Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
ANTI, D IMMUNOGLOBULIN, HUMAN
CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Germany
J06BB01
ANTI-D IMMUNOGLOBULIN, HUMAN 150 µg/ml
SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
ANTI-D IMMUNOGLOBULIN, HUMAN 150 µg/ml
POM
IMMUNE SERA AND IMMUNOGLOBULINS
Authorised
2017-04-25
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER RHOPHYLAC ® 300 MICROGRAMS / 2 ML, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Human anti-D immunoglobulin PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor or healthcare professional. - If you get any side effects, talk to your doctor or healthcare professional. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Rhophylac is and what it is used for 2. What you need to know before you are given Rhophylac 3. How to use Rhophylac 4. Possible side effects 5. How to store Rhophylac 6. Contents of the pack and other information 1. WHAT RHOPHYLAC IS AND WHAT IT IS USED FOR WHAT RHOPHYLAC IS This medicine is a ready-to-use solution for injection, which comes in a pre-filled syringe. The solution contains special proteins, isolated from human blood plasma. These proteins belong to the class of “immunoglobulins”, also called antibodies. The active ingredient of Rhophylac 300 is a specific antibody called “anti-D (Rh) immunoglobulin”. This antibody works against Rhesus factor type D. WHAT RHESUS FACTOR TYPE D IS Rhesus factors are special characteristics of human red blood cells. About 85 % of the population carry the so called Rhesus factor type D (abbreviated “Rh(D)”). These people are called _Rh(D) positive_ . People who do not carry Rhesus factor type D are called _Rh(D) _ _negative_ . WHAT ANTI-D (RH) IMMUNOGLOBULIN IS Anti-D (Rh) immunoglobulin is an antibody, which works against Rhesus factor type D and is produced by the human immune system. When a Rh(D) negative person receives Rh(D) positive blood, their immune system will recognise the Rh(D) positive red blood cells as “foreign” to their body, and will attempt to destroy them. For this purpose, the immune system will build specific antibodies ag Baca dokumen lengkapnya
Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Rhophylac 300 micrograms / 2 ml, solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 1500 IU (300 micrograms) human anti-D immunoglobulin*. One ml contains 750 IU (150 micrograms) human anti-D immunoglobulin. The product contains a maximum of 30 mg/ml of human plasma proteins of which 10 mg/ml is human albumin as stabiliser. At least 95 % of the other plasma proteins are IgG. Distribution of the IgG subclasses (approximate values): IgG 1 84.1 % IgG 2 7.6 % IgG 3 8.1 % IgG 4 1.0 % The content of immunoglobulin A (IgA) is not more than 5 micrograms/ml. *Produced from the plasma of human donors. Excipient with known effect: The maximal sodium content is 11.5 mg (0.5 mmol) per syringe. Rhophylac contains no preservatives. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. The solution is clear or slightly opalescent and colourless or pale yellow. Rhophylac has an osmolality of at least 240 mosmol/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of Rh(D) isoimmunisation in Rh(D) negative women • Antepartum prophylaxis - Planned antepartum prophylaxis - Antepartum prophylaxis following complications of pregnancy including: Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole, intrauterine fetal death, transplacental haemorrhage resulting from ante-partum haemorrhage, Page 2 of 10 amniocentesis, chorionic biopsy, obstetric manipulative procedures e.g. external version, invasive interventions, cordocentesis, blunt abdominal trauma or fetal therapeutic intervention. • Postpartum prophylaxis - Delivery of a Rh(D) positive (D, D weak , D partial ) baby An Rh(D) incompatible pregnancy is assumed if the fetus/baby is either Rh(D) positive or Rh(D) unknown or if the father is either Rh(D) positive or Rh(D) unknown. Treatment of Rh(D) negative adults, children and adolescents (0-18 years) after in Baca dokumen lengkapnya