In patients with secondary hyperparathyroidism, the benefits and risks of the use of a solution with 1.25 mmol/l calcium, such as PHYSIONEAL 40, should be carefully considered as it might worsen hyperparathyroidism. Use in patients with elevated lactate levels. Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. N�?���N � Nutrineal PD4 (1.1% Amino Acid Peritoneal Dialysis Solution) Page 1 of 31 PRODUCT MONOGRAPH NUTRINEAL™ PD4 1.1% Amino Acid Peritoneal Dialysis Solution Peritoneal Dialysis Solution Baxter Corporation 7125 Mississauga Road Mississauga ON L5N 0C2 www.baxter.ca Date of Revision: July 30, 2012 Submission Control No: 155366 startxref The product, once removed from its overpouch and mixed, should be used within 24 hours. %%EOF <<9171AA2AFB0DA24DA08A7022158B923B>]>> PHYSIONEAL 40 is not recommended during pregnancy and in women of childbearing potential not using contraception. The lineo connector that may equip the Y transfer line of the twin bag, contains 10.5% of Povidone iodine ointment. • After removal of the overpouch, immediately break the interchamber frangible pin to mix the two solutions. endstream endobj 174 0 obj <> endobj 175 0 obj <> endobj 176 0 obj <>stream 194 0 obj <>stream Peritoneal Dialysis Solution With 4.25% Dextrose DESCRIPTION DIANEAL Peritoneal Dialysis Solutions are sterile, nonpyrogenic solutions in AMBU-FLEX and ULTRABAG containers for intraperitoneal administration only. DIANEAL PD-2 (3.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose is indicated for patients in acute or chronic renal failure. • Aminoglycosides should not be administered with penicillins in the same bag due to chemical incompatibility. To date, however, there are no data available which indicate that clinical complications overall are reduced or that regular use of such solutions might translate into meaningful benefits over the longer-term. Adverse reactions (occurring in 1% of patients or more) from the clinical trials and post marketing are listed below. In case of infusion of unmixed solution, the patient should immediately drain the solution and use a newly mixed bag. 0000000016 00000 n Electrolyte disturbances shall be managed according to the specific electrolyte disturbance verified by blood test. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. After dwell time, the solution is saturated with toxic substances and must be changed.

0000002119 00000 n Serum electrolyte concentrations (particularly bicarbonate, potassium, magnesium, calcium and phosphate), blood chemistry (including parathyroid hormone and lipid parameters) and haematological parameters should be monitored periodically. Peritoneal dialysis increases your risk for a hernia for a couple of reasons. Baxter, Dianeal, and UltraBag are trademarks of Baxter International Inc. Store at room temperature (77° F) and in moisture barrier overwrap and in carton until ready for use. Possible consequences of overdose include hypervolaemia, hypovolaemia, electrolyte disturbances or (in diabetic patients) hyperglycaemia. Hypovolaemia may be managed by fluid replacement either orally or intravenously, depending on the degree of dehydration. Needle Free Connectors & Catheter Extension Sets, Catheter Extension Sets without Connector, ARTISS [FIBRIN SEALANT HUMAN] Accessories, Floseal Hemostasis Matrix and Accessories, Peri-Strips Dry with VERITAS compatible with Covidien staplers, Peri-Strips Dry with VERITAS compatible with Ethicon staplers, Peri-Strips Dry with VERITAS with SECURE GRIP TECHNOLOGY compatible with Ethicon Staplers, Flo-Rester® Internal Vessel Occluder-Vascular, Flo-Rester® Internal Vessel Occluder-Coronary, TachoSil® [Absorbable FIBRIN SEALANT Patch], Cardioplegic Solution for Cardiac Perfusion, DOPamine Hydrochloride and 5% Dextrose Injections, Heparin Sodium and 0.9% Sodium Chloride Injections, Potassium Chloride Highly Concentrated Injections, DOXIL (doxorubicin HCl liposome injection), Infusion Systems and Specialized Patient Monitoring, SIGMA Spectrum Infusion System Accessories, SIGMA Spectrum Large Volume Infusion Pumps, Starling Fluid Management Monitoring System, Gravity Compounding Containers, Sets & Accessories, IV & Irrigation Solutions & Drug Reconstitution, Lactated Ringer's & Ringer's for Injection, OSMITROL Injection (Mannitol Injection, USP), PLASMALYTE (Multiple Electrolyte) Injections, Potassium Chloride in Dextrose & Sodium Chloride Injections, Sodium Chloride Processing & Device Care Solutions, Molecular Adsorbent Recirculating System (MARS), PrisMax Auto -Effluent Set Extension Line, Parenteral Nutrition Solutions & Additives, EXACTAMIX Automated Compounder & Accessories, Rockwell RenalPure® 36.83X Liquid Acid Concentrate Formulations - Cases, Rockwell RenalPure® 36.83X Liquid Acid Concentrate Formulations - Drums, Rockwell RenalPure® 45X Liquid Acid Concentrate Formulations - Cases, Rockwell RenalPure® 45X Liquid Acid Concentrate Formulations - Drums, Rockwell RenalPure® Bicarbonate Formulations - Cases, Rockwell CitraPure® 36.83X Liquid Acid Concentrate Formulations - Cases, Rockwell CitraPure® 36.83X Dry Acid Concentrate Formulations, Rockwell CitraPure® 45X Liquid Acid Concentrate Formulations - Drums, Rockwell CitraPure® 45X Liquid Acid Concentrate Formulations - Cases, Rockwell CitraPure® 45X Dry Acid Concentrate Formulations, Rockwell Dri-Sate® 45X Dry Acid Concentrate Formulations, Rockwell Dri-Sate® 36.83X Dry Acid Concentrate Formulations, Rockwell Dri-Sate® 35X Dry Acid Concentrate Formulations, Rockwell SteriLyte® Bicarbonate Formulations - Cases, Amia Automated PD System with Sharesource Connectivity Platform, DIANEAL Peritoneal Dialysis (PD) Solutions for CAPD, EXTRANEAL Peritoneal Dialysis Solution for CAPD. See section 4.9. `i>V �I����Qf � �3��7�[���`b|���' ,���`Ԑ���m�Pu� Å"�s@�@���N�"7A�����;�S� �/��,z@ The intraperitoneal solution must be infused within 24 hours after mixing. %%EOF

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In vitro and ex vivo studies have shown evidence of improved biocompatibility indicators of PHYSIONEAL 40 in comparison with standard lactate buffered solution. 0000006972 00000 n x�bb``b``��c� �f � DIANEAL Peritoneal Dialysis Solution is for Intraperitoneal Administration Only. In situations in which there is a normal serum potassium level or hypokalaemia, the addition of potassium chloride (up to a concentration of 4 mEq/l) may be indicated to prevent severe hypokalaemia and should be made after careful evaluation of serum and total body potassium, only under the direction of a physician. To avoid the risk of severe dehydration, hypovolaemia and to minimise the loss of proteins, it is advisable to select the peritoneal dialysis solution with the lowest osmolarity consistent with fluid removal requirements for each exchange. endstream endobj 126 0 obj <>/Size 102/Type/XRef>>stream 0000001324 00000 n The dwell time with EXTRANEAL is between 6 – 12 hours in CAPD, and 14 – 16 hours in APD. Pharmacotherapeutic group: Peritoneal Dialytics, Hypertonic solutions. Not for intravenous administration. —ë`FÑÆ›H17dŸe°P:ÏcxN/.¦´hè‡ñ(’3UJGWQ¨ M&ĞÛÈ. endstream endobj 103 0 obj <>/Metadata 23 0 R/PieceInfo<>>>/Pages 22 0 R/PageLayout/OneColumn/StructTreeRoot 25 0 R/Type/Catalog/LastModified(D:20101217103423)/PageLabels 20 0 R>> endobj 104 0 obj <>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC/ImageI]/ExtGState<>>>/Type/Page>> endobj 105 0 obj [106 0 R] endobj 106 0 obj <>/A 118 0 R/F 4/H/I/StructParent 1/Border[0 0 0]/Type/Annot>> endobj 107 0 obj <> endobj 108 0 obj <> endobj 109 0 obj <> endobj 110 0 obj [/ICCBased 116 0 R] endobj 111 0 obj [/Indexed 110 0 R 234 120 0 R] endobj 112 0 obj <> endobj 113 0 obj <> endobj 114 0 obj <> endobj 115 0 obj <>stream
xref No non-clinical studies have been performed with PHYSIONEAL 40. �J{�~��+��P��l���s�@�@B--�D3wt4@4�� -� Since pioneering peritoneal dialysis in 1960, Baxter has been committed to providing ESRD patients with this life-saving therapy. solution in the abdomen. The single bag is a two-chamber bag (small chamber "A" and large chamber "B", see section 2) to be used in Automated Peritoneal Dialysis. 0000018424 00000 n 0000034670 00000 n Not for Intravenous Administration. 0000002681 00000 n The lower chamber is fitted with a port for connection to a suitable administration set allowing dialysis operations. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from PHYSIONEAL 40 therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Transfer of substances between the patient's peritoneal capillaries and the dialysis fluid is made across the peritoneal membrane according to the principles of osmosis and diffusion.

Excessive use of PHYSIONEAL 40 peritoneal dialysis solution with a higher dextrose (glucose) during a peritoneal dialysis treatment may result in excessive removal of water from the patient. 0000000831 00000 n Hyperglycaemia (in diabetic patients) shall be managed by adjusting the insulin dose according to the insulin scheme prescribed by the treating physician. End stage renal disease (ESRD) patients undergoing peritoneal dialysis may experience undesirable effects, which could affect the ability to drive or use machines. 0000038664 00000 n Stop the infusion immediately and drain the solution from the peritoneal cavity if any signs or symptoms of a suspected hypersensitivity reaction develop. 0000039131 00000 n Therefore the clinical benefits of PHYSIONEAL 40 have to be balanced versus the risks of side effects in this patient category. However, only dry heat (for example, heating pad, warming plate) should be used. 0 Protein, amino acids, water soluble vitamins and other medicines may be lost during peritoneal dialysis and may require replacement. Improving Access to PD Therapy and Raising the Quality of Care. To bookmark a medicine you must sign up and log in. 1000 ml of final solution after mixing corresponds to 362.5 ml of solution A and 637.5 ml of solution B. PHYSIONEAL 40 should not be used in patients with: • uncorrectable mechanical defects that prevent effective PD or increase the risk of infection. o¡gLŒ¿VjSèñ Ç~©M¡®¤Lğm STEP 3: Dwell. For details on the conditions of administration see section 4.2. • After removal of the overpouch, immediately break the interchamber frangible pin to mix the two solutions. When suggestions are available use up and down arrows to review and ENTER to select. Safety and efficacy in paediatric patients have not been established. • Drugs should be added through the medication port in the top chamber before breaking the interchamber frangible pin. Baxter International Inc. is developing a peritoneal dialysis solution generation system that would produce sterile PD solutions in patients' homes. When the new solution has been filled, the … Date of first authorisation/renewal of the authorisation. First, you have an opening in your muscle for your catheter. 0000038919 00000 n • Chemical and physical in-use stability has been demonstrated for 6 hours at 25°C for insulin (Actrapid 10 IU/L, 20 IU/L and 40 IU/L). After a few hours, the solution containing the waste is pumped out and replaced with a fresh solution. 0000018479 00000 n For patients with renal failure, peritoneal dialysis is a procedure for removing toxic substances produced by nitrogen metabolism and normally excreted by the kidneys, and for aiding the regulation of fluid and electrolyte as well as acid base balances. Solutions for peritoneal dialysis made by Baxter … 0000003091 00000 n PHYSIONEAL 40 is indicated whenever peritoneal dialysis is employed, including: • Drug intoxication with dialysable substances, when a more adequate therapeutic alternative is not available. h�b```f``��l, ���=p!Ɔf?�����rȰ��`9̺���C:_��i���o��p%q=d��,�z��A�]RE{�԰��i�`��9+h��k"�� �tMo�|�&���T��2� =(�bƖ�;r�� ��@�kCGcGqt0wt40itt0h�X��!�0�t2 �`�� �Q��La`��ف����0�g������Ol����Nr�1��iFT.XU�_�� �^ �g`a��� x�wp All Rights Reserved. �O��l1��ާ�A��._{��}LS�=k� W����^����fw�ɋ$v,I�?A��0�]ړ�{�o|�2%���dѦ��>�uZ���j�*��5��v�� ^$=Z����4��V��������EnStQ���U+�/�Z-��R��:�!�a����ؚ�l���������{�����?p�şy To email a medicine you must sign up and log in. The evaluation of the results obtained for this group does not show any difference to the rest of the patients.


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