Human Albumin 50g/L Baxter Solution For Infusion
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Package leaflet: Information for the user
HUMAN ALBUMIN 50 g/l BAXTER
Solution for Infusion
Human albumin
0001852
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Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Human Albumin 50 g/l Baxter is and what it is used for
2. What you need to know before you use Human Albumin 50 g/l Baxter
3. How to use Human Albumin 50 g/l Baxter
4. Possible side effects
5. How to store Human Albumin 50 g/l Baxter
6. Contents of the pack and other information
1. What Human Albumin 50 g/l Baxter is and what it is used for
Human Albumin 50 g/l Baxter contains a protein called albumin found in the liquid component of the blood (the plasma) and belongs to the group of medical products called “plasma substitutes and plasma protein fractions”. It is made from human blood collected from blood donors.
A vial of 250 ml contains 12.5 g of human albumin.
A vial of 500 ml contains 25 g of human albumin.
Human albumin is used to restore and maintain blood volume in patients who have lost blood or fluid due to certain medical conditions. The choice of albumin rather than an artificial substitute and the dose needed will depend on the clinical situation of the individual patient.
2. What you need to know before you use Human Albumin 50 g/l Baxter
Do not use Human Albumin 50 g/l Baxter:
- if you are allergic to human albumin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Human Albumin 50 g/l Baxter.
- if you think you have an allergic reaction during the treatment, with difficulty breathing, feeling faint or other symptoms. If this happens, tell your doctor or nurse immediately because the infusion will have to be stopped and medical treatment for shock may need to be implemented.
- if you have:
- uncontrolled heart failure
- high blood pressure
- oesophageal varices (swollen veins in the oesophagus)
- pulmonary oedema (fluid on the lungs)
- a tendency to spontaneous bleeding
- severe anemia (lack of red blood cells)
- no urine formation.
If you think any of these applies to you, inform your doctor so that he/she can take appropriate precautions.
When medicines are made from human blood or plasma, certain steps are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/ infections. Manufacturers of these products also include steps 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 Human Albumin 50 g/l Baxter the name and batch number of the product are recorded in order to maintain a record of the batches used.
Other medicines and Human Albumin 50 g/l Baxter
- Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- No specific complications of taking human albumin with other medicinal products are known.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby ask your doctor or pharmacist before taking this medicine. Your doctor will decide if you can use Human Albumin 50 g/l Baxter during pregnancy or breast-feeding.
Driving and using machines
No effect on the ability to drive or use machines has been observed.
Human Albumin 50 g/l Baxter contains sodium
Human Albumin 50 g/l Baxter contains 130 - 160 mmol/l sodium. This is to be taken into consideration by patients on a controlled sodium diet.
3. How to use Human Albumin 50 g/l Baxter
Human Albumin 50 g/l Baxter is a medicine for hospital use. It will therefore be administered in a hospital by appropriate health care personnel. Your doctor will establish the amount of product to be administered, the frequency of dosing and the duration of treatment based on your specific condition. He/she will monitor your condition,
Perforation
B
- Human Albumin Solution 50 g/l should be administered by the intravenous route, infusing the package contents directly.
- Human Albumin Solution 50 g/l should not be diluted with water for injection, since this could cause hemolysis in the recipient of the product.
- Do not use unless seal is intact. If leaks are found, discard.
- Solutions should be clear, slightly viscous, almost colourless, yellow, amber or green. Solutions that are turbid or showing sediments should not be used, since this could be an indication that the protein is unstable or the solution has been contaminated. Once the package has been opened, its contents must be used immediately.
- Infusion is performed by the intravenous route using a disposable sterile and pyrogen-free infusion set. Before inserting the infusion
set in the cap, this should be disinfected with an appropriate antiseptic. Once the infusion set is attached to the vial, the contents should be perfused immediately. Unused solutions should be adequately discarded.
- The infusion rate should be adjusted according to the individual circumstances and the indication.
- In plasma exchange the infusion rate should be adjusted to the rate of removal.
- If large volumes are administered, the product should be warmed to room temperature before use.
- When concentrated albumin is administered, adequate hydration of the patient must be ensured. Patients should be adequately monitored to prevent circulatory overload and overhydration.
measuring your blood pressure and heart rate and taking blood tests, while you are receiving Human Albumin to make sure that you are not given too much. If you experience headache, difficulties in breathing or increased blood pressure, please tell your doctor.
If you take more Human Albumin 50 g/l Baxter than you should
If you may have got more Human Albumin 50 g/l Baxter than you should consult your doctor or pharmacist immediately.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects listed below occurs, the infusion should be stopped immediately and appropriate treatment initiated:
• anaphylactic shock (very rare: may affect up to 1 in 10,000 people)
• hypersensitivity/allergic reactions (not known: frequency cannot be estimated from the available data)
The following side effects have also been reported:
Rare: may affect up to 1 in 1,000 people
- nausea (feeling sick)
- flushing
- skin rash
- fever
Not known: frequency cannot be estimated from the available data
- headache
- altered sense of taste
- heart attack
- irregular heartbeat
- rapid heartbeat
- abnormally low blood pressure
- accumulation of fluid in the lung
- breathlessness or breathing discomfort
- vomiting
- hives
- itchiness
- chills
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below.
United Kingdom
The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie
Malta
ADR Reporting The Medicines Authority Post-Licensing Directorate 203 Level 3, Rue D'Argens GZR-1368 Gzira
Website: www.medicinesauthority.gov.mt e-mail: postlicensing.medicinesauthority@gov. mt
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Human Albumin 50 g/l Baxter
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not freeze.
Keep the glass vial in the outer carton in order to protect from light. Once the package has been opened, the contents must be used immediately.
Do not use Human Albumin 50 g/l Baxter if you notice the solution is cloudy or has particles in it.
6. Contents of the pack and other information
What Human Albumin 50 g/l Baxter contains
- The active substance is: human albumin.
Every 100 ml contain 5 g of total protein, of which at least 95% is human albumin.
- The other ingredients are: sodium chloride, sodium caprylate, sodium N-acetyltryptophanate, water for injection.
Total amount of sodium ions: 130 -160 mmol/l
What Human Albumin 50 g/l Baxter looks like and contents of the pack
It is a clear, slightly thick liquid; it is almost colourless, yellow, amber or green. It is a sterile solution for intravenous infusion in 250 ml or 500 ml glass vials.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Baxter Healthcare Ltd
Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
Manufacturer
Baxter AG
IndustriestraBe 67, A-1221 Vienna, Austria
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Baxter Healthcare Ltd
Wallingford Road, Compton, Newbury, RG20 7QW, United Kingdom Tel: 01635 206345
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Human Albumin Baxter 50 g/l - Infusionslosung Belgium, Bulgaria, Cyprus, Czech Republic, Germany, Greece, Ireland, Luxemburg, Malta, Poland, Slovakia, Slovenia, United Kingdom:
Human Albumin 50 g/l Baxter
Denmark, Estonia, Finland, Iceland, Norway, Sweden:
Albumin Baxter 50 g/l
Italy: Albumina Baxter 50 g/l
Latvia: Albumin Baxter 50 g/l skidums infuzijam
Lithuania: Albumin Baxter 50 g/l infuzinis tirpalas
Portugal: Albumina Humana Baxter
Romania: Albumina Umana Baxter 50 g/l solutie perfuzabila
This leaflet was last revised in 01/2015
Perforation
- When albumin is administered, the electrolyte balance of the patient should be monitored and, if required, appropriate measures should be taken to restore or maintain it.
- Adequate replacement of other blood components (coagulation factors, electrolytes, platelets and erythrocytes) must be ensured.
- For safety reasons, the batch number of Human Albumin 50 g/l Baxter administered should be recorded.
- Human albumin must not be mixed with other medicinal products, whole blood and packed red cells. Further human albumin should not be mixed with protein hydrolysates (e.g. parenteral nutrition) or solutions containing alcohol since these combinations may cause the proteins to precipitate.
- Hypervolaemia may occur if the dosage and rate of infusion are too high. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised central venous pressure, and pulmonary oedema, the infusion should be stopped immediately and the patient's haemodynamic parameters carefully monitored.
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Baxter
0001854
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o
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Package leaflet: Information for the user
HUMAN ALBUMIN 50 g/l BAXTER
Solution for Infusion
Human albumin
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Human Albumin 50 g/l Baxter is and what it is used for
2. What you need to know before you use Human Albumin 50 g/l Baxter
3. How to use Human Albumin 50 g/l Baxter
4. Possible side effects
5. How to store Human Albumin 50 g/l Baxter
6. Contents of the pack and other information
1. What Human Albumin 50 g/l Baxter is and what it is used for
Human Albumin 50 g/l Baxter contains a protein called albumin found in the liquid component of the blood (the plasma) and belongs to the group of medical products called “plasma substitutes and plasma protein fractions”. It is made from human blood collected from blood donors.
A vial of 250 ml contains 12.5 g of human albumin.
A vial of 500 ml contains 25 g of human albumin.
Human albumin is used to restore and maintain blood volume in patients who have lost blood or fluid due to certain medical conditions. The choice of albumin rather than an artificial substitute and the dose needed will depend on the clinical situation of the individual patient.
2. What you need to know before you use Human Albumin 50 g/l Baxter Do not use Human Albumin 50 g/l Baxter:
- if you are allergic to human albumin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Human Albumin 50 g/l Baxter.
- if you think you have an allergic reaction during the treatment, with difficulty breathing, feeling faint or other symptoms. If this happens, tell your doctor or nurse immediately because the infusion will have to be stopped and medical treatment for shock may need to be implemented.
- if you have:
- uncontrolled heart failure
- high blood pressure
- oesophageal varices (swollen veins in the oesophagus)
- pulmonary oedema (fluid on the lungs)
- a tendency to spontaneous bleeding
- severe anemia (lack of red blood cells)
- no urine formation.
If you think any of these applies to you, inform your doctor so that he/she can take appropriate precautions.
When medicines are made from human blood or plasma, certain steps are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps 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 Human Albumin 50 g/l Baxter the name and batch number of the product are recorded in order to maintain a record of the batches used.
Other medicines and Human Albumin 50 g/l Baxter
- Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- No specific complications of taking human albumin with other medicinal products are known.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby ask your doctor or pharmacist before taking this medicine. Your doctor will decide if you can use Human Albumin 50 g/l Baxter during pregnancy or breast-feeding.
Driving and using machines
No effect on the ability to drive or use machines has been observed.
Human Albumin 50 g/l Baxter contains sodium
Human Albumin 50 g/l Baxter contains 130 - 160 mmol/l sodium. This is to be taken into consideration by patients on a controlled sodium diet.
3. How to use Human Albumin 50 g/l Baxter
Human Albumin 50 g/l Baxter is a medicine for hospital use. It will therefore be administered in a hospital by appropriate health care personnel. Your doctor will establish the amount of product to be administered, the frequency of dosing and the duration of treatment based on your specific condition. He/she will monitor your condition, measuring your blood pressure and heart rate and taking blood tests, while you are receiving Human Albumin to make sure that you are not given too much. If you experience headache, difficulties in breathing or increased blood pressure, please tell your doctor.
If you take more Human Albumin 50 g/l Baxter than you should
If you may have got more Human Albumin 50 g/l Baxter than you should consult your doctor or pharmacist immediately.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects listed below occurs, the infusion should be stopped immediately and appropriate treatment initiated:
• anaphylactic shock (very rare: may affect up to 1 in 10,000 people)
• hypersensitivity/allergic reactions (not known: frequency cannot be estimated from the available data)
The following side effects have also been reported:
Rare: may affect up to 1 in 1,000 people
- nausea (feeling sick)
- flushing
- skin rash
- fever
Not known: frequency cannot be estimated from the available data
- headache
- altered sense of taste
- heart attack
- irregular heartbeat
- rapid heartbeat
- abnormally low blood pressure
- accumulation of fluid in the lung
- breathlessness or breathing discomfort
- vomiting
- hives
- itchiness
- chills
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below.
United Kingdom
The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie
Malta
ADR Reporting The Medicines Authority Post-Licensing Directorate 203 Level 3, Rue D'Argens GZR-1368 Gzira
Website: www.medicinesauthority.gov. mt e-mail: postlicensing.medicinesauthority@gov.mt
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Human Albumin 50 g/l Baxter
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not freeze.
Keep the glass vial in the outer carton in order to protect from light.
Once the package has been opened, the contents must be used immediately.
Do not use Human Albumin 50 g/l Baxter if you notice the solution is cloudy or has particles in it.
6. Contents of the pack and other information
What Human Albumin 50 g/l Baxter contains
- The active substance is: human albumin.
Every 100 ml contain 5 g of total protein, of which at least 95% is human albumin.
- The other ingredients are: sodium chloride, sodium caprylate, sodium N-acetyltryptophanate, water for injection.
Total amount of sodium ions: 130 -160 mmol/l
What Human Albumin 50 g/l Baxter looks like and contents of the pack
It is a clear, slightly thick liquid; it is almost colourless, yellow, amber or green. It is a sterile solution for intravenous infusion in 250 ml or 500 ml glass vials.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom
Manufacturer
Baxter AG IndustriestraBe 67 A-1221 Vienna Austria
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Baxter Healthcare Ltd Wallingford Road Compton Newbury RG20 7QW United Kingdom Tel: 01635 206345
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Human Albumin Baxter 50 g/l - Infusionslosung
Belgium, Bulgaria, Cyprus, Czech Republic, Germany, Greece, Ireland,
Luxemburg, Malta, Poland, Slovakia, Slovenia, United Kingdom:
Human Albumin 50 g/l Baxter
Denmark, Estonia, Finland, Iceland, Norway, Sweden:
Albumin Baxter 50 g/l
Italy: Albumina Baxter 50 g/l
Latvia: Albumin Baxter 50 g/l skidums infuzijam
Lithuania: Albumin Baxter 50 g/l infuzinis tirpalas
Portugal: Albumina Humana Baxter
Romania: Albumina Umana Baxter 50 g/l solutie perfuzabila
This leaflet was last revised in 01/2015
Perforation
Baxter
The following information is intended for healthcare professionals only:
- Human Albumin Solution 50 g/l should be administered by the intravenous route, infusing the package contents directly.
- Human Albumin Solution 50 g/l should not be diluted with water for injection, since this could cause hemolysis in the recipient of the product.
- Do not use unless seal is intact. If leaks are found, discard.
- Solutions should be clear, slightly viscous, almost colourless, yellow, amber or green. Solutions that are turbid or showing sediments should not be used, since this could be an indication that the protein is unstable or the solution has been contaminated. Once the package has been opened, its contents must be used immediately.
- Infusion is performed by the intravenous route using a disposable sterile and pyrogen-free infusion set. Before inserting the infusion set in the cap, this should be disinfected with an appropriate antiseptic. Once the infusion set is attached to the vial, the contents should be perfused immediately. Unused solutions should be adequately discarded.
- The infusion rate should be adjusted according to the individual circumstances and the indication.
- In plasma exchange the infusion rate should be adjusted to the rate of removal.
- If large volumes are administered, the product should be warmed to room temperature before use.
- When concentrated albumin is administered, adequate hydration of the patient must be ensured. Patients should be adequately monitored to prevent circulatory overload and overhydration.
- When albumin is administered, the electrolyte balance of the patient should be monitored and, if required, appropriate measures should be taken to restore or maintain it.
- Adequate replacement of other blood components (coagulation factors, electrolytes, platelets and erythrocytes) must be ensured.
- For safety reasons, the batch number of Human Albumin 50 g/l Baxter administered should be recorded.
- Human albumin must not be mixed with other medicinal products, whole blood and packed red cells. Further human albumin should not be mixed with protein hydrolysates (e.g. parenteral nutrition) or solutions containing alcohol since these combinations may cause the proteins to precipitate.
- Hypervolaemia may occur if the dosage and rate of infusion are too high. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised central venous pressure, and pulmonary oedema, the infusion should be stopped immediately and the patient's haemodynamic parameters carefully monitored.
Perforation
0001854_GB-IE-MT_V1.indd 6 02.02.15 15:37