100 mg / ml solution for infusion
Human normal immunoglobulin (IVIg)
What Panzyga is and what it is used for
What Panzyga is
Panzyga is a solution of human normal immunoglobulin (IgG) (solution containing human antibodies ) for intravenous use ( infusion into a vein). Immunoglobulins are normal constituents of human blood and help the body’s immune system. Panzyga contains all IgG antibodies found in the blood of healthy people. Appropriate doses of Panzyga can restore abnormally low IgG levels to normal levels.
Panzyga contains a wide range 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 congenital antibody deficiency (primary immunodeficiency syndrome, such as congenital agammaglobulinemia and hypogammaglobulinemia, common variable immunodeficiency, severe combined immunodeficiency)
- Patients with an acquired (non-congenital) deficiency of antibodies (secondary immunodeficiency) caused by specific diseases and/or treatments and who suffer from severe or recurrent infections.
Panzyga can also be used to treat (immune modulation) the following autoimmune diseases (ie when the patient’s antibody damages the body’s cells):
- Patients with immunological thrombocytopenia (ITP), a condition in which platelets break down and therefore decrease in number, as well as patients with an increased risk of bleeding or who need to correct the number of platelets before surgery
- Patients with Kawasaki disease, a condition that causes inflammation in various organs
- Patients with Guillain-Barré syndrome, a condition that causes inflammation in certain parts of the nervous system
- Patients with chronic demyelinating polyneuropathy (CIDP), a disease that leads to chronic inflammation in peripheral parts of the nervous system (which does not belong to the brain and spinal cord) which causes muscle weakness and/or numbness, especially in the legs and arms
- Patients with multifocal motor neuropathy (MMN), a condition characterized by slowly progressing asymmetric (unevenly distributed) weakness in the legs and arms without loss of sensation.
What you need to know before using Panzyga
Do not use Panzyga
- if you are allergic to human normal immunoglobulin or any of the other ingredients of Panzyga (listed in section 6).
- if you have immunoglobulin A ( IgA ) deficiency and if you have developed antibodies to IgA immunoglobulin.
Warnings and cautions
Talk to your doctor or pharmacist before using Panzyga.
When you are given Panzyga, it is recommended that the product name and batch number be registered to enable the tracking of the product used.
Some side effects may occur more often:
- at a high infusion rate
- when you receive Panzyga for the first time or, in rare cases, when it has been a long time since the last infusion.
- when you have an untreated infection or an underlying chronic inflammation
If you get a side effect, your doctor will either reduce the infusion rate or stop the infusion. How a side effect is treated depends on the type and severity of the side effect.
Circumstances and conditions that increase the risk of side effects
- If you have a history of kidney problems or if you have certain risk factors such as diabetes, obesity, or are over 65 years of age, Panzyga should be given as slowly as possible, as cases of acute kidney failure have been reported in patients with these risk factors. Tell your doctor if any of the above applies to you, or if you have had it before.
- Thromboembolic events such as heart attack, stroke, and a blood clot in a vein (deep vein thrombosis ) in, for example, the calves or a blood vessel in the lungs, can occur in very rare cases after using Panzyga. These types of events are more common in patients with risk factors such as obesity, old age, high blood pressure, diabetes, previous thrombotic disease, long periods of immobility, and intake of certain hormones (eg pills ). Be sure to drink enough fluids during the day to avoid signs of low fluid intake (eg, feeling thirsty) before infusing one. Panzyga should also be given as slowly as possible.
- Allergic reactions are rare but can cause anaphylactic shock even in patients who have tolerated previous treatments.
- Rare cases of severe headache and stiff neck may occur from several hours to two days after treatment with Panzyga.
- The risk of red blood cells being broken down by the administered immunoglobulins (so-called hemolysis ) is higher in patients with blood groups A, B, or AB as well as patients with certain inflammatory conditions.
When may you need to slow down or stop the infusion?
- Severe headaches and stiff neck may occur from several hours to two days after treatment with Panzyga.
- Allergic reactions are rare but can cause an allergic shock even in patients who have tolerated previous treatments. A sudden drop in blood pressure or shock can be the result of an acute and severe allergic reaction.
- In very rare cases, transfusion-related acute lung injury (TRALI) may occur after treatment with immunoglobulins such as Panzyga. This leads to an accumulation of fluid in the lungs that is not due to heart problems (non-cardiogenic pulmonary edema ). TRALI is characterized by severe breathing difficulties, normal heart function, and elevated body temperature (fever). Symptoms usually appear within 1 to 6 hours after treatment.
Tell your doctor or healthcare professional immediately if you notice any of the above symptoms in the meantime, or after infusion of Panzyga. He or she will decide if the infusion rate should be reduced or if the infusion should be stopped altogether or if other measures are required.
- Occasionally, immunoglobulin solutions such as Panzyga may cause a decrease in the number of white blood cells. This condition resolves spontaneously on its own within 1-2 weeks.
Effects on blood tests
Panzyga contains a variety of antibodies and some of these may affect blood test results. If you take a blood sample after receiving Panzyga, tell the person taking the sample or your doctor that you have received human normal immunoglobulin.
Virus security
When medicines are made from human blood or human plasma, special measures are taken to prevent the transmission of infection to patients. These include:
- a careful selection of blood and plasma donors to ensure that people at risk of becoming carriers are excluded
- testing of individual donations and plasma pools for signs of virus/infection
- introduction of steps in the preparation one of blood or plasma that can inactivate or remove viruses
Despite these measures, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or plasma are given. This also applies to new, hitherto unknown viruses and other types of infection.
The measures taken 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. This may be because the medicine contains antibodies against these infectious agents, which have a protective effect.
Children and young people
There are no special or additional warnings or precautions for children and adolescents.
Other drugs 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 been vaccinated in the last three months.
Panzyga may impair the effectiveness of certain vaccines (live attenuated viral vaccines) such as :
- measles
- rubella
- mumps
- chicken-pox
After administration of this drug, it should be 3 months before vaccination with live attenuated virus vaccines is given. For measles, the risk of reduced effect can persist for up to 1 year.
Panzyga with food, drink, and alcohol
No effects were noted. When using Panzyga 100 mg/ml, adequate fluid supply to the patient before infusion should be considered.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist if you can or should continue to use Panzyga.
The safety of the drug during use in human pregnancy has not been established in controlled clinical trials. It should therefore be given with caution to pregnant and lactating women. Drugs with immunoglobulins have been shown to pass through the placenta, increasing in size during the last third of pregnancy. Experience with the use of immunoglobulins does not indicate harmful effects
expected during pregnancy or on the fetus and the newborn.
Immunoglobulins are excreted in breast milk. No adverse effects are expected on the breast-fed infant/infant.
Driving and using machines
Panzyga has no or negligible effect on the ability to drive and use machines. However, patients who experience side effects during treatment should not drive or use machines until they have passed.
Panzyga contains sodium
This medicine contains 69 mg of sodium (the main ingredient in table salt/table salt) per 100 ml. This corresponds to 3.45% of the maximum recommended daily intake of sodium for adults.
This should be considered by patients on a low-salt diet.
How to use Panzyga
Your doctor will decide if you need Panzyga and what dose you should be given. Panzyga is given as an intravenous infusion ( infusion into a vein) by healthcare professionals. Dosage one and dosage one depend on the indication and may need to be individually adjusted for each patient.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Use for children and adolescents
Panzyga ( intravenously ) is given in the same way to children and adolescents (0-18 years) as to adults.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor as soon as possible if you experience any of the following serious side effects ( all of which are very rare and may occur in up to 1 in
10,000 infusions ). In some cases, the doctor may need to discontinue the infusion one and lower the dose or stop the treatment.
- Swelling of the face, tongue, and trachea can cause severe breathing problems
- Sudden allergic reaction with shortness of breath, rash, wheezing, and drop in blood pressure
- Stroke that can cause weakness and/or loss of sensation along one side of the body
- A myocardial infarction that causes chest pain
- Blood clots that cause pain and swelling in the arms and legs
- Blood clot in the lung that causes chest pain and shortness of breath
- Anemia that causes shortness of breath or pallor
- Severe kidney disease that can make you unable to urinate
- A lung disease called transfusion-related acute lung injury (TRALI) causes difficulty breathing, blue skin, fever, drop in blood pressure
If you experience any of the above symptoms, contact your doctor as soon as possible.
The following side effects have also been reported:
Common side effects ( may affect up to 1 in 10 people ):
Headache, nausea, fever
Uncommon side effects ( may affect up to 1 in 100 people ):
Skin rash, back pain, chest pain, chills, dizziness, fatigue, cough, vomiting, abdominal pain, diarrhea, joint pain, muscle pain, itching at the infusion site, skin rash, neck pain, pain in arms or legs, decreased sensation of touch or sensation, decreased number of red blood cells, decreased white blood cell count, aseptic meningitis (non-infectious meningitis, a syndrome characterized by headache, neck stiffness and mild fever) (see also section Warnings and precautions), itchy eyes, palpitations, high blood pressure, earache, stiffness, coldness, malaise, malaise, chills, numbness, altered liver function values (measured by blood tests).
Reporting of side effects ar
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.
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 carton. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Store the glass bottle in the outer carton. Sensitive to light.
Do not freeze.
The medicine can be stored outside the refrigerator for 12 months (without exceeding the expiry date) and stored between 8 ° C and 25 ° C. After this period, the medicine should not be put back in the refrigerator but should be thrown away. The date when the medicine was taken out of the refrigerator must be noted on the outer carton.
Do not use this medicine if you notice that the solution is cloudy, has precipitated, or has a strong color.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is human normal immunoglobulin (human antibody ). Panzyga contains 100 mg/ml of human protein of which at least 95% is immunoglobulin G (IgG).
- The other ingredients are glycine and water for injections.
What the medicine 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 and 30 g / 300 ml).
Pack sizes:
1 vial (1 g / 10 ml, 2.5 g / 25 ml)
1 bottle (5 g / 50 ml, 6 g / 60 ml, 10 g / 100 ml, 20 g / 200 ml, 30 g / 300 ml)
3 bottles (10 g / 100 ml, 20 g / 200 ml)
The solution is clear or slightly opalescent, colorless, or pale yellow.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Octapharma AB
112 75 Stockholm
Manufacturer:
Octapharma
72 rue du Maréchal Foch, 67380 Lingolsheim, France
Octapharma Pharmazeutika Produktionsges.mbH
Oberlaaer Strasse 235, 1100 Vienna, Austria
This medicinal product is authorized under the European Economic Area under the names:
Belgium, Bulgaria, Denmark, Estonia, Finland, France, Ireland, Iceland, Croatia, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Austria, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, UK, Sweden, Czech Republic, Germany, Hungary: Panzyga
Italy: Global