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 Rabies 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 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
Human Rabies Immunoglobulin contains the active ingredient human rabies immunoglobulin. It is prepared from blood plasma from screened donors. Human Rabies Immunoglobulin is used in adults and children after suspected or proven exposure to rabies virus (post-exposure prophylaxis). Rabies is an infection that can be transmitted when a person is bitten, scratched or even just licked by an infected animal, particularly when the skin is already injured. Even contact with animal traps that were licked or bitten by infected animals can cause infections in humans. 2.
What you need to know before you take it
e Human Rabies Immunoglobulin
Warnings and precautions Talk to your doctor, nurse or healthcare professional before you are given Human Rabies Immunoglobulin. True allergic reactions to the medicine are rare when it is injected into the muscle as directed. Even if you have had this medicine before, you could still have a reaction. If this happens, urgent medical attention is needed (see also section 4). If you do not have enough immunoglobulin A (IgA deficiency) you may develop antibodies. If you know you have antibodies to IgA tell your doctor or nurse before you use this medicine. If you suffer from high blood pressure, diabetes, have a history of blood clots or problems with your veins or arteries or a blood related disorder, tell your doctor or nurse before using this medicine. If you have recently had any vaccinations or know you are going to have any vaccinations, tell your doctor or nurse. If you develop pain, swelling, unusual warmth of a limb, sudden shortness of breath and chest pain worsening on deep breathing, numbness or weakness on one side, difficulty speaking or confusion, talk to you doctor or nurse immediately as you may have a blood clot. Tell your doctor or nurse if you are having any blood tests. This medicine will raise the level of some antibodies in your blood for several weeks. If you require a blood test during this period, 1
tell your doctor or nurse when you last had this medicine injected as misleading results may occur with different 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 enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus and parvovirus B19 viruses. 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. It is strongly recommended that every time you receive a dose of Human Rabies Immunoglobulin, the name and batch number of the product are recorded to maintain a record of the batches used. Children and adolescents The listed warnings and precautions apply to both adults and children. Other medicines and Human Rabies Immunoglobulin Tell your doctor, nurse or healthcare professional if you are using, have recently used or might use any other medicines. Vaccinations Human Rabies Immunoglobulin provides you with a range of antibodies. These antibodies will interfere with the response to some vaccines, especially MMR (measles, mumps and rubella) and varicella (chickenpox) vaccines. If you are given Human Rabies Immunoglobulin injection within 3 months of receiving these vaccines, tell your doctor, as this medicine can affect those vaccines from working properly. You may need to receive another vaccine 3 months after using Human Rabies Immunoglobulin. 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, nurse or healthcare professional for advice before taking this medicine. Driving and using machines Human Rabies Immunoglobulin has no influence on the ability to drive and use machines. Human Rabies Immunoglobulin contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodiumfree'.
How to take it
Human Rabies Immunoglobulin Your doctor, nurse or healthcare professional will inject Human Rabies Immunoglobulin in to a muscle. Your doctor, nurse or healthcare professional will decide how much to give you. 2
If you use more Human Rabies Immunoglobulin than you should If you are given more Human Rabies 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
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you feel unwell, tell your doctor immediately. Side effects may occur even if you have previously received human immunoglobulins and tolerated them well. The following side effects have been reported with the Human Rabies Immunoglobulin: Rare (may affect up to 1 in 1,000 people): • allergic reaction • headache • increased heart rate • low blood pressure • feeling sick (nausea), being sick (vomiting) • skin rash, reddening skin, itchy skin • joint pain • fever • tiredness • 'flu-like' illness • shivers • injection site swelling, soreness, warmth redness, itching, bruising or hardening of the skin Severe allergic reactions may include difficulty in breathing, the tongue or lips turning blue, dizziness and falling, difficulty in swallowing, swelling of the face, lips, tongue or throat. If these signs or symptoms occur, tell your doctor straight away or go immediately to the nearest Accident and Emergency department because urgent medical help may be needed. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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 Rabies Immunoglobulin
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the containers after "EXP". The expiry date refers to the last day of that month. Store in a refrigerator (2°C – 8°C). Do not freeze.
3
A short period (up to 1 week) of storage at room temperature (up to 25°C) in the dark, will not damage the product. Keep the vials in the outer carton to protect from light. Do not use this medicine if you notice small bits in the solution. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist or doctor 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 Rabies Immunoglobulin contains The active substance is human rabies immunoglobulin The excipients 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 150 IU of human rabies immunoglobulin. The potency of this biological medicinal product may vary between batches, therefore, the specific human rabies immunoglobulin potency (IU/ml) and fill volume (ml) are printed on the vial label. What Human Rabies Immunoglobulin looks like and the contents of the pack Human Rabies Immunoglobulin is a clear to slightly cloudy, colourless to pale yellow sterile solution, available as single dose vials containing nominally 500 IU in glass vials with a closure to prevent tampering. Marketing Authorisation Holder Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX, United Kingdom tel: +44 (0) 20 8957 2255 e-mail: [email protected] Manufacturer Bio Products Laboratory Limited, Dagger Lane, Elstree, Borehamwood, WD6 3BX, United Kingdom This leaflet was last revised in January 2023
4
Frequently asked questions about Human Rabies Immunoglobulin
What is the active substance in Human Rabies Immunoglobulin?
The active substance in Human Rabies Immunoglobulin is immunoglobulin.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Human Rabies 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 Rabies 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: 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
Post-exposure prophylaxis of rabies infection in persons after exposure to scratches, bites or other injuries including mucous membrane contamination with infectious tissue, such as saliva, caused by a suspected rabid animal.
Human rabies immunoglobulin must always be used in combination with a rabies vaccine.
4.2. Posology and method of administration
Posology
Post-exposure prophylaxis consists of a regimen of one dose of immunoglobulin and full courses of rabies vaccination. Rabies immunoglobulin and the first dose of rabies vaccine should be given as soon as possible after exposure. Additional doses of rabies vaccine should be given according to official guidelines or the manufacturer's instructions.
Rabies prophylaxis exclusively with simultaneous vaccination: recommended dose of rabies immunoglobulin is 20 IU/kg body weight.
Because of the risk of interference with antibody production related to vaccination, neither the dose should be increased nor repeat rabies immunoglobulin be given (even if the onset of the simultaneous prophylaxis is delayed).
Method of administration
Human rabies 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.
The immunoglobulin and the vaccine should be administered at two different sites of the body.
The wound should be cleaned with soap and disinfectant.
Injections of the immunoglobulin should preferably be administered in the bitten site. The immunoglobulin should be carefully infiltrated in the depth of and around the wound. Any remainder should be injected intramuscularly at a site distant from that used for the rabies vaccine.
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.
4.3. Contraindications
Because of the life-threatening risk due to rabies, there are no contraindications to the administration of rabies immunoglobulin.
4.4. Special warnings and precautions for use
Ensure that Human Rabies Immunoglobulin is not administered into a blood vessel, because of the risk of shock.
Hypersensitivity
True hypersensitivity reactions are rare.
Human Rabies 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.
Rarely, human rabies 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 antiglobulin test (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 Rabies 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.
Paediatric population
The listed warnings and precautions apply both to adults and children.
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 4 months.
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 in human milk and may contribute to protecting the neonate from pathogens which have a mucosal port of entry.
Fertility
No animal fertility studies have been conducted with human rabies immunoglobulin. Clinical experience with immunoglobulin suggests that no harmful effects on fertility are to be expected (see section 5.3).
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
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
Hypersensitivity, anaphylactic shock
Rare
Nervous system disorders
Headache
Rare
Cardiac disorders
Tachycardia
Rare
Vascular disorders
Hypotension
Rare
Gastrointestinal disorders
Nausea, vomiting
Rare
Skin and subcutaneous tissue disorders
Skin reaction, erythema, pruritus
Rare
Musculoskeletal and connective tissue disorders
Arthralgia
Rare
General disorders and administration site conditions
Fever (pyrexia), malaise, chills
At injection site: swelling, pain, erythema, induration, warmth, rash
Rare
For safety information with respect to transmissible agents, see section 4.4.
Reporting of 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 adverse reactions 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.
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 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.
- Gamma anty-D 150 partial — not the same combinationImmunoglobulinum humanum anti-D Immunoglobulina ludzka anty-D · injection / infusion
- Gamma anty-D 50 partial — not the same combinationImmunoglobulinum humanum anti-D Immunoglobulina ludzka anty-D · injection / infusion
- GAMMA anty-HBs 200 partial — not the same combinationImmunoglobulinum humanum hepatitidis B. Immunoglobulina ludzka przeciw wirusowemu zapaleniu wątroby typu B · injection / infusion
- Thymoglobuline 5 mg/ml partial — not the same combinationImmunoglobulinum anti-T lymphocytorum ex animale ad usum humanum · injection / infusion
- Grafalon partial — not the same combinationImmunoglobulinum anti-T lymphocytorum ex animale ad usum humanum · injection / infusion
- Igantet 500 partial — not the same combinationImmunoglobulinum humanum tetanicum · 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 Rabies 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.