Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Human Varicella-Zoster Immunoglobulin
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Human varicella-zoster immunoglobulin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
This medicine is a solution containing varicella-zoster immunoglobulin (antibodies). It is prepared from blood plasma from screened donors. It is used to protect you against infection by the varicella-zoster virus (VZV), a virus which causes chickenpox (varicella) and shingles (herpes zoster), in the following at risk groups exposed to the virus: –
newborn babies whose mothers develop chickenpox (varicella) within 7 days before and 7 days after their baby's birth.
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pregnant women with no antibodies to chickenpox or shingles especially up to about 30 weeks of pregnancy.
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newborn babies whose mothers have never had chickenpox and/or are not immune.
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premature infants born before 28 weeks of pregnancy, or newborns with a low birth weight.
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adults and children who have never had chickenpox (varicella) and/or are not immune and their ability to fight infection (immune response) is reduced by certain medicines such as steroids, anti-cancer drugs or by certain treatments such as radiotherapy or recent stem cell transplantation.
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adults and children who have a reduced immune system which makes them more likely to catch infections such as chicken pox or shingles, unless they are receiving other types of regular antibody (immunoglobulin) treatment.
Your doctor will explain further why this medicine has been given to you.
2.
What you need to know before you take it
Human Varicella-Zoster Immunoglobulin
Do not use Human Varicella-Zoster Immunoglobulin if you are:
- allergic to human immunoglobulins
- allergic to any of the ingredients in this product (listed in Section 6). Warnings and precautions Talk to your doctor, nurse or healthcare professional before you are given Human VaricellaZoster Immunoglobulin –
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–
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True allergic reactions to this product are rare, when it is injected into the muscle as directed. However, even if you have had this medicine before, you could still have a reaction. In the case of an allergic reaction, urgent medical attention is needed (see also section 4 'Possible side effects'). If you are lacking immunoglobulin A (IgA deficient) you might develop antibodies to IgA, although this is not common. If you know you already have antibodies to IgA, tell your doctor, nurse or healthcare professional before your injection. If you suffer from high blood pressure, diabetes, a history of blood clots or problems with your veins or arteries, or a blood/blood related disorder, tell your doctor, nurse or healthcare professional before this medicine is injected. If you have had any vaccinations recently or know you are about to have any vaccinations tell your doctor, nurse or healthcare professional. Immunoglobulins may increase the risk of having a blood clot. If you develop pain, swelling and unusual warmth of a limb, sudden shortness of breath and chest pain worsening on deep breathing, numbness or weakness on one side, difficulty with speaking or confusion, contact your doctor or nurse immediately as these symptoms may indicate that you have a blood clot. Tell your doctor, nurse or healthcare professional if you are having any blood tests. This product will raise the level of various antibodies in your blood for several weeks. If you require a blood test during this period, tell your doctor, nurse or healthcare professional when you last had this product injected as misleading positive results may occur with certain tests.
Viral Safety 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 the inclusion of 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 viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis A (HAV) and parvovirus B19 viruses. Immunoglobulins have not been associated with HAV or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective. It is strongly recommended that every time you receive a dose of Human Varicella-Zoster Immunoglobulin the name and batch number of the medicine are recorded in order to maintain a record of the batches used. Other medicines and Human Varicella-Zoster Immunoglobulin Tell your doctor, nurse or healthcare professional if you are taking, have recently taken or might take any other medicines. Vaccinations Besides Human Varicella-Zoster antibodies, Human Varicella-Zoster Immunoglobulin provides you with a range of other antibodies. These antibodies will interfere with the response to some vaccines, especially MMR (measles, mumps and rubella) and varicella (chickenpox) vaccines. Such vaccinations should be given at least three weeks before Human Varicella-Zoster Immunoglobulin or not until three months after. In the case of the MMR vaccine, at least 5 months should pass before Human Varicella-Zoster Immunoglobulin is administered. Human Varicella-Zoster Immunoglobulin is unlikely to contain an antibody to yellow fever; so this vaccine can be given whenever needed. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Driving and using machines Human Varicella-Zoster Immunoglobulin has no influence on the ability to drive and use machines. Human Varicella-Zoster Immunoglobulin contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
3.
How to take it
Human Varicella-Zoster Immunoglobulin
This medicine will be given to you by your doctor, nurse or healthcare professional by injection into a muscle. Your doctor, nurse or healthcare professional will decide how much Human Varicella-Zoster Immunoglobulin you should receive.
This medicine must not be injected into the vein since it may cause a severe reaction if given in this way. Injections must be given to you by your doctor, nurse or healthcare professional into a muscle. Large doses (over 5 ml) will be injected into different parts of the body. No other medicines or fluids should be added to this product as their effects on the product have not been established. If you receive more Human Varicella-Zoster Immunoglobulin than you should If you are given more Human Varicella-Zoster Immunoglobulin than recommended, your doctor, nurse or healthcare professional may carry out some blood tests. It is not known what effects an overdose would have. If you have any further questions on the use of this medicine, ask your doctor, nurse or healthcare professional.
4.
Possible side effects
As with all medicines, Human Varicella-Zoster Immunoglobulin may cause side effects, although not everybody gets them. If you feel unwell, tell your doctor, nurse or healthcare professional immediately. Side effects may occur even if you have previously been given human immunoglobulins and tolerated them well. On rare occasions, (may affect up to 1 in 1,000 people) you may experience a strong allergic reaction or a sudden drop in blood pressure. • Tell your doctor, nurse or healthcare professional immediately if you find it difficult to breathe, if you feel dizzy and faint or if you develop swellings and a red itchy rash. You may need additional treatment to correct your symptoms. There may be some short-term discomfort at the site of injection such as swelling, soreness, warmth, redness, itching, bruising, or hardening of the skin. The following side effects have been reported with Human Varicella-Zoster Immunoglobulin: Not known: frequency cannot be estimated from the available data. • allergic reaction • low blood pressure • feeling sick (nausea), being sick (vomiting) • back pain • fever • chills • joint pains • headache • dizziness • heart beating very fast (tachycardia) • skin rash, reddening skin, itchy skin
•
joint pains
Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5.
How to store it
Human Varicella-Zoster Immunoglobulin
Keep this medicine out of the sight and reach of children. Do not use the medicine after the expiry date which is stated on the container after "EXP". The expiry date refers to the last day of the month. Store in a refrigerator (2°C – 8°C). Do not freeze. Short periods (up to 1 week) of storage at room temperature (25°C) will not damage the product. Keep the vial in the outer carton in order to protect from light. Do not use the medicine if you notice the solution is cloudy or has deposits. Disposal Your doctor, nurse or healthcare professional will dispose of any solution that remains, along with used syringes, needles and containers. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6.
Contents of the pack and other information
What Human Varicella-Zoster Immunoglobulin contains: • •
The active substance is human varicella-zoster immunoglobulin. The other ingredients are: sodium chloride, glycine, sodium acetate trihydrate, hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment. Each ml of solution contains at least 100 IU of human varicella-zoster immunoglobulin. The volume required to give the stated dose is printed on the vial label.
What Human Varicella-Zoster Immunoglobulin looks like and the contents of the pack Human Varicella-Zoster Immunoglobulin is a clear to slightly yellow solution in a clear glass container with a closure to prevent tampering. Do not use solutions that are cloudy or have deposits. Pack Size Human Varicella-Zoster Immunoglobulin 100 IU/ml solution for injection 1 x 250 mg vial Marketing Authorisation Holder Bio Products Laboratory Ltd, Dagger Lane, Elstree, WD6 3BX, Hertfordshire, United Kingdom. Manufacturer Bio Products Laboratory Ltd, Dagger Lane, Elstree, WD6 3BX, Borehamwood, United Kingdom. For any information about this medicine, please contact the Marketing Authorisation Holder. Please e-mail: [email protected] This leaflet was last revised in December 2021
Frequently asked questions about Human Varicella-Zoster Immunoglobulin
What is the active substance in Human Varicella-Zoster Immunoglobulin?
The active substance in Human Varicella-Zoster Immunoglobulin is human varicella-zoster immunoglobulin.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Human Varicella-Zoster Immunoglobulin, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Human Varicella-Zoster Immunoglobulin without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: human varicella-zoster immunoglobulin
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Prophylaxis against varicella zoster virus (VZV) infection in at risk patients exposed to varicella (chickenpox) or herpes zoster:
1. pregnant women with negative VZV immune status especially up to early in the third trimester
2. neonates whose mothers develop varicella infection within 7 days before and 7 days after delivery
3. neonates whose mothers have no history of varicella and/or a negative immune status
4. premature infants <28 weeks of gestation or newborns with low birth weight
5. adults and children with no history of varicella and/or a negative immune status, receiving immunosuppressive therapy including steroids, cytostatic agents, radiotherapy, recent stem cell transplantation, or who have congenital or acquired immunodeficiency disorders and are not receiving replacement therapy with immunoglobulin.
Notes on use of Human Varicella-Zoster Immunoglobulin
Whenever possible, contacts without a definite history of chickenpox should be screened for antibody by a sensitive test (e.g. ELISA, radioimmunoassay or immunofluorescence). There is no need to test neonates for antibody.
If antibodies to VZV are detectable, Human Varicella-Zoster Immunoglobulin is generally NOT needed. The following infants will possess maternal antibody and do NOT require Human Varicella-Zoster Immunoglobulin.
(i) Infants born more than seven days after the onset of maternal chickenpox.
(ii) Infants whose mothers have a positive history of chickenpox and/or a positive antibody result.
(iii) Infants whose mothers develop zoster (shingles) before or after delivery.
4.2. Posology and method of administration
Posology
≥15 IU/kg body weight as soon as possible, ideally within 3 days but within 10 days maximum.
Alternative dose levels for treatment are as follows:
0 - 5 years
250 mg (1 vial)
6 - 10 years
500 mg (2 vials)
11 - 14 years
750 mg (3 vials)
15 years and older
1000 mg (4 vials)
If a second exposure to chickenpox occurs three weeks or more after the first dose of Human Varicella-Zoster Immunoglobulin, a second dose is required.
Method of administration
Human Varicella-Zoster Immunoglobulin should be administered via the intramuscular route. If a large volume (>2 ml for children or >5 ml for adults) is required, it is recommended to administer this in divided doses at different sites.
If intramuscular administration is contraindicated (bleeding disorders), the injection can be administered subcutaneously. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route.
The safety and efficacy of Human Varicella-Zoster Immunoglobulin in children aged 0-18 years has not been established. No data are available.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Hypersensitivity to human immunoglobulins especially in patients with antibodies against IgA.
4.4. Special warnings and precautions for use
Ensure that Human Varicella-Zoster Immunoglobulin is not administered into a blood vessel, because of the risk of shock.
Hypersensitivity
True hypersensitivity reactions are rare but allergic type responses to human varicella-zoster immunoglobulin may occur.
Human Varicella-Zoster Immunoglobulin contains a small quantity of IgA. Individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA. The physician must therefore weigh the benefit of treatment with Human Varicella-Zoster Immunoglobulin against the potential risks of hypersensitivity reactions.
Rarely, Human Varicella-Zoster Immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who have tolerated previous treatment with human immunoglobulin.
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.
Thromboembolism
Arterial and venous thromboembolic events including myocardial infarction, stroke, deep venous thrombosis and pulmonary embolism have been associated with the use of immunoglobulins. Patients should be sufficiently hydrated before use of immunoglobulins. Caution should be exercised in patients with pre-existing risk factors for thrombotic events (such as hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilisation, severely hypovolemic patients, patients with diseases which increase blood viscosity).
Patients should be informed about first symptoms of thromboembolic events including shortness of breath, pain and swelling of a limb, focal neurological deficits and chest pain and should be advised to contact their physician immediately upon onset of symptoms.
Interference with serological testing
After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's 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 cell antibodies for example the direct antiglobulin test (DAT, direct Coombs' test).
Transmissible agents
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 human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) and for the non-enveloped hepatitis A and parvovirus B19 viruses.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins 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 Human Varicella-Zoster Immunoglobulin is administered 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 interfere with the development of an immune response to live attenuated virus vaccines, such as rubella, mumps and varicella, for a period of up to 3 months. After administration of this product, an interval of at least 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 5 months.
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Pregnancy
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.
Breast-feeding
Immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal portal of entry.
Fertility
No animal fertility studies have been conducted with Human Varicella-Zoster Immunoglobulin. Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
4.7. Effects on ability to drive and use machines
No effects on ability to drive and use machines have been observed.
4.8. Undesirable effects
Summary of the safety profile
Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.
Rarely, human immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.
Local reactions at injection sites: swelling, soreness, redness, induration, local heat, itching, bruising and rash.
The following adverse reactions have been reported from post-marketing experience.
Tabulated list of adverse reactions
The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
MedDRA Standard System Organ Class
Adverse reaction
Frequency
Immune system disorders
Anaphylactic shock, Hypersensitivity
Not known
Nervous system disorders
Headache
Not known
Cardiac disorders
Tachycardia
Not known
Vascular disorders
Hypotension
Not known
Gastrointestinal disorders
Nausea, Vomiting
Not known
Skin and subcutaneous tissue disorders
Skin reaction
Erythema, itching
Pruritus
Not known
Musculoskeletal and connective tissue disorders
Arthralgia
Not known
General disorders and administration site conditions
Fever, malaise, chill
At injection site: swelling, pain, erythema, induration, warmth, pruritus, rash, itching
Not known
Not known
For safety with respect to transmissible agents, see section 4.4.
Reporting suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected reactions via the United Kingdom Yellow Card Scheme: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Consequences of an overdose are not known.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Human varicella-zoster immunoglobulin. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- Rhophylac 300 partial — not the same combinationImmunoglobulinum humanum anti-D · injection / infusion
- Rhesonativ partial — not the same combinationImmunoglobulinum humanum anti-D · injection / infusion
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Human Varicella-Zoster Immunoglobulin. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.