WHAT IS BHARGLOB 16.5%?

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BHARGLOB 16.5% contains Human normal immunoglobulin

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WHAT BHARGLOB 16.5% IS USED FOR?

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It is used to:

nIncrease abnormally low immunoglobulin levels in your blood to normal levels (replacement therapy)
nTreat certain inflammatory disorders (immunomodulation)
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WARNING & PRECAUTION:

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TALK TO DOCTOR

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Talk to your Doctor, if you:

nAre allergic or hypersensitive to any of the other ingredients of this medicine
nHave developed antibodies against immunoglobulins of the type IgA in your blood
nSuffer from hyperprolinaemia type I or II (a genetic disorder causing high levels of the amino acid proline in the blood)
nHave an underlying inflammatory condition
nHave diabetes
nHave low blood volume (hypovolemia) and problems with your blood vessels (vascular diseases)
nHave an increased tendency for blood clotting (thrombophilia or thrombotic episodes)
nHave a disease or a condition which causes your blood to thicken (hyper viscous blood)
nHave or had heart or kidney problems
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PREGNANCY & BREAST FEEDING

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Medicines containing antibodies have been used in pregnant and breast-feeding women, if you receive this medicine while you are breast-feeding the antibodies in this medicine will also be found in the breast milk
nIf you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine

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CHILDREN & ADOLESCENTS

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This medicine is recommended to children and adolescents
nYour doctor will give the right dose depends on child?s age and body weight

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DRIVING & USING MACHINES

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Do not drive or operate any machines while taking this medicine it may cause dizziness or nausea

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INTERACTIONS:

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Tell your doctor if you are taking,

nVaccinations like measles, mumps, rubella and varicella
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DIRECTIONS & FOR USE:

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This medicine is usually administered by your doctor or nurse
nIt is given solely for the infusion into a vein (intravenous infusion)

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If you receive more BHARGLOB 16.5%

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If you think you have given too much of this medicine, contact your doctor or go to nearest hospital

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Symptoms of overdose: blood may become too thick (hyperviscous), which might increase the risk of developing blood clots.

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SIDE EFFECTS OF BHARGLOB 16.5%:

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SERIOUS

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• Sudden fall in blood pressure, dizziness, faint on standing, cold in the hands and feet, sense an abnormal heartbeat or chest pain, or have blurred vision
n• Formation of blood clots
n• Myocardial infarction
n• Muscle weakness
n• Painful respiration due to transfusion related lung injury
n• Temporary non-infectious meningitis (reversible aseptic meningitis)
n• Stiff neck, fever, nausea, vomiting, headache, abnormal sensitivity to light, mental disturbances
n• Increase in blood creatinine level
n• Proteinuria
n• Acute renal failure
n• Transient decrease in red blood cells, anaemia, leukopenia, anisocytosis (including microcytosis)

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COMMON

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• Headache, upset stomach, pain, (including back pain, pain in extremities, joints and bones)
n• Flu-like illness, runny nose, sore throat, blisters in mouth and throat, throat tightness
n• Temporary lowering of red blood cell count, breakdown of red blood cells (haemolysis)
n• High blood pressure (hypertension), flushing, hypotension (including decreased blood pressure), •   breathlessness
n• Vomiting, loose stools, diarrhoea, skin disorder, redness of the skin, peeling of the skin, pain in the   muscles (including muscle cramps and rigidity), tiredness (fatigue), physical weakness
n• Changes to liver functions (hyperbilirubinaemia) as well as changes in blood count
n• Increased alanine aminotransferase, increased aspartate aminotransferase, increased blood lactate     dehydrogenase

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UNCOMMON

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• Non-infectious meningitis (reversible aseptic meningitis)
n• Irregularity of red blood cell shape, presence of high platelet counts in the blood (thrombocytosis)
n• Sleepiness, shiver, palpitations, tachycardia, thromboembolic events, lack of blood supply to the lower extremities causing pain when walking
n• Presence of an excess of serum proteins in the urine, injection site pain

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STORAGE:

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Keep this medicine out of reach of children
nStore in a refrigerator at 2-8°C