Neorecormon

Package leaflet: Information for the user

NeoRecormon 500 IU, 2000 IU, 3000 IU, 4000 IU, 5000 IU, 6000 IU, 10000 IU, 20000 IU, 30000 IU

solution for injection in pre-filled syringe
epoetin beta
Please read carefully this leaflet before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What NeoRecormon is and what it is used for
2. What you need to know before using NeoRecormon
3. How to use NeoRecormon
4. Possible side effects
5. How to store NeoRecormon
6. Contents of the pack and other information

1. What NeoRecormon is and what it is used for

NeoRecormon is a clear, colourless solution for injection under the skin ( subcutaneously ) or into a vein ( intravenously ). It contains a hormone called epoetin beta , which stimulates the production of red blood cells. Epoeitin beta is produced using a special genetic technique and acts exactly like the natural hormone erythropoietin.
Contact your doctor if you do not feel better or if you feel worse.
NeoRecormon is indicated only for:

• the treatment of symptomatic anaemia caused by chronic renal failure (renal anaemia) in patients undergoing dialysis or not yet on dialysis;
• the prevention of anaemia in premature infants (with a body weight from 750 to 1500 g and a gestational age of less than 34 weeks);
• the treatment of anaemia with related symptoms in adult patients with tumours who are undergoing chemotherapy ;
• the treatment of patients who donate their own blood prior to surgical procedures. Epoeitin beta injections increase the amount of blood that can be collected from the body before surgery and re-transfused during or after the operation (this is known as autologous transfusion ).

2. What you need to know before using NeoRecormon

Do not use NeoRecormon:

• if you are allergic (hypersensitive) to epoetin beta or to any of the other ingredients of this medicine (listed in section 6);
• if you have uncontrolled blood pressure problems;
• if you are donating blood prior to surgery and:
• you have had a heart attack or stroke within the previous month before treatment;
• you suffer from unstable angina pectoris – recent or worsening chest pain;
• you are at risk of developing blood clots in the veins ( deep vein thrombosis ) – for example, if you have previously experienced blood clots.

If any of the above conditions apply, or might apply, inform your doctor immediately.
Warnings and precautions:
Talk to your doctor before using NeoRecormon

• If your child requires treatment with NeoRecormon, he/she must be closely monitored for potential risks to the eyes.
• if your anemia does not improve following treatment with epoetin;
• if you have low levels of certain B vitamins (folic acid or vitamin B12);
• if you have very high levels of aluminium in your blood;
• if you have a high platelet count;
• if you have chronic liver disease;
• if you have epilepsy;
• if you have developed antibodies against erythropoietin and developed pure red cell aplasia ( reduced or absent production of red blood cells) during previous exposure to any erythropoiesis-stimulating agent. In this case, you must not switch to treatment with NeoRecormon.

Exercise particular caution with other products that stimulate red blood cell production:
NeoRecormon belongs to a group of products that stimulate red blood cell production, such as the human protein erythropoietin. Your doctor must always record the specific product you are using.
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with epoetin treatment.
Stevens-Johnson syndrome and toxic epidermal necrolysis may initially appear as red, target-like spots or circular patches, often with central blisters, typically on the trunk. Mouth, throat, nose, genital, and eye ulcers (red, swollen eyes) may also occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and life-threatening complications.
If you develop a severe rash or any of these skin symptoms, stop taking NeoRecormon and contact your doctor immediately.
Special warnings:
During treatment with NeoRecormon
If you have chronic renal failure, and particularly if you do not respond adequately to NeoRecormon, your doctor will monitor your NeoRecormon dose carefully, because if you do not respond to treatment, repeatedly increasing the NeoRecormon dose may increase the risk of heart or blood vessel problems and could increase the risk of myocardial infarction, stroke, and death.
If you have a tumour, you should be aware that NeoRecormon can act as a growth factor for blood cells and, under certain circumstances, may have negative effects on the tumour. Depending on your individual situation, a blood transfusion may be preferable. Discuss this with your doctor.
If you have nephrosclerosis and are not undergoing dialysis, your doctor will decide whether treatment is appropriate for you, as it cannot be completely ruled out that treatment might accelerate the progression of kidney disease.
Your doctor may regularly prescribe blood tests to monitor:

• potassium levels. If your potassium levels are high or increasing, your doctor may reconsider your treatment;
• platelet count. Platelet counts may increase from mild to moderate during epoetin treatment, which could lead to changes in blood clotting.

If you have kidney disease and are undergoing haemodialysis, your doctor may adjust your dose of heparin to prevent blockage of the dialysis system.
If you have kidney disease, are undergoing haemodialysis, and are at risk of shunt thrombosis, blood clots (thrombosis) may form in your shunt (the blood vessel used to connect to the dialysis system). Your doctor may prescribe acetylsalicylic acid or modify the shunt.
If you are donating blood prior to surgery, your doctor must:

• ensure you are eligible to donate blood, especially if you weigh less than 50 kg;
• confirm you have sufficient red blood cells (haemoglobin levels of at least 11 g/dl);
• ensure that a single blood donation does not exceed 12% of your total blood volume.

Do not misuse NeoRecormon
Misuse of NeoRecormon by healthy individuals may cause an increase in blood cells and consequently make the blood thicker. This may in turn lead to serious, potentially life-threatening complications affecting the heart or blood vessels.
Other medicines and NeoRecormon
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Pregnancy, breast-feeding and fertility
Experience with NeoRecormon in pregnant or breast-feeding women is limited. Consult your doctor or pharmacist before taking any medicine.
Available evidence indicates that NeoRecormon does not impair fertility in animals. The potential risk in humans is unknown.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
NeoRecormon contains phenylalanine and sodium
This medicine contains phenylalanine and may be harmful to patients with phenylketonuria.
If you have phenylketonuria, discuss this with your doctor regarding treatment with NeoRecormon.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.

3. How to use NeoRecormon

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will use the lowest effective dose to control the symptoms of anaemia.
If you do not respond adequately to NeoRecormon, your doctor will check the administered dose and inform you if it is necessary to adjust the dosage of the medicine.
Treatment must be initiated under the supervision of your doctor. Subsequent injections may be given by your doctor or, after proper training, you may self-inject NeoRecormon (see instructions at the end of this leaflet).
NeoRecormon can be injected under the skin into the abdomen, arm, or thigh, or into a vein. Your doctor will decide which route is most appropriate for you.
Your doctor will perform regular blood tests to monitor whether the anaemia is responding to treatment by measuring haemoglobin levels.

Dosage of NeoRecormon
The dose of NeoRecormon depends on the condition being treated, the route of administration (subcutaneous or intravenous), and your body weight. Your doctor will determine the exact dose for you.
Your doctor will use the lowest effective dose to control symptoms of anaemia.
If you do not respond adequately to NeoRecormon, your doctor will check the dose you are receiving and inform you if any changes are needed.

• Symptomatic anaemia caused by chronic renal failure
  Injections are given either subcutaneously or intravenously. If the solution is injected intravenously, the injection should last about 2 minutes. For example, patients on haemodialysis will receive the injection via the arteriovenous access at the end of dialysis. For patients not on haemodialysis, injections are usually given subcutaneously.

Treatment with NeoRecormon is divided into two phases:
a) Correction of anaemia
Initial dose for subcutaneous injections: 20 IU 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 inadequate, may increase the dose up to 40 IU/kg per injection, three times a week. If necessary, your doctor may continue to increase the dose at monthly intervals.
The weekly dose may also be divided into daily doses.
Initial dose for intravenous injections: 40 IU 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 inadequate, may increase the dose up to 80 IU/kg per injection, three times a week. If necessary, your doctor may continue to increase the dose at monthly intervals.
For both types of injection, the maximum dose must not exceed 720 IU per kg of body weight per week.
b) Maintenance of adequate red blood cell levels
Maintenance dose: Once red blood cell levels have reached an acceptable level, the dose is reduced to half of that used for correction of anaemia. The weekly dose may be given once weekly or divided into three or seven doses per week. If your red blood cell level remains stable with weekly administration, the dose may be extended to once every two weeks. In this case, dose increases may be required.
Every one or two weeks, your doctor may adjust the dosage to determine your individual maintenance dose.
Children will start treatment following the same principles. In clinical studies, children generally required higher doses of NeoRecormon (the younger the child, the higher the dose).
Treatment with NeoRecormon is usually long-term. However, if necessary, it can be stopped at any time.

• Anaemia in premature infants

Injections are given subcutaneously.
Initial dose: 250 IU per injection per kg of the infant’s body weight, three times a week.
Premature infants who have received blood transfusions before starting NeoRecormon treatment are unlikely to benefit as much as those who have not been transfused.
The recommended duration of treatment is 6 weeks.

• Adults with symptomatic anaemia undergoing chemotherapy for cancer

Injections are given subcutaneously.
Your doctor may start NeoRecormon treatment if your haemoglobin level is ≤10 g/dL.
After starting therapy, your doctor will aim to maintain your haemoglobin level between 10 and 12 g/dL.
Initial weekly dose: 30,000 IU. This may be given as a single weekly injection or divided into 3–7 weekly injections. Your doctor will take regular blood samples and may increase or reduce the dose, or stop treatment, based on test results. Haemoglobin levels must not exceed 12 g/dL.
Treatment should continue for up to 4 weeks after completion of chemotherapy.
Maximum weekly dose: must not exceed 60,000 IU.

• Patients donating blood prior to surgery

Injections are given intravenously over 2 minutes or subcutaneously.
The dose of NeoRecormon depends on your health status, red blood cell levels, and the amount of blood to be donated before surgery.
The dose calculated by your doctor will be administered twice weekly for 4 weeks. When you donate blood, you will receive NeoRecormon at the end of the donation session.
Maximum dose: must not exceed

• for intravenous injections: 1600 IU per kg of body weight per week;
• for subcutaneous injections: 1200 IU per kg of body weight per week.

If you use more NeoRecormon than you should
Do not increase the dose prescribed by your doctor. If you think you have injected more NeoRecormon than prescribed, contact your doctor. It is unlikely to be a serious problem. No symptoms of poisoning have been observed, even at very high blood levels.
If you forget to use NeoRecormon
If you have forgotten to give an injection or have injected too low a dose, contact your doctor.
Do not inject a double dose to make up for a missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects that may occur in any patient

• In many patients (very common side effects may affect more than 1 in 10 people), a reduction in iron levels in the blood occurs. Almost all patients need to be treated with iron supplements during therapy with NeoRecormon.
• Rarely (side effects may affect up to 1 in 1,000 people), allergic reactions or skin reactions such as rash or hives, itching, or reactions around the injection site have occurred.
• Very rarely (side effects may affect up to 1 in 10,000 people), a severe allergic reaction has occurred, especially shortly after injection, a condition that must be treated immediately. If you notice unusual wheezing or have difficulty breathing; swelling (edema) of the tongue, face, or throat, or swelling around the injection site; if you feel confused or feel you might faint or collapse, call your doctor immediately.
• Very rarely (side effects may affect up to 1 in 10,000 people), patients have experienced flu-like symptoms, especially at the beginning of treatment. These symptoms include fever, chills, headache, limb pain, bone pain and/or general malaise. These reactions have usually been mild to moderate in intensity and disappeared within a few hours or days.
• Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with epoetin therapy. These may appear as red, target-like spots or circular patches, often with central blisters on the trunk, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms. Stop using NeoRecormon and contact your doctor immediately if you develop any of these symptoms. See also section 2.

Additional side effects in patients with chronic renal failure (renal anaemia)

• Increased blood pressure, worsening of pre-existing hypertension and headache are the most common side effects (very common side effects may affect more than 1 in 10 people). Your doctor will monitor your blood pressure regularly, especially at the beginning of therapy. Your doctor may treat hypertension with medications or temporarily discontinue NeoRecormon therapy.
• Call your doctor immediately if you experience headache, especially sudden, severe and migraine-like, confusion, speech disturbances, unsteady gait, or seizures. These may be signs of very high blood pressure (hypertensive crisis), even if blood pressure is usually normal or low. This condition must be treated immediately.
• In case of hypotension (low blood pressure) or shunt complications, you may be at risk of shunt thrombosis (a blood clot in the blood vessel used for connection to the dialysis system).
• Very rarely (side effects may affect up to 1 in 10,000 people), patients have had elevated levels of potassium or phosphate in the blood. These can be treated by your doctor.
• Pure red cell aplasia (PRCA) caused by neutralizing antibodies has been observed during erythropoietin therapy, including isolated cases during NeoRecormon therapy. Pure red cell aplasia means that the body has stopped or reduced production of red blood cells. This causes severe anaemia, the symptoms of which include unusual tiredness and lack of energy. If your body produces neutralizing antibodies, your doctor will stop your NeoRecormon therapy and determine the best treatment for managing your anaemia.

Additional side effects in adults undergoing chemotherapy for cancer

• Occasionally, increased blood pressure and headache may occur. Your doctor may treat hypertension with medications.
• An increased risk of blood clots has been observed.

Additional side effects in patients donating blood prior to surgery

• A slight increase in the risk of blood clots has been observed.

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NeoRecormon

• Keep this medicine out of the sight and reach of children.
• Do not use NeoRecormon after the expiry date stated on the carton and label.
• Store in a refrigerator (2°C - 8°C).
• The pre-filled syringe may be removed from the refrigerator and kept at room temperature for a single period not exceeding 3 days (but not above 25°C).
• Keep the pre-filled syringe in its outer packaging to protect it from light.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer require. This will help protect the environment.

6. Package contents and other information

What NeoRecormon contains

• The active substance is epoetin beta. One pre-filled syringe contains 500, 2000, 3000, 4000, 5000, 6000, 10,000, 20,000 or 30,000 IU (international units) of epoetin beta in 0.3 ml or 0.6 ml of solution.
• The excipients are urea, sodium chloride, polysorbate 20, monobasic sodium phosphate dihydrate, dibasic sodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-leucine, L-isoleucine, L-threonine, L-glutamic acid and L-phenylalanine, and water for injections (see section 2 “NeoRecormon contains phenylalanine and sodium”).

Description of the appearance of NeoRecormon and contents of the pack
NeoRecormon is an injectable solution in a pre-filled syringe.
The solution is colourless and ranges from clear to slightly opalescent.
NeoRecormon 500 IU, 2000 IU, 3000 IU, 4000 IU, 5000 IU and 6000 IU: each pre-filled syringe contains 0.3 ml of injectable solution.
NeoRecormon 10,000 IU, 20,000 IU and 30,000 IU: each pre-filled syringe contains 0.6 ml of injectable solution.
NeoRecormon is supplied in the following pack sizes:
NeoRecormon 500 IU
1 pre-filled syringe with 1 needle (30G1/2) or
6 pre-filled syringes with 6 needles (30G1/2).
NeoRecormon 2000 IU, 3000 IU, 4000 IU, 5000 IU, 6000 IU, 10,000 IU and 20,000 IU
1 pre-filled syringe with 1 needle (27G1/2) or
6 pre-filled syringes with 6 needles (27G1/2).
NeoRecormon 30,000 IU
1 pre-filled syringe with 1 needle (27G1/2) or
4 pre-filled syringes with 4 needles (27G1/2).
Not all 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 on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Instructions for Use

The instructions below describe how to administer a NeoRecormon injection. Before injecting NeoRecormon, make sure to read, understand, and follow these Instructions for Use and the Package Leaflet. A healthcare professional must show you how to properly prepare and inject NeoRecormon before you use it for the first time.
Do not self-inject the medicine unless you have received adequate training. If you need further information, consult your healthcare professional.
Always follow all instructions provided in these Instructions for Use, as they may differ from your previous experience. These instructions will minimize risks, such as accidental needlestick injury and prevent incorrect use.
NeoRecormon can be administered in 2 ways; your doctor will decide which method is most appropriate for you:

• Intravenous administration (into a vein or via a venous port), which must be performed only by healthcare professionals.
• Subcutaneous administration (under the skin).

Before Starting

• Do not remove the needle cap until you are ready to inject NeoRecormon.
• Do not attempt to open the syringe.
• Do not reuse the same syringe.
• Do not use if the syringe has been dropped or appears damaged.
• Do not leave the syringe unattended.
• Keep the syringe, needle, and puncture-resistant sharps container out of the reach of children.
• If you have any questions, contact your healthcare professional.

Storage Instructions

• Keep unused syringes and needles in their original packaging and store them in the refrigerator at 2°C–8°C.
• Protect the syringe and needle from direct sunlight.
• Do not freeze.
• Do not use if the syringe has been frozen.
• Always keep the syringe and needle dry.

Materials Required for Injection
Included in the Package:

• Pre-filled syringe(s) of NeoRecormon.

Glass barrel
Plunger
Rubber stopper

• Injection needle(s) (27G or 30G) (depending on prescribed dosage), with safety shield (for preparation, dose setting, and injection).

Safety shield
Needle cap
NB: each NeoRecormon package contains either 1 syringe/1 needle, 4 syringes/4 needles, or 6 syringes/6 needles.

• Instructions for Use and Package Leaflet
  Not included in the package:
• 1 alcohol swab.
• 1 dry sterile gauze pad.
• 1 puncture-resistant sharps container for safe disposal of the rubber stopper, needle cap, and used syringe.

Preparing the Injection
1 Choose a clean, flat, well-lit work surface.

• Remove the package containing the syringe(s) and corresponding needle(s) from the refrigerator.

2 Check the package, the perforation on the front of the box, and the seal. Also check the expiration date.

• Do not use if the expiration date has passed or if the package appears damaged. In this case, go to step 20 and contact your healthcare professional.
  ● Do not use if the perforation or seal is damaged. In this case, go to step 20 and contact your healthcare professional.

3 Open the package by pressing along the perforation around the seal.
4 Remove one syringe from the package and one needle from its box. Handle the syringe carefully. Always hold the syringe as shown in the image.

• Do not turn the package upside down to remove the syringe.
• Do not handle the syringe by touching the plunger or the needle cap.

Caution: If you have a multi-pack, return the box containing remaining syringes and needles to the refrigerator.

5 Carefully inspect the syringe and needle.

• Check the syringe and needle for any damage. Do not use the syringe if it has been dropped or if any component appears damaged.
• Check the expiration date printed on the syringe and needle. Do not use the syringe or needle if the expiration date has passed.
• Check the liquid inside the syringe. The solution should be clear and colourless. Do not use the syringe if the liquid is cloudy, discoloured, or contains particles.

6 Place the syringe on a clean, flat surface.

• Allow the syringe to sit for 30 minutes so it reaches room temperature naturally. During this time, leave the needle cap on the syringe.
• Do not accelerate the warming process in any way, and do not place the syringe in a microwave or warm water.
  Caution: Failure to allow the syringe to reach room temperature may make the injection uncomfortable and make it difficult to push the plunger.

7 Attach the needle to the syringe.

• Remove the needle from its blister pack.
• Remove the rubber stopper from the end of the syringe (A).
• Immediately dispose of the rubber stopper in a puncture-resistant sharps container.
• Do not touch the tip of the syringe.
• Do not push or pull the plunger.
• Hold the syringe barrel and attach the needle to it (B).
• Gently rotate until the needle is securely fixed (C).

A) Rubber stopper Rubber stopper

B)

C)
8 Place the syringe on a clean, flat surface until ready for use.
9 Wash your hands thoroughly with soap and water.
10 Choose an injection site:

• Recommended sites are the upper thigh or the lower abdominal area, below the navel.
• Do not inject within a 5 cm radius directly surrounding the navel.
• Select a different site for each new injection.
• Do not inject into moles, scars, bruises, or areas where the skin is painful, red, hardened, or broken.
• Do not inject into a vein or muscle.

= injection sites
11 Clean the injection site with an alcohol swab and allow it to dry for 10 seconds.

• Do not fan or blow on the cleaned area.
• Do not touch the injection site again before administering the injection.

Subcutaneous Administration of Injection
12 Slide the safety shield away from the needle in the direction toward the syringe barrel.

13 Firmly hold the syringe and needle at the junction point and carefully remove the needle cap. Use the syringe within 5 minutes after removing the cap to prevent the needle from becoming blocked.

• Do not touch the plunger while removing the needle cap.
• Do not touch the needle after removing the cap.
• Do not recap the needle.
  ● Do not straighten the needle if it is bent or damaged. Immediately dispose of the needle cap in a sharps container.

14 Hold the syringe with the needle pointing upward. Remove larger air bubbles by gently tapping the syringe barrel with your fingers until the bubbles rise to the top. Then slowly press the plunger to expel the air bubbles from the syringe.

15 Adjust the syringe content to the prescribed dose by slowly pressing the plunger.

16 Pinch the selected injection site and insert the needle fully at an angle of 45–90° with a quick, firm motion.

• Do not touch the plunger while inserting the needle into the skin.
• Do not insert the needle through clothing. After inserting the needle, release the skin and hold the syringe firmly in place.

17 Inject the prescribed dose slowly by gently pressing the plunger all the way down.

• Withdraw the needle and syringe from the injection site, maintaining the same angle used during insertion.

After the Injection
18 Mild bleeding at the injection site may occur. You may apply a dry sterile gauze pad to the site. Do not rub the injection site.

• If needed, you may cover the injection site with a light bandage.
• If the medicine comes into contact with the skin, rinse the affected area with water.

19 Push the safety shield forward by 90°, away from the syringe barrel (A). While holding the syringe with one hand, press the safety shield downward onto a flat surface with a quick, firm motion until you hear a "click" (B).

• If you do not hear a "click", check that the needle is completely covered by the safety shield.
• Always keep your fingers behind the safety shield and away from the needle.

A)

B)
20 Immediately place the used syringe into a sharps disposal container after use.

• Do not attempt to remove the used needle from the syringe.
• Do not recap the used needle.
• Do not dispose of (discard) the syringe in household waste.
  Important: Always keep the sharps disposal container out of the reach of children.

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Instructions for Intravenous Administration – For Healthcare Professionals Only
The instructions below describe how to administer an intravenous injection of NeoRecormon. Before injecting NeoRecormon, ensure that you have read, understood, and followed these Instructions for Use and the

Package leaflet

Intravenous injection administration (for healthcare professional only)
Preparation of the injection: follow steps 1 to 9 for subcutaneous administration (see above).
10 Select a vein. Change the vein with each injection to avoid site discomfort.

• Do not administer the injection into red or swollen areas.
• Do not administer the injection into muscles. Disinfect the skin over the vein using an alcohol swab and allow it to dry.
• Do not fan or blow on the disinfected area.
• Do not touch the injection site again before administering the injection.

11 Prepare the syringe and needle: follow steps 12 to 15 for subcutaneous administration (see above).
16 Insert the needle into the vein.

• Do not hold or press the plunger during needle insertion. 17 Slowly inject the prescribed dose by gently pushing the plunger fully down. Remove the needle and syringe from the injection site, maintaining the same angle used during insertion.

After injection, follow steps 18 to 20 for subcutaneous administration (see above).
Intravenous injection administration via a dedicated port (for healthcare professional only)
Preparation of the injection: follow steps 1 to 9 for subcutaneous administration (see above).
10 Disinfect the skin over the injection port using an alcohol swab and allow it to dry.
Disinfect the injection port according to the manufacturer's instructions.

• Do not fan or blow on the disinfected area.
• Do not touch the injection site again before administering the injection.

11 Prepare the syringe and needle: follow steps 12 to 15 for subcutaneous administration (see above).
16 Insert the needle into the injection port (follow the injection port manufacturer's instructions).

• Do not hold or press the plunger during needle insertion. 17 Slowly inject the prescribed dose by gently pushing the plunger fully down. Remove the needle and syringe from the injection port, maintaining the same angle used during insertion.

After injection, follow steps 18 to 20 for subcutaneous administration (see above).