Information for professionals for Cytotect CP Biotest: Biotest (Switzerland) AG Complete information for professionals DDD Print

Transcription

1 Information for professionals for Cytotect CP Biotest: Biotest (Switzerland) AG Complete information for professionals DDD Print Composition 1 ml solution contains: Active ingredients:. plasma proteins 50 mg of it immunoglobulin G (IgG) 96%, antibody titers against cytomegalovirus 100 E * of people. * units of the reference preparation of the Paul-Ehrlich-Institut is the distribution of IgG subclasses ca. of 65% IgG1, 30% IgG2, IgG3 about 3%, about 2% IgG4. The maximum level of immunoglobulin A (IgA) is 2 mg / ml. adjuvants: glycine 300 micromol / ml, water for injections to 1 ml. Dosage form and amount of active ingredient per unit 1 ml solution contains 100 U * antibodies against cytomegalovirus. * units of the reference preparation of the Paul-Ehrlich-Institute Indications / Applications Prophylaxis clinical manifestations of cytomegalovirus infection in patients receiving immunosuppressive therapy, particularly transplant recipients. Dosage / Application Dosage and dosage regimen are dependent on the intended use. Normally single doses should be administered at 50 units per kg body weight (bw). With the administration should be started before the day of transplantation, or in the case of bone marrow transplantation, on the day. Prophylaxis can be started up to 10 days before the transplantation, in particular in patients who are cytomegalovirus carrier. A total of at least 6 individual doses should be given at intervals of 2 to 3 weeks. Specific dosage instructions children and young people in general, single doses are administered from 50 to 100 units per kg body weight (bw). The total dose is thereby infused within 1 to 4 hours maximum. 2 German centers in 304 children were treated in 2005, according to this dosage recommendation. This collective shall be composed of five premature infants and neonates, 40 infants, 177 children (2-11 years) and 77 adolescents (12-18 years) together. Cytotect CP Biotest is administered intravenously with an infusion rate of 0.08 ml per kg KG per hour. infused over a period of 10 minutes. If well tolerated, the infusion rate may be increased to a maximum of 0.8 ml per kg body weight per hour., And so leave the remainder of the infusion gradually. Contraindications Hypersensitivity to any components of the preparation. Hypersensitivity to homologous immunoglobulins, especially in very rare cases of IgA deficiency when the patient has antibodies against IgA. Warnings and Precautions Certain severe adverse effects may be associated with the rate of infusion. Since with increasing infusion rate, a tendency is linked to the increase in adverse events under 'must Dosage / Application 'recommended infusion rate are observed, and the patient must be monitored throughout the duration of the infusion and observed for any symptoms. Certain adverse reactions may be more common occur when:

2 a high rate of infusion, patients with hypo-or agammaglobulinemia with or without IgA deficiency, patients receiving first human immunoglobulin, or, in rare cases, when changing the immunoglobulin preparation or after a long interval. True hypersensitivity reactions are rare. They can occur in the very rare cases of IgA deficiency with anti-iga antibodies. Rarely can cause drop in blood pressure with anaphylactic reaction by administration of immunoglobulin, even in patients who have tolerated previous immunoglobulin gifts no hypersensitivity reactions. Possible complications can often be avoided be, if it is ensured that: patients are not hypersensitive to human immunoglobulin, the preparation (0.08 ml / kg / hr.) is administered slowly, the patient carefully monitored throughout the duration of the infusion and for any symptoms observed. In particular, those patients who have received their first immunoglobulin people who were previously treated with another immunoglobulin preparation or who had a longer rest period should be observed for one hour after the first infusion of possible side effects during the entire duration of the first infusion well. All other patients should be observed for at least 20 minutes after administration. There is clinical evidence of an association between the administration of intravenous immunoglobulins (IVIg) and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis. It is believed that in high risk patients, the supply of immunoglobulins results in a relative increase in blood viscosity. Caution should be exercised when prescribing and infusion of immunoglobulins to the following persons: obese patients, and patients with pre-existing risk factors for thrombotic events such as advanced age, hypertension, diabetes mellitus, known vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged physical immobilisation, severely hypovolemic patients, and patients with diseases which increase blood viscosity. Cases of acute renal failure have been reported in patients who received treatment with intravenous immunoglobulin. In most cases, risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolemia, overweight, concomitant nephrotoxic medicinal products or age over 65 years. In case of renal impairment, discontinuation of immunoglobulin preparation should be considered. these reports of renal dysfunction and acute renal failure have been associated with the use of many approved intravenous immunoglobulin preparations, however, the proportion of the preparations was the sucrose as a stabilizer contained disproportionately large. In high-risk patients, the use of sucrose-free immunoglobulin preparations should be considered. Cytotect CP Biotest does not contain sucrose. IVIg products should be administered in patients who are at risk for acute renal failure or thromboembolic adverse reactions, with the minimum rate of infusion and at the lowest possible dosage. In all patients, the administration of intravenous immunoglobulin requires: adequate hydration prior to the start of the immunoglobulin infusion, monitoring of urine output, monitoring of serum creatinine levels,. avoidance of concomitant use of loop diuretics risk patients.'s chapter ' overdose. '. In case of shock, standard medical measures for shock should be implemented

3 Standard measures to prevent infections by the administration of drugs that were prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation / removal of viruses. However, the possibility of transmitting infective agents in the administration of drugs that have been prepared from human blood or plasma, can not be completely excluded. This also applies to unknown or emerging viruses and other pathogens. The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped virus HAV. The virus elimination / inactivation is possibly non-enveloped viruses such as parvovirus B19 is of limited value. clinical experience has confirmed that hepatitis A or parvovirus B19 transmission with immunoglobulins are not, it is also assumed that the antibody content an important contribution to the viral safety is made. It is recommended to document the batch number with each application of the preparation. Interactions Live attenuated vaccines Immunoglobulin administration may impair the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella vaccines for a period of at least 6 weeks and up to 3 months. After administration of this product is before vaccination with live attenuated vaccines is a waiting period of three months to comply. For measles, this impairment may persist for up to one year. Therefore, the antibody status should in patients receiving measles vaccine, are reviewed. Pregnancy, lactation The safety of this medicinal product for use during pregnancy has not been studied in controlled clinical trials and therefore should be used in pregnant and breastfeeding women only after careful benefit-risk assessment. Clinical experience with immunoglobulins suggests that no harmful effects are to be expected in the course of pregnancy, the fetus or the newborn. immunoglobulins are excreted in human milk and may contribute to the transfer of protective antibodies to the neonate. Effect on the ability to drive and use machines There is no evidence that immunoglobulins affect the ability to actively participate in driving or operating machinery. Adverse effects In the evaluation of side effects Frequencies are defined as: Very common: ³ 1/10; Common: ³ 1/100, <1/10; Uncommon: ³ 1/1000, <1/100; Rare: ³ 1/10 000, <1/1000; Very rare: <1/ infections and infestations Very rarely reversible aseptic meningitis Blood and lymphatic system disorders Very rare reversible haemolytic anemia / haemolysis immune system disorders Uncommon Allergic reactions rarely hypersensitivity reactions with sudden drop in blood pressure, in some cases up to anaphylactic shock, even when the patient with previous applications has shown no reaction nervous system disorders Uncommon Headache

4 Vascular disorders Uncommon Hypotension Very rare Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis Gastrointestinal disorders Uncommon nausea, vomiting disorders of the skin and subcutaneous tissue Rare Transient cutaneous reaction dysfunctions Musculoskeletal, connective tissue and bone Occasionally, joint pain, mild back pain Renal and urinary disorders Very rare rise in serum creatinine and / or acute renal failure General disorders and and administration site conditions Uncommon fever, chills information about the risk of infection see ' Warnings and Precautions '. Overdose An overdose can lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with impaired renal function. Properties / effects ATC code: J06BB09 Pharmacotherapeutic group: Specific immunoglobulins, cytomegalovirus-human immunoglobulins for intravenous use Cytotect CP Biotest is an immunoglobulin preparation from plasma of donors who have high antibody titers against cytomegalovirus. The IgG subclasses closely proportional to that of human plasma. Pharmacokinetics Absorption Cytotect CP Biotest is after intravenous administration immediately and completely bioavailable in the blood stream of the recipient. Distribution It is distributed relatively rapidly between plasma and extravascular fluid. After 3-5 days, the balance between intra-and extravascular compartments is reached. metabolism / elimination Cytotect CP Biotest has a half-life of approximately 25 days. This half-life may vary from patient to patient. In transplant recipients, who have gone through to make a CMV infection or a shortened half-life (4-14 days) must be considered. IgG and IgG-complexes are broken down in the cells of the reticuloendothelial system. Preclinical data Immunoglobulins are normal constituents of the human body. The determination of acute toxicity in animals has no relevance since higher doses lead to circulatory overload. Studies of chronic toxicity and embryofetal toxicity are not feasible due to the induction of, and interference with antibodies. Experimental animal studies are not considered necessary. Clinical experience provides no indication of tumorigenic or mutagenic effects. Effect of the preparation on the immune system of the newborn have

5 not been studied. Other information Incompatibilities This medicinal product must not be mixed with other medicinal products, since a change in the electrolyte concentration or the ph may result in precipitation or denaturation of proteins. influence of diagnostic methods when evaluating serological test results must be taken into account that after the administration of an immunoglobulin can the transitory rise passively transferred antibodies cause positive test results. Passive transmission of antibodies to erythrocyte antigens, eg A, B, and D, with some serological tests can distort for red cell allo-antibodies (eg Coombs test), reticulocyte count and the Haptoglobintest. shelf life, once opened, the solution should be administered immediately. Due to the risk of bacterial contamination is not solution used discarded. After the expiration date, the product should no longer apply. Special precautions for storage at 2-8 C (in a refrigerator). Do not freeze. Store in the original package in order to protect from light. Instructions for use The product should be warmed to room or body temperature before use. before using a visual inspection of the preparation is to be carried out: The solution should be clear or be slightly opalescent. Turbid solutions or have deposits must not be used! application undiluted as an intravenous injection / infusion. This can optionally be done with the aid of a syringe pump. Larger volumes can be applied undiluted, in the form of a drip. Non-product or waste material should be disposed of in accordance with local requirements. In patients interest is recommended to document the name and batch number of the product as possible at each administration of Cytotect CP Biotest. Approval number 00'506 (Swissmedic). Packs Packs of 1 vial of 1000 E (10 ml) [B] 1 Vial of 5000 E (50 ml) [B] Authorization holder Biotest (Switzerland) AG 5102 Rupperswil Date of information June 2013