Patient Leaflet Updated 19-Jun-2019 | Octapharma Limited
Panzyga 100 mg/ml solution for infusion
Package leaflet: Information for the user
Panzyga, 100 mg/ml solution for infusion
Human Normal Immunoglobulin (IVIg)
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Panzyga is and what it is used for
2. What you need to know before you use Panzyga
3. How to use Panzyga
4. Possible side effects
5. How to store Panzyga
6. Contents of the pack and other information
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:
Panzyga can be further used in the treatment of the following autoimmune disorders (immunomodulation):
2. What you need to know before you use Panzyga
Do NOT use Panzyga:
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 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
When may slowing or stopping the infusion be required?
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.
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:
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.
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.
Panzyga may impair the effect of live attenuated virus vaccines such as
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, 100 mg/ml with food, drink and alcohol
No effects have been observed. While using Panzyga, 100 mg/ml 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 medicinal product 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.
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:
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, nausea, fever
Uncommon side effects (may affect up to 1 in 100 infusions):
Skin rash, back pain, chest pain, chills, dizziness, feeling tired, cough, vomiting, belly pain, diarrhoea, joint pain, muscle pain, infusion site itching, rash, neck pain, pain in arm or leg, reduced sense of touch or sensation, reduction of red blood cells, reduction of white blood cells, aseptic meningitis (see also section Warnings and Precautions), eye itching, fast beating of the heart, increased blood pressure, ear pain, stiffness, feeling cold, feeling hot, feeling unwell, shiver, numbness, changes in blood tests that report on how the liver is working.
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. 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 12months (without exceeding the expiry date) and stored above +8°C and below +25°C. At the end of this period, the product should not be refrigerated again and should be disposed of. The date at which the product was taken out of the refrigerator should be recorded 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
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; 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, colourless or slightly yellow.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturers
This medicinal product is authorised in the member states of the EEA 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, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom: Panzyga®
Italy: Globiga®
This leaflet was last approved in 05/2019.
20190503
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http://www.octapharma.co.uk
+44 (0)161 837 3799