Haemaccel Sy (r.pack)

HAEMACCEL SY (R.PACK)

Name

• Brand Name: Haemaccel
• Common Name/Active Ingredient: Polygeline

Composition

Haemaccel is a solution for infusion containing Polygeline (35 g per 1000 ml or 17.5 g per 500 ml) as its active ingredient. It also contains several excipients, including sodium chloride (4.25 g per 500 ml), potassium chloride (0.20 g per 500 ml), and calcium chloride (0.466 g per 500 ml).

Uses

Haemaccel is primarily used as a plasma volume substitute to restore and maintain circulating blood volume. Its therapeutic indications include:

• Hypovolaemic Shock: Short-term measure for plasma volume restoration due to blood or plasma loss from hemorrhage, burns, peritonitis, pancreatitis, crush injuries, dehydration, or peri-operative fluid loss.
• Fluid Replacement: Used in plasma exchange.
• Special Procedures: Utilized in extra-corporeal circulation and isolated organ perfusion.
• Carrier Solution: Can serve as a carrier solution for insulin.

Dosage and Administration

Haemaccel is administered intravenously.

• Infusion Rate: The rate depends on the patient's condition. Typically, 500 ml is infused in no less than 60 minutes, but in emergencies, it can be infused rapidly.
• Temperature: It should ideally be warmed to body temperature before use; however, it can be infused at ambient temperatures in emergencies.
• Specific Guidance:
  • Hypovolaemic Shock: Initially, 500-1000 ml is infused intravenously. Losses up to 1500 ml can be replaced entirely by Haemaccel. For larger blood losses (1500-4000 ml), it should be given with blood, and for losses over 4000 ml, the ratio of blood to Haemaccel should be two parts blood to one part Haemaccel.
  • Burns: A suggested dosage is at least 1 ml per kg of body weight multiplied by the percentage of body surface burned for each 24 hours for two days.

Side Effects

Common and occasional side effects include:

• Transient urticarial skin reactions (wheals)
• Hypotension (low blood pressure)
• Tachycardia (rapid heart rate)
• Bradycardia (slow heart rate)
• Nausea and vomiting
• Dyspnoea (difficulty breathing)
• Increases in temperature and/or shivering
• Injection site reactions (pain, redness) Rarely, severe hypersensitivity reactions, including shock, have been observed.

Precautions

• Hypersensitivity: Contraindicated in patients with known hypersensitivity to its constituents or existing anaphylactoid reactions.
• Cardiovascular Conditions: Administer with caution in conditions where increased intravascular volume or hemodilution could pose a risk, such as congestive heart failure, hypertension, and pulmonary edema.
• Renal Conditions: Use with caution in patients with renal and post-renal anuria.
• Histamine Release: Caution is advised in patients at increased risk of histamine release (e.g., allergic individuals or those with a history of histamine response). Rapid administration, especially to normovolaemic patients, may cause the release of vasoactive substances.
• Interactions:
  • Cardiac Glycosides: Caution is necessary in patients receiving cardiac glycosides due to the calcium content in Haemaccel.
  • Citrated Blood: Should NOT be mixed directly with citrated blood as it may cause clotting.
  • Compatible water-soluble drugs like insulin can be infused in Haemaccel.

Storage

Haemaccel should be stored under the conditions mentioned on the product pack and kept out of reach of children and pets.

What is Haemaccel SY (R.PACK) used for?

Haemaccel SY (R.PACK) is a plasma volume expander primarily used for the short-term restoration or replacement of fluids in cases of hypovolaemia. This can be due to various reasons such as blood loss (hemorrhage), plasma loss (e.g., from burns, peritonitis, pancreatitis, crush injuries), dehydration, or fluid loss during surgical procedures. It is also used in extra-corporeal circulation, isolated organ perfusion, and as a carrier solution for insulin.

How does Haemaccel SY (R.PACK) work?

Haemaccel SY (R.PACK) contains Polygeline, a modified gelatin molecule, along with electrolytes like sodium chloride, potassium chloride, and calcium chloride. It works by increasing the osmotic pressure of the blood, which draws fluid from the spaces between cells (interstitial space) into the bloodstream. This process effectively increases the circulating blood volume, helping to maintain blood pressure and ensure adequate oxygen delivery to vital organs.

What is the usual dosage of Haemaccel SY (R.PACK)?

Haemaccel SY (R.PACK) is administered intravenously. The dosage volume and infusion rate depend on the individual patient's condition and their response to treatment. Typically, 500 ml is infused over a period of not less than 60 minutes, but in emergency situations, it can be infused more rapidly. For conditions like hypovolaemic shock, an initial infusion of 500-1,000 ml is common. Up to 1,500 ml of blood loss can be replaced by Haemaccel alone; for larger losses, it may be used in conjunction with blood.

What are the possible side effects of Haemaccel SY (R.PACK)?

Possible side effects can include transient skin reactions (like hives), low blood pressure (hypotension), changes in heart rate (tachycardia or bradycardia), nausea, vomiting, shortness of breath, increases in body temperature, and shivering. Rare but severe hypersensitivity reactions, including shock, have been observed. Other reported side effects include indigestion, fever, and reactions at the injection site such as pain or redness. Rapid administration, especially in patients with normal blood volume, may lead to histamine release, causing some of these reactions.

Is Haemaccel SY (R.PACK) safe during pregnancy or breastfeeding?

Haemaccel has been used for many years during childbirth and other obstetric or gynaecological procedures requiring plasma volume replacement without apparent ill effects, especially when blood is not available. However, a doctor should assess the benefits and risks for each patient during pregnancy. Information regarding its use during breastfeeding is limited, so it is advisable to consult a doctor if you are breastfeeding.

Can Haemaccel SY (R.PACK) be taken with other medications?

Caution is advised when Haemaccel is administered to patients taking cardiac glycosides (e.g., digoxin) due to the calcium content in Haemaccel, which could potentially increase the risk of toxicity. It should not be mixed with citrated blood as it can cause clotting. However, it is compatible with many other infusion solutions like saline, dextrose, and Ringer's solution, and can be used as a carrier for water-soluble drugs such as insulin and streptokinase. Interactions may occur with corticosteroids and diuretics, potentially affecting electrolyte balance, and it should not be given with certain antibiotics like ceftriaxone in newborns.

What precautions should be taken with Haemaccel SY (R.PACK)?

It should be administered with caution and close monitoring in patients with conditions where an increase in intravascular volume or interstitial fluid volume, or haemodilution, could pose a risk. These conditions include congestive heart failure, hypertension, oesophageal varices, pulmonary oedema, hemorrhagic diathesis, and certain kidney conditions. Special care is needed for individuals at an increased risk of histamine release (e.g., allergic persons or those recently given histamine-releasing drugs). Rapid administration, especially in normovolaemic patients, should be avoided. Patients on cardiac glycosides should have their serum calcium levels monitored. It should not be used if you are allergic to any of its components.

What happens if a dose of Haemaccel SY (R.PACK) is missed?

Haemaccel SY (R.PACK) is typically administered in a hospital or clinical setting by a doctor or nurse, who will monitor the patient closely. Therefore, it is highly unlikely that a dose will be missed.

How should Haemaccel SY (R.PACK) be stored?

Haemaccel SY (R.PACK) should be stored under the conditions specified on the product packaging and kept out of the reach of children and pets. An unopened bottle has a shelf life of up to 5 years. Once opened, it should be used immediately.