200 g / l of infusion solution

Read all of this leaflet carefully before you start using this medicine.

– 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 is Albumin Octapharma and what is it used for? 
2. Before you use Albumin Octapharma 
3. How to use Albumin Octapharma 
4. Possible side effects 
5. Storage of Albumin Octapharma
6. Other information

What does Albumin Octapharma contain?

The active substance is human albumin.

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

Marketing Authorisation Holder

Octapharma AB

112 75 Stockholm

Manufacturer

Octapharma Pharmazeutika Produktionges. mbH

Oberlaaerstrasse 235

A-1100 Vienna

Austria

and

Octapharma SAS

70-72 rue du Maréchal Foch, BP33

67380 Lingolsheim

France

1. WHAT IS ALBUMIN OCTAPHARMA AND WHAT IS IT USED FOR?

The appearance of the drug:

Albumin Octapharma is a solution for infusion into a vein and is available in vials (10 g / 50 ml, 20 g / 100 ml).

Pharmaceutical group

Albumin Octapharma belongs to the pharmacotherapeutic group: Plasma volume enhancer.

What is Albumin Octapharma used for?

The product is given to patients to restore and maintain circulating blood volume where volume deficiency has been demonstrated.

2. BEFORE YOU USE ALBUMIN OCTAPHARMA

Do not use Albumin Octapharma

– if you are allergic (hypersensitive) to albumin products or to any of the other ingredients.

Take special care with Albumin Octapharma:

– if you get an allergic reaction to this albumin, the infusion will be stopped and your doctor will recommend an alternative treatment.

– if you are at high risk of increased blood volume, for example, if you have certain heart problems, high blood pressure, fluid in the lungs, coagulation disease, low red blood cell count, dilated veins in the esophagus, or no urine flow.

– In case of signs of increased blood volume (headache, respiratory disease, increased pressure in the jugular vein) and increased blood pressure, the infusion will be stopped immediately.

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 infected are excluded

– Test of individual donations and plasma pools for signs of virus/infection

– Production 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 Albumin Octapharma, it is recommended that the product name and batch number be registered to enable tracking of the product used.

Pregnancy

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.

Breast-feeding

Human albumin is a normal component of human blood. No adverse effects are known when using this product during breast-feeding.

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 excipient (s) in Albumin Octapharma:

– This medicine contains 15 mmol sodium per 100 ml solution. This should be considered for patients prescribed a low-salt diet. Tell your doctor if this applies to you.

– This medicine contains less than 1 mmol potassium per 100 ml solution, ie essentially ‘potassium-free’.

Use of other medicines:

No interactions between human albumin and other products are known to date. However, albumin Octapharma solution should not be mixed with other medicines, whole blood, or concentrated red blood cells in the same injection.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

3. HOW TO USE ALBUMIN OCTAPHARMA

Dosage instructions

The albumin Octapharma is ready for use as an infusion (“drip”) into a vein. Dose one and the infusion rate (how fast you are given albumin in a vein) depends on your particular condition. Your doctor will decide which treatment is best for you.

The product can be given to premature babies and dialysis patients.

If you use more Albumin Octapharma than you should:

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Albumin Octapharma 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 (by less than 1 in 1000):

Low blood pressure or allergic reaction.

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

Severe allergic reaction, confusion, headache, unusually fast or slow pulse, high blood pressure, hot flashes, shortness of breath, nausea, hives, swelling around the eyes, nose, mouth, 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 via the national reporting system (see details below). By reporting side effects , you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

5. STORAGE OF ALBUMIN OCTAPHARMA

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label.

Store and transport to a maximum of 25 ° C.

Store in the original package. Sensitive to light.

Do not freeze.

Before use, the product should be warmed to room or body temperature.

The solution should be clear or slightly opaque.

Do not use a solution that is cloudy or has particles.

Once the infusion bottle has been opened, the contents should be used immediately.

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. FURTHER INFORMATION

Content declaration

– The active substance is human albumin.

A 50 ml bottle contains 10 g of human albumin.

A 100 ml bottle contains 20 g of human albumin

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

What the medicine looks like and the contents of the pack

Albumin Octapharma is a solution for infusion into a vein and is available in vials (10 g / 50 ml, 20 g / 100 ml). Pack of 1 bottle.

Muhammad Nadeem

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