hemofiltration fluid
citrate,\u00a0sodium, chloride<\/p>\n\n\n\n
This drug is a\u00a0haemofiltration fluid\u00a0that prevents the blood from clotting during\u00a0continuous\u00a0kidney replacement therapy (CRRT), which is a form of dialysis treatment.\u00a0This medicine is used in seriously ill patients, especially when the medicine\u00a0heparin, which is usually given to prevent blood clotting, can not be used.\u00a0The effect on the blood’s ability to coagulate is achieved by citrate binding to\u00a0calcium\u00a0in the blood.<\/p>\n\n\n\n
The active substances (citrate,\u00a0sodium, chloride) contained in Regiocit may also be authorized for the treatment of other diseases not mentioned in this product information.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.<\/p>\n\n\n\n
Allergy to the active substances or any of the other ingredients (listed in section 6)<\/p>\n\n\n\n
Severe hepatic impairment<\/p>\n\n\n\n
Significantly reduced blood flow in the muscles<\/p>\n\n\n\n
Talk to your doctor, pharmacist, or nurse before using this medicine.<\/p>\n\n\n\n
This medicine is not intended for direct\u00a0intravenous\u00a0infusion.\u00a0It should only be used with a machine that can perform\u00a0continuous\u00a0kidney replacement therapy (CRRT) which is a type of\u00a0dialysis\u00a0used specifically for seriously ill patients with\u00a0kidney failure.\u00a0The CRRT machine must be suitable for use with citrates that counteract the clotting ability of the blood.<\/p>\n\n\n\n
Regiocite can be heated to 37 \u00b0 C to increase patient well-being.\u00a0Heating the liquid before use may only be done with dry heat.\u00a0Liquids should not be heated in water or a microwave oven.\u00a0Regiocite should be inspected visually for particulate matter and discoloration before\u00a0administration.\u00a0Do not administer\u00a0unless the liquid is clear, free of visible particles and the seal is intact.<\/p>\n\n\n\n
If the cover or liquid bag is damaged, the liquid may be contaminated and must not be used. The treatment includes other fluids given by infusion in addition to this medicine. The composition or rate of administration of these other liquids may need to be adjusted to fit well with this medicine.<\/p>\n\n\n\n
Your doctor will closely monitor the balance between your\u00a0blood pressure\u00a0and blood flow (\u00a0hemodynamics\u00a0status), fluid balance, blood sugar level,\u00a0electrolyte\u00a0– and acid\/base balance before and during treatment.\u00a0Sodium,\u00a0magnesium,\u00a0potassium,\u00a0phosphate,\u00a0and\u00a0calcium\u00a0will be closely monitored.<\/p>\n\n\n\n
The treatment will be adjusted if necessary.<\/p>\n\n\n\n
Regiocite does not contain\u00a0calcium\u00a0.\u00a0Use of Regiocite may lead to low levels of\u00a0calcium\u00a0in the blood (hypocalcemia).<\/p>\n\n\n\n
Regiocite does not contain\u00a0magnesium.\u00a0The use of Regiocite may lead to low levels of\u00a0magnesium\u00a0in the blood (hypomagnesemia).\u00a0The level of\u00a0magnesium\u00a0in the blood will be closely monitored and\u00a0infusion\u00a0of\u00a0magnesium\u00a0may be necessary.<\/p>\n\n\n\n
Regiocite does not contain\u00a0glucose.\u00a0The use of Regiocite may lead to low blood\u00a0glucose\u00a0(hypoglycemia).\u00a0Blood glucose levels should be monitored regularly.<\/p>\n\n\n\n
Regiocite does not contain\u00a0potassium.\u00a0Serum potassium levels must be monitored before and after treatment.<\/p>\n\n\n\n
Your doctor will pay special attention to the infusion rate of citrate.\u00a0Too much citrate leads to low blood levels of\u00a0calcium\u00a0and a high\u00a0pH\u00a0in the blood, which can cause neurological complications and heart complications.\u00a0A high\u00a0pH\u00a0in the blood can be corrected by adjusting the dialysis settings and by\u00a0infusing\u00a00.9% sodium chloride solution after the hemofilter or changing the composition of the CRRT fluid.\u00a0Low blood levels of\u00a0calcium\u00a0can be treated by\u00a0infusion\u00a0of\u00a0calcium.<\/p>\n\n\n\n
Your doctor will pay special attention to whether you suffer from liver failure or\u00a0shock.\u00a0Because the breakdown of citrate can be significantly reduced, leading to accumulation of citrate and a low\u00a0pH\u00a0in the blood.\u00a0Your doctor will decide if your treatment needs to be adjusted.\u00a0If the ratio of total \/ ionized\u00a0calcium\u00a0exceeds 2.3, the citrate buffer should be reduced or stopped.<\/p>\n\n\n\n
If Regiocit is administered to patients with hepatic impairment, frequent monitoring of\u00a0pH,\u00a0electrolytes, and the ratio of total \/ ionized\u00a0calcium\u00a0to\u00a0systemic\u00a0ionized\u00a0calcium\u00a0is important to avoid\u00a0electrolyte\u00a0and\/or acid\/base imbalance.\u00a0Do not use it if you have severe hepatic impairment.<\/p>\n\n\n\n
In case of the abnormally high volume of fluid in the body (\u00a0hypervolemia\u00a0), the rate of net ultrafiltration prescribed for the CRRT unit may be increased, and\/or the rate of administration of fluids other than replacement fluid and\/or dialysate may be reduced.<\/p>\n\n\n\n
In case of the abnormally low volume of fluid in the body (\u00a0hypovolemia\u00a0), the rate of net ultrafiltration prescribed for the CRRT unit may be reduced, and\/or the rate of administration of fluids other than replacement fluid and\/or dialysate may be increased.<\/p>\n\n\n\n
Regiocite is hypoosmolar\/hypotonic about common CRRT replacement fluids and should be used with caution in patients with traumatic brain injury, cerebral\u00a0edema,\u00a0or elevated\u00a0intracranial pressure.<\/p>\n\n\n\n
The user instructions must be strictly followed.\u00a0Improper use of outflow ports or other flow restrictions can lead to an improper weight loss in the patient and trigger the dialysis machine alarm.\u00a0If treatment is continued without addressing the cause of the problem, it could lead to patient injury or death.<\/p>\n\n\n\n
Other medicines and Regiocit<\/strong><\/p>\n\n\n\n Tell your doctor, pharmacist, or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.\u00a0This is important because the concentration of other medicines may decrease during dialysis treatment.\u00a0Your doctor will decide if the\u00a0dosage\u00a0of any of the medicines you are taking needs to be adjusted.<\/p>\n\n\n\n You must tell your doctor if you are taking medicines that contain:<\/p>\n\n\n\n Fertility:<\/p>\n\n\n\n No effects on\u00a0fertility\u00a0are expected as\u00a0sodium, chloride, and nitrate are normal components in the body.<\/p>\n\n\n\n Pregnancy and breast-feeding:<\/p>\n\n\n\n There are no data on the use of this medicine during pregnancy or breastfeeding.\u00a0This medicine should only be given to pregnant or breastfeeding women if there is a clear need.<\/p>\n\n\n\n Regiocit has no known effect on the ability to drive or use machines.<\/p>\n\n\n\n You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.\u00a0Descriptions of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n For\u00a0intravenous\u00a0use.\u00a0This medicine should be used in a hospital and should only be given by healthcare professionals.\u00a0The volume used, and thus the\u00a0dose of\u00a0the medicine depends on your condition.\u00a0The dose-volume will be determined by your doctor.<\/p>\n\n\n\n The recommended rates of administration of this drug in adults and adolescents:<\/p>\n\n\n\n Use in the elderly:<\/p>\n\n\n\n The recommended flow rates are the same as for adults and adolescents.<\/p>\n\n\n\n Use in children:<\/p>\n\n\n\n In neonates and infants (0 to 23 months), a\u00a0dose\u00a0of 3 mmol citrates per liter of blood flow Regiocit should be sought, in\u00a0continuous\u00a0venous-venous\u00a0haemofiltration\u00a0or haemodiafiltration.\u00a0In children (2 to 11 years), the\u00a0dosage\u00a0should be adjusted according to both the patient’s weight and the blood flow rate.<\/p>\n\n\n\n Liver failure or shock:<\/p>\n\n\n\n In these conditions, the initial starting dose of citrate should be reduced.<\/p>\n\n\n\n Instructions for use<\/strong><\/p>\n\n\n\n Regiocit will be given to you at a hospital. Your doctor will know how to use Regiocit.<\/p>\n\n\n\n The instructions for use can be found at the end of this leaflet.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.\u00a0Your blood will be checked regularly by a doctor or nurse to detect any\u00a0side effects.\u00a0Use of this liquid may cause:<\/p>\n\n\n\n Common: may affect up to 1 in 10 users<\/strong><\/p>\n\n\n\n Has been reported: occurs in an unknown number of users<\/strong><\/p>\n\n\n\n * Side effects associated with dialysis treatment rather than with this medicine.<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n No special storage instructions. Do not freeze.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the label and the carton.\u00a0The expiration date is the last day of the specified month.<\/p>\n\n\n\n Do not use this medicine if the product is damaged or if you detect visible particles in the liquid.<\/p>\n\n\n\n The liquid can be flushed out via the drain without damaging the environment.<\/p>\n\n\n\n Theoretical osmolarity: 244 mOsm \/ l<\/p>\n\n\n\n pH \u2248 7.4<\/p>\n\n\n\n Other ingredients are:<\/p>\n\n\n\n Dilute hydrochloric acid (for pH adjustment) E 507<\/p>\n\n\n\n Water for injection<\/p>\n\n\n\n This drug is a clear and colorless\u00a0haemofiltration fluid\u00a0packaged in a single chamber pouch made of a multilayer film containing polyolefins and elastomers.\u00a0The fluid is\u00a0sterile\u00a0and free from bacterial\u00a0endotoxins.\u00a0Each bag contains 5,000 ml of liquid and the bag has a cover of\u00a0transparent\u00a0film.\u00a0Each box contains two bags and a package leaflet.<\/p>\n\n\n\n Baxter Holding BV<\/p>\n\n\n\n Kobaltweg 49<\/p>\n\n\n\n 3542CE Utrecht<\/p>\n\n\n\n Netherlands<\/p>\n\n\n\n Manufacturer<\/strong><\/p>\n\n\n\n Bieffe Medical SpA<\/p>\n\n\n\n Via Stelvio, 94<\/p>\n\n\n\n 23035 Sondalo (SO)<\/p>\n\n\n\n Italy<\/p>\n\n\n\n Baxter Healthcare SA<\/p>\n\n\n\n Moneen Road<\/p>\n\n\n\n Castlebar<\/p>\n\n\n\n County Mayo<\/p>\n\n\n\n F23 XR63<\/p>\n\n\n\n Ireland<\/p>\n\n\n\n Local representative<\/strong><\/p>\n\n\n\n Baxter Medical AB<\/p>\n\n\n\n Box 63<\/p>\n\n\n\n 164 94 Kista<\/p>\n","protected":false},"excerpt":{"rendered":" This drug is a haemofiltration fluid that prevents the blood from clotting during continuous kidney replacement therapy (CRRT), which is a form of dialysis treatment. This medicine is used in seriously ill patients, especially when the medicine heparin , which is usually given to prevent blood clotting, can not be used. The effect on the blood’s ability to coagulate is achieved by citrate binding to calcium in the blood.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200,18529],"tags":[22513,22508,22509,22512,22514,22507,22510,22511],"class_list":["post-21801","post","type-post","status-publish","format-standard","hentry","category-medicines","category-r","tag-benefits-of-regiocit","tag-citrate","tag-regiocit","tag-regiocit-side-effects","tag-regiocit-usage","tag-sodium","tag-what-is-regiocit","tag-what-regiocit-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21801","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=21801"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21801\/revisions"}],"predecessor-version":[{"id":21824,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21801\/revisions\/21824"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=21801"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=21801"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=21801"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
How to use Regiocit<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Regiocit<\/h2>\n\n\n\n
Contents of the pack and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
Composition:<\/th> <\/th><\/tr> Sodium chloride<\/td> 5.03 g \/ l<\/td><\/tr> Sodium citrate<\/td> 5.29 g \/ l<\/td><\/tr>
The active substances are:<\/td>
<\/td><\/tr>Sodium , Na +<\/sup><\/td> 140 mmol \/ l<\/td><\/tr> Chloride, Cl –<\/sup><\/td> 86 mmol \/ l<\/td><\/tr> Citrate, C 6<\/sub> H 5<\/sub> O 7 <\/sub>3 <\/sup>–<\/sup><\/td> 18 mmol \/ l<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
Marketing Authorisation Holder<\/h2>\n\n\n\n