Nepexto 50 mg solucion inyectable en pluma precargada
Про препаратIntroduction
Package Insert: Information for the User
Nepexto 50 mg Pre-filled Syringe
etanercept
Read this package insert carefully before starting to use this medication, as it contains important information for you.
- Keep this package insert, as you may need to read it again.
- Your doctor will also give you a Patient Information Leaflet, which contains important safety information that you need to know before and during treatment with Nepexto.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- This medication has been prescribed to you or a child in your care and should not be given to others even if they have the same symptoms as you or the child in your care, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
1. What is Nepexto and what is it used for
Etanercept is the active ingredient in Nepexto.
Nepexto is a medication made from two human proteins. It blocks the activity of another protein in the body that produces inflammation. This medication acts by reducing the inflammation associated with certain diseases.
Nepexto can be used in adults (18 years and older) for:
- Rheumatoid Arthritis(an autoimmune disorder that mainly affects the joints) of moderate to severe.
- Psoriatic Arthritis(a type of inflammatory arthritis that can affect any joint in the body).
- Severe Axial Spondyloarthritis(a type of chronic inflammatory arthritis that affects the spine or sacroiliac joints) includingAnkylosing Spondylitis(a type of arthritis that affects the spine).
- Poriasis(raised, red, scaly areas on the skin) of mild to moderate.
Nepexto is used when other commonly used treatments have not worked well enough, or when those treatments are not suitable.
In the treatment ofRheumatoid Arthritis, this medication is usually used in combination with methotrexate, although it can also be used as a single medication if methotrexate treatment is not suitable. Nepexto can slow down the damage caused by rheumatoid arthritis in your joints and improve your ability to perform daily activities, whether used alone or in combination with methotrexate.
In patients withPsoriatic Arthritiswith multiple joint involvement, this medication can improve your ability to perform normal daily activities.
In patients withsymmetrical multiple swollen or painful joints(for example, hands, wrists, and feet),
this medication can delay the progression of structural damage to these joints caused by the disease.
Nepexto is also indicated for the treatment in children and adolescents with the following diseases:
- For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked well enough, or when it is not suitable for them:
- Polyarthritis (with positive or negative rheumatoid factor) and extended oligoarthritis in patients aged 2 years and older and weighing 62.5 kg.
- Psoriatic Arthritis in patients aged 12 years and older and weighing 62.5 kg.
- For arthritis related to enthesitis in patients aged 12 years and older and weighing 62.5 kg for whom the use of other commonly used treatments has not worked well enough, or when those treatments are not suitable for them.
- Severe Psoriasis in patients aged 6 years and older and weighing 62.5 kg who have had an inadequate response to (or are unable to take) phototherapy or other systemic therapies.
2. What you need to know before starting to use Nepexto
No use Nepexto
- Si usted o el niño que está a su cuidado son alérgicos a etanercept o a cualquiera de los demás componentes de Nepexto (incluidos en la sección 6). Si usted o el niño experimentan reacciones alérgicas, tales como opresión torácica, respiración jadeante, vértigo o erupción, no inyecte más Nepexto y póngase inmediatamente en contacto con su médico.
- Si usted o el niño padecen o tienen riesgo de desarrollar una infección grave de la sangre denominada sepsis. Si no está seguro, consulte a su médico.
denominada sepsis. Si no está seguro, consulte a su médico.
- Si usted o el niño padecen una infección de cualquier tipo . Si no está seguro, consulte a su médico.
Advertencias y precauciones
Consulte a su médico antes de empezar a usar Nepexto.
- Reacciones alérgicas : Si usted o el niño experimentan reacciones alérgicas, tales como opresión torácica, respiración jadeante, vértigo o erupción, deje de usar este medicamento y póngase inmediatamente en contacto con su médico.
- Infecciones/cirugía : Si usted o el niño desarrollan una nueva infección o están a punto de someterse a una intervención de cirugía mayor, su médico podría tener interés en controlar el tratamiento con este medicamento.
- Infecciones/diabetes : Informe a su médico si usted o el niño tienen historial de infecciones recurrentes o si padecen diabetes u otros trastornos que aumenten el riesgo de infección.
- Infecciones/monitorización : Informe a su médico de cualquier viaje reciente fuera de la región europea. Si usted o el niño desarrollan síntomas de una infección tales como fiebre, escalofríos o tos, notifíqueselo a su médico inmediatamente. Su médico debe decidir si continuar monitorizándole a usted o al niño para ver la presencia de infecciones después de que usted o el niño dejen el tratamiento con Nepexto.
- Tuberculosis : Ya que se han notificado casos de tuberculosis en pacientes tratados con Nepexto, su médico examinará los signos y síntomas de tuberculosis antes de empezar con este medicamento. Esto puede incluir una historia médica minuciosa, radiografía-torácica y una prueba de tuberculosis. La realización de estos análisis debe ser registrada en la Tarjeta para el Paciente. Es muy importante que le diga a su médico si usted o el niño han tenido tuberculosis, o si han estado en contacto directo con alguien que ha tenido tuberculosis. Si los síntomas de tuberculosis (tales como tos persistente, pérdida de peso, apatía, fiebre moderada), o alguna otra infección aparece durante o después del tratamiento, informe a su médico inmediatamente.
- Hepatitis B : Informe a su médico si usted o el niño tienen o han tenido hepatitis B alguna vez. Su médico debe hacerle la prueba de la hepatitis B antes de que usted o el niño comiencen el tratamiento con este medicamento. El tratamiento con Nepexto puede reactivar la hepatitis B en pacientes que hayan estado previamente infectados por el virus de la hepatitis B. Si esto ocurre, debe dejar de usar este medicamento.
- Hepatitis C : Informe a su médico si usted o el niño tienen hepatitis C. Su médico puede querer monitorizar el tratamiento con este medicamento en el caso de que la infección empeore.
- Trastornos de la sangre : Informe inmediatamente a su médico si usted o el niño tienen signos o síntomas tales como, fiebre persistente, dolor de garganta, hematomas, sangrado o palidez. Tales síntomas pueden ser debidos a la existencia de un problema sanguíneo grave que haga necesaria la interrupción del tratamiento con Nepexto.
- Trastornos del sistema nervioso y de la visión : Informe a su médico si usted o el niño presentan esclerosis múltiple, neuritis óptica (inflamación de los nervios ópticos) o mielitis transversa (inflamación de la médula espinal). Su médico decidirá si este medicamento es un tratamiento adecuado.
- Insuficiencia cardiaca congestiva : Informe a su médico si usted o el niño tienen antecedentes de insuficiencia cardiaca congestiva (el músculo del corazón no bombea la sangre como debería), porque este medicamento debe usarse con precaución en esas circunstancias.
- Cáncer : Informe a su médico si usted tiene o ha tenido linfoma (un tipo de cáncer sanguíneo) o cualquier otro cáncer antes de que se le administre este medicamento. Los pacientes con artritis reumatoide grave, que han tenido la enfermedad durante mucho tiempo, pueden correr un riesgo mayor que el promedio de desarrollar linfoma. Los niños y adultos que están tomando este medicamento pueden tener un riesgo incrementado de desarrollar linfoma u otro cáncer. Algunos pacientes adolescentes y niños que han recibido etanercept u otros medicamentos que funcionan de la misma manera que etanercept han desarrollado cánceres, incluyendo tipos inusuales, que algunas veces dieron como resultado la muerte. Algunos pacientes que reciben Nepexto han desarrollado cáncer de piel. Informe a su médico si usted o el niño desarrollan cualquier cambio en el aspecto de la piel o crecimientos en la piel.
- Varicela : Informe a su médico si usted o el niño están expuestos a la varicela mientras utilizan este medicamento. Su médico determinará si es apropiado el tratamiento preventivo para la varicela.
- Alcoholismo : No use este medicamento para el tratamiento de hepatitis relacionada con alcoholismo. Informe a su médico si usted o el niño que está a su cuidado tienen un historial de alcoholismo.
- No se recomienda este medicamento para el tratamiento de granulomatosis de Wegener , una enfermedad inflamatoria rara. Informe a su médico si usted o el niño que está a su cuidado tienen granulomatosis de Wegener.
- Medicamentos antidiabéticos : Informe a su médico si usted o el niño tienen diabetes o están tomando medicamentos para tratar la diabetes. Su médico puede decidir si usted o el niño necesitan menos medicamento antidiabético mientras toman este medicamento.
Niños y adolescentes
- Vacunaciones : Si es posible, los niños deben tener actualizadas todas las vacunaciones antes de utilizar Nepexto. Algunas vacunas, como la vacuna de la polio oral, no se deben administrar mientras se está utilizando este medicamento. Consulte a su médico antes de utilizar usted o el niño cualquier vacuna.
No se debe usar Nepexto en niños y adolescentes que pesen menos de 62,5 kg.
Nepexto no se debe usar en niños menores de 2 años con poliartritis u oligoartritis extendida, en niños menores de 12 años con artritis relacionada con entesitis o artritis psoriásica, ni en niños menores de 6 años con psoriasis.
Uso de Nepexto con otros medicamentos
Informe a su médico o farmacéutico si usted o el niño están utilizando, han utilizado recientemente o podrían tener que utilizar cualquier otro medicamento (incluyendo sulfasalazina), incluso aquellos no prescritos por su médico.
Usted o el niño no deben usar Nepexto junto con medicamentos que contengan los principios activos anakinra o abatacept.
Embarazo y lactancia
Nepexto solo debe utilizarse durante el embarazo si es claramente necesario. Consulte a su médico si está embarazada, cree que podría estar embarazada o tiene intención de quedarse embarazada.
Si ha recibido Nepexto durante el embarazo, su bebé puede presentar un mayor riesgo de contraer una infección. Además, en un estudio se observaron más defectos de nacimiento cuando la madre había recibido etanercept durante el embarazo, en comparación con las madres que no habían recibido este medicamento ni otros similares (antagonistas del TNF), pero no hubo ningún patrón en los tipos de defectos de nacimiento notificados. Otro estudio no encontró un mayor riesgo de defectos congénitos cuando la madre había recibido etanercept durante el embarazo. Su médico le ayudará a decidir si los beneficios del tratamiento superan el riesgo potencial para su bebé.
Consulte a su médico si desea dar el pecho mientras está en tratamiento con Nepexto. Es importante que informe al pediatra y a otros profesionales sanitarios sobre el uso de Nepexto durante el embarazo y la lactancia antes de que su bebé reciba cualquier vacuna.
Conducción y uso de máquinas
No se espera que el uso de Nepexto afecte a la capacidad para conducir y usar máquinas.
Nepexto contiene sodio
Este medicamento contiene menos de 1 mmol (23 mg) de sodio por cada dosis, esto es, esencialmente “exento de sodio”.
3. How to use Nepexto
Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, ask your doctor or pharmacist.
If you estimate that the action of Nepexto is too strong or too weak, inform your doctor or pharmacist.
Use in adults
Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitisThe usual dose is 25 mg administered twice a week or 50 mg administered once a week, in the form of a subcutaneous injection.
However, your doctor may determine an alternative frequency at which to inject Nepexto.
Plaque psoriasis
The usual dose is 25 mg twice a week or 50 mg once a week.
Alternatively, 50 mg may be administered twice a week for a maximum of 12 weeks, followed by 25 mg twice a week or 50 mg once a week.
Your doctor will decide how long you should use Nepexto and if you need a repeat of the treatment based on your response. If Nepexto has no effect on your disease after 12 weeks, your doctor may instruct you to stop using this medication.
Use in children and adolescents
The appropriate dose and dosing frequency will depend on the child's or adolescent's body weight and disease.
Your doctor will instruct you on how to prepare and measure the appropriate dose for the child. Nepexto should not be used in children and adolescents weighing less than 62.5 kg.
Other medications containing etanercept are available with a formulation suitable for children.
For extended oligoarthritis or polyarthritis in patients aged 2 years or older, or psoriatic arthritis-related arthritis in patients aged 12 years or older, the usual dose is 0.4 mg of etanercept per kg of body weight (up to a maximum of 25 mg) twice a week, or 0.8 mg of etanercept per kg of body weight (up to a maximum of 50 mg) once a week.
For plaque psoriasis in patients aged 6 years or older, the usual dose is 0.8 mg of etanercept per kg of body weight (up to a maximum of 50 mg) once a week. If Nepexto has no effect on the child's disease after 12 weeks, your doctor may instruct you to stop using this medication.
Form and route of administration
Nepexto is administered via a subcutaneous injection.
See section 7: “Instructions for use”, for detailed instructions for preparing and injecting Nepexto.
The solution should not be mixed with any other medication.
To help you remember, it may be useful to note in a diary which days of the week you should use Nepexto.
If you use more Nepexto than you should
If you use more Nepexto than you should (either by injecting a high amount on a single occasion or by using it too frequently), you should speak with a doctor or pharmacist immediately. Always carry the medication packaging with you, even if it is empty.
If you forget to inject Nepexto
If you forget a dose, you should inject it as soon as you remember, unless the next dose is scheduled for the following day, in which case you should omit the missed dose. Then, continue injecting the medication on the usual days. If you do not remember until the day when the next dose is due, do not inject a double dose (two doses on the same day) to compensate for the missed dose.
If you interrupt treatment with Nepexto
Your symptoms may return after treatment interruption.
If you have any other doubts about using this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medications, this medication may cause side effects, although not everyone will experience them.
Allergic Reactions
If you notice any of the following reactions, do not inject Nepexto again.Inform your doctor immediately or go to the nearest hospital's Emergency Department.
- Difficulty swallowing or breathing.
- Swelling of the face, throat, hands, and feet.
- Sensation of nervousness or anxiety, palpitations, sudden redness of the skin, and/or sensation of heat.
- Severe rash, itching, or urticaria (prominent skin rashes, red or pale, often accompanied by itching).
Severe allergic reactions are rare. However, any of the above symptoms may be a sign of an allergic reaction to this medication, so you must seek urgent medical attention immediately.
Severe Side Effects
If you notice any of the following side effects, you or the child may need emergency medical attention.
- Signs ofserious infections, such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a painful, sensitive, red, and warm area on the skin or joints.
- Signs ofblood disorders, such as bleeding, bruises, or paleness.
- Signs ofneurological disorders, such as numbness or tingling, visual disturbances, eye pain, or weakness in an arm or leg.
- Signs ofheart failureorexacerbation of heart failure, such as fatigue or shortness of breath with activity, swelling of the ankles, sensation of fullness in the neck or abdomen, shortness of breath at night, or cough, blue discoloration of the nails or around the lips.
- Signs ofcancer: Cancer can affect any part of the body, including the skin and blood, and the possible signs will depend on the type and location of the cancer. These signs may include weight loss, fever, swelling (with or without pain), persistent cough, presence of lumps or thickening in the skin.
- Signs ofautoimmune reactions(in which antibodies may develop that can damage normal body tissues) such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision.
- Signs of lupus or lupus-like syndrome such as weight changes, persistent rash, fever, muscle or joint pain, or fatigue.
- Signs of inflammation of blood vessels such as pain, fever, redness, or heat of the skin, or itching.
These side effects are rare or uncommon, but are serious (some of them may be fatal in rare cases). If any of the above occur, inform your doctor immediately or go to the nearest hospital's Emergency Department.
The following are known side effects of etanercept, grouped by decreasing frequency:
- Very common(may affect more than 1 in 10 people):
Infections (including colds, sinusitis, bronchitis, urinary tract infections, and skin infections); reactions at the injection site (including bleeding, bruising, redness, itching, pain, and swelling) (do not occur as frequently after the first month of treatment; some patients have developed a reaction at the injection site used recently); and headache.
- Common(may affect up to 1 in 10 people):
Allergic reactions; fever; itching; and antibodies directed against normal tissues (autoantibody formation).
- Uncommon(may affect up to 1 in 100 people):
Severe infections (including pneumonia, non-superficial skin infections, joint infections, blood infections, and generalized infections); exacerbation of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil count (a type of white blood cell); low platelet count; skin cancer (excluding melanoma); localized skin swelling (angioedema); urticaria (prominent skin rashes, red or pale, often accompanied by itching); eye inflammation, psoriasis (new or worsening); inflammation of blood vessels affecting multiple organs; increased liver enzymes in blood tests (in patients also receiving methotrexate, the increase in liver enzymes is common); cramp and abdominal pain, diarrhea, weight loss, or blood in stool (signs of intestinal problems).
- Rare(may affect up to 1 in 1,000 people):
Severe allergic reactions (including localized severe skin swelling and labored breathing); lymphoma (a type of blood cancer); leukemia (cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); combined low red blood cell, white blood cell, and platelet count; neurological disorders (with severe muscle weakness and symptoms and signs similar to multiple sclerosis or inflammation of the optic nerves or spinal cord); tuberculosis; new-onset congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and fatigue); skin eruption, which may lead to severe blistering and skin peeling; lymphoid reactions (pruritic, red-brown skin eruption and/or thick white-gray lines on mucous membranes); autoimmune hepatitis (inflammation of the liver caused by the immune system; in patients also receiving methotrexate, the frequency is uncommon); immunological disorder that may affect the lungs, skin, and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also receiving methotrexate, the frequency of inflammation or scarring of the lungs is uncommon), damage to the small filters within the kidneys, leading to impaired renal function (glomerulonephritis).
- Very rare(may affect up to 1 in 10,000 people): Bone marrow failure to produce critical blood cells.
- Frequency not known(cannot be estimated from available data):
Merkel cell carcinoma (a type of skin cancer); Kaposi's sarcoma, a rare cancer related to human herpesvirus 8 infection. Kaposi's sarcoma usually manifests as purple skin lesions; excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); reactivation of hepatitis B (a liver infection); exacerbation of a condition called dermatomyositis (inflammation and weakness of the muscles accompanied by skin rash).
Other side effects in children and adolescents
The side effects observed in children and adolescents, as well as their frequencies, are similar to those previously described.
Reporting side effects
If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Nepexto Storage
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the packaging and the preloaded pen after “EXP”. The expiration date is the last day of the month indicated.
Store in the refrigerator (between 2 °C and 8 °C). Do not freeze.
Keep the preloaded pens in the outer packaging to protect them from light.
After removing the preloaded pen from the refrigerator,wait approximately 30 minutes for the Nepexto solution in the preloaded pen to reach room temperature. Do not heat it in any other way. Use it immediately.
Nepexto can be stored outside the refrigerator at a maximum temperature of 25 °C, and for a single period of up to four weeks; after which, the medication cannot be refrigerated again. Nepexto must be discarded if it has not been used within four weeks of its removal from the refrigerator. It is recommended that you note the date on which Nepexto was removed from the refrigerator and the date from which Nepexto must be discarded (not exceeding 4 weeks from the removal of the packaging from the refrigerator).
Inspect the solution in the pen. It should be between transparent and opalescent, colorless or yellow, and may contain small white or almost transparent protein particles. This is the normal appearance of Nepexto. Do not use the solution if it is discolored or cloudy, or if it contains particles other than those described above. If you are concerned about the appearance of the solution, contact your pharmacist.
Medications should not be thrown away through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.
6. Contents of the packaging and additional information
Composition of Nepexto
- The active principle is etanercept. Each pre-filled pen contains 50 mg of etanercept.
- The other components are sodium citrate, sodium dihydrogen phosphate dihydrate, glycine, sucrose, sodium chloride, and injection water.
Appearance of the product and contents of the pack
Nepexto is presented as a pre-filled pen containing a transparent or opalescent, colourless or yellowish injection solution.
Nepexto is available in packs containing 4 or 12 pre-filled pens. Only some pack sizes may be marketed.
Marketing Authorisation Holder
Biosimilar Collaborations Ireland Limited
Unit 35/36
Grange Parade,
Baldoyle Industrial Estate,
Dublin 13
DUBLIN
Ireland
D13 R20R
Manufacturer
Biosimilar Collaborations Ireland Limited
Block B, The Crescent Building, Santry Demesne
Dublin
D09 C6X8
Ireland
You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:
België/Belgique/Belgien Biocon Biologics Belgium BV Tél/Tel:0080008250910 | Lietuva Biosimilar Collaborations Ireland Limited Tel:0080008250910 |
Luxembourg/Luxemburg Biocon Biologics France S.A.S Tél/Tel:0080008250910 | |
Ceská republika Biocon Biologics Germany GmbH Tel:0080008250910 | Magyarország Biosimilar Collaborations Ireland Limited Tel.:0080008250910 |
Danmark Biocon Biologics Finland OY Tlf:0080008250910 | Malta Biosimilar Collaborations Ireland Limited Tel.:0080008250910 |
Deutschland Biocon Biologics Germany GmbH Tel:0080008250910 | Nederland Biocon Biologics France S.A.S Tel:0080008250910 |
Eesti Biosimilar Collaborations Ireland Limited Tel:0080008250910 | Norge Biocon Biologics Finland OY Tlf:+47 800 62 671 |
Ελλ?δα Biocon Biologics GreeceΜΟΝΟΠΡΟΣΩΠΗΙ..Κ.Ε Τηλ.:0080008250910 | Österreich Biocon Biologics Germany GmbH Tel:0080008250910 |
España Biocon Biologics Spain S.L. Tel:0080008250910 | Polska Biosimilar Collaborations Ireland Limited Tel: 0080008250910 |
France Biocon Biologics France S.A.S Tel:0080008250910 | Portugal Biocon Biologics Spain S.L. Tel:0080008250910 |
Hrvatska Biocon Biologics Germany GmbH Tel:0080008250910 | România Biosimilar Collaborations Ireland Limited Tel:0080008250910 |
Ireland Biosimilar Collaborations Ireland Limited Tel:1800 777 794 | Slovenija Biosimilar Collaborations Ireland Limited Tel:0080008250910 |
Ísland Biocon Biologics Finland OY Sími: +345 800 4316 | Slovenskárepublika Biocon Biologics Germany GmbH Tel:0080008250910 |
Italia Biocon Biologics Spain S.L. Tel:0080008250910 | Suomi/Finland Biocon Biologics Finland OY Puh/Tel:99980008250910 |
Κ?προς Biosimilar Collaborations Ireland Limited Τηλ:0080008250910 | Sverige Biocon Biologics Finland OY Tel:0080008250910 |
Latvija Biosimilar Collaborations Ireland Limited Tel:0080008250910 |
Last update of the summary of product characteristics:08/2024.
Further information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu, and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/).
This summary of product characteristics can be found on the website of the European Medicines Agency in all languages of the European Union/European Economic Area.
7.Instructions for use
Read the instructions for use before starting to use Nepexto and each time you receive a replacement prescription. It may contain new information.
- Do not attempt to self-inject unless your doctor or nurse has shown you how to do it.
The pack does not include:
- Alcohol wipe
- Gas and bandages
- Sharps disposal container
Parts of the device
Expiry date | Expiry date | |
Viewfinder | Red viewfinder (full injection) | |
Injectable solution Red cap in place | Green safety cap | |
Red cap removed |
- Preparation for injection
Find a flat, clean, and well-lit surface and gather all the necessary items.
Please read section 5, which includes the instructions for the storage of Nepexto. If you have any doubts about the storage, contact your doctor, nurse, or pharmacist for more detailed information.
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Examine the medicine through the viewfinder.
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Remove one pre-filled pen from the pack stored in the refrigerator and leave it at room temperature for at least 30 minutes before injecting it. This is important to make the medicine easier and more comfortable to inject.
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4.Choose an injection site: The pre-filled pen is used for subcutaneous injection. It should be injected into the thigh, abdomen, or the back of the buttock (see the image on the right). Alternate the injection site. |
If you inject into the abdomen, choose a site that is at least 5 cm from the navel. |
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B.Steps for injection
Step 1: Wash your hands with soap and water. | |
Step 2: Clean the skin at the injection site with an alcohol wipe. See section 4: “Choose an injection site” for information on how to choose the injection site.
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Step 3: Remove the needle cap in a straight line and dispose of it in a sharps disposal container or a puncture-proof container.
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Step 4: Gently stretch the skin at the clean injection site. Place the pre-filled pen at approximately 90 degrees to the skin.
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Step 5: Press the pre-filled pen firmly into the skin to start the injection. The device will click when the injection starts. Continue to hold the pre-filled pen firmly in place. The device will click a second time. | Press “CLICK”downwards |
Step 6: After the second click, count slowly to 15 to ensure the injection is complete.
| The viewfinder turns red when the injection is complete. |
Step 7: Remove the empty pre-filled pen from the skin. The safety cap will cover the needle completely. Check that the plunger rod is red in the viewfinder to ensure the full dose has been administered. | |
Disposal: Dispose of the empty pre-filled pen in a sharps disposal container. Ask your healthcare provider for instructions on how to correctly dispose of the full sharps disposal container. Sharps disposal containers can be purchased at a pharmacy.
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- Care of the injection site
If bleeding occurs at the injection site, press the area with a gauze.
- Do not rub the injection site.
If necessary, cover the injection site with a bandage.
If you have any doubts or need more information, contact your doctor, nurse, or pharmacist.
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