Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Varitect 25 IU/ml
Solution for Infusion.
Human Varicella Immunoglobulin for Intravenous Administration.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human varicella zoster immunoglobulin
1 ml solution contains:
1gG subclass distribution:
1gG1 approx. 62.0 %
1gG2 approx. 34.0 %
1gG3 approx. 0.5 %
1gG4 approx. 3.5 %
1gA content =5mg
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Solution for infusion.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
1. Prophylaxis of varicella after exposure for:
o Children with negative history of varicella who are receiving immunosuppressive, cytostatic or radiotherapy or
suffer from hereditary immunodeficiences;
o Immunocompromised adults who, after careful evaluation are believed susceptible and have had significant
o Newborns of mothers who develop chicken pox within 5 days before and 2 days after delivery;
o Premature infants whose mothers have negative histories of varicella, as long as they require hospital care;
o Premature infants of less than 28 weeks of gestation or with a birth weight of 1000 g or less, regardless of
maternal varicella history;
2. Adjuvant therapy of severe or complicated varicella zoster in immunocompromised patients or newborns at
Human plasma protein 100 mg
Thereof immunoglobulin =95 %
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4.2 Posology and method of administration
Prevention of chicken pox: 0.2ml – 1 ml (5 - 25 I.U.) per kg body weight. In repeated exposure, e.g. household
contact, higher doses are preferable. For post-exposure prophylaxis, Varitect should be administered as soon as
possible within 96 h of exposure, but may be given up to 10 days after exposure.
Treatment of zoster infection: 1 ml – 2 ml (25 – 50 I.U.) per kg body weight, with additional applications depending on
the course of clinical manifestations.
Method of administration
is intended for intravenous use. During the infusion, the rate of 20 drops per minute (corresponding to 1 ml
per minute) must not be exceeded.
Hypersensitivity to any of the components.
Hypersensitivity to homologous immunoglobulins, especially in very rare cases of IgA deficiency, when the patient has
antibodies against IgA.
4.4 Special warnings and precautions for use
Certain severe adverse drug reactions may be related to the rate of infusion. The recommended infusion rate given
under “section 4.2, Posology and method of administration” must be closely followed. Patients must be closely
monitored and carefully observed for any symptoms throughout the infusion period.
Certain adverse reactions may occur more frequently:
o in case of high rate of infusion,
o in patients with hypo- or agammaglobulinaemia with or without IgaA deficiency,
o in patients who receive human immunoglobulin for the first time or, in rare cases, when the human
immunoglobulin product is switched or when there has been a long interval since the previous infusion.
True hypersensitivity reactions are rare. They can occur in the very seldom cases of IgA deficiency with anti-IgA
Rarely, human immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who
had tolerated previous treatment with human immunoglobulin.
Potential complications can often be avoided by ensuring:
o that patients are not sensitive to human immunoglobulin by first injecting the product slowly (0.1 ml/kg/h),
o that patients are carefully monitored for any symptoms throughout the infusion period. In particular, patients
naive to human immunoglbulin, patients switched from the alternative intravenous immunoglobulin (IVIg)
product or when there has been a long interval since the previous infusion and for the first hour after the first
infusion, in order to detect potential adverse signs. All other patients should be observed for at least 20 minutes
There is clinical evidence of an association between IVIg administration and thromboembolic events such as
myocardial infarction, stroke, pulmonary embolism and deep vein thromboses which is assumed to be related to a
relative increase in blood viscosity through the high influx immunoglobulin in at-risk patients.
Caution should be exercised in prescribing and infusing IVIg in obese patients and in patients with pre-existing risk
factors for thrombotic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or
thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of
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Cases of acute renal failure have been reported in patients receiving IVIg therapy. In most cases, risk factors have been
identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolemia, overweight, concomitant
nephorotoxic medicinal products or age over 65.
In case of renal impairment, IVIg discontinuation should be considered.
While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the
licensed IVIg products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total
number. In patients at risk, the use of IVIg products that do not contain sucrose may be considered. Varitect® does not
In patients at risk for acute renal failure or thromboembolic adverse reactions, IVIg products should be administered at
theminimum rate of infusion and dose practicable.
In all patients, IVIg administration requires:
o adequate hydration prior to the initiation of the infusion of IVIg,
o monitoring of urine output,
o monitoring of serum craetinine levels,
o avoidance of cocncomitant use of loop diuretics.
In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. The treatments
required depend on the nature and severity of the side effect.
In case of shock, standard medical treatment for shock should be implemented.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or
plasma include selection of donors, screening of individual donations and plasma pools for specific markers of
infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when
medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective
agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV. The measures taken
may be of limited value against non-enveloped viruses such as HAV and parvovirus B19.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with
immunoglobulis and it is also assumed that the antibody content makes an important contribution to the viral safety.
It is strongly recommended that every time that Varitect® is andmnistered 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.
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 and varicella. After administration of this product, an
interval of 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this
impairment may persist for up to 1 year.
Therefore patients receiving measles vaccine should have their antibody status checked.
Interference with serological testing
After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patients
blood may result in misleading positive results in serological testing.
Passive transmission of antibodies to erythrocyte antigens, e.g. A, B D may interfere with some serological tests for red
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4.6 Pregnancy and lactation
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials
and therefore should only be given with caution to pregnant women and breast-feeding mothers. Clinical experience
with immunoglobulins suggests that no harmful effects on the course of pregnancy, on the foetus and the neonate are to
Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.
4.7 Effects on ability to drive and use machines
There are no indications that Varitect may impair the ability to drive and use machines.
4.8 Undesirable effects
Adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure
and moderate low back pain may occur occasionally.
Rarely, immunglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even
when the patient has shown no sensitivity to previous administration.
Cases of reversible aseptic meningitis, isolated cases of reversible haemolytic anaemia/haemolysis and rare cases of
transient cutaneous reactions, have been observed with human normal immunoglobulin.
Increase in serum creatinine level and/or acute renal failure have been observed.
Thrombotic events have been reported in the elderly, in patients with signs of cerebral or cardiac ischemia, and in
overweight and severely hypovolaemic patients.
For information on viral safety see section 4.4, Special warnings and precautions for use.
Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or
patients with renal impairment.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Human varicella zoster immunoglobulin for intravenous administration.
ATC code: J06BB03
Varitect is an immunoglobulin preparation from the plasma of donors who possess a high antibody titer against
varicella zoster virus.
5.2 Pharmacokinetic properties
Varitect is immediately and completely bioavailable in the recipients circulation after intravenous administration. It is
distributed relatively rapidly between plasma and extravescular fluid; after approximately 3-5 days an equilibrium is
reached between the intra-and extra-vascular compartments.
Varitect has a half-life of about 3 weeks. This half-life may vary from patient to patient, in particular in primary
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IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
5.3 Preclinical safety data
Immunoglobulins are normal constituents of the human body.
In animals, single dose toxicity testing is of no relevance since higher doses result in overloading. Repeated dose
toxicity testing and embryo-foetal toxicity studies are impracticable due to the induction of, and interference with
antibodies. Effects of the product on the immune system of the newborn have not been studied.
Since clinical experience provides no hint for tumorogenic or mutagenic effects of immunoglobulins, experimental
studies, particularly in heterologous species, are not considered necessary.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride, water for injections.
This medicinal product must not be mixed with other medicinal products.
Varitect is miscible with physiological saline solution. However, no other preparations may be added to the Varitect
solution as any changes in the electrolyte concentration or the pH may result in precipitation or denaturization of the
6.3 Shelf Life
6.4 Special precautions for storage
should not be used after the expiry date indicated on the label.
Varitect should be stored in the refrigerator at +2 to +8°C, protected from light.
Do not freeze.
The solution should be administered immediately after opening the ampoule.
6.5 Nature and contents of container
Varitect is provided in glass ampoules of 5ml (125 I.U.) and 20ml (500 I.U.)
6.6 Special precautions for disposal of a used medicinal product or waste materials derived from
such medicinal product and other handling of the product
The product should be brought to room or body temperature before use.
The solution should be clear or slightly opalescent. Do not use solutions which are cloudy or which have a deposit.
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7 MARKETING AUTHORISATION HOLDER
Biotest Pharma GmbH
8 MARKETING AUTHORISATION NUMBER
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorization: 21 April 1995
Date of last renewal: 21 April 2005
10 DATE OF REVISION OF THE TEXT
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