VARITECT

Main information

  • Trade name:
  • VARITECT Solution for Injection
  • Available from:
  • Biotest Pharma GmbH
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VARITECT Solution for Injection
    Ireland
  • Language:
  • English

Other information

Status

  • Source:
  • IMB
  • Authorization date:
  • 21-04-1995
  • Last update:
  • 09-08-2016

Summary of Product characteristics


Part II

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:

Active substance

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

exposure;

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

Posology

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

Varitect ®

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.

4.3 Contraindications

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

antibodies.

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

after administration.

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

contain sucrose.

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

be expected.

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.

4.9 Overdose

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.

6.2 Incompatibilities

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

proteins.

6.3 Shelf Life

2 years.

6.4 Special precautions for storage

Varitect ®

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

Landsteinerstrasse 5

D-63303 Dreieich

Germany

8 MARKETING AUTHORISATION NUMBER

PA0592/003/001

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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There are no safety alerts related to this product.

There are no news related to this product.