YIMMUGO 100 mg /Ml Infusion Solution

Зміст інструкції

1. Yimmugo 100 mg/ml solution for infusion
   1. What is Yimmugo and what is it used for
   2. What you need to know before using Yimmugo
   3. How to use Yimmugo
   4. Possible side effects
   5. How to store Yimmugo
   6. Package Contents and Other Information

Yimmugo 100 mg/ml solution for infusion

Normal human immunoglobulin (IVIg)
Medicinal product subject to additional monitoring. This will allow the rapid identification of new
safety information. You can contribute by reporting any adverse effects experienced
during the use of this medicine. See the end of section 4 for information on how
to report adverse effects.

Read this leaflet carefully before using this medicine as 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.
• 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 Yimmugo is and what it is used for
• 2. What you need to know before using Yimmugo
• 3. How to use Yimmugo
• 4. Possible side effects
• 5. How to store Yimmugo
• 6. Contents of the pack and other information

1. What is Yimmugo and what is it used for

Yimmugo

• belongs to the class of medicines called “normal human immunoglobulins”. These medicines

contain human antibodies, which are also present in your blood. Antibodies can help
the body prevent and fight infections.

Yimmugo is used for the treatment ofadults, children and adolescents (0-18 years) who do not have
sufficient antibodies (replacement therapy):

• 1. Patients born with a deficiency of antibodies (primary immunodeficiency syndromes, PID)
• 2. Acquired deficiency of antibodies (secondary immunodeficiency syndrome, SID) in patients who suffer from severe or recurrent infections and ineffective antimicrobial treatment, with documented defect of specific antibodies or with low levels of Immunoglobulin G (<4 g l)< li>

Yimmugo is also used for the treatment of adults, children and adolescents (0-18 years) with
inflammatory diseases (immunomodulation), such as:

• 1. Patients with a deficiency of platelets in the blood (immune thrombocytopenic purpura, ITP) who will undergo surgery in the near future or who are at risk of bleeding
• 2. Patients affected by a disease associated with multiple inflammations of the peripheral nerves (Guillain-Barré syndrome)
• 3. Patients affected by a disease that leads to inflammation of various organs of the body, particularly the blood vessels (Kawasaki disease)
• 4. Patients affected by a chronic disease characterized by inflammation of the peripheral nerves. This disease causes muscle weakness and/or numbness especially in the legs and upper limbs (chronic inflammatory demyelinating polyneuropathy, CIDP)
• 5. Patients affected by a disease of the motor nerves, characterized by slowly progressive weakness of the arms and legs (multifocal motor neuropathy, MMN)

2. What you need to know before using Yimmugo

Do not use Yimmugo

• if you are allergic to human immunoglobulinsor to any of the other ingredients of this medicine (listed in section 6).
• if you have insufficient amounts of immunoglobulin A (IgA), especially if you haveantibodiesdirected against IgAin your blood. This can lead to serious allergic reactions (anaphylaxis).

Warnings and precautions
Before using this medicine:
Consult your doctor, pharmacist or nurse before using Yimmugo:

• if you have an active infectionor an underlying chronic inflammation
• if you are allergicto immunoglobulins (see "Do not use Yimmugo")
• if you have or have had a kidney disease
• if you have been given medicines that can damage the kidneys

In very rare cases, immunoglobulins can increase the risk of heart attack, stroke, pulmonary embolism or deep vein thrombosis. Consult your doctor, pharmacist or nurse:

• if you are overweight, elderlyor diabetic
• if you have high blood pressure, a reduced blood volume(hypovolemia) or blood that is more viscous than normal(high blood viscosity)
• if you have been confined to bedfor a long time, have problems with blood vessels(vascular diseases) or other risk factors for thrombotic events(blood clots)

In all these cases, your doctor will monitor you particularly closely.

Monitoring will be necessary during and after the infusion:

• if you have never received this medicine before or if it has been a long time (e.g. several weeks) since you last received it (monitoring after the infusion: at least 1 hour by the doctor or nurse)
• if Yimmugo has been given to you recently (monitoring after the infusion: at least 20 minutes by the doctor or nurse)

It may be necessary to slow down or stop the infusion:

• if you experience symptoms such as headache, flushing, chills, muscle pain, wheezing, rapid heartbeat, lower back pain, nausea and low blood pressureduring the infusion. These can rarely be signs of an allergic reaction. Another reason may be that the infusion rate is too high and needs to be reduced (in this case, it is referred to as an infusion-related reaction). Inform your doctor immediatelyof any symptoms that appear during the infusion
• if you have severe difficulty breathing(respiratory distress), rapid breathing(tachypnea), abnormally low oxygen levels in the blood (hypoxia) and an increased body temperature(fever). These are symptoms of acute transfusion-related lung injury(TRALI). TRALI occurs very rarely after the administration of immunoglobulins. This condition leads to an accumulation of fluid, not due to heart problems, in the air spaces of the lungs (non-cardiogenic pulmonary edema). Symptoms typically appear 1 to 6 hours after treatment. Inform your doctor immediatelyif you notice these types of reactions during Yimmugo infusions. The doctor will immediately stop the infusion.
• if you experience fever, neck stiffnessand headache. These are symptoms of aseptic meningitis syndrome(AMS, inflammation of the membrane covering the brain and spinal cord). AMS has been reported in association with immunoglobulin infusion. Discontinuation of immunoglobulin treatment has led to remission of AMS within a few days,

without further consequences. Your doctor can provide you with more information about this disease and its symptoms.
Based on your situation, your doctor will determine the appropriate infusion rate and duration of treatment, and decide whether treatment with Yimmugo should be discontinued and/or whether other medical measures should be taken.

Effects on red blood cells and blood tests

• This medicine may contain antibodies directed against blood group antigens. Rarely, these can increase the risk of red blood cell breakdown (hemolysis). Your doctor will check for clinical signs and symptoms of hemolysis and hemolytic anemia.
• Low levels of white blood cells (neutropenia) have been reported with immunoglobulins. This condition resolves spontaneously within 7-14 days. Your doctor can provide you with more information about the symptoms.
• For a certain period, Yimmugo may affect blood tests. Before undergoing any blood tests, inform your doctor about the treatment with Yimmugo.

Safety information regarding infections
Yimmugo is made from human plasma (the liquid part of blood). For medicines derived from blood or human plasma, all necessary measures are taken to prevent the transmission of infectious agents to the patient with the administration of these medicines. All blood donors are tested for viruses and infections. In addition, the processing of blood or plasma includes steps to inactivate or remove viruses.
Despite these precautionary measures, the risk of transmitting infections can never be completely eliminated when administering medicines derived from blood or human plasma.
The measures taken are considered effective against enveloped viruses, such as:

• the human immunodeficiency virus (HIV)
• the hepatitis B virus (HBV)
• the hepatitis C virus (HCV)
• the hepatitis A virus (HAV)
• parvovirus B19

Your doctor is strongly recommended to record the name and batch number of the product each time you are given a dose of Yimmugo. The batch number provides information about the specific starting material of the medicine you receive. If necessary, it will then be possible to trace the starting material used for you.

Children and adolescents
The special warnings and precautions listed for adults also apply to children and adolescents.

Other medicines and Yimmugo
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Yimmugo may reduce the effectiveness of some vaccines, such as those for

• measles
• rubella
• mumps
• chickenpoxYou may need to wait up to 3 months before being vaccinated with certain vaccines, and up to a year before being vaccinated against measles.

Do not use loop diuretics(medicines that increase fluid excretion by the kidneys) together with Yimmugo.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor for advice before taking this medicine.
The doctor will decide whether Yimmugo can be used during pregnancy and breastfeeding.

Driving and operating machinery
Yimmugo slightly impairs the ability to drive and operate machinery. If you experience reactions such as nausea or dizziness, you should wait until these reactions have disappeared before driving or operating machinery.

3. How to use Yimmugo

Dosage and route of administration
Yimmugo is intended exclusively for intravenous administration (intravenous infusion) and will be
administered to you by a doctor or nurse. The doctor will determine the dose, frequency and infusion rate
based on your disease and body weight. The product must be brought to room temperature or body
temperature before use.
At the beginning of treatment, the infusion rate will be slow. Afterwards, if you tolerate it well, the doctor or
nurse may gradually increase the infusion rate.

Use in children and adolescents
Use in children and adolescents (0-18 years) is identical to that in adults.

If an infusion is missed
Contact your doctor to decide how to proceed.

If you have been given too much Yimmugo
The blood may become too thick (hyperviscous). This can happen especially in children, the
elderly, or in case of heart or kidney problems. Remember to drink adequate fluids so as not to
become dehydrated and inform your doctor of any medical problems.
If you have any doubts about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Immediately inform your doctor if you notice any of the following effects:

• skin rash
• itching
• wheezing
• difficulty breathing
• swelling of the eyelids, face, lips, throat or tongue
• extremely low blood pressure with symptoms such as dizziness, confusion, fainting, rapid pulse This may be an allergic reaction or, in rare cases, a severe allergic reaction (anaphylactic shock) or a hypersensitivity reaction.

The following side effects have been reported during controlled clinical trials conducted with
Yimmugo.
The frequencies reported below are calculated based on the number of patients treated.

Very common(may affect more than 1 in 10 people)

• headache

Common(may affect up to 1 in 10 people)

• dizziness
• fatigue (tiredness), chills, fever
• nausea, abdominal pain or oral pain
• increased blood pressure, positive Coombs' test
• skin reaction
• back pain, pain in the arms and legs
• difficulty breathing (dyspnea), pain in the mouth and throat (oropharyngeal pain)
• decreased number of white blood cells (neutropenia), decreased number of red blood cells (hemolysis)
• difficulty maintaining balance (vertigo), ringing in the ears (tinnitus)
• allergic/anaphylactic reaction
• confusion
• hot flushes

Immunoglobulin-containing products in general can also cause the following side effects
(in decreasing order of frequency):

• vomiting, joint pain and low blood pressure
• decreased number of red blood cells, due to the breakdown of these cells in the blood vessels (hemolytic reactions (reversible)) and hemolytic anemia requiring transfusions
• sudden decrease in blood pressure and, in isolated cases, anaphylactic shock
• temporary skin reactions (including cutaneous lupus erythematosus)
• formation of blood clots that can enter the circulation (thromboembolic reactions) causing a heart attack (myocardial infarction), a stroke, clots in the blood vessels of the lung (pulmonary embolism), clots in a vein (deep vein thrombosis)
• cases of temporary acute inflammation of the protective membranes covering the brain and spinal cord (reversible aseptic meningitis)
• blood test results indicating that kidney function is impaired and/or sudden kidney failure
• cases of acute lung injury related to transfusion (TRALI), see also section “Warnings and precautions”

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
adverse
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Yimmugo

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 package after
Exp.
Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original package to
protect the medicine from light.
Yimmugo can be stored at room temperature (up to 25°C) for a single period not
exceeding 6 months. Note the date of commencement of storage of Yimmugo at room temperature
on the product packaging. Do not return Yimmugo to the refrigerator after storing it at room
temperature.
After first opening, immediate use is recommended.
Do not use this medicine if the solution is cloudy or contains deposits.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Yimmugo contains

• The active ingredient is Normal Human Immunoglobulin. 1 ml contains 100 mg of normal human immunoglobulin (purity: at least 96% IgG). The distribution of IgG subclasses is approximately 62% IgG1, 32% IgG2, 4% IgG3 and 1% IgG4. The maximum content of IgA is 500 micrograms/ml.
• The other ingredients are: glycine, polysorbate 80 and water for injections.

Description of the appearance of Yimmugo and contents of the pack
Yimmugo is a solution for infusion. The solution should be clear or slightly opalescent and
from colourless to pale yellow.
50 ml, 100 ml or 200 ml of solution in a vial (type II glass) with a stopper (bromobutyl) and a
snap-on closure cap (plastic).
Pack of 1 vial containing 50 ml, 100 ml or 200 ml of solution.
Pack of 3 vials containing 100 ml or 200 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Biotest Pharma GmbH
Landsteinerstrasse 5
63303 Dreieich
Germany
Tel.: + 49 6103 801-0
Fax: + 49 6103 801-150
E-mail: [email protected]
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The following information is intended for healthcare professionals only:
Dosage and Administration
The recommended dosages are summarised in the following table:

Method of administration
Intravenous use.
Infuse Yimmugo intravenously at an initial rate not exceeding 0.3 ml/kg/h for
30 minutes. See section 2. If adverse reactions occur, the rate of
administration must be reduced or the infusion stopped. If well tolerated, the infusion rate may be
gradually increased to a maximum of 2 ml/kg/h for the first infusion. For subsequent
infusions, if well tolerated, the infusion rate may be gradually increased to a
maximum of 6 ml/kg/h.

Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or
with other IVIg-containing products.