj nežno pritisnite kosem vate ali gazo (Slika T).
Idacio is indicated for the treatment of Crohn's disease in children aged 6 to 17 years.
Zdravilo Idacio je namenjeno za zdravljenje Crohnove bolezni pri otrocih, starih 6 do 17 let.
It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with Idacio.
Priporočljivo je, da med zdravljenjem z zdravilom Idacio bolnik vsak dan uporablja topikalno antiseptično čistilno sredstvo za čiščenje lezij HS.
CI 95% for HRa p Value b
N Neuspeh Srednji čas do RTa IZ 95 % p vrednost b
If you accidentally inject a larger amount of Idacio liquid, or if you inject Idacio more frequently than told to by your doctor, call your doctor and tell him/her that your child has taken more.
Če ste uporabili večji odmerek zdravila Idacio, kot bi smeli Če pomotoma injicirate večjo količino zdravila Idacio tekočine ali če injicirate zdravilo Idacio pogosteje, kot vam je naročil zdravnik, se morate posvetovati z njim in mu povedati, da je vaš otrok uporabil večji odmerek.
Table 11 Distribution of patients by age and adalimumab dose received during the OL LI phase Age group
Preglednica 11 Porazdelitev bolnikov po starosti in odmerku adalimumaba, ki so ga dobivali med odprto uvajalno fazo
In an exploratory clinical trial evaluating the use of another TNF-antagonist, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
V eksplorativnem kliničnem preskušanju drugega antagonista TNF, infliksimaba, pri bolnikih z zmerno do hudo kronično obstruktivno pljučno boleznijo (KOPB), so med prejemniki infliksimaba zabeležili več malignomov, večinoma pljuč ali glave in vratu, kot med primerjalnimi bolniki.
Idacio is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Zdravilo Idacio se uporablja za zdravljenje Crohnove bolezni pri odraslih in otrocih, starih 6 do 17 let.
• mouth infections (including tooth infections and cold sores);
• okužbe ust (vključno z okužbami zob in herpesom);
Patients demonstrating a Pediatric ACR 30 response at week 16 were eligible to be randomised into the double blind (DB) phase and received either adalimumab 24 mg/m2 up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Bolniki, ki so 16. teden dosegli odziv »Pediatric ACR« 30, so bili primerni za randomizacijo v dvojno slepo fazo in so nadaljnjih 32 tednov ali do zagona bolezni vsak drugi teden dobili adalimumab 24 mg/m2 (do največ 40 mg) ali placebo.
• If your child experiences allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Idacio and contact your doctor immediately since, in rare cases, these reactions can be life threatening.
• Če vaš otrok doživi alergijske reakcije s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila Idacio ne injicirajte več in se takoj posvetujte s svojim zdravnikom, saj so v redkih primerih te reakcije lahko življenje ogrožajoče.
If your child received Idacio during her pregnancy, her baby may have a higher risk for getting an infection.
Če je vaš otrok prejemal zdravilo Idacio med nosečnostjo, obstaja večje tveganje, da bo njegov dojenček dobil okužbo.
• The Idacio pre-filled pen comes as a ready to use single-use pre-filled pen to give a full dose of adalimumab.
• Zdravilo Idacio je napolnjen injekcijski peresnik, ki je pripravljen za uporabo in omogoča dajanje polnega odmerka adalimumaba.
• If your child is about to have surgery or dental procedures tell your doctor that he/she is taking Idacio.
• Če bo vaš otrok imel kirurški poseg ali poseg na zobeh, povejte svojemu zdravniku, da jemlje zdravilo Idacio.
Idacio dose for patients with polyarticular juvenile idiopathic arthrtis
Odmerjanje zdravila Idacio pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom
Idacio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Zdravilo Idacio je indicirano za zdravljenje hude psoriaze v plakih pri otrocih in mladostnikih od 4. leta starosti, ki so se neustrezno odzvali na ali niso ustrezni kandidati za topikalno zdravljenje in fototerapije.
At week 4, patients were randomised 1:1 to either the Standard Dose (40/20 mg eow) or Low Dose (20/10 mg eow) maintenance treatment groups based on their body weight.
V 4. tednu so bili bolniki randomizirani 1:1 bodisi v skupino s standardnim vzdrževalnim odmerkom (40/20 mg vsak drugi teden) ali v skupino z majhnim vzdrževalnim odmerkom (20/10 mg vsak drugi teden), odvisno od njihove telesne mase.
Discontinuation of immunomodulators2
Prenehanje z imunomodulatorji2
Table 26 Paediatric CD study PCDAI clinical remission and response
Preglednica 26 Študija Crohnove bolezni pri pediatričnih bolnikih PCDAI klinična remisija in odziv Standardni odmerek
Idacio is recommended for use in combination with methotrexate.
Priporoča se kombinirana uporaba zdravila Idacio z metotreksatom.
• If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Idacio and contact your doctor immediately since, in rare cases, these reactions can be life threatening.
• Če imate alergijsko reakcijo s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila Idacio ne injicirajte več in se takoj posvetujte s svojim zdravnikom, saj so v redkih primerih te reakcije lahko življenje ogrožajoče.
If these medicines do not work well enough, you will be given Idacio to treat your rheumatoid arthritis.
Če ta zdravila ne delujejo dovolj dobro, boste za zdravljenje revmatoidnega artritisa dobili zdravilo Idacio.
If these medicines do not work well enough, you will be given Idacio.
Če ta zdravila ne bodo dovolj delovala, boste dobili zdravilo Idacio.
The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a Physician's Global Assessment (PGA) ≥ 4 or > 20% BSA involvement or > 10% BSA involvement with very thick lesions or Psoriasis Area and Severity Index (PASI) ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Učinkovitost adalimumaba je bila ocenjena v randomizirani, dvojno slepi, kontrolirani študiji, v katero je bilo vključenih 114 pediatričnih bolnikov od 4. leta starosti, s hudo kronično psoriazo v plakih (definirano z zdravnikovo globalno oceno (PGA - Physician's Global Assessment) ≥ 4 ali 20 % zajete telesne površine ali > 10 % zajete telesne površine z zelo grobimi lezijami ali indeksom obsežnosti in izrazitosti psoriaze (PASI - Psoriasis Area and Severity Index) ≥ 20 ali ≥ 10 s klinično pomembnim zajetjem obraza, genitalij ali dlani/stopal), ki ni bila ustrezno nadzorovana s topikalnim zdravljenjem in helioterapijo ali fototerapijo.
• If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Idacio.
• Če imate kakšno okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se pred uporabo zdravila Idacio posvetujte s svojim zdravnikom.
2 Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the subject met the clinical response criterion 3 defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive post
2Zdravljenje z imunosupresivi je bilo lahko prekinjeno v 26. tednu ali po njem po raziskovalčevi diskreciji, če je bolnik izpolnjeval kriterije kliničnega odziva.
**p < 0.01, adalimumab versus placebo
**p < 0,01, adalimumaba v prim.
1.6 Place the remaining syringe(s) in its (their) original box back in the refrigerator (Figure D).
1.6 Drugo injekcijsko brizgo (druge injekcijske brizge) položite nazaj v hladilnik v originalni ovojnini (Slika D).
Table 16 ACR response in placebo-controlled psoriatic arthritis studies (percent of patients)
Preglednica 16: Odziv ACR v študijah pri psoriatičnem artritisu, kontroliranih s placebom (odstotek bolnikov) Študija pri psoriatičnem
• If your child has an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Idacio.
• Če ima vaš otrok kakšno okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se pred uporabo zdravila Idacio posvetujte s svojim zdravnikom.
It is important that you tell your baby's doctors and other health care professionals about your Idacio use during your pregnancy so they can decide when your baby should receive any vaccine.
Zato je pomembno, da obvestite zdravnika vašega otroka in druge zdravstvene delavce, da ste med nosečnostjo prejemali zdravilo Idacio, da se lahko odločijo, kdaj bo vaš otrok lahko prejel katero koli cepivo.
Idacio is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Zdravilo Idacio je indicirano za zdravljenje aktivnega artritisa, povezanega z entezitisom pri bolnikih, starih 6 let in več, ki so se neustrezno odzvali ali so intolerantni za običajno zdravljenje (glejte poglavje 5.1).
- Your doctor will also give you a patient reminder card, which contains important safety information that you need to be aware of before your child is given Idacio and during treatment with Idacio.
Ta vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden vaš otrok prejme zdravilo Idacio in med zdravljenjem z njim.
***, **, * Statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between adalimumab and placebo.
***, **, * Statistično pomembno pri p < 0,001, < 0,01 in < 0,05, v tem zaporedju, za vse primerjave med adalimumabom in placebom.
If you accidentally inject Idacio more frequently than you should, call your doctor or pharmacist and explain that you have taken more than required.
Če ste uporabili večji odmerek zdravila Idacio, kot bi smeli Če pomotoma injicirate zdravilo Idacio pogosteje, kot bi morali, se morate posvetovati z zdravnikom ali s farmacevtom in mu razložiti, da ste uporabili večji odmerek od predpisanega.
Idacio 40 mg/0.8 mL solution for injection for paediatric use is supplied in a glass vial.
Idacio 40 mg/0,8 ml raztopina za injiciranje za pediatrično uporabo je na voljo v stekleni viali.
3.7 Place the syringe on a clean, flat surface.
3.7 Injekcijsko brizgo položite na čisto, ravno površino.
Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral)
zelo pogosti okužbe respiratornega trakta (vključno z okužbo spodnjega in zgornjega respiratornega trakta, pljučnico, vnetjem sinusa, vnetjem sluznice žrela, vnetjem nosnega dela žrela in pljučnim virusnim herpesom)
Steroid-free remission for ≥ 90 days a
Remisija brez steroidov za ≥ 90 dni a 8. in 52. teden
After 12 weeks of therapy, patients who had received adalimumab in Period A were re-randomised in Period B to 1 of 3 treatment groups (adalimumab 40 mg every week, adalimumab 40 mg every other week, or placebo from week 12 to week 35).
Po 12 tednih terapije so bolnike, ki so prejemali adalimumab v obdobju A, ponovno randomizirali v obdobju B v eno izmed treh skupin zdravljenja (adalimumab 40 mg vsak teden, adalimumab 40 mg vsak drugi teden ali placebo od 12. do 35. tedna).
- The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, mannitol, sodium chloride, citric acid monohydrate, sodium citrate, polysorbate 80, sodium hydroxide and water for injections.
- Druge sestavine zdravila so natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat, manitol, natrijev klorid, citronska kislina monohidrat, natrijev citrat, polisorbat 80, natrijev hidroksid in voda za injekcije.
Once removed from the refrigerator for room temperature storage, your vial must be used within 14 days or discarded, even if it is later returned to the refrigerator.
Ko ga enkrat , namesto v hladilniku, shranjujete pri sobni temperaturi, morate vialo porabiti v 14 dneh ali pa zavreči, tudi če jo kasneje vrnete v hladilnik.
It is important that you tell your baby's doctors and other health care professionals about your Idacio use during your pregnancy before the baby receives any vaccine (for more information see section on vaccination).
Pomembno je, da obvestite zdravnika dojenčka in druge zdravstvene delavce, da je vaš otrok med nosečnostjo prejemal zdravilo Idacio, preden bo dojenček prejel katerokoli cepivo (za več informacij glejte poglavje o cepljenju).
Each box contains 1 vial, 1 sterile injection syringe, 1 sterile needle, 1 vial adaptor and 2 alcohol pads.
1 vialo, 1 sterilno injekcijsko brizgo 1 sterilno iglo, 1 adapter za vialo in 2 alkoholna zloženca.
• If you have or develop demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Idacio.
• Če imate ali pa se pri vas razvija demielinizirajoča bolezen (bolezen, ki vpliva na izolacijsko plast okoli živcev, kot je multipla skleroza), bo zdravnik presodil, ali lahko dobivate oziroma tudi še nadalje dobivate zdravilo Idacio.
The recommended dose of Idacio for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Priporočeni odmerek zdravila Idacio za odrasle bolnike z revmatoidnim artritisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku v subkutani injekciji.
• Tell your doctor if your child has lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are common.
• Zdravniku morate povedati, če je vaš otrok živel ali je potoval v predele, kjer so pogoste glivične okužbe, npr. histoplazmoza, kokcidioidomikoza ali blastomikoza.
Table 21 Paediatric CD study Discontinuation of corticosteroids or immunomodulators and fistula remission Standard dose 40/20 mg eow
Preglednica 21 Študija Crohnove bolezni pri pediatričnih bolnikih Prenehanje zdravljenja s kortikosteroidi ali imunomodulatorji in remisija fistule Standardni odmerek 40/20 mg vsak drugi teden
• Do not insert your fingers into the opening of the clear needle guard.
• Ne dajajte prstov v režo na prozornem varovalu za injekcijsko iglo.
If your child has mild heart failure and is being treated with Idacio, his/her heart failure status must be closely monitored by your doctor.
Če ima vaš otrok blago srčno popuščanje in se zdravi z zdravilom Idacio, mora zdravnik natančno nadzorovati stanje srčnega popuščanja pri vašem otroku.
Table 27 Paediatric CD study Discontinuation of corticosteroids or immunomodulators and fistula remission Standard dose 40/20 mg eow
Preglednica 27 Študija Crohnove bolezni pri pediatričnih bolnikih Prenehanje zdravljenja s kortikosteroidi ali imunomodulatorji in remisija fistule Standardni odmerek 40/20 mg vsak drugi teden
• Do not use an Idacio pre-filled syringe that has been frozen or left in direct sunlight.
• Zdravila Idacio napolnjena injekcijska brizga ne uporabljajte, če je bila brizga zamrznjena ali dlje časa izpostavljena neposredni sončni svetlobi.
• Tell your doctor if you have lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are common.
• Zdravniku morate povedati, če ste živeli ali ste potovali v predele, kjer so pogoste glivične okužbe, npr. histoplazmoza, kokcidioidomikoza ali blastomikoza.
6.4 If there is blood or liquid on the skin, treat the injection site by gently pressing a cotton ball or gauze on the site (Figure R).
6.4 Če je na mestu injiciranja kri ali tekočina, nanj nežno pritisnite s kosem vate ali gazo (Slika R).
• Idacio Vial Kit is for single use only.
• Zdravilo Idacio komplet z vialo je namenjen le enkratni uporabi.
6.1 With the other hand, gently pinch a fold of cleaned skin and maintain it.
6.1 Z drugo roko nežno naredite kožno gubo in jo držite.
Idacio is used to treat rheumatoid arthritis in adults.
Zdravilo Idacio se uporablja za zdravljenje revmatoidnega artritisa pri odraslih.
Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, mannitol, sodium chloride, citric acid monohydrate, sodium citrate, polysorbate 80, sodium hydroxide and water for injections.
Pomožne snovi: natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat, manitol, natrijev klorid, citronska kislina monohidrat, natrijev citrat, polisorbat 80, natrijev hidroksid in voda za injekcije.
The recommended dose of Idacio for patients with Crohn's disease from 6 to 17 years of age is based on body weight (Table 4).
Priporočeni odmerek zdravila Idacio pri bolnikih s Crohnovo boleznijo, starih od 6 do 17 let, temelji na telesni masi (preglednica 4).
• systemic lupus erythematosus (an immune disorder including inflammation of skin, heart, lung,
• sistemski eritematozni lupus (imunske motnje vključno z vnetjem kože, srca, pljuč, sklepov in drugih organskih sistemov);
If you accidentally inject a smaller amount of Idacio liquid, or if you inject Idacio less frequently than told to by your child's doctor or pharmacist, you should call your child's doctor or pharmacist and tell him/her that your child has taken less.
Če ste uporabili manjši odmerek zdravila Idacio, kot bi morali Če pomotoma injicirate manjši odmerek zdravila Idacio, ali če zdravilo Idacio injicirate manj pogosto, kot vam je naročil otrokov zdravnik, se morate posvetovati z njim ali s farmacevtom in mu povedati,
What Idacio is and what it is used for 2.
Kaj je zdravilo Idacio in za kaj ga uporabljamo
Idacio is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Zdravilo Idacio je indicirano za zdravljenje zmerno do hudo aktivnega ulceroznega kolitisa pri odraslih bolnikih, ki so se ne odzovejo zadostno na običajno zdravljenje, na primer na kortikosteroide in 6-merkaptopurin (6-MP) ali azatioprin (AZA), ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
Idacio is injected under the skin (subcutaneous use).
Zdravilo Idacio se injicira pod kožo (subkutana uporaba).
In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see Table 18).
Pri bolnikih z vsaj delnim odzivom na adalimumab v odmerku 40 mg vsak teden v 12. tednu, je bila stopnja kliničnega odziva (HiSCR) v 36. tednu višja pri bolnikih, ki so nadaljevali zdravljenje z adalimumabom vsak teden kot pri bolnikih, pri katerih so pogostnost odmerjanja zmanjšali na vsak drugi teden, ali pri katerih je bilo zdravljenje ukinjeno (glejte preglednico 18).
Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient-years among adalimumab- treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Med temi kožnimi raki je bil delež (95 % interval zaupanja) skvamocelularnega karcinoma 2,7 (1,4; 5,4) na 1000 bolnikov-let med bolniki, ki so dobivali adalimumab, in 0,6 (0,1; 4,5) na 1000 bolnikov-let v kontrolni skupini bolnikov.
• If your child has or develops a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if he/she should receive or continue to receive Idacio.
• Če vaš otrok ima ali pa se pri njem razvija demielinizirajoča bolezen (bolezen, ki vpliva na izolacijsko plast okoli živcev, kot je multipla skleroza), bo zdravnik presodil, ali lahko dobiva zdravilo Idacio.
Single use pre-filled syringe (adalimumab) for subcutaneous injection 40mg
Napolnjena injekcijska brizga (adalimumab) za subkutano injiciranje za enkratno uporabo 40 mg
Idacio may have a minor influence on the ability to drive, cycle or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Idacio ima lahko blag vpliv na sposobnost vožnje, kolesarjenja ali upravljanja strojev.
- Your doctor will also give you a patient reminder card, which contains important safety information that you need to be aware of before you are given Idacio and during treatment with Idacio.
Ta vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden prejmete zdravilo Idacio in med zdravljenjem z njim.
Idacio can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.
Zmanjša lahko tudi bolečino, ki je pogosto povezana s to boleznijo.
• Only use Idacio pre-filled syringe if your healthcare professional has trained you on how to use the pre-filled syringe correctly.
• Zdravilo Idacio napolnjena injekcijska brizga lahko uporabljate le, če vas je zdravstveni delavec naučil, kako pravilno uporabljati napolnjeno injekcijsko brizgo.
Figure I Warning: Do not use the syringe if it shows any sign of damage.
Opozorilo: Injekcijske brizge ne uporabljajte, če je kakor koli poškodovana.
Idacio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Zdravilo Idacio je indicirano za zdravljenje aktivne zmerne do hude oblike hidradenitis suppurativa (acne inversa) pri mladostnikih, starejših od 12 let, ki se ne odzovejo zadovoljivo na konvencionalno sistemsko HS zdravljenje (glejte poglavji 5.1 in 5.2).