40 g / 50 g/ 200 g / 250 g / l 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 about it.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you personally. You should not pass it on to others. It may harm them, even if they show symptoms similar to yours.

In this leaflet you will find information about: 
1. WHAT ALBUNORM IS AND WHAT IT IS USED FOR 
2. BEFORE YOU USE ALBUNORM 
3. HOW TO USE ALBUNORM 
4. POSSIBLE SIDE EFFECTS 
5. HOW ALBUNORM SHOULD 
BE DISPOSED

1. WHAT ALBUNORM IS AND WHAT IT IS USED FOR

Albunorm belongs to the group of medicines: blood substitutes and plasma proteins.

The product is given to patients to restore and maintain circulating blood volume in the event of a detected volume deficiency.

2. BEFORE YOU USE ALBUNORM

Do not use Albunorm

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

Take special care with Albunorm

  • If you are at particularly high risk with increased blood volume, e.g. if you have severe heart problems, high blood pressure, dilated veins in the esophagus, fluid in the lungs, bleeding disorder, very low red blood cell count, or no urine production.
  • If there are signs of increased blood volume (headache, breathing problems, high pressure in the jugular vein) or high blood pressure. Infusion one should then be stopped immediately.
  • If there are signs of an allergic reaction. Infusion one should then be stopped immediately.
  • If the medicine is used in patients with severe brain damage.

Virus security

When medicines are made from human blood or plasma, special measures are taken to prevent the transmission of infection to patients. This includes:

  • Careful selection of blood and plasma donors to ensure that people at risk of being carriers are excluded.
  • Testing of individual donations and plasma pools for signs of virus/infection.
  • Manufacturing steps in the processing of blood and plasma that can inactivate or secrete 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 infections.

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

When you are given Albunorm, it is recommended that the product name and batch number be registered to enable the saving of the used product.

Pregnancy and breastfeeding

Human albumin is a normal component of human blood. No adverse effects are known when using this product during pregnancy. Blood volume must be adjusted in pregnant women. Consult a doctor before taking any medicine.

Human albumin is a normal component of human blood. No adverse effects are known when using this product during breast-feeding. Consult a doctor before taking any medicine.

Driving and using machines

There is no evidence that human albumin affects the ability to drive or use machines.

Important information about some of the ingredients of Albunorm

This product contains sodium and potassium and may be harmful to people on a low salt or potassium diet. Tell your doctor if this applies to you.

3. HOW TO USE ALBUNORM

Albunorm can be given directly as an infusion (“drip”) into a friend. Dosage one and the infusion rate (how fast the albumin is given in the vein) depends on your particular condition. Your doctor will decide what is the best treatment for you.

Instructions

  • The product must be at room or body temperature before use.
  • The solution must be clear and must not contain precipitates.
  • Unused solution should be discarded.
  • If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you use more Albunorm than you should  

If the dose is one and the infusion rate is too high, you may experience headaches, increased blood pressure, and difficulty breathing. Infusion one should then be stopped immediately and your doctor will decide if any other treatment is required.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Albunorm can cause side effects, although not everybody gets them.

Side effects after infusion of human albumin are rare and usually disappear when the infusion rate is reduced or the infusion is stopped.

Rare side effects are (affecting 1 to 10 users 10 000):

Redness, hives, fever, and nausea.

Rare side effects are (affecting less than 1 in 10 000):

Shock due to hypersensitivity reaction.

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

Confusion, headache, increased or decreased heart rate, high blood pressure, and low blood pressure, feeling hot, shortness of breath, nausea, hives, swelling around the eyes, nose, and mouth, rash, increased sweating, fever, chills.

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

SE-751 03 Uppsala

Website: www.lakemedelsverket.se

5. HOW TO STORE ALBUNORM

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton. The expiration date is the last day of the specified month.

Do not store above 25 ° C. Store in the original package. Sensitive to light. Do not freeze. Once the infusion bottle has been opened, the contents should be used immediately.

The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or contain precipitates.

The medicine 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.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

Content declaration

– The active substance is 40 g / l human albumin produced from human plasma (bottle of 100, 250, and 500 ml respectively).

The other ingredients are sodium chloride, N-Acetyl-DL-tryptophan, caprylic acid, and water for injections.

What the medicine looks like and the contents of the pack

The solution is clear, yellow, amber, or green.

Marketing Authorization Holder and Manufacturer

Octapharma AB, 112 75 Stockholm

Octapharma Pharmazeutika, Produktionsges.mbH, Oberlaaerstrasse 235, 1100 Vienna, Austria

Octapharma SAS, 32, Rue du Maréchal Foch, 67380 Lingolsheim, France

Octapharma Produktionsgesellschaft Deutschland GmbH, Elddagsener Strasse 38, 31832 Springe, Germany

Octapharma GmbH, Otto-Reuter Strasse 3, 06847 Dessau-Rosslau, Germany

Content declaration

The active substance is 40 g / l human albumin produced from human plasma (bottle of 100, 250, and 500 ml respectively).

The other ingredients are sodium, potassium, N-Acetyl-DL-tryptophan, caprylic acid, and water for injections.

Pack sizes

Albunorm 40 g / l is an infusion solution in a bottle (100 ml – 1 pack)

Albunorm 40 g / l is an infusion solution in a bottle (250 ml – pack of 1)

Albunorm 40 g / l is an infusion solution in a bottle (500 ml pack of 1 or 12)

Not all pack sizes may be marketed in all countries.

Marketing Authorization Holder:

Octapharma AB, 112 75 Stockholm

Manufacturer:

Octapharma Pharmazeutika, Produktionsges.m.bH., Oberlaaerstr. 235, 1100 Vienna, Austria

Octapharma SAS, 72, Rue du Maréchal Foch, 67380 Lingolsheim, France

Octapharma Produktionsgesellschaft Deutschland GmbH, Wolfgang-Marguerre-Allee 1, 31832 Springe, Germany

Octapharma GmbH, Otto-Reuter-Str. 3, 06847 Dessau-Rosslau, Germany

Muhammad Nadeem

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