powder and liquid for infusion, solution
human normal immunoglobulin
1. What Gammagard S / D is and what it is used for
Gammagard S / D belongs to a group of medicines called immunoglobulins. These medicines contain human antibodies, which are also found in your blood. Antibodies help your body fight infection. Medicines such as Gammagard S / D are used in patients who do not have enough antibodies in their blood and who often suffer from infections. They can also be used in patients who need additional antibodies to treat certain inflammatory diseases (autoimmune diseases).
Gammagard S / D is used for:
Treatment of patients who do not have enough antibodies ( substitution therapy ). There are five groups:
- Patients with congenital deficiency of antibody production (primary immunodeficiency syndrome)
- Patients with cancer of the blood ( chronic lymphocytic leukemia ) leading to a lack of antibody production and recurrent infections , where antibiotics for preventive purposes have not worked.
- Patients with bone marrow cancer (multiple myeloma ) and lack of antibody production with recurrent infection , and who have not responded to vaccines against certain bacteria ( pneumococci ).
- Children and adolescents (0 to 18 years) with AIDS from birth and recurrent bacterial infection .
- Patients with low antibody production after transplantation of bone marrow cells from another person.
Treatment of patients with certain inflammatory diseases (immune modulation). There are three groups:
- Patients who do not have enough platelets (primary immunothrombocytopenia) and who are at high risk of bleeding or who need surgery shortly.
- Patients who have a disease that causes multiple inflammation in the body’s nerves ( Guillain-Barré syndrome ).
- Patients who have a disease that causes several inflammation in several of the body’s organs (Kawasaki disease).
2. What you need to know before using Gammagard S / D
Do not use Gammagard S / D
- if you are allergic to human normal immunoglobulin, especially if you have antibodies to immunoglobulin A ( IgA ) in your blood or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Gammagard S / D.
How long monitoring is required during infusion one
The risk of side effects may be greater:
- if Gammagard S / D is administered at high speed
- if you suffer from a condition with low levels of antibodies in the blood (hypo- or agammaglobulinemia)
- if you have not been given this medicine before or if it has been a long time since you received it (eg several weeks).
You will be closely monitored during infusion one and one hour after the end of infusion one, to ensure that you do not suffer a reaction. If you have already received Gammagard S / D before and received the latest treatment recently, you will be observed during infusion one and for at least 20 minutes after infusion one. Your doctor will make sure that the speed at which Gammagard S / D is given is right for you.
If the infusion rate needs to be reduced or the infusion stopped
In rare cases, your body may have previously reacted to specific antibodies and may therefore be sensitive to drugs that contain antibodies. This is especially true if you suffer from immunoglobulin A deficiency. In these rare cases, you may experience allergic reactions such as a sudden drop in blood pressure or shock, even if you have been treated with medicines such as Gammagard S / D before.
If you experience any of the following reactions during infusion one with Gammagard S / D, tell your doctor or nurse immediately:
- Sudden wheezing, difficulty breathing or pressure over the chest
- Headache
- Fever
- Swelling of eyelids, face, lips or blood vessels
- Lumps on the skin or red itchy rash
- Itching all over the body
Your doctor will decide if the infusion rate should be reduced or the infusion a stopped completely.
Special patient groups
Your doctor will be extra careful if you are overweight, elderly, or unable to move. Talk to your doctor or nurse before receiving Gammagard if you have:
- diabetes
- high blood pressure
- small blood volume ( hypovolemia )
- elevated blood viscosity or problems with blood vessels (vascular diseases).
Your doctor will then observe you carefully. In these conditions, immunoglobulins may increase the risk of heart attack, stroke, pulmonary embolism, or deep vein thrombosis. However, this is very rare.
Tell your doctor or nurse:
- if you have or have ever had kidney problems
- If you are taking medicines that can damage the kidneys (nephrotoxic medicines), there is a very small risk of acute kidney failure .
- if you have kidney disease.
The protein content can increase the viscosity of the blood. Your doctor will take special precautions.
Impact on blood test results
Gammagard S / D contains a variety of antibodies and some of these may affect blood tests. If you are taking a blood sample after receiving Gammagard S / D, you should inform the person taking the blood sample or your doctor that you are taking this medicine.
Information about the original material in Gammagard S / D
When medicines are made from human plasma or blood, special measures are taken to prevent the transmission of infection to patients. This includes careful selection of blood and plasma donors to ensure that people at risk of being infected are excluded, as well as testing of individual donations and plasma pools for signs of virus/infection. The manufacturers of these products also include steps in the processing of blood and plasma that can inactivate and secrete viruses. Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or plasma are given. This also applies to new, hitherto unknown viruses as well as other types of infection er.
The measures taken are considered to be effective against enveloped viruses, such as HIV, hepatitis B, and hepatitis C viruses.
The measures may be of limited value against non-enveloped viruses such as hepatitis A virus and parvovirus B19.
When you are given Gammagard S / D, it is recommended that the product name and batch number be registered to enable the tracking of the used product.
Other medicines and Gammagard S / D
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
- If you have been vaccinated during the last 6 weeks and up to three months, infusion of immunoglobulins such as Gammagard S / D may affect the effect of some live virus vaccines, e.g. measles, rubella, mumps and chickenpox. Once you have received these medicines, you may have to wait up to three months before you can receive live attenuated vaccine. You may have to wait up to a year after receiving immunoglobulins before you can get the measles vaccine.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Your doctor will decide if you can use Gammagard S / D during pregnancy and while breastfeeding.
No clinical studies have been performed with Gammagard S / D in pregnant or lactating women. However, drugs containing antibodies have been used by pregnant and lactating women and it has been shown that there are no harmful effects on the pregnancy or the expectant child.
If you are breastfeeding and taking Gammagard S / D, the antibodies may be present in the breast milk. Therefore, your child may be protected against certain infections.
No adverse effects on fertility can be expected.
Driving and using machines
Patients may experience side effects (eg dizziness and nausea) during treatment with Gammagard S / D, which may affect their ability to drive and use machines. If this happens, wait until the reaction has disappeared.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Gammagard S / D contains glucose and sodium
Gammagard S / D contains approximately 20 mg/ml glucose. This should be considered by patients with diabetes mellitus.
This medicine contains 668 mg sodium (the main ingredient in table salt/table salt) per vial (10 g). This corresponds to 34% of the highest recommended daily intake of sodium for adults.
3. How to use Gammagard S / D
Gammagard S / D is for intravenous administration ( infusion into a vein). It is the doctor or nurse who gives you the infusion. Dosage one and how often you get infusion one varies depending on your condition and your body weight.
At the beginning of infusion one, you get Gammagard S / D at a slow speed. Depending on how you feel, your doctor may then slowly increase the infusion rate.
Use for children
The same indications, dose, and frequency of infusion as for adults apply to children (0-18 years).
If you use more Gammagard S / D than you should
Because the medicine is given to you in a hospital, it is unlikely that you will receive too little or too much medicine. If you have any further questions, ask your doctor or healthcare professional.
If you have any further questions on the use of this product, ask your doctor or healthcare professional.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occasionally occur after treatment with immunoglobulins (medicines like Gammagard S / D): chills, headache, fever, vomiting, allergic reactions, nausea, joint pain, low blood pressure, and moderate low back pain.
In rare cases, sudden drops in blood pressure and eczema-like symptoms may be seen (transient skin reactions) and in some cases allergic reactions (anaphylactic shock ), although no reaction has occurred with previous infusions.
Cases of transient meningitis ( reversible aseptic meningitis ) and cases of a temporary decrease in red blood cell count ( reversible haemolytic anemia/hemolysis) and increase in blood creatinine and renal failure have been observed.
Very rare: Blood clot formation in the blood vessels (thromboembolic reactions) can lead to heart attack, stroke, lung injury ( pulmonary embolism ), and deep vein thrombosis.
The following is a list of side effects reported with Gammagard S / D:
- Common (affects less than 1 patient in 10):
headache, flushing , vomiting, nausea, tiredness, chills, fever - Uncommon (affects less than 1 in 100 people):
Influenza , decreased appetite, anxiety, agitation, abnormal drowsiness, blurred vision, palpitations, changes in blood pressure, shortness of breath, nosebleeds, diarrhea, inflammation of the mouth, pain in the upper abdomen, discomfort in stomach, hives , itching , cold sweats, heightened sweating, back pain, muscle cramps ( spasms ), pain in the legs and arms, chest pain, malaise, pain, chest discomfort, abnormal sensation, feeling cold, feeling hot, flu-like illness, redness at infusion site, leakage of the infusion at the infusion site, infusion site pain, elevated blood pressure. - Have reported (affecting unknown number of users):
Meningitis , degradation of red blood cells , anemia , decreased platelets , swollen lymph nodes , severe allergic reactions (anaphylactic or anaphylactoid reactions), anaphylactic shock (allergic shock ), hypersensitivity, restlessness, stroke , transient strokes, seizures, migraines, dizziness, abnormal sensation in the skin eg tingling and burning sensation, fainting, involuntary tremors, bleeding in the brain, blood clot in a blood vessel in the eye, visual disturbances, eye pain, photosensitivity, heart attack, bluish color in the skin due to decreased oxygenation of the blood, increased heart rate , slow heart rate , blood clots in the blood vessels, inflammation in the veins, low blood pressure , high blood pressure , pallor, blood clots in the blood vessels in the lungs, fluid in the lungs, decreased amount of oxygen in the blood, difficulty breathing due to respiratory cramps, wheezing, powerful and rapid breathing , constricted throat, cough, abdominal pain, indigestion, inflammation of the liver (non- infectious hepatitis), swelling of the skin, inflammation of the skin, redness of the skin, rash, joint and muscle pain, kidney failure , reactions at the injection and infusion site, weakness, swelling of body tissues, positive test for the detection of antibodies .
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Gammagard S / D
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 carton after EXP. dat. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Do not freeze.
Keep the vial in the outer carton. Sensitive to light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is human normal immunoglobulin (IVIg). Human protein content is 50 mg / ml of which at least 90% is immunoglobulin G (IgG).
- The other ingredients are
Powder : Human albumin (0.06 g / g IgG), glycine , sodium chloride, glucose monohydrate, hydrochloric acid , sodium hydroxide.
Diluent : Water for injections
What the medicine looks like and contents of the pack
Freeze-dried white or very pale yellow powder (cake).
Gammagard S / D is available in 5 g and 10 g packages.
Each pack of 5 g and 10 g contains the diluent (96 ml and 192 ml respectively), a sterile transfer kit, and a sterile filter administration kit.
Marketing Authorization Holder and Manufacturer
Baxalta Innovations GmbH
Industriestrasse 67
1220 Vienna
Austria
Manufacturer :
Baxalta Belgium Manufacturing SA
Boulevard René Branquart 80
7860 Lessines
Belgium
Agent
Takeda Pharma AB
Vasagatan 7
111 20 Stockholm