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Kineret 100 mg/0,67 ml solucion inyectable en jeringa precargada

Kineret 100 mg/0,67 ml solucion inyectable en jeringa precargada

About the medicine

Como usar Kineret 100 mg/0,67 ml solucion inyectable en jeringa precargada

Introduction

Prospecto: information for the user

Kineret100mg/0.67ml injectable solution in pre-filled syringe

Anakinra

Read this prospect carefully before starting to use this medication, as it contains important information for you.

  • Keep this prospect, as you may need to read it again.
  • If you have any doubts, consult your doctor or pharmacist.
  • This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Kineret and for what it is used

2.What you need to know before starting to use Kineret

3.How to use Kineret

4.Possible adverse effects

5.Storage of Kineret

6.Contents of the package and additional information

1. What is Kineret and what is it used for

Kineret contains the active ingredient anakinra. It is a type of cytokine (an immunosuppressant agent) used to treat:

  • Rheumatoid Arthritis (RA)
  • Covid-19 in patients with pneumonia, who require supplemental oxygen and have a risk of pulmonary insufficiency
  • Periodic fever syndromes:

-Periodic syndromes associated with cryopyrin (CAPS)

  • Neonatal-onset multisystem inflammatory disease (NOMID)/chronic infantile neurologic, cutaneous, and articular (CINCA) syndrome
  • Muckle-Wells syndrome (MWS)
  • Familial cold autoinflammatory syndrome (FCAS)
  • Familial Mediterranean fever (FMF)
  • Still's disease, including juvenile idiopathic systemic arthritis (JIAS) and adult-onset Still's disease (AOSD)

Cytokines are proteins produced by our body that coordinate cell communication and help control cellular activity. In RA, CAPS, FMF, Still's disease, and Covid-19 pneumonia, the body produces an excessive amount of a cytokine called interleukin-1. This leads to harmful effects causing inflammation and resulting in disease symptoms. Normally, the body produces a protein that blocks the harmful effects of interleukin-1. The active ingredient in Kineret is anakinra, which acts similarly to the natural protein that blocks interleukin-1. Anakinra is obtained through recombinant DNA technology using the microorganism E. coli.

In RA, Kineret is used to treat disease signs and symptoms in adults (18 years of age and older) in combination with another medication called methotrexate. Kineret is intended for patients whose response to methotrexate alone is not sufficient to control rheumatoid arthritis.

In Covid-19, Kineret is used to treat hyperinflammation associated with the disease in adults (18 years of age and older) who have pneumonia, require supplemental oxygen to help them breathe (low or high oxygen flow), and have a risk of pulmonary insufficiency.

In CAPS, Kineret is used to treat inflammation signs and symptoms associated with this disease, such as rash, joint pain, fever, headache, and fatigue, in both adults and children (8 months of age and older).

In FMF, Kineret is used to treat inflammation signs and symptoms associated with this disease, such as recurrent fever, fatigue, abdominal pain, muscle or joint pain, and rash. Kineret can be used in combination with colchicine, as needed.

In Still's disease, Kineret is used to treat inflammation signs and symptoms associated with this disease, such as rash, joint pain, and fever.

2. What you need to know before starting to use Kineret

No use Kineret

  • If you are allergic to anakinra or any of the other components of this medication (listed in section6)
  • If you are allergic to other products produced by DNA recombinant technology that use the microorganismE.coli
  • If you have neutropenia (low white blood cell count) determined after a blood test.

Contact your doctor immediately

  • If you experience a rash all over your body, difficulty breathing, wheezing, rapid pulse, or sweating after injecting Kineret. These may be symptoms of an allergic reaction to Kineret.
  • If you have ever had a generalized atypical rash or skin peeling after taking Kineret.

Warnings and precautions

Consult your doctor before starting to use Kineret:

  • If you have a history of recurrent infections or if you have asthma, as Kineret may worsen these conditions
  • If you have cancer. Your doctor will have to decide if you can receive Kineret
  • If you have a history of elevated liver enzyme levels
  • If you need to be vaccinated. You should not be vaccinated with live vaccines while being treated with Kineret.

Still's disease

  • In rare cases, patients with Still's disease, especially children, may develop lung disease, also during treatment with Kineret. The risk may be increased in patients with Down syndrome (trisomy21). Symptoms of lung disease may include, for example, shortness of breath during light exercise, morning cough, and difficulty breathing. If you develop symptoms of lung disease, contact your doctor as soon as possible.
  • Rarely, a severe skin reaction, DRESS (drug reaction with eosinophilia and systemic symptoms), has been associated with treatment with Kineret, especially in patients with systemic juvenile idiopathic arthritis (AIJS). Seek medical attention immediately if you observe a generalized atypical rash, which may appear with high fever and swollen lymph nodes.

CAPS

  • A few cases of systemic amyloidosis (a condition in which abnormal proteins accumulate in tissues and organs) have been reported in patients with NOMID/CINCA, who presented skin nodules at the injection sites (amyloid deposits) as the first manifestation. These patients had been using anakinra at high doses for several years. Symptoms of systemic amyloidosis may include swelling (especially in the legs and ankles), foamy urine, increased or decreased frequency of urination, muscle cramps, unexplained weight loss, diarrhea, or constipation, and fatigue. Inform your doctor if you notice any of these symptoms.

Children and adolescents

  • RA: The use of Kineret in children and adolescents with rheumatoid arthritis (RA) has not been extensively investigated and therefore cannot be recommended.
  • COVID19: The use of Kineret in children and adolescents with COVID19 has not been investigated and therefore cannot be recommended.
  • CAPS, FMF, Still's disease: The use of Kineret is not recommended in children under 8months, as there are no data available for this age group.

Other medications and Kineret

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Tumor necrosis factor (TNFα) inhibitors, such as etanercept, should not be used with Kineret, as this may increase the risk of infections.

When you start using Kineret, the chronic inflammation in your body will decrease. This may require adjusting the doses of other medications, such as warfarin or phenytoin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Kineret has not been tested in pregnant women. It is not recommended to use Kineret during pregnancy or in women of childbearing age who do not use a contraceptive method. It is essential to inform your doctor if you are pregnant, think you may be pregnant, or intend to become pregnant. Your doctor will discuss with you the possible risks of taking Kineret during pregnancy.

The excretion of anakinra in breast milk is unknown. Stop breastfeeding if you are using Kineret.

Kineret contains sodium

This medication contains less than1mmol of sodium (23mg) per dose of100mg; this is essentially "sodium-free".

3. How to Use Kineret

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. Kineret is injected under the skin (subcutaneous injection) daily. You should try to give yourself the injection at the same time every day.

The recommended dose is 20 to 90 mg or 100 mg. Your doctor will tell you the dose you need, or if you need a dose greater than 100 mg.

COVID-19: the recommended dose is 100 mg injected under the skin (subcutaneously) daily for 10 days.

Self-Administration of Kineret

Your doctor may decide that it is more convenient for you to inject Kineret yourself. Your doctor or nurse will teach you how to do it. Do not attempt to inject yourself if you have not been explained how to do it.

For information on how to inject Kineret yourself or inject it into your child, please read the section “Instructions for preparing and administering a Kineret injection” included at the end of this prospectus.

If You Use More Kineret Than You Should

You should not have any serious problems if, accidentally, you use more Kineret than you need. However, you should contact your doctor or pharmacist if this occurs. If you do not feel well, you should contact your doctor immediately.

If You Forget to Use Kineret

If you forget to give yourself a dose of Kineret, you should contact your doctor to discuss when you should give yourself the next dose.

4. Possible Adverse Effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The possible side effects are similar whether Kineret is used for RA or CAPS, FMF, Still's disease, or COVID-19.-

If any of the following side effects occur, inform your doctor immediately:

  • Severe infectionssuch as pneumonia (chest infection) or skin infections can occur during Kineret treatment. Symptoms may include persistent high fever, chills, cough, headache, and skin redness and pain. Other possible signs of infection are low-grade fever, weight loss, and persistent cough.
  • Thesevere allergic reactionsare rare. However, some of the following symptoms may indicate a Kineret allergic reaction for which you should seek immediate medical attention. Do not inject more Kineret:

-Swelling of the face, tongue, or throat

-Difficulty swallowing or breathing

-Sudden sensation of rapid heartbeat or sweating

-Itching on the skin or rash

Very common side effects(may affect more than 1 in 10people):

  • Redness, swelling, appearance of petechiae, or itching at the injection site. These symptoms are usually mild to moderate and more frequent at the beginning of treatment.
  • Headache.
  • Increased total cholesterol levels in the blood.

Common side effects(may affect up to 1 in 10people):

  • Neutropenia (low white blood cell count) determined after a blood test. Neutropenia may increase the risk of infection. Symptoms of an infection may include fever or sore throat.
  • Severe infections such as pneumonia (chest infection) or skin infections.
  • Trombocytopenia (low platelet count in the blood).

Rare side effects(may affect up to 1 in 100people):

  • Severe allergic reactions that include swelling of the face, tongue, or throat, difficulty swallowing or breathing, sudden sensation of rapid heartbeat or sweating, itching on the skin or rash.
  • High levels of liver enzymes detected after a blood test.

Side effects of unknown frequency(cannot be estimated from available data):

  • Signs of liver disorders, such as yellow skin and eyes, nausea, loss of appetite, dark urine, and pale stools.
  • If Kineret is repeatedly injected in the same place, there is a risk of a lump (amyloid deposit) forming under the skin. Alternate the injection site to avoid it.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Kineret

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the box after “CAD”. The expiration date is the last day of the month indicated.

Store in the refrigerator (between2°Cand8°C). Do not freeze.

Store in the original box to protect it from light.

Do not use Kineret if you believe it has been frozen. Once a syringe has been removed from the refrigerator and has reached room temperature (up to25°C), it must be used within the72hours following or discard. Do not store it back in the refrigerator if it has been stored at room temperature.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

6. Content of the packaging and additional information

Composition of Kineret

  • The active ingredient is anakinra. Each pre-filled syringe contains 100 mg of anakinra.
  • The other components (excipients) are: anhydrous citric acid, sodium chloride, disodium edetate dihydrate, polisorbate 80, sodium hydroxide, and water for injection.

Appearance of the product and contents of the pack

Kineret is a transparent, colourless to slightly white solution presented in a pre-filled syringe ready for use. The solution may contain protein particles with a translucent to white appearance, the presence of which does not affect the quality of the product.

Pack sizes of 1, 7 or 28 (multipack with 4 packs of 7 pre-filled syringes) pre-filled syringes.

Only some pack sizes may be marketed.

Holder of the marketing authorisation and responsible person for manufacture

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm

Sweden

Last date of revision of the package leaflet: 11/2024

Further information is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

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Consulte um médico online

Tem perguntas sobre este medicamento ou sintomas? Obtenha orientação de um médico qualificado, de forma prática e segura.

5.0(79)
Doctor

Alina Tsurkan

Medicina familiar12 anos de experiência

A Dra. Alina Tsurkan é médica de clínica geral e familiar licenciada em Portugal, oferecendo consultas online para adultos e crianças. O seu trabalho centra-se na prevenção, diagnóstico preciso e acompanhamento a longo prazo de condições agudas e crónicas, com base em medicina baseada na evidência.

A Dra. Tsurkan acompanha pacientes com uma ampla variedade de queixas de saúde, incluindo:

  • Infeções respiratórias: constipações, gripe, bronquite, pneumonia, tosse persistente.
  • Problemas otorrinolaringológicos: sinusite, amigdalite, otite, dor de garganta, rinite alérgica.
  • Queixas oftalmológicas: conjuntivite alérgica ou infeciosa, olhos vermelhos, irritação ocular.
  • Problemas digestivos: refluxo ácido (DRGE), gastrite, síndrome do intestino irritável (SII), obstipação, inchaço abdominal, náuseas.
  • Saúde urinária e reprodutiva: infeções urinárias, cistite, prevenção de infeções recorrentes.
  • Doenças crónicas: hipertensão, colesterol elevado, controlo de peso.
  • Queixas neurológicas: dores de cabeça, enxaquecas, distúrbios do sono, fadiga, fraqueza geral.
  • Saúde infantil: febre, infeções, problemas digestivos, seguimento clínico, orientação sobre vacinação.

Outros serviços disponíveis:

  • Atestados médicos para a carta de condução (IMT) em Portugal.
  • Aconselhamento preventivo e consultas de bem-estar personalizadas.
  • Análise de resultados de exames e relatórios médicos.
  • Acompanhamento clínico e revisão de medicação.
  • Gestão de comorbilidades e situações clínicas complexas.
  • Prescrições e documentação médica à distância.

A abordagem da Dra. Tsurkan é humanizada, holística e baseada na ciência. Trabalha lado a lado com cada paciente para desenvolver um plano de cuidados personalizado, centrado tanto nos sintomas como nas causas subjacentes. O seu objetivo é ajudar cada pessoa a assumir o controlo da sua saúde com acompanhamento contínuo, prevenção e mudanças sustentáveis no estilo de vida.

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Doctor

Nuno Tavares Lopes

Medicina familiar17 anos de experiência

Dr. Nuno Tavares Lopes é médico licenciado em Portugal com mais de 17 anos de experiência em medicina de urgência, clínica geral, saúde pública e medicina do viajante. Atualmente, é diretor de serviços médicos numa rede internacional de saúde e consultor externo do ECDC e da OMS. Presta consultas online em português, inglês e espanhol, oferecendo um atendimento centrado no paciente com base na evidência científica.
Áreas de atuação:

  • Urgência e medicina geral: febre, infeções, dores no peito ou abdómen, feridas, sintomas respiratórios e problemas comuns em adultos e crianças.
  • Doenças crónicas: hipertensão, diabetes, colesterol elevado, gestão de múltiplas patologias.
  • Medicina do viajante: aconselhamento pré-viagem, vacinas, avaliação “fit-to-fly” e gestão de infeções relacionadas com viagens.
  • Saúde sexual e reprodutiva: prescrição de PrEP, prevenção e tratamento de infeções sexualmente transmissíveis.
  • Gestão de peso e bem-estar: planos personalizados para perda de peso, alterações no estilo de vida e saúde preventiva.
  • Dermatologia e sintomas de pele: acne, eczemas, infeções cutâneas e outras condições dermatológicas.
  • Baixa médica (Baixa por doença): emissão de certificados médicos válidos para a Segurança Social em Portugal.
Outros serviços:
  • Certificados médicos para troca da carta de condução (IMT)
  • Interpretação de exames e relatórios médicos
  • Acompanhamento clínico de casos complexos
  • Consultas online multilíngues (PT, EN, ES)
O Dr. Lopes combina um diagnóstico rápido e preciso com uma abordagem holística e empática, ajudando os pacientes a lidar com situações agudas, gerir doenças crónicas, viajar com segurança, obter documentos médicos e melhorar o seu bem-estar a longo prazo.
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Doctor

Taisiya Minorskaya

Pediatria12 anos de experiência

A Dra. Taisia Minorskaya é médica licenciada em Espanha nas áreas de pediatria e medicina familiar. Presta consultas online para crianças, adolescentes e adultos, oferecendo cuidados abrangentes para sintomas agudos, doenças crónicas, prevenção e saúde no dia a dia.

Acompanhamento médico para crianças:

  • infeções, tosse, febre, dores de garganta, erupções cutâneas, problemas digestivos;
  • distúrbios do sono, atraso no desenvolvimento, apoio emocional e nutricional;
  • asma, alergias, dermatite atópica e outras doenças crónicas;
  • vacinação, exames regulares, controlo do crescimento e da saúde geral;
  • aconselhamento aos pais sobre alimentação, rotina e bem-estar da criança.
Consultas para adultos:
  • queixas agudas: infeções, dor, hipertensão, problemas gastrointestinais ou de sono;
  • controlo de doenças crónicas: hipertensão, distúrbios da tiroide, síndromes metabólicos;
  • apoio psicológico leve: ansiedade, cansaço, oscilações de humor;
  • tratamento da obesidade e controlo de peso: avaliação médica, plano personalizado de alimentação e atividade física, uso de medicamentos quando necessário;
  • medicina preventiva, check-ups, análise de exames e ajustes terapêuticos.
A Dra. Minorskaya combina uma abordagem baseada na medicina científica com atenção personalizada, tendo em conta a fase da vida e o contexto familiar. A sua dupla especialização permite prestar um acompanhamento contínuo e eficaz tanto a crianças como a adultos, com foco na saúde a longo prazo e na melhoria da qualidade de vida.
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Jonathan Marshall Ben Ami

Medicina familiar8 anos de experiência

O Dr. Jonathan Marshall Ben Ami é médico licenciado em medicina familiar em Espanha. Ele oferece cuidados abrangentes para adultos e crianças, combinando medicina geral com experiência em medicina de urgência para tratar tanto problemas de saúde agudos como crónicos.

O Dr. Ben Ami oferece diagnóstico, tratamento e acompanhamento em casos como:

  • Infeções respiratórias (constipações, gripe, bronquite, pneumonia).
  • Problemas de ouvidos, nariz e garganta, como sinusite, otite e amigdalite.
  • Problemas digestivos: gastrite, refluxo ácido, síndrome do intestino irritável (SII).
  • Infeções urinárias e outras infeções comuns.
  • Gestão de doenças crónicas: hipertensão, diabetes, distúrbios da tiroide.
  • Condições agudas que exigem atenção médica urgente.
  • Dores de cabeça, enxaquecas e lesões ligeiras.
  • Tratamento de feridas, exames de saúde e renovação de receitas.

Com uma abordagem centrada no paciente e baseada em evidência científica, o Dr. Ben Ami acompanha pessoas em todas as fases da vida — oferecendo orientação médica clara, intervenções atempadas e continuidade nos cuidados.

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