HyperRAB 300 IU/mL solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Hyperrab 300 IU/ml solution for injection

Human rabies immunoglobulin

This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Section 4, towards the end, includes information on how to report side effects.

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Hyperrab is and what it is used for
2. What you need to know before using Hyperrab
3. How to use Hyperrab
4. Possible side effects
5. How to store Hyperrab
6. Contents of the pack and other information

1. What Hyperrab is and what it is used for

Hyperrab is a solution containing a high concentration of antibodies against rabies. Hyperrab is prepared from human plasma obtained from selected donors, using a manufacturing process that includes steps to inactivate and/or remove viruses.

Generally, Hyperrab is administered if you have had contact with an animal suspected of being infected with the rabies virus and the animal may have bitten, scratched, or caused other injuries including contamination of the mucous membrane with the animal's saliva.

Hyperrab is used to protect you against rabies and is given with the first dose of rabies vaccine or, at the latest, within 7 days after. Your doctor will explain in more detail why this medicine has been administered to you. Inform your doctor if you have ever received the rabies vaccine.

2. What you need to know before using Hyperrab

Do not use Hyperrab:

• If you have received the complete series of rabies vaccination. Consult your doctor if you have already received the anti-rabies vaccine.

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to use Hyperrab.

• You may experience a severe allergic reaction, including anaphylaxis, to Hyperrab, especially if you have a medical history of allergic reactions to treatment with human immunoglobulin. Your doctor will have epinephrine available to treat any acute allergic symptoms you may experience.
• You may experience a severe allergic reaction, including anaphylaxis, to Hyperrab if you have IgA deficiency.

Hyperrab is purified from human plasma obtained from healthy donors. When biological medicines are administered, the possibility of infectious diseases due to pathogen transmission cannot be completely excluded. However, for products prepared from human plasma, the risk of pathogen transmission is reduced by: (1) epidemiological monitoring of the donor population and selection of individual donors through medical interviews; (2) testing of individual donations and plasma pools for markers of viral infection; and (3) manufacturing procedures with demonstrated capacity to inactivate/eliminate pathogens.

Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of transmission of infections cannot be completely ruled out. This also applies to unknown or emerging viruses or other types of infections.

The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, and against non-enveloped viruses such as hepatitis A virus. The measures taken may have limited effectiveness against non-enveloped viruses such as parvovirus B19.

Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, possibly because the antibodies against these infections contained in the medicine are protective.

It is strongly recommended that each time you are administered a dose of this medicine, the name and batch number of the medicine (shown on the label and on the box after "Lot") be recorded to maintain a record of the batches used.

Before starting treatment with Hyperrab, inform your doctor if:

• You are pregnant, planning to become pregnant, or are breastfeeding.
• You are sensitive to any food or medication.
• You are receiving treatment with immunoglobulin products, such as Hyperrab, as certain components of the vaccine (those containing a live virus component) may be less effective in your case.
• If you need to be vaccinated, inform your doctor or nurse that you are receiving treatment with Hyperrab. The antibodies contained in Hyperrab may reduce the effectiveness of the vaccine.

Children and adolescents

The safety and efficacy of Hyperrab in pediatric patients have not been established.

Other medicines and Hyperrab

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been observed.

3. How to use Hyperrab

The dose and treatment regimen will be determined solely by your doctor.

You will receive Hyperrab at the same time as the rabies vaccine. However, if you have already started the vaccination series, you may receive Hyperrab only during the first week. Your doctor will determine the dose of Hyperrab you will receive.

First, wounds will be thoroughly cleaned with water and soap.

Second, your doctor will inject Hyperrab into and around the wounds. The full dose should be administered around the wounds, although your doctor may decide to inject any remaining amount into the thigh or into the muscle of the upper arm.

Third, your doctor will inject the rabies vaccine into the thigh of the other leg or into the muscle of the other upper arm.

Follow the rabies vaccination schedule recommended by your doctor. To prevent rabies, you must receive all booster vaccinations exactly on the dates indicated by your doctor. If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Hyperrab can cause adverse effects, although not everyone experiences them.

The following adverse effects were reported in a study conducted with the product, with the following frequency:

Very common (may affect more than 1 in 10 people):

• Pain at the injection site.

Common (may affect up to 1 in 10 people):

• Abdominal pain
• Diarrhea
• Excess gas in the intestinal tract (flatulence)
• Headache
• Nasal congestion
• Nodule at the injection site (solid, papule, or lesion at the injection site)
• Sore throat and pain in the back of the mouth (oropharyngeal pain)

The following adverse effects have been observed with unknown frequency during post-marketing use of Hyperrab:

• Allergic reactions and hypersensitivity
• Headache
• Dizziness (feeling lightheaded or confused)
• Hypoesthesia and paraesthesia (or numbness in certain parts of the body, mainly in the limbs)
• Nausea and/or vomiting
• Skin rash, erythema and/or pruritus (red rash with itching and urticaria)
• Malaise
• Chills
• Pain in the extremities
• Joint swelling (arthralgia)
• Muscle pain (myalgia)
• Pain at the injection site with inflammation and itching
• Pyrexia (fever)

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Hyperrab

Keep this medicine out of the sight and reach of children.

• Store in a refrigerator (between 2 °C and 8 °C).

• Hyperrab may be stored at temperatures not exceeding 25 °C for a maximum of 6 months at any time before the expiry date.

• On the day the medicine is removed from the refrigerator, write in the "Date of disposal" space provided on the carton the date 6 months from that date or the expiry date printed on the carton flap, whichever comes first.

• If stored at room temperature, do not return the medicine to the refrigerator. Use the medicine before the "Date of disposal" or discard it.

• Discard any unused portion.

• Do not freeze.

• Keep the vial in the outer packaging to protect from light.

Do not use this medicine after the expiry date stated on the label and carton. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hyperrab

• The active substance is human rabies immunoglobulin.

Hyperrab contains 300 IU/ml of human rabies immunoglobulin. The human protein content is 15% to 18%, of which at least 96% is human immunoglobulin G. The percentages of IgG subclasses are approximately 63% IgG1, 31% IgG2, 3.9% IgG3 and 2.7% IgG4. It contains some IgA (not more than 250 micrograms/ml).

• The other components are glycine and water for injections.

Nature of the product and contents of the container

The solution is from clear to slightly opalescent, colourless or pale yellow or light brown.

Hyperrab is supplied in a carton containing a clear glass vial with a stopper, an aluminium cap, a plastic cap and a tamper-evident seal which ensure the integrity of the container.

Hyperrab is available in the following pack sizes:

300 IU / 1 ml

900 IU / 3 ml

1500 IU / 5 ml

Each carton contains 1 vial of Hyperrab and 1 patient information leaflet.

Marketing Authorisation Holder and Manufacturer

Instituto Grifols, S.A.

Can Guasch, 2 - Parets del Vallès

08150 Barcelona - Spain

Date of the most recent revision of this leaflet: July 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).