Ruconest

Package leaflet: Information for the patient

Ruconest 2100 Units Powder for solution for injection

conestat alfa
Please read this leaflet carefully 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.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet:

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

1. What Ruconest is and what it is used for

The active substance in Ruconest is conestat alfa. Conestat alfa is a recombinant (not derived from blood) form of human C1 inhibitor protein (rhC1-INH).
Ruconest is indicated for the treatment of adult, adolescent, and paediatric patients (aged 2 years and older) with a rare inherited blood disorder called hereditary angioedema (HAE). In patients with this condition, the C1 inhibitor protein is deficient, which can lead to recurrent attacks of swelling, abdominal pain, breathing difficulties, and other symptoms.
Administration of Ruconest aims to correct the deficiency of C1 inhibitor protein and thereby reduce the symptoms of an acute HAE attack.

2. What you need to know before using Ruconest

Do not use Ruconest

• If you are or think you may be allergic to rabbit.
• If you are allergic to conestat alfa or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before using Ruconest.
If you experience allergic reactions, such as hives, rash, itching, dizziness, wheezing, breathing difficulties, or swelling of the tongue after taking Ruconest, seek immediate medical attention at an emergency department so that symptoms of the allergic reaction can be treated urgently.
Before starting treatment with Ruconest, it is important to inform your doctor if you have or have had blood clotting problems (thrombotic events). In such cases, you will be closely monitored.
Hypersensitivity reactions cannot be ruled out, and these reactions may present with symptoms similar to those of angioedema attacks.

Children and adolescents
Do not administer this medicine to children under 2 years of age. Ruconest has not been studied in children under 5 years of age. Your doctor will decide whether or not treatment with Ruconest is appropriate for the child. Additionally, further monitoring for signs of allergic reactions is required throughout the administration period.

Other medicines and Ruconest
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
If you are receiving tissue plasminogen activator as acute treatment to prevent blood clots, you must not be treated with Ruconest at the same time.

Pregnancy and breastfeeding
Use of Ruconest is not recommended during pregnancy and breastfeeding.
If you are planning a pregnancy, consult your doctor before using this medicine.

Driving and using machines
Do not drive or operate machinery if you experience dizziness or headache after receiving Ruconest.

Ruconest contains sodium (19.5 mg per vial)
This should be taken into consideration for patients on a low-sodium diet.

3. How to use Ruconest

Treatment with Ruconest must be initiated by a physician experienced in the diagnosis and treatment
of hereditary angioedema.
Ruconest will be administered to you directly into a vein over a period of approximately 5 minutes by a physician or
a nurse. The dose, up to 2 vials, will be calculated based on your body weight.
A single dose is often sufficient. Your doctor may decide to administer an additional dose if symptoms have not improved after 120 minutes (for adults and adolescents) or 60 minutes (for children). No more than two doses should be administered within 24 hours.
The instructions for use are clearly described in the informational material available to the physician and are reported here.
If you have any questions about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If your symptoms worsen and/or you develop a rash, tingling, breathing difficulties, or swelling of the face or tongue, consult your doctor immediately. This could indicate that you have developed an allergy to Ruconest.
Some side effects may occur during treatment with Ruconest:
Common: may affect from 1 to 10 patients

• Nausea

Uncommon: may affect from 1 to 100 patients

• Abdominal pain, diarrhoea
• Tingling, prickling or numbing sensations in the mouth
• Headache, dizziness
• Reduced sense of touch or sensation in the skin or limbs
• Throat irritation
• Hives (urticaria)
• Swelling of the ears and surrounding area
• Allergic shock

Not known: frequency not known

• Hypersensitivity reactions

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ruconest

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and
on the label of the vial after the words "Exp./EXP". The expiry date refers to the last
day of that month.
Do not store above 25°C.
Keep in the original packaging to protect the medicine from light.
Before administration, Ruconest must be reconstituted with water for injections by healthcare professionals.
Once reconstituted, the product should be used immediately.
Do not use this medicine if the solution has changed colour or contains particles.

6. Package contents and other information

What Ruconest contains
The active substance is conestat alfa. Each vial contains 2100 units (U) of conestat alfa, equivalent to
2100 units in 14 ml after reconstitution, or a concentration of 150 units/ml.
The other components are: sucrose, sodium citrate (E331), and citric acid.

Description of the appearance of Ruconest and contents of the pack
Ruconest is a single glass vial containing a white to off-white powder for injectable solution. After
dissolving the powder in water for injections, the solution is clear and colourless.
Ruconest is supplied in a cardboard package containing one vial.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pharming Group N.V.
Darwinweg 24
2333 CR Leiden
The Netherlands

Manufacturer:
Pharming Technologies B.V.
Darwinweg 24
2333 CR Leiden
The Netherlands

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

The following information is intended for healthcare professionals only:

DOSAGE AND METHOD OF ADMINISTRATION
Dosage
Patients with body weight up to 84 kg

• An intravenous injection of 50 U/kg body weight

Patients with body weight of 84 kg or more

• An intravenous injection of 4200 U (two vials).

In most cases, a single dose of Ruconest is sufficient to treat an acute attack of angioedema.
If there is an insufficient clinical response, an additional dose may be administered (50 U/kg body weight up to 4200 U).
No more than two doses should be administered within 24 hours.

Dose calculation
Determine the patient's body weight.

Patients with body weight up to 84 kg

• For patients weighing up to 84 kg, calculate the required volume to be administered using the following formula:

Volume to administer (ml) = body weight (kg) × 50 (U/kg) / 150 (U/ml)

Patients with body weight of 84 kg or more

• For patients weighing 84 kg or more, the required volume to be administered is 28 ml, corresponding to 4200 U (2 vials).

Reconstitute each vial with 14 ml of water for injections (see section on Reconstitution).
The reconstituted solution in each vial contains 2100 U of conestat alfa at a concentration of 150 U/ml.
The required volume of reconstituted solution should be administered by slow intravenous injection over approximately 5 minutes.

SPECIAL PRECAUTIONS FOR DISPOSAL AND HANDLING
Each vial of Ruconest is for single use only.
Use aseptic techniques for reconstitution, combining, and mixing of solutions.

Reconstitution
Each vial of Ruconest (2100 U) must be reconstituted with 14 ml of water for injections. The water for injections should be added slowly to avoid strong impact on the powder, then gently mixed to minimize foam formation. The reconstituted solution in each vial contains 2100 U of conestat alfa at 150 U/ml and appears as a clear, colourless solution.

The reconstituted solution in each vial should be inspected visually for particulate matter and discoloration. Do not use any solution that contains particulate matter or shows discoloration. The medicinal product should be used immediately.

Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.

Patient information leaflet

Ruconest 2100 Units powder and solvent for injectable solution

conestat alfa
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.

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

Contents of this leaflet:

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

1. What Ruconest is and what it is used for

The active substance in Ruconest is conestat alfa. Conestat alfa is a recombinant (non-blood-derived) form of human C1 inhibitor protein (rhC1-INH).
Ruconest is indicated for the treatment of acute attacks in adult patients, adolescents, and children (aged 2 years and older) with a rare inherited blood disorder called hereditary angioedema (HAE). In patients with this condition, the C1 inhibitor protein is deficient, which can lead to recurrent episodes of swelling, abdominal pain, breathing difficulties, and other symptoms.
Administration of Ruconest aims to correct the deficiency of C1 inhibitor protein and thereby reduce the symptoms of an acute HAE attack.

2. What you need to know before using Ruconest

Do not use Ruconest

• If you are or think you may be allergic to rabbit.
• If you are allergic to conestat alfa or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before using Ruconest.
If you experience allergic reactions, such as hives, rash, itching, dizziness, wheezing, breathing difficulties, or swelling of the tongue after taking Ruconest, seek immediate medical attention so that symptoms of the allergic reaction can be treated urgently.
Before starting treatment with Ruconest, it is important to inform your doctor if you have or have had blood clotting disorders (thrombotic events). In such cases, you will be closely monitored.
Hypersensitivity reactions cannot be ruled out, and these reactions may present with symptoms similar to those of angioedema attacks.

Children and adolescents
Do not administer this medicine to children under 2 years of age. Ruconest has not been studied in children under 5 years of age. Your doctor will decide whether or not treatment with Ruconest is appropriate for the child. Additionally, further monitoring of the child for signs of allergic reactions is required throughout the administration period.

Other medicines and Ruconest
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
If you are receiving a tissue plasminogen activator as acute treatment to prevent blood clot formation, you must not be treated with Ruconest at the same time.

Pregnancy and breastfeeding
The use of Ruconest is not recommended during pregnancy and breastfeeding.
If you are planning a pregnancy, consult your doctor before using this medicine.

Driving and operating machinery
Do not drive or operate machinery if you experience dizziness or headache after administration of Ruconest.

Ruconest contains sodium (19.5 mg per vial)
This should be taken into consideration for individuals on a low-sodium diet.

3. How to use Ruconest

Treatment with Ruconest should be initiated by a physician experienced in the diagnosis and treatment
of hereditary angioedema.
Ruconest must be administered by healthcare professionals until you or your caregiver has been
adequately trained and is able to administer Ruconest independently.
Use this medicine exactly as described in this leaflet or as instructed by your doctor or nurse. If you have any doubts, consult your doctor or nurse.
Ruconest is administered intravenously over approximately 5 minutes. The dose will be calculated based on your body weight.
In most cases, a single dose is sufficient. An additional dose may be administered if symptoms do not improve after 120 minutes (for adults and adolescents) or 60 minutes (for children). No more than two doses should be administered within 24 hours, calculated as described in step 7.
You or your caregiver may only inject Ruconest after receiving adequate instructions and training from your doctor or nurse.

Instructions for use
Do not mix or administer Ruconest with other medicines or solutions. The following describes the preparation and administration procedures for the Ruconest solution.

Before you begin

• Ensure that the kit packaging is complete and contains all components listed in section 6 of this leaflet.
• The following additional items are required along with the kit:
• a tourniquet
• adhesive tape to secure the needle
  • Inspect the vials and other components.
• all vials must be sealed with an aluminum and plastic cap and free from visible damage such as cracks in the glass.
• check the expiration date. Never use any component of the kit after the expiry date printed on the outer larger packaging. Different components within a single kit package may have different expiry dates. The expiry date on the outer packaging reflects the shortest shelf life among the components.
  • Allow the required vials of powder and solvent to reach room temperature as described in step 1.

Preparation of the solution
Step 1: Cleaning and other requirements

• Wash hands thoroughly.
• Place the required vials of powder and solvent on a clean, flat surface.
  • for body weight equal to or less than 42 kg: 1 vial of powder and 1 vial of solvent
  • for body weight greater than 42 kg: 2 vials of powder and 2 vials of solvent
• Place the vial adapters on the work surface. Do not remove the adapter packaging.
  • 2 adapters if using 1 vial of powder and 1 vial of solvent
  • 4 adapters if using 2 vials of powder and 2 vials of solvent
• Place the syringe(s) on the work surface. Do not remove the syringe packaging.
  • 1 syringe if using 1 vial of powder and 1 vial of solvent
  • 2 syringes if using 2 vials of powder and 2 vials of solvent

Step 2: Disinfection of vial stoppers

• Remove the plastic pull-off cap from the powder and solvent vials.
• Use an alcohol-impregnated swab to disinfect all vial stoppers and wait at least 30 seconds for the stoppers to dry.

• After disinfection, do not touch the stoppers with fingers or any other body part or object.

Step 3: Assembling the adapters onto the vials

• Hold one adapter in its plastic packaging in one hand and remove the cap. The adapter
  must remain inside its plastic packaging.

• Place the adapter onto the powder vial, piercing the stopper, until it locks into place on the neck of the vial.

• Leave the plastic packaging on the adapter until inserting the syringe in steps 4 and 5.
• Repeat the above steps to assemble the adapter onto the solvent vial. The adapters provided in the kit are identical.
• If a second powder and solvent vial are required, repeat the steps described above.

Step 4: Aspirating the solvent

• Remove one sterile syringe from its packaging.
• Remove the packaging from the adapter on the solvent vial.

• Hold the adapter with one hand. With the other hand, insert the syringe and secure it by rotating clockwise until locked.

• Turn the solvent vial with the attached adapter and syringe upside down. While holding it vertically, slowly aspirate 14 ml of solvent. If air bubbles appear, minimize them by gently tapping the syringe and slightly pushing the plunger. Continue filling the syringe with 14 ml of solvent.

• Unlock the syringe from the adapter by rotating counterclockwise.

• Discard the vial with the remaining solvent inside.
• Place the syringe on the work surface, taking care that the tip of the syringe does not touch the surface or any other object.

Step 5: Adding solvent to the powder and dissolving

• Remove the packaging from the adapter on the powder vial.
• Take the syringe containing the solvent prepared in step 4.
• Hold the adapter with the free hand and insert the syringe. Secure the syringe by rotating clockwise until locked.
• Slowly and in one continuous motion, push the solvent into the powder vial to minimize foam formation.

• Leave the syringe attached to the adapter and gently rotate the vial for about half a minute. Do not shake. After rotation, leave the vial on the surface for several minutes until the solution becomes clear. If undissolved powder is observed, repeat the procedure.

• Repeat steps 4 and 5 if a second solution needs to be prepared.

Step 6: Checking the prepared solutions

• Verify that the powder in the vials has completely dissolved and that the plunger is fully inserted into the syringe.
• After dissolution, the solution should be clear and colorless.
• Do not use the prepared solution if it appears cloudy, contains particles, or has changed color. In such cases, inform healthcare professionals. A small amount of foam is acceptable.

Step 7: Aspirating the prepared solution

• Calculate the number of milliliters of solution to be injected.

• Holding the syringe in a vertical position, draw up the required volume of prepared solution. If:
  • one vial of solution has been prepared, draw up the volume as calculated
  • two vials have been prepared and body weight is less than 84 kg, draw up as follows: a) 14 ml from the first vial b) from the second vial, the difference between the calculated volume and the 14 ml from the first vial
  • two vials have been prepared and body weight is equal to or greater than 84 kg, draw up 14 ml from each vial into each syringe. If air bubbles appear, minimize them by gently tapping the syringe and slightly depressing the plunger. Continue filling the syringe to the required volume.

• Never exceed a volume of 14 ml per syringe.
• Unlock the syringe(s) by rotating them counterclockwise and discard the vial(s) with the adapter.
• Place the syringe(s) on the work surface, taking care that the tip of the syringe does not touch the surface or any other object.

Step 8: Check of prepared syringes

• Double-check that the volume in the syringes prepared in step 7 is correct.

Intravenous administration
The prepared solution must be injected directly into a vein and not into an artery or surrounding tissue.
Inject the Ruconest solution immediately after preparation, preferably while sitting.

Step 9: Required components

• Check that all required components are placed on the work surface:
  • 1 or 2 syringes containing the prepared solution
  • 1 infusion set with 25G needle
  • 1 alcohol-impregnated swab
  • 1 sterile non-woven fabric swab
  • 1 self-adhesive plaster
  • 1 tourniquet
  • 1 plaster to secure the needle

Step 10: Preparation of the infusion set

• Remove the screw cap from the needle-free end of the infusion set.
• Holding this end in one hand, connect the syringe tip and secure it by rotating clockwise until locked.
• Hold the syringe with the tip pointing upwards. Slowly depress the plunger to carefully fill the infusion set with the prepared solution.

• Ensure that there is no air in the syringe, infusion tubing, or needle.

Step 11: Preparation of the injection site

• Place the tourniquet above the injection site, preferably in the middle of the arm, and tighten to compress the vein. Effectiveness is increased by keeping the fist clenched.
• Identify a suitable vein with the free hand.
• Thoroughly disinfect the injection site with an alcohol-impregnated swab and allow the skin to dry.

Step 12: Administration of the prepared solution

• Remove the needle cap.
• Carefully insert the needle of the infusion set into the vein at the flattest possible angle.

• Secure the needle by applying the approximately 7 cm plaster over the wings of the needle.
• Gently pull back on the syringe plunger until blood appears in the tubing, to confirm correct placement of the needle in the vein.
• Release the tourniquet.
• If no blood appears in the tubing, remove the needle and repeat steps from step 11 to reposition the needle.
• If blood is seen in the tubing, slowly inject the solution into the vein as shown in the figure. Inject over approximately 5 minutes or longer.

• If two syringes have been prepared:
  • clamp the tubing near the connector of the infusion set to prevent backflow
  • unscrew the empty syringe from the infusion set and immediately replace it with the second syringe

• unclamp the tubing and slowly inject the solution as with the first syringe

Step 13: After administration

• Carefully remove the plaster securing the needle and remove the needle from the vein.
• Immediately after needle removal, apply the sterile swab to the injection site and press for several minutes to minimize bleeding.

• Apply a self-adhesive plaster over the injection site.
• Fold the yellow protective needle cap back over the needle.
• Safely dispose of the used infusion set with needle, unused solution, syringe, and empty vial in a suitable container for medical waste, as these materials may cause harm to others if not properly disposed of. Do not reuse any of the provided materials.

Step 14: Recording of administration
Record (e.g., in a diary):

• date and time of administration
• batch number indicated on the label of the powder vial

If you use more Ruconest than you should
In this case, contact your doctor or the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If your symptoms worsen and/or you develop a rash, tingling, breathing difficulties, or swelling of the
face or tongue, consult your doctor immediately. This could indicate that you have developed an
allergy to Ruconest.
Some side effects may occur during treatment with Ruconest:
Common: may affect up to 1 in 10 people

• Nausea

Uncommon: may affect up to 1 in 100 people

• Abdominal pain, diarrhoea
• Tingling, prickling or numbness sensation in the mouth
• Headache, dizziness
• Reduced sense of touch or sensation in the skin and limbs
• Throat irritation
• Hives
• Swelling of the ears and surrounding area
• Allergic shock

Not known: frequency not known

• Hypersensitivity reactions

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor. You can
also report side effects directly via the national reporting system listed in Annex V. By reporting side
effects, you can help provide more information on the safety of this medicine.

5. How to store Ruconest

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and on the vial label after the word "Exp./EXP". The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the vial of powder in its original packaging to protect the medicine from light.
Before administering Ruconest, the powder must be dissolved in the solvent supplied in the pack (see section 3).
Once reconstituted, the product should be used immediately.
Do not use this medicine if, after dissolution, the solution contains particles or shows any change in colour. A small amount of foam formation is acceptable.

6. Package Contents and Other Information

What Ruconest Contains
Vial of powder:

• The active substance is conestat alfa. Each single vial of powder contains 2100 units of conestat alfa, corresponding to 2100 units in 14 ml after reconstitution, or a concentration of 150 units/ml.
• The other components of the powder are: sucrose, sodium citrate (E331), and citric acid.

Vial of solvent:

• The component of the solvent is water for injections.

Description of the Appearance of Ruconest and Contents of the Package
Ruconest is supplied as a single glass vial containing a white to off-white powder for solution for injection, together with a glass vial containing a clear, colourless solvent to dissolve the powder. After dissolving the powder in water for injections, the solution is clear and colourless.
Ruconest is supplied with an administration kit in a cardboard package containing:

• 1 powder vial (2100 U)
• 1 vial of 20 ml solvent
• 2 vial adapters
• 1 syringe
• 1 infusion set with a 35 cm tube and a 25G needle
• 2 alcohol swabs
• 1 sterile non-woven fabric swab
• 1 self-adhesive plaster

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pharming Group N.V.
Darwinweg 24
2333 CR Leiden
The Netherlands

Manufacturer:
Pharming Technologies B.V.
Darwinweg 24
2333 CR Leiden
The Netherlands

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

The following information is intended exclusively for healthcare professionals:
DOSAGE AND ADMINISTRATION
Dosage
Patients with body weight up to 84 kg

• An intravenous injection of 50 U/kg body weight

Patients with body weight of 84 kg or more

• An intravenous injection of 4200 U (two vials).

In most cases, a single dose of Ruconest is sufficient to treat an acute attack of angioedema.
If the clinical response is inadequate, an additional dose may be administered (50 U/kg body weight up to a maximum of 4200 U).
No more than two doses should be administered within 24 hours.

Dose Calculation
Determine the patient's body weight.

Patients with body weight up to 84 kg

• For patients weighing up to 84 kg, calculate the required volume to be administered using the following formula:

Volume to administer (ml) = body weight (kg) × 50 (U/kg) / 150 (U/ml)

Patients with body weight of 84 kg or more

• For patients weighing 84 kg or more, the required volume to be administered is 28 ml, corresponding to 4200 U (2 vials).

Reconstitute each vial with 14 ml of water for injections (see section below on Reconstitution).
The reconstituted solution in each vial contains 2100 U of conestat alfa at a concentration of 150 U/ml.
The required volume of reconstituted solution should be administered by slow intravenous injection over approximately 5 minutes.

SPECIAL PRECAUTIONS FOR DISPOSAL AND HANDLING
Preparation and Handling
Each Ruconest vial is for single use only.
Ruconest is administered intravenously after reconstitution with water for injections. Aseptic technique must be used during reconstitution, combination, and mixing of solutions.

Reconstitution

1. Each Ruconest vial (2100 U) must be reconstituted with 14 ml of water for injections.
2. Disinfect the rubber stoppers of both the powder and solvent vials, and attach one vial adapter to each of the powder and solvent vials by pushing and twisting clockwise until it clicks into place on the vial neck.
3. Insert the syringe into the adapter on the solvent vial and rotate clockwise until locked. Draw up 14 ml of solvent. Unlock the syringe by rotating it counterclockwise. Repeat this step if a second powder vial needs to be reconstituted.
4. Insert the syringe containing solvent into the adapter on the powder vial and rotate clockwise until locked. The water for injections should be added slowly to avoid a strong impact on the powder, then gently mixed to minimize foam formation. Leave the syringe attached to the adapter. Repeat this step if a second powder vial needs to be reconstituted.
5. The reconstituted solution in each vial contains 150 U/ml and appears as a clear, colourless solution. The reconstituted solution in each vial should be inspected visually for particulate matter and discoloration. Do not use any solution that contains particulate matter or shows discoloration. A small amount of foam is acceptable. The medicinal product should be used immediately.

Administration

1. Draw up the required volume of prepared solution into a syringe. Never exceed 14 ml per syringe. Unlock the syringe by rotating it counterclockwise and discard the vial(s) with the adapter.
2. Attach the infusion set to the syringe and rotate clockwise until locked. Hold the syringe with the tip pointing upwards and gently depress the plunger to fill the infusion set with solution.
3. Disinfect the injection site with an alcohol swab. Remove the needle cap from the infusion set and carefully insert the needle into the vein.
4. Ensure the tourniquet has been removed. Inject the solution slowly into the vein – administer over approximately 5 minutes or longer.
5. If preparing two syringes: clamp the tubing to prevent backflow, remove the empty syringe from the infusion set (by rotating counterclockwise), and immediately replace it with the second syringe. Slowly inject the solution from the second syringe.

Disposal
Safely dispose of the used infusion set with needle, unused solution, syringe, and empty vial in a proper medical waste container, as these materials may cause harm to others if not disposed of correctly. Do not reuse any of the supplied materials.