ALBUDAC 20% Injection 100ml

INTRODUCTION ABOUT ALBUDAC 20% INJECTION

ALBUDAC 20% 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).

ALBUDAC 20% INJECTION is also used to manage 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). ALBUDAC 20% INJECTION can also be used during cardiopulmonary bypass
surgery and Hemolytic Disease of the Newborn (a blood disorder in a new-born).

ALBUDAC 20% INJECTION is not recommended for use if you have severe anemia or
heart failure with normal or increased intravascular volume. Before receiving
ALBUDAC 20% 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. ALBUDAC 20% 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 ALBUDAC 20% INJECTION for
your child based on their body weight.

The most common side effects of receiving ALBUDAC 20% 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 ALBUDAC 20% INJECTION

Used to manage

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

HOW ALBUDAC 20% INJECTION WORKS

ALBUDAC 20% 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

ALBUDAC 20% 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 ALBUDAC 20% 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 ALBUDAC 20% 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

ALBUDAC 20% INJECTION should be used with caution in women who are pregnant or
planning for pregnancy. Consult your doctor before receiving it.

!### BREASTFEEDING

ALBUDAC 20% INJECTION should be used with caution in breastfeeding mothers.
Consult your doctor before receiving it.

!### DRIVING AND USING MACHINES

ALBUDAC 20% INJECTION has no known effects on the ability to drive or use
machines. Consult your doctor for advice.

!### KIDNEY

ALBUDAC 20% INJECTION is not recommended for use in patients with chronic kidney
insufficiencies due to the potential for accumulations of aluminium. ALBUDAC 20%
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 ALBUDAC 20% INJECTION if you are allergic to albumin preparations
or any of the other ingredients of this medicine.

!### LUNGS

ALBUDAC 20% 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

ALBUDAC 20% INJECTION is not recommended for use in patients suffering from
heart failure with normal or increased intravascular volume. ALBUDAC 20%
INJECTION should be used with caution in patients with high blood pressure.
Consult your doctor before receiving it.

OTHERS

Before receiving ALBUDAC 20% 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 ALBUDAC 20% 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 ALBUDAC 20% INJECTION in elderly
patients. Consult your doctor before receiving it.

INTERACTIONS

A. Drug-Drug Interactions:

Before receiving ALBUDAC 20% INJECTION, inform your doctor if you are taking,
have taken or might take any other medicine, including prescri
non-prescri

Overdosage:

ALBUDAC 20% 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 ALBUDAC 20% INJECTION out of reach in children
• Store ALBUDAC 20% INJECTION at room temperature

FAQs ABOUT ALBUDAC 20% INJECTION

Can ALBUDAC 20% INJECTION be given to infants?

The safety of ALBUDAC 20% 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 management
for your child.

What happens if you take more ALBUDAC 20% INJECTION than your required dose?

ALBUDAC 20% 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 ALBUDAC 20% INJECTION?

Please stick to the prescribed schedule as agreed with your doctor for o
efficacy of ALBUDAC 20% INJECTION management. Tell your doctor whenever you miss
any dose.

Can I stop receiving ALBUDAC 20% INJECTION on my own?

Continue receiving ALBUDAC 20% 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 ALBUDAC 20% INJECTION safe to use in pregnancy?

ALBUDAC 20% 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 management with ALBUDAC 20% 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