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HIZENTRA Solution for injection (2022)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Hizentra 200 mg/ml solution for subcutaneous injection. Hizentra 200 mg/ml solution for subcutaneous injection in pre-filled syringe.

2. Qualitative and quantitative composition

Human normal immunoglobulin (SCIg). <u>One ml contains:</u> Human normal immunoglobulin 200 mg. (purity: at least 98% is immunoglobulin type G (IgG)) Vials <u>Each vial of 5 ml solution contains:</u> 1 ...

3. Pharmaceutical form

Solution for subcutaneous injection. The solution is clear and pale-yellow or light-brown. Hizentra has an approximate osmolality of 380 mOsmol/kg.

4.1. Therapeutic indications

<u>Replacement therapy in adults, children and adolescents (0-18 years) in:</u> Primary immunodeficiency syndromes with impaired antibody production (see section 4.4). Secondary immunodeficiencies (SID) ...

4.2. Posology and method of administration

The dose and dose regimen are dependent on the indication. Therapy should be initiated and monitored under the supervision of a healthcare professional experienced in the treatment of immunodeficiency/CIDP ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4). Patients with hyperprolinaemia type I or II. Hizentra must not be given intravascularly.

4.4. Special warnings and precautions for use

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hizentra is for subcutaneous use ...

4.5. 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 ...

4.6. Fertility, pregnancy and lactation

Pregnancy Data from prospective clinical trials on the use of human normal immunoglobulin in pregnant women is limited. Therefore, Hizentra should only be given with caution to pregnant women. Clinical ...

4.7. Effects on ability to drive and use machines

Hizentra has minor influence on the ability to drive and use machines, e.g. dizziness (see section 4.8). Patients who experience adverse reactions during treatment should wait for these to resolve before ...

4.8. Undesirable effects

Summary of safety profile Adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally. Rarely ...

4.9. Overdose

Consequences of an overdose are not known.

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> immune sera and immunoglobulins: immunoglobulins, normal human, for extravascular administration <b>ATC code:</b> J06BA01 Human normal immunoglobulin contains mainly immunoglobulin ...

5.2. Pharmacokinetic properties

Absorption and Distribution Following subcutaneous administration of Hizentra, peak serum levels are achieved after approximately 2 days. Elimination IgG and IgG-complexes are broken down in cells of the ...

5.3. Preclinical safety data

Immunoglobulins are a normal constituent of the human body. L-proline is a physiological, nonessential amino acid. The safety of Hizentra has been assessed in several preclinical studies, with particular ...

6.1. List of excipients

L-proline Polysorbate 80 Water for injections Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH adjustment)

6.2. Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3. Shelf life

30 months. Once a vial or the blistered pre-filled syringe has been opened, the solution should be used immediately.

6.4. Special precautions for storage

Do not store above 25°C. Do not freeze. Keep the vial or the blistered pre-filled syringe in the outer carton in order to protect from light. For storage conditions after first opening of the medicinal ...

6.5. Nature and contents of container

Vials 5, 10 or 20 ml of solution in a vial (type I glass) and 50 ml of solution in a vial (type II glass), with a stopper (halobutyl), a cap (aluminium crimp) and a flip off disc (plastic). Pack sizes ...

6.6. Special precautions for disposal and other handling

Hizentra comes as a ready-to-use solution in single-use vials or single-use pre-filled syringes. Because the solution contains no preservative, Hizentra should be used/infused as soon as possible after ...

7. Marketing authorization holder

CSL Behring GmbH, Emil-von-Behring-Strasse 76, D-35041 Marburg, Germany

8. Marketing authorization number(s)

<u>Vials:</u> EU/1/11/687/001 EU/1/11/687/002 EU/1/11/687/003 EU/1/11/687/004 EU/1/11/687/005 EU/1/11/687/006 EU/1/11/687/010 EU/1/11/687/011 EU/1/11/687/012 EU/1/11/687/013 EU/1/11/687/014 <u>Pre-filled ...

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 14 April 2011 Date of first renewal: 18 February 2016

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