The active substance is at least 95% human albumin (200 g/litre of protein) obtained from blood from screened donors. These donors are selected from the USA.
Each solution for infusion contains 20% w/v of human albumin solution.
Excipients/Inactive Ingredients: Sodium chloride, potassium citrate, aluminum (trace) and sodium-n-octanoate (as a stabilizer). For potassium and sodium see important information about some of the ingredients of Zenalb 20.
Because Zenalb 20 only contains a trace of aluminum, it is suitable for premature babies and patients on kidney dialysis.
Zenalb 20 is a solution containing the active substance called human albumin (a protein found naturally in your blood which is needed for many different functions). Human albumin is obtained from blood plasma from screened donors selected from the USA.
Zenalb 20 is used to replace the blood or body fluids that the patient have lost because of bleeding, surgery, or kidney dialysis (blood "cleaning" by a machine). It contains four times the amount of albumin as normal blood.
The product is given by injection into a vein (intravenous infusion) either undiluted or in a solution containing 5% glucose or 0.9% sodium chloride. It is only available on a physician's prescription.
This medicine is also suitable for premature babies and patients on kidney dialysis as it contains only very small quantities of aluminum.
The physician or nurse will calculate how much Zenalb 20 to give the patient and how often the patient should receive it. The amount given will depend on the individual needs.
During and after treatment with Zenalb 20, the physician may check any or all of the following: How well the medicine is working by taking the pulse or heart rate; the blood pressure; the pressure inside the heart or lungs by placing a very thin tube into the vein or artery; heart and breathing will be checked regularly, particularly if the patient is elderly or very young; blood tests may be carried out to check when the right; amounts of protein, sodium and potassium are present and treatment can stop.
Children: The amount given will depend on the age of the child. The physician will take this into account when calculating the amount to give.
The usual dose for infusion will be decided by the physician depending on the condition and the response to treatment.
The medicine can be diluted with 5% glucose or 0.9% sodium chloride by the physician but no other medicine should be added to the liquid before it is given.
If the patient experience headache, difficulty in breathing, jugular vein congestion (signs that the heart is becoming overloaded), or increased blood pressure, raised venous pressure or pulmonary oedema, the infusion will be stopped immediately.
This medicine will not interfere with blood tests that are carried out after it has been given.
If the patient is given more ZENALB 20 than the patient should the patient may experience: high blood pressure, difficulty in breathing (particularly when lying down) and high pressure inside the heart, which the physician can measure.
In the unlikely event that too much medicine is given, the infusion will be stopped immediately and the physician may give the treatment to remove the excess fluid. If the patient feel unwell afterwards or have any discomfort, tell the physician.
Administration: The patient will be given Zenalb 20 as an infusion (an injection given very slowly into a vein). It is unlikely that the patient will have to use Zenalb 20; infusion fluids are mainly given by a physician or nurse.
The bottle will be warmed to room temperature before it is used.
A thin plastic tube and connector will be inserted into the vein using a needle; the needle will be removed and the connector will be attached to a plastic tube.
The bottle of medicine will be attached to the other end of the tube and hung in the plastic sling above the patient.
The medicine will pass down the tube slowly, through a filter and into the body through the thin plastic tube.
Do not allow Zenalb 20 to be given to patient if: Allergic to albumin or any of the other ingredients of Zenalb 20 (see Description).
The patient must tell the physician before receiving Zenalb 20 if any of the following conditions applies to the patient: Allergic or violent reaction to Zenalb 20 when injected. Treatment should be stopped immediately; Blood problems, especially severe anaemia, or a tendency to bleeding disorders;
Heart problems where the heart is not pumping properly (heart failure);
High blood pressure (hypertension);
Increased blood volume and associated complaints;
Severe kidney problems or a chronic liver condition;
Fluid accumulation in the lungs;
A young child;
Receiving regular or repeated infusions of Zenalb 20. The patient may need to have a vaccination for hepatitis A and B.
The patient will need to be monitored closely during treatment and should be checked for dehydration and salt (electrolyte) balance in the body. If the patient start to feel ill, then tell the physician immediately, because the infusion rate may have to be altered or the treatment stopped.
Water should not be added to the Zenalb 20 solution as it may cause breaking down of some of the red blood cells.
Potassium and odium are ingredients in this product.
If the patient has been told that he/she has a reduced kidney function or is on a potassium- or sodium-controlled diet, tell the physician before giving the infusion.
Effects on the Ability to Drive and Using Machines: There are no restrictions on driving or using machines after being treated with Zenalb 20.
Tell the physician before receiving Zenalb 20 if the patient is pregnant, likely to become pregnant or is breast-feeding.
Like all medicines, Zenalb 20 can cause side effects, though not everybody gets them.
The following side effects may occur infrequently and are usually mild: Feeling sick; flushing; feeling feverish; itchy, raised bumps on the skin; shaking of the body (rigors;) high blood pressure (hypertension); low blood pressure (hypotension); feeling cold; increased heart rate (tachycardia); tremor; shortness of breath; chest tightness; wheezing; noisy breathing from throat (stridor); dizziness.
If the patient feel unwell, the patient must tell the physician immediately.
Some people may have an allergic reaction ranging from a mild skin rash to more serious cases of shock (when the patient's blood pressure falls dangerously low).
Symptoms of this are: dizziness; sweating; cold, clammy skin.
The physician will stop the infusion and treat the allergic reaction if this happens.
If any of these side effects gets serious or if the patient notice any side effects not listed please tell the physician.
Please note: Although no patients have developed virus infections from human albumin solutions, the possibility of infection from using medicines made from human blood cannot be totally ruled out. This warning includes known, unknown and new viruses and some other germs. Several different steps have been taken to make this possibility very unlikely. These include the careful selection of donors and testing of the plasma they provide for specific types of infection.
The method used to produce the medicine from their blood plasma includes steps to kill or remove viruses such as HIV, hepatitis A, hepatitis B, and hepatitis C.
Please remember: The expected benefits of the medicine will usually be greater than the risks of suffering any harmful side effects.
Other medicines are unlikely to affect the treatment with Zenalb 20. However, please tell the physician or pharmacist if the patient is taking or have recently taken any other medicines; including medicines obtained without a prescription.
Zenalb 20 can be diluted with 5% glucose or 0.9% sodium chloride, but must not be diluted with water for injections. It may also be necessary to receive whole blood, plasma or red blood cells.
Disposal: The physician will discard any unused solution. Medicines should not be disposed of via wastewater or household waste, to help protect the environment.
Keep Zenalb 20 out of the reach and sight of children.
The medicine should be stored in a fridge or in a cool place between 2°C and 25°C.
DO NOT FREEZE. Keep it in its original carton to protect it from light.
Note to doctor or nurse: Do not use Zenalb 20 if the solution is cloudy or has deposits.
Do not use Zenalb 20 after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Use within 3 hours of opening as there is no preservative in Zenalb 20.
B05AA01 - albumin ; Belongs to the class of blood substitutes and plasma protein fractions. Used as blood substitutes.
Infusion 20% (sterile, almost colourless yellow, amber or green thick (viscous) liquid) x 50 mL.