Evropská unie - litevština - EMA (European Medicines Agency)

biopartners gmbh - ribavirin - hepatitas c, lėtinis - antivirusiniai vaistai sisteminiam naudojimui - ribavirino biopartners yra skirtas lėtine hepatito c viruso (hcv) infekcija suaugusiems, trejų metų ir vyresniems vaikams ir paaugliams gydyti ir turi būti naudojami tik kaip kombinuoto su interferonu alfa-2b. ribavirino monoterapiją negalima vartoti. nėra informacijos apie saugumą ir veiksmingumą apie ribavirino vartojimą su kitomis interferono formomis (i. ne alfa-2b). naivu patientsadult patientsribavirin biopartners yra nurodytas kartu su interferonu alfa-2b, gydyti suaugusiems pacientams su visų tipų lėtinis hepatitas c, išskyrus atvejus, genotipo 1, ne anksčiau gydyti, be kepenų funkcijos dekompensacija, su padidėjusiu alaninas aminotransferazä (alt), kurie yra teigiami hepatito c virusinės ribonucleic rūgšties (hcv-rnr) (žr. skyrių 4. 4)vaikams, trijų metų amžiaus ir vyresni, ir adolescentsribavirin biopartners yra skirtas naudoti kartu režimas su interferonu alfa-2b, vaikų gydymas trijų metų amžiaus ir vyresni) ir paaugliai, kurie visų tipų lėtinis hepatitas c, išskyrus atvejus, genotipo 1, ne anksčiau gydyti, be kepenų funkcijos dekompensacija, ir, kurie yra teigiami hcv-rnr. kai sprendimą atidėti gydymą iki pilnametystės, tai yra svarbu apsvarstyti galimybę, kad angliavandenilių terapijos sukeltas augimo inhibavimo. grįžtamumo augimo slopinimo yra neaiškus. sprendimas gydyti, turėtų būti priimtas kiekvienu atveju atskirai (žr. skyrių 4. ankstesnio gydymo-gedimo patientsadult patientsribavirin biopartners yra nurodytas kartu su interferonu alfa-2b, gydyti suaugusiems pacientams, sergantiems lėtiniu hepatitu c, kurie anksčiau atsakė (su normalizuoti alt gydymo pabaigoje), kad interferonas alfa monotherapy, bet kurie vėliau atsinaujino (žr. skyrių 5.

Evropská unie - portugalština - EMA (European Medicines Agency)

janssen-cilag international n.v. - telaprevir - hepatite c, crônica - antivirais para uso sistêmico - incivo, em combinação com o interferão alfa e ribavirina, é indicado para o tratamento do genótipo-1 hepatite crônica c em pacientes adultos com doença hepática compensada (incluindo cirrose):quem é o tratamento ingênuo;que tenham sido previamente tratados com interferon alfa (peguilado ou não-peguilado) em monoterapia ou em combinação com ribavirina, incluindo relapsers, parcial respondentes e nulo respondentes.

Evropská unie - italština - EMA (European Medicines Agency)

biopartners gmbh - ribavirina - epatite c, cronica - antivirali per uso sistemico - ribavirin biopartners è indicato per il trattamento dell'infezione cronica da virus di epatite-c (hcv) in adulti, bambini di tre anni di età e adolescenti e deve essere utilizzato solo come componente di un regime di combinazione con interferone alfa-2b. la monoterapia con ribavirina non deve essere utilizzata. non sono disponibili informazioni sulla sicurezza o l'efficacia sull'uso di ribavirina con altre forme di interferone (i. non alfa-2b). ingenuo patientsadult patientsribavirin biopartners è indicato, in combinazione con interferone alfa-2b, per il trattamento di pazienti adulti con tutti i tipi di epatite cronica c, ad eccezione di genotipo 1, non trattati in precedenza, senza scompenso epatico, con elevata alanina aminotransferasi (alt), che sono positivi per epatite virale c acido ribonucleico (hcv-rna) (vedere paragrafo 4. 4)i bambini di tre anni di età e anziani e adolescentsribavirin biopartners è inteso per l'uso, in un regime di combinazione con interferone alfa-2b, per il trattamento di bambini di tre anni e più e adolescenti, che hanno tutti i tipi di epatite cronica c, ad eccezione di genotipo 1, non trattati in precedenza, senza scompenso epatico, e che sono positivi per hcv-rna. quando si decide di non ritardare il trattamento fino all'età adulta, è importante considerare che la terapia di combinazione indotta da una inibizione della crescita. la reversibilità di inibizione della crescita è incerto. la decisione di trattare deve essere fatta caso per caso (si veda la sezione 4. precedente-trattamento-fallimento patientsadult patientsribavirin biopartners è indicato, in combinazione con interferone alfa-2b, per il trattamento di pazienti adulti con epatite cronica c che hanno precedentemente risposto (con normalizzazione delle alt al termine del trattamento) a monoterapia con interferone alfa ma che abbiano successivamente recidivato (vedere la sezione 5.

Evropská unie - italština - EMA (European Medicines Agency)

biopartners gmbh - somatropina - crescita - pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists - somatropin biopartners è indicato per la terapia sostitutiva dell'ormone della crescita endogeno negli adulti con deficit dell'ormone della crescita (ghd) nell'infanzia o nell'età adulta. in età adulta: i pazienti con ghd in età adulta sono definiti come pazienti con noto ipotalamo-ipofisi patologia e almeno un ulteriore nota la carenza di un ormone ipofisario esclusione di prolattina. questi pazienti devono essere sottoposti a un singolo test dinamico per diagnosticare o escludere una ghd. esordio infantile: in pazienti con esordio infantile isolato ghd (nessuna evidenza di ipotalamo-ipofisi malattia o irradiazione cranica), due dinamici test deve essere eseguito dopo il completamento di crescita, fatta eccezione per coloro che hanno un basso insulino-simile-growth-factor-i (igf-i) concentrazioni (< -2 standard deviation score (sds)), che può essere considerato per una prova. il cut-off del test dinamico devono essere rigorosi.

Evropská unie - angličtina - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1%. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.2).,

Spojené státy - angličtina - NLM (National Library of Medicine)

ipsen biopharmaceuticals, inc. - mecasermin (unii: 7gr9i2683o) (mecasermin - unii:7gr9i2683o) - mecasermin 40 mg in 4 ml - severe primary igf-1 deficiency (primary igfd) increlex is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with: - severe primary igf-1 deficiency or - growth hormone (gh) gene deletion who have developed neutralizing antibodies to gh. severe primary igf-1 deficiency (igfd) is defined by: - height standard deviation score ≤ –3.0 and - basal igf-1 standard deviation score ≤ –3.0 and - normal or elevated growth hormone (gh). limitations of use: increlex is not a substitute to gh for approved gh indications. increlex is not indicated for use in patients with secondary forms of igf-1 deficiency, such as gh deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory corticosteroids. - known hypersensitivity increlex should not be used by patients who are allergic to mecasermin (rhigf-1) or any of the inactive ingredients in increlex, or who have experienced a severe hypersensitivity to increlex [see warnings and precautions (5.2) and adverse reactions (6.3)]. - closed epiphyses increlex should not be used for growth promotion in patients with closed epiphyses. - malignant neoplasia increlex is contraindicated in pediatric patients with malignant neoplasia or a history of malignancy [see warnings and precautions (5.7) and adverse reactions (6.3)]. risk summary there are no available data on increlex use in pregnant women. exposure to increlex during pregnancy is unlikely because the drug is not indicated for use after epiphyseal closure. in animal reproduction studies, there were no observed embryo-fetal development abnormalities with intravenous administration of increlex to pregnant rats and rabbits during fetal organogenesis given at exposures up to 11 and 3 times the maximum recommended human dose (mrhd) of 0.24 mg/kg/day based on body surface area (bsa), respectively (see data) . the estimated background risk of birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data studies to assess embryo-fetal toxicity evaluated the effects of increlex during organogenesis in sprague dawley rats given 1, 4, and 16 mg/kg/day and in new zealand white rabbits given 0.125, 0.5, and 2 mg/kg/day, administered intravenously. there were no observed embryo-fetal developmental abnormalities in rats given up to 16 mg/kg/day (11 times the mrhd based on bsa comparison). in the rabbit study, the noael for fetal toxicity was 0.5 mg/kg/day (approximately equivalent to the mrhd based on bsa) due to an increase in fetal death at 2 mg/kg. increlex displayed no teratogenicity or maternal toxicity in rabbits given up to 2 mg/kg (3 times the mrhd based on bsa). risk summary there is no information available on the presence of mecasermin in human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for increlex and any potential adverse effects on the breast-fed child from increlex or from the underlying maternal condition. toxicity (gasping syndrome) with benzyl alcohol serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and infants in the intensive care unit who received drugs containing benzyl alcohol as a preservative. in these cases, benzyl alcohol dosages of 99 mg/kg/day to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 mmol/l to 1.378 mmol/l). increlex contains 9 mg/ml benzyl alcohol as a preservative. additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. use of increlex in infants is not recommended [see warnings and precautions (5.8)] . safety and effectiveness in pediatric patients below the age of 2 years of age have not been established. the safety and effectiveness of increlex in patients aged 65 and over has not been established. instructions for use increlex® (eenk-ruh-lex) (mecasermin) injection for subcutaneous use read this instructions for use before you start using increlex and each time you get a refill. there may be new information. this information does not take the place of talking to your child's doctor about your child's medical condition or treatment. do not share your child's needles and syringes with another person. your child may give another person an infection or your child could get an infection from them. important : - inject increlex exactly as your child's doctor or nurse has shown you. - follow your doctor's instructions for the type of syringe and needle to use to prepare and inject your child's dose of increlex . - always use a new, unopened needle and syringe for each injection. - only use single-use, disposable needles and syringes. never reuse disposable needles and syringes. - throw away used needles and syringes in a puncture-resistant, disposable sharps container as soon as you finish giving the injection. see step 5 "how should i throw away (dispose of) used needles and syringes? " at the end of these instructions. supplies needed to give the injection: - 1 vial of increlex - 1 alcohol swab - 1 gauze or cotton ball - alcohol (to clean the skin at the injection site) - 1 sharps container for throwing away (disposing of) used needles and syringes. see step 5 "how should i throw away (dispose of) used needles and syringes? " at the end of these instructions. preparing the dose: - wash your hands before getting increlex ready for your child's injection. - check the liquid to make sure it is clear and colorless. do not use if it is cloudy or if you see particles. - check the expiration date printed on the label of the vial. do not use increlex if the expiration date has passed. - if you are using a new vial, remove the protective cap. do not remove the rubber top (see figure 1). figure 1: remove the protective cap - wipe the rubber top on the vial with an alcohol swab (see figure 2). figure 2: wipe rubber top with alcohol swab - before putting the needle into the vial, pull back on plunger to draw air into the syringe equal to the increlex dose. put the needle through the rubber top of the vial and push the plunger to inject air into the vial (see figure 3). figure 3: inject air into vial - leave the syringe in the vial and turn both upside down. hold the syringe and vial firmly (see figure 4). figure 4: prepare to withdraw liquid - make sure the tip of the needle is in the liquid (see figure 5). pull the plunger to withdraw the correct dose into the syringe (see figure 6). figure 5: tip in liquidfigure 6: withdraw correct dose - before you take the needle out of the vial, check the syringe for air bubbles. if bubbles are in the syringe, hold the vial and syringe with needle straight up and tap the side of the syringe until the bubbles float to the top. push the bubbles out with the plunger and draw liquid back in until you have the correct dose (see figure 7). figure 7: remove air bubbles and refill syringe - remove the needle from the vial. do not let the needle touch anything. you are now ready to inject (see figure 8). figure 8: ready to inject injecting the dose: inject increlex exactly as your child's doctor or nurse has shown you. do not give the increlex injection if your child is unable to eat within 20 minutes before or after the injection . - put used needles and syringes in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. - do not try to touch the needle. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how to throw away needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - for the safety and health of you and others, needles and used syringes must never be re-used. - the used alcohol swabs, cotton balls, and gauze may be placed in your household trash. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - always keep the sharps disposal container out of the reach of children. how should i store increlex? - before opening : store new, unopened vials of increlex in the refrigerator between 36°f to 46°f (2°c to 8°c). - after opening : store opened vials of increlex in the refrigerator between 36°f to 46°f (2°c to 8°c) for 30 days after you start using the vial. throw away any unused increlex after 30 days. - do not freeze increlex. if a vial freezes, throw it away. - keep increlex out of direct light. - do not use increlex after the expiration date printed on the label. keep increlex and all medicines out of reach of children. this instructions for use has been approved by the u.s. food and drug administration. for additional information, call 855-463-5127. manufactured by: ipsen biopharmaceuticals, inc. cambridge, ma 02142 usa u.s. license no. 2194 www.ipsenus.com revised: october 2023

Izrael - angličtina - Ministry of Health

amgen europe b.v. - blinatumomab - powder for concentrate for solution for infusion - blinatumomab 35 mcg / 1 vial - blinatumomab - • blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b- precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options.• blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1%.• blincyto is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b-cell precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.• blincyto is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b precursor all as part of the consolidation therapy.limitations of use: after failure of two previous treatments and with no cns involvement.

Izrael - angličtina - Ministry of Health

lundbeck israel ltd. - nalmefene as hydrochloride dihydrate - film coated tablets - nalmefene as hydrochloride dihydrate 18.06 mg - nalmefene - selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (drl), without physical withdrawal symptoms and who do not require immediate detoxification.selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.selincro should be initiated only in patients who continue to have a high drl two weeks after initial assessment.

Izrael - angličtina - Ministry of Health

lundbeck israel ltd. - nalmefene as hydrochloride dihydrate - film coated tablets - nalmefene as hydrochloride dihydrate 18.06 mg - nalmefene - selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (drl), without physical withdrawal symptoms and who do not require immediate detoxification.selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.selincro should be initiated only in patients who continue to have a high drl two weeks after initial assessment.

Belgie - nizozemština - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

bioorganics b.v. - pemetrexeddinatriumhemipentahydraat - eq. pemetrexeddinatrium 1000 mg - poeder voor concentraat voor oplossing voor infusie - 1000 mg - pemetrexeddinatriumhemipentahydraat - pemetrexed