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AstraZeneca

Flebogamma DIF (previously Flebogammadif)
human normal immunoglobulin

Package leaflet: Information for the user


Flebogamma DIF 50 mg/ml solution for infusion

Human normal immunoglobulin (IVIg)


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


What Flebogamma DIF looks like and contents of the pack


Flebogamma DIF is a solution for infusion. The solution is clear or slightly opalescent and colourless or pale yellow.


Flebogamma DIF is supplied as 0.5 g/10 ml, 2.5 g/50 ml, 5 g/100 ml, 10 g/200 ml and 20 g/400 ml vials.

Pack size of 1 vial.

Not all sizes may be marketed.


Marketing Authorisation Holder and Manufacturer


Instituto Grifols, S.A.

Can Guasc, 2 - Parets del Vallès 08150 Barcelona - Spain


For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:


AT/BE/BG/EE/ES/HR/HU/IE/LV/ LT/LU/MT/NL/RO/SI/SK/UK(NI)

Instituto Grifols, S.A.

Tel: +34 93 571 01 00

CY/EL

Instituto Grifols, S.A. Τηλ: +34 93 571 01 00


CZ

Grifols S.R.O.

Tel: +4202 2223 1415

DE

Grifols Deutschland GmbH Tel: +49 69 660 593 100

DK/FI/IS/NO/SE

Grifols Nordic AB Tel: +46 8 441 89 50

FR

Grifols France

Tél: +33 (0)1 53 53 08 70


IT

Grifols Italia S.p.A. Tel: +39 050 8755 113

PL

Grifols Polska Sp. z o. o. Tel: +48 22 378 85 60


PT

Grifols Portugal, Lda. Tel: +351 219 255 200


This leaflet was last revised in MM/YYYY


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The following information is intended for healthcare professionals only (see section 3 for further information):


Posology and method of administration


The dose and dose regimen is dependent on the indication.


The dose may need to be individualised for each patient dependent on the clinical response. Dose based on body weight may require adjustment in underweight or overweight patients. The following dosage regimens are given as a guideline.


The dose recommendations are summarised in the following table:


Indication

Dose

Frequency of injections

Replacement therapy:

Primary immunodeficiency syndromes

Starting dose: 0.4 - 0.8 g/kg


Maintenance dose:

0.2 - 0.8 g/kg


every 3 - 4 weeks

Secondary immunodeficiencies

0.2 - 0.4 g/kg

every 3 - 4 weeks

Immunomodulation:

Primary immune thrombocytopenia

0.8 - 1 g/kg


or


0.4 g/kg/d

on day 1, possibly repeated once

within 3 days


for 2 - 5 days

Guillain Barré syndrome

0.4 g/kg/d

for 5 days

Kawasaki disease

2 g/kg

in one dose in association with acetylsalicylic acid


Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

Starting dose:

2 g/kg


Maintenance dose:

1 g/kg


in divided doses over 2 - 5 days


every 3 weeks over 1 - 2 days

Multifocal motor neuropathy (MMN)

Starting dose:

2 g/kg


Maintenance dose:

  1. g/kg

  2. g/kg


or



in divided doses over 2 - 5 consecutive days


every 2 - 4 weeks


every 4 - 8 weeks in divided doses over 2 - 5 days


Flebogamma DIF should be infused intravenously at an initial rate of 0.01 - 0.02 ml/kg/min for the first thirty minutes. If well tolerated, the rate of administration may gradually be increased to a maximum of 0.1 ml/kg/min.


A significant increase in median platelet levels was achieved in a clinical trial in chronic ITP patients (64,000/µl) although it did not reach normal levels.


Paediatric population


As the dosage for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned conditions, the dosage in children is not considered to be different to that of adults.


Incompatibilities


Flebogamma DIF should not be mixed with other medicines or intravenous solutions and it should be administered by a separate intravenous line.


Special precautions 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 babies and young children (aged 0 - 2 years) hereditary fructose intolerance (HFI) may not yet be diagnosed and may be fatal, thus, they must not receive this medicinal product.

In persons more than 2 years old with HFI, a spontaneous aversion for fructose-containing foods develops and may be combined with the onset of symptoms (vomiting, gastro-intestinal

disorders, apathy, height and weight retardation). Therefore a detailed history with regard to HFI symptoms has to be taken of each patient prior to receiving Flebogamma DIF.

In case of inadvertent administration and suspicion of fructose intolerance the infusion has to be

stopped immediately, normal glycaemia has to be re-established and organ function has to be stabilized by means of intensive care.


Interferences with determination of blood glucose levels are not expected.


It is strongly recommended that every time that Flebogamma DIF is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

Instructions for handling and disposal


The product should be brought at room temperature (no more than 30 ºC) before use.


The solution should be clear or slightly opalescent. Do not use Flebogamma DIF if you notice that the solution is cloudy or has deposits.


Any unused medicinal product or waste material should be disposed of in accordance with local requirements.