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Nplate 500 microgramos polvo y disolvente para solucion inyectable

About the medicine

Como usar Nplate 500 microgramos polvo y disolvente para solucion inyectable

Introduction

Product Information for the User

Nplate 250 micrograms powder and solvent for solution for injection

Nplate 500 micrograms powder and solvent for solution for injection

Romiplostim

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.
  • If you have any questions, consult your doctor, pharmacist, or nurse.
  • This medicine has been prescribed only for you, and you must 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, pharmacist, or nurse, even if they are not listed in this product information. See section 4.
  1. What you need to know before starting to use Nplate
  2. How to use Nplate
  3. Possible adverse effects
  4. Storage of Nplate
  5. Contents of the pack and additional information
  6. Instructions for preparing and administering a Nplate injection

1. What is Nplate and how is it used

The active ingredient of Nplate is romiplostim, which is a protein used to treat low platelet counts in patients with primary immune thrombocytopenia (PTI). PTI is a disease in which the immune system of your body destroys your own platelets. Platelets are the blood cells that help heal wounds and form blood clots. Very low platelet counts can cause severe bruises and bleeding.

Nplate is used in adult patients (18 years or older) with PTI who may or may not have had their spleen removed and who have previously been treated with corticosteroids or immunoglobulins that did not work for them.

Nplate works by stimulating the bone marrow (part of the bone that generates blood cells) to produce more platelets. This should help prevent the bruises and bleeding related to PTI.

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

Do not use Nplate

  • If you are allergic to romiplostim or any of the other components of this medication (listed in section 6).
  • If you are allergic to other medications produced using DNA technology that utilizes the microorganismEscherichia coli(E. coli).

Warnings and precautions

  • If you stop taking Nplate, it is likely that your platelet count will decrease again (thrombocytopenia). If you stop taking Nplate, your platelet count will need to be monitored, and your doctor will discuss the necessary precautions with you.
  • If you have a risk of blood clots or if blood clots are frequent in your family. The risk of blood clots may also be increased if:
    • You have liver problems;
    • You are 65 years of age or older;
    • You are bedridden;
    • You have cancer;
    • You are taking birth control pills or hormone replacement therapy;
    • You have recently undergone surgery or have suffered an injury;
    • You are obese (overweight);
    • You are a smoker.

Consult your doctor, pharmacist, or nurse before starting to use Nplate.

If you have a very high platelet count, you may increase the risk of blood clots. Your doctor will adjust your Nplate dose to ensure that your platelet count is not too high.

Bone marrow changes(increase in reticulin and possible fibrosis in the bone marrow)

The long-term use of Nplate may cause changes in your bone marrow. These changes may lead to abnormal blood cells or a decrease in the production of blood cells. The mild form of these changes in the bone marrow is called “increase in reticulin” and has been observed in Nplate clinical trials. It is unknown if this could progress to a more severe form called “fibrosis.” Your blood tests may show signs of bone marrow changes as anomalies. Your doctor will decide if an abnormal blood test means that a bone marrow test should be done or if treatment with Nplate should be interrupted.

Worsening of blood cancer

Your doctor may decide to perform a bone marrow biopsy if they consider it necessary to ensure that you have PTI and not another disease such as Myelodysplastic Syndrome (MDS). If you have MDS and receive Nplate, you may experience an increase in blast cells and a worsening of MDS to acute myeloid leukemia, which is a type of blood cancer.

Loss of response to romiplostim

If you experience a loss of response to romiplostim or inability to maintain a platelet response during treatment with romiplostim, your doctor will investigate the reasons, including if you are experiencing an increase in bone marrow fibers (reticulin) or if you have developed antibodies that neutralize the activity of romiplostim.

Children and adolescents

Nplate is not recommended for use in children under 18 years of age.

Other medications and Nplate

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

If you are also taking other medications that prevent blood clot formation (anticoagulant or antiplatelet therapy), there is a higher risk of bleeding. Your doctor will discuss this aspect with you.

If you are taking corticosteroids, danazol, and/or azathioprine, which you may be receiving to treat your PTI, you may need to reduce or discontinue their administration when combined with Nplate.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication. Nplate is not recommended during pregnancy unless your doctor advises it.

The excretion of romiplostim in human milk is unknown. Nplate is not recommended during breastfeeding. The decision to interrupt breastfeeding or interrupt romiplostim treatment should be made considering the benefits of breastfeeding for the baby and the benefits of romiplostim treatment for the patient.

Driving and operating machinery

Consult your doctor before driving or operating machinery, as some side effects (e.g., temporary episodes of dizziness) may impair your ability to perform these activities safely.

3. How to Use Nplate

Nplate should be administered under the direct supervision of a doctor who will accurately control the amount of Nplate administered.

Nplate is administered once a week through subcutaneous injection.

The initial dose is 1 microgram of Nplate per kilogram of body weight once a week. Your doctor will indicate the amount of Nplate you should use. Nplate should be injected once a week for platelet count maintenance. Your doctor will regularly draw blood samples to evaluate how your platelets are responding and adjust the dose if necessary.

Once your platelet count is controlled, your doctor will continue to perform blood tests for monitoring. Your dose may be adjusted later to maintain long-term control of your platelet count.

Always follow exactly the Nplate administration instructions indicated by your doctor. In case of doubt, consult your doctor again on how to use Nplate.

Instructions for preparing and administering a Nplate injection

After adequate training, your doctor may also allow you to self-inject Nplate. Please read the instructions at the end of this prospectus on how to inject Nplate, as discussed with your doctor. If your doctor has allowed you to self-inject, you must follow up with him every month to determine if Nplate is working or if you should consider another treatment.

After the first month of self-injecting Nplate, you will need to demonstrate that you can still prepare and inject Nplate correctly.

If you use more Nplate than you should

Your doctor will ensure that you receive the correct amount of Nplate. If you have received more Nplate than you should, you may not present any physical symptoms, but your blood platelet levels may increase to very high levels and this may increase the risk of blood clotting. Therefore, if your doctor suspects that you have received more Nplate than you should, it is recommended that you be monitored for any signs or symptoms of side effects and that you be administered the appropriate treatment immediately.

If your doctor has allowed you to self-inject and you use more Nplate than you should, inform your doctor immediately.

If you use less Nplate than you should

Your doctor will ensure that you receive the correct amount of Nplate. If you have received less Nplate than you should, you may not present any physical symptoms, but your blood platelet levels may decrease to low levels and this may produce a risk of bleeding. Therefore, if your doctor suspects that you have received less Nplate than you should, it is recommended that you be monitored for any signs or symptoms of side effects and that you be administered the appropriate treatment immediately.

If your doctor has allowed you to self-inject and you use less Nplate than you should, inform your doctor immediately.

If you forget to use Nplate

If you forget a dose of Nplate, your doctor will indicate when you should receive the next dose.

If your doctor has allowed you to self-inject and you forgot to administer your injection, inform your doctor immediately.

If you interrupt treatment with Nplate

If you stop using Nplate, it is likely that you will experience a low platelet count (thrombocytopenia) again. Your doctor will decide if you should stop taking Nplate.

Self-injecting Nplate

Your doctor may decide that it is better for you to inject Nplate. Your doctor, nurse, or pharmacist will show you how to inject Nplate. Do not attempt to inject yourself if you have not been trained. It is very important that you prepare Nplate correctly and take the correct dose (see section 7. Instructions for preparing and administering a Nplate injection, at the end of this prospectus).

4. Possible Adverse Effects

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

Very common: may affect more than 1 in 10 people

  • headache;
  • allergic reaction;
  • upper respiratory tract infection.
  • Common: may affect up to 1 in 10 people
  • bone marrow disorder, including an increase in bone marrow fibers (reticulina);
  • difficulty falling asleep (insomnia);
  • dizziness;
  • tingling or numbness in the hands or feet (paresthesia);
  • migraine;
  • flushing of the skin (rubor);
  • blood clot in a pulmonary artery (pulmonary embolism);
  • nausea;
  • diarrhea;
  • abdominal pain;
  • indigestion (dyspepsia);
  • constipation;
  • itching of the skin (pruritus);
  • bruising under the skin (ecchymosis);
  • hematomas (contusion);
  • skin rash;
  • joint pain (arthralgia);
  • muscle pain or weakness (myalgia);
  • pain in the hands and feet;
  • muscle spasm;
  • back pain;
  • bone pain;
  • fatigue (fatigue);
  • reaction at the injection site;
  • swelling in the hands and feet (peripheral edema);
  • flu-like symptoms (influenza-like illness);
  • pain;
  • weakness (asthenia);
  • fever (pyrexia);
  • chills;
  • contusion;
  • swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema);
  • gastroenteritis;
  • palpitations;
  • sinusitis;
  • bronchitis.

Common: may affect up to 1 in 10 people (may be observed in blood or urine tests)

  • low platelet count in the blood (thrombocytopenia) and low platelet count in the blood (thrombocytopenia) after stopping treatment with Nplate;
  • high platelet count (thrombocytosis);
  • anemia.

Rare: may affect up to 1 in 100 people

  • bone marrow disorder; bone marrow disorder that causes scarring (myelofibrosis); enlargement of the spleen (splenomegaly); vaginal bleeding (vaginal hemorrhage), rectal bleeding (rectal hemorrhage); bleeding in the mouth (oral hemorrhage); bleeding at the injection site (hemorrhage at the injection site);
  • heart attack (myocardial infarction); increased heart rate;
  • dizziness or spinning sensation (vertigo);
  • eye problems including: bleeding in the eyes (conjunctival hemorrhage); difficulty focusing or blurred vision (visual accommodation disorder, papilloedema, or eye disorder); blindness; itching in the eyes (ocular pruritus); increased tearing (excessive lacrimation); or visual disturbances;
  • digestive problems including: vomiting; bad breath (halitosis); difficulty swallowing (dysphagia); indigestion or acid reflux (gastroesophageal reflux disease); blood in the stool (hematochezia); stomach discomfort; mouth ulcers or blisters in the mouth (stomatitis); tooth discoloration (dental discoloration);
  • weight loss; weight gain; intolerance to alcohol; loss of appetite (anorexia or decreased appetite); dehydration;
  • general feeling of discomfort (discomfort); chest pain; irritability; facial swelling (facial edema); feeling of heat; increased body temperature; nervous sensation;
  • flu; localized infection; inflammation of the nasal passages and throat (nasopharyngitis);
  • nasal and throat problems including: cough; nasal discharge (rhinorrhea); dry throat; shortness of breath or difficulty breathing (dyspnea); nasal congestion; chest pain when breathing (painful respiration);
  • swollen, painful joints, caused by uric acid (a breakdown product of food) (gout);
  • muscle stiffness; muscle weakness; shoulder pain; muscle contractions;
  • nervous system problems including involuntary muscle contractions (clonus); distorted sense of taste (dysgeusia); decreased sense of taste (hypogeusia); decreased sensitivity, especially in the skin (hypoaesthesia); nerve function disturbances in arms and legs (peripheral neuropathy); blood clot in the transverse sinus (transverse sinus thrombosis);
  • depression; abnormal dreams;
  • hair loss (alopecia); sensitivity to light (photosensitivity reaction); acne; allergic reaction in the skin from contact with allergens (contact dermatitis); skin manifestations with rash and blisters (eczema); dry skin; skin redness (erythema); severe peeling or exfoliative rash (exfoliative dermatitis); abnormal hair growth; skin thickening and itching from repeated scratching (prurigo); bruising under the skin or petechiae under the skin (purpura); skin rash with itching (papular eruption); skin rash with itching (pruriginous eruption); generalized itching rash (urticaria); skin nodule (skin nodule); abnormal skin odor (abnormal skin odor);
  • circulation problems including blood clots in the hepatic vein (portal vein thrombosis); deep vein thrombosis; low blood pressure (hypotension); high blood pressure; peripheral embolism; reduced blood flow to the hands, ankles, or feet (peripheral ischemia); swelling and coagulation in a vein, which may be extremely soft to the touch (phlebitis or superficial thrombophlebitis); blood clot (thrombosis);
  • a rare condition characterized by periods of burning pain, redness, and heat in the feet and hands (erythromelalgia).

Rare: may affect up to 1 in 100 people (may be observed in blood or urine tests)

  • a rare type of anemia in which the red blood cells, white blood cells, and platelets are reduced in number (aplastic anemia);
  • increased white blood cell count (leukocytosis);
  • excessive production of platelets (thrombocytosis); increased platelet count; abnormal platelet count;
  • abnormalities in some blood tests (increased transaminases; increased lactate dehydrogenase in the blood);
  • multiple myeloma;
  • proteins in the urine.

Reporting of adverse reactions

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

5. Storage of Nplate

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 on the vial label after CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C).

Do not freeze.

Store in the original packaging to protect it from light.

When stored in the original packaging, this medication may be kept at room temperature (up to 25°C) for a maximum period of 30 days.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Nplate

  • The active ingredient is romiplostim.

Each vial of Nplate 250 micrograms powder for injectable solution contains a total of 375 micrograms of romiplostim. An additional volume has been added to each vial to ensure that 250 micrograms of romiplostim can be administered. After dissolution, a volume of 0.5 ml of the final product solution contains 250 micrograms of romiplostim (500 micrograms/ml).

Each vial of Nplate 500 micrograms powder for injectable solution contains a total of 625 micrograms of romiplostim. An additional volume has been added to each vial to ensure that 500 micrograms of romiplostim can be administered. After dissolution, a volume of 1 ml of the final product solution contains 500 micrograms of romiplostim (500 micrograms/ml).

  • The other components are:

Powder: mannitol (E421), sucrose, L-histidine, hydrochloric acid (for pH adjustment), and polisorbate 20.

Solvent: water for injectable preparations.

Appearance of the product and contents of the package

Nplate is a white powder for injectable solution that is supplied in a single-dose glass vial of 5 ml.

Nplate is supplied in a single-use or multi-use package with 4 packages. Each package contains:

1 vial of 250 micrograms or 500 micrograms of romiplostim.

1 pre-loaded syringe containing 0.72 ml or 1.2 ml of water for injectable preparations for reconstitution.

1 plunger for the pre-loaded syringe.

1 sterile vial adapter.

1 sterile 1 ml syringe with Luer lock.

1 safety needle.

4 alcohol wipes.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Marketing authorization holder

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Responsible manufacturer

Amgen Technology (Ireland) Unlimited Company

Pottery Road

Dun Laoghaire

Co Dublin

Ireland

Responsible manufacturer

Amgen NV

Telecomlaan 5-7

1831 Diegem

Belgium

You can request more information about this medicine by contacting the local representative of the marketing authorization holder.

België/Belgique/BelgienLietuva

s.a. Amgen n.v.Amgen Switzerland AG Vilniaus filialas

Tel/Tél: +32 (0)2 7752711Tel: +370 5 219 7474

????????Luxembourg/Luxemburg

?????? ???????? ????s.a. Amgen

???.: +359 (0)2 424 7440Belgique/Belgien

Tel/Tél: +32 (0)2 7752711

Ceská republikaMagyarország

Amgen s.r.o.Amgen Kft.

Tel: +420 221 773 500Tel.: +36 1 35 44 700

DanmarkMalta

Amgen filial af Amgen AB, SverigeAmgen B.V.

Tlf: +45 39617500The Netherlands

Tel: +31 (0)76 5732500

DeutschlandNederland

AMGEN GmbHAmgen B.V.

Tel.: +49 89 1490960Tel: +31 (0)76 5732500

EestiNorge

Amgen Switzerland AG Vilniaus filialasAmgen AB

Tel: +372 586 09553Tel: +47 23308000

Ελλ?δαÖsterreich

Amgen Ελλ?ς Φαρμακευτικ? Ε.Π.Ε.Amgen GmbH

Τηλ.: +30 210 3447000Tel: +43 (0)1 50 217

EspañaPolska

Amgen S.A.Amgen Biotechnologia Sp. z o.o.

Tel: +34 93 600 18 60Tel.: +48 22 581 3000

FrancePortugal

Amgen S.A.S.Amgen Biofarmacêutica, Lda.

Tél: +33 (0)9 69 363 363Tel: +351 21 4220606

HrvatskaRomânia

Amgen d.o.o.Amgen România SRL

Tel: +385 (0)1 562 57 20Tel: +4021 527 3000

IrelandSlovenija

Amgen Ireland LimitedAMGEN zdravila d.o.o.

Tel: +353 1 8527400Tel: +386 (0)1 585 1767

ÍslandSlovenská republika

Vistor hf.Amgen Slovakia s.r.o.

Sími: +354 535 7000Tel: +421 2 321 114 49

ItaliaSuomi/Finland

Amgen S.r.l.Amgen AB, sivuliike Suomessa/Amgen AB, filial

Tel: +39 02 6241121i Finland

Puh/Tel: +358 (0)9 54900500

K?προςSverige

C.A. Papaellinas LtdAmgen AB

Τηλ.: +357 22741 741Tel: +46 (0)8 6951100

LatvijaUnited Kingdom

Amgen Switzerland AG Rigas filialeAmgen Limited

Tel: +371 257 25888Tel: +44 (0)1223 420305

Last review date of this leaflet in

Other sources of information

The detailed information on this medicine is available on the European Medicines Agency websitehttp://www.ema.europa.eu

  1. Instructions for preparing and administering a Nplate injection

This section contains information on how to self-inject Nplate. It is essential that you do not attempt to self-administer the injection if you have not received training from your doctor, nurse, or pharmacist. If you have questions about how to administer the injection, consult your doctor, nurse, or pharmacist. It is crucial that the product is prepared correctly and that the correct dose is administered.

This section is divided into the following sub-sections:

Before starting

Step 1. Place the injection materials

Step 2. Prepare the vial for use, place the vial adapter

Step 3. Prepare the sterile water syringe

Step 4. Dissolve Nplate by injecting water into the vial

Step 5. Prepare a new syringe for the injection

Step 6. Prepare the safety needle for the injection

Step 7. Choose and prepare the injection site

Step 8. Inject the Nplate liquid

Step 9. Disposal of supplies

Before starting

Read all the usage instructions carefully.These instructions are for patients who have alreadybeen trained by their healthcare professional, such as their doctor, nurse, or pharmacist, in self-injection. If you have not been trained, please contact your healthcare professional.

The Nplate auto-injection kit should be kept in the original packaging until use to protect the Nplate vial from light. Store the Nplate auto-injection kit in the refrigerator between 2°C and 8°C.

Once Nplate has been dissolved, inject immediately.

You may be left with excess Nplate after administering the prescribed dose. Do not reuse Nplate! Any excess dissolved Nplate must be disposed of immediately after completing the injection process. The excess Nplate from the vial MUST NOT be reused for another injection.

Step 1. Place the injection materials

Do the following:

  • Select a flat and well-lit work surface, such as a table.
  • Take the Nplate auto-injection kit from the refrigerator.Do not use if frozen.If you have any doubts about storage, contact your healthcare professional for further instructions.

Check the expiration date included in the auto-injection kit. If the expiration date has passed, do not use it.Do not continue and inform your healthcare professional.

  • Nota:If your doctor has prescribed a dose of Nplate that requires more than one injection,you will need to use more than one auto-injection kit. Follow the steps described in this leaflet and use as many auto-injection kits as necessary to complete the prescribed dose of Nplate.
  • Ensure that you have the following components:

Alcohol wipe packagex4

1 vial of 250 micrograms or

Adapter for vial of 13 mmx1

500 microgramsx1

Plunger for sterile water syringex1Sterile water syringex1

Syringe of 1 ml with Luer lockx1Safety needle for injectionx1

  • Do notopen the components until indicated in the instructions.
  • Do notuse components that have been altered or damaged.
  • Do notreuse the components.

Step 2. Prepare the vial for use, place the vial adapter

Use:2 alcohol wipes, 1 vial, and 1 vial adapter package.

Do the following:

  • Wash your handswith soap and warm water.
  • Clean the flat work surface with a new alcohol wipe.
  • Remove the red plastic cap (250 micrograms) or blue

(500 micrograms) from the vial.

  • Using a new alcohol wipe, clean the cap of the vial
  • Do nottouch the cap of the vial after cleaning it
  • Remove the backing paper slowly from the vial adapter, keeping the vial adapter in the plastic packaging.
  • Do nottouch the cap of the vial or the tip of the vial adapter.
  • Maintainingthe vial on the table, and maintaining the vial adapter in the plastic packaging,align the tip of the vial adapter with the center of the cap of the vial.
  • Push the vial adapter down until the vial isfirmly in place and cannot be pushed down any further.
  • Remove the plastic packaging from the vial adapter, leaving the vial adapter in the vial.
  • Do nottouch the top of the vial adapter.

Step 3. Prepare the sterile water syringe

Use:The pre-loaded sterile water syringe and plunger.

Before starting Step 3, please note the following:

  • The transparent plastic plunger always MUST be connected before breaking the white tip of the pre-loaded sterile water syringe. Carry out Step 3a before Step 3b.

Do the following:

  • Step 3a: Connect the transparent plastic plunger to the pre-loaded sterile water syringe,placing the threadedend of the plunger on the syringe and turning the plunger carefully clockwise on the syringe's piston grey, until you feel a slight resistance. Do not tighten too much.
  • Step 3b: Holding the syringe with one hand, bend the white plastic tip cover downwards with the other hand.This will break the seal of the white plastic tip cover.
  • Once the seal is broken,remove thewhite plastic tip cover. You will see the grey rubber in the tip.

Step 4. Dissolve Nplate, inject water into the vial

Use:The pre-loaded sterile water syringe and vial with vial adapter attached.

Before starting Step 4, please note the following:

  • Dissolveslowly and carefully. It is a protein and, as such, can be easily damagedby inadequate and excessive mixing.

Do the following:

  • Maintaining the vial on the table, place the syringe in the vial adapter,sitting one side of thevial adapter with one hand and turning the tip of the syringe clockwise inside the vial adapter until you feel a slight resistance.
  • Very slowly and carefully, press the plunger down, to inject all the water from the syringe into the vial.The water shouldflow slowly over the powder.
  • Do notforce the water into the vial.
  • Nota:After injecting the water into the vial,it is normal for the plunger to return upwards. You do not need to maintain pressure on the plunger for the rest of Step 4.

Press slowly and carefully

Before continuing:

  • Ensurethat all the water is injected from the syringe into the vial before dissolving it.
  • Maintaining between your fingers the area where the vial and its adapter connect, gently rock the vial with a wrist rotation until all the powder has dissolved and the liquid in the vial is clear and colorless.
  • Rockthe vial gently.

Correct

  • Do notshake the vial
  • Do notroll the vial between your palms
  • Nota:The powder may take up to 2 minutesto dissolve completely.

Incorrect

Before continuing:

  • Inspectvisually the dissolved liquid in search of particles and/or discoloration. It should beclear and colorless and completely dissolved.
  • Nota:If there isany color or particles in the liquid,contact your healthcare professional.
  • Ensurethat the liquid is completely dissolved before removing the syringe.
  • When Nplate is completely dissolved, remove the empty syringe from the vial adapter, turning it counterclockwise.
  • Dispose of the empty syringein a sharps container. Keep the vialof dissolved Nplate. Immediately prepare a new syringe for the injection.
  • Do notdelay the injection of Nplate

Step 5. Prepare a new syringe for the injection

Use:A new 1 ml syringe from the package and the vial with dissolved and transparent Nplate.

Before continuing:

  • Reviewyour dose before starting this step.
  • Nota:Nplate liquid is very potent, so the accuracy and measurement of the dose areimportant.
  • Ensurethat all air bubbles have been removed before the injection.

Do the following:

  • Extract a 1 ml syringe from the package.
  • Take air into the syringe until the 1 ml mark.
  • Do notpull the plunger beyond the 1 ml mark.

Take air into the syringe until the

1 ml mark

  • Place the 1 ml syringe on the vialadapter of the dissolved Nplate, turning the tipof the syringe clockwise on the vial adapter until you feel a slight resistance.
  1. Introduce air into the vial.
  1. Maintain pressure on the plunger.
  1. Turn the vial and syringe combination upwards,so that the vial isdirectly above the syringe.

A.B.C.

Turn downwards

  • Suck all the liquid content into the syringe.
  • The maximum final volume of the 250 micrograms vial is 0.5 ml and for the 500 micrograms vial is 1 ml.
  • Do notpull the plunger beyond the end
  • Ensurethat the plunger remains in the syringe.

Correct

  • Check and remove all air bubbles from the syringe.
  • Gentlytap the syringe with your fingers to separate the air bubbles from the liquid.
  • Slowlypress the plunger upwardsto force the air bubblesout of the syringe.

Air bubbles: Correct

Incorrect

  • Slowly press the plunger to leave only the prescribed dose by your healthcare professional.
  • Ensure that the tip of the plunger head aligns with the mark on the syringe corresponding to your prescribed dose.If necessary, returnliquid to the vial to achieve the desired dose.

Adjust the amount to your prescribed dose

  • Make a final check to ensure that the correct amount of liquid for your dose is in the syringeandthat all air bubbles have been removed.

Before continuing:

  • Ensurethat the correct amount of liquid for your dose remains in the syringe.
  • Ensurethat all air bubbles have been removed from the syringe.
  • Once all air bubbles have been removed and the syringe is full with the correct dose,remove the syringe from the vial adapter.
  • Maintain the syringe full in your hand and do not touch the tip of the syringe.
  • Do notplace the syringe with the tip down after removing the vial.

Step 6. Prepare the safety needle for the injection

Use:The full syringe and safety needle.

Do the following:

  • Maintaining the syringe in the palm of your hand with the tip pointing upwards,remove the safety needle from the package.
  • Place the safety needlein the syringefull.Apply forceto the safety needle on the syringeturning clockwiseto close the Luer lock tip.
  • The product is now ready for injection. IMMEDIATELY continue with Step 7.

Step 7. Choose and prepare the injection site

Use:New alcohol wipes.

Do the following:

  • Choose the injection sites.Threeinjection sites are recommended for Nplate.
  • Front of the middle thigh
  • Abdomen, except for the area within 5 cm of the navel
  • If someone else is injecting you, you can also use the outer area of the upper arm
  • Rotatethe different sites for eachinjection.
  • Do notinject in areas where the skin is soft, bluish, or hard.
  • Do notinject in areas with scars or stretch marks.
  • Clean the area where Nplate will be injected with an alcohol wipe, using a circular motion.
  • Do nottouch the area again before injecting.

Step 8. Inject the Nplate liquid

Use:The full syringe and safety needle.

Do the following:

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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

Duarte Meneses

Medicina familiar4 anos de experiência

O Dr. Duarte Meneses é médico licenciado em medicina familiar e clínica geral em Portugal, com experiência adicional em medicina do trabalho. Realiza consultas médicas online para adultos, prestando apoio tanto em sintomas agudos como em doenças crónicas.

  • Sintomas comuns: febre, dor de garganta, tosse, fadiga ou queixas digestivas
  • Doenças crónicas: hipertensão, diabetes, colesterol elevado e problemas da tiroide
  • Saúde mental: stress, insónias, ansiedade e burnout
  • Cuidados preventivos: check-ups, aconselhamento sobre estilo de vida e seguimento de tratamentos
  • Questões de saúde relacionadas com o trabalho, emissão de baixas médicas e orientação para o regresso à atividade laboral
O Dr. Meneses formou-se na Universidade da Beira Interior e tem vários anos de experiência com populações diversas.

Adota uma abordagem próxima, clara e orientada para fornecer aconselhamento médico prático, adaptado às necessidades de cada pessoa.

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Doctor

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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  • Remove the pink safety cap(towards the syringe and away from the needle).
  • Remove the transparent needle cap,keeping the syringe in one handand carefully pulling the cap directly with the other hand.
  • Removethe transparent needle cap from the needlebefore injecting.