HYPERRAB 300 IU/mL INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

Hyperrab 300UI/mlinjectable solution

Human rabies immunoglobulin

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you 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, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Hyperrab is and what it is used for

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

In general, Hyperrab is administered if you have come into contact with an animal suspected of being infected with the rabies virus and it is possible that the animal has bitten, scratched, or otherwise wounded you, including contamination of the mucous membrane by the animal's saliva.

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

2. What you need to know before you use Hyperrab

Do not use Hyperrab:

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

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting treatment with 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 an IgA deficiency.

Hyperrab is purified from human plasma obtained from healthy donors. When biological medicines are administered, the possibility of infectious diseases due to the transmission of pathogens cannot be completely excluded. However, in the case of products prepared from human plasma, the risk of pathogen transmission is reduced by: (1) epidemiological controls of the donor population and selection of individual donors through a medical interview; (2) analysis of individual donations and plasma pools for detection of viral infection markers; and (3) manufacturing procedures with demonstrated capability 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 excluded. This also applies to 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 non-enveloped viruses such as hepatitis A virus. The measures taken may have limited value 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 (which appears on the label and on the carton after the Batch) be recorded to maintain a record of the batches used.

Before starting treatment with Hyperrab, tell your doctor if:

• You are pregnant, plan to become pregnant, or are breastfeeding.
• You are sensitive to any food or medicine.
• 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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

No effects on the ability to drive and use machines 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, your wounds will be thoroughly cleaned with water and soap.

Second, your doctor will inject Hyperrab into and around the wounds. You should receive the complete dose around the wounds, although your doctor may decide to inject the rest into your 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 upper arm.

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

4. Possible side effects

Like all medicines, Hyperrab can cause side effects, although not everybody gets them.

The following side effects were reported during a study with the product at the following frequency:

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

• Pain at the injection site.

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

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

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that the side effects are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es.

By reporting side effects, 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 can be stored at temperatures not exceeding 25°C for a maximum of 6 months at any time before the expiry date.
• On the day you remove the medicine from the refrigerator, write the date 6 months later or the expiry date printed on the carton flap, whichever is earlier, in the space "Expiry date" provided on the carton.
• If stored at room temperature, do not put the medicine back in the refrigerator. Use the medicine before the "Expiry date" or discard it.
• Discard the unused portion.

• Do not freeze.
• Keep the vial in the outer packaging to protect it from light.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines 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 UI/ml of human rabies immunoglobulin. The protein content is 15% to 18%, of which at least 96% is human immunoglobulin G. The percentage of IgG subclasses is approximately 63% IgG1, 31% IgG2, 3.9% IgG3, and 2.7% IgG4. It contains some amount of IgA (not more than 250 micrograms/ml).

• The other ingredients are glycine and water for injections.

Appearance of the product and pack contents

The solution is clear to slightly opalescent and colorless or pale yellow or light brown.

Hyperrab is presented in a carton containing a transparent glass vial with a stopper, an aluminum cap, a plastic cap, and a security seal that guarantee the integrity of the packaging.

Hyperrab is available in pack sizes of:

300 UI / 1 ml

900 UI / 3 ml

1500 UI / 5 ml

Each carton contains 1 vial of Hyperrab and 1 package leaflet.

Marketing authorization holder and manufacturer

Instituto Grifols, S.A.

Can Guasch, 2 - Parets del Vallès

08150 Barcelona - Spain

Date of last revision of this leaflet: July 2024

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