• WINRHO® SDF is a medication containing an active substance that belongs to the group of proteins called “Immunoglobulins”, also known as antibodies.
• WINRHO® SDF is available in the form of glass vials that contain a sterile, colourless and clear solution.
• Each vial is provided in one of the following strengths:
o 600 international units (120 micrograms) of human Anti-D immunoglobulin (a protein present in the immune system of humans)
o 1,500 international units (300 micrograms) of human Anti-D immunoglobulin (a protein present in the immune system of humans).
• Each vial contains medication which is intended for injection by a healthcare provider.
WhatWINRHO® SDF is used for:
• To protect against development of harmful antibodies in Rh-negative women who are exposed to Rh-positive blood (prophylaxis). This exposure may occur in a Rh-negative woman:
- After the transfusion of Rh-positive blood
- During pregnancy or after delivery if the baby is Rh-positive or the Rh status is unknown.
• The treatment of Immune Thrombocytopenic Purpura (ITP)
- In children with chronic or acute ITP
- In adults with chronic ITP
- In children and adults with ITP secondary to human immunodeficiency virus (HIV) infection.
Protection against the development of harmful antibodies in Rh-negative women who are exposed to Rh-positive blood (prophylaxis)
Pregnant women often have different blood groups from their babies. This is normal and
usually not a problem. However, in some cases, these blood groups differ in an important way,
which is the presence or absence of a particular protein on the outside of the red blood cell. If
you have this protein, you are “Rh positive”. If you do not have this protein, you are “Rh
negative”
Sometimes during pregnancy and delivery, a small amount of the baby’s blood can cross the
placenta and enter the mother’s blood stream. This can also happen in events such as a
miscarriage, abdominal injury, abortion and amniocentesis. If this transfer of blood occurs from
an Rh positive fetus to an Rh negative mother, the mother’s immune system will see the baby’s
blood as “foreign” and will produce antibodies which destroy the baby’s blood cells. In the first
pregnancy, most of these antibodies will remain in the mother’s circulation and the baby is usually not significantly affected. During subsequent pregnancies, however, a problem may
occur if the new baby is Rh positive and if there is another transfer of blood across the placenta.
The mother’s immune system has a good memory. It can rapidly produce the same antibodies again, and they can re-cross the placenta in large numbers and start to destroy the new baby’s own blood before birth, causing a number of serious complications.
WinRho SDF is an injection of antibodies administered with every pregnancy, when the
mother is known to be Rh-negative. It works in your bloodstream to destroy any circulating blood cells from your baby before your immune system has a chance to make its own antibodies. Your baby is not affected by this injection.
Injections may also be given in connection with abortion, miscarriage or amniocentesis or because of blood transfusion. As a result of the WinRho SDF injection, your immune system never makes its own antibodies to your baby’s Rh positive red blood cells, so you and your baby are protected.
The treatment of Immune Thrombocytopenic Purpura (ITP)
ITP is a bleeding disorder caused by an abnormally low level of platelets. Platelets are found in the bloodstream and are needed for blood to clot properly. When blood does not clot properly, there is a tendency to bruise and bleed easily. ITP is a disorder of the immune system. Usually, the body will manufacture antibodies which coat disease-causing organisms, aiding their removal by the spleen. This process helps the immune system fight infection in the body. In ITP, the body mistakenly produces antibodies against its own platelets. When these antibodies coat the platelets, it results in their rapid and premature destruction by the spleen. ITP can affect adults or children; it can occur without warning and for no apparent reason, or it can occur as a result of a primary illness or infection. There is no evidence to suggest that ITP is inherited or related to personal habits or diet. It cannot be passed to other people like the common cold.
WinRho SDF contains a concentration of antibodies which specifically bind to Rh positive red blood cells. When administered to an Rh positive patient, it is thought that WinRho SDF coats the Rh positive red cells, causing their destruction by the spleen, thereby preventing the
destruction of platelets. This results in increased levels of circulating platelets and an alleviation of the symptoms of ITP.

• Do not take WINRHO® SDF if you developed a sudden hypersensitivity (allergy) or a serious systemic reaction to human immunoglobulins or to any of the components of WINRHO® SDF.
• Do not take WINRHO® SDF for Rh prophylaxis, if you are Rh-positive, or if you are Rh-negative but transfused with Rh-positive blood.
• Do not take WINRHO® SDF for the treatment of ITP if you are Rh-negative or your spleen is surgically removed.
• Do not take WINRHO® SDF if your ITP is secondary to other conditions including active viral infections such as viruses (Epstein-Barr virus or Hepatitis C virus) that cause blood cancer (leukemia), lymphoma or other serious diseases.
• Do not take WINRHO® SDF for the treatment of ITP if you have a condition that causes the destruction of red blood cells (namely, hemolytic anemia).
• Do not take WINRHO® SDF for the treatment of ITP if you are an elderly patient with conditions that may increase the risk of developing acute hemolytic reactions (AHR) or complications.
• WINRHO® SDF should not be used for treatment if you have an IgA deficiency.
Before taking WINRHO® SDF, consult your health care provider in the following cases:
• If you have experienced allergic reactions to blood products in the past,
• If you have a known IgA deficiency,
• If you have recently received an vaccinations,
• If you are allergic to WINRHO® SDF or any of its ingredients or to components of the container,
• If you are taking any other medications including over-the-counter medications and herbal products,
• If you are above the age of 65 and have any other existing medical conditions such as those related to your heart, lungs, liver or kidneys.
Using WINRHO® SDF with other medicines
The interaction with other medications has not been determined.
Immunoglobulin administration such as WINRHO® SDF may decrease the effectiveness of vaccines against live viruses such as measles, rubella, mumps, and chickenpox.
Please tell your health care provider if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Using WINRHO® SDF with food and drinks
It is unknown whether the product interacts with food, alcohol, and other herbal products.
Pregnancy
Consult your health care provider before using the medication.
According to current data, using WINRHO® SDF for the prevention of Rh immunization in pregnant women, does not harm the fetus.
WINRHO® SDF should not be used in cases where the blood type of mother is Rh-positive, or the mother do not become sensitized after the exposure.
It is not reported whether or not it is safe to use WINRHO® SDF during childbirth.
If you become pregnant during your treatment, consult your health care provider immediately.
Breastfeeding
Consult your doctor or health care provider before using the medication.
According to current data, it is unknown if WINRHO® SDF passes into the breast milk.
Excretion of Anti-D immunoglobulin in milk has not been studied in animals. When deciding whether the breastfeeding should be stopped or the treatment should be avoided or not, the benefit of breastfeeding and the harm of WINRHO® SDF treatment to the child, should be taken into consideration.
Driving and using machines
There is no indication that WINRHO® SDF impairs the use of a vehicle or machine.
Important information about some of the ingredients of WINRHO® SDF
WINRHO® SDF contains maltose. Maltose found in similar products has been shown to cause inaccurately high measurements of blood sugar levels in some blood sugar tests.

This medicine will be injected by your health care provider into a muscle or directly into a vein. Your doctor will decide how much WINRHO® SDF you should receive, and which is the appropriate route of administration.
The product should be brought to room temperature (25°C) before use.
One vial should be used for one patient only (even if some product is left in the vial).
You should be observed for at least 20 minutes after having received WINRHO® SDF for Rh prophylaxis and at least 8 hours after having received WINRHO® SDF for ITP.

Like all medicines, WINRHO® SDF may cause side effects although not everybody gets them. Such side effects may occur even if you previously received human immunoglobulins and tolerated them well.
Allergic reactions (hypersensitivity reactions) have been observed rarely (affects 1 to 10 users in 10,000). Early signs may appear as small itching bubbles on your skin (hives) or all over your body (generalised urticaria). They may progress to severe hypersensitivity / anaphylactic reactions such as a sudden fall in blood pressure or shock (e.g., you may feel light-headed, dizzy, faint on standing, cold in the hands and feet, sense an abnormal heartbeat or chest pain, tightness of the chest, wheezing or have blurred vision) even when you have shown no hypersensitivity on previous administrations.
If you experience any of these symptoms, call your doctor immediately.
Reactions to WINRHO® SDF are rare in Rh-negative individuals. Discomfort or slight swelling at the injection site and slight elevation in temperature have been reported in a small number of cases.
Most WINRHO® SDF patients do not experience any drug related adverse effects after having received WINRHO® SDF for treatment of ITP. Among the few who do, the most commonly reported effects include headache, chills and fever. Rare side effects such as vomiting, nausea, low blood pressure, an increase in your heartbeat, joint pain, anemia (decrease in red blood cells), intravascular hemolysis (destruction of red blood cells), back pain, shaking chills, hemoglobinuria (brownish discolouration of urine), and acute renal insufficiency (kidney failure) may also occur. If you experience any of the following symptoms after receiving WINRHO® SDF for ITP, you should call your doctor immediately:
• back pain,
• discoloured or darkened urine,
• decreased urine production,
• yellow colour to skin or eyes,
• swelling,
• shortness of breath
• Tell your doctor or healthcare provider immediately if you notice such signs during the administration or after having received WINRHO® SDF. He or she will decide whether to stop the administration and start the appropriate treatment.
Side effects are listed in the following categories:
Very common: may affect at least 1 in 10 people.
Common: May affect less than 1 in 10 people, but more than 1 in 100 people.
Uncommon: May affect less than 1 in 100 people, but more than 1 in 1000 people.
Rare: May affect less than 1 in 1000 patients.
Very rare: May affect less than 1 in 10,000 patients.
Unknown: Cannot be estimated with the current data.
Uncommon:
• Nausea (feeling sick)
• Fatigue
• Chromaturia (abnormal coloration of the urine)
• Shortness of breath
• Chills
• Headache
• Dizziness
• Fever
Rare:
• Anaphylactic reaction/shock
• Hypersensitivity (allergic reaction)
• Myocardial infarction (heart attack)
• Intravascular hemolysis (destruction of the red blood cells)
• Disseminated intravascular coagulation (blood clots)
• Pain
• Rapid heartbeat or pulse rate (tachycardia)
• Discomfort or minor swelling in the injection area
• Acute renal failure (renal failure)
• Chest pain
• Jaundice (yellow color to skin or eyes)
• Muscle spasms
• Renal failure (kidney failure)
• Hematuria (blood in urine)
• Hemoglobinuria (brown urine)
• Acute respiratory distress syndrome (respiratory failure)
• Hyperhidrosis (excessive sweating)
• Pruritus
• Rash
Very Rare:
• Hemoglobinemia (excess of hemoglobin in the blood plasma)
• Transfusion related acute lung injury
• Cardiac Failure
• Swelling (edema)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your health care provider.

To report any side effect(s):
• Saudi Arabia:
• The National Pharmacovigilance Centre (NPC):
- SFDA Call Center: 19999
- E-mail: npc.drug@sfda.gov.sa
- Website: https://ade.sfda.gov.sa/
• Other GCC States:
- Please contact the relevant competent authority.

• Keep WINRHO® SDF out of sight and reach of children.
• Store the product in a refrigerator at 2° to 8°C.
• Do not freeze it. Do not use frozen products by defrosting them.
• Dispose of the unused portion of the product.
• Use the medicine in compliance with the expiry date.
• Do not use WINRHO® SDF after the expiry date shown on its package/vial.
• Do not use WINRHO® SDF if you notice any defects in the product and/or its packaging.
• Do not use if the solution is cloudy or contains particulates.
• Medicines should not be disposed of via wastewater or household waste. Ask your
health care provider how to dispose of medicines no longer required.