HyQvia

Package leaflet: Information for the user

HyQvia 100 mg/mL solution for infusion for subcutaneous use

normal human immunoglobulin
Read all of this leaflet carefully before you start 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What HyQvia is and what it is used for

What HyQvia is
HyQvia contains 2 solutions for infusion (intravenous drip) under the skin (subcutaneous infusion or SC infusion). It is supplied in a pack containing:

• one vial of 10% normal human immunoglobulin (the active substance)
• one vial of recombinant human hyaluronidase (a substance that helps deliver the 10% normal human immunoglobulin into the bloodstream).

The 10% normal human immunoglobulin belongs to a class of medicines called "normal human immunoglobulins". Immunoglobulins are also known as antibodies and are present in the blood of healthy individuals. Antibodies are part of the immune system (the body's natural defences) and help the body fight infections.
How HyQvia works
Recombinant human hyaluronidase is a protein that facilitates the subcutaneous infusion of immunoglobulins and their entry into the bloodstream.
The immunoglobulin vial is prepared from the blood of healthy donors. Immunoglobulins are produced by the human body's immune system. They help the body fight infections caused by bacteria and viruses or maintain balance within the immune system (a process known as immunomodulation). The medicine acts in the same way as immunoglobulins naturally present in the blood.
What HyQvia is used for
Replacement therapy in adults and children (aged 0 to 18 years)
HyQvia is used in patients who have a weakened immune system and do not have enough antibodies in their blood, making them more susceptible to frequent infections, including the following groups:

• patients with a congenital inability or reduced ability to produce antibodies (primary immunodeficiencies)
• patients with severe or recurrent infections due to a weakened immune system caused by other conditions or treatments (secondary immunodeficiencies).

Regular and adequate doses of HyQvia can increase abnormally low levels of immunoglobulins in the blood to normal levels (replacement therapy).
Immunomodulatory therapy in adults, children and adolescents (aged 0 to 18 years)
HyQvia is used in adult, paediatric and adolescent patients (aged 0 to 18 years) with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a form of autoimmune disease. CIDP is characterised by chronic inflammation of the peripheral nerves, causing muscle weakness and/or numbness, primarily in the legs and arms. It is believed that the body's defence system attacks the peripheral nerves, causing nerve damage and inflammation. The immunoglobulins in HyQvia are thought to help protect the nerves from damage caused by the immune system.

2. What you need to know before using HyQvia

Do not inject or infuse HyQvia:

• if you are allergic to immunoglobulins, hyaluronidase, recombinant hyaluronidase, or any of the other ingredients of this medicine (listed in section 6, “Contents of the pack and other information”).
• if you have anti-immunoglobulin A (IgA) antibodies in your blood, for example, if you have IgA deficiency. Since HyQvia contains traces of IgA, you may develop an allergic reaction.
• into a blood vessel (intravenously) or into a muscle (intramuscularly).

Warnings and precautions
Talk to your doctor or nurse before using HyQvia.
► Inform your doctor or healthcare professional before treatment if any of the following circumstances apply to you or your child:

• You or your child may be allergic to immunoglobulins without knowing it. Allergic reactions such as sudden drop in blood pressure or anaphylactic shock (a sudden drop in blood pressure with other symptoms such as throat swelling, breathing difficulties, and skin rash) are rare but may occasionally occur even if you have not previously had problems with similar treatments. You are at higher risk of allergic reactions if you have IgA deficiency and have anti-IgA antibodies. Signs or symptoms of these rare allergic reactions include:
  • confusion, dizziness, or fainting; or skin rash and itching, mouth or throat swelling, difficulty breathing, wheezing;

or abnormal heart rate, chest pain, blue coloration of lips or fingers and toes;
or blurred vision.
► If you notice any of the following signs during infusion, inform your doctor or nurse immediately, who will decide whether to slow down the infusion rate or stop the infusion completely.
Your doctor or nurse will infuse the recombinant human hyaluronidase (HY) followed by the immunoglobulin (IG) slowly and will monitor you closely during the first infusion to detect and treat any possible allergic reaction promptly.
Your doctor will pay particular attention if you are overweight, elderly, have diabetes, have been bedridden for a long time, have high blood pressure, have low blood volume (hypovolemia), have blood vessel problems (vascular diseases), have a higher tendency for blood clotting (thrombophilia or thrombotic episodes), or have a disease or condition causing increased blood viscosity (hyperviscous blood). In these circumstances, immunoglobulins may increase the risk of heart attack (myocardial infarction), stroke, blood clots in the lung (pulmonary embolism), or blockage of a blood vessel in the leg, although this is very rare.
► If you notice any of these signs and symptoms, including shortness of breath, pain, swelling of a limb, or chest pain during infusion, inform your doctor or nurse immediately. They will decide whether to slow down the infusion rate or stop it completely.
Your doctor or nurse will monitor you closely during infusions so that any thromboembolic events can be detected and treated immediately.

• You will receive this medicine at high doses for 1 or 2 days and if you have blood group A, B, or AB and an underlying inflammatory condition. In these circumstances, immunoglobulins have commonly been reported to increase the risk of red blood cell breakdown (hemolysis).
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis syndrome) has been reported in association with immunoglobulin treatment. ► If you notice any of these signs and symptoms, including severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomiting after infusion, inform your doctor or nurse immediately. Your doctor will decide whether further investigations are needed and whether to continue treatment with HyQvia.

Infusion rate
It is very important that the medicine is infused at the correct rate. Your doctor or nurse will inform you of the appropriate infusion rate to use when self-administering HyQvia at home (see section 3, “How to use HyQvia”).

Monitoring during infusion
Certain adverse effects may occur more frequently if:

• you are using HyQvia for the first time.
• you have switched to HyQvia after receiving another immunoglobulin.
• a long interval has passed (e.g., more than 2 or 3 infusion intervals) since your last dose of HyQvia. ► In these cases, you will be closely monitored during the first infusion and for the first hour after the infusion ends.

In all other cases, during the first infusions, you should be observed during the infusion and for at least 20 minutes after administration of HyQvia.

Home treatment
Before starting home treatment, it is advisable to have someone to care for you.
You and your caregiver will be trained to recognize early signs of adverse effects, particularly allergic reactions. The person caring for you should help monitor for potential adverse effects. During the infusion, careful observation for early signs of adverse effects is necessary (for further information, see section 4, “Possible side effects”).
► If adverse effects occur, the patient or caregiver must immediately stop the infusion and contact the doctor.
► In case of a serious adverse effect, the patient or caregiver must immediately seek emergency medical treatment.

Spread of localized infections
Do not infuse HyQvia into or near an infected, swollen, or red area of skin, as HyQvia could cause the infection to spread.
During clinical studies, no long-term (chronic) skin changes were observed. However, you should report to your doctor any long-term inflammation, nodules, or inflammation at the infusion site that last longer than a few days.

Effects on blood tests
HyQvia contains many different antibodies, some of which may affect blood tests (serological tests).
► Before undergoing any blood test, inform your doctor that you are being treated with HyQvia.

Information about the source material of HyQvia
The normal human immunoglobulin 10% in HyQvia and human serum albumin (a component of recombinant human hyaluronidase) are derived from human plasma (the liquid part of blood).
When medicines are made from human blood or plasma, certain measures are taken to prevent transmission of infections to patients, including:

• careful selection of blood and plasma donors to exclude those at risk of transmitting infections,
• testing of each individual donation and pooled donations of blood and plasma for signs of viruses/infections.

Manufacturers of such medicines also include processing steps that can inactivate or remove viruses. Despite these measures, when medicines derived from human blood or plasma are used, the possibility of transmitting infections cannot be completely ruled out. This also applies to unknown or emerging viruses or other types of infections.
The measures taken in the production of HyQvia are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, as well as against non-enveloped viruses such as hepatitis A virus and parvovirus B19.
Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, likely because the antibodies against these infections contained in HyQvia exert a protective effect.
► It is strongly recommended that every time you use HyQvia, you record in your treatment diary the following information:

• the name of the product
• the date of administration
• the batch number of the medicine
• the volume infused, the infusion rate, the number and location of infusion sites.

Children and adolescents
Replacement therapy
For children and adolescents (aged 0 to 18 years), the same indications, dosage, and infusion frequency as in adults apply.
Immunomodulatory therapy in CIDP patients
The safety and efficacy of HyQvia in children and adolescents (aged 0 to 18 years) with CIDP have not been established.

Other medicines and HyQvia
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Vaccinations
HyQvia may reduce the effect of certain antiviral vaccines such as measles, rubella, mumps, and varicella (vaccines containing live viruses). Therefore, after administration of HyQvia, an interval of 3 months should elapse before vaccination with certain vaccines. For measles, an interval of up to 1 year may be required.
► Inform the doctor or nurse administering the vaccine that you are being treated with HyQvia.

Pregnancy, breastfeeding, and fertility
Data on the long-term effects of recombinant human hyaluronidase on pregnancy, breastfeeding, and fertility are limited. HyQvia should be used in pregnant and breastfeeding women only after discussion with their doctor.

Driving and using machines
Patients may experience side effects such as dizziness or nausea during treatment with HyQvia, which may affect their ability to drive, ride a bicycle, or operate machinery. If such reactions occur, you or your child should wait until they resolve before resuming these activities. If you or your child experiences any adverse effect, consult your doctor.

HyQvia contains sodium
This medicine contains 5.0 to 60.5 mg of sodium (a main component of table salt) in each vial of HyQvia containing recombinant human hyaluronidase. This corresponds to 0.25–3% of the maximum daily dietary intake recommended for an adult. The IG 10% component is essentially sodium-free.

3. How to use HyQvia

Use this medicine exactly as your doctor has instructed you. If you have any doubts, consult your
doctor.
HyQvia must be infused under the skin (subcutaneous administration or SC).
Treatment with HyQvia will be initiated by your doctor or nurse, but you may be allowed to use the
medicine at home after your first infusions have been administered under medical supervision and
once you (and/or your caregiver) have received adequate training. You and your doctor will decide
whether you can use HyQvia at home. Do not start treatment with HyQvia at home without having
received complete instructions on its use.

Dosage
Replacement therapy
Your doctor will calculate the correct dose for you based on your body weight, any previous
treatments you may have received, and your response to treatment. The recommended initial dose
provides 400–800 mg of active substance per kg of body weight per month. Initially, one-quarter of this
dose will be administered at weekly intervals. With subsequent infusions, the dose will be increased
and administered every 3–4 weeks. Sometimes your doctor may recommend that higher doses be
divided and administered at two sites. Your doctor may adjust the dose according to your response to
treatment.

Immunomodulatory therapy
Your doctor will calculate the correct dose for you based on previous treatments received and your
response to treatment. Therapy generally starts 1–2 weeks after the last infusion of immunoglobulins,
administered subcutaneously at the calculated weekly equivalent dose. Your doctor may adjust the dose
and frequency based on your response to treatment.

If the maximum daily dose is exceeded (> 120 g) or if you do not tolerate the volume of immunoglobulin
infusion, the dose may be divided and administered over several days, with an interval of 48–72 hours
between administrations to ensure proper absorption; hyaluronidase administration should also be
appropriately divided.

Initiation of treatment
Treatment will be initiated by a doctor or nurse experienced in treating patients with weakened immune
systems (immunodeficiency) and CIDP, with the aim of training these patients for home treatment. You
will be closely monitored throughout the entire infusion and for at least 1 hour after the infusion is
stopped to assess how well you tolerate the medicine. Initially, the doctor or nurse will use a slow
infusion rate and gradually increase it during the first infusion and in subsequent infusions. Once the
doctor or nurse has established the correct dose and infusion rate for you, you may be allowed to self-
administer the treatment at home.

Home treatment
Do not use HyQvia at home until you have received instructions and training from a healthcare
professional. You will be taught:

• The use of germ-free (aseptic) infusion techniques,
• The use of an infusion pump or timed syringe (if necessary),
• How to maintain a treatment diary,
• The measures to take in case of serious adverse effects.

You must carefully follow your doctor’s instructions regarding the dose, infusion rate, and infusion
schedule of HyQvia to ensure the treatment is effective.

The following infusion rates are recommended for 10% IG per infusion site:

The infusion rates above refer to a single infusion site. If the patient requires 2 or 3 infusion sites, the infusion rates may be adjusted accordingly (i.e., doubled or tripled according to the pump's maximum infusion rate).
If there is leakage at the infusion site
Ask your doctor, pharmacist, or nurse whether a needle of a different size might be more appropriate.
Any change in needle size must be supervised by the treating physician.
If you use more HyQvia than you should
If you think you have used more HyQvia than you should, contact your doctor as soon as possible.
If you forget to use HyQvia
Do not use a double dose of HyQvia to make up for a forgotten dose. If you think you have missed a dose, contact your doctor as soon as possible.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.
Detailed instructions for use are provided in the following section.

1. Remove HyQvia from its packaging: •Allow the vials to reach room temperature. This may take up to 1 hour. Do not use heating devices, including microwave ovens. •Do not heat or shake HyQvia. •Inspect each HyQvia vial before use: •Expiry date: do not use after the expiry date. •Colour: Recombinant human hyaluronidase should be clear and colourless.Human normal immunoglobulin 10% should be clear and colourless or pale yellow.Do not use if either solution is cloudy or contains particles. •Seal cap: the dual vial unit is equipped with a protective purple seal cap. Do not use the product if the seal cap is missing.
2. Gather all necessary supplies: Collect all items required for infusion, including: HyQvia dual vial unit, infusion materials (subcutaneous needle, solution container [bag or syringe], sterile transparent dressing and tape, pump tubing, transfer devices, syringes, gauze and tape), sharps container, pump, treatment log, and any other required materials.
3. Prepare a clean work area.
4. Wash hands: Wash hands thoroughly. Place all prepared materials on a clean surface and open them according to healthcare provider instructions.
5. Open the HyQvia dual vial unit(s): •Remove the protective purple seal cap(s) and ensure that the blue vial closure caps have been removed. If not, manually remove the blue closure caps to expose the vial stoppers. •Prepare for transfer of the recombinant human hyaluronidase component of HyQvia by wiping each vial stopper with an alcohol swab, if instructed, and allow it to air dry (at least 30 seconds).
6. Prepare the recombinant human hyaluronidase vial (HY): •Remove the smaller sterile syringe from its packaging and attach it to a non-vented needle or transfer device. •Pull back the plunger to fill the smaller syringe with air equal to the volume of recombinant human hyaluronidase in the HY vial(s). •Remove the cap from the non-vented transfer needle/device. •Insert the needle/device into the center of the vial stopper and push down to inject air into the vial. •Invert the vial, keeping the transfer needle/device inserted. The syringe tip will now be pointing upward. •Withdraw all recombinant human hyaluronidase into the syringe. •Repeat step 6 if more than one recombinant human hyaluronidase vial is required for the dose. •If possible, combine all required recombinant human hyaluronidase into a single syringe for the entire IgG dose. •Hold the syringe with the tip pointing upward and gently tap the syringe with a finger to remove any air bubbles. Slowly and carefully push the plunger to expel any residual air.
7. Prepare the needle with recombinant human hyaluronidase (HY): If using the push method for administration (HY): •Attach the syringe filled with recombinant human hyaluronidase to the subcutaneous needle. •Push the plunger of the smaller syringe to remove air and prime the subcutaneous needle up to the wings with recombinant human hyaluronidase. •Note: The healthcare provider may recommend using a Y-connector (for multiple sites) or another needle configuration. If using the pump method for administration (HY): •Connect the syringe filled with recombinant human hyaluronidase (HY) to the pump tubing and attach the needle. •Push the syringe plunger (size may vary with larger volumes) to remove air and prime the pump tubing and subcutaneous needle up to the wings with recombinant human hyaluronidase.

8. Prepare the human immunoglobulin vial

normal 10%: (a) (b)

• Prepare transfer of the immunoglobulin component

by wiping the stopper of each vial with a separate alcohol swab, if instructed to do so, and allow it to dry in air (at least 30 seconds).

• HyQvia 10% immunoglobulin can be infused:  by transferring the contents of the vials into the larger syringe ( a ) or into an infusion bag ( b ), according to healthcare provider instructions, depending on the pump used; or  directly from the IG vial. Insert the luer tip of the vented pump tubing or a vented needle tip into the vial or vials of 10% normal human immunoglobulin. Fill the administration pump tubing and set it aside until administration of recombinant human hyaluronidase is complete.
• If more than one vial is required for a full dose, use subsequent vials after administration of the first.

9. Prepare the pump:

Follow the manufacturer's instructions to prepare the pump.

10. Prepare the infusion site:

• Select one or more infusion sites on the middle or upper abdomen or on the thighs. See the image for infusion site locations.  Choose infusion sites on opposite sides of the body if you have been instructed to administer at two sites for doses greater than 600 mL.  If using three sites, they should be at least 10 cm apart from each other.

• Avoid bony areas, visible blood vessels, scars, and inflamed or infected areas.
• Alternate infusion sites by selecting opposite sides of the body for each infusion.
• If instructed by your healthcare provider, clean the infusion site(s) with an alcohol wipe. Allow to dry (at least 30 seconds).

11. Insert the needle: •Remove the needle cap. Firmly grasp and pinch at least 2–2.5 cm of skin between two fingers. •Insert the needle completely into the skin up to the wings with a quick motion at a 90-degree angle. The needle wings should lie flat against the skin. •Secure the needle with sterile tape. •Repeat this step if using a second or third infusion site.	90-degree angle with the skin
12. Check that the needle is properly positioned before starting the infusion, if instructed to do so by the healthcare provider.
13. Secure the needle to the skin: •Secure the needle(s) in place using a sterile transparent dressing. •Periodically check the infusion site(s) to ensure there is no displacement or leakage.
14. Administer the recombinant human hyaluronidase infusion first: If using more than one site, divide the contents equally among all sites. If administering HY using the push method: •Slowly push the plunger of the smaller syringe containing recombinant human hyaluronidase at an initial rate of approximately 1–2 mL per minute per site, increasing if tolerated. If administering HY using an infusion pump: •If using a pump, prepare it for recombinant human hyaluronidase infusion at an initial rate of 60–120 mL/hour/site, increasing if tolerated.
15. Administer normal human immunoglobulin 10%: After infusing the entire contents of the smaller syringe (recombinant human hyaluronidase), disconnect the syringe from the subcutaneous needle connector/pump tubing. Connect the pump tubing to the IG vial/bag or connect the larger syringe containing normal human immunoglobulin 10% to the subcutaneous needle. Administer normal human immunoglobulin 10% using a pump at the rate prescribed by the healthcare provider and begin the infusion.
16. If instructed by the healthcare provider, flush the pump tubing at the end of the infusion: •If instructed, connect a bag of sodium chloride solution to the pump tubing/needle to push the remaining normal human immunoglobulin 10% through to the wings of the subcutaneous needle.
17. Remove the needle: •Remove the subcutaneous needle by loosening the dressing around all edges. •Pull the needle wings upward and outward. •Gently press a piece of gauze over the infusion site and cover with a protective dressing. •Dispose of the needle(s) into a sharps container. Dispose of the sharps container according to the instructions provided with the container or consult your healthcare provider.
18. Record the infusion: •Remove the detachable label from the HyQvia vial showing the product lot number and expiration date, and affix it to the treatment log. •Record the date, time, dose, infusion site(s) (to assist in rotating sites), and any reactions following each infusion. •Discard any unused product remaining in the vial and dispose of all single-use materials according to healthcare provider instructions. •Consult with your doctor as instructed.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects, such as headache, chills or body aches, may be reduced by slowing down the infusion rate.

Serious side effects
Infusions of medicines such as HyQvia may occasionally cause rare but serious allergic reactions.
You may experience a sudden drop in blood pressure and, in isolated cases, anaphylactic shock.
Doctors are aware of these possible side effects and will monitor you during and after the initial infusions.
Typical signs and symptoms include: feeling confused, dizziness or fainting, skin rash and itching, swelling of the mouth or throat, difficulty breathing, wheezing, abnormal heart rate, chest pain, blue colouring of the lips or fingers and toes, blurred vision.
If you notice any of these signs during the infusion, inform your doctor or nurse immediately.
When using HyQvia at home, you must have the infusion administered in the presence of a caregiver who can help you monitor for allergic reactions, stop the infusion, and seek help if necessary.
See also section 2 of this leaflet for information on the risks of allergic reactions and the use of

HyQvia at home.

Very common side effects (may affect more than 1 in 10 infusions):
Local reactions at the infusion site (includes all reactions at the infusion sites listed below). These reactions usually disappear after a few days.
Common side effects (may affect up to 1 in 10 infusions):

• headache
• nausea
• reactions at the infusion site including pain, discomfort, tenderness, redness, swelling, and itching
• feeling of warmth, fever
• weakness (asthenia), fatigue, lack of energy (lethargy), and general malaise (discomfort)

Uncommon side effects (may affect up to 1 in 100 infusions):

• dizziness
• migraine
• sensations of numbness, tingling, prickling (paresthesia)
• fast heartbeat (tachycardia)
• high blood pressure (hypertension)
• abdominal pain/tenderness
• stomach swelling (abdominal distension)
• diarrhea
• vomiting
• skin redness (erythema)
• rash
• itching
• itchy rash (urticaria)
• muscle pain (myalgia)
• joint pain (arthralgia)
• back pain
• pain in extremities (including limb discomfort)
• musculoskeletal chest pain
• joint stiffness
• infusion site reactions (such as abnormal coloration, bruising, redness (hematoma), bleeding (hemorrhage), blood vessel perforation, mass (nodule), hardening, swelling (edema), chills, burning sensation, rash)
• swelling of the genitals

Rare side effects (may affect up to 1 in 1,000 infusions):

• agitation (tremor)
• stroke
• low blood pressure (hypotension)
• breathing difficulties (dyspnea)
• groin pain
• brown urine (haemosiderinuria)
• excessive sweating (hyperhidrosis)
• inflammation at the infusion site
• warmth at the infusion site
• sensations of numbness, tingling, prickling at the infusion site (infusion site paresthesia)
• positive Coombs test

Frequency not known (frequency cannot be estimated from the available data):

• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• allergic reactions (hypersensitivity)
• leakage at the infusion site
• influenza-like illness

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. 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 HyQvia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the carton after "Exp". The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
The product may be kept outside the refrigerator for a maximum of 3 months and stored at a temperature above +8 °C and below +25 °C. Do not refrigerate once stored at room temperature. Discard after 3 months at room temperature or upon reaching the expiry date, whichever occurs first.
Record on the outer packaging the date when the product is removed from the refrigerator.
Do not shake.
Keep the vials in the outer packaging to protect them from light.
Do not use this medicine if you notice that the solutions are cloudy or contain particles or deposits.
After opening, discard any unused solution remaining in the vials.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What HyQvia contains
HyQvia is a dual vial unit containing:

• a solution of recombinant human hyaluronidase (HyQvia step 1/infuse this vial first) and
• a solution of 10% normal human immunoglobulin (HyQvia step 2/infuse this vial second).

The contents of each vial are described below:

1. Recombinant human hyaluronidase

This vial contains recombinant human hyaluronidase.
Other components are sodium chloride, sodium phosphate, human albumin, ethylenediaminetetraacetic acid (EDTA) disodium, calcium chloride and water for injections
(see also section 2, “HyQvia contains sodium”).

2. 10% normal human immunoglobulin

One mL of solution in this vial contains 100 mg of normal human immunoglobulin, of which at least 98% is immunoglobulin G (IgG).
The active substance of HyQvia is normal human immunoglobulin. This medicine contains traces of immunoglobulin A (IgA) (not more than 140 micrograms/mL, average 37 micrograms).
Other components of this vial are glycine and water for injections.

Description of the appearance of HyQvia and pack contents
HyQvia 100 mg/mL solution for infusion for subcutaneous use (infused under the skin)
HyQvia is supplied in a pack containing:

• one glass vial of recombinant human hyaluronidase and
• one glass vial of 10% normal human immunoglobulin.

Recombinant human hyaluronidase is a clear, colourless solution.
10% normal human immunoglobulin is a clear, colourless or pale yellow solution.
The following pack sizes are available:

It is possible that not all pack sizes are marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Baxalta Innovations GmbH
Industriestrasse 67
A-1221 Vienna
Austria
Manufacturer:
Baxalta Belgium Manufacturing SA
Boulevard René Branquart 80
B-7860 Lessines
Belgium
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Takeda Belgium NV Takeda, UAB
Tél/Tel: +32 2 464 06 11 Tel: +370 521 09 070
[email protected] [email protected]
България Luxembourg/Luxemburg
Takeda Bulgaria EOOD Takeda Belgium NV
Tel.: +359 2 958 27 36 Tél/Tel: +32 2 464 06 11
[email protected] [email protected]
Česká republika Magyarország
Takeda Pharmaceuticals Czech Republic s.r.o. Takeda Pharma Kft.
Tel: +420 234 722 722 Tel: +36 1 270 7030
[email protected] [email protected]
Danmark Malta
Takeda Pharma A/S Drugsales Ltd
Tlf.: +45 46 77 10 10 Tel: +356 21419070
[email protected] [email protected]
Deutschland Nederland
Takeda GmbH Takeda Nederland B.V.
Tel: +49 (0)800 825 3325 Tel: +31 20 203 5492
[email protected] [email protected]
Eesti Norge
Takeda Pharma OÜ Takeda AS
Tel: +372 6177 669 Tlf: +47 800 800 30
[email protected] [email protected]
Ελλάδα Österreich
Takeda ELLAS A.E. Takeda Pharma Ges.m.b.H.
Tηλ: +30 210 6387800 Tel: +43 (0) 800-20 80 50
[email protected] [email protected]
España Polska
Takeda Farmacéutica España, S.A. Takeda Pharma Sp. z o.o.
Tel: +34 917 90 42 22 Tel: +48223062447
[email protected] [email protected]
France Portugal
Takeda France SAS Takeda Farmacêuticos Portugal, Lda.
Tél. +33 1 40 67 33 00 Tel: +351 21 120 1457
[email protected] [email protected]
Hrvatska România
Takeda Pharmaceuticals Croatia d.o.o. Takeda Pharmaceuticals SRL
Tel: +385 1 377 88 96 Tel: +40 21 335 03 91
[email protected] [email protected]
Ireland Slovenija
Takeda Products Ireland Ltd Takeda Pharmaceuticals farmacevtska družba d.o.o.
Tel: 1800 937 970 Tel: +386 (0) 59 082 480
[email protected] [email protected]
Ísland Slovenská republika
Vistor ehf. Takeda Pharmaceuticals Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 (2) 20 602 600
[email protected] [email protected]
Italia Suomi/Finland
Takeda Italia S.p.A. Takeda Oy
Tel: +39 06 502601 Puh/Tel: 0800 774 051
[email protected] [email protected]
Κύπρος Sverige
Proton Medical (Cyprus) Ltd Takeda Pharma AB
Τηλ: +357 22866000 Tel: 020 795 079
[email protected] [email protected]
Latvija
Takeda Latvia SIA
Tel: +371 67840082
[email protected]
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/