INFUSAMIN Injection 20gm

INTRODUCTION

INFUSAMIN INJECTION contains Human albumin that belongs to the group of
medicines called Plasma expanders. It is used to restore and maintain blood
volume in hypovolemia (reduced blood volume in the circulatory system or
extracellular fluid of the body, characterized by symptoms such as sweating,
light-headedness, confusion, fatigue or decreased blood pressure).

INFUSAMIN INJECTION is also used to treat hypoalbuminemia (low levels of albumin
protein that's responsible for keeping fluid in your blood vessels) in burns,
Adult Respiratory Distress Syndrome (ARDS) and nephrosis (excess protein in
urine). INFUSAMIN INJECTION can also be used during cardiopulmonary bypass
surgery and Hemolytic Disease of the Newborn (a blood disorder in a new-born).

INFUSAMIN INJECTION is not recommended for use if you have severe anemia or
heart failure with normal or increased intravascular volume. Before receiving
INFUSAMIN INJECTION, inform your doctor if you have high blood pressure,
enlarged veins in the gut, water on the lungs, tendency to bleed or decreased or
no urine production.

Your doctor will monitor you to check your circulatory situation with the
electrolyte balance and blood volume. INFUSAMIN INJECTION should be used with
caution in pregnant and breastfeeding women so, consult your doctor before
receiving it. Your doctor will decide a proper dose of INFUSAMIN INJECTION for
your child based on their body weight.

The most common side effects of receiving INFUSAMIN INJECTION are anaphylactoid
type reactions (skin reactions like hives, itching and flushed or pale skin, low
blood pressure, wheezing and trouble breathing, a weak and rapid pulse).Call
your doctor if any of the symptoms get worse over time.

USES OF INFUSAMIN INJECTION

Used to treat

• hypovolemia
• hypoalbuminemia in burns, Adult Respiratory Distress Syndrome (ARDS) and nephrosis
• cardiopulmonary bypass surgery
• Hemolytic Disease of the Newborn

HOW INFUSAMIN INJECTION WORKS

INFUSAMIN INJECTION contains human albumin which has properties that are
equivalent to the normal human plasma in equal quantities. It works by
increasing the circulating plasma volume by an amount approximately equal to the
volume infused. The infused albumin stays for longer hours in the body and takes
less time in bringing blood volume to normal levels.

DIRECTIONS FOR USE

INFUSAMIN INJECTION will be given to you only by a doctor or a nurse into the
vein. Your doctor will decide the correct dose and duration for you depending
upon your age, body weight and disease condition.

SIDE EFFECTS OF INFUSAMIN INJECTION

COMMON

• anaphylactoid type reactions (skin reactions like hives, itching and flushed or pale skin, low blood pressure, wheezing and trouble breathing, a weak and rapid pulse)

RARE

• flushing
• nettle rash
• fever
• nausea
• low blood pressure

Stop receiving INFUSAMIN INJECTION and contact your doctor if you experience any
of the following side effects:

• severe reactions like shock
• cardiovascular overload (headache, difficulty breathing, a fluid build-up in a neck vein, increased blood or vein pressure, water on the lungs)

HOW TO MANAGE SIDE EFFECTS

Nausea:

Take regular sips of a cold drink. Have ginger or peppermint tea. Stick to
simple meals. Avoid eating oily or spicy foods. If symptom persists, contact
your doctor.

WARNING & PRECAUTIONS

!###### PREGNANCY

INFUSAMIN INJECTION should be used with caution in women who are pregnant or
planning for pregnancy. Consult your doctor before receiving it.

BREASTFEEDING

INFUSAMIN INJECTION should be used with caution in breastfeeding mothers.
Consult your doctor before receiving it.

!###### DRIVING AND USING MACHINES

INFUSAMIN INJECTION has no known effects on the ability to drive or use
machines. Consult your doctor for advice.

!###### KIDNEY

INFUSAMIN INJECTION is not recommended for use in patients with chronic kidney
insufficiencies due to the potential for accumulations of aluminium. INFUSAMIN
INJECTION should be used with caution in patients having renal and post-renal
anuria (decreased or no urine production). Consult your doctor before receiving
it.

!###### ALLERGY

Do not receive INFUSAMIN INJECTION if you are allergic to albumin preparations
or any of the other ingredients of this medicine.

!###### LUNGS

INFUSAMIN INJECTION is not recommended for use in patients with pulmonary edema
(presence of excess fluid in the lungs). Consult your doctor before receiving
it.

!###### HEART DISEASE

INFUSAMIN INJECTION is not recommended for use in patients suffering from heart
failure with normal or increased intravascular volume. INFUSAMIN INJECTION
should be used with caution in patients with high blood pressure. Consult your
doctor before receiving it.

OTHERS

Before receiving INFUSAMIN INJECTION, inform your doctor if you:

• have oesophageal varices (enlarged veins in the gut)
• have haemorrhagic diathesis (tendency to bleed abnormally or spontaneously)
• have severe anaemia (reduced red blood cells)

Use in Paediatrics:

Your child’s doctor will adjust the dose of INFUSAMIN INJECTION based on child’s
age and body weight. Consult your child’s doctor for advice.

Use in Geriatrics:

There is no proper information about the use of INFUSAMIN INJECTION in elderly
patients. Consult your doctor before receiving it.

INTERACTIONS

A. Drug-Drug Interactions:

Before receiving INFUSAMIN INJECTION, inform your doctor if you are taking, have
taken or might take any other medicine, including prescri
or any herbal medicine.

Overdosage:

INFUSAMIN INJECTION will be given to you only by a doctor or nurse in a hospital
and so it is unlikely to receive an overdose. However, if you experience any
unusual symptoms, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

Drug	:	Human albumin
Pharmacological Category	:	Plasma expanders
Therapeutic Indication	:	Hypovolemia
Dosage Forms	:	Injection, Infusion, Solution, PFS

MORE INFORMATION

• Keep INFUSAMIN INJECTION out of reach in children
• Store INFUSAMIN INJECTION at room temperature

FAQs ABOUT INFUSAMIN INJECTION

Can INFUSAMIN INJECTION be given to infants?

The safety of INFUSAMIN INJECTION has been demonstrated in children provided the
dose is appropriate for body weight. Consult your child’s doctor for advice. The
doctor will decide a proper dose or select a suitable alternative treatment for
your child.

What happens if you take more INFUSAMIN INJECTION than your required dose?

INFUSAMIN INJECTION will be given to you only by a doctor or nurse in a hospital
and so it is unlikely to receive an overdose. However, if you experience
anything unusual like headache, difficulty breathing, a fluid build-up in a neck
vein, increased blood or vein pressure, water on the lungs (symptoms of
overdose), consult your doctor immediately or visit the nearby hospital.

What if I miss a dose of INFUSAMIN INJECTION?

Please stick to the prescribed schedule as agreed with your doctor for o
efficacy of INFUSAMIN INJECTION treatment. Tell your doctor whenever you miss
any dose.

Can I stop receiving INFUSAMIN INJECTION on my own?

Continue receiving INFUSAMIN INJECTION until your doctor tells you to stop,
unless you experience any unwanted effects, worsening of your condition or any
new symptoms. Contact your doctor in such situation.

Is INFUSAMIN INJECTION safe to use in pregnancy?

INFUSAMIN INJECTION should be used with caution in pregnancy. If you are
pregnant, think you may be pregnant or are planning for a baby, contact your
doctor before taking it. Inform your doctor immediately if you become pregnant
during treatment with INFUSAMIN INJECTION.

REFERENCES

1. Sean C Sweetman. Blood Products Plasma Expanders and Haemostatics. Martindale
   The Complete Drug Reference. 36th edition. Page- 1052.

2. Alejandro Campos Munoz, Nitesh K. Jain, Mohit Gupta. Albumin Colloid. NIH
   National Library of Medicine. National Centre for Biotechnology Information. PMC
   PubMed Central. January 2022. [Accessed 13th July
   2022].

3. Ho JJ, Adnan AS, Kueh YC, Ambak NJ, Van Rostenberghe H, Jummaat F. Human
   albumin infusion for treating oedema in people with nephrotic syndrome (Review).
   National Library of Medicine. National Centre for Biotechnology Information.
   Cochrane Library. 2019. [Accessed on 13th July
   2022].

4. Biotest Pharma GmbH. European Medicines Agency (EMA). [Revised in February
   2020] [Accessed on 13th July
   2022].

5. Baxalta Incorporated. BUMINATE (albumin human injection, solution). [Revised
   in July 2017] [Accessed on 13th July
   2022].

6. Grifols Biologicals LLC. ALBUTEIN 5% (albumin [human]). [Revised in June
   2018]. [Assessed 13th July 2022].

USEFUL DIAGNOSTIC TESTS

• Complete Blood Count (CBC)
• Kidney Function Test