Human albumin grifols 20%
Poland
Table of Contents
Human Albumin Grifols 20%, 200 g/l, infusion solution
Human Albumin
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.
- Keep this leaflet for future reference.
- If you have any doubts, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
- If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of contents:
- What Human Albumin Grifols 20% is and what it is used for
- Important information before using Human Albumin Grifols 20%
- How to use Human Albumin Grifols 20%
- Possible side effects
- How to store Human Albumin Grifols 20%
- Contents of the pack and other information
1. What Human Albumin Grifols 20% is and what it is used for
Human Albumin Grifols 20% is an infusion solution. It contains proteins derived from human plasma, which is the liquid component of blood. Over 95% of the plasma protein content in this product consists of human albumin at a concentration of 20% mass per volume.
Human Albumin Grifols 20% belongs to a group of medicines called plasma substitutes and plasma protein fractions.
Human Albumin Grifols 20% is used:
to supplement and maintain circulating blood volume in conditions where blood volume is too low and plasma substitution is indicated.
If you have any questions about Human Albumin Grifols 20%, consult your doctor.
2. Important information before using Human Albumin Grifols 20%
When not to use Human Albumin Grifols 20%:
- if the patient is allergic (hypersensitive) to human albumin or to any of the other components of Human Albumin Grifols 20% (listed in section 6) (see "Important information about components of Human Albumin Grifols 20%" at the end of this section).
Warnings and precautions Before starting treatment with Human Albumin Grifols 20%, discuss this with your doctor, pharmacist, or nurse. Infusion must be stopped immediately if the patient develops symptoms of an allergic reaction with breathing difficulties, weakness, or other symptoms. If known, the patient should inform the doctor about the following conditions and diseases:
- heart problems
- hypertension
- esophageal varices (inflammation of esophageal veins)
- pulmonary edema (fluid accumulation in the lungs)
- thrombotic conditions or bleeding disorders
- severe anemia
- urinary excretion disorders
The presence of the above conditions and diseases may exclude the use of Human Albumin Grifols 20% or may prompt the doctor to adjust the dose/infusion rate to avoid complications. To prevent potential infections from products derived from human blood or plasma, the following precautions are taken:
- donor selection to exclude those with infectious diseases
- screening tests on individual blood donations and pooled plasma for specific viral/infectious markers
- implementation of effective viral inactivation/removal procedures during blood or plasma processing
Despite these precautions, when blood-derived products are administered, the risk of transmitting infectious agents, including unknown viruses or other types of infections, cannot be completely ruled out.
There are no confirmed reports of virus transmission associated with albumin preparations manufactured using the approved process according to specifications provided in the European Pharmacopoeia. It is strongly recommended that the product name and batch number be recorded each time Human Albumin Grifols 20% is administered to a patient, to ensure traceability of the specific product batch to the treated patient.
Human Albumin Grifols 20% and other medicines Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take.
No specific interactions of this product with other medicines are known.
Pregnancy, breastfeeding, and fertility The patient should inform the doctor if she is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child. She should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery No influence on the ability to drive or operate mechanical equipment has been observed.
Important information about components of Human Albumin Grifols 20% The product contains 1.5 mmol (33.4 mg) of sodium per 10 ml vial, 7.3 mmol (166.8 mg) of sodium per 50 ml bottle, and 14.5 mmol (333.5 mg) of sodium per 100 ml bottle. This should be taken into account in patients on a low-sodium diet. The product contains less than 1 mmol (39 mg) of potassium per vial, meaning it is essentially potassium-free.
3. How to use Human Albumin Grifols 20%
Human Albumin Grifols 20% is a medicine intended for hospital use only. It is administered as an intravenous infusion by medical personnel and must not be self-administered by the patient.
The albumin concentration, dose, infusion rate, frequency of administration, and duration of treatment will be adjusted according to the individual patient's condition. This will be determined by the physician.
If you receive more Human Albumin Grifols 20% than you should
Administering too high a dose or infusing too rapidly may lead to excessive increase in blood volume (hypervolemia).
At the first signs of overdose, the infusion will be immediately stopped by medical personnel.
Missed dose of Human Albumin Grifols 20%
Inform your doctor or pharmacist immediately and follow their instructions.
Do not administer a double dose to make up for a missed dose.
4. Possible adverse reactions
Like any other medicinal product, this medicine may cause adverse reactions, although not everyone experiences them.
Contact your doctor if any of the following adverse reactions occur:
- Severe allergic reactions such as anaphylactic shock may very rarely occur. In such cases, the infusion must be stopped immediately and appropriate treatment initiated.
- Mild reactions such as:
- flushing
- skin rash (urticaria)
- fever
- nausea
The above mild reactions may occur rarely and usually resolve quickly after slowing down or stopping the infusion.
Information regarding viral safety – see section 2.
Reporting of adverse reactions
If any adverse reactions occur, including any symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C,
PL-02 222 Warsaw,
Tel.: + 48 22 49 21 301,
Fax: + 48 22 49 21 309,
e-mail: [email protected]
Reporting adverse reactions enables continuous monitoring of the benefit-risk balance of the medicine and helps to increase knowledge about its safe use.
5. How to store Human Albumin Grifols 20%
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and
carton.
Store below 25°C. Do not freeze.
To protect from light, store in the original packaging.
The solution should be clear to slightly opalescent. Do not use this medicine
if the solution is cloudy or contains a precipitate.
After opening, use immediately.
Do not dispose of unused medicine via wastewater or household waste.
Pharmacists can provide information on how to properly dispose of unused medicines.
This helps protect the environment.
6. Contents of the pack and other information
What Human Albumin Grifols 20% contains
Active substance: Human albumin. One litre of Human Albumin Grifols 20% contains 200 g of protein, of which at least 95% is human albumin.
Other ingredients: sodium chloride, sodium caprylate, sodium N-acetyltryptophanate, water for injections.
The solution contains 130 to 160 mmol/l of sodium and no more than 2 mmol/l of potassium.
For more information on the excipients, see "Important information about the ingredients of Human Albumin Grifols 20%" at the end of section 2.
What Human Albumin Grifols 20% looks like and contents of the pack
Human Albumin Grifols 20% is an infusion solution. A clear, slightly viscous liquid: almost colourless, pale yellow, pale amber, or pale green.
Available pack sizes:
Human Albumin Grifols 20%, 1 vial of 10 ml, 1 bottle of 50 ml, and 1 bottle of 100 ml.
Pack containing 1 bottle.
Marketing Authorisation Holder and Manufacturer
INSTITUTO GRIFOLS, S.A.
Poligono Levante, c/Can Guasch, 2
08150 Parets del Vallès, Barcelona, SPAIN
For further information, please contact the Marketing Authorisation Holder.
Grifols Polska Sp. z o.o.
Ul. Grzybowska 87
00-844 Warsaw
Tel: +48 22 378 85 61
Date of preparation of the leaflet: