Patient Medication Information: uses, side effects, how to take - Sandoglobulin NF Liquid
ABOUT THIS MEDICATION
Sandoglobulin® NF Liquid contains “immunoglobulins” which are antibodies found in the blood. Immunoglobulins are produced by the body’s immune system to fight infections caused by bacteria and viruses. If you have a shortage of antibodies you may not be able to fight off diseases.
What the medication is used for:
Sandoglobulin® NF Liquid is a prescription medication used to treat adults and children who need antibody replacement therapy due to Primary or Secondary Immune Deficiencies (conditions where your antibody levels are low, referred to as immunodeficiency).
What it does:
Sandoglobulin® NF Liquid increases your levels of antibodies (in cases of Primary or Secondary Immunodeficiencies).
When it should not be used:
If you have had an allergic reaction, skin rash, swelling of the face, wheezing or difficulty breathing to any of the components of Sandoglobulin® NF Liquid or to homologous immunoglobulins, especially in very rare cases of immunoglobulin A deficiency when you have been told you have antibodies to immunoglobulin A.
If you have maple syrup urine disease you should not take Sandoglobulin® NF Liquid as it contains L-isoleucine. This is a very rare disease which is caused by the inability to metabolize (eliminate) L-isoleucine.
If you have hyperprolinemia you should not take Sandoglobulin ® NF Liquid as it contains L-proline. This is a very rare disease which is caused by the inability to metabolize (eliminate) L-proline.
What the medicinal ingredient is:
Immune Globulin Intravenous (Human)
What the important nonmedicinal ingredients are:
- L-Isoleucine, Ph.Eur./USP;
- L-proline, Ph.Eur./USP;
- Nicotinamide, Ph.Eur./USP.
For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.
What dosage forms it comes in:
Sandoglobulin® NF Liquid is a solution for intravenous infusion.
It is supplied in 6 g (50 ml bottle) or 12 g (100 ml bottle) filling sizes. The concentration of the active ingredient (Immune Globulin Intravenous (Human)) is 12% or 120 g/L.
WARNINGS AND PRECAUTIONS
NG
Serious Warnings and Precautions
$ Sandoglobulin® NF Liquid is made from human plasma.
Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. Because Sandoglobulin® NF Liquid is made from human blood, there may be a risk of transmission of infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob Disease (CJD) agent.
$ Developing allergic reactions which may include fever, chills, nausea, and vomiting are possible. On very rare occasions these reactions may lead to shock.
BEFORE you use Sandoglobulin® NF Liquid talk to your doctor or pharmacist if:
- You have hypogammaglobulinaemia or agammaglobulinaemia with or without immunoglobulin A deficiency
- This is your first treatment with any human normal immunoglobulin or it has been longer than 8 weeks since you had your last treatment
- You have diabetes
- You have epilepsy or are taking phenytoin
- You have kidney disease
- You have hypovolemia
- You are overweight
- You are over 65
Pregnancy:
Ask your doctor for advice before taking any medicine.
Breast-feeding:
Ask your doctor for advice before taking any medicine.
Important information about some of the ingredients in Sandoglobulin® NF Liquid:
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, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps 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 enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A and parvovirus B19 viruses.
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 Sandoglobulin® NF Liquid the name and batch number of the product are recorded in order to maintain a record of the batches used.
Taking/using other medicines:
Please inform your doctor if you are taking, or have recently taken, any other medicine, including any products either bought or prescribed.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with Sandoglobulin® NF Liquid include the following anticonvulsants used in the treatment of epilepsy:
- Phenytoin
- Primidone
- Carbamazepine
Vaccines:
Please inform your doctor if you are planning to have a vaccination. Sandoglobulin® NF Liquid can impair the efficacy of certain live attenuated virus vaccines, such as measles, rubella, mumps and varicella for a period of at least 6 weeks and up to 3 months. After receiving this product, a period of 3 months should be allowed before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may continue for up to 1 year, so patients receiving the measles vaccine should have their antibody status checked.
Interference with serological testing:
Passive spread of antibodies to erythrocyte (red blood cell) antigens may interfere with some blood tests which detect the presence of antibodies e.g. Coombs test. Prior to any blood tests please inform your doctor you have received this product.
PROPER USE OF THIS MEDICATION
Usual dose:
Your doctor or nurse will usually give you your Sandoglobulin® NF Liquid by intravenous infusion.
Your doctor will work out the correct dose and dosing intervals of Sandoglobulin® NF Liquid for you depending on your body weight and why you need to take Sandoglobulin® NF Liquid.
Overdose:
If you think you have been given too many infusions or the infusion is going in too quickly, talk to a doctor or nurse immediately.
Missed Dose:
If you miss a dose contact your doctor for instructions.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines Sandoglobulin® NF Liquid can have side effects.
Some people may develop adverse reactions such as chills, headache, fever, nausea, vomiting, allergic reactions, arthralgia (pain in a joint), low blood pressure, moderate low back pain, thrombotic events and acute renal failure.
Rarely, human normal immunoglobulins may cause anaphylactic shock which is a life-threatening allergic reaction characterised by swelling of body tissue, difficulty in breathing and sudden fall in blood pressure. If this happens your doctor or nurse should be informed immediately.
Cases of reversible aseptic (not caused by a bacteria) meningitis or inflammation of the membrane that envelops the brain and spinal cord, have been seen. The symptoms to watch for include: Malaise, fever, headache which can be severe, stiffness of the neck and back, nausea, vomiting, drowsiness, photophobia, painful eye movement.
Isolated cases of reversible haemolytic anaemia/haemolysis (where you have too few red blood cells caused either by red blood cells dying early or dying because their cell membrane has been disrupted) have been reported. The symptoms to watch for include: Fatigue, weakness, dizziness, headache, rapid heartbeat, ringing in the ears.
Also, rare cases of temporary inflammation/redness of the skin have been reported.
Tell your doctor or nurse if you suffer from any of these effects or from any other side-effect not mentioned in this leaflet.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
The following symptoms are common. If any of the listed symptoms occur, are severe of if they worry you, talk to your doctor or pharmacist:
- Chills
- Headache
- Fever
- Nausea
- Vomiting
Allergic reactions (hives, skin redness, swelling of the
mouth, lips or throat)
- Diarrhea
- Infections
- Dizziness
Low blood pressure (manifested by dizziness and
faintness)
- Joint pain
- Abdominal pain
- Moderate to low back pain
The following symptoms occur rarely but if they occur, you need to talk to your doctor or pharmacist about them:
Aseptic meningititis: This is an inflammation of the
membrane that envelops the brain and spinal cord, which is not caused by bacteria. The symptoms to watch for include: Malaise, fever, headache which can be severe, stiffness of the neck and back, nausea, vomiting, drowsiness, photophobia, painful eye movement.
- Temporary inflammation or redness of the skin
If the following rare symptoms occur, stop your medication and call your doctor or pharmacist without delay:
Sudden fall in blood pressure (manifested by dizziness
and faintness);
Anaphylactic shock: A rapid occurring severe allergic
reaction that involves the whole body. The symptoms to watch for are: Hives, swelling of the lips, tongue or throat, difficulty in breathing, low blood pressure, faintness, abdominal pain, nausea and vomiting.
Hemolytic anemia/hemolysis (where you have too few
red blood cells caused either by red blood cells dying early or dying because their cell membrane has been disrupted). The symptoms to watch for include: Fatigue, weakness, dizziness, headache, rapid heartbeat, ringing in the ears.
This is not a complete list of side effects. For any unexpected effects while taking Sandoglobulin® NF Liquid, contact your doctor or pharmacist.
HOW TO STORE IT
Store at 2 to 8oC and protect from light, by keeping Sandoglobulin® NF Liquid in its original packaging. Do not freeze. Do not use after the expiration date printed on the label. Prior to the expiration date, the product can be held for a single storage period at room temperature (≤ 25 °C) for a maximum of 6 months, after which unused product must be discarded.
Do not use Sandoglobulin® NF Liquid if it is cloudy or has deposits.
Keep Sandoglobulin® NF Liquid out of the reach and sight of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345
toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca*
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
* We recommend that CSL Behring Canada be copied when reporting suspected side effects, at the following address:
adversereporting@cslbehring.com
or be informed by pager
Pager Number: 1-613-783-1892
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.cslbehring.com
or for more information you may communicate with the sponsor, CSL Behring Canada at: 1-613-783-1892