Albuminar-5

Name: Albuminar-5

Albuminar-5 Interactions

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with albumin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Albuminar-5 or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Albuminar-5. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Albumin (Human) USP, 5% Albuminar®-5

Rx only

Warnings

Do not use if the solution is turbid or if there is a sediment in the bottle. Since the product contains no antimicrobial preservative, do not begin administration more than 4 hours after the container has been entered. Destroy unused portions to prevent the possibility of subsequent use of a solution that may have become contaminated.

Albuminar®-5 is made from human plasma. Products made from human plasma may contain infectious agents such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses during manufacture. The manufacturing procedure for Albuminar®-5 includes processing steps designed to reduce further the risk of viral transmission. Stringent procedures utilized at plasma collection centers, plasma testing laboratories, and fractionation facilities are designed to reduce the risk of viral transmission. Albuminar®-5 is pasteurized in the final container at 60.0 +/- 0.5ºC for 10-11 hours. Virus elimination/inactivation is also achieved by the cold alcohol fractionation process. (See DESCRIPTION section for further information on viral reduction measures.) Despite these measures, such products may still potentially contain human pathogenic agents, including those not yet known or identified. Thus the risk of transmission of infectious agents cannot be totally eliminated. Any infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to CSL Behring at 1-866-915-6958. The physician should discuss the risks and benefits of this product with the patient.

Albumin is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.

Adverse Reactions

The incidence of untoward reactions to Albuminar®-5 is low. Reports have been received of anaphylaxis, which may be severe, and hypersensitivity reactions (including urticaria, skin rash, pruritus, edema, erythema, hypotension and bronchospasm). Nausea, vomiting, increased salivation, chills and febrile reactions have also been reported (see also PRECAUTIONS).

How Supplied

Albumin (Human) 5%, Albuminar-5 is supplied as a 5% solution in:

50 mL vials containing 2.5 grams of albumin (NDC 0053-7670-06)

250 mL vials containing 12.5 grams of albumin (NDC 0053-7670-31)

500 mL vials containing 25 grams of albumin (NDC 0053-7670-32)

Albumin (Human) 5%, Albuminar -5 is also supplied as a 5% solution in bottles with administration set:

250 mL bottles containing 12.5 grams of albumin (NDC 0053-7670-01)

500 mL bottles containing 25 grams of albumin (NDC 0053-7670-02)

1000 mL bottles containing 50 grams of albumin (NDC 0053-7670-03)

Store between 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

The packaging of this product contains dry natural rubber.

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