Infusion solution 
Human albumin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save 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. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Albumin Baxalta 200 g / l is and what it is used for 
2. What you need to know before you use Albumin Baxalta 200 g / l 
3. How to use Albumin Baxalta 200 g / l 
4 . Possible side effects 
5. How to store Albumin Baxalta 200 g / l 
6. Contents of the pack and other information 

What Albumin Baxalta 200 g / l is and what it is used for

Albumin Baxalta 200 g / l contains a protein called albumin, which is found in the fluid component of the blood (in the plasma). It belongs to the group of drugs Plasma substitutes and plasma protein fractions. It is made from human blood collected from blood donors.

A vial of 50 ml contains 10 g human albumin.

A vial with 100 ml containing 20 g of human albumin.

Human albumin is used to regain and maintain blood volume in patients who have lost blood and fluid due to special medical conditions.

The choice of albumin instead of artificial colloid and the required dose will be made taking into account the patient’s clinical condition.

What you need to know before using Albumin Baxalta 200 g / l

Do not use Albumin Baxalta 200 g / l

If you are allergic to human albumin or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Albumin Baxalta 200 g / l

  • If you think you may have an allergic reaction during treatment, with difficulty breathing, fainting, or other symptoms. If this happens, tell your doctor or nurse immediately as the infusion must be stopped and medical treatment for shock may need to be instituted.
  • If you have:
    • untreated heart failure
    • high blood pressure
    • esophageal varices (dilated blood vessels in the esophagus)
    • pulmonary edema (accumulation of fluid in the lungs)
    • the tendency to spontaneous bleeding
    • severe anemia (lack of red blood cells )
    • non-existent urine production.

If you think any of these apply to you, inform your doctor so that he/she can take appropriate precautions.

When medicines are made from human blood or plasma, special measures are taken to prevent the transmission of infection to patients. This includes a careful selection of blood and plasma donors to ensure that those at risk of being carriers are excluded, as well as testing of individual donations and plasma pools for signs of virus/infection. The manufacturers of these products also include steps in the management of blood and plasma that can inactivate or secrete any viruses. Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or plasma are given. This also applies to new, hitherto unknown viruses and other types of infectious agents.

There are no reports of virus transmission with albumin produced according to European Pharmacopoeia specifications and established procedures.

When you are given Albumin Baxalta 200 g / l, it is strongly recommended that the product name and batch number be registered at each treatment occasion to enable the tracing of the product used.

Other medicines and Albumin Baxalta 200 g / l

  • Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
  • No complications of taking albumin with other drugs are known.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice. Your doctor will decide if you can use Albumin Baxalta 200 g / l during pregnancy or while breastfeeding.

Driving and using machines

No effect on the ability to drive and use machines has been observed.

Albumin Baxalta 200 g / l contains sodium

50 ml vial:

This medicine contains 115–149.5 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 5.8–7.5% of the highest recommended daily intake of sodium for adults.

100 ml vial:

This medicine contains 230-299 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 11.5–15% of the highest recommended daily intake of sodium for adults.

3. How to use Albumin Baxalta 200 g / l

Albumin Baxalta 200 g / l is a medicine used in hospitals. It will therefore be given to you by qualified healthcare professionals at the hospital. Your doctor will decide how much and how often you should receive the medicine, as well as how long the treatment should last, based on your individual needs. He/she will monitor your condition, measure your blood pressure and heart rate, and take blood samples while you are receiving Albumin Baxalta to ensure that you do not get too much. If you get headaches, difficulty breathing, or increased blood pressure, tell your doctor.

If you use more Albumin Baxalta 200 g / l than you should 

If you have been given more Albumin Baxalta 200 g / l than you should, contact 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 occur, the infusion should be stopped immediately and appropriate treatment instituted:

  • anaphylactic shock (very rare, may affect up to 1 in 10,000 people)
  • hypersensitivity / allergic reactions (no known frequency, can not be calculated 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)
  • redness
  • rash
  • fever

No known frequency (cannot be calculated from the available data):

  • headache
  • changed taste experience
  • heart attack
  • irregular heartbeats
  • fast heartbeat
  • abnormally low blood pressure
  • accumulation of fluid in the lungs
  • shortness of breath or discomfort when breathing
  • vomiting
  • hives
  • itching
  • overindulge

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Albumin Baxalta 200 g / l

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 expiration date is the last day of the specified month.

Do not store above 25 ° C. Do not freeze.

Keep the vial in the outer carton. Sensitive to light.

The contents should be used immediately after opening the vial.

Do not use Albumin Baxalta 200 g / l if you notice that the solution is cloudy or has precipitated.

6. Contents of the packaging and other information

Content declaration

  • The active substance is human albumin. 
    100 ml of solution contains a total of 20 g of protein, of which at least 95% is human albumin.
  • The other ingredients are sodium chloride, sodium caprylate, sodium acetyltryptophan, water for injections.

The total amount of sodium ions: 100 – 130 mmol / l.

What the medicine looks like and the contents of the pack

The solution is clear and slightly viscous. It is almost colorless, yellow, amber, or green.

It is a sterile solution for intravenous infusion provided in 50 ml glass vials respectively. 100 ml solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Baxalta Innovations GmbH

Industristrasse 67

1221 Vienna

Austria

Manufacturer

Baxter AG

Industriestraße 67

A-1221 Vienna

Austria

Takeda Manufacturing Austria AG

Industriestrasse 67

A-1221 Vienna

Austria

Agent

Takeda Pharma AB

Vasagatan 7, 6 tr

111 20 Stockholm

This medicinal product is authorized under the European Economic Area under the names:

Austria: Human Albumin Baxter 200 g / l – Infusion solution

Belgium, Germany, Luxembourg: Human Albumin 200 g / l Baxalta

Bulgaria, Cyprus, Czech Republic, Greece, Ireland, Malta, Poland, Slovakia, Slovenia, United Kingdom:

Human Albumin 200 g / l Baxter

Estonia: Albumin Baxter 200 g / l

Denmark, Finland, Iceland, Norway,

Baxalta albumin 200 g / l

France: Baxalta 200 g / l Albumine humaine

Italy: Albumina Baxalta 200 g / l

Latvia: Baxter 200 g / l album infusion

Lithuania: Albumin Baxter 200 g / l infusions tirpalas

Netherlands: Humane Albumin 200 g / l Baxalta

Portugal: Albumina Humana Baxalta

Romania: Albums Umană Baxter 200 g / l perfusive solution

This leaflet was last modified on 10 October 2020

Other sources of information

Further information about this medicine is available on the Medical Products Agency’s website.

The following information is intended for medical or healthcare professionals only

  • Albumin Baxalta 200 g / l can be administered intravenously by infusing the contents of the pack directly, or after first diluting in an isotonic solution (eg 50 mg/ml glucose or 9 mg/ml sodium chloride).
  • Albumin Baxalta 200 g / l should not be diluted with water for injections as it may lead to hemolysis in the recipient.
  • Use only if the seal is intact. In case of leakage, the solution must be discarded.
  • The solution should be clear and slightly viscous. It is almost colorless, yellow, amber, or green. Do not use solutions that are cloudy or have precipitates. This may be because the protein is unstable or the solution has become contaminated. The contents should be used immediately after opening the vial.
  • Infusion is given intravenously with a sterile, pyrogen-free, single-use infusion set. Before inserting the infusion set through the rubber stopper, disinfect it with a suitable disinfectant. The contents should be used immediately after the infusion set has been inserted into the vial. Unused solution should be disposed of in an appropriate manner.
  • The infusion rate should be adjusted according to individual conditions and the indication.
  • For plasma exchange, the infusion rate should be adjusted to the elimination rate.
  • If large volumes are administered, the product should be warmed to room temperature or body temperature before use.
  • When concentrating albumin, care must be taken to ensure that the patient receives adequate fluid supply. Patients should be closely monitored for circulatory congestion and hydration.
  • When administering albumin, the patient’s electrolyte status should be monitored and necessary measures are taken to restore or maintain electrolyte balance.
  • Appropriate replacement of other blood components ( coagulation factors, electrolytes, platelets, and electrolytes ) must be ensured.
  • From a safety point of view, the batch number should be noted when Albumin Baxalta 200 g / l is given to a patient.
  • Albumin solutions must not be mixed with other medicinal products (except those recommended for dilution such as 50 mg/ml glucose or 9 mg/ml sodium chloride), whole blood, or erythrocyte concentrate. Human albumin should also not be mixed with protein hydrolysates (eg parenteral nutrition ) or alcohol-containing solutions as such combinations may cause protein precipitation.
  • Hypervolemia may occur if the dosage or infusion rate is too high. At the first sign of cardiovascular congestion (headache, shortness of breath, jugular vein stasis) or increased blood pressure, elevated central venous pressure, or pulmonary edema, the infusion should be stopped immediately and the patient’s hemodynamic parameters closely monitored.

Muhammad Nadeem

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