INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo RHESUGAM IM (solution for intramuscular injection)

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form)

RHESUGAM IM (solution for intramuscular injection)

COMPOSITION
Descriptive name
:
Human anti-D (Rho) immunoglobulin
Rhesugam IM contains gammaglobulin derived from pooled human plasma, sourced from healthy Rho-negative donors, with a high titre of antibodies to the D (Rho) erythrocyte antigen.
Each unit of plasma has been individually tested and found non-reactive for hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus (HCV) and antibodies to the human immunodeficiency viruses, HIV-1 and HIV-2, using approved methods.
Rhesugam IM is prepared by cold ethanol fractionation, to further reduce the risk of viral transmission. In addition, only plasma pools tested and found non-reactive for anti-HIV-1 & 2, HBsAg and anti-HCV by serological testing; and for HIV, HCV, hepatitis B virus (HBV) and hepatitis A virus (HAV) by nucleic acid amplification testing (NAT), are used in the manufacture of Rhesugam IM.
Each 2 mL ampoule contains 500 IU (100 µg) of human anti-D (Rho) immunoglobulin.
This preparation contains no antimicrobial preservative and is stabilised with human albumin and glycine.

PHARMACOLOGICAL CLASSIFICATION
A 30.2 Biologicals (Antibodies)

PHARMACOLOGICAL ACTION
Anti-D (Rho) immunoglobulin prevents active immunisation to the D (Rho) erythrocyte antigen in Rho-negative individuals exposed to Rho-positive blood.

INDICATIONS
1. Antenatal
  Rhesugam IM is indicated for antenatal prophylaxis when a Rho-negative mother is known to be carrying a Rho-positive child or if the Rho-status of the foetus is unknown.
  It is specifically recommended after the following potentially sensitising events:
* Amniocentesis
* Antepartum haemorrhage
* Abdominal trauma
* External cephalic version
* Ectopic pregnancy
* Chorionic villus sampling
* Stillbirth
* Foetal Blood Sampling
2. Abortions
  Rhesugam IM should be given to all Rho-negative women after:
* Therapeutic abortions.
* Spontaneous abortions, after 12 weeks gestation, and especially if there is surgical intervention.
* Early spontaneous abortions (first trimester). Sensitisation can occur as early as eight weeks gestation.
* Threatened abortions after 12 weeks gestation.
* Induced abortions (termination of pregnancy)
3. Postnatal
  Rhesugam IM is essential after every delivery involving a Rho-negative mother and a Rho-positive child, provided that there is no evidence of prior maternal sensitisation to the D (Rho) erythrocyte antigen. If the Rho type of the neonate cannot be determined, this preparation should still be administered to the mother.
  If antepartum anti-D (Rho) immunoglobulin has been given, an additional postpartum dose is also necessary. Rho-negative women with blood group antibodies other than anti-D should still be treated with this preparation.
4. Rhesus Incompatible Transfusions
  Although the transfusion of Rho-negative individuals with Rho-positive red cell concentrate, whole blood and platelets should be avoided whenever possible; anti-D (Rho) immunoglobulin may also be given in this instance. It is particularly important after transfusion of a Rho-negative woman of child-bearing age with Rho-positive red blood cells, whole blood or platelets.

CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients, including excipients.

WARNINGS
This intramuscular preparation must not be given intravenously because of the risk of shock.
Intramuscular injections are not advocated for patients with bleeding disorders (Refer “Special Precautions”).
Anti-D (Rho) immunoglobulin is not effective once the mother has formed anti-D antibodies.
Rhesugam IM should not be given to:
* The baby
* A Rho-positive mother
* A Rho-negative mother who has given birth to a known Rho-negative baby
* A Rho-negative mother with previous sensitisation to the D (Rho)) erythrocyte antigen

INTERACTIONS
Live attenuated virus vaccines
Active immunisation with live virus vaccines (e.g. measles, mumps or rubella) should be postponed for 3 months after the last administration of anti-D (Rho) immunoglobulin, as the efficacy of the live virus vaccine may be impaired.
If anti-D (Rho) immunoglobulin needs to be administered within 2-4 weeks of a live virus vaccination, then the efficacy of such a vaccination may be impaired
.
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.

PREGNANCY AND LACTATION
This medicinal product has been used in pregnancy. No harmful effects are known with respect to the course of pregnancy and to the newborn and neonate.

DOSAGE AND DIRECTIONS FOR USE
For optimal protection, anti-D (Rho) immunoglobulin should be administered intramuscularly as soon as possible, but always within 72 hours of the possible sensitising event.
Immunisation to the D (Rho) erythrocyte antigen is directly related to the volume of Rh-positive cells infused or to the size of a foeto-maternal haemorrhage. A 500 IU dose gives protection for foeto-maternal haemorrhage of up to 4 mL of red cells. Post delivery or following a potential sensitising event after 20 weeks gestation, a Kleihauer-Betke test (which determines the number of foetal cells in the mother's circulation) should be done at the time when the dose of anti-D is being considered. If this shows that the foeto-maternal bleed is larger than 4 mL, an additional dose of anti-D (Rho) immunoglobulin must be given. This is calculated using the formula that 125 IU of anti-D (Rho) immunoglobulin is administered per 1 mL of red cells.

Recommended dosages
The following are recommended dosages of Rhesugam IM. Please note that where appropriate, dosages should be determined by doing a Kleihauer-Betke test immediately after any sensitising event.
Indication                        Recommended Dosage
Pregnancy associated indications:                       
Antenatal prophylaxis 500 IU (100 µg) is given at 28 and/or 34 weeks gestation. If the infant is Rho-positive, a similar or higher dose should be administered after delivery.
Prophylaxis following potentially sensitising events, including abortions 250 IU (50 µg) is recommended for events up to 20 weeks. For events occurring after 20 weeks, a dose of 500 IU (100 µg) is recommended.
Postnatal prophylaxis 500 IU (100 µg) is recommended.
Non-pregnancy associated indications:                               
Transfusion of Rho incompatible blood The dose is calculated to clear the estimated quantity of red cells given, i.e. 125 IU (25 µg) for each 1 mL of red cells.
Transfusion of Rho-positive platelets in Rho-negative women of child-bearing age 250 IU (50 µg) for each dose of platelets (i.e. 5-6 units). If more than 10 units are used, administer 500 IU (100 µg).

Method of administration
Warm the ampoule to body temperature before injecting intramuscularly.
If anti-D (Rho) immunoglobulin is introduced into fat rather than into muscle, the uptake could be substantially lowered. Anti-D (Rho) immunoglobulin should therefore be injected into the deltoid muscle.
If a large volume (>5 mL) is required, it is recommended that this be administered in divided doses at different sites.
This medicinal product must not be mixed with other medicinal products.
Any unused product or waste material should be disposed of in accordance with local procedures.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Side effects
The following undesirable effects have been reported with intramuscular immunoglobulins:
Skin And Appendages: Cutaneous reactions, local reactions
Central & Peripheral Nervous System: Headache, lightheadedness
Gastro-Intestinal System: Nausea, vomiting
Cardiovascular (General): Hypotension
Heart Rate And Rhythm: Tachycardia, shock
Vascular (Extracardiac): Flushing
Body As A Whole - General: Pain and tenderness at injection site, chills, backache, allergic or anaphylactic reactions, fever

Special Precautions
Treating Rho-negative individuals with anti-D (Rho) immunoglobulin poses few risks. It should be noted that inadequate therapy will result in Rho allo-immunisation.
Intramuscular injections are not advocated for persons with bleeding disorders, unless special precautions are taken.
True hypersensitivity reactions are rare.
Anaphylactic reactions may occur especially if this intramuscular preparation is given intravenously. Measures to treat anaphylaxis, including adrenaline, must be immediately available when administering Rhesugam IM.
Persons with selective immunoglobulin A (IgA) deficiency may develop antibodies to the small amount of IgA in this preparation, leading to sensitisation and subsequent reaction to IgA-containing material. The risk-benefit ratio in patients with a history of IgA deficiency or severe anaphylactic reactions to plasma products should be considered.
Patients in receipt of incompatible transfusion, who receive very large doses of anti-D immunoglobulin, should be monitored clinically and by biological parameters, because of the risk of haemolytic reaction.
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 pathogens.
Consideration should be given to appropriate vaccination of patients receiving human blood or plasma-derived medicinal products on a routine basis.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV. The measures taken may be of limited value against non-enveloped viruses such as HAV and parvovirus B19.
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 viral safety.
It is strongly recommended that when Rhesugam IM 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.

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

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Consequences of an overdose are not known.

IDENTIFICATION
A colourless, pale-yellow to light brown liquid exhibiting slight opalescence.

PRESENTATION
500 IU in a single dose, clear, colourless 2 mL glass ampoule.

STORAGE INSTRUCTIONS
Transport within 72  hours below 37ºC.
Store between 2ºC and 8ºC.
Do not freeze.
Protect from light.
Keep out of reach of children.

REGISTRATION NUMBER
T/30.2/750

NAME AND BUSINESS ADDRESS OF THE APPLICANT
NATIONAL BIOPRODUCTS INSTITUTE
Company Reg. No. 1994/002044/08
NPO Reg. No. 020-898-NPO
PRIVATE BAG X9043         10 EDEN ROAD
PINETOWN         PINETOWN
3600         3610
Telephone:        086 016 2472         Telefax:        (031) 708 5614

DATE OF PUBLICATION OF THIS PACKAGE INSERT
2012/03/26

NAMIBIA         S2
Reg. No.:        04/30.2/1141

2011/07P54

Updated on this site: August 2014
Source: Pharmaceutical Industry

Disclaimer:
Please note that the National Bioproducts Institute cannot be held responsible for the accuracy of the text. The package insert on the screen may not be the latest version. We therefore recommend that an alternative source of information be consulted, particularly when confirmation of dosages and indications are required. Please refer to the printed package inserts inside the packs, recognised reference books or alternatively, you may contact the NBI Information Centre at +27 (031) 714 6700 or +27 082 870 3705 or +27 082 320 3306
.
Email: info@nbisa.org.za

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