FLEBOGAMMA DIF Solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Flebogamma DIF 50 mg/ml solution for infusion.
Qualitative and quantitative composition
Human normal immunoglobulin (IVIg). <u>One ml contains:</u> Human normal immunoglobulin 50 mg (purity of at least 97% of IgG). Each vial of 10 ml contains: 0.5 g of human normal immunoglobulin. Each vial ...
Pharmaceutical form
Solution for infusion. The solution is clear or slightly opalescent and colourless or pale yellow. Flebogamma DIF is isotonic, with an osmolality from 240 to 370 mOsm/kg.
Therapeutic indications
Replacement therapy in adults, children and adolescents (2-18 years) in: Primary immunodeficiency syndromes (PID) with impaired antibody production. Secondary immunodeficiencies (SID) in patients who suffer ...
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 (human immunoglobulins) or to any of the excipients (see sections 4.4 and 6.1). Fructose intolerance (see section 4.4). In babies and young children (aged 0-2 years) ...
Special warnings and precautions for use
Sorbitol Each ml of this medicinal product contains 50 mg of sorbitol. Patients with rare hereditary problems of fructose intolerance must not take this medicine. In persons more than 2 years old with ...
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 should only be given with caution to pregnant women and breast-feeding ...
Effects on ability to drive and use machines
The ability to drive and operate machines may be impaired by some adverse reactions, such as dizziness, associated with Flebogamma DIF. Patients who experience adverse reactions during treatment should ...
Undesirable effects
Summary of the safety profile Adverse reactions caused by human normal immunoglobulins (in decreasing frequency) encompass (see also section 4.4): chills, headache, dizziness, fever, vomiting, allergic ...
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
Single dose toxicity studies were carried out in rats and mice. The absence of mortality in the non-clinical studies performed with Flebogamma DIF with doses up to 2500 mg/kg, and the lack of any confirmed ...
List of excipients
D-sorbitol 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.
Special precautions for storage
Do not store above 30°C. Do not freeze.
Nature and contents of container
10 ml, 50 ml, 100 ml, 200 ml or 400 ml solution in a vial (type II glass) with stopper (chloro-butyl-rubber). Pack size: 1 vial Not all pack sizes may be marketed.
Special precautions for disposal and other handling
The product should be brought to room or body temperature before use. The solution should be clear or slightly opalescent and colourless or pale yellow. Solutions that are cloudy or have deposits should ...
Marketing authorization holder
Instituto Grifols, S.A., Can Guasc, 2 Parets del Vallès, 08150, Barcelona Spain
Marketing authorization number(s)
EU/1/07/404/001-005
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 August 2007 Date of latest renewal: 24 April 2017
Date of revision of the text
07/2019
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