CSL Behring
Vivaglobin,
160mg/ml solution for injection
(for subcutaneous use)
Human Normal Immunoglobulin
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Vivaglobin is and what it is used for
- 2. Before you use Vivaglobin
- 3. How to use Vivaglobin
- 4. Possible side effects
- 5. How to store Vivaglobin
- 6. Further information
What Vivaglobin Is And What It Is Used For
What is Vivaglobin?
Vivaglobin is a solution for injection under the skin (subcutaneous use). The solution contains human normal immunoglobulin.
Immunoglobulins are important components of the body’s immune response system. They are produced from cells in the blood and act as inhibitors (antibodies) to foreign substances.
Human normal immunoglobulin contains mainly immunoglobulin G (IgG) having a broad spectrum of antibodies against various infectious agents. Vivaglobin contains the immunoglobulin G antibodies present in the healthy population. Adequate doses of this medicinal product may restore abnormally low immunoglobulin G levels to the normal range.
What is Vivaglobin used for?
Vivaglobin is used for:
- Replacement of antibodies in adults and children suffering from 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.
Before You Use Vivaglobin
The following sections contain information that you and your doctor should consider before using Vivaglobin.
Do NOT infuse Vivaglobin
- if you are allergic (hypersensitive) to any of the components of the product (see section 6). Please inform your doctor if you are allergic to any medicine or food.
- into a blood vessel
- into a muscle if you suffer of a severe deficiency of blood platelets (thrombocytopenia) or other disorders of blood clotting
Take special care with Vivaglobin
- if Vivaglobin 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
- 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 allergic reactions are rare. They can occur in the very rare cases of IgA deficiency with anti-IgA antibodies. In this case your doctor will treat you with caution.
Rarely, Vivaglobin can induce a fall in blood pressure with anaphylactic (allergic) reaction. This reaction may also occur if you had tolerated previous treatment with normal human immunoglobulin.
Potential complications can often be avoided by ensuring
- that you are not sensitive to human normal immunoglobulin. The product should initially be injected slowly. The recommended infusion rate should be adhered to (see 3. 'How to use Vivaglobin')
- that you are carefully monitored for any symptoms throughout the infusion period especially if:
- you receive human normal immunoglobulin for the first time
- you switched from an alternative product or
- there has been a long interval since the previous infusion.
In these cases you should be monitored during the first infusion and for the first hour thereafter. All other patients should be observed for at least 20 minutes after administration.
On suspicion of an allergic or anaphylactic reaction the administration has to be discontinued immediately. In case of shock the current medical standards for shock treatment have to be applied.
Information on safety with respect to infections
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include:
- careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded
- the testing of each donation and pools of plasma for signs of virus/infections.
Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV, the AIDS virus), hepatitis B virus and hepatitis C virus (liver inflammation), and for the non-enveloped hepatitis A virus and parvovirus B19 (Sticker's disease).
Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.
Every time you take Vivaglobin you should record the following data in your treatment diary:
- the date of administration
- the batch number of the product
- the injected volume
Taking other medicines
- Please ask your doctor or pharmacist for advice before taking any other medicines including vaccines or medicines obtained without a prescription.
- You must not mix this medicinal product with other medicinal products, solvents or diluents.
- Results of some blood tests may be affected by Vivaglobin. If you are due to receive blood tests of any sort, make sure the doctor treating you knows you are receiving Vivaglobin.
Pregnancy and lactation
- Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast feeding your baby.
- The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials.
- Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
- Your doctor will decide if it is suitable for you to receive Vivaglobin if you are pregnant or breast feeding your baby.
Driving and using machines
Vivaglobin does not affect your ability to drive and use machines.
Important information about some of the ingredients of Vivaglobin
Vivaglobin contains up to 110 mg (4.8 mmol) sodium per dose (75 kg body weight) if the maximum daily dose is given (11.25 g = 70.3 ml). This should be taken into consideration if you are on a controlled sodium diet.
How To Use Vivaglobin
Always use Vivaglobin 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 millilitres per kilogram 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 millilitres per kilogram of body weight
Method of administration
- Home treatment should be initiated and monitored by a physician experienced in the treatment of immunodeficiency and in the guidance of patients for home treatment. You will be instructed in:
- the use of a syringe driver
- infusion techniques
- the keeping of a treatment diary and
- measures to be taken in case of severe adverse events.
- Vivaglobin is a ready-for-use solution. (see section 5. 'How to store Vivaglobin' and 6. subsection 'What Vivaglobin looks like and content of the pack').
- Do not use solutions that are cloudy or have deposits.
- The solution should be administered at body temperature.
- Vivaglobin should be administered via the subcutaneous route.
- The recommended infusion rate is 22 ml/hour (millilitres per hour).
Vivaglobin should preferentially be administered into the fleshy part of the abdominal wall, thigh and/or buttocks. No more than 15 ml should be injected into a single site. Doses over 15 ml should be divided and injected into 2 or more sites.
Your doctor will instruct you how to dispose of unused product or waste material.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Overdose/missed doses
If you think you have had too much Vivaglobin or have missed a dose, speak to your doctor.
Possible Side Effects
Like all medicines Vivaglobin 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 you notice the following:
Very rarely (less than 1 in 10,000 treated persons)
Allergic reactions including difficulty breathing, skin reactions, swelling of the throat and lips and a fall in blood pressure. These reactions may be severe (anaphylaxis). This may happen even if you have had no reaction to previous treatment with Vivaglobin or a similar product.
Fainting e.g. dizziness, dimming of vision and ringing in the ears
Cardiovascular reactions e.g. a fall in blood pressure, particularly if the product has been inadvertently injected into a blood vessel (see also section 2 subheading 'Take special care with Vivaglobin')
Please contact your doctor if any of the following side effects occur, or if you notice any effects not listed in this leaflet
Generalised reactions e.g. chills, fever, headache (possibly caused by increased blood pressure), generally feeling unwell, feeling/being sick, rash, dizziness, joint pain or moderate back pain
Nervous system disorders e.g. migraine
Very common side effects (more than 1 in 10 treated persons)
Local reactions at the injection site e.g. swelling, soreness, redness, hardening of the skin, local heat, itching, bruising or rash
The frequency of these local reactions declines rapidly within the first ten infusions, when patients became used to this form of treatment.
How To Store Vivaglobin
- 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!
- Keep out of the reach and sight of children.
- Do not use Vivaglobin after the expiry date, which is stated on the label and carton.
- 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 Vivaglobin looks like and contents of the pack').
- The product may be stored at room temperature (up to 25 °C) for a limited period of three months or until the expiry date (whichever date comes first) without being refrigerated again during this period. The new expiry date at room temperature should be noted on the carton. At the end of this period the product has to be used or discarded.
- Once an ampoule or injection vial has been opened the solution should be used immediately
- Any unused product or waste material should be disposed of in accordance with local requirements.
Further Information
What Vivaglobin contains
The active substance is: human normal immunoglobulin, 160 mg/ml solution for injection, 480 mg/3 ml vial or 800 mg/5 ml ampoule or 1600 mg/10 ml vial or 3200 mg/20 ml vial.
Other ingredients are: glycine, sodium chloride, hydrochloric acid or sodium hydroxide (for pH adjustment), water for injections
What Vivaglobin looks like and contents of the pack
Vivaglobin is a clear solution for subcutaneous injection.
The colour can vary from colourless to pale-yellow up to light-brown during its shelf-life.
Pack sizes
3 ml of solution in a vial - pack of 1 or 10 vials
5 ml of solution in an ampoule - pack of 1 ampoule (UK only)
10 ml of solution in a vial - pack of 1, 10 or 20 vials
20 ml of solution in a vial - pack of 1 vial
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
This leaflet was last approved in: October 2009
For further information contact
No comments:
Post a Comment