Beriglobin ® P 2 ml Solution

Beriglobin P is used for

• Replacement therapy in adults and children in congenital (primary) immunodeficiency syndromes such as:
• Congenital absence of antibodies (agammaglobulinaemia)
• or antibody deficiency (hypogammaglobulinaemia).
• Common variable immunodeficiency
• Severe combined immunodeficiency
• IgG subclass deficiencies with recurrent infections
• Replacement of antibodies in
• cancer of bone marrow (myeloma) or
• malignant illness of white blood cells (chronic lymphatic leukaemia). This disease leads to severe antibody deficiency (secondary hypogammaglobulinaemia) and recurrent infections.
• Hepatitis A prophylaxis
• in travellers who present less than 2 weeks before possible exposure, preferably in combination with vaccination. For long-term hepatitis A prophylaxis, active immunisation is recommended.
• in persons exposed less than 2 weeks previously.
• Therapy of inflammation of mucous membranes caused by radiotherapy (radiogenic mucositis).

The following information should be considered by you and your doctor before you use Beriglobin P.

Do not use BERIGLOBIN ® P:

• if you are allergic (hypersensitive) to any of the components of the product.
• Please inform your doctor if you are allergic to any medicine or food.
• into a blood vessel
• into a muscle if you suffer from a disorder of blood clotting.

Take special care with BERIGLOBIN ® P:

• if Beriglobin P is accidentally administered into a blood vessel. You could develop a severe allergic reaction (anaphylactic shock). This reaction is seen as a fall in blood pressure and shortness of breath. You could also develop blood clots (thromboembolic events);
• if you receive human normal immunoglobulin for the first time;
• if you have received another product for treatment of the same symptoms in the past;
• when treatment has been interrupted for more than eight weeks.

True hypersensitivity reactions are rare. They can occur in the very rare cases of IgA deficiency with anti-IgA antibodies. In this case you should be treated with caution. Rarely, Beriglobin P can induce a fall in blood pressure with anaphylactic reaction. This reaction may also occur if you had tolerated previous treatment with normal human immunoglobulin.

Thromboembolic events associated with subcutaneous substitution therapy: With the subcutaneous use of high doses of immunoglobulins for substitution therapy (e.g. primary immunodeficiency syndrome) there have been reports of blood clots (thromboembolic events). They may lead to heart attack (myocardial infarction), stroke, blood clots in the leg (deep venous thrombosis) and blood clots in the arteries of the lungs (pulmonary embolism).

Always use BERIGLOBIN ® P exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Dosage:

The dosage and intervals of infusion are dependent on the indication.

Replacement therapy:

The product should be administered via the subcutaneous route. Always use Beriglobin P exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will calculate the correct dose for you taking into account your weight and response to treatment. A loading dose of at least 1,3 to 3,1 ml/kg body weight – divided over several days – may be required. Following this, maintenance doses may be given (usually weekly) to reach a cumulative monthly dose of about 2,5 to 5 ml per kg of body weight.

Hepatitis A prophylaxis:

The product is to be administered via the intramuscular route.

• Short-term prophylaxis in travellers who present less than 2 weeks before possible exposure: For stays in endemic areas of less than 3 months a dose of 0,003 to 0,004 g/kg (0,02 ml/kg) bodyweight is recommended to be administered intramuscularly. Beriglobin P can be given in combination with Hepatitis A vaccine, but at different sites of the body.
• Hepatitis A prophylaxis in persons exposed less than 2 weeks previously: 0,003 to 0,004 g/kg (0,02 ml/kg) bodyweight administered intramuscularly.

Therapy of radiogenic mucositis

The product is to be administered via the intramuscular route. Initially 10 ml (1600 mg), after 2 days 5 ml (800 mg) and after a further 2 days again 5 ml (800 mg). The treatment can be repeated as often as necessary.

Like all medicines, Beriglobin P can have side effects, although not everybody gets them. Please contact your doctor immediately or go to the Emergency Department at your nearest hospital immediately if any of the listed side effects occur, or if you notice any side effects not listed in this leaflet.

The following undesirable effects have been reported in a clinical study with subcutaneous administration:

Local reactions at the injection site:

Very common, i.e. more than 1 out of 10 treated persons: swelling, soreness, redness, induration, local heat, itching, bruising or rash. The frequency of these local reactions declined very rapidly within the first ten infusions, when patients became used to this form of treatment.

Immune system disorders:

In single cases, i.e. less than 1 out of 10,000 treated persons: allergic reactions including fall in blood pressure.

Generalised reactions:

In single cases, i.e. less than 1 out of 10,000 treated persons: e.g. chills, fever, headache, generally feeling unwell, moderate back pain, unconsciousness, dizziness, rash, wheezing.

In addition to the reactions which have been observed during clinical trials, the following adverse reactions have been reported after introduction to the market:

Immune system disorders:

Allergic/anaphylactic reactions including difficulty breathing and skin reactions. In isolated cases these reactions can lead to a severe allergic reaction (anaphylactic shock). This may happen even if you have well tolerated previous administration with Beriglobin P or a similar product.

Generalised reactions:

Generalised reactions concerning the whole body e.g. nausea, vomiting, joint pain.

Heart and vascular disorders:

Circulatory disorders particularly if the product has been inadvertently injected into a blood vessel. With the subcutaneous use of high doses of immunoglobulins for substitution therapy (e.g. primary immunodeficiency syndrome), vascular disorders: Formation of unwanted blood clots (arterial and venous thromboembolic events) have been reported. Symptoms of these may include:

• severe chest pain or chest pressure (heart attack)
• weakness, paralysis or numbness on one side of the body, loss of vision in one or both eyes, speech difficulties (stroke)
• cough, chest pain, rapid breathing, rapid heart rate (pulmonary embolism)
• swelling, pain, redness of the leg (deep vein thrombosis)

Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.

Do not use Beriglobin P after the expiry date which is stated on the label and carton.

• Store in a refrigerator (+2 °C to +8 °C) and keep the container in the outer carton in order to protect from light. Do not freeze!
• The product must be inspected visually prior to administration and should not be used if there is any variation of physical appearance (see also section 3. subheading “Method of administration” and section 6. subheading “What Beriglobin P looks like and contents of the pack”).
• Once a container has been opened, its contents are to be used immediately.

Keep all medicines out of the reach and sight of children. Return all unused medicine to your pharmacist.