Zenalb 4.5 A 45g/L Of Human Albumin Solution For Infusion (4.5% Solution)
ADL19
PACKAGE LEAFLET: INFORMATION FOR THE USER ZENALB®4.5
4.5% W/V SOLUTION FOR INFUSION HUMAN ALBUMIN SOLUTION
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor.
In This Leaflet:
1. WHAT ZENALB® 4.5 IS AND WHAT IT IS USED FOR
2. BEFORE YOU ARE GIVEN ZENALB® 4.5
3. HOW YOU WILL BE GIVEN ZENALB® 4.5
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ZENALB® 4.5
6. FURTHER INFORMATION
1. WHAT ZENALB® 4.5 IS AND WHAT IT IS USED FOR
Zenalb 4.5® 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 4.5® is used to replace the blood or body fluids that you have lost because of bleeding, surgery, or kidney dialysis (blood “cleaning” by a machine). It contains a similar amount of albumin as normal blood.
The product is given by injection into a vein (intravenous infusion). It is only available on a doctor’s prescription.
This medicine is also suitable for premature babies and patients on kidney dialysis as it contains only very small quantities of aluminium.
2. BEFORE YOU ARE GIVEN ZENALB® 4.5
Do not allow Zenalb® 4.5 to be given to you if you:
• are allergic to albumin or any of the other ingredients of Zenalb® 4.5 (see Section 6 and end of Section 2 Important information about some of the ingredients of Zenalb® 4.5).
Take special care with Zenalb® 4.5
You must tell your doctor before receiving Zenalb® 4.5 if any of the following conditions applies to you:
• allergic or violent reaction to Zenalb® 4.5 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
• elderly
• a young child
• receiving regular or repeated infusions of Zenalb® 4.5. You may need to have a vaccination for hepatitis A and B.
You will need to be monitored closely during treatment and should be checked for dehydration and salt (electrolyte) balance in your body. If you start to feel ill, then tell the doctor immediately, because the infusion rate may have to be altered or the treatment stopped.
Water should not be added to the Zenalb® 4.5 solution as it may cause breaking down of some of your red blood cells.
Taking other medicines
Other medicines are unlikely to affect your treatment with Zenalb® 4.5. However, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Zenalb® 4.5 must not be diluted with water for injections. It may also be necessary to receive whole blood, plasma or red blood cells.
Pregnancy and breast-feeding
Tell your doctor before receiving Zenalb® 4.5 if you are pregnant, likely to become pregnant or are breast-feeding.
Driving and using machines
There are no restrictions on driving or using machines after being treated with Zenalb® 4.5.
Important information about some of the ingredients of Zenalb® 4.5
Potassium and sodium are ingredients in this product.
If you have been told that you have reduced kidney function or are on a potassium- or sodium-controlled diet, tell the doctor before he/she gives you the infusion.
3. HOW YOU WILL BE GIVEN ZENALB® 4.5
You will be given Zenalb® 4.5 as an infusion (an injection given very slowly into a vein). It is unlikely that you will ever have to use Zenalb® 4.5 yourself; infusion fluids are mainly given by a doctor or nurse.
The bottle will be warmed to room temperature before it is used. A thin plastic tube and connector will be inserted into your 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 you. The medicine will pass down the tube slowly, through a filter and into your body through the thin plastic tube.
How much you will be given:
Your doctor or nurse will calculate how much Zenalb® 4.5 to give you and how often you should receive it. The amount given will depend on your individual needs.
During and after treatment with Zenalb® 4.5, your doctor may check any or all of the following:
• how well the medicine is working by taking your pulse or heart rate
• your blood pressure
• the pressure inside your heart or lungs by placing a very thin tube into your vein or artery
• your heart and breathing will be checked regularly, particularly if you are 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 your child.
Your doctor will take this into account when calculating the amount to give.
The usual dose for infusion will be decided by your doctor depending on your condition and your response to treatment.
If you experience headache, difficulty in breathing, jugular vein congestion (signs that your 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 you are given more ZENALB® 4.5 than you should
If you receive more Zenalb® 4.5 than you should, you may experience:
• high blood pressure, difficulty in breathing (particularly when lying down) and high pressure inside your heart, which your doctor can measure.
In the unlikely event that too much medicine is given, the infusion will be stopped immediately and your doctor may give you treatment to remove the excess fluid.
If you feel unwell afterwards or have any discomfort, tell your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zenalb® 4.5 can cause side effects, although 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 you feel unwell, you must tell your doctor immediately.
Some people may have an allergic reaction ranging from a mild skin rash to more serious cases of shock (when your blood pressure falls dangerously low). Symptoms of this are:
• dizziness
• sweating
• cold, clammy skin.
Your doctor will stop the infusion and treat the allergic reaction if this happens.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
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 your medicine will usually be greater than the risks of suffering any harmful side effects.
5. HOW TO STORE ZENALB® 4.5
Keep Zenalb® 4.5 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® 4.5 if you notice the solution is cloudy or has deposits.
• Do not use Zenalb® 4.5 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® 4.5.
Disposal
Your doctor will discard any unused solution.
Medicines should not be disposed of via wastewater or household waste, to help protect the environment.
6. FURTHER INFORMATION What ZENALB® 4.5 contains
The active substance is at least 95% human albumin (45g/litre of protein) obtained from blood from screened donors. These donors are selected from the USA.
The other ingredients are sodium chloride, potassium citrate, aluminium (trace) and sodium-n-octanoate (as a stabilizer).
For potassium and sodium see end of Section 2: Important information about some of the ingredients of Zenalb® 4.5.
Because Zenalb® 4.5 only contains a trace of aluminium, it is suitable for premature babies and patients on kidney dialysis.
What ZENALB® 4.5 looks like and contents of the pack
Zenalb® 4.5 is a sterile, almost colourless yellow, amber or green thick (viscous) liquid in a glass bottle with a rubber bung and sealed cap.
This product is available in 50 ml, 100 ml, 250 ml and 500 ml sizes, with a sling to hold the bottle during infusion.
Marketing Authorisation Holder, and manufacturer
BioProductsLaboratoryLimited
DaggerLane
Elstree
Hertfordshire
WD6 3BX,U.K.
Marketing Authorisation Number
PL 08801/0006
This leaflet was last approved in
March 2007
For further information or if you have any questions about the use of this product, please contact BPL via the Marketing Department at the address above or through info@bpl.co.uk.
Bio Products Laboratory
Date of leaflet preparation: July 2012
Bio Products Laboratory Limited
Dagger Lane, Elstree, Herts. WD6 3BX, U.K.
Version: ADL19