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Plasmanate is a solution for intravenous infusion containing proteins extracted from human plasma, which is the liquid part of the blood. Each bottle contains a solution of human albumin protein.
This medicinal product belongs to a group of medicines known as plasma substitutes and plasma protein fractions.
Plasmanate is used to restore and maintain the circulating blood volume where volume deficiency has been demonstrated, and use of a plasma substitute is appropriate. The choice of an albumin solution rather than an artificial plasma substitute will depend on the clinical situation of the individual patient, based on official recommendations.
Therapeutic indications:
Treatment of Shock: a predominant loss of plasma fluids; emergency treatment of shock due to hemorrhage.
a. Do not use Plasmanate
You should not receive Plasmanate during cardiopulmonary bypass procedures, which may lead to a severe drop in blood pressure.
Do not use if you have been diagnosed with severe anemia (absence of red blood cells), congestive heart failure (weak heart), or increased blood volume.
b. Take special care with Plasmanate
Plasmanate does not provide coagulation factors and therefore does not correct coagulation disorders.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This applies to any unknown or emerging viruses or other types of infections.
No cases of transmission of infections have been identified for human albumin.
c. Taking other medicines, herbal or dietary supplements
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. No specific interactions of human albumin with other medicines are known.
d. Using Plasmanate with food and drink
There is no information regarding the use of Plasmanate with food and drink. Please discuss this with your doctor.
e. Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or breast-feeding you must tell your doctor who will decide if Plasmanate can be used.
f. Driving and using machines
No effects on the ability to drive and use of machines have been observed.
g. Important information about some of the ingredients of Plasmanate
This product contains sodium and may be harmful to people on a low sodium or potassium diet. Tell your doctor if this applies to you.
Plasmanate is for hospital administration only. It will be administered as an intravenous infusion by medical staff and must not be self-administered. The dosage and the infusion rate you will receive depend upon your medical condition. Your doctor will tell you how often and at what intervals Plasmanate should be given.
a. If you use more Plasmanate than you should
There is no information regarding over dosage with Plasmanate.
b. If you forget to use Plasmanate
Tell your doctor immediately and follow his/her instructions. You must not be given a double dose to make up for a forgotten dose.
c. If you stop using Plasmanate
If treatment with Plasmanate is stopped, your condition may worsen. Please talk to your doctor if you wish to end treatment with Plasmanate prematurely.
If you have any further questions on the use of this product, ask your doctor.
Like all medicines, Plasmanate can cause side effects, although not everybody gets them.
Hypotension may occur, particularly following rapid infusion or intra-arterial administration to patients on cardio-pulmonary bypass. The blood pressure may normalize spontaneously after the slowing or discontinuation of the infusion.
Flushing, hives, back pain, nausea and headache have been occasionally reported by conscious patients.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Keep out of the reach and sight of children.
Do not store above 30°C. Do not freeze. Store in original carton.
Do not use Plasmanate after the expiry date which is stated on the bottle label and the carton. Do not use Plasmanate if you notice that the solution is cloudy or has deposits.
The active substance is Plasma Protein Fraction (Human) 5%, USP.
The other ingredients are sodium caprylate, N-acetyl-DL-tryptophan, sodium (from all sources) and water for injection.
Grifols Therapeutics Inc.
Research Triangle Park, NC 27709 USA
النشرة غير مترجمة للعربية حاليا لأن المستحضر للمستشفيات فقط، سوف يتم اضافة النشرة العربية بعد تقديمها واعتمادها من قبل الهيئة
النشرة غير مترجمة للعربية حاليا لأن المستحضر للمستشفيات فقط، سوف يتم اضافة النشرة العربية بعد تقديمها واعتمادها من قبل الهيئة
النشرة غير مترجمة للعربية حاليا لأن المستحضر للمستشفيات فقط، سوف يتم اضافة النشرة العربية بعد تقديمها واعتمادها من قبل الهيئة
النشرة غير مترجمة للعربية حاليا لأن المستحضر للمستشفيات فقط، سوف يتم اضافة النشرة العربية بعد تقديمها واعتمادها من قبل الهيئة
النشرة غير مترجمة للعربية حاليا لأن المستحضر للمستشفيات فقط، سوف يتم اضافة النشرة العربية بعد تقديمها واعتمادها من قبل الهيئة
النشرة غير مترجمة للعربية حاليا لأن المستحضر للمستشفيات فقط، سوف يتم اضافة النشرة العربية بعد تقديمها واعتمادها من قبل الهيئة
النشرة غير مترجمة للعربية حاليا لأن المستحضر للمستشفيات فقط، سوف يتم اضافة النشرة العربية بعد تقديمها واعتمادها من قبل الهيئة
النشرة غير مترجمة للعربية حاليا لأن المستحضر للمستشفيات فقط، سوف يتم اضافة النشرة العربية بعد تقديمها واعتمادها من قبل الهيئة
Treatment of Shock
Plasmanate is indicated in the treatment of shock due to burns, crushing injuries, abdominal emergencies, and any other cause where there is a predominant loss of plasma fluids and not red blood cells. It is also effective in the emergency treatment of shock due to hemorrhage. Following the emergency phase of therapy, blood transfusions may be indicated depending on the severity of the blood loss.
In infants and small children, Plasmanate has been found to be very useful in the initial 36 therapy of shock due to dehydration and infection.
Dosage is based almost entirely on the nature of the individual case and response to therapy. The usual minimum effective dose in adults is 250–500 mL. As with any plasma expander, the rate should be adjusted or slowed according to the clinical response and rising blood pressure.
Administration should be by vein and preferably through an area of skin at some distance from any site of infection or trauma. Plasmanate is compatible with the usual carbohydrate and electrolyte solutions.
Rapid infusion of Plasmanate (greater than 10 mL/minute) has produced hypotension in patients undergoing surgery or in the preoperative or postoperative period. Blood pressure should be monitored during use and infusion slowed or ceased if sudden hypotension occurs.
Plasmanate does not provide coagulation factors and therefore does not correct coagulation disorders.
Transmissible Infectious Agents
Plasmanate is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob Disease (CJD) agent 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. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Grifols Therapeutics Inc. [1-800-520-2807].
The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient.
Pediatric Use
Safety and effectiveness in the pediatric population have not been established
Plasmanate is compatible with whole blood, packed red cells as well as the standard carbohydrate and electrolyte solutions intended for intravenous use. It should, however, not be mixed with protein hydrolysates or solutions containing alcohol.
Pregnancy Category C
Animal reproduction studies have not been conducted with Plasmanate. It is also not known if Plasmanate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Plasmanate should be given to a pregnant woman only if clearly needed.
There is no information on potential effects regarding tasks requiring alertness or concentration.
Hypotension may occur, particularly following rapid infusion or intra-arterial administration to patients on cardiopulmonary bypass. The blood pressure may normalize spontaneously after the slowing or discontinuation of the infusion. Vasopressors will also correct the hypotension.
Flushing, urticaria, back pain, nausea and headache have been occasionally reported by conscious patients.
There is no information regarding over dosage with Plasmanate.
Pharmacotherapeutic group: plasma substitutes and plasma protein fractions, ATC code: B05AA01.
Plasmanate administration results in increased blood volume in the treatment of shock.
In normal human volunteers, Plasmanate has resulted in an increased blood volume which has lasted up to 48 hours. Clinical experience has indicated that it is an adequate replacement for human plasma in the treatment of shock and is a suitable means of providing human proteins for their osmotic effect.
No signs of acute toxicity have been described in animal models.
Plasmanate is compatible with whole blood, packed red cells as well as the standard carbohydrate and electrolyte solutions intended for intravenous use. It should, however, not be mixed with protein hydrolysates or solutions containing alcohol.
Store at room temperature not exceeding 30°C (86°F). Solution that has been frozen should not be used. Do not use after expiration date.
Plasmanate is available in 250 mL vials. Each single dose vial contains plasma protein in the following approximate amount:
Size 250 mL
Grams Protein 12.5
Preparation for Administration
Remove seal to expose stopper. Always swab stopper top immediately with suitable antiseptic prior to entering vial.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Only a 16 gauge needle or dispensing pin should be used and inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.
A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.
Administration
Plasmanate must be administered intravenously.
Solutions which are turbid or which have been frozen should not be used. Do not use if turbid.
Do not begin administration more than 4 hours after the container has been entered. Partially used vials must be discarded. Vials which are cracked or which have been previously entered or damaged should not be used, as this may have allowed the entry of microorganisms. Plasma Protein Fraction (Human) 5%, USP - Plasmanate® contains no preservative.
