KIOVIG Solution for infusion (2022)
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
KIOVIG 100 mg/ml solution for infusion.
Qualitative and quantitative composition
Human normal immunoglobulin (IVIg). <u>One ml contains:</u> Human normal immunoglobulin 100 mg (purity of at least 98% IgG). Each vial of 10 ml contains: 1 g of human normal immunoglobulin. Each vial of ...
Pharmaceutical form
Solution for infusion. The solution is clear or slightly opalescent and colourless or pale yellow.
Therapeutic indications
<u>Replacement therapy in adults, and children and adolescents (0-18 years) in:</u> Primary immunodeficiency syndromes (PID) with impaired antibody production (see section 4.4). Secondary immunodeficiencies ...
Posology and method of administration
Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency. Posology The dose and dose regimen is dependent on the indication. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA. Patients with ...
Special warnings and precautions for use
Infusion reaction Certain severe adverse reactions (e.g. headache, flushing, chills, myalgia, wheezing, tachycardia, lower back pain, nausea, and hypotension) may be related to the rate of infusion. The ...
Interaction with other medicinal products and other forms of interaction
Live attenuated virus vaccines Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps ...
Fertility, pregnancy and lactation
Pregnancy The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore it should only be given with caution to pregnant women and ...
Effects on ability to drive and use machines
The ability to drive and operate machines may be impaired by some adverse reactions associated with KIOVIG. Patients who experience adverse reactions during treatment should wait for these to resolve before ...
Undesirable effects
Summary of the safety profile Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally. ...
Overdose
Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment (see section 4.4). Paediatric population ...
Pharmacodynamic properties
Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration ATC code: J06BA02 Human normal immunoglobulin contains mainly immunoglobulin ...
Pharmacokinetic properties
Human normal immunoglobulin is immediately and completely bioavailable in the recipients circulation after intravenous administration. It is distributed relatively rapidly between plasma and extravascular ...
Preclinical safety data
Immunoglobulins are normal constituents of the human body. The safety of KIOVIG has been demonstrated in several non-clinical studies. Non-clinical data reveal no special risk for humans based on conventional ...
List of excipients
Glycine Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, nor with any other IVIg products.
Shelf life
2 years. If dilution to lower concentrations is required, immediate use after dilution is recommended. The in-use stability of KIOVIG after dilution with a 5% glucose solution to a final concentration ...
Special precautions for storage
Do not store above 25°C. Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
10, 25, 50, 100, 200 or 300 ml of solution in a vial (Type I glass) with a stopper (bromobutyl). Pack size: 1 vial. Not all presentations may be marketed.
Special precautions for disposal and other handling
The product should be brought to room or body temperature before use. If dilution is required, 5% glucose solution is recommended. For obtaining an immunoglobulin solution of 50 mg/ml (5%), KIOVIG 100 ...
Marketing authorization holder
Takeda Manufacturing Austria AG, Industriestrasse 67, A-1221, Vienna, Austria
Marketing authorization number(s)
EU/1/05/329/001 EU/1/05/329/002 EU/1/05/329/003 EU/1/05/329/004 EU/1/05/329/005 EU/1/05/329/006
Date of first authorization / renewal of the authorization
Date of first authorization: 19 January 2006 Date of latest renewal: 06 December 2010
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
