Human normal immunoglobulin (SCIg)<\/a><\/p>\n\n\n\n
What Xembify is and what it is used for<\/h2>\n\n\n\n
What Xembify is<\/strong><\/p>\n\n\n\n Xembify is a solution with human immunoglobulins (\u00a0antibodies, mainly immunoglobulin G) that help the body fight\u00a0infection.<\/p>\n\n\n\n Xembify contains immunoglobulins extracted from the\u00a0plasma\u00a0of healthy people.\u00a0Immunoglobulins help fight\u00a0infection\u00a0caused by bacteria and\u00a0viruses.\u00a0The medicine works in the same way as the immunoglobulins produced by the immune system and found naturally in the blood.<\/p>\n\n\n\n What Xembify is used for<\/strong><\/p>\n\n\n\n You are using Xembify because you have abnormally low levels of immunoglobulins due to a disease called immunodeficiency. Infusion with Xembify raises the levels of immunoglobulin ( antibodies ) in the blood to normal levels, especially immunoglobulin G (IgG).<\/p>\n\n\n\n This medicine is for adults, children, and adolescents (0\u201318 years) who do not have enough\u00a0antibodies\u00a0(\u00a0substitution therapy\u00a0).<\/p>\n\n\n\n Human normal immunoglobulin (SCIg) contained in Xembify may also be approved to treat other conditions not mentioned in this product information.\u00a0Ask a doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions. If you have had\u00a0side effects\u00a0from an immunoglobulin or any of the other ingredients, you must tell your doctor, pharmacist, or nurse before receiving Xembify.<\/p>\n\n\n\n Talk to your doctor, pharmacist, or nurse before using Xembify.<\/p>\n\n\n\n Allergic reactions<\/p>\n\n\n\n Allergic reactions are rare.\u00a0However, you may be allergic to immunoglobulins without knowing it.\u00a0Allergic reactions such as a sudden drop in blood pressure or anaphylactic\u00a0shock\u00a0(severe drop in blood pressure combined with other symptoms such as swelling of the throat, difficulty breathing, and skin rash) are rare, but can sometimes occur even if you have not had\u00a0side effects\u00a0from immunoglobulins before.\u00a0The risk of allergic reactions is greater if you have an\u00a0IgA\u00a0deficiency with anti\u00a0–\u00a0IgA\u00a0antibodies.\u00a0If you have\u00a0IgA\u00a0deficiency, you must tell your doctor.\u00a0Xembify contains a certain amount of\u00a0IgA, which may increase the risk of an\u00a0allergic reaction.\u00a0Information on signs and symptoms of an\u00a0allergic reaction\u00a0can be found in section 4 of this leaflet (Possible\u00a0side effects\u00a0).<\/p>\n\n\n\n Risk of disease transmission<\/p>\n\n\n\n Xembify is purified from\u00a0human\u00a0plasma\u00a0that comes from healthy donors.\u00a0When biological medicines are given, the risk of infectious diseases being transmitted through disease-causing\u00a0organisms\u00a0cannot be completely ruled out.\u00a0However, for drugs produced from human\u00a0plasma, the risk of transmission of disease-causing\u00a0organisms\u00a0is reduced by: (1) screening of donors;\u00a0selection of donors through a medical interview;\u00a0(2) testing individual donations and plasma pools for evidence of viral infections;\u00a0and (3) manufacturing measures proven to inactivate\/remove disease-causing\u00a0organisms.<\/p>\n\n\n\n Despite these measures, the risk of transmission of\u00a0infection\u00a0when medicines made from human blood or plasma are administered cannot be completely ruled out.\u00a0This also applies to unknown and new\u00a0viruses\u00a0or other types of\u00a0infection.<\/p>\n\n\n\n The measures taken are considered effective against enveloped\u00a0viruses\u00a0such as human immunodeficiency virus (\u00a0HIV\u00a0),\u00a0hepatitis\u00a0B\u00a0virus,\u00a0and\u00a0hepatitis\u00a0C\u00a0virus\u00a0as well as for non-enveloped\u00a0hepatitis\u00a0A\u00a0viruses.\u00a0The measures taken may be of limited value against non-enveloped\u00a0viruses\u00a0such as parvovirus B19.<\/p>\n\n\n\n Immunoglobulins have not been associated with infection with hepatitis A virus or parvovirus B19, possibly because the antibodies contained in the medicine have a protective effect.<\/p>\n\n\n\n It is strongly recommended that the name of the medicinal product and the batch number (listed on the label and carton after the Lot) be recorded each time Xembify is given so that there is a record of batches used.<\/p>\n\n\n\n The section “Warnings and precautions” applies to adults, children, and adolescents.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n Always take Xembify separately and do not mix it with any other medicine.<\/p>\n\n\n\n If you are to be vaccinated, tell the doctor that you are being treated with Xembify.\u00a0Xembify can impair the effectiveness of certain vaccines (live virus vaccines) such as measles, mumps, rubella, and chicken pox vaccines.\u00a0You may have to wait up to 3 months after receiving Xembify to get vaccinated.\u00a0You may have to wait up to 1 year for the measles vaccine.<\/p>\n\n\n\n This impact on vaccines applies to children, adults, and the elderly.<\/p>\n\n\n\n If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.<\/p>\n\n\n\n Xembify has not been studied in pregnant or breastfeeding women, so your doctor or pharmacist will guide you.\u00a0Experience from the use of\u00a0immunoglobulin\u00a0er does not indicate any harmful effects during pregnancy, on the fetus, or the child.\u00a0If you are breastfeeding, the immunoglobulins in Xembify may also be present in your breast milk.\u00a0These can protect your child against certain\u00a0infections.\u00a0Clinical experience with immunoglobulins shows that no harmful effects on\u00a0fertility\u00a0are expected.<\/p>\n\n\n\n The ability to drive and use machines may be impaired due to specific\u00a0side effects\u00a0that Xembify can cause, such as dizziness.\u00a0If you experience\u00a0side effects\u00a0during treatment, you must wait until these have passed before driving or using machinery.<\/p>\n\n\n\n You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0A description of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0Discuss with a doctor or pharmacist if you are unsure. Always use this medicine as directed by your doctor. Consult a doctor if you are unsure.<\/p>\n\n\n\n Xembify must be infused under the skin ( subcutaneous administration ).<\/p>\n\n\n\n Treatment with Xembify is started by a doctor or nurse. Do not start treatment with Xembify at home until you have received full instructions.<\/p>\n\n\n\n Dose<\/strong><\/p>\n\n\n\n Recommended\u00a0dose\u00a0and dosage schedule are determined by the doctor.\u00a0The doctor calculates the right\u00a0dose\u00a0for you based on your body weight, any previous treatment you may have received, and how you respond to treatment.\u00a0Always use this medicine as described in this leaflet or as directed by your doctor, pharmacist, or nurse.\u00a0Consult them if you are unsure.<\/p>\n\n\n\n Your first dose may be a so-called “loading dose”, which is intended to quickly increase the levels of immunoglobulin in the blood. The doctor will decide if you need a “loading dose” (for adults and children) of at least 1 to 2.5 ml\/kg body weight. You can get this loading dose divided over several days.<\/p>\n\n\n\n You receive Xembify regularly from daily to once every two weeks. The total dose once per month is approximately 1.5 to 5 ml\/kg body weight. The doctor may adjust the dose depending on how you respond to the treatment.<\/p>\n\n\n\n Do not change dose one or the time interval to the next dose without first talking to your doctor.<\/p>\n\n\n\n If you think you need a different\u00a0dose\u00a0or want to change your dosing schedule, you must first talk to your doctor.\u00a0Contact your doctor if you miss a\u00a0dose.<\/p>\n\n\n\n Routine blood tests will be taken to measure the level of immunoglobulin in your blood. Discuss the schedule with your doctor.<\/p>\n\n\n\n There is no difference in\u00a0dosage\u00a0for adults, including the elderly (65 years and older), children, or infants because the amount of Xembify is based on body weight.<\/p>\n\n\n\n Mode of administration<\/strong><\/p>\n\n\n\n You receive Xembify by a slow\u00a0infusion\u00a0under the skin into fatty tissue (\u00a0subcutaneous\u00a0infusion\u00a0).\u00a0Xembify is given via a pump or injector.\u00a0Subcutaneous\u00a0infusion\u00a0for home treatment should be initiated and supervised by healthcare professionals experienced in instructing patients in-home treatment.<\/p>\n\n\n\n You (or your carer) must be instructed in:<\/p>\n\n\n\n For the treatment to work, you must follow the doctor’s instructions carefully regarding the\u00a0dose, infusion rate, and schedule of\u00a0infusion\u00a0of Xembify.<\/p>\n\n\n\n Infusion sites<\/strong><\/p>\n\n\n\n Xembify is intended for\u00a0subcutaneous\u00a0infusion\u00a0only.\u00a0<\/em>Infuse Xembify into\u00a0subcutaneous\u00a0tissue\u00a0in eg<\/p>\n\n\n\n When choosing an infusion site, avoid bony areas, visible blood vessels, scars, and any areas that are inflamed (irritated) or infected.\u00a0Change the infusion site between each\u00a0infusion.<\/p>\n\n\n\n For the first two\u00a0infusions, the infusion rate starts at 10 ml per hour per infusion site.\u00a0If you do not experience any\u00a0side effects\u00a0(see section 4), the rate can be increased every 10 minutes to a maximum of 20 ml per hour per infusion site for children and adolescents, and 25 ml per hour per infusion site for adults.\u00a0After two rounds of infusion, the dose rate can be gradually increased to 35 ml per hour and the infusion site.\u00a0Talk to your doctor before increasing the infusion rate.<\/p>\n\n\n\n You can give\u00a0an infusion\u00a0in more than one place at the same time as long as there is at least a 5 cm distance between the infusion sites.\u00a0Adults can divide the\u00a0dose\u00a0into several places, especially if the volume is greater than 30 ml.\u00a0There is no limit to the number of places you can use.\u00a0You can use more than one pump to do this.<\/p>\n\n\n\n Instructions for use<\/strong><\/p>\n\n\n\n Subcutaneous\u00a0infusion\u00a0for home treatment should be initiated and supervised by healthcare professionals experienced in instructing patients in-home treatment.\u00a0Infusion pumps suitable for\u00a0subcutaneous\u00a0administration\u00a0of immunoglobulins can be used.\u00a0The patient or a carer must be given instructions on how to use an infusion pump, on infusion techniques, how to keep a treatment diary, and how to identify serious\u00a0side effects,\u00a0and what measures to take.<\/p>\n\n\n\n Follow the steps below and use the aseptic technique to\u00a0administer\u00a0Xembify.<\/p>\n\n\n\n Allow the solution to reach room or body temperature (20\u201337 \u00b0C) before use. It may take 60 minutes or longer.<\/p>\n\n\n\n Do not apply heat or use a microwave oven.<\/p>\n\n\n\n Step 1: Gather the materials<\/u><\/strong><\/p>\n\n\n\n Obtain the Xembify vial(s), accessories, sharps and sharps container, treatment diary\/logbook, and infusion pump(s).<\/p>\n\n\n\n Step 2: Clean the surface<\/u><\/strong><\/p>\n\n\n\n Prepare a site for infusion on a clean, flat, non-porous surface, such as a kitchen counter.<\/p>\n\n\n\n Avoid porous surfaces such as wood. Clean the surface with an alcohol-moistened compress in circular motions from the center outwards.<\/p>\n\n\n\n Step 3: Wash your hands<\/u><\/strong><\/p>\n\n\n\n Wash and dry your hands thoroughly before using Xembify.<\/p>\n\n\n\n The health care professional may recommend that you use antibacterial soap or gloves.<\/p>\n\n\n\n Step 4: Check the vials<\/u><\/strong><\/p>\n\n\n\n The liquid in the bottle should be clear to slightly opalescent and colorless or slightly yellow or light brown.<\/p>\n\n\n\n Do not use the bottle if:<\/p>\n\n\n\n Step 5: Remove the protective cover<\/u><\/strong><\/p>\n\n\n\n Remove the protective cap from the vial so that the center of the vial stopper is visible.<\/p>\n\n\n\n Wipe the bottle cap with alcohol and let it dry.<\/p>\n\n\n\n Step 6: Transfer Xembify from the vial(s) to the syringe<\/u><\/strong><\/p>\n\n\n\n Make sure that fingers or other objects do not touch the plunger shaft, the syringe tip, or other areas that may come into contact with the Xembify solution.\u00a0Make sure all needles have needle covers on until they are used and that needles and syringes remain in the clean area you prepared in step 2 at all times. This is called the \u201caseptic technique\u201d and prevents bacteria from getting into the Xembify solution.<\/p>\n\n\n\n Attach the needle to the syringe tip using an aseptic technique.<\/p>\n\n\n\n Step 7: Prepare the syringe and draw Xembify solution into the syringe<\/u><\/strong><\/p>\n\n\n\n Remove the needle cover.<\/p>\n\n\n\n Pull back the syringe plunger to the level corresponding to the amount of Xembify to be withdrawn from the vial.<\/p>\n\n\n\n Place the vial on a clean, flat surface and insert the needle into the center of the vial stopper.<\/p>\n\n\n\n Inject air into the vial. The amount of air should be equal to the amount of Xembify that needs to be drawn up.<\/p>\n\n\n\n Turn the vial upside down and withdraw the correct amount of Xembify.\u00a0If several vials are needed to get the correct\u00a0dose, repeat steps 4-7.<\/p>\n\n\n\n Use the solution immediately after transferring Xembify from the vial to the syringe.<\/p>\n\n\n\n Step 8: Prepare the infusion pump<\/u><\/strong><\/p>\n\n\n\n Follow the pump manufacturer’s instructions on how to prepare the infusion pump, administration tubing, and Y-connect tubing, if necessary.<\/p>\n\n\n\n Fill the administration tube with Xembify to remove any air remaining in the box or needle.\u00a0To fill the box, hold the syringe in one hand and the administration tube needle, with the needle cover on, in the other hand.\u00a0Gently press the plunger until you see a drop of Xembify come out of the needle.<\/p>\n\n\n\n Step 9: Select the number and location of the infusion sites<\/u><\/strong><\/p>\n\n\n\n Select one or more infusion sites as directed by the healthcare professional.<\/p>\n\n\n\n It is the volume of the total dose that determines the number of infusion sites and their location.<\/p>\n\n\n\n Suitable infusion sites are the abdomen, thighs, upper arms, and side of the hip.<\/p>\n\n\n\n Avoid bony areas, visible blood vessels, scars, and any areas that are inflamed (irritated) or infected.<\/p>\n\n\n\n Change the infusion site between each\u00a0infusion.<\/p>\n\n\n\n Step 10: Prepare the infusion site<\/u><\/strong><\/p>\n\n\n\n Wipe the infusion site(s) with a\u00a0sterile\u00a0alcohol-moistened\u00a0pad in circular motions from the center outwards.\u00a0Allow the infusion site(s) to dry (for at least 30 seconds).<\/p>\n\n\n\n Before starting\u00a0the infusion, the injection sites must be clean, dry, and at least 5 cm apart.<\/p>\n\n\n\n Step 11: Insert the needle<\/u><\/strong><\/p>\n\n\n\n Grasp the skin with two fingers (make sure to leave at least 2.5 cm between the fingers).\u00a0Insert the needle into\u00a0the tissue\u00a0under the skin (\u00a0subcutaneous\u00a0tissue\u00a0) at a 90-degree angle.<\/p>\n\n\n\n Step 12: Make sure the needle is not in a blood vessel<\/u><\/strong><\/p>\n\n\n\n After inserting the needle into tissue one (and before infusing one), you must ensure that you have not accidentally hit a blood vessel. To do this, you connect a sterile syringe to the filled administration stroke. Pull back on the syringe plunger and see if blood is drawn into the administration tube.<\/p>\n\n\n\n If you see blood, remove and discard the needle and administration tube.<\/p>\n\n\n\n Repeat the steps to prime the tubing and insert the needle with a new needle, administration tubing, and a new infusion site.<\/p>\n\n\n\n Secure the needle by placing a sterile gauze pad or sterile transparent dressing over the needle.<\/p>\n\n\n\n Step 13: Repeat for other locations, as needed<\/u><\/strong><\/p>\n\n\n\n Step 14: Infuse Xembify<\/u><\/strong><\/p>\n\n\n\n Infuse Xembify as soon as possible after preparing the solution.<\/p>\n\n\n\n Follow the manufacturer’s instructions for filling the tubing and using the infusion pump.<\/p>\n\n\n\n Step 15: After infusion a<\/u><\/strong><\/p>\n\n\n\n Follow the manufacturer’s instructions on how to turn off the pump.<\/p>\n\n\n\n Remove and discard any dressings or tape.<\/p>\n\n\n\n Carefully remove the inserted needles.<\/p>\n\n\n\n Dispose of any unused solution in an appropriate waste container as directed.<\/p>\n\n\n\n Dispose of any used equipment in a suitable waste container.<\/p>\n\n\n\n Store the material in a safe place.<\/p>\n\n\n\n Follow the manufacturer’s instructions for the care of the syringe pump.<\/p>\n\n\n\n Step 16: Record each infusion<\/u><\/strong><\/p>\n\n\n\n Peel the peel-off label with the medicinal product batch number from the vial and use the label to complete the treatment diary. Include information about each infusion such as:<\/p>\n\n\n\n Don’t forget to take the diary with you when you go to the doctor’s appointment.\u00a0The doctor may ask to see your treatment diary\/log book.<\/p>\n\n\n\n Tell the doctor if you experience problems during the\u00a0infusions.\u00a0Call a healthcare professional for medical advice about\u00a0side effects.<\/p>\n\n\n\n In infants and children, the infusion site may be changed every 5 to 15 mL.<\/a><\/p>\n\n\n\n If you have ingested too much medicine or if, for example,\u00a0If a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.<\/p>\n\n\n\n Do not take a double\u00a0dose\u00a0to make up for a missed\u00a0dose.\u00a0Contact your doctor for instructions.<\/p>\n\n\n\n
<\/p>\n\n\n\nWhat you need to know before using Xembify<\/h2>\n\n\n\n
Do not use Xembify<\/h2>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Other medicines and Xembify<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
<\/p>\n\n\n\nHow to use Xembify<\/h2>\n\n\n\n
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Use for children and adolescents<\/h2>\n\n\n\n
If you have used too much Xembify<\/h2>\n\n\n\n
If you forgot to use Xembify<\/h2>\n\n\n\n
If you stop using Xembify<\/h2>\n\n\n\n