Human albumin Grifols: detailed information

Package leaflet: Information for the user

Human Albumin Grifols 50 g/l infusion solution

human albumin
Please read this leaflet carefully before you use this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Human Albumin Grifols 50 g/l is and what it is used for
What you need to know before using Human Albumin Grifols 50 g/l
How to use Human Albumin Grifols 50 g/l
Possible side effects
How to store Human Albumin Grifols 50 g/l
Package contents and other information

1. What Albumina Umana Grifols 50 g/l is and what it is used for

Albumina Umana Grifols 50 g/l is an intravenous infusion solution containing proteins extracted from human plasma (plasma proteins), i.e. the liquid component of blood. Each vial/bag contains a solution of 50 g of plasma proteins per litre, consisting of at least 95% human albumin.
This medicine belongs to a group of medicines known as plasma substitutes and plasma protein fractions.
Albumina Umana Grifols 50 g/l is used to restore and maintain the circulating blood volume in cases where a volume deficit has been demonstrated and the use of a plasma substitute is considered appropriate.
Albumina Umana Grifols can be used at any age. For children, see section 4.
For any questions regarding the use of Albumina Umana Grifols 50 g/l, please consult your doctor.

2. What you should know before using Human Albumin Grifols 50 g/l

Do not use Human Albumin Grifols 50 g/l

if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to use Human Albumin Grifols 50 g/l.
Human Albumin Grifols 50 g/l must be administered with particular caution

if you are especially at risk due to increased blood volume, for example in case of severe heart disease, high blood pressure, esophageal varices, pulmonary edema, coagulation disorders, severe reduction in red blood cells, or absence of urine.
if symptoms indicating increased blood volume (headache, breathing difficulties, jugular vein distension) or increased blood pressure occur. The infusion must be stopped immediately.
if signs of an allergic reaction occur. The infusion must be stopped immediately.
when used in patients with severe brain injury due to trauma.

For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive result in anti- doping tests.
When medicines are prepared from human blood or plasma, certain measures are taken to prevent transmission of infections to patients. These measures include:

careful selection of blood and plasma donors to ensure potentially infected donors are excluded,
testing of each donation and plasma pool for signs of viruses/infections,
inclusion of specific manufacturing steps that can inactivate or remove viruses.

Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be completely ruled out. This applies also to unknown or emerging viruses or other types of infectious agents.
No cases of viral infections have been reported with albumin produced by well-established processes and meeting European Pharmacopoeia specifications.
It is strongly recommended that, each time you receive a dose of Human Albumin Grifols 50 g/l, both the name and the batch number of the medicine are recorded, in order to maintain traceability of the batches used.

Children
The safety and efficacy of Human Albumin Grifols 50 g/l in children have not been established in controlled clinical trials. However, clinical experience with albumin use in children suggests that harmful effects are not expected, provided particular attention is paid to the administered dose in order to avoid circulatory overload.
See also section 4.

Other medicines and Human Albumin Grifols 50 g/l
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No specific interactions between human albumin and other medicines are known.

Pregnancy, breastfeeding, and fertility
Pregnancy
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of using Human Albumin Grifols 50 g/l during pregnancy has not been established in controlled clinical trials. However, clinical experience with albumin suggests that harmful effects on the course of pregnancy, the fetus, or the newborn are not expected.

Breastfeeding
It is not known whether Human Albumin Grifols 50 g/l is excreted in human milk. Excretion of human albumin in milk has not been studied in animals. The decision whether to continue or interrupt breastfeeding or to continue or interrupt treatment with Human Albumin Grifols should be made taking into account the benefit of breastfeeding for the child and the benefit of treatment with Human Albumin Grifols for the mother.

Fertility
Reproduction studies in animals have not been conducted with Human Albumin Grifols 50 g/l.
However, albumin is a normal constituent of human blood.

Driving and using machines
No effects on the ability to drive vehicles or operate machinery have been observed.

Human Albumin Grifols 50 g/l contains sodium
This medicine contains 333.5 mg of sodium (the main component of table salt) per 100 ml bottle/bag, 833.8 mg of sodium per 250 ml bottle/bag, and 1667.5 mg of sodium per 500 ml bottle/bag. This corresponds to 16.7%, 41.7%, and 83.4% of the maximum daily recommended dietary intake for an adult, respectively.
This medicine contains potassium, less than 39 mg (1 mmol) per bottle/bag, i.e., essentially 'potassium-free'.

3. How to use Human Albumin Grifols 50 g/l

Human Albumin Grifols 50 g/l is a medicinal product for hospital use; therefore, it is administered in a hospital by qualified healthcare personnel.
The dose and infusion rate of Human Albumin Grifols 50 g/l you will receive, as well as the frequency and duration of treatment, will be adjusted according to your individual needs. These will be determined for you by your doctor.
If you are given more Human Albumin Grifols 50 g/l than you should
If you have been administered a dose of Human Albumin Grifols 50 g/l higher than required, inform your doctor immediately.
If you forget to use Human Albumin Grifols 50 g/l
Do not administer a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Mild reactions such as skin redness, skin rash, fever and nausea may occur rarely.
Severe allergic reactions (anaphylactic shock) may occur very rarely.
For information on viral safety, see section 2.

Additional side effects in children
There are no specific data available to evaluate the possible occurrence of different adverse reactions in this population.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly via https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Human Albumin Grifols 50 g/l

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
Do not store above 30°C.
Do not freeze.
Keep the vial/bag in the outer packaging to protect the medicine from light.
Do not use this medicine if you notice that the solution is cloudy or contains deposits.
Once the container has been opened to assemble the infusion set, the contents must be used immediately.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Albumina Umana Grifols 50 g/l contains

The active substance is human albumin. One millilitre of Albumina Umana Grifols 50 g/l contains 50 mg of plasma proteins, consisting of at least 95% human albumin.
The other components are: sodium chloride, sodium caprylate, sodium N-acetyltryptophanate, water for injections.

Manufactured from plasma obtained from human donors.
For further information on the components, see also “Albumina Umana Grifols 50 g/l contains
sodium” at the end of section 2.

Description of the appearance of Albumina Umana Grifols 50 g/l and package contents
Albumina Umana Grifols 50 g/l is an infusion solution. The solution is clear, slightly viscous, nearly colourless, yellow, amber, or green.
Albumina Umana Grifols 50 g/l may be supplied in:

Vials with a chlorobutyl rubber stopper, aluminium seal, plastic top, and a plastic tamper-evident shrink band to ensure product integrity. The vials contain 100 ml, 250 ml, or 500 ml of product.
Bags (FlexBag) made of polyethylene, with a protective overwrap of polypropylene. The bags contain 100 ml, 250 ml, or 500 ml of product.

Packaging:

1 vial of 100 ml, 250 ml, or 500 ml per carton
1 bag of 100 ml, 250 ml, or 500 ml per carton

Marketing Authorisation Holder and Manufacturer
Instituto Grifols, S.A.
Can Guasch, 2 - Parets del Vallès
08150 Barcelona - SPAIN

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Bulgaria, Croatia, Finland, France, Germany, Greece, Ireland, Iceland, Poland, Portugal,
Czech Republic, Romania, Slovakia, Sweden: Albutein 50 g/l
Denmark, Norway: Albumin Grifols 50 g/l
Italy: Albumina Umana Grifols 50 g/l
Spain: Albutein 50 g/l solución para perfusión

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency: https://www.aifa.gov.it

The following information is intended for healthcare professionals only:

Albumina Umana Grifols 50 g/l can be administered directly by intravenous infusion.
Human albumin must not be mixed with other medicinal products, whole blood, or concentrated red blood cells.
Do not use solutions that appear cloudy or contain deposits. This may indicate that the protein is unstable or that the solution has been contaminated. Once the container has been opened, the contents must be used immediately.
Infusion must be performed intravenously using a sterile, pyrogen-free, single-use infusion set. Before inserting the infusion set into the stopper, the stopper must be disinfected using an appropriate antiseptic solution. After connecting the infusion set to the vial, the contents must be infused immediately.
The infusion rate must be adjusted according to the individual patient's clinical condition and indication. In plasma exchange procedures, the infusion rate must be adjusted according to the removal rate. If the dose and infusion rate are not appropriate for the patient's circulatory status, hypervolaemia may occur. In the event of early clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein distension), increased arterial pressure or increased venous pressure, or pulmonary oedema, the infusion must be stopped immediately.
If large volumes are to be administered, warm the medicinal product to room or body temperature before use.
When administering albumin, monitor the patient's electrolyte status and take appropriate measures to restore or maintain normal electrolyte balance.
Care must be taken to ensure adequate replacement of other blood components (coagulation factors, electrolytes, platelets, and erythrocytes).
Unused medicinal product and waste material must be disposed of in accordance with local requirements.

Bag:

Do not remove the protective overwrap until the time of use. Moisture or condensation may be observed inside the protective overwrap. This is normal and does not affect the quality or safety of the albumin solution.
Check the bag for leaks before use by firmly squeezing it. If leaks are detected, discard the solution.
To connect the infusion set, break the valve by twisting it.
Once the infusion set and bag have been assembled, the contents must be infused immediately.
Do not use bags connected in series. This method of use could cause gas embolism due to aspiration of residual air from the primary bag before completion of fluid administration from the secondary bag.

Patient Information Leaflet: Information for the User

Human Albumin Grifols 200 g/l solution for infusion

human albumin
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Human Albumin Grifols 200 g/l is and what it is used for
What you need to know before using Human Albumin Grifols 200 g/l
How to use Human Albumin Grifols 200 g/l
Possible side effects
How to store Human Albumin Grifols 200 g/l
Contents of the pack and other information

1. What Albumina Umana Grifols 200 g/l is and what it is used for

Albumina Umana Grifols 200 g/l is an intravenous infusion solution containing proteins
extracted from human plasma (plasma proteins), i.e. the liquid component of blood. Each
vial/bottle/bag contains a solution of 200 g of plasma proteins per litre, consisting of at least 95%
human albumin.
This medicine belongs to a group of medicines known as plasma substitutes and plasma protein fractions.
Albumina Umana Grifols 200 g/l is used to restore and maintain circulating blood volume
in cases where a volume deficit has been demonstrated and the use of a plasma substitute is considered
appropriate.
Albumina Umana Grifols can be used at any age. For children, see section 4.
For any questions regarding the use of Albumina Umana Grifols 200 g/l, please consult your doctor.

2. What you need to know before using Albumin Human Grifols 200 g/l

Do not use Albumin Human Grifols 200 g/l

if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to use Albumin Human Grifols 200 g/l.
Albumin Human Grifols 200 g/l must be administered with particular caution

if you are particularly at risk due to increased blood volume, for example in cases of severe heart disease, high blood pressure, esophageal varices, pulmonary edema, blood coagulation disorders, severe reduction in red blood cells, or absence of urine.
if symptoms indicating increased blood volume (headache, difficulty breathing, jugular vein distension) or increased blood pressure occur. Infusion must be stopped immediately.
if signs of an allergic reaction occur. Infusion must be stopped immediately.
when used in patients with severe traumatic brain injury.

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
When medicines are prepared from human blood or plasma, certain measures are taken to prevent transmission of infections to patients. These measures include:

careful selection of blood and plasma donors to ensure potentially infected donors are excluded,
testing of each donation and plasma pool for signs of viruses/infections,
inclusion of specific manufacturing steps that can inactivate or remove viruses.

Despite these measures, when administering medicines prepared from human blood or plasma, the possibility of transmitting infectious agents cannot be completely ruled out. This also applies to viruses or other types of infectious agents that are unknown or emerging.
No cases of viral infections have been reported with albumin produced by well-established processes and conforming to the specifications of the European Pharmacopoeia.
It is strongly recommended that, each time you receive a dose of Albumin Human Grifols 200 g/l, both the name and batch number of the medicine are recorded, in order to maintain traceability of the batches used.

Children
The safety and efficacy of Albumin Human Grifols 200 g/l in children have not been established in controlled clinical trials. However, clinical experience with the use of human albumin in children suggests that harmful effects are not expected, provided particular attention is paid to the administered dose to avoid circulatory overload.
See also section 4.

Other medicines and Albumin Human Grifols 200 g/l
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No specific interactions of human albumin with other medicines are known.

Pregnancy, breastfeeding, and fertility
Pregnancy
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of using Albumin Human Grifols 200 g/l during pregnancy has not been established in controlled clinical trials. However, clinical experience with albumin suggests that harmful effects on the course of pregnancy, the fetus, or the newborn are not expected.

Breastfeeding
It is not known whether Albumin Human Grifols 200 g/l is excreted in breast milk. Excretion of human albumin in milk has not been studied in animals. The decision whether to continue/stop breastfeeding or to continue/interrupt treatment with Albumin Human Grifols must be made considering the benefit of breastfeeding for the child and the benefit of treatment with Albumin Human Grifols for the mother.

Fertility
No animal reproduction studies have been conducted with Albumin Human Grifols 200 g/l.
However, albumin is a normal constituent of human blood.

Driving and using machines
No effects on the ability to drive or operate machinery have been observed.

Albumin Human Grifols 200 g/l contains sodium
This medicine contains 33.4 mg of sodium (a main component of table salt) per 10 ml vial, 166.8 mg of sodium per 50 ml bottle/bag, and 333.5 mg of sodium per 100 ml bottle/bag. This corresponds to 1.7%, 8.3%, and 16.7% of the maximum recommended daily dietary intake of sodium for an adult, respectively.
This medicine contains potassium, less than 39 mg (1 mmol) per vial/bottle/bag, i.e. essentially ‘potassium-free’.

3. How to use Human Albumin Grifols 200 g/l

Human Albumin Grifols 200 g/l is a hospital-use medicine and will therefore be administered to you
in a hospital by qualified healthcare personnel.
The dose and infusion rate of Human Albumin Grifols 200 g/l you will receive, as well as the
frequency and duration of treatment, will be adjusted according to your individual needs. These will
be determined for you by your doctor.
If you are given more Human Albumin Grifols 200 g/l than you should have
If you have been given a dose of Human Albumin Grifols 200 g/l higher than required,
inform your doctor immediately.
If you miss a dose of Human Albumin Grifols 200 g/l
Do not receive a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Mild reactions such as skin redness, rash, fever and nausea may occur rarely.
Severe allergic reactions (anaphylactic shock) may occur very rarely.
For information on viral safety, see section 2.

Additional side effects in children
There are no specific data available to assess the possible occurrence of different adverse reactions in this population.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly via
https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Human Albumin Grifols 200 g/l

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
Do not store above 30ºC.
Do not freeze.
Keep the vial/bottle/bag in the outer packaging to protect the medicine from light.
Do not use this medicine if you notice that the solution is cloudy or contains particles.
Once the container has been opened to assemble the infusion set, the contents must be used immediately.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Albumina Umana Grifols 200 g/l Contains

The active substance is human albumin. One millilitre of Albumina Umana Grifols 200 g/l contains 200 mg of plasma proteins, consisting of at least 95% human albumin.
The other components are: sodium chloride, sodium caprylate, sodium N-acetyltryptophanate, water for injections.

Manufactured from plasma obtained from human donors.
For further information on the components, see also “Albumina Umana Grifols 200 g/l contains
sodium” at the end of section 2.

Description of the Appearance of Albumina Umana Grifols 200 g/l and Contents of the Pack

Albumina Umana Grifols 200 g/l is an infusion solution. The solution is clear, slightly viscous, almost colourless, yellow, amber, or green.
Albumina Umana Grifols 200 g/l may be supplied in:

Vials/bottles with a chlorobutyl rubber stopper, aluminium seal, plastic top, and a plastic shrink band to ensure product integrity. Vials contain 10 ml of product and bottles contain 50 ml or 100 ml of product.
Polyethylene bags (FlexBag), with a protective polypropylene overwrap. The bags contain 50 ml or 100 ml of product.

Pack sizes:

1 vial of 10 ml per box
1 bottle of 50 ml or 100 ml per box
1 bag of 50 ml or 100 ml per box

Marketing Authorisation Holder and Manufacturer
Instituto Grifols, S.A.
Can Guasch, 2 - Parets del Vallès
08150 Barcelona - SPAIN

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Bulgaria, Croatia, Finland, France, Germany, Greece, Ireland, Iceland, Poland, Portugal,
Czech Republic, Romania, Slovakia, Sweden: Albutein 200 g/l
Denmark, Norway: Albumin Grifols 200 g/l
Italy: Albumina Umana Grifols 200 g/l
Spain: Albutein 200 g/l solución para perfusión

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency: https://www.aifa.gov.it

The following information is intended for healthcare professionals only:

Albumina Umana Grifols 200 g/l may be administered directly intravenously, or may also be diluted in an isotonic solution (e.g., 5% glucose or 0.9% sodium chloride). Mixing with electrolyte solutions must be performed under aseptic conditions.
Albumin solutions must not be diluted with water for injections, as this may cause haemolysis in recipients.
Human albumin must not be mixed with other medicinal products, whole blood, or concentrated erythrocytes.
Do not use solutions that appear cloudy or contain deposits. This may indicate that the protein is unstable or that the solution has been contaminated. Once the container has been opened, the contents must be used immediately.
Infusion is performed intravenously using a sterile, pyrogen-free, single-use infusion set. Before inserting the infusion set into the stopper, disinfect it using an appropriate antiseptic solution. After connecting the infusion set to the vial/bottle, the contents must be infused immediately.
The infusion rate must be determined according to the individual clinical condition of the patient and the indication. In plasma exchange procedures, the infusion rate should be adjusted according to the removal rate. If the dose and infusion rate are not appropriate for the patient's circulatory status, hypervolaemia may occur. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein distension), increased arterial pressure or increased venous pressure, or pulmonary oedema, the infusion must be stopped immediately.
If large volumes are to be administered, warm the medicinal product to room or body temperature before use.
Albumina Umana Grifols 200 g/l has a corresponding hyperoncotic effect. When administering concentrated albumin, care must be taken to ensure adequate hydration of the patient.
Patients must be carefully monitored to avoid circulatory overload and overhydration.
When administering albumin, monitor the patient's electrolyte status and take appropriate measures to restore or maintain normal electrolyte balance.
Care must be taken to ensure adequate replacement of other blood components (coagulation factors, electrolytes, platelets, and erythrocytes).
Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.

Bag:

Do not remove the protective overwrap until the time of use. Moisture or condensation may be observed inside the protective overwrap. This is normal and does not affect the quality or safety of the albumin solution.
Check the bag before use for possible leaks by squeezing it firmly. If leaks are detected, discard the solution.
To connect the infusion set, break the valve by twisting it.
Once the infusion set and the bag have been assembled, the contents must be infused immediately.
Do not use bags connected in series. This method of use could cause gas embolism due to aspiration of residual air from the primary bag before completion of fluid administration from the secondary bag.