Patient leaflet - Panzyga 100 mg / ml solution for infusion
1. What Panzyga is and what it is used for What Panzyga is
Panzyga is a human normal immunoglobulin (IgG) solution (i.e. solution of human antibodies) for intravenous administration (i.e. infusion into a vein). Immunoglobulins are normal constituents of the human blood and support the immune defense of your body. Panzyga contains all IgG which are present in the human blood of healthy people. Adequate doses of Panzyga may restore abnormally low IgG levels to the normal range. Panzyga has a broad spectrum of antibodies against various infectious agents.
What Panzyga is used for
Panzyga is used as replacement therapy in children and adolescents (0–18 years), and adults in different groups of patients:
Patients with inborn deficiency of antibodies (primary immunodeficiency syndromes, such as: congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency, severe combined immuno-deficiencies)
- Patients with an acquired deficiency of antibod-ies (secondary immunodeficiency) due to specific diseases and/or treatments and experiencing severe or recurrent infections
Panzyga can be used for treatment of susceptible adults, children and adolescents (0–18 years) who have been exposed to measles or are at risk of measles exposure and in whom active vaccination against measles is not indicated or not advised. Panzyga can be further used in the treatment of the following autoimmune disorders (immuno-modulation):
- In patients with immune thrombocytopenia (ITP), a condition where the platelets get destroyed and are therefore reduced in number, and who have a high risk of bleeding or need to correct the platelet count prior to surgery – In patients with Kawasaki disease, a condition that leads to inflammation of various organs – In patients with Guillain Barré syndrome, a condition that leads to inflammation of certain parts of the nervous system
- In patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a disease that leads to chronic inflammation of the peripheral parts of the nervous system which causes muscle weakness and/or numbness mainly in the legs and arms.
- In patients with multifocal motor neuropathy (MMN), a condition that is characterized by slow progressive asymmetrical weakness of limbs without sensory loss
2. What you need to know before you use Panzyga
Do NOT use Panzyga:
- if you are allergic to human normal immunoglobulin or any of the other ingredients contained in Panzyga (listed in section 6). – if you have a deficiency of immunoglobulin A (IgA deficiency) and if you have developed antibodies against immunoglobulins of the type IgA.
Warnings and precautions
Talk to your doctor or pharmacist before using Panzyga.
It is strongly recommended that every time you receive a dose of Panzyga the name and batch number of the product are recorded in order to maintain a record of the batches used.
Certain adverse reactions may occur more frequently:
- in case of high rate of infusion
- when you receive Panzyga for the first time or, in rare cases, when there has been a long interval since the previous infusion.
- when you have an untreated infection or an underlying chronic inflammation
In the case of an adverse reaction, your doctor will either reduce the rate of administration or stop the infusion. The treatment of the adverse event required will depend on the nature and severity of the adverse event.
Circumstances and conditions increasing the risk of having side effects
- Thromboembolic events such as heart attack, stroke, and obstructions of a deep vein for example in the calves or of a blood vessel in the lung may occur very rarely after administration of Panzyga. These types of events occur more commonly in patients with risk factors, such as obesity, advanced age, high blood pressure, diabetes, previous occurrences of such events, prolonged periods of immobilisations, and intake of certain hormones (e.g. the pill). Ensure a balanced fluid intake; moreover Panzyga should be administered as slowly as possible. – If you had kidney problems in the past or if you have certain risk factors like diabetes, overweight, or age over 65, Panzyga should be administered as slowly as possible because cases of acute kidney failure have been reported in patients with such risk factors. Tell your doctor, even when any of the above-mentioned circumstances had happened to you in the past. – Patients with blood group A, B or AB as well as patients with certain inflammatory conditions have a higher risk of red blood cells being destroyed by the administered immunoglobulins (called haemolysis).
When may slowing or stopping the infusion be required?
- Strong headaches and neck stiffness may occur several hours to 2 days following Panzyga treatment.
Allergic reactions are rare, but can induce an anaphylactic shock, even in patients who had tolerated the previous treatments. A sudden fall in blood pressure or shock may be consequences of an anaphylactic reaction.
Children and adolescents
There are no specific or additional warnings or precautions applicable for children and adolescents.
Other medicines and Panzyga
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, or if you have received a vaccination in the last three months.
The concomitant use of medicines that increase the excretion of water from your body (loop diuretics) should be avoided during treatment with Panzyga. Your doctor will decide whether you should use or continue treatment with loop diuretics.
Panzyga may impair the effect of live attenuated virus vaccines such as
- measles
- rubella
- mumps
varicella.
After administration of this product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 1 year.
Panzyga with food, drink and alcohol
No effects have been observed. While using Panzyga adequate hydration before infusion should be taken into account.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist if you can get or continue with Panzyga.
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers. Immunoglobulin preparations have been shown to cross the placenta, increasingly during the third trimester. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
Immunoglobulins are excreted into human milk. No negative effects on the breastfed newborns/ infants are anticipated
Driving and using machines
Panzyga has no or negligible influence on the ability to drive and use machines. However, patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines
Panzyga contains sodium
This medicine contains 69 mg sodium (main component of cooking/table salt) per vial of 100 ml. This is equivalent to 3.45% of the recommended maximum daily dietary intake of sodium for an adult.
To be taken into consideration by patients on a controlled sodium diet.
3. How to use Panzyga
Your doctor will decide if you need Panzyga and at what dose. Panzyga is administered as an intravenous infusion (infusion into a vein) by healthcare personnel. The dose and dosage regimen is dependent on the indication and may need to be individualised for each patient. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Use in children and adolescents
The administration (intravenously) of Panzyga in children and adolescents (0–18 years) does not differ from the administration in adults.
If you receive more Panzyga than you should
Overdose is very unlikely to occur because Panzyga is usually administered under medical supervision. If, in spite of this, you receive more Panzyga than you should, your blood may become too thick (hyperviscous) which might increase the risk of developing blood clots. This may happen particularly if you are a patient at risk, for example if you are elderly or if you suffer from a heart or kidney disease. Make sure you are well hydrated. Tell your doctor if you are known to have medical problems.
If you forgot to use Panzyga
Please talk to your doctor and discuss on how to further proceed.
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- In very rare cases transfusion-related acute lung injury (TRALI) can occur after receiving immunoglobulins including Panzyga. This will lead to non-heart related accumulation of fluid in the air spaces of the lungs. You will recognize TRALI by severe difficulty in breathing, normal heart function and increased body temperature (fever). Symptoms typically appear within 1 to 6 hours after receiving treatment. Tell your doctor or healthcare professional immediately if you notice any of the above mentioned symptoms during or after the infusion of Panzyga. He or she will decide whether to decrease the infusion rate or to stop the infusion completely or if further measures are necessary. – Sometimes immunoglobulin solutions such as Panzyga can trigger a decrease in the number of white blood cells. Normally this condition resolves spontaneously within 1–2 weeks.
Effects on blood tests
Panzyga contains a wide variety of different antibodies, some of which can affect blood tests. If you have a blood test after receiving Panzyga, please inform the person taking your blood or your doctor that you have received a human normal immunoglobulin solution.
Virus safety
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include:
- careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded
- testing of each donation and pools of plasma for signs of virus/infections
- steps included by the manufacturers in the processing of the blood or plasma that can inactivate or remove viruses.
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections. The measures taken are considered effective for encapsulated viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus and for the non-encapsulated viruses such as hepatitis A virus and parvovirus B19.
Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact your doctor as soon as possible if you suffer from any of the serious side effects listed below (all are very rare and may affect up to 1 in 10,000 infusions). In some cases your doctor may need to interrupt treatment and reduce your dose or stop treatment:
- Swelling of the face, tongue and windpipe that can cause great difficulty in breathing – A sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure
- Stroke that may cause weakness and / or loss of sensation down one side of the body – Heart attack causing chest pain
- Blood clot causing pain and swelling of limbs – Blood clot in lung causing chest pain and breathlessness
- Anaemia causing shortness of breath or looking pale
- Severe kidney disorder that may cause you to not pass urine
- A lung condition referred to as transfusion-related acute lung injury (TRALI) causing difficulty in breathing, bluish skin, fever, a decrease in blood pressure
If you experience any of the symptoms above, contact your doctor as soon as possible. The following other side effects have also been reported:
Common side effects (may affect up to 1 in 10 infusions):
Headache, fever
Uncommon side effects (may affect up to 1 in 100 infusions):
- Vomiting, Belly pain, Nausea
- Peeling of the skin; Inflammation of the skin; (Itchy) rash; Skin rash; Itching
- Weakness
- Sleepiness; Dizziness
- Flu-like illness; Chills
- Fast beating of the heart
- Increased blood pressure
- Cough
- Reduction of white blood cells; Reduction of red blood cells
Changes in blood tests that report on how the liver is working
Rare side effects (may affect up to 1 in 1000 infusions):
- Discomfort in the chest or in the abdomen; Diarrhoea
- Reddening of the skin; Infusion site itching – Muscle stiffness or pain, Muscle pain; Joint pain; Pain
- Aseptic meningitis (also see section Warning and Precautions); Reduced sense of touch – Peripheral swelling; Feeling tired; Feeling cold – Chest pain
- Decreased blood pressure
- Difficulty breathing; Fast breathing
- Destruction of red blood cells; Decreased haemoglobin in the blood
- Eye itching
- Ear pain
Frequency not known (cannot be estimated from available data):
- Sudden, severe allergic reaction; Allergic reactions; Swelling in the face; Rapid swelling under the skin
- Stroke; Loss of consciousness; Confusional state; Migraine; Sensations like numbness, tingling, pins and needles; Nervousness; Agitation – Excessive contraction of the airway muscles causing breathing difficulties; Lack of oxygen in body tissues; Swelling of the lungs; Wheezing – Muscle spasm; Neck pain; Pain in extremity – Flushing; Hot flush; Excessive sweating; Swelling; Injection site reaction; Burning sensation; Feeling unwell; Feeling hot; Shiver; Lack of energy
- Pains to the chest, jaw and back due to physical effort and to problems with the blood flow to the heart; Slow heart rate; Forceful heartbeat; Pallor; Bluish skin and lips
- Abnormal sensitivity of the eyes to light – Abnormal measure of lung function
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Panzyga
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of the month. Store in a refrigerator (2°C – 8°C). Keep the container in the outer carton in order to protect from light. Do not freeze.
The product may be removed from the refrigerator for a period of 12 months (without exceeding the expiry date) and stored above +8°C and below +25°C. During this period, the product must not be refrigerated again. Discard the product if it is not used during this period or after the expiry date whichever is sooner. Record the date at which the product was taken out of the refrigerator on the outer carton.
Do not use this medicine if you notice that the solution is cloudy, has deposits or is coloured intensively.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Panzyga contains
- The active substance is human normal immunoglobulin (human antibodies). Panzyga contains 100 mg/ml human protein of which at least 95% is immunoglobulin G (IgG). – The other ingredients are glycine and water for injections.
What Panzyga looks like and contents of the pack
Panzyga is a solution for infusion and is available in vials (1 g/10 ml, 2.5 g/25 ml) or bottles (5 g/50 ml, 6 g/60 ml, 10 g/100 ml, 20 g/200 ml, 30 g/300 ml). Pack sizes:
1 vial (1 g/10 ml or 2.5 g/25 ml)
1 bottle (5 g/50 ml; 6 g/60 ml; 10 g/100 ml; 20 g/200 ml or 30 g/300 ml)
3 bottles (3 × 10 g/100 ml or 3 × 20 g/200 ml) The solution is clear or slightly opalescent, colourless or slightly yellow.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Octapharma Ltd.
Glassworks House
32 Shudehill
Manchester M4 1EZ
United Kingdom
Manufacturers
Octapharma
72 rue du Maréchal Foch
67380 Lingolsheim
France
Octapharma Pharmazeutika
Produktionsges.m.b.H.
Oberlaaer Strasse 235
1100 Vienna
Austria
This medicinal product is authorised in the member states of the EEA and in the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Bulgaria,
Croatia, Czech Republic,
Denmark Estonia, Finland,
France, Germany, Hungary,
Iceland, Ireland, Latvia,
Lithuania, Luxembourg, Malta,
The Netherlands, Norway,
Portugal, Romania, Slovakia,
Slovenia, Spain, Sweden,
United Kingdom (Northern
Ireland): Panzyga
Italy: Globiga
This leaflet was last approved in 11/2025.
The following information is intended for medical or healthcare professionals only:
- The product should be brought to room or body temperature before use.
- The solution should be clear to slightly opalescent and colourless to slightly yellow. – Solutions that are cloudy or have deposits should not be used.
- Any unused product or waste material should be disposed of in accordance with local requirements.
- This medicinal product should not be mixed with other medicinal products.
- In order to infuse any product that may remain in the infusion tubing at the end of the infusion the tubing may be flushed with either 0.9% (9 mg/ml) saline or 5% (50 mg/ml) dextrose solution.
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