EQUINGAM 50 mg /Ml Концентрат Для Инфузионного Раствора

Содержание инструкции

1. Equingam 50 mg/mL concentrate for solution for infusion
   1. What is Equingam and what is it used for
   2. What you need to know before you are given Equingam
   3. How Equingam is administered
   4. Possible side effects
   5. How to store Equingam
   6. Contents of the pack and other information

Equingam 50 mg/mL concentrate for solution for infusion

equine anti-human T-lymphocyte immunoglobulins (eATG)

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 medicinal product. See the end of section 4 for information on how
to report adverse effects.

Read this leaflet carefully before taking this medicine as it contains important
information for you.
medicine. If this medicine is administered to your child, replace “you” with “your
child” throughout the text.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4. Contents of this leaflet:
• 1. What Equingam is and what it is used for
• 2. What you need to know before Equingam is administered to you
• 3. How Equingam is administered
• 4. Possible side effects
• 5. How to store Equingam
• 6. Contents of the pack and other information

1. What is Equingam and what is it used for

Equingam is produced by injecting human thymus cells into horses. It contains immunoglobulins
(antibodies) that attach to some of the cells of the body's immune system and destroy them.
It is used to treat a condition called aplastic anemia. Aplastic anemia develops when the body's
immune system mistakenly attacks its own cells and the bone marrow is unable to produce a
sufficient number of red blood cells, white blood cells, and platelets. When used together with
other medicines, Equingam helps the bone marrow to produce these blood cells again. It can also
help avoid the need for blood transfusions. Medicines that suppress the immune system do not cure
aplastic anemia. However, they can relieve its symptoms and reduce complications. These medicines
are often used for people who cannot undergo blood and bone marrow stem cell transplants or who are
waiting for a bone marrow transplant. Equingam can be used in children aged 2 years and older and in
adults.

2. What you need to know before you are given Equingam

Do not use Equingam

• if you are allergic to the active ingredient (equine anti-human T-lymphocyte immunoglobulins) or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to any other preparation containing equine gammaglobulins.

Warnings and precautions
Only a doctor experienced in immunosuppressive therapy can treat you with Equingam. The facility
responsible for treatment must have trained personnel with access to medical support resources. During treatment with Equingam, patients will be constantly monitored.

Talk to your doctor or nurse before receiving Equingam

• If you think you have an infection or are experiencing symptoms that may indicate an infection, such as fever, sweating, chills, muscle aches, cough, shortness of breath, warm or red or painful skin, or sores on the body, diarrhea, or stomach pain (or any other symptom listed in section 4).
• If you are to be vaccinated. Vaccines may be less effective when given with Equingam. Your doctor will decide when it is best for you to receive the vaccine. When medicines are made from blood or plasma, certain measures are taken to prevent the transmission of infections to patients. For example:
• Careful selection of blood and plasma donors to ensure that those at risk of carrying infections are excluded.
• Analysis of each blood and plasma donation and batch to identify the presence of viruses/infections.
• Inclusion of steps to inactivate or remove viruses in the processing of blood or plasma.

Despite these measures, when medicines made from blood or plasma are administered, it is not
possible to completely exclude the possibility of transmitting infections. This also applies to any
unknown or emerging viruses and other types of infections.

Pay particular attention during treatment with Equingam
Immediately inform your doctor if you experience any of these serious and potentially life-threatening side effects related to Equingam (these symptoms, which require you to contact your doctor immediately, are repeated in section 4):

• any serious infection: symptoms may include fever, sweating, chills, muscle aches, cough, shortness of breath, warm or red or painful skin, or sores on the body, diarrhea, or stomach pain;
• allergic reactions: symptoms may include a widespread rash, increased heart rate, difficulty breathing, decreased blood pressure, and weakness;
• serum sickness: an allergic reaction that causes fever, joint pain, rash, and swollen lymph nodes;
• the upper layer of the skin may detach from its normal position anywhere on the body;
• fever, swelling, chills, increased heart rate, decreased blood pressure, and difficulty breathing. These symptoms may suggest so-called cytokine release syndrome.

Other tests
The doctor will perform a blood test before you start taking Equingam, as well as during and after
treatment, to determine if you have a low number of white blood cells, a low number of red blood cells, or a decrease in platelets. If there are severe abnormalities in blood cells, treatment
with Equingam may be stopped.
To determine if you are at higher risk of developing serious allergic reactions, a skin test may be performed before treatment. This test checks for allergies to any of the components of
Equingam. The test results will help your doctor decide whether or not to administer
Equingam.
When patients with aplastic anemia are treated with Equingam, they may experience abnormal results in liver and kidney function tests.

Other medicines and Equingam
Tell your doctor if you are taking, have recently taken, or may take any other
medicines.
When the dose of corticosteroids and other immunosuppressants is reduced, some reactions to Equingam previously hidden may appear. You will be carefully monitored during the infusion of
Equingam to check for the occurrence of such reactions.

Pregnancy and breastfeeding
Pregnancy
Tell your doctor if you suspect you are pregnant.
It is not known whether Equingam has effects on the fetus during pregnancy. Therefore, it is preferable to avoid using
Equingam during pregnancy.
If you become pregnant while taking this medicine, you should inform your doctor immediately.
Women of childbearing potential must use an effective method of contraception (birth control) during treatment with Equingam and for up to 10 weeks after the last dose. Talk to your doctor for
information on the most suitable contraceptive methods for you.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed.
It is not known whether Equingam passes into breast milk. The risk to the breastfed child cannot be excluded.
You and your doctor must decide whether you should breastfeed or be treated with Equingam.

Driving and operating machinery
Equingam may affect your ability to drive and operate machinery. Caution should be exercised when driving vehicles or operating machinery during treatment
with this medicine.

Equingam contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
However, it may be prepared with a solution containing sodium. Tell your doctor if you are on a low-salt (sodium) diet.

3. How Equingam is administered

Equingam is infused into a vein by a doctor or healthcare professional. For further information,
you should consult your doctor or pharmacist.
Equingam. These instructions are intended for healthcare professionals.
Dosage recommendations are based on body weight (bw).
The recommended total dose is 160 mg/kg bw with additional immunosuppressive therapy.
You may receive Equingam as indicated below:

• 16 mg/kg bw/day for 10 days or
• 20 mg/kg bw/day for 8 days or
• 40 mg/kg bw/day for 4 days

Before administering Equingam, you may be given other medicines (such as a
corticosteroid and an antihistamine) to help prevent possible undesirable effects related
to the infusion. You may also be given a medicine to reduce fever.

If you receive more Equingam than you should
Since Equingam will be administered by a doctor or nurse, it is very unlikely that you will be
given an amount of Equingam greater than the recommended dose. If you believe that a dose of
Equingam greater than the prescribed one has been administered, contact your doctor or
nurse immediately.
If you have any doubts about the use of this medicine, contact your doctor or nurse.

If you forget to use Equingam
Since Equingam will be administered by the doctor or nurse, it is very unlikely that you will not receive the
medicine at the appropriate time. If you believe you have not received Equingam at the appropriate time, contact your doctor or
nurse immediately.
If you have any doubts about the use of this medicine, contact your doctor or nurse.

4. Possible side effects

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

Seek immediate medical attention if you experience any of these serious and potentially life-threatening side effects of Equingam (these symptoms, which require you to contact your doctor immediately, are also listed in section 2 above):

• serious infections (very common): symptoms can include fever, sweating, chills, muscle aches, cough, shortness of breath, warm or red or painful skin, or sores on the body, diarrhea or stomach pain;
• allergic reactions (uncommon): symptoms can include widespread rash, increased heart rate, difficulty breathing, decreased blood pressure and weakness;
• serum sickness (very common): an allergic reaction that causes fever, joint pain, rash and swollen lymph nodes;
• the upper layer of skin detaching from its normal position in any part of the body (frequency not known).

Other side effects
Very common: may affect more than 1 in 10 people

• low number of white blood cells
• rashes, skin redness, itching and skin irritation
• pain, including joint pain, back pain, chest pain, muscle pain, of hands and feet, of the hips
• fever, chills, headache
• infections (bacterial and viral)
• high or low blood pressure
• diarrhea, abdominal pain, nausea, vomiting
• swelling of arms or legs
• abnormal liver function tests

Common: may affect up to 1 in 10 people

• red blood cell breakdown
• enlarged or swollen lymph nodes
• dizziness, fainting, feeling unwell
• seizure
• tingling or numbness of hands or feet
• fast or slow heart rate
• swelling and pain in a part of the body caused by a blood clot located in the vein
• shortness of breath or difficulty breathing, temporary cessation of breathing
• hives
• nosebleeds
• cough
• fluid in the lungs
• bleeding in the stomach or intestines
• mouth sores, swelling of the mouth, mouth pain
• increased blood sugar
• kidney abnormalities, kidney failure

Uncommon: may affect up to 1 in 100 people

• agitation
• redness, swelling, pain at the infusion site
• swelling around the eyes
• low number of platelets

Not known: frequency cannot be estimated from available data

• painful swelling of the brain, painful swelling of blood vessels
• difficulty moving, muscle stiffness
• confusion, tremors
• heart failure
• blood clot in the blood vessels of the intestine, hole in the intestine (perforation)
• spasm in the throat, hiccups
• excessive sweating, night sweats
• opening of a wound
• failure to develop cells
• loss of strength or energy

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

5. How to store Equingam

Keep this medicine out of the sight and reach of children.
The following information is intended for the doctor or nurse responsible for the storage, handling and disposal of Equingam.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”. The expiry date refers to the last day of that month.
Store the vials in a refrigerator (2°C - 8°C). Do not freeze. Keep the vial in the outer packaging to protect the medicine from light.
The diluted solution can be stored at room temperature (20°C - 25°C). The solution must be used within 24 hours (including the infusion time).
From a microbiological point of view, unless the opening/dilution method avoids the risk of microbial contamination, opened vials or the medicine contained in syringes must be used immediately. If not, the storage times and conditions before use are the responsibility of the user and dilution must occur under controlled and validated aseptic conditions.

6. Contents of the pack and other information

What Equingam contains

• The active substance is equine anti-human T-lymphocyte immunoglobulin. Each vial of sterile concentrate contains 250 mg of equine anti-human T-lymphocyte immunoglobulin.
• The other ingredients are glycine, water for injections, sodium hydroxide (for pH adjustment) and hydrochloric acid (for pH adjustment) (see section 2 “Equingam contains sodium”). Description of the appearance of Equingam and contents of the pack

Equingam is a sterile, transparent or slightly opalescent aqueous solution, from colourless to light pink or light brown.
During storage, it may develop a slight deposit of granules or floccules.
It is available in a box of 5 vials, each containing 5 mL of sterile concentrate.

Marketing authorisation holder and manufacturer
Pfizer S.r.l.
Via Isonzo, 71
04100 Latina
Italy

Manufacturer
Pfizer Service Company BV
Hoge Wei 10
Zaventem, 1930
Belgium
For any information on this medicinal product, please contact the local representative of the Marketing
Authorisation Holder.

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) with the following denominations:
Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Latvia,
Luxembourg, Netherlands, Norway, Poland, Romania, Slovenia, Sweden, United
Kingdom (Northern Ireland)
Atgam
Italy Equingam

Other sources of information
Detailed information on this medicinal product is available on the website of the Italian Medicines Agency.
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The following information is intended exclusively for healthcare professionals:

Preparation of the infusion solution
Since Equingam is a gammaglobulin, the concentrate and the diluted solution must be visually inspected
for the presence of particulate matter or colour change before administration, whenever the solution and
container permit. The concentrate and diluted solution should be transparent or slightly opalescent, from
colourless to light pink or light brown, and both may develop a slight deposit of granules or floccules
during storage.
Equingam (diluted or undiluted) should not be shaken as this may cause excessive foaming and/or protein
denaturation. The Equingam concentrate must be diluted before infusion by inverting the container of the
sterile diluent so that undiluted Equingam does not come into contact with the air inside.
Add the total daily dose of Equingam to an inverted vial or bag of one of the following sterile diluents:

• 0.9% sodium chloride solution;
• glucose/sodium chloride solution:
• 50 mg/mL (5%) glucose in 0.45% (4.5 mg/mL) sodium chloride solution;
• 50 mg/mL (5%) glucose in 0.225% (2.25 mg/mL) sodium chloride solution.

Due to the possible precipitation of Equingam, it is not recommended to dilute it with glucose solution alone.
The recommended concentration of diluted Equingam is 1 mg/mL in the chosen diluent. The concentration
should not exceed 4 mg/mL of Equingam.
The Equingam diluted solution should be rotated or gently swirled to mix it thoroughly.
Once diluted, for intravenous administration only.
Diluted Equingam must reach room temperature (20°C - 25°C) before infusion. Infusion volumes of 250 mL to
500 mL can be used. Equingam must be administered into a central high-flow vein through an in-line filter
(0.2-1.0 micron).
For all Equingam infusions, an in-line filter (not supplied) must be used to prevent the administration of
insoluble material that may develop in the product during storage.
It is recommended to use the solution immediately after dilution. Diluted Equingam must be stored at room
temperature (20 °C-25 °C) if not used immediately. The total time in dilution should not exceed 24 hours
(including infusion time).
From a microbiological point of view, unless the opening and dilution method avoids the risk of microbial
contamination, the product must be used immediately.
Unused medicinal product and waste derived from such medicinal product must be disposed of in accordance
with local regulations.