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D-Gam Human Anti-D Immunoglobulin 500 Iu Solution For Injection

Informations for option: D-Gam Human Anti-D Immunoglobulin 500 Iu Solution For Injection, show other option

SDL8

PACKAGE LEAFLET:

INFORMATION FOR THE USER D-GAM® 250 IU, 500 IU, 1,500 IU AND    |

2,500 IU SOLUTION FOR INJECTION

human anti-d immunoglobulin

Read all of this leaflet carefully before using this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or your midwife.

This medicine will be administered to you by your doctor or your midwife.

If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your midwife.

In this leaflet:

1.    What D-Gam® is and what it is used for

2.    Before you use D-Gam®. Some of the information is for your safety

3.    How to use D-Gam®

4.    Possible side effects

5.    How to store D-Gam®

6.    Further information

1.    what D-GAM® IS AND WHAT IT IS USED FOR

The product D-Gam is a solution for injection containing an increased amount of anti-D gammaglobulin (antibodies which can protect against certain conditions). It is made from blood plasma from screened donors from the USA and virally-inactivated during manufacture.

D-Gam also contains sodium chloride at the same strength as is normally found in your body, glycine and sodium acetate with a small quantity of sodium hydroxide to control acidity/alkalinity during manufacture. D-Gam is available in four dose sizes of 250 IU,

500 IU, 1,500 IU and 2,500 IU (IU means International Unit of anti-D). D-Gam is used to prevent RhD negative women of child-bearing age, becoming sensitised (reactive) to RhD positive red blood cells, to protect a RhD positive baby’s red blood cells either during the current pregnancy or, more particularly, in future pregnancies.

It should be used:

•    Soon after giving birth to a baby whose red blood cells are RhD positive, irrespective of the ABO blood group of the mother;

•    Soon after an abortion when sensitisation is possible;

•    Soon after any accident or intervention during pregnancy which might lead to bleeding across the placenta;

•    As a routine preventative measure during pregnancy;

•    Soon after blood components containing RhD positive red blood cells have been given, for any reason, even when you are not pregnant.

Your doctor or your midwife will tell you if it is advisable for you to have D-Gam.

The product is for injection into muscles, and is only available on a doctor’s prescription.

2.    BEFORE YOU USE D-GAM®

Speak to your doctor or your midwife and do not use D-Gam®:

•    If you think you could be allergic (hypersensitive) to the active substance or to any of the other ingredients of D-Gam (see Section 6 for a list of these).

•    If you suffer from any blood disorders, which interfere with clotting.

Take special care with D-Gam®

•    This product must not be injected intravenously (into veins), since it may cause a severe reaction if given in this way. Injections must be intramuscular.

•    If you start to feel unwell when this medicine is being injected, then the injection must be stopped immediately.

•    True allergic reactions to this product are rare, when it is injected intramuscularly as directed. In the case of shock, urgent medical advice is needed.

•    Large doses (over 5 mL) will be injected into different parts of the body.

•    This medicine is not for injection into the newborn baby.

Using other medicines

Vaccinations

•    Please tell your doctor or your midwife of any vaccinations you have recently had or are about to have.

•    Besides anti-D, D-Gam provides you with a range of antibodies. These antibodies will interfere with the response to some vaccines, especially MMR (measles, mumps and rubella) and varicella (chickenpox) vaccines. Such vaccinations should be given at least three weeks before D-Gam or not until three months after. D-Gam is unlikely to contain an antibody to yellow fever; so this vaccine can be given whenever needed.

Blood tests

•    This product will raise the level of various antibodies in your blood for several weeks.

If you require a blood test during this period, tell your doctor when you last had this product injected, as misleading positive results may occur with certain tests.

Driving and using machines

This medicine has been widely used for many years in pregnant women without any harmful effects. There are no known effects on the ability to drive or operate machinery after injection of this product.

3.    HOW TO USE D-GAM®

D-Gam will be administered to you by your doctor or your midwife by injection into a large muscle, ideally of your upper arm just below the shoulder (deltoid).

Injection should be as soon as it is convenient after an accident or intervention during pregnancy and after delivery (ideally within 72 hours). Injection of this medicine, should be as close to the time of the incident as possible.

No other medicines or fluids should be added to this product as their effects on the product have not been established.

If you suffer from certain blood disorders your doctor or midwife may inject this product just under the skin.

The recommended doses of D-Gam are outlined below.

Following Birth:

The recommended dose is 500 IU. Occasionally, more may need to be given.

Preventative Measures Before Birth:

500 IU given at 28 and 34 weeks of pregnancy; or 1,500 IU at 28 weeks of pregnancy.

Following an Accident or Intervention During Pregnancy:

Up to 20 weeks, the recommended dose is 250 IU;

After 20 weeks the recommended dose is 500 IU. Occasionally, more may need to be given. Prevention of Immunisation (Protection) in RhD negative Patients Given Blood Components Containing RhD positive Red Cells:

250 IU for every 3 adult doses of platelets from RhD positive donors; or 125 IU per mL of red cells injected.

Your doctor or midwife will tell you if it is advisable for you to have this medicine, how much and when.

If you are administered much more D-Gam than recommended, your doctor may carry out some blood tests. If you feel un well afterwards or have any discomfort, tell your doctor, nurse or midwife.

If you have any further questions on the use of this product, ask your doctor or your midwife.

4.    possible side effects

If you start to feel unwell while this medicine is being injected, then the injection must be stopped immediately.

You should remain with another person for at least twenty minutes after injection.

•    Allergic reactions, such as breathing difficulties, faintness, anaphylaxis and possibly shock can occur rarely.

•    Not everybody gets side effects, but the following have been reported after injection:

chest pain,    shortness of breath,    dizziness,    swelling of the face,

headache,    feeling cold,    shaking,    feeling or being sick,

joint pains,    coating of the tongue,    mouth ulcers

As with all intramuscular injections, there may be some short-term discomfort at the site of injection. Very rarely, a hardened area may develop where the injection was given.

•    If you have any of these or continuous pain, itching, rash or any other unusual reaction or are just feeling unwell, you must tell your doctor or your midwife.

Please note

When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include: - careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, - the testing of each donation and pools of plasma for signs of virus/ infections, - the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any 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 the nonenveloped hepatitis A and parvovirus B19 viruses. Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.

Please remember

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5.    how to store d-gam®

D-Gam should be stored in the original container at 2-8°C but DO NOT FREEZE. If necessary, the product can be kept at room temperature (25°C) for a short period (up to one week).

Do not use D-Gam after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

The condition of date-expired or incorrectly stored product cannot be guaranteed.

Do not use D-Gam if you notice the solution is cloudy or has deposits.

Keep out of the reach and sight of children.

Disposal

Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

6.    further information

What D-Gam® contains

The active substance is Human Anti-D Immunoglobulin.

The other ingredients are:

sodium chloride, glycine, sodium acetate trihydrate, sodium hydroxide.

What D-Gam® looks like and contents of the pack

D-Gam, in the form of a solution for injection, comes in quantities of 250 IU, 500 IU,

1,500 IU and 2,500 IU in glass vials. These vials are closed with a rubber stopper, held on by an aluminium ring with a snap-off plastic cap.

Marketing Authorisation Holder, and manufacturer Bio Products Laboratory Limited,

Dagger Lane, Elstree, Herts. WD6 3BX, U.K.

Tel: +44 (0)20 8957 2200 Marketing Authorisation Number PL 08801/0047 - 250 IU dose size PL 08801/0048 - 500 IU dose size PL 08801/0049 - 1,500 and 2,500 IU dose size Date of Revision of Text

December 2014    SDL8

For further information or if you have any questions about the use of this product, please contact BPL via the Marketing Department at the address above or through info@bpl.co.uk.

Bio Products Laboratory