Neorecormon 6000 ui solucion inyectable en jeringa precargada

Leaflet: information for the user

NeoRecormon500UI

NeoRecormon2.000UI

NeoRecormon3.000UI

NeoRecormon4.000UI

NeoRecormon5.000UI

NeoRecormon6.000UI

NeoRecormon10.000UI

NeoRecormon20.000UI

NeoRecormon30.000UI

pre-filled syringe solution for injection

epoetin beta

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you onlyaloneand should not be given to others even if they have the same symptomsas you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist,even if they are not listed in this leaflet.(See section 4).

1.What isNeoRecormonand what it is used for

2.What you need to knowbefore starting touseNeoRecormon

3.How to useNeoRecormon

4.Possible side effects

5.Storage ofNeoRecormon

6.Contents of the pack and additional information

NeoRecormon isa clear, colorless solution for injection under the skin (subcutaneously) or into a vein (intravenously).It containsepoetin beta, a hormone that stimulates the production of red blood cells. Epoetin beta is produced by specialized genetic technology and functions exactly the same way as the natural human erythropoietin hormone.

You should consult your doctor if you worsen or do not improve.

NeoRecormonis indicated for:

• Treatment of symptomatic anemia caused by chronic kidney disease(renal anemia) in patients undergoing dialysis or not yet undergoing dialysis.
• Prevention of anemia in premature infants(with a birth weight of 750 to 1,500g and a gestational age of less than 34 weeks).
• Treatment of anemia with symptoms related to patients with cancer treated with chemotherapy.
• Treatment of individuals who are donating their own blood before undergoing a surgical procedure.The epoetin beta injections will increase the amount of blood that can be extracted from your body before the operation, to be used during the procedure or after (this is anautologous transfusion).

No useNeoRecormon:

• if you are allergicto epoetin beta or any of the other components of this medication (listed in section 6).
• if you have uncontrolled high blood pressure.
• if you are going to donate your own blood before undergoing surgery and:
• have had aheart attack or strokein the month prior to treatment.
• if you experienceunstable angina– new chest pain or increasing pain.
• if you have arisk of blood clots forming in your veins(deep vein thrombosis) – for example, if you have had previous clots.

If you experience any of these situations or may develop them,inform your doctor immediately.

Warnings and precautions

Consult your doctor before starting to use NeoRecormon.

• If your baby needs treatment with NeoRecormon, your baby will be closely monitored for possible effects on the eye
• if your anemia does not improvewith epoetin treatment.
• if you have low levels of some B vitamins(folate or vitamin B12)
• if you have high levels of aluminumin your blood.
• if your platelet count is high
• if you have chronic liver disease
• if you have epilepsy
• if you have developed anti-erythropoietin antibodies and pure red cell aplasia(decrease or cessation of red blood cell production) during previous exposure to any erythropoietic substance. In this case, do not switch to NeoRecormon.

Be especially careful with other medications that stimulate red blood cell production:NeoRecormon is one of the erythropoiesis-stimulating agents like human recombinant erythropoietin. Your doctor should always record the exact product you are using.

Severe skin reactions, such as Stevens-Johnson syndrome (SSJ) and toxic epidermal necrolysis (TEN), have been observed with the administration of epoetins.

SSJ/TEN may initially appear as circular, red, scaly patches with central blisters on the trunk. Ulcers may also occur in the mouth, throat, nose, genitals, and eyes (eye irritation and swelling). These severe skin reactions are often preceded by fever and/or flu-like symptoms. The skin reaction may progress to generalized skin peeling and potentially life-threatening complications.

If you experience a severe skin reaction or any of these other skin symptoms, stop taking NeoRecormon and contact your doctor or seek medical attention immediately.

Special warning

During treatment with NeoRecormon

If you are a patient with chronic kidney disease,and particularly if you do not respond adequately to NeoRecormon, your doctor will monitor your NeoRecormon dose as repeated increases in the NeoRecormon dose if you are not responding to treatment may increase the risk of heart or vascular problems, and may increase the risk of heart attack, stroke, and death.

If you are a cancer patient,you should know that NeoRecormon may act as a growth factor for blood cells and that in some circumstances it may have a negative effect on cancer. Depending on your individual situation, it may be preferable to have a blood transfusion. Please discuss this with your doctor.

If you are a nephrosclerotic patientnot yet on dialysis, your doctor will decide whether treatment is suitable for you. This is because it cannot be ruled out with certainty that the treatment may accelerate renal insufficiency.

Your doctor may perform regular blood tests to monitoryour levels of potassium. If you have high or increasing potassium levels, your doctor should reconsider your treatment.

• Your platelet count. During treatment with epoetin, the number of platelets may increase slightly to moderately, which may cause changes in blood coagulation.

If you are a patient with renal impairment undergoing hemodialysis,your doctor will adjust your heparin dose. This will prevent blockage of the dialysis system tubes.

If you are a patient with renal impairment undergoing hemodialysis and at risk of catheter thrombosis,clots (thrombosis) may form in yourcatheter(the tube used to connect the dialysis system). Your doctor may prescribe aspirin or modify the catheter.

If you are donating your own blood before surgery,your doctor will need to:

• check that you can donate blood, especially if your weight is less than 50kg
• check that you have sufficient red blood cells (hemoglobin of at least 11g/dl)
• ensure that only 12% of your blood volume can be extracted at one time.

Do not use NeoRecormon inappropriately:

Inappropriate use of NeoRecormon by healthy individuals may lead to an increase in blood cells and, consequently, thickening of the blood that may be associated with life-threatening cardiovascular or vascular complications.

Use ofNeoRecormonwith other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

Pregnancy, breastfeeding, and fertility

No adequate experience has been obtained with NeoRecormon inwomen duringpregnancy and lactation. Consult your doctor or pharmacist before taking any medication.

NeoRecormonhas not shown evidence of altered fertility in animals. The potential risk in humans is unknown.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been described.

NeoRecormon contains phenylalanine and sodium

This medication contains phenylalanine. It may be harmful to individuals with phenylketonuria.

If you havephenylketonuria,consult your doctorabout treatment withNeoRecormon.

This medication contains less than 1mmol of sodium (23mg) per dose; it is essentially “sodium-free”.

Use this medication exactly as your doctor has told you to. If you are unsure, consult your doctor or pharmacist.

Your doctor will use the lowest effective dose to control your anemia symptoms.

If you do not respond adequately to NeoRecormon, your doctor will check your dose and inform you if you need to change your dose.

Treatment should be initiated under the supervision of a doctor.

Other injections will be administered by your doctor or, after being trained, you may inject NeoRecormon (see instructions at the end of this prospectus).

NeoRecormon can be injected under the skin in the abdomen, arm, or thigh, or into a vein. Your doctor will decide what is best for you.

Your doctor will perform periodic blood tests to control how your anemia is responding to treatment by measuring your hemoglobin level.

Dosage of NeoRecormon

The dosage of NeoRecormon depends on your disease state, the method of injection (subcutaneous or intravenous), and your body weight. Your doctor will calculate the appropriate dose for you.

Your doctor will use the lowest effective dose to control your anemia symptoms.

If you do not respond adequately to NeoRecormon, your doctor will check your dose and inform you if you need to change your dose of NeoRecormon.

• Anemia caused by chronic kidney disease

Injections are administered subcutaneously or intravenously. If the solution is administered intravenously, it should be injected over a period of 2 minutes, for example, in patients undergoing hemodialysis via the arteriovenous fistula at the end of dialysis.

Patients not undergoing hemodialysis will normally receive subcutaneous administration.

Treatment with NeoRecormon is divided into two phases:

a)Correction of anemia

The initial dose for subcutaneous administrationis 20UI per injection per kg of body weight, administered three times a week.

After 4 weeks, your doctor will perform tests and may increase your dose to 40UI/kg per injection, administered three times a week. Your doctor may continue to increase your dose at monthly intervals if necessary.

The weekly dose can be divided into daily doses.

The initial dose for intravenous administrationis 40UI per injection per kg of body weight, administered three times a week.

After 4 weeks, your doctor will perform tests and if the response to treatment is not sufficient, your dose may be increased to 80UI/kg per injection, administered three times a week. Your doctor may continue to increase your dose at monthly intervals if necessary.

For both types of injection, the maximum dose should not exceed 720UI per kg of body weight per week.

b)Maintenance of red blood cell levels

Maintenance dose: Once your red blood cell levels are acceptable, the dose is reduced to half the dose used to correct anemia. The weekly dose can be administered once a week, or divided into three or seven doses per week. If your red blood cell levels remain stable on a once-weekly regimen, you may switch to a once-every-two-weeks regimen. In this case, you may need to increase your dose.

Your doctor may adjust your doseevery one or two weeksuntil finding your individual maintenance dose.

Childrenwill start treatment following the same guidelines. In clinical trials, children usually needed higher doses of NeoRecormon (the smaller the child, the higher the dose).

Treatment with NeoRecormon is usually long-term treatment. However, it can be interrupted at any time if necessary.

• Anemia in premature infants

Injections are administered subcutaneously.

The initial doseis 250UI injected per kg of body weight, three times a week.

It is likely that premature infants who have already received a previous transfusion when starting treatment withNeoRecormonwill not benefit as much as non-transfused premature infants.

The recommended treatment duration is 6 weeks.

• Adults with anemia caused by cancer treated with chemotherapy

Injections are administered subcutaneously.

Your doctor may start treatment with NeoRecormon if your hemoglobin level is less than or equal to 10g/dl. After starting treatment, your doctor will maintain your hemoglobin level between 10 and 12g/dl.

The initial weekly doseis 30,000UI. This dose can be administered as a weekly injection, or divided into 3 to 7 injections per week.Your doctor will take regular blood samples. Based on the test results, your doctor may increase or decrease your dose or discontinue treatment. Hemoglobin levels will not exceed 12g/dl.

Treatment should continue until 4 weeks after completing chemotherapy.

The maximum doseshould not exceed 60,000UI per week.

• Patients donating their own blood before undergoing surgery

Injections are administered intravenously in 2 minutes, or subcutaneously.

The NeoRecormon dosewill depend on your condition, red blood cell levels, and the amount of blood you will donate before the procedure.

The dose calculated by your doctor is administered twice a week for 4 weeks. When you donate blood, you will receiveNeoRecormonat the end of the donation.

The maximum doseshould not exceed

• for intravenous injection: 1,600UI per kg of body weight per week
• for subcutaneous injections: 1,200UI per kg of body weight per week

If you inject too muchNeoRecormon

Do not increase the dose given by your doctor. If you think you have injected moreNeoRecormon than you should, contact your doctor. It is unlikely to be serious. Evenin the presence of high blood levels, no symptoms of intoxication have been observed.

If you forget to useNeoRecormon

If you have forgotten an injection or injected too little, tell your doctor.

Do not administer a double doseto compensate for missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

Side effects that may affect any patient

• Most patients (very common may affect more than 1 in 10 people) present low iron levels in the blood. Almost all patients must be treated with iron supplements during treatment with NeoRecormon.
• Rarely (may affect up to 1 in 1,000 people)have appearedallergic or skin reactionssuch as hives or urticaria or reactions at the injection site.
• Very rarely (may affect up to 1 in 10,000 people) have appeared severe forms of allergic reaction, especially after injection. These must be treated immediately. If you experienceshortness of breath or difficulty breathing; inflammation in the tongue, face, throat, or around the injection site; if you feel dizzy or faint or if you fall, call your doctor immediately.
• Very rarely (may affect up to 1 in 10,000 people) people experience flu-like symptoms, especially when starting treatment.These symptoms includefever, chills, headaches, limb pain, bone pain, and/or general discomfort. These reactions were usually mild or moderate and disappeared within hours or days.
• Severe skin eruptions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been observed with the administration of epoetins. These reactions may appear as red, circular patches with central blisters on the trunk, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms. Stop using NeoRecormon if you experience these symptoms and contact your doctor or seek medical attention immediately. See section 2.

Side effects in patients with chronic kidney disease (renal anemia)

• The mostcommonside effects (very common may affect more than 1 in 10 people)areincreased blood pressure, worsening of existing high blood pressure, and headaches. Your doctor should treatrhigh blood pressure with appropriate medications or temporarily interrupt treatment with NeoRecormon.
• If you haveheadaches, especially sudden, stabbing, migrainous, confusion, speech alteration, instability while walking, seizures, or convulsions, call your doctor immediately. They may be symptoms of extremely high blood pressure (hypertensive crisis), although blood pressure is usually normal or low. This symptomatology must be treated immediately.
• If you have low blood pressure or complications from the shunt, you may experience a shunt thrombosis(a blood clot in the vessel used to connect to the dialysis system).
• Very rarely (may affect up to 1 in 10,000 people), patients present elevated potassium or phosphate levelsin the blood. These can be treated by your doctor.
• Pure red cell aplasia (PRCA) caused by neutralizing antibodies has been observed during treatment with erythropoietin, including some isolated cases during treatment with NeoRecormon. PRCA means that the body either reduces or stops producing red blood cells. This causes severe anemia, among whose symptoms include unusual fatigue and lack of energy. If your body produces neutralizing antibodies, your doctor will interrupt the therapy with NeoRecormon, and determine the best course of action to treat your anemia.

Additional side effects in adults with cancer treated with chemotherapy

• Occasionally, it may causeincreased blood pressure and headaches. Your doctor may treat high blood pressure with medications.
• There has been an observedincrease in the incidence of blood clots.

Additional side effects in patients who donate their own blood before undergoing surgery

• There has been observeda slight increase in the incidence of blood clots.

Reporting of side effects

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

• Keep this medication out of the sight and reach of children.
• Do not use NeoRecormon after the expiration date that appears on the box and on the label.
• Store in refrigerator (between 2°C – 8°C).
• The syringe can be kept out of the refrigerator for a single period of up to 3 days at room temperature (not above 25°C).
• Keep the preloaded syringe in the outer packaging, to protect it from light.
• Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help to protect the environment.

Composition of NeoRecormon

• The active ingredient is epoetin beta. 1 pre-filled syringe contains500, 2,000, 3,000, 4,000, 5,000, 6,000, 10,000, 20,000 or 30,000UI(international units)of epoetin beta in0.3ml or 0.6ml of solution.
• The other components are:

urea, sodium chloride, polisorbate 20, monohydrate monosodium phosphate, dodecahydrate disodium phosphate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid and L-Phenylalanine and water for injection. (See section 2 "NeoRecormon contains phenylalanine and sodium").

Appearance of NeoRecormon and contents of the pack

NeoRecormon is a clear, colourless solution in a pre-filled syringe for injection.

NeoRecormon 500UI, 2,000UI, 3,000UI, 4,000UI, 5,000UI and 6,000UI: each pre-filled syringe contains 0.3ml of solution.

NeoRecormon 10,000UI, 20,000UI and 30,000UI: each pre-filled syringe contains 0.6ml of solution.

NeoRecormon is available in the following pack sizes:

NeoRecormon 500UI

1 pre-filled syringe with 1 needle (30G1/2) or

6 pre-filled syringes with 6 needles (30G1/2).

NeoRecormon 2,000UI, 3,000UI, 4,000UI, 5,000UI, 6,000UI, 10,000UI and 20,000UI

1 pre-filled syringe with 1 needle (27G1/2) or

6 pre-filled syringes with 6 needles (27G1/2).

NeoRecormon 30,000UI

1 pre-filled syringe with 1 needle (27G1/2) or

4 pre-filled syringes with 4 needles (27G1/2).

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG

Emil-Barell-Strasse 1

D-79639 Grenzach-Wyhlen

Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Last update of the summary of product characteristics

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

NeoRecormon pre-filled syringe

Instructions for use

The following instructions explain how to administer a NeoRecormon injection. Make sure to read, understand and follow the instructions for use as well as the summary of product characteristics before injecting NeoRecormon. The healthcare professional will show you how to prepare and inject NeoRecormon correctly before using it for the first time.

Do not inject yourself unless you have received training. Consult a healthcare professional if you need more training.

Always follow all the instructions in these instructions for use, as they may differ from your experiences. These instructions will minimize risks such as accidental needlestick and prevent misuse.

NeoRecormon can be administered in two ways, your doctor will decide which method is suitable for you:

• Intravenous administration (in the vein or venous access), only to be performed by healthcare professionals.
• Subcutaneous administration (under the skin).

Before starting to use

• Do not remove the needle cap until you are ready to inject NeoRecormon.
• Do not try to remove the syringe at any time.
• Do not use the syringe if it has been dropped or damaged.
• Do not leave the syringe unattended.
• Keep the syringe and needle, as well as the puncture-proof container or sharp object container, out of the reach of children.
• If you have any questions, contact a healthcare professional.

Instructions for storage

• Store the (pre-filled syringe(s) and needle(s) in the original packaging and keep it in the refrigerator at a temperature of 2 °C to 8 °C.
• Keep the syringe and needle out of direct sunlight.
• Do not freeze.
• Do not use if the syringe has been frozen.
• Always keep the syringe and needle dry.

Materials needed to administer the injection

Included in the pack:

• Pre-filled syringe(s) of NeoRecormon.

• Needle(s) for injection (27G or 30G) (depending on the prescribed dose of the medicinal product) with safety guard (used for preparation, dose adjustment and injection of the medicinal product).

Nota: Each pack of NeoRecormon contains 1 syringe / 1 needle, 4 syringes / 4 needles or 6 syringes / 6 needles.

• Instructions for use and summary of product characteristics.

Not included in the pack:

• 1 alcohol wipe.

• 1 sterile dry gauze.

• 1 puncture-proof container or sharp object container for safe disposal of the rubber cap, needle cap and used syringe.

Preparing for the injection

1. Find a well-lit, clean and flat work surface.

• Take the carton with the (pre-filled syringe(s) and needle(s) out of the refrigerator

1. Check the packaging, perforations on the front and the seal. Also check the expiry date.

• Do not use if the expiry date has passed, or if the packaging appears to have been tampered with. In this case, continue with step 20 and contact a healthcare professional.
• Do not use if the perforations or seal are broken. In this case, go to step 20 and contact a healthcare professional.

1. Open the packaging by pushing through the perforation around the seal.

1. Take out a syringe from the carton and a needle from the needle box. Be careful when taking out the syringe. Always hold the syringe as shown in the image below.

• Do not put the carton upside down to take out the syringe.
• Do not handle the syringe by holding the plunger or needle cap.

Observation:If you have a multipack, put the carton with the (pre-filled syringe(s) and needle(s) left in the refrigerator.

1. Inspect the syringe and needle closely

• Check that the syringe and needle are not damaged.Do not use the syringe if it has been dropped or if any part of the syringe appears to be damaged.
• Check the expiry date on the syringe and needle.Do not use the syringe or needle if the expiry date has passed.
• Check the liquid in the syringe. The liquid should be clear and colourless.Do not use the syringe if the liquid is cloudy, discoloured or has particles.

1. Place the syringe on a clean and flat surface.

• Leave the syringe aside for 30 minutes to reach room temperature. Leave the needle cap on while it is warming up.
• Do not accelerate the warming process in any way, and do not put the syringe in a microwave or in warm water.

Observation:If the syringe does not reach room temperature, this may make the injection uncomfortable and make it difficult to push the plunger.

1. Attach the needle to the syringe.

• Remove the needle from its ampoule.
• Remove the rubber cap from the end of the syringe (A).
• Dispose of the rubber cap immediately in a puncture-proof container or sharp object container.
• Do not touch the tip of the syringe.
• Do not push or pull the plunger.
• Hold the syringe by the barrel and push the needle over the syringe (B).
• Turn it gently until it is fully attached (C).

A)

B)

C)

1. Place the syringe on a clean and flat surface until it is ready for use.

1. Wash your hands with soap and water.

1. Choose an injection site:

• The recommended injection sites are the upper part of your thigh or the lower part of your abdomen below the navel.Do not inject within 5 cm (2 inches) directly around your navel.
• Choose a different injection site for each new injection.
• Do not inject in moles, scars, haematomas or areas where the skin is sensitive, red, hard or not intact.
• Do not inject into a vein or muscle.

1. Clean the injection site with an alcohol wipe and let it dry for 10 seconds.

• Do not ventilate or blow on the clean area.
• Do not touch the injection site again before putting the injection.

Subcutaneous injection administration

1. Remove the safety guard from the needle towards the syringe barrel.

1. Hold the syringe and needle firmly in place and carefully remove the needle cap from the syringe. Use the syringe within 5 minutes after removing the needle cap; otherwise, the needle may become blocked.

• Do not hold the plunger while removing the needle cap.
• Do not touch the needle after removing the needle cap.
• Do not re-cap the needle.
• Do not straighten the needle if it is bent or damaged.

Dispose of the needle cap immediately in the sharp object container.

1. Hold the syringe with the needle pointing upwards. Remove any large air bubbles by gently tapping the syringe barrel with your fingers until the air bubbles rise to the top of the syringe. Then, slowly push the plunger upwards to push the air bubbles out of the syringe.

1. Adjust the prescribed dose by slowly pushing the plunger.

1. Pinch the injection site and insert the needle completely at an angle of 45 ° to 90 ° with a quick and firm action.

• Do not touch the plunger while inserting the needle into the skin.
• Do not insert the needle through clothing.

Once you have inserted the needle, release the pinch and hold the syringe firmly in place.

1. Inject the prescribed dose slowly by gently pushing the plunger until the end.

• Remove the needle and syringe from the injection site at the same angle that it was inserted.

After the injection

1. You may experience some bleeding at the injection site. You can press a sterile dry gauze over the injection site.Do not rub the injection site.

• If necessary, you can cover the injection site with a small bandage.
• In case of contact with the medication, wash the area that came into contact with the medication with water.

1. Push the safety guard forward 90°, moving it away from the syringe barrel (A).

Hold the syringe with one hand, and press the safety guard against a flat surface with a firm and quick motion until you hear a "click" (B).

• If you do not hear a click, observe that the needle is completely covered by the safety guard.
• Keep your fingers behind the safety guard and away from the needle at all times.

A)

B)

1. Put the used syringe in a puncture-proof container immediately after use.

• Do not try to remove the used needle from the used syringe.
• Do not re-cap the needle.
• Do not throw the syringe in your household waste.

Important:Always keep the puncture-proof container out of the reach of children.

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Instructions for use for intravenous injection, intended only for healthcare professionals

The following instructions for use explain how to administer an intravenous injection of NeoRecormon. Make sure to read, understand and follow the instructions for use as well as the summary of product characteristics before injecting NeoRecormon.

Intravenous injection administration (only for healthcare professionals).

Preparing for the injection: follow steps 1 to 9 of subcutaneous injection administration (above).

1. Choose a vein. Change the vein for each injection to prevent pain at one point.

• Do not inject into a red or swollen area.
• Do not inject into a muscle.

Clean the skin above the vein with an alcohol wipe and let it dry.

• Do not ventilate or blow on the clean area.
• Do not touch the injection site again before putting the injection.

1. Prepare the syringe and needle: follow steps 12 to 15 of subcutaneous injection administration (above).

1. Insert the needle into the vein.

• Do not hold or push the plunger while inserting the needle.

1. Inject the prescribed dose slowly by gently pushing the plunger until the end. Remove the needle and syringe from the injection site at the same angle that it was inserted.

After the injection, follow steps 18 to 20 of subcutaneous injection administration (above).

Intravenous injection administration through the injection port (only for healthcare professionals).Preparing for the injection: follow steps 1 to 9 of subcutaneous injection administration (above).

1. Clean the skin around the injection site with an alcohol wipe and let it dry.

Clean the injection site according to the device manufacturer's instructions.

• Do not ventilate or blow on the clean area.
• Do not touch the injection site again before putting the injection.

1. Prepare the syringe and needle: follow steps 12 to 15 of subcutaneous injection administration (above)

1. Insert the needle into the injection site (follow the device manufacturer's instructions for venous access).

• Do not hold or push the plunger while inserting the needle.

1. Inject the prescribed dose slowly by gently pushing the plunger until the end. Remove the needle and syringe from the injection site at the same angle that it was inserted.

After the injection, follow steps 18 to 20 of subcutaneous injection administration (above).