INTRODUCTION
GLOBUCEL 5GM contains Human normal immunoglobin which belongs to the group of medicines called Immunoglobins. It supplements our body with sufficient antibodies (agents which are responsible for providing immunity) that are required to fight against various infections.
It is primarily used in patients with a poor immune system and in patients who cannot produce enough antibodies on their own. It can also be used to treat various inflammatory auto-immune disorders in both adults and in children (including new-borns and infants).
Human Normal Immunoglobulin contains antibodies (IgG) derived from the blood of healthy donors. Following administration, it supports our immune system by supplementing our body with sufficient antibodies that are required to fight against various infections. It can also modulate the functions of immune system in case of autoimmune disorders.
Do not receive GLOBUCEL 5GM if you are allergic to immunoglobulins or if you are deficient in a type of immunoglobulin called IgA. You must also inform your doctor if you have any untreated infections or any problems in your blood vessels.
Before receiving GLOBUCEL 5GM inform your doctor if you have diabetes, kidney, or heart problems or if you are severely dehydrated as a precaution. GLOBUCEL 5GM should be used in pregnant and breastfeeding women only if it is considered necessary by the physician.
Inform your doctor immediately if you experience severe headache with flushing, muscle pain, dizziness, chills, wheezing or nausea while receiving GLOBUCEL 5GM.
USES OF GLOBUCEL 5GM
It is used in both adults and in children (aged 0-18 years) to treat:
- Primary immune thrombocytopenia (immune disorder causing low platelet counts in blood)
- Guillain-Barré syndrome (inflammation of the nerves)
- Kawasaki disease (inflammation of the blood vessel throughout the body)
- Chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy (inflammation of the peripheral nerves that causes muscle weakness and/or numbness mainly in the legs and arms)
It can also be used to improve immunity against various infections (like hepatitis A and B, measles, mumps, poliomyelitis) in patients who have a poor immune system.
HOW GLOBUCEL 5GM WORKS
GLOBUCEL 5GM supports our immune system by supplementing our body with sufficient antibodies that are required to fight against various infections. It can also regulate the functions of immune system and reduces the risk of autoimmune disorders.
DIRECTIONS FOR USE
GLOBUCEL 5GM will be administered to you only by a doctor or a nurse into the vein (intravenously). Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and health condition.
SIDE EFFECTS OF GLOBUCEL 5GM
COMMON
- headache
- back pain, joint pain, muscle pain, neck pain
- fever, flu-like symptoms (runny nose, sore throat)
- sores or blisters in the mouth and throat
- throat tightness
- anaemia (severe tiredness or weakness with pale skin)
- dizziness or spinning sensation
- hot flushes
- changes in blood pressure
- stomach pain, diarrhoea
- skin rash with redness
- tiredness, weakness
UNCOMMON
- pain at the site of injection
Contact your doctor immediately, if you experience any of the following side effects after receiving GLOBUCEL 5GM:
- signs of a brain infection called aseptic meningitis syndrome (such as nausea, vomiting, severe headache, neck stiffness, drowsiness, fever, fear to look lights (photophobia))
- signs of blood clots (such as pain, swelling and unusual warmth of the hands and legs, sudden shortness of breath with chest pain, worsening on deep breathing, numbness, or weakness on one side, difficulty in speaking or confusion)
- signs of allergic reactions (such as sudden fall in blood pressure or shock, dizziness, light-headedness, feeling faint while standing, cold hands and feet, abnormal heartbeat, chest pain, or blurred vision)
- signs of acute lung injury (such as build-up of fluid in the lungs, severe difficulty in breathing, bluish discoloration of the skin, abnormally low level of oxygen in the blood, and decrease in blood pressure with fever)
- headache, chills, flushing, muscle pain, lower back pain, wheezing, rapid heartbeat, nausea, or low blood pressure
HOW TO MANAGE SIDE EFFECTS
Pain at injection site:
Place an ice pack on the injected site. Do not move the affected area frequently. If the symptom worsens, consult your doctor.
WARNING & PRECAUTIONS
PREGNANCY
GLOBUCEL 5GM should be used with caution in pregnant women. Therefore, consult your doctor before receiving it.
BREASTFEEDING
GLOBUCEL 5GM should be used with caution in breastfeeding women. Therefore, consult your doctor before receiving it.
DRIVING AND USING MACHINES
Do not drive or handle heavy machines if you feel dizzy after receiving GLOBUCEL 5GM.
ALCOHOL
Avoid consumption of alcohol while receiving GLOBUCEL 5GM.
KIDNEY
GLOBUCEL 5GM should be used with caution in patients with kidney diseases. Therefore, consult your doctor before receiving it.
ALLERGY
Do not receive GLOBUCEL 5GM if you are allergic to Human normal immunoglobin or other immunoglobins.
HEART DISEASE
GLOBUCEL 5GM is not recommended for use in patients with heart diseases (such as high blood pressure). Therefore, consult your doctor before receiving it.
OTHERS
GLOBUCEL 5GM is not recommended for use if you:
- are deficient in immunoglobulin A (first line antibodies that protects our body from infections)
- have antibodies against immunoglobulin A in the blood (a type of inherited autoimmune disorder)
- have blood clotting problems
- have hyperprolinemia type I or II (a rare genetic disorder causing high levels of an amino acid called proline in the blood)
Before receiving GLOBUCEL 5GM inform your doctor if you:
- are due to have any blood test
- have received this medicine recently or are receiving after a long interval
- have an untreated infection
- are overweight
- are diabetic
- are staying bed-ridden for a longer period
- have low blood volume (signs include severe dehydration, pale skin and rapid breathing, confusion)
- have problems with blood vessels (like atherosclerosis)
- are at risk of forming blood clots in the body
- have thick blood or increased tendency for blood clotting
Use in pediatrics:
GLOBUCEL 5GM should be used with caution in children and adolescents (below 18 years). Therefore, consult your doctor before receiving it.
Use in geriatrics:
GLOBUCEL 5GM should be used with caution in elderly patients (65 years or above). Therefore, consult your doctor before receiving it.
INTERACTIONS
A. Drug - Drug interactions:
Before receiving GLOBUCEL 5GM, inform your doctor if you are taking:
- loop diuretics (medicines used to increase urine output and to reduce blood pressure) Ex. furosemide
- live-attenuated viral vaccines (Ex. MMR, chickenpox, varicella)
Overdosage:
GLOBUCEL 5GM will be administered to you only by a doctor or a nurse in a hospital, and so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unpleasant symptoms after receiving GLOBUCEL 5GM.
SYNOPSIS
| Drug | : | Human Normal Immunoglobulin |
| Pharmacological Category | : | Immunoglobulins |
| Therapeutic Indication | : | Immune deficiency States, Inflammatory immune disorders |
| Dosage Forms | : | Injection |
MORE INFORMATION
- Keep GLOBUCEL 5GM out of reach of children
- Store GLOBUCEL 5GM in a refrigerator (2-8°C)
FAQs ABOUT GLOBUCEL 5GM
What is GLOBUCEL 5GM?
GLOBUCEL 5GM is an immunoglobulin (antibody) used to treat immune deficiency states and auto-immune diseases both in adults and in children (aged 0-18 years).
How to take GLOBUCEL 5GM?
GLOBUCEL 5GM should be used only under medical supervision. It will be given to you only by a doctor or a nurse into the vein (intravenously). During therapy with GLOBUCEL 5GM, your doctor will constantly monitor your health condition once in every 20 minutes to avoid unwanted reactions.
What are the uses of GLOBUCEL 5GM?
GLOBUCEL 5GM improves immune functions in patients having weak immune system. It can also be used to treat various inflammatory auto-immune disorders in both adults and in children.
Is GLOBUCEL 5GM injection safe?
GLOBUCEL 5GM should be used under medical supervision. It may cause few side effects like are nausea, vomiting, headache, muscle pain, joint pain, and body pains. To avoid this, your doctor will constantly monitor your health condition once in every 20 minutes while you are receiving GLOBUCEL 5GM.
What does GLOBUCEL 5GM do?
GLOBUCEL 5GM supports our immune system by supplementing our body with sufficient antibodies that are required to fight against various infections. It can also regulate the functions of immune system and reduces the risk of autoimmune disorders.
What are the precautions to be known before receiving GLOBUCEL 5GM?
Before receiving GLOBUCEL 5GM inform your doctor if you are deficient in a type of immunoglobulin called IgA. You must also inform your doctor if you have diabetes, kidney, or heart problems or if you are severely dehydrated as a precaution. Do not get yourself vaccinated with any viral vaccines (like MMR, chickenpox, or varicella) while receiving GLOBUCEL 5GM. Tell your doctor immediately if you experience any allergic reactions or severe headache with flushing and muscle pain while receiving GLOBUCEL 5GM.
Can I stop receiving GLOBUCEL 5GM by my own once the symptoms subside?
Do not stop taking GLOBUCEL 5GM without consulting your physician, as sudden discontinuation of GLOBUCEL 5GM may reduce your immune functions once again. If you feel better after receiving GLOBUCEL 5GM, it means that it is working for you. If you wish to stop GLOBUCEL 5GM, consult your doctor for advice.
How long does it take for GLOBUCEL 5GM to show its effects?
It may take a few weeks (3-5 weeks) for GLOBUCEL 5GM to show the results. However, this duration varies from patient to patient depending upon their health condition. Consult your doctor if you cannot see any improvement in your condition even after using GLOBUCEL 5GM for a prolonged period.
REFERENCES
1. KD. Tripathi. Vaccines and Sera. Miscellaneous Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 926.
2. Philip Wood. Human normal immunoglobulin in the treatment of primary immunodeficiency diseases. NCBI; PMC US National Library of Medicine, National Institute of Health. April 2012. [Accessed on 2nd April 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3333462/
3. Biotest (UK) Ltd. Electronic Medicines Compendium (EMC). [Revised in September 2020] [Accessed on 2nd April 2022] https://www.medicines.org.uk/emc/medicine/23175#DOCREVISION
4. Biotest Pharma GmbH. Electronic Medicines Compendium (EMC). [Revised in March 2020] [Accessed on 2nd April 2022] https://www.medicines.org.uk/emc/files/pil.576.pdf
5. CSL Behring GmbH. Electronic Medicines Compendium (EMC). [Accessed on 2nd April 2022] https://www.ema.europa.eu/en/documents/product-information/privigen-epar-product-information_en.pdf
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