GRAFALON Concentrate for solution for infusion (2022)
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Περιεχόμενα
1. Name of the medicinal product
Grafalon 20 mg/ml concentrate for solution for infusion.
2. Qualitative and quantitative composition
20 mg anti-human T-lymphocyte immunoglobulin from rabbits per 1 ml Grafalon (100mg/5ml vial or 200mg/10ml vial). For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion. Clear to slightly opalescent and colourless to pale yellow solution, pH = 3.4-4.0
4.1. Therapeutic indications
Grafalon is indicated in combination with other immunosuppressive medicinal products for the suppression of immune competent cells, which are the cause for acute rejection. It is usually administered for ...
4.2. Posology and method of administration
Grafalon should be prescribed only by physicians who are experienced in the use of immunosuppressive therapies. Grafalon must be administered under qualified medical supervision. Posology The dose of Grafalon ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Grafalon is contraindicated in patients with bacterial, viral or mycotic and parasitic infections, which are ...
4.5. Interaction with other medicinal products and other forms of interaction
Patients receiving Grafalon must be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources to provide emergency treatment if necessary. Grafalon must be administered ...
4.6. Fertility, pregnancy and lactation
Pregnancy For Grafalon no clinical or animal data on exposed pregnancies and breastfeeding mothers are available. The potential risk for the fetus is unknown. Caution should be exercised when prescribing ...
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
Summary of the safety profile Grafalon is an immunoglobulin product with immunosuppressive properties. Well-known class-related adverse effects include cytokine-release related symptoms, hypersensitivity ...
4.9. Overdose
In case of overdose, immediate use of broad-spectrum antibiotics, antimycotic and antiviral therapy is recommended. Grafalon therapy must be discontinued, and any other concurrent immunosuppressive treatment ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> immunosuppressive drug, immunoglobulin against human T lymphocytes (rabbit) <b>ATC code:</b> L04AA04 Grafalon is a high-titre anti-T-lymphocyte immunoglobulin preparation ...
5.2. Pharmacokinetic properties
Grafalon is administered by the intravenous route and therefore is 100 % bioavailable. Pharmacokinetic studies showed that during intravenous administration of 4 mg/kg BW/d (for 7 days) Grafalon serum ...
5.3. Preclinical safety data
After intravenous administration of 900 mg/kg BW in rabbits, the animals demonstrated no pathological changes in either the clinical picture or in the haematological test results. With a dosage of 100 ...
6.1. List of excipients
Sodium dihydrogen phosphate dihydrate Phosphoric acid (85%) (for pH adjustment) Water for injections
6.2. Incompatibilities
Grafalon must not be mixed with glucose, blood, blood-derivatives and solutions containing lipids and sodium heparin.
6.3. Shelf life
3 years. Chemical and physical in-use stability of the diluted solution has been demonstrated for 24 hours at room temperature. However, from a microbiological point of view, the diluted product should ...
6.4. Special precautions for storage
Store in a refrigerator (2°C-8°C). 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. For instruction on ...
6.5. Nature and contents of container
Pack with 1 or 10 vials containing 5 ml solution. Pack with 1 or 10 vials containing 10 ml solution.
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Neovii Biotech GmbH, Am Haag 6+7, 82166 Graefelfing, Germany
8. Marketing authorization number(s)
PA1015/001/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 05 June 2001 Date of last renewal: 05 June 2006
10. Date of revision of the text
March 2022
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