OCTALBIN Solution for infusion (2017)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
<b>Route of Administration</b> <b>Dosage Form/Strength</b> <b>Clinically Relevant Nonmedicinal Ingredients</b> Intravenous infusion Solution for Infusion<br>Each mL contains 250 mg protein, of which ...
Description
Octalbin 25% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of Octalbin 25% is obtained from collection centres ...
Indications and clinical use
Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate. The choice of albumin rather than artificial colloid will depend ...
Contraindications
Hypersensitivity to albumin preparations or to any of the excipients.
Warnings and precautions
General Standard measure to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma ...
Adverse reactions
Adverse Drug Reaction Overview Adverse reactions for Octalbin 25% are rare. These reactions normally disappear rapidly when the infusion rate is slowed down or the infusion is stopped. In case of severe ...
Drug interactions
Overview No specific interactions of human albumin with other medicinal products are known. Human albumin solution must not be mixed with other medicinal products, whole blood and packed red cells. Drug-Food ...
Dosage and administration
Dosing Considerations Human albumin should always be directly administered by the intravenous route. Octalbin 25% may also be diluted in an isotonic solution (e.g. 5% glucose or 0.9% sodium chloride). ...
Overdosage
Hypervolaemia may occur if the dosage and rate of infusion are too high. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, ...
Action and clinical pharmacology
Mechanism of Action Albumin is the predominant product of hepatic protein synthesis and one of the more abundant plasma proteins. Among its multiple physiologic roles that include binding and transport ...
Storage and stability
Special precautions for storage: Store and transport at +2°C to +25°C. Store in the original container in order to protect from light. Do not use after expiry date. Do not freeze. Keep out of the reach ...
Special handling instructions
The product should be brought to room or body temperature before use. Do not use non-homogenous solutions, or those which have a deposit. Solutions which have been frozen should not be used. Do not begin ...
Dosage forms, composition and packaging
Solution for infusion Octalbin 25% is human albumin from human plasma source. Octalbin 25% is a hyperoncotic pasteurized solution for intravenous use. It is a clear or slightly opalescent solution containing ...
Pharmaceutical information
Drug Substance Proper name: Octalbin 25% Chemical name: Human Albumin Molecular formula and molecular mass: not applicable Structural formula: not applicable Physicochemical properties: Human serum albumin ...
Detailed pharmacology
Albumin is a protein of 584 amino acids. It is highly soluble and has a strong negative charge. Several variants in the amino acid sequence, alloalbumins, coexist with normal albumin. Albumin makes up ...
Clinical trials
Not applicable.
Toxicology
Albumin is a normal constituent of the human organism. In animals, single dose toxicity testing is of no relevance, since the high doses required would result in Albumin overload. Repeated dose toxicity ...
Marketing authorization holder
Octapharma Pharmazeutika Produktionsges m.b.H., Oberlaaer Strasse 235, A-1100 Vienna, Austria Manufactured for: Octapharma Canada, Inc., 308-214 King St W, Toronto, ON M5H 3S6, Canada
Submission control number
208685
Date of approval
October 30, 2017
Date of revision
August 22, 2017
References
1. CPMP (Committee for Proprietary Medicinal Products), Core SPC for Human Albumin, CPMP/PhVWP/BPWG/2231/99, (2000)
Serious warnings and precautions box
This product is prepared from large pools of human plasma, which may contain the causative agents of hepatitis and other viral diseases. The physician should discuss the risks and benefits of this product ...
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
