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This medicine is also suitable for premature babies and The bottle will be warmed to room temperature before it is
patients on kidney dialysis as it contains only very small used. A thin plastic tube and connector will be inserted into
quantities of aluminium. your vein using a needle; the needle will be removed and the
connector will be attached to a plastic tube. The bottle of
2. BEFORE YOU ARE GIVEN ZENALB® 4.5 medicine will be attached to the other end of the tube and
Do not allow Zenalb® 4.5 to be given to you if you: hung in the plastic sling above you. The medicine will pass
• are allergic to albumin or any of the other ingredients of down the tube slowly, through a filter and into your body
Zenalb® 4.5 (see Section 6 and end of Section 2 through the thin plastic tube.
Important information about some of the ingredients of
Zenalb® 4.5). How much you will be given:
Your doctor or nurse will calculate how much Zenalb® 4.5 to
Take special care with Zenalb 4.5®
give you and how often you should receive it. The amount
You must tell your doctor before receiving Zenalb® 4.5 if any given will depend on your individual needs.
of the following conditions applies to you:
During and after treatment with Zenalb® 4.5, your doctor
• allergic or violent reaction to Zenalb® 4.5 when injected. may check any or all of the following:
Treatment should be stopped immediately. • how well the medicine is working by taking your pulse or
• blood problems, especially severe anaemia, or a heart rate
tendency to bleeding disorders • your blood pressure
• heart problems where the heart is not pumping • the pressure inside your heart or lungs by placing a very
properly (heart failure) thin tube into your vein or artery
• high blood pressure (hypertension) • your heart and breathing will be checked regularly,
• increased blood volume and associated complaints particularly if you are elderly or very young,
• severe kidney problems or a chronic liver condition. • blood tests may be carried out to check when the right
• fluid accumulation in the lungs amounts of protein, sodium and potassium are present
• elderly and treatment can stop.
• a young child
• receiving regular or repeated infusions of Zenalb® 4.5. Children:
You may need to have a vaccination for hepatitis A and B. The amount given will depend on the age of your child.
Your doctor will take this into account when calculating the
You will need to be monitored closely during treatment and amount to give.
should be checked for dehydration and salt (electrolyte)
balance in your body. If you start to feel ill, then tell the The usual dose for infusion will be decided by your doctor
doctor immediately, because the infusion rate may have to depending on your condition and your response to treatment.
be altered or the treatment stopped.
REDE DESIGN Ltd. Tel: 020 8863 7676 Job No. 7754
Client: BPL
Contact: Chidi Wek
Project Name: Zenalb 4.5 PIL UK Leaflet UK
Client Order No. BPL233413 Proof Approved
Proof No. 7
Operator: Hema Joshi Signed
If you experience headache, difficulty in breathing, jugular plasma includes steps to kill or remove viruses such as HIV,
vein congestion (signs that your heart is becoming hepatitis A, hepatitis B, and hepatitis C.
overloaded), or increased blood pressure, raised venous
pressure or pulmonary oedema, the infusion will be Please remember:
stopped immediately. The expected benefits of your medicine will usually be
greater than the risks of suffering any harmful side effects.
This medicine will not interfere with blood tests that are
carried out after it has been given. 5. HOW TO STORE ZENALB® 4.5
Keep Zenalb® 4.5 out of the reach and sight of children.
If you are given more ZENALB® 4.5 than you should
If you receive more Zenalb® 4.5 than you should, you may The medicine should be stored in a fridge or in a cool place
experience: between 2°C and 25°C. DO NOT FREEZE. Keep it in its
• high blood pressure, difficulty in breathing (particularly original carton to protect it from light.
when lying down) and high pressure inside your heart,
which your doctor can measure. Note to doctor or nurse:
• Do not use Zenalb® 4.5 if you notice the solution is
In the unlikely event that too much medicine is given, the cloudy or has deposits.
infusion will be stopped immediately and your doctor may • Do not use Zenalb® 4.5 after the expiry date which is
give you treatment to remove the excess fluid. stated on the label. The expiry date refers to the last day
If you feel unwell afterwards or have any discomfort, tell of that month.
your doctor. • Use within 3 hours of opening as there is no preservative
in Zenalb® 4.5.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zenalb® 4.5 can cause side effects, Disposal
although not everybody gets them. Your doctor will discard any unused solution.
Medicines should not be disposed of via wastewater or
The following side effects may occur infrequently and are household waste, to help protect the environment.
usually mild:
• feeling sick 6. FURTHER INFORMATION
• flushing What ZENALB® 4.5 contains
• feeling feverish The active substance is at least 95% human albumin
• itchy, raised bumps on the skin (45g/litre of protein) obtained from blood from screened
• shaking of the body (rigors) donors. These donors are selected from the USA.
• high blood pressure (hypertension)
• low blood pressure (hypotension) The other ingredients are sodium chloride, potassium
• feeling cold citrate, aluminium (trace) and sodium-n-octanoate (as
• increased heart rate (tachycardia) a stabilizer).
• tremor
• shortness of breath For potassium and sodium see end of Section 2: Important
• chest tightness information about some of the ingredients of Zenalb® 4.5.
• wheezing
• noisy breathing from throat (stridor) Because Zenalb® 4.5 only contains a trace of aluminium, it is
• dizziness suitable for premature babies and patients on kidney dialysis.
If you feel unwell, you must tell your doctor immediately.
What ZENALB® 4.5 looks like and contents of the pack
Some people may have an allergic reaction ranging from a Zenalb® 4.5 is a sterile, almost colourless yellow, amber or
mild skin rash to more serious cases of shock (when your green thick (viscous) liquid in a glass bottle with a rubber
blood pressure falls dangerously low). Symptoms of this are: bung and sealed cap.
• dizziness This product is available in 50 ml, 100 ml, 250 ml and
• sweating 500 ml sizes, with a sling to hold the bottle during infusion.
• cold, clammy skin.
Marketing Authorisation Holder, and manufacturer
Your doctor will stop the infusion and treat the allergic BPL, Bio Products Laboratory
reaction if this happens. Dagger Lane,
Elstree,
If any of these side effects gets serious, or if you notice Herts. WD6 3BX
any side effects not listed in this leaflet, please tell United Kingdom.
your doctor.
Marketing Authorisation Number
Please note PL 08801/0006
Although no patients have developed virus infections from
human albumin solutions, the possibility of infection from This leaflet was last approved in
using medicines made from human blood cannot be totally March 2007
ruled out. This warning includes known, unknown and new
viruses and some other germs. Several different steps have For further information or if you have any questions
been taken to make this possibility very unlikely. These about the use of this product, please contact BPL via
include the careful selection of donors and testing of the the Marketing Department at the address above or
plasma they provide for specific types of infection. The through info@bpl.co.uk.
method used to produce the medicine from their blood
REDE DESIGN Ltd. Tel: 020 8863 7676 Job No. 7754
Client: BPL
Contact: Chidi Wek
Project Name: Zenalb 4.5 PIL UK Leaflet UK
Client Order No. BPL233413 Proof Approved
Proof No. 7
Operator: Hema Joshi Signed