Albumin Octapharma
PACKAGE LEAFLET: INFORMATION FOR THE USER
Albumin Octapharma 50 g/l
Human albumin 50 g/l Solution for infusion
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Read all of this leaflet carefully before you start using this medicine.
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In this leaflet:
What Albumin Octapharma is and what it is used for
Before you use Albumin Octapharma
How to use Albumin Octapharma
Possible side effects
How to store Albumin Octapharma
Further information
WHAT ALBUMIN OCTAPHARMA IS AND WHAT IT IS USED FOR
Albumin Octapharma belongs to the pharmacotherapeutic group: plasma substitutes and plasma protein fractions.
The product is given to patients to restore and maintain circulating blood volume where a deficiency in volume has been demonstrated.
BEFORE YOU USE ALBUMIN OCTAPHARMA
Do not use Albumin Octapharma :
if you are allergic (hypersensitive) to albumin preparations or any of the other ingredients
Take special care with Albumin Octapharma :
if you develop an allergic reaction to this albumin treatment, the infusion will be stopped and your doctor will recommend an alternative treatment.
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if you are at special risk from increased blood volume eg in case of some heart conditions, high blood pressure, fluid in the lung, bleeding disorders, low red blood cell count, dilated veins of the oesophagus or no urine output.
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when there are signs for increased blood volume (headache, breathing disorder, jugular vein congestion), increased blood pressure. The infusion should be stopped immediately
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This medicinal product contains 15 mmol sodium per 100 ml solution. To be taken into consideration by patients on a controlled sodium diet. Tell your doctor if this applies to you.
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This medicine contains less than 1 mmol potassium per 100 ml solution, i.e. essentially “potassium-free”.
Virus safety
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include:
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careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded
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testing of each donation and pools of plasma for signs of virus/infections
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steps included by the manufacturers in the processing of the blood or plasma that can inactivate or remove viruses.
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.
There are no reports of virus infections with albumin manufactured to European Pharmacopoeia specifications by established processes.
It is strongly recommended that every time you receive a dose of Albumin Octapharma the name and batch number of the product are recorded in order to maintain a record of the batches used.
Using other medicines
No interactions of human albumin with other products are known so far. However, Albumin Octapharma solution should not be mixed in the same injection with other drugs, whole blood or packed red cells.
Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines without a prescription.
Pregnancy and breast-feeding
Human albumin is a normal constituent of human blood. No harmful effects are known when this product is used during pregnancy or breast-feeding. Particular care should be taken to adjust blood volume in pregnant women.
Driving and using machines
There are no indications that human albumin impairs the ability to drive or to operate machines.
HOW TO USE ALBUMIN OCTAPHARMA
Albumin Octapharma is ready for use as an infusion (“drip”) into a vein. The dosage and infusion rate (how quickly you are given albumin into a vein) will depend on your particular condition. Your doctor will decide what treatment is best for you.
The product can be given to premature infants and dialysis patients.
If you use more Albumin Octapharma than you should:
If the dosage and rate of infusion are too high, you may develop headache, high blood pressure and discomfort breathing. The infusion should be stopped immediately and your doctor will decide if any other treatment is necessary.
POSSIBLE SIDE EFFECTS
Like all medicines, Albumin Octapharma can cause side effects, although not everybody gets them.
Side effects after infusion of human albumin are rare and they normally disappear when the infusion-rate is slowed down or stopped.
Rare side effects (frequency: more than 1 of 10,000 and fewer than 1 of 1,000 transfusions):
Low blood pressure or allergic reaction.
Very rare side effects (frequency: fewer than 1 of 10,000 transfusions):
Severe allergicreaction; confusional state; headache; increased or decreased heart rate; high blood pressure; heat sensation; shortageofbreath; feeling sick; nettle rash; swelling around eyes, nose, mouth; rash; increased sweating; fever; chills.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
HOW TO STORE ALBUMIN OCTAPHARMA
Keep out of the reach and sight of children.
Do not use Albumin Octapharma after the expiry date which is stated on the label.
Store and transport below +25°C. Keep the container in the outer carton in order to protect from light. Do not freeze.
Before use the product should be warmed to room or body temperature.
The solution should be clear or slightly opalescent. Do not use solutions which are cloudy or have deposits. Once the infusion container has been opened, the content should be used immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
FURTHER INFORMATION
What Albumin Octapharma contains
The active substance is human albumin.
One bottle of 100 ml contains 5 g of human albumin.
One bottle of 250 ml contains 12.5 g of human albumin.
The other ingredients are sodium, potassium, N-Acetyl-DL-tryptophan, caprylic acid and water for injections.
What Albumin Octapharma looks like and contents of the pack
Albumin Octapharma is a solution for infusion into a vein and is available in a bottle (5 g/100 ml, 12.5 g/250 ml). Pack size of 1.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
[to be completed nationally]
Manufacturer:
Octapharma Pharmazeutika, Produktionsges.m.b.H., Oberlaaerstrasse 235, A-1100 Vienna, Austria
This leaflet was last approved in2009-09-25.