GLOBIGA 100 mg /Ml Infusion Solution

Зміст інструкції

1. Globiga
   1. What is Globiga and what is it used for
   2. What you need to know before using Globiga
   3. How to use Globiga
   4. Possible side effects
   5. How to store Globiga
   6. Contents of the pack and other information

Globiga

100 mg/ml solution for infusion
Normal human immunoglobulin (IVIg)

Read this leaflet carefully before you use this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Globiga is and what it is used for
• 2. What you need to know before you use Globiga
• 3. How to use Globiga
• 4. Possible side effects
• 5. How to store Globiga
• 6. Contents of the pack and other information

1. What is Globiga and what is it used for

What is Globiga
Globiga is a solution of normal human immunoglobulins (IgG), meaning a solution of human antibodies,
for intravenous administration (i.e., infusion into a vein). Immunoglobulins are normal
constituents of human blood and support the body's immune defense. Globiga contains only
IgG present in blood from healthy people. With adequate doses of Globiga, it is possible to restore
abnormally low levels of IgG, bringing them back into the normal range.
Globiga contains a broad spectrum of antibodies against various infectious agents.

What is Globiga used for
Globiga 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 syndromes, for example: agammaglobulinemia and congenital hypogammaglobulinemia, common variable immunodeficiency, severe combined immunodeficiencies
• Patients with an acquired antibody deficiency (secondary immunodeficiency) caused by specific diseases and/or treatments and who experience severe or recurrent infections

Globiga can be used for the treatment of susceptible adults, children and adolescents (0-18 years)
who have been exposed to measles or are at risk of exposure to measles, and in whom active
vaccination against measles is not indicated or is not recommended.
Globiga can also be used in the treatment of the following autoimmune disorders
(immunomodulation):

• In patients with immune thrombocytopenia (ITP), a condition in which platelets decrease because they are destroyed, who have a high risk of bleeding or who require correction of the platelet count before surgery
• In patients with Kawasaki disease, a condition that causes inflammation of various organs
• In patients with Guillain Barré syndrome, a condition that causes inflammation of parts of the nervous system
• In patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a disease that causes chronic inflammation of the peripheral parts of the nervous system which causes muscle weakness and/or numbness, especially in the legs and arms
• In patients with multifocal motor neuropathy (MMN), a disease characterized by slowly progressive weakness of the limbs without loss of sensation.

2. What you need to know before using Globiga

DO NOT use Globiga:

• if you are allergic to normal human immunoglobulins or to any of the other ingredients of Globiga (listed in section 6).
• if you have a deficiency of immunoglobulin A (IgA deficiency) and if you have developed antibodies against IgA-type immunoglobulins.

Warnings and precautions
Talk to your doctor or pharmacist before using Globiga.
It is strongly recommended to record, with each administration of Globiga, the name and lot number of the product to maintain traceability of the batch used.
Some adverse reactions may occur more frequently:

• in case of high infusion rate
• when you receive Globiga for the first time or, in rare cases, after a prolonged interval from the previous infusion.
• when you have an untreated infection or an underlying chronic inflammation

In case of an adverse reaction, the doctor will reduce the administration rate or stop the infusion.
Treatment of the adverse event will depend on the nature and severity of the event itself.
Circumstances and conditions that increase the risk of undesirable effects

• Very rarely, after the administration of Globiga, thromboembolic events such as myocardial infarction, stroke and obstruction of a deep vein, for example in the calf, or of a blood vessel in the lungs, may occur. These events occur more commonly in patients with risk factors such as obesity, advanced age, high blood pressure, diabetes, previous thromboembolic events, prolonged periods of immobilization, taking certain hormones (e.g. oral contraceptive pill). It is necessary to take fluids in a balanced way and administer Globiga as slowly as possible.
• If you have had kidney problems in the past, or if you have some risk factors such as diabetes, overweight, age over 65 years, Globiga must be administered as slowly as possible, because cases of acute renal failure have been reported in patients with these risk factors. Tell your doctor about these situations, even if they have occurred in the past.
• Patients with blood group A, B or AB and patients with certain inflammatory conditions are at greater risk of red blood cell destruction by the administered immunoglobulins (hemolysis).

When may it be necessary to slow down or stop the infusion?

• Severe headache and neck stiffness may occur a few hours to 2 days after treatment with Globiga.
• Allergic reactions are rare, but can cause anaphylactic shock, even in patients who have tolerated previous treatments. A sudden drop in blood pressure or shock may be a consequence of an anaphylactic reaction.
• In very rare cases, acute transfusion-related lung injury (TRALI) may occur after the administration of immunoglobulins, including Globiga. This can cause fluid to accumulate in the air spaces of the lungs not due to cardiac causes. You will recognize TRALI in case

of severe difficulty in breathing, normal heart function and increased temperature (fever). Symptoms usually appear within 1-6 hours of treatment administration.
Immediately inform your doctor or healthcare provider if you experience any of the symptoms described above during or after the infusion with Globiga. He/she will decide whether to reduce the infusion rate or completely stop the infusion, or whether further measures are necessary.

• Sometimes immunoglobulin solutions, such as Globiga, can trigger a decrease in the number of white blood cells. This condition generally resolves spontaneously within 1-2 weeks.

Effects on blood tests
Globiga contains a wide variety of different antibodies, some of which may alter blood tests. If you have taken Globiga and need to have a blood test, tell the personnel taking the sample or your doctor that you have received a normal human immunoglobulin solution.
Viral safety
When medicines are made from human blood or plasma, certain measures are taken to prevent the transmission of infections to patients. These measures include:

• careful selection of blood and plasma donors, to ensure that donors at risk of carrying infections are excluded
• performing tests on each donation and plasma pool to exclude the presence of viruses or infections
• specific procedures adopted by manufacturers in the processing of blood or plasma, to inactivate or remove viruses.

Despite these measures, when administering medicines prepared from human blood or plasma, it is not possible to completely exclude the possibility of transmitting infections. This applies also to unknown or emerging viruses or other types of infections.
These measures are considered effective for enveloped viruses such as HIV (human immunodeficiency virus), hepatitis B virus and hepatitis C virus, and for non-enveloped viruses such as hepatitis A virus and parvovirus B19.
Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, probably because the antibodies that fight these infections are contained in the product and have a protective effect.

Children and adolescents
There are no specific or additional warnings or precautions for children and adolescents.

Other medicines and Globiga
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription, or if you have received a vaccine in the last three months.
During treatment with Globiga, concomitant use of medicines that increase water elimination from the body (loop diuretics) should be avoided. The doctor will decide whether you should use or continue treatment with loop diuretics.
Globiga may alter the effect of live attenuated virus vaccines such as

• measles
• rubella
• mumps
• varicella.

After the administration of this product, an interval of 3 months must pass before the administration of a live attenuated virus vaccine. In the case of measles, impairment may persist for up to 1 year.

Globiga with food, drinks and alcohol
No effects have been observed. During the use of Globiga, adequate hydration should be provided before the infusion.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist if you can take Globiga or continue treatment with Globiga.
The safety of use of this medicine during pregnancy in humans has not been evaluated in controlled clinical studies, so it should be administered only with extreme caution in pregnant or breastfeeding women. Immunoglobulin-based products have been shown to cross the placenta, increasingly during the third trimester of pregnancy. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy or on the fetus and newborn are to be expected.
Immunoglobulins are excreted in breast milk. No adverse effects on infants/newborns are expected.

Driving and using machines
Globiga does not impair or negligibly impairs the ability to drive vehicles and use machines.
However, patients who experience adverse reactions during treatment should wait for the reactions to resolve before driving vehicles or using machines.

Globiga contains sodium
This medicine contains 69 mg of sodium (the main component of table salt) per 100 ml vial. This is equivalent to 3.45% of the recommended daily intake with the diet of an adult.
To be taken into consideration for patients following a low-sodium diet.

3. How to use Globiga

Your doctor will decide if you need Globiga and at what dose. Globiga is administered via
intravenous infusion (infusion into a vein) by clinical personnel. The dose and dosage regimen
depend on the indication and may need to be adjusted to the individual patient.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

Use in children and adolescents
The administration (by intravenous route) of Globiga in children and adolescents (0-18 years) is not
different from the administration in adults.

If you receive more Globiga than you should
An overdose is very unlikely to occur, because Globiga is generally administered
under medical supervision. However, if you should receive more Globiga than
you should, your blood may become too thick (hyperviscous) and this may increase the risk of
developing clots. This can happen especially in patients at risk, such as the elderly or
patients with heart or kidney disease. Make sure to maintain adequate hydration. Inform your
doctor if you have any known medical conditions.

If you forget to use Globiga
Contact your doctor to discuss how to proceed.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor as soon as possible if you experience any of the following side effects (they are all
very rareand can affect up to 1 infusion in 10,000). In some cases your doctor may need to
suspend treatment and reduce the dose or stop treatment:

• Swelling of the face, tongue and trachea, which can cause great difficulty in breathing
• A sudden allergic reactionwith shortness of breath, rash, wheezing and decreased blood pressure
• Strokewhich can cause weakness and/or loss of sensation on one side of the body
• Heart attackwhich can cause chest pain
• Blood clotwhich can cause pain and swelling in the limbs
• Blood clot in the lungwhich causes chest pain and difficulty breathing
• Anemiawhich causes shortness of breath or pale appearance
• Severe kidney diseasewhich can cause inability to urinate
• A lung conditioncalled acute respiratory distress syndrome (ARDS) which causes difficulty breathing, bluish skin discoloration, fever, a decrease in blood pressure

If you experience any of the symptoms listed above, seek immediate medical attention.
The following side effects have also been reported:

Common side effects(may occur in up to 1 infusion in 10):
Headache, nausea, fever

Uncommon side effects(may occur in up to 1 infusion in 100):
Rash, back pain, chest pain, chills, dizziness, fatigue, cough, vomiting,
abdominal pain, diarrhea, joint pain, muscle pain, itching at the infusion site, rash,
neck pain, arm or leg pain, reduced tactile sensitivity, reduced red blood cells, reduced white blood cells, aseptic meningitis (see also section “Warnings and
precautions”), itchy eyes, fast heartbeat, increased blood pressure, ear pain, stiffness, feeling cold, feeling hot, feeling unwell, chills,
numbness, changes in blood tests related to liver function.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Globiga

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 on the pack. The expiry
date refers to the last day of that month.
Store in a refrigerator (2°C-8°C). Keep the container in the outer packaging to protect it
from light. Do not freeze.
The product may be removed from the refrigerator for 12 months (without exceeding the expiry date) and
stored between +8°C and +25°C. During this period, the product must not be returned to the refrigerator.
Dispose of the product if it is not used during this period or after the expiry date, whichever
occurs first. Note the date on which the product was removed from the refrigerator
on the outer pack.
Do not use this medicine if you notice that the solution is cloudy, contains visible particles or has an
intense colour.
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. Contents of the pack and other information

What Globiga contains

• The active ingredient is normal human immunoglobulin (human antibodies). Globiga contains 100 mg/ml of human protein, of which at least 95% are immunoglobulin G (IgG).
• The other ingredients are glycine and water for injections.

Description of Globiga and contents of the pack
Globiga is a solution for infusion 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).
Packs:
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 x 10 g/100 ml or 3 x 20 g/200 ml).
Clear or slightly opalescent solution, from colourless to pale yellow.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
OCTAPHARMA ITALY S.p.A.
Via Cisanello, 145
56100 Pisa
Italy

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 European Economic Area and in the United
Kingdom (Northern Ireland) under the following denominations:
Austria, Belgium, Bulgaria, Croatia, Denmark,
Estonia, Finland, France, Germany, Ireland,
Iceland, Latvia, Lithuania, Luxembourg, Malta,
Norway, Netherlands, Portugal, United Kingdom
(Northern Ireland), Czech Republic, Slovak Republic, Romania, Slovenia, Spain, Sweden,
Hungary:
Panzyga
Italy: Globiga

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The following information is intended for healthcare professionals only:

• The product must be brought to room temperature or body temperature before use.
• The solution should be clear or slightly opalescent and from colourless to slightly yellow.
• Do not use if the solution is turbid or contains visible particles.
• Unused medicinal product and waste materials derived from such medicinal product should be disposed of in accordance with local regulations.
• This medicinal product must not be mixed with other medicinal products.
• To administer any product that may remain in the infusion tubes at the end of the infusion, the tubes can be flushed with 0.9% saline solution (9 mg/ml) or 5% dextrose solution (50 mg/ml).