Albunorm 40 g / 50 g/200 g / 250 g / Infusion solution Human albumin
1. What Albunorm Is And What Is Albunorm 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
- No urine production
- If there are signs of
- Increased blood volume
- Headache
- Breathing problems
- High pressure in the jugular vein
- High blood pressure
- Infusion one should then be stopped immediately
- Increased blood volume
- 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 uses
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 Of Albunorm
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 of Albunorm are (affecting 1 to 10 users 10 000):
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
- 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.
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.
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.
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
- 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.
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
The Medical Products Agency
Box 26
SE-751 03 Uppsala
Website: www.lakemedelsverket.se