Globuprime 5 Gm Solution 100 Ml

• Replacement therapy in primary immunodeficiency syndromes, including common variable immunodeficiency, X-linked agammaglobulinaemia, Wiskott-Aldrich syndrome and severe combined immunodeficiency
• Replacement therapy in secondary immunodeficiency syndromes
• Paediatric HIV-1 infection in children who have bacterial infections
• Kawasaki syndrome, given together with aspirin
• Idiopathic thrombocytopenic purpura (ITP), acute or chronic
• Allogeneic bone marrow transplantation, to reduce the risk of infection and acute graft-versus-host disease
• Guillain-Barre syndrome
• Chronic inflammatory demyelinating polyneuropathy (CIDP)

• If you have ever had an allergic/anaphylactic or severe whole-body reaction to an immunoglobulin, or to any ingredient of Globuprime 5 Gm Solution 100 Ml.
• If you have selective IgA deficiency, or IgA deficiency with antibodies against IgA.

• Common side effects
• Headache
• Nausea, vomiting, diarrhoea, upper abdominal pain
• Chills
• Tiredness or weakness
• Fever
• Back pain, pain in an arm or leg, joint pain, muscle pain
• Excessive sweating
• Flushing or hot flush
• Dizziness
• Rash, itching, hives
• Cough, shortness of breath
• Fast heartbeat, palpitations
• Chest pain
• Raised liver enzymes
• Serious side effects that need immediate medical attention
• Severe allergic reaction, or swelling of the face or throat
• Sudden kidney failure or other kidney problems
• Blood clots, which may show as chest pain, heart attack, stroke or a transient ischaemic attack, leg swelling or pain, a clot in the lung, or vision problems from a blocked blood vessel in the eye
• Destruction of red blood cells, which may show as a fast heartbeat, swelling, tiredness, difficulty breathing, yellowing of the skin or eyes, or dark urine
• Aseptic meningitis, which may show as a severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea and vomiting
• Transfusion-related acute lung injury, which may show as severe difficulty breathing, low oxygen levels and fever, usually within a few hours of the infusion
• A sudden drop in blood pressure during the infusion, or less commonly a rise in blood pressure
• Fits, loss of consciousness, coma or stroke
• Low white blood cell or platelet counts
• Severe skin reactions, including Stevens-Johnson syndrome, erythema multiforme or blistering of the skin

Other General Warnings

• You have kidney disease or diabetes, or you are dehydrated, as these increase the risk of kidney problems.
• You have had blood clots before, or you have high blood pressure, cerebrovascular or coronary artery disease, a clotting disorder, a long period of immobility, or you are overweight, as these increase the risk of a clot.
• You have cryoglobulins, very high triglycerides or a monoclonal gammopathy, which can increase the thickness of the blood.
• You have IgA deficiency, as you may be at greater risk of a severe allergic reaction.
• You are 65 years of age or older, as you may be at increased risk of blood clots and sudden kidney failure.
• You have a history of migraine, as this may increase the chance of aseptic meningitis with this type of medicine.
• You are pregnant, planning a pregnancy or breastfeeding.
• You are due to have any vaccination, particularly a live vaccine.

• Globuprime 5 Gm Solution 100 Ml is for intravenous use only and is given by a healthcare professional.
• It is given as a slow infusion into a vein, in a hospital or specialist healthcare setting.
• The infusion is usually started slowly and the rate increased gradually, which lowers the chance of an infusion reaction.
• Never attempt to change, delay, skip or repeat a dose on your own.
• It must not be mixed with any other medicine, or given through the same infusion line as another medicine.
• It must not be mixed with immunoglobulin products from other manufacturers.
• Tell the nursing staff straight away if you feel unwell at any point during the infusion.

• Globuprime 5 Gm Solution 100 Ml is a hospital-administered medicine, so the pharmacy normally handles its storage, preparation and disposal.
• Store it between 2 and 8 degrees Celsius, in its original container, protected from light.
• Do not freeze it. Do not use it if it has been frozen.
• Keep it out of the sight and reach of children.
• Do not use it after the expiry date printed on the pack.
• Unused product and any waste are disposed of by the hospital or pharmacy, in line with local requirements. Do not dispose of it yourself.

• Report to your doctor symptoms of reduced urination, unexplained weight gain, fluid retention or shortness of breath to your doctor straight away, as these can be signs of a kidney problem.
• Chest pain, sudden weakness on one side of the body, leg swelling or pain, or shortness of breath may signal a blood clot and need immediate medical attention.
• A severe headache with neck stiffness and fever, or a fast heartbeat with swelling, yellowing of the skin or eyes or dark urine, should be reported without waiting for your next appointment.
• Tell the healthcare team immediately if you develop severe breathing difficulty, dizziness or fever, particularly within a few hours of your infusion.
• Tell your doctor about your vaccination history. Live vaccines are usually delayed for 3 months or more after treatment.
• Keep a note of the brand you are given at each infusion, as immunoglobulin products from different manufacturers are not interchangeable.

Overdose

Missed a Dose

Interactions with other medicines

• Globuprime 5 Gm Solution 100 Ml must not be mixed with other medicines, or given through the same infusion line as any other intravenous preparation, and must not be mixed with immunoglobulin products from other manufacturers.
• The antibodies in Globuprime 5 Gm Solution 100 Ml may reduce the response to live virus vaccines, including the measles, mumps and rubella (MMR) vaccine and the varicella vaccine. Live vaccines are generally delayed for 3 months or more after treatment. For the measles vaccine this effect can last up to a year, so your doctor may check your antibody status.
• The antibodies passed on through Globuprime 5 Gm Solution 100 Ml can interfere with the results of certain blood tests, so tell anyone taking a sample that you are on this treatment.
• Tell your doctor about all prescription medicines, over-the-counter medicines, supplements and herbal products you take, before and during treatment.

Interactions with food items

• Globuprime 5 Gm Solution 100 Ml is given into a vein by a healthcare professional, so interactions with food do not apply.