Rhesonativ

Package Leaflet: Information for the User

Rhesonativ, 625 IU/ml, Solution for Injection
Human Anti-D Immunoglobulin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this package leaflet, you may need to read it again.
In case of any doubts, consult a doctor, pharmacist, or nurse.
This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 1. What Rhesonativ is and what it is used for
• 2. Important information before using Rhesonativ
• 3. How to use Rhesonativ
• 4. Possible side effects
• 5. How to store Rhesonativ
• 6. Package contents and other information

1. What Rhesonativ is and what it is used for

Rhesonativ is an immunoglobulin and contains antibodies against the Rh factor. If a woman who does not have the Rh factor on her red blood cells (Rh negative) is pregnant and her unborn child has the Rh factor (Rh positive), her immune system may be stimulated to produce antibodies against the Rh factor. These antibodies can harm the unborn child, especially in subsequent pregnancies.
Rhesonativ is used to prevent immunization of Rh-negative women during pregnancy and childbirth, thereby preventing damage to the unborn child. Rhesonativ is used in Rh-negative women in the following cases:
Preventive therapy for serological conflict in pregnant women with negative Rh;
Birth of an Rh-positive child;
Miscarriage/threatened miscarriage;
Ectopic pregnancy, certain uterine pathologies (molar pregnancy) or in case of bleeding and fetal blood entering the mother's isolated circulation or fetal death in the later stages of pregnancy;
Invasive procedures during pregnancy, such as amniocentesis, fetal blood sampling, biopsy, or manipulative obstetric procedures, e.g., manual rotation of the fetus to improve its position in the uterus or after abdominal trauma, as well as intrauterine surgical procedures on the fetus.
Rhesonativ may also be used in Rh-negative patients who have been mistakenly transfused with Rh-positive blood.

2. Important information before using Rhesonativ

When not to use Rhesonativ:

if the patient is allergic to human normal immunoglobulin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Rhesonativ, the patient should discuss it with their doctor, pharmacist, or nurse.
The patient should inform their doctor about other illnesses.
Rhesonativ is not indicated for administration to Rh (D) positive individuals or to individuals who have been previously immunized with the Rh (D) antigen.
Actual hypersensitivity reactions (allergic reactions) are rare but may occur.
In case of suspected allergy or severe allergic reaction (anaphylactic reaction), the patient should immediately inform their doctor or nurse. Symptoms of these reactions include, for example, dizziness, rapid heartbeat, low blood pressure, difficulty breathing and swallowing, chest tightness, itching, generalized urticaria, swelling of the face, tongue, or throat, collapse, and rash. If any of these symptoms occur, the patient should seek immediate medical attention.
If the patient experiences symptoms such as shortness of breath, pain, and swelling of the limb, chest pain, they should immediately contact their doctor or nurse, as these may be signs of a blood clot.

Children

There are no available data on the use of Rhesonativ in children.

Overweight patients

In the case of overweight/obese patients, the use of an anti-D product for intravenous administration should be considered.
Viral safety
For medicines derived from human blood or plasma, methods are used to prevent the transmission of infection to the patient. These include:

• careful selection of blood and plasma donors to exclude individuals who may be carriers of infection
• testing of individual donations and plasma pools for the presence of viruses/infections
• use of inactivation or removal of viruses in the processing of blood or plasma. Despite these methods, when using medicines derived from human blood or plasma, it is not possible to completely eliminate the risk of transmission of infection. This also applies to unknown or new viruses or other types of infection.

The methods used appear to be effective against enveloped viruses, such as human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus, and for non-enveloped hepatitis A virus.
These methods may have limited effectiveness against non-enveloped viruses, such as parvovirus B19.
The use of immunoglobulin products is not associated with the occurrence of hepatitis A or parvovirus B19 infection, possibly due to the presence of protective antibodies against these infections in these products.
In any case, when using Rhesonativ, it is recommended to record the name and batch number of the product for identification of the batches used.

Rhesonativ and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Rhesonativ may reduce the effectiveness of live vaccines, such as measles, mumps, rubella, and chickenpox vaccines. This applies to vaccines administered approximately 2-4 weeks before or after the administration of Rhesonativ. After administration of Rhesonativ, vaccination with these vaccines should be performed after 3 months. Therefore, the patient should inform their doctor, who intends to perform the vaccination, about the use of Rhesonativ.
In the case of blood sampling for laboratory tests, the patient should inform their doctor about the use of immunoglobulins, as this treatment may affect the results of laboratory tests.

Pregnancy and breastfeeding

Rhesonativ is intended for use during pregnancy and may be used during breastfeeding.

Driving and using machines

No effects on the ability to drive and use machines have been observed.

Rhesonativ contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of solution (625 IU), which means that the medicine is considered "sodium-free".

3. How to use Rhesonativ

The need for Rhesonativ and its dose will be decided by the doctor. Rhesonativ is administered by intramuscular injection by medical personnel.

4. Possible side effects

Like all medicines, Rhesonativ can cause side effects, although not everybody gets them.
The frequency of the following side effects is unknown (frequency cannot be estimated from the available data): headache, rapid heartbeat, low blood pressure, wheezing, vomiting, nausea, skin reactions, joint pain, lower back pain, dizziness, fever, feeling of discomfort, including discomfort in the chest, chills, reactions at the injection site, such as swelling and pain, decrease in red blood cell count, and acute allergic reactions, including anaphylactic shock.
In case of symptoms of anaphylactic shock, such as dizziness, nausea, vomiting, stomach cramps, cough, difficulty breathing and swallowing, cyanosis, itching, urticaria, rash, rapid heartbeat, low blood pressure, swelling of the face, tongue, or throat, collapse, or chest pain, the patient should immediately contact their doctor to obtain immediate medical attention.

Reporting side effects

If side effects occur, including any not listed in the package leaflet, the patient should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
Al. Jerozolimskie 181C
02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Rhesonativ

The medicine should be stored out of sight and reach of children.
Store in a refrigerator (2°C – 8°C). Do not freeze. Store the ampoules in the outer packaging to protect from light.
Within the shelf life, the product can be stored at a temperature below 25°C for up to one month without the need to return it to the refrigerator, but it must be discarded if not used within this time.
Do not use this medicine after the expiry date stated on the label and outer packaging after: EXP (abbreviation used to describe the expiry date). The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Rhesonativ contains

• The active substance is human anti-D immunoglobulin. 1 ml contains 625 IU (125 micrograms) of human anti-D immunoglobulin.
• One ampoule of 1 ml contains 625 IU (125 micrograms) of human anti-D immunoglobulin. One ampoule of 2 ml contains 1250 IU (250 micrograms) of human anti-D immunoglobulin.
• The protein content is 165 mg, of which at least 95% is immunoglobulin G.
• The other ingredients are: glycine, sodium chloride, sodium acetate, polysorbate 80, and water for injections.

What Rhesonativ looks like and package contents

Rhesonativ is a solution for injection (625 IU/ml or 1250 IU/ml in an ampoule).
Package sizes: 1x1 ml, 1x2 ml, and 10x2 ml.
The solution may be colorless, pale yellow, or light brown.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Octapharma (IP) SPRL
Allée de la Recherche 65
1070 Anderlecht
Belgium

Manufacturer

Octapharma AB
Lars Forssells gata 23
112 75 Stockholm
Sweden

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet: 24.05.2021

Information intended for healthcare professionals only:

Before use, the product should be brought to room temperature or body temperature.
Do not use a solution that is not homogeneous or contains sediment.
The contents of the ampoule should be used immediately after opening. Unused medicinal product or its residues should be disposed of in accordance with local regulations.
Rhesonativ must be administered intramuscularly. Before injection, the plunger of the syringe should be withdrawn to ensure that the needle is not in a blood vessel.
In situations where intramuscular administration is contraindicated (coagulation disorders), the injection can be performed subcutaneously if an intravenous product is not available. In this case, gentle pressure should be applied using a swab at the injection site.
If larger volumes are required (more than 2 ml in children and more than 5 ml in adults), it is recommended to administer them in divided doses at different sites.
This medicinal product must not be mixed with other medicinal products.
In the case of overweight/obese patients, the use of an intravenous anti-D product is recommended due to the possible lack of effectiveness with intramuscular administration.