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Enbrel 25 mg polvo y disolvente para solucion inyectable

О препарате

Introduction

Product Information for the User

Enbrel 25 mg Powder and Diluent for Injectable Solution

etanercept

Read this entire product information carefully before starting to use this medicine, as it contains important information for you.

  • Keep this product information, 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 Enbrel.
  • If you have any questions, consult your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you or the child in your care, and you must not give it to other people even if they have the same symptoms as you or the child in your care, as it may harm them.
  • If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

The information inthisproduct information is organizedinthe following 7 sections:

1.What Enbrel is and for what it is used

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

3.How to use Enbrel

4.Possible side effects

5.Storage of Enbrel

6.Contents of the pack and additional information

7.Instructions for use

1. What is Enbrel and what is it used for

Enbrel is a medication made from two human proteins. It blocks the activity of another protein found in the body, which produces inflammation. Enbrel acts by reducing the inflammation associated with certain diseases.

Enbrel may be used in adults 18 years of age or older for the treatment ofmoderate to severe rheumatoid arthritis,psoriatic arthritis,axial spondyloarthritissevere, includingankylosing spondylitisandpsoriasismoderate to severe, usually, depending on each case, when other treatments have not been sufficiently effective or are not appropriate for you.

In the treatment of rheumatoid arthritis, Enbrel is usually used in combination with methotrexate, although it may also be used as a single medication, in the case that methotrexate treatment is not suitable for you. Enbrel may slow 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 the case of patients with psoriatic arthritis with multiple joint involvement, Enbrel may improve your ability to perform normal daily activities.In the case of patients with multiple symmetrical, swollen, or painful joints (for example, in hands, wrists, and feet), Enbrel may delay the progression of structural damage to these joints caused by the disease.

Enbrel is also indicated for the treatment of children and adolescents with the following diseases:

  • For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked adequately, or is not suitable for them:
  • Polyarthritis (with positive or negative rheumatoid factor) and extended oligoarthritis in patients from 2 years old.
  • Psoriatic arthritis in patients from 12 years old.
  • For arthritis related to enthesitis in patients from 12 years old of age for whom the use of other more commonly used treatments have not worked adequately, or those treatments are not suitable for them.
  • Severe psoriasis in patients from 6 years old 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 Enbrel

No use Enbrel

  • If you or the child in your care are allergic to etanercept or any of the other components of Enbrel (listed in section 6). If you or the child experience allergic reactions, such as chest tightness, rapid breathing, dizziness, or rash, do not inject more Enbrel and immediately contact your doctor.
  • If you or the child have or are at risk of developing a severe blood infection called sepsis. If unsure, consult your doctor.
  • If you or the child have any type of infection. If unsure, consult your doctor.

Warnings and precautions

Consult your doctor before starting to use Enbrel.

  • Allergic reactions: If you or the child experience allergic reactions such as chest tightness, rapid breathing, dizziness, or rash, do not inject more Enbrel and immediately contact your doctor.
  • Latex:The syringe cap is made of latex (natural dried rubber). Contact your doctor before using Enbrel if the syringe is to be handled by, or if Enbrel is to be administered to, someone with known or possible latex hypersensitivity.
  • Infections/surgery:If you or the child develop a new infection or are about to undergo major surgery, your doctor may be interested in controlling Enbrel treatment.
  • Infections/diabetes:Inform your doctor if you or the child have a history of recurrent infections or if you suffer from diabetes or other conditions that increase the risk of infection.
  • Infections/monitoring:Inform your doctor of any recent travel outside the European region. If you or the child develop symptoms of an infection such as fever, chills, or cough, notify your doctor immediately. Your doctor must decide to continue monitoring you or the child to see the presence of infections after you or the child leave Enbrel treatment.
  • Tuberculosis:Since cases of tuberculosis have been reported in patients treated with Enbrel, your doctor will examine the signs and symptoms of tuberculosis before starting Enbrel. This may include a thorough medical history, chest X-ray, and tuberculosis test. The performance of these tests must be recorded in the Patient Information Card. It is very important to tell your doctor if you or the child have had tuberculosis, or have been in direct contact with someone who has had tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, apathy, moderate fever), or any other infection appear during or after treatment, inform your doctor immediately.
  • Hepatitis B:Inform your doctor if you or the child have or have had hepatitis B at any time. Your doctor must perform the hepatitis B test before you or the child start Enbrel treatment. Enbrel treatment may reactivate hepatitis B in patients who have been previously infected with the hepatitis B virus. If this occurs, you must stop using Enbrel.
  • Hepatitis C:Inform your doctor if you or the child have hepatitis C. Your doctor may want to monitor Enbrel treatment in case the infection worsens.
  • Blood disorders:Immediately inform your doctor if you or the child have signs or symptoms such as persistent fever, sore throat, bruises, bleeding, or pallor. Such symptoms may indicate the presence of a serious blood disorder that requires Enbrel treatment to be interrupted.
  • Nervous system and vision disorders:Inform your doctor if you or the child experience multiple sclerosis, optic neuritis (inflammation of the optic nerves) or transverse myelitis (inflammation of the spinal cord). Your doctor will decide if Enbrel is an appropriate treatment.
  • Heart failure:Inform your doctor if you or the child have a history of congestive heart failure, as Enbrel needs to be used with caution in such circumstances.
  • Cancer:Inform your doctor if you have or have had lymphoma (a type of blood cancer) or any other cancer before Enbrel is administered.

Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher risk of developing lymphoma.

Children and adults taking Enbrel may be at increased risk of developing lymphoma or other cancer.

Some adolescent and child patients who have received Enbrel or other medications that work in the same way as Enbrel have developed cancers, including rare types, which sometimes resulted in death.

Some patients taking Enbrel have developed skin cancers. Inform your doctor if you or the child develop any changes in skin appearance or growths on the skin.

  • Chickenpox:Inform your doctor if you or the child are exposed to chickenpox while using Enbrel. Your doctor will determine if preventive treatment for chickenpox is appropriate.
  • Alcoholism:Enbrel should not be used to treat alcohol-related hepatitis. Please inform your doctor if you or the child in your care have a history of alcoholism.
  • Wegener's granulomatosis:Enbrel is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease. If you or the child in your care have Wegener's granulomatosis, please discuss this with your doctor.
  • Antidiabetic medications: Inform your doctor if you or the child have diabetes or are taking medications to treat diabetes. Your doctor may decide if you or the child need less antidiabetic medication while taking Enbrel.

Children and adolescents

Vaccinations:If possible, children should have all vaccinations updated before using Enbrel. Some vaccines, such as the oral polio vaccine, should not be administered while using Enbrel. Consult with your doctor before using any vaccine.

Enbrel should not normally be used in children under 2 years with polyarthritis or oligoarthritis, in children under 12 years with arthritis related to enthesitis or psoriatic arthritis, or in children under 6 years with psoriasis.

Other medications and Enbrel

Inform your doctor or pharmacist if you or the child are using, have used recently, or may need to use any other medication (including anakinra, abatacept, or sulfasalazine), even those not prescribed by your doctor.You or the child should not use Enbrel with medications containing the active principles anakinra or abatacept.

Pregnancy and breastfeeding

Enbrel should only be used during pregnancy if clearly necessary. Consult your doctor if you are pregnant, think you may be pregnant, or intend to become pregnant.

If you have received Enbrel during pregnancy, your baby may be at increased risk of infection. Additionally, in one study, more birth defects were observed when the mother had received Enbrel during pregnancy, compared to mothers who had not received Enbrel or similar medications (TNF antagonists), but no pattern was observed in the types of birth defects reported. Another study found no increased risk of congenital defects when the mother had received Enbrel during pregnancy. Your doctor will help you decide if the benefits of treatment outweigh the potential risk to your baby.

Consult your doctor if you wish to breastfeed while on Enbrel treatment. It is essential to inform the pediatrician and other healthcare professionals about the use of Enbrel during pregnancy and breastfeeding before your baby receives any vaccine.

Driving and operating machinery

It is not expected that Enbrel use will affect the ability to drive and operate machinery.

3. How to Use Enbrel

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

If you estimate that the action of Enbrel is too strong or too weak, inform your doctor or pharmacist.

Dosage for adult patients(18 years of age or older)

Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, including ankylosing spondylitis

The usual dose is 25 mg administered twice a week or 50 mg administered once a week, in the form of a subcutaneous injection under the skin. However, your doctor may determine an alternative frequency for injecting Enbrel.

Plaque psoriasis

The usual dose is 25 mg twice a week or 50 mg once a week.

Alternatively, 50 mg can 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 take Enbrel and if you need a repeat treatment based on your response. If Enbrel 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 extended oligoarthritis or polyarthritis in patients aged 2 years or older, or psoriatic arthritis related to enthesitis or psoriatic arthritis in patients aged 12 years or older, the usual dose is 0.4 mg of Enbrel per kg of body weight (up to a maximum of 25 mg) administered twice a week, or 0.8 mg of Enbrel per kg of body weight (up to a maximum of 50 mg) administered once a week.

For plaque psoriasis in patients aged 6 years or older, the usual dose is 0.8 mg of Enbrel per kg of body weight (up to a maximum of 50 mg) administered once a week. If Enbrel 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

Enbrel is administered via a subcutaneous injection under the skin.

Enbrel can be administered with or without food or beverages.

The powder must be dissolved before use.Insection 7, “Instructions for use”, detailed instructions for preparing and injecting Enbrel are included.Enbrel solution should not be mixed with any other medication.

To help you remember, it may be helpful to note in a diary which day(s) of the week you should use Enbrel.

If you use more Enbrel than you should

If you use more Enbrel than you should (either by injecting a high amount in one 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 Enbrel

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 day(s). If you do not remember until the day you should administer the next dose, do not inject a double dose (two doses on the same day) to compensate for the missed dose.

If you interrupt Enbrel treatment

Your symptoms may return after interrupting treatment.

If you have any other questions 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 Enbrel again. Inform your doctor immediately or go to the nearest hospital emergency department.

  • Difficulty swallowing or breathing.
  • Swelling of the face, throat, hands, and feet.
  • Feeling of nervousness or anxiety, palpitations, sudden redness of the skin, and/or feeling 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 Enbrel, 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 one arm or leg.
  • Signs of heart failure orworsening heart failure, such as fatigue or shortness of breath with activity, swelling of the ankles, feeling 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 on the skin.
  • Signs ofautoimmune reactions(in which antibodies may form that can damage normal body tissues) such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision.
  • Signs oflupus or lupus-like syndromesuch as weight changes, persistent rash, fever, muscle or joint pain, or fatigue.
  • Signs ofvasculitissuch as pain, fever, redness, or warmth of the skin, or itching.

These side effects are rare or uncommon, but are serious conditions (some of them may be fatal in rare cases). If these signs occur, inform your doctor immediately or go to the nearest hospital emergency department.

The following are known side effects of Enbrel, 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); reactionsatthe 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 reactionatthe injection site that they had recently used); and headache.

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

Allergic reactions; fever; rash; itching; and autoantibodies directed against normal tissues (formation of autoantibodies).

  • Uncommon(may affect up to 1 in 100 people):

Severe infections (including pneumonia, non-superficial skin infections, joint infections, blood infections, and generalized infections); worsening 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 multiple organs affecting blood vessels; increased liver enzymes in blood tests (in patients also receiving methotrexate treatment, the increase in liver enzymes is common); abdominal cramps and pain, diarrhea, weight loss, or blood in the 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 that may lead to severe blistering and skin peeling; lichenoid reactions (pruritic, red-brown skin eruption and/or thick white-gray lines on mucous membranes); autoimmune hepatitis caused by the immune system (in patients also receiving methotrexate treatment, 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 treatment, the frequency of inflammation or scarring of the lungs is uncommon); damage to the small filters within the kidneys that lead to impaired kidney function (glomerulonephritis).

  • Very rare(may affect up to 1 in 10,000 people):

Failure of the bone marrow 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);worsening of a disease called dermatomyositis (inflammation and weakness of muscles accompanied by skin eruption).

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 any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Enbrel 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 label after “EXP.” The expiration date is the last day of the month indicated.

Store in the refrigerator (2 °C - 8 °C).Do not freeze.

Before preparing the Enbrel solution, Enbrel can be stored outside the refrigerator at a maximum temperature of 25 °C, and for a single period of up to 4 weeks; after which, the medication cannot be refrigerated again. Enbrel must be discarded if not used within 4 weeks following its removal from the refrigerator. It is recommended that you note the date when Enbrel is removed from the refrigerator and the date from which Enbrel must be discarded (not exceeding 4 weeks from the removal of the packaging from the refrigerator).

After preparing the Enbrel solution, immediate use is recommended. However, the solution can be used within the 6 hours following reconstitution when stored at temperatures not exceeding 25 °C.

Do not use this medication if you observe that the solution is not transparent or contains particles. The solution must be transparent, colorless to pale yellow or pale brown, without lumps, scales, or particles.

Properly discard any Enbrel solution that has not been injected within 6 hours.

Medications should not be disposed of through 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

Enbrel Composition

The active ingredient of Enbrel is etanercept. Each vial of Enbrel 25 mg contains 25 mg of etanercept.

The other components are:

Powder: Mannitol (E421), sucrose, and tromethamine

Vehicle: Water for injection

Appearance of the product and contents of the pack

Enbrel 25 mg is presented as a white powder and a vehicle for injectable solution (powder for injection). Each pack contains 4, 8, or 24 vials of single dose, 4, 8, or 24 pre-filled syringes with water for injection, 4, 8, or 24 needles, 4, 8, or 24 vial adapters, and 8, 16, or 48 cotton balls with alcohol. Some pack sizes may not be marketed.

Marketing Authorization Holder:

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturer:

Pfizer Manufacturing Belgium NV

Rijksweg 12,

2870 Puurs-Sint-Amands

Belgium

For further information about this medicinal product, please consult the representative of the marketing authorization holder in your country.

Spain

Pfizer, S.L.

Tel: +34 91 490 99 00

Last update of the leaflet:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

7.Instructions for use

This section is divided into the following subsections:

  1. Introduction
  2. Preparing for an injection
  3. Preparing the Enbrel dose for injection
  4. Adding the vehicle
  5. Extracting the Enbrel solution from the vial
  6. Placing the needleinthe syringe
  7. Choosing an injection site
  8. Preparing the injection site and injecting the Enbrel solution
  9. Disposal of materials

a.Introduction

The following instructions explain how to prepare and inject Enbrel. Read these instructions carefully and follow them step by step. Your doctor or nurse will teach you the self-injection or injection administration techniques for children. Do not attempt to administer an injection until you are sure you understand how to prepare the injection and administer it.

This injection should not be mixed with another medicine.

b.Preparing for an injection

  • Wash your hands thoroughly.
  • Choose a good light source and a flat work surface.
  • The tray should contain the following items. (If not, do not use it and consult your pharmacist). Use only the items listed.DOnot use any other syringe.

1 Vial of Enbrel

1 Syringe pre-filled with transparent colorless vehicle (water for injection)

1 Needle

1 Vial adapter

2 Cotton balls with alcohol

  • Check the expiration date on the labels of the vial and syringe. Do not use them after the month and year indicated.

c.Preparing the Enbrel dose for injection

  • Remove the contents from the tray.
  • Remove the plastic cap from the Enbrel vial (see Figure 1). Do not remove the grey stopper or the aluminum cap surrounding the top of the vial.

Figure 1

  • Use a new cotton ball with alcohol to clean the stopper of the Enbrel vial. After cleaning it, do not touch the stopper with your hands or allow it to touch any surface.
  • Place the vial in a vertical position and upwards on a clean and flat surface.
  • Remove the covering from the vial adapter package.
  • Placing the vial adapter on the top of the Enbrel vial, with the needle of the adapter centered within the circle on the top of the stopper (Figure 2).
  • Hold the vial firmly with one hand on the flat surface. With the other hand, push the vial adapter firmly in a straight line until you feel the needle penetrate the stopper and you hear the adapter click into place (Figure 3). Do not push the adapter at an angle (Figure 4). It is essential that the needle of the vial adapter penetrates the stopper completely.

Figure 2

Figure 3

Figure 4

CORRECT

INCORRECT

  • While holding the vial in one hand, remove the plastic cap from the vial adapter (Figure 5).

Figure 5

  • Remove the protective covering from the syringe tip by breaking the white cap along the perforation. This is done by holding the ring of the white cap while grasping the syringe tip with the other hand and bending it up and down until it breaks (Figure 6). Do not remove the white ring that remains attached to the syringe.

Figure 6

  • Do not use the syringe if the perforation is already broken. Start again with a new tray.
  • Hold the syringe body (not the white ring) in one hand and the vial adapter (not the vial) in the other hand, connect the syringe to the vial adapter by inserting the syringe tip into the opening and turning it clockwise until it is securely attached (Figure 7).

Figure 7

d.Adding the vehicle

  • While holding the vial in a vertical position on a flat surface, slowly push the plunger until all the vehicle enters the vial. This will help reduce foam formation (many bubbles) (Figure 8).
  • Once the vehicle has been added to Enbrel, the plunger may move on its own. This is due to air pressure and is not a cause for concern.

Figure 8

  • With the syringe still attached, slowly rotate the vial in a circular motion for a few minutes to dissolve the powder (Figure 9). Do not shake the vial. Wait until all the powder has dissolved (usually less than 10 minutes). The solution should be transparent and colorless to pale yellow or pale brown, without lumps, scales, or particles. It is normal for there to be white foam in the vial.
  • Do not use Enbrel if the powder in the vial has not dissolved in 10 minutes. Start again with a new tray.

Figure 9

e.Extracting the Enbrel solution from the vial

  • With the syringe still attached to the vial and adapter, hold the vial upside down at eye level. Push the plunger completely into the syringe (Figure 10).

Figure 10

  • Then, slowly pull the plunger back to extract the liquid from the syringe (Figure 11). For adult patients, extract the total volume. For children, extract only the amount of liquid indicated by the child's doctor. After extracting Enbrel from the vial, you may find some air in the syringe. Do not worry, as the air will be eliminated in the final stage.

Figure 11

  • Hold the vial upside down and separate the syringe from the vial adapter by turning it counterclockwise (Figure 12).

Figure 12

  • Place the filled syringe on a clean and flat surface. Make sure the tip does not touch anything. Be careful not to push the plunger down.

(Note: After completing these steps, a small amount of liquid may remain in the vial. This is normal.)

f.Placing the needleinthe syringe

  • The needle is included in a plastic package to keep it sterile.
  • To open the plastic package, hold the shorter and wider end in one hand. Place the other hand on the longer end of the package.
  • To break the seal, bend the longer end up and down until it breaks (Figure 13).

Figure 13

  • Once the seal is broken, remove the shorter and wider end of the package.
  • The needle will remain in the longer end of the package.
  • While holding the needle and package in one hand, grasp the syringe and insert its tip into the opening of the needle.
  • Insert the syringe into the needle by turning it clockwise until it is securely attached (Figure 14).

Figure 14

  • Remove the needle cap from the syringe by pulling it firmly, being careful not to touch the needle and avoiding it touching any surface (Figure 15). Be careful not to bend or twist the cap while removing it to avoid damaging the needle.

Figure 15

  • While holding the syringe in a vertical position, eliminate the bubbles by slowly pushing the plunger until the air is extracted (Figure 16).

Figure 16

g.Choosing an injection site

  • The three recommended injection sites for Enbrel include: (1) the central front of the thighs; (2) the abdomen, except for the area within 5 cm of the navel; and (3) the outer upper arm (Figure 17). If you are self-injecting, you should not inject into the outer upper arm.

Figure 17

  • A different site should be used for each new injection. Each new injection should be at least 3 cm away from the previous injection site.Donot inject into sensitive, bruised, red, or hardened skin areas. Avoid areas with scars or stretch marks (It may be helpful to note the previous injection sites).
  • If you or the child have psoriasis, they should try not to inject directly into any area of thickened, swollen, red, or scaly skin (“psoriatic skin lesions”).

h.Preparing the injection site and injecting the Enbrel solution

  • Clean the injection site with an alcohol-soaked cotton ball in a circular motion.DOnot touch this area again until the injection has been administered.
  • When the previously cleaned skin area has dried, pinch it and hold it firmly with one hand. With the other hand, hold the syringe like a pencil.
  • With a quick and short motion, push the needle until it is fully inserted, at an angle between 45° and 90° (Figure 18). With practice, you will find the most comfortable angle for you or the child. Be careful not to push the needle too slowly or with too much force.

Figure 18

  • When the needle is fully inserted, release the skin you were holding. With your free hand, hold the needle close to its base to stabilize it. Then, push the plunger to inject the solution at a slow and steady pace (Figure 19).

Figure 19

  • When the syringe is empty, remove the needle from the skin; be careful to keep the syringe at the same angle it was when inserted.
  • Press a cotton ball on the injection site for 10 seconds. There may be some bleeding.DOnot rub the injection site. If you want, you can apply a bandage or dressing.
  1. Disposal of materials
  • The syringe and needlesNEVERshould be reused. Dispose of them according to the instructions of your doctor, nurse, or pharmacist.

If you have any questions, consult a doctor, nurse, or pharmacist who is familiar with the use of Enbrel.

Страна регистрации
Активное вещество
Требуется рецепт
Да
Производитель
Состав
Manitol (e-421) (0 - mg), Sacarosa (0 - mg)
Информация носит справочный характер и не является медицинской рекомендацией. Перед приёмом любых препаратов проконсультируйтесь с врачом. Oladoctor не несёт ответственности за медицинские решения, принятые на основе этого контента.

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Doctor

Анна Морет

Дерматологія18 лет опыта

Анна Морет — лікарка-дерматолог і дерматовенеролог із міжнародною сертифікацією. Спеціалізується на дерматології дорослих і дітей, венерології, естетичному догляді за шкірою та загальній медицині. Проводить онлайн-консультації, базуючись на доказовій медицині та індивідуальних потребах кожного пацієнта.

Сфера допомоги охоплює: • захворювання шкіри: екзема, акне, розацеа, дерматити, псоріаз • проблеми з волоссям і шкірою голови: випадіння волосся, лупа, себорейний дерматит • дитяча дерматологія — від новонароджених до підлітків • венерологія та інфекції, що передаються статевим шляхом (ІПСШ) • естетичні запити: вікові зміни шкіри, неінвазивні косметологічні процедури • алергічні реакції та підвищена чутливість шкіри • перевірка родимок, оцінка новоутворень, скринінг раку шкіри • поради щодо догляду за шкірою та підбір індивідуальної космецевтики

Поєднуючи дерматологію із загальноклінічним досвідом, Анна Морет надає всебічну допомогу, що охоплює як стан шкіри, так і супутні захворювання. Має сертифікацію Канадської ради естетичної медицини, що підтверджує міжнародний підхід до естетичної дерматології.

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Аліна Цуркан

Сімейна медицина12 лет опыта

Аліна Цуркан — ліцензована лікарка сімейної медицини в Португалії. Проводить онлайн-консультації для дорослих і дітей, допомагаючи пацієнтам у вирішенні широкого спектра щоденних медичних запитів з професійним підходом і увагою до деталей.

Звернутися можна з такими станами: • респіраторні інфекції: застуда, грип, бронхіт, пневмонія • Захворювання очей: кон’юнктивіт (інфекційний і алергічний) • ЛОР-захворювання: синусит, отит, тонзиліт • проблеми з травленням: гастрит, кислотний рефлюкс, синдром подразненого кишківника (СПК) • інфекції сечових шляхів та інші поширені інфекції • хронічні захворювання: артеріальна гіпертензія, діабет, порушення функції щитоподібної залози • головний біль і мігрень

Окрім лікування симптомів, Аліна Цуркан приділяє особливу увагу профілактиці та ранньому виявленню захворювань. Проводить планові огляди, надає медичні рекомендації, здійснює повторні консультації та виписує рецепти — з урахуванням індивідуальних потреб кожного пацієнта.

Її підхід — комплексний, уважний і адаптований до кожного етапу життя пацієнта: від гострих станів до довготривалого контролю здоров’я.

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Андрій Попов

Терапія6 лет опыта

Андрій Попов — ліцензований в Іспанії терапевт і фахівець із лікування болю. Проводить онлайн-консультації для дорослих, допомагаючи впоратися з хронічним і гострим болем, а також із широким спектром загальних медичних запитів.

Спеціалізується на діагностиці та лікуванні болю, що триває понад 3 місяці або суттєво знижує якість життя. Працює з такими станами, як: • хронічний біль будь-якого походження • мігрень і повторювані головні болі • біль у шиї, спині, попереку та суглобах • посттравматичний біль після травм, розтягнень або операцій • невропатичний біль, фіброміалгія, невралгії

Окрім знеболення, Андрій Попов допомагає пацієнтам у веденні загальних медичних станів, зокрема: • респіраторні інфекції (застуда, бронхіт, пневмонія) • артеріальна гіпертензія, порушення обміну речовин, цукровий діабет • профілактичні огляди та контроль загального стану здоров’я

Онлайн-консультація триває до 30 хвилин і включає детальний аналіз симптомів, рекомендації щодо обстежень, формування індивідуального плану лікування та подальший супровід за потреби.

Андрій Попов дотримується принципів доказової медицини, поєднуючи клінічний досвід із уважним і персоналізованим підходом до кожного пацієнта.

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Євген Яковенко

Загальна хірургія11 лет опыта

Євген Яковенко — ліцензований лікар-хірург і терапевт в Іспанії. Спеціалізується на загальній і дитячій хірургії, внутрішній медицині та лікуванні болю. Проводить онлайн-консультації для дорослих і дітей, поєднуючи хірургічну практику з терапевтичним супроводом.

Сфера медичної допомоги охоплює: • діагностику та лікування гострого й хронічного болю • перед- і післяопераційний супровід, оцінку ризиків, контроль стану • хірургічні захворювання: грижі, жовчнокам’яна хвороба, апендицит • консультації з дитячої хірургії: вроджені стани, дрібні втручання • травми: переломи, ушкодження м’яких тканин, обробка ран • онкохірургія: консультації, планування, супровід після лікування • внутрішні захворювання: патології серцево-судинної та дихальної систем • ортопедичні стани, реабілітація після травм • інтерпретація результатів візуалізації для хірургічного планування

Євген Яковенко активно займається науковою діяльністю та міжнародною співпрацею. Член Асоціації хірургів Німеччини (BDC), співпрацює з Асоціацією сімейних лікарів Лас-Пальмаса та Німецьким консульством на Канарських островах. Регулярно бере участь у міжнародних медичних конференціях і публікує наукові статті.

Поєднуючи багатопрофільний досвід із доказовою медициною, він надає точну та індивідуалізовану допомогу для пацієнтів із різними медичними запитами.

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