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PANZYGA 100 MG/ML SOLUTION FOR INFUSION

Active substance(s): HUMAN NORMAL IMMUNOGLOBULIN / HUMAN NORMAL IMMUNOGLOBULIN / HUMAN NORMAL IMMUNOGLOBULIN

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2017.05.02 / 135 x 420 / B.821.000.UK / DataMatrix: code is a sample / Design Satzstudio Borngräber / Versions-Nr.: 03
B.821.000.UK

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 9 months
(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
–– The active substance is human normal immunoglobulin. 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; 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
Octapharma Ltd.
The Zenith Building, 26 Spring Gardens, M2 1AB Manchester, 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
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 05/2017.
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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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.

B.821.000.UK

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Package leaflet: Information for the user

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 further questions, ask your doctor or pharmacist.
–– This medicine has been prescribed for you only. Do not pass it on to others. It
may harm them, even if their signs of illness are the same as yours.
–– If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
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 defence 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 for the treatment of children and
adults (replacement therapy). There are 4 groups
of patients where replacement therapy is used:
–– Patients with inborn deficiency of antibodies (primary immunodeficiency
syndromes, such as: congenital agammaglobulinaemia and hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiencies)
–– Patients with diseases of the blood that lead to a lack of antibodies and to
recurrent infections (Myeloma or chronic lymphatic leukaemia with severe
secondary hypogammaglobulinaemia and recurrent infections)
–– Patients who have low levels of immunoglobulins after the transplantation of
stem cells
–– Patients with congenital AIDS who have repeated bacterial infections
Panzyga can be further used in the treatment of inflammatory disorders (immunomodulation). There are 5 groups of patients:
–– 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
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.

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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.
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
–– 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 slow
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.
–– 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
slow as possible.
–– Allergic reactions are rare, but can induce an anaphylactic shock, even in
patients who had tolerated the previous treatments.
–– Strong headaches and neck stiffness may rarely occur several hours to 2 days
following Panzyga treatment.
–– 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).
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 the human normal
immunoglobulin.
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.
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.
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
–– measles
–– mumps
–– rubella
–– 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.
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.
Driving and using machines
The ability to drive and operate machines may be impaired by some adverse
reactions associated with Panzyga. 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 not more than 0.03 mmol (or 0.69 mg) sodium
per ml. 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 of Panzyga in children and adolescents (intravenously) 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:
–– 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
–– Meningitis causing strong headache
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, joint pain, muscle pain, infusion site itching, reduced sense of touch
or sensation, reduction of red blood cells, reduction of white blood cells, aseptic
meningitis, eye itching, fast beating of the heart, increased blood pressure, ear
pain, stiffness, feeling cold, 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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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