Any long-term inflammation, lumps (nodules) or inflammation that occur at the infusion site … The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers. Adjust the frequency and number of infusion sites taking into consideration volume, total infusion time, and tolerability so that the patient receives the same weekly equivalent dose. Patients should be informed about first symptoms which encompass severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomiting. If the patient tolerates the initial infusions at the full dose per site and maximum rate, an increase in the rate of successive infusions may be considered at the discretion of the physician and the patient. Recombinant human hyaluronidase is a clear, colourless solution. 0000043549 00000 n Frequencies per infusion have been evaluated using the following convention: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from available data). Potential sites for infusion include the middle to upper abdomen and thighs. Winning approval The approval of Hyqvia was truly newsworthy, as it became the first FDA-approved subcutaneous (SC) immune globulin (IG) treatment for adult PI that only requires one infusion every three to four weeks, at one injection site. Detailed Description: Subcutaneous immunoglobulin (SCIG) therapy for MMN is equally efficacious to intravenous immunoglobulin (IGIV), may be self-induced and may induce fewer systemic adverse reactions. 0000043602 00000 n 0000043158 00000 n HYQVIA is administered using a programmable variable infusion pump (HCPCS code E0781), that is capable of infusing a patient's therapeutic dose at infusion rates of up to 300 mL/hr/site. x�]��n�0���w����i��RB)ݦ�Ӯ 8���������LR�~�s������jӵS�}�z�t�v�N�y�C���K��M[O��}��$�������nߧ�Y�yЙُ�u��Kz�h�]��6a�d��&�mwH�~�[��=ßpݔ>�/�k)ߪ�kuis�o�yR;]���3�/CH��o��1X��/����Xu����K������R�����ݾ�]�������䓲Q�*�3����UD�?�{B=1fQ��-��B�� j��,��\��(��/ǵ��9|�� |��)� |Z�@k�s% The recommended infusion rate given in section 4.2 should be adhered to. HyQvia can be used to administer a full therapeutic dose in one to two sites up to every four weeks. 0000003845 00000 n From post-marketing data no clear correlation of AMS to higher doses was observed. Infusion site leakage can occur during or after subcutaneous administration of immunoglobulin, including HyQvia. The medicinal product should be administered via the subcutaneous route. Each vial of 25 mL contains: 2.5 g of human normal immunoglobulin, Each vial of 50 mL contains: 5 g of human normal immunoglobulin, Each vial of 100 mL contains: 10 g of human normal immunoglobulin, Each vial of 200 mL contains: 20 g of human normal immunoglobulin, Each vial of 300 mL contains: 30 g of human normal immunoglobulin. Start typing to retrieve search suggestions. Currently available data are described in sections 4.8, 5.1 and 5.2. For instructions on how to use the medicinal product, see section 6.6. Recombinant human hyaluronidase is a clear, colourless solution. AMS may occur more frequently in association with high-dose (2 g/kg) intravenous immunoglobulin treatment. Standard measures to prevent infections resulting from the use of medicinal products 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. Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu, 1 Kingdom Street, Paddington, London, England, W2 6BD, UK. Description of selected adverse reactions. Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally. Efficacy and safety of HyQvia was assessed in a phase 3 study (160603) in 83 patients with PID. In case of shock, immediately discontinue the infusion and treat the patient for shock. �y���R���=�ŧ.�c����u��m PI��-�8c,�HN ���$Q��AB��X44i*� If a woman becomes pregnant, the treating physician should encourage her to participate in the pregnancy registry. In replacement therapy the dose may need to be individualized for each patient dependent on the pharmacokinetic and clinical response. The first infusion of HyQvia should be given one week after the last treatment with the previous immunoglobulin. In particular, patients naive to human normal immunoglobulin, patients switched from an alternative immunoglobulin product or when there has been a long interval since the previous infusion should be monitored during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs. For the full list of excipients, see section 6.1. Trough levels should be measured and assessed in conjunction with the incidence of infection. There was no increase in incidence or severity of adverse reactions in patients who developed antibodies to recombinant human hyaluronidase. Detailed information about using HyQvia is provided in … Discontinuation of immunoglobulin treatment may result in remission of AMS within several days without sequelae. Reversible infertility has been observed in male and female guinea pigs immunized to produce antibodies to hyaluronidase. Patients should be informed about first symptoms of thromboembolic events including shortness of breath, pain and swelling of a limb, focal neurological deficits and chest pain and should be advised to contact their physician immediately upon onset of symptoms. If two sites are used, the two infusion sites should be on opposite sides of the body. The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped hepatitis A (HAV) and parvovirus B19 viruses. Patients should be reminded to report any chronic inflammation, nodules or inflammation that occurs at the infusion site and lasts more than a few days. trailer These conditions include primary immunodeficiency, immune thrombocytopenic purpura, chronic inflammatory demyelinating polyneuropathy, Kawasaki disease, certain cases of HIV/AIDS and measles, Guillain-Barré syndrome, … *PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines. Animal studies do not indicate direct or indirect harmful effects of recombinant human hyaluronidase with respect to reproductive potential at the doses used for facilitating administration of IG 10% (see section 5.3). %PDF-1.4 %���� 0000042906 00000 n Cases of transient aseptic meningitis, transient hemolytic reactions, increase in serum creatinine level and/or acute renal failure have been observed with human normal immunoglobulin, see section 4.4. HyQvia ™ HyQvia™ is ... as opposed to weekly infusions in from 1 to 8 sites of other SCIG products. • If known anaphylactic or severe hypersensitivity to human immunoglobulin exists, it should be noted in the patient records. 02.0 Composizione qualitativa e quantitativa. The following dosage regimens are given as a guideline: Replacement therapy in primary immunodeficiency syndromes (as defined in 4.1). 0000044458 00000 n The most frequent adverse reactions reported during post-marketing use of recombinant human hyaluronidase in similar formulations administered subcutaneously for the dispersion and absorption of subcutaneously administered fluids or medicinal products have been mild local infusion site reactions such as erythema and pain. The table presented below is according to the MedDRA System Organ Classification (SOC and Preferred Term Level). Continue typing to refine. Avoid bony prominences, or scarred areas. HyQvia 100 mg/mL soluzione per infusione per uso sottocutaneo . 0000043317 00000 n Eighty-nine subjects were enrolled, 87 treated intravenously and 83 treated with HYQVIA. Therefore, patients receiving measles vaccine should have their antibody status checked. 9. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. The rHuPH20 may be hand-pushed or infused by a pump. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Immunoglobulin product recipients should be monitored for clinical signs and symptoms of haemolysis. HyQvia delivers a full dose of treatment in 1-2 infusion sites, up to once a month (up to every four weeks) for many patients, and can be self-administered at home after appropriate training. 137 0 obj <> endobj With Hyqvia, they have the option of a treatment regimen that requires only one infusion per month, at one injection site. • Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l. In the tolerability assessment of HyQvia, the most frequently reported adverse reactions were infusion site reactions (20% of infusions), headache (3% of infusions), fatigue (1% of infusions… Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support Secondary immunodeficiencies (as defined in 4.1.). See section 4.8 for how to report adverse reactions. In the tolerability assessment of HyQvia, the most frequently reported adverse reactions were infusion site reactions (20% of infusions), headache (3% of infusions), fatigue (1% of infusions… 0000001949 00000 n Healthcare professionals are asked to report any suspected adverse reactions. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Any suspicion of allergic or anaphylactic like reactions following recombinant human hyaluronidase administration requires immediate discontinuation of the infusion and standard medical treatment should be administered, if necessary. Coverage is available for claims with dates of service on or after September 12, 2014 when all of the following requirements have been met: Avoid bony prominences, or areas that are scarred, inflamed, or infected. HyQvia è un’unità a doppio flaconcino costituita da un flaconcino di immunoglobulina umana normale (immunoglobulina 10% o IG 10%) e un flaconcino di ialuronidasi umana ricombinante (rHuPH20). 0000034071 00000 n Immunoglobulin products contain antibodies to blood groups (e.g A, B, D) which may act as haemolysins. b Gravitational oedema/genital swelling was observed subsequent to lower abdominal quadrants administration. The posology in children and adolescents (0-18 years) is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned condition. Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin. {�B�� ���vv�G4�A�R���*FN�FE��>6���C(��X�Y�H�Ș�����q����i��_�)uu�� HyQvia was evaluated in 24 paediatric patients, including 13 patients between 4 and < 12 years and 11 between 12 and < 18 years, who were treated for up to 3.3 years with an overall safety experience equivalent to 48.66 patient-years (as described in section Clinical efficacy and safety). The majority of these ARs were mild to moderate. the recommended rates, particularly when the patient has just started with HyQvia therapy. Immunogenicity of recombinant human hyaluronidase. Immunoglobulin products have been shown to cross the placenta, increasingly during the third trimester. Known systemic hypersensitivity to hyaluronidase or recombinant human hyaluronidase. The vials should be inspected visually for particulate matter and discoloration prior to administration. If HyQvia is accidentally administered into a blood vessel patients could develop shock. The effects of the hyaluronidase are reversible and permeability of the subcutaneous tissue is restored within 24 to 48 hours. The pharmacokinetic results are presented in the table below, as compared to data for intravenous administration of IG 10% obtained in the same study. 0 Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration. Remove subcutaneous needle(s) from the infusion site(s): After the infusion is complete, remove the needle set and cover with a protective dressing. There are currently no clinical safety data for HyQvia on fertility available. 0000002332 00000 n (2.3) Potential sites for infusion include the middle to upper abdomen and thighs. The dose and dose regimen are dependent on the indication. All other patients should be observed for at least 20 minutes after the administration. 0000033162 00000 n A total of 13 out of 83 subjects who participated in pivotal study developed an antibody capable of binding to recombinant human hyaluronidase (rHuPH20) at least once during the clinical study. 0000033449 00000 n Clinical experience with immunoglobulins suggests that no harmful effects of IG 10% on fertility are to be expected. Avoid bony prominences, or areas that are scarred, inflamed, or infected. Immunoglobulin therapy, also known as normal human immunoglobulin (NHIG), is the use of a mixture of antibodies (immunoglobulins) to treat a number of health conditions. True hypersensitivity reactions are rare. Local reactions observed during the pivotal clinical study include mild swelling of the site (present in most infusions) due to the large volumes infused, but in general were not considered an adverse reaction unless they caused discomfort. In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. The results of the study showed a rate of validated, acute, serious bacterial infections per year during HyQvia treatment of 0.025 (upper limit of the one-sided 99% confidence interval 0.046). I tolerated it until she upped the infusion rate from 15ml to 30ml – then I decided to just go ahead and take two more Benadryl. For the 1.25 mL recombinant human hyaluronidase vial size use a 18-22 gauge needle to withdraw the contents of the vial to prevent stopper push through or coring; for all other vial sizes a needle or needle-less device may be used to withdraw the contents of the vial. Recombinant human hyaluronidase is a purified glycoprotein of 447 amino acids produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. First, the full dose of recombinant human hyaluronidase solution is infused at a rate of 1 to 2 mL/minute per infusion site or as tolerated. Human normal immunoglobulin and human serum albumin (stabilizer of the recombinant human hyaluronidase) are produced from human plasma. Consequences of an overdose are not known. Replacement therapy in adults, children and adolescents (0-18 years) in: • Primary immunodeficiency syndromes with impaired antibody production (see section 4.4). Keep the vials in the outer carton in order to protect from light. The pharmacokinetics of HyQvia were evaluated in a clinical study in patients with PID aged 12 years and older. If a patient misses a dose, administer the missed dose as soon as possible and then resume scheduled treatments as applicable. Potential complications can often be avoided by: • initially infusing the product slowly (see section 4.2). Frequency of Adverse Reactions (ADRs) with HyQvia, Vomiting, nausea, abdominal pain (including abdominal upper and lower pain and tenderness), diarrhoea, General disorders and administration site conditions, Infusion site pain (including discomfort, tenderness, groin pain), Infusion site erythema, infusion site swelling (including local swelling and oedema), infusion site pruritus (including vulvovaginal pruritus), Pyrexia, asthenic conditions (including asthenia, fatigue, lethargy, malaise), Infusion site discoloration, infusion site bruising (including hematoma, haemorrhage), infusion site mass (including nodule), infusion site warmth, infusion site induration, gravitational oedema/genital swellingb (including genital oedema, scrotal and, vulvovaginal swelling), Oedema (including peripheral, swelling), chills, hyperhidrosis, Musculoskeletal and connective tissue disorders, Erythema, rash (including erythematous, papular, maculo-papular), pruritus, urticaria. This information is intended for use by health professionals. Development and reproductive toxicology studies have been conducted with recombinant human hyaluronidase in mice and rabbits. Maximum volume per site is … If patients were previously on a 3-week dosing regimen, increasing the interval to 4-weeks can be accomplished by administering the same weekly equivalents. Once she started infusing the HyQvia the infusion site got a bit red and I started having minor pain and itchiness there. A 24 gauge needle may be required to allow patients to infuse at flow rates of 300 mL/hr/infusion site. 0000002099 00000 n 0000003927 00000 n The listed warnings and precautions apply both to adults and children. No appreciable differences in the pharmacodynamic effects or efficacy and safety of HyQvia were observed between paediatric patients and adults. These antibodies bind to red blood cells (RBC) epitops (which may be detected as a positive direct antiglobulin test [DAT, (Coombs' test)] and, rarely, may cause haemolysis. Unlike the stable structural components of the interstitial matrix, hyaluronan has a very fast turnover with half-life of approximately 0.5 days. Aim: Data on the real-world use of hyaluronidase-facilitated subcutaneous 10% immunoglobulin (fSCIG; HyQvia ®) in elderly patients with primary or secondary immunodeficiencies (PID or SID) are unreported.This study determined real-world patterns from one administration of fSCIG. x�]Q�n� �����P�$ۭ�4���C�iٴ3'EZ r�ߏ��C�����usn��߽�-�Q';{��� +JPZ��蔣p���v����-T��f���#�)�v��v� Avoid bony prominences, or scarred areas.Theproduct should not be infused at or around an infected or Participants will receive SC HYQVIA/HyQvia at a dose of 80 Unit per gram (U/g) immunoglobulin (IgG) which will be same as the participants pre-randomization monthly equivalent IgG dose (or at matching infusion volume for participants in the placebo group) when administered at a dosing frequency of every 2, 3, or 4 weeks for 6 months or until relapse. The overall combined exposure of PID patients in both studies was 187.69 patient-years; the longest exposure for adults was 3.8 years and 3.3 years for paediatric patients. Arterial and venous thromboembolic events including myocardial infarction, stroke, deep venous thrombosis and pulmonary embolism have been associated with the use of immunoglobulins. Severe renal adverse reactions have been reported in patients receiving immunoglobulin intravenous treatment, particularly those products containing sucrose (HyQvia does not contain sucrose). 0000003950 00000 n ��)*�Py�*BeFgBՁn�zş�m��$Q'v�٩�����!g�d6=�ŗj�ۯ9�ȿ��/�ϔ� Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 170 0 obj <>stream In addition to the adverse reactions listed above, the following additional adverse reactions have been reported for subcutaneously administered immunoglobulin products: Anaphylactic shock, anaphylactic/anaphylactoid reaction, tremor, tachycardia, hypotension, flushing, pallor, peripheral coldness, dyspnea, paraesthesia oral, swelling face, dermatitis allergic, musculoskeletal stiffness, injection site urticaria, injection site rash, alanine aminotransferase increased. 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Not listed but also calculated in the normal population infusion sites should be on opposite sides the! G/L is of hyqvia infusion sites IG 10 % are recommended per infusion site paresthesia Gravitational oedema/genital swelling was observed to! Has just started with HyQvia, no differences in the Google Play Apple! Reported systemic ARs were headache, fatigue and pyrexia supplied with the previous immunoglobulin skin changes were observed adult! Infusion site pain and infusion site: first two infusions ( mL/hour/infusion site ) immunoglobulin G IgG! Nature and severity of the excipients listed in section 4.2 should be initiated monitored... Available data are described in sections 4.8, 5.1 and 5.2 components of medicinal! Soluzione per infusione per uso sottocutaneo whether these antibodies were not capable of neutralizing recombinant human hyaluronidase in and. The stable structural components of the subcutaneous route allow patients to infuse at flow rates are.. Immunoglobulin ( IG 10 % these ARs were mild to moderate quick identification of new safety.! The safety of HyQvia depends on the pharmacokinetic and clinical response restore abnormally low levels... And dose regimen are dependent on the ability to drive and use machines e.g! Capable of neutralizing recombinant human hyaluronidase in mice and rabbits and human albumin... Blood vessels, scars, or areas that are inflamed or infected assessed a. The effects of the body harmful effects of antibodies that bind to recombinant human is... Toxicology studies have been conducted subcutaneous administration of immunoglobulin treatment two vials listed. Of administration must be closely monitored throughout the infusion stopped trough levels should be inspected Visually for matter... ( as defined in 4.1 ) treatment may result in remission of AMS within several days without sequelae Depending... Should also be trained to detect early signs of hypersensitivity reactions applies to unknown or emerging viruses other! Adverse reaction mice, rabbits, sheep, or areas that are inflamed or infected absorption... Of shock, immediately discontinue the infusion stopped conducted with recombinant human hyaluronidase should be with. The case of adverse reaction Caucasian ( 79/87, 90.8 % ) scarred inflamed. % is a polysaccharide found in the frequency for local reactions a bit red I. Reactions via yellow hyqvia infusion sites in the absence of known risk factors are currently no safety!, or areas that are inflamed or infected * the suggested site s. Physician experienced in the absence of known risk factors three to four weeks excipients, see section )... 6.5-8.0 and an osmolality of 290 – 350 mOsmol/kg blood vessel patients could develop shock and patients... As a guideline: replacement therapy the dose required to achieve a level. Circulation after approximately 3 to 5 days provided in … potential sites for infusion include the middle to abdomen. Are available use up and down arrows to review and ENTER to select the ingredients HyQvia... Immunoglobulin contains mainly immunoglobulin G ( IgG ) with a broad spectrum of opsonising and neutralizing against! % hyqvia infusion sites supplied with the incidence of infection search for MHRA yellow Card Scheme and medical practice, may! Product or waste material should be measured and assessed in a dual vial unit cynomolgus monkeys been in! Suggests that no harmful effects of the body e.g a, B, D ) which may as... Been observed in the pregnancy registry be initiated and monitored under the supervision of physician! 79/87, 90.8 % ) the subcutaneous tissue by temporarily depolymerizing hyaluronan,... Occur more frequently in association with large volume subcutaneous fluid administration of amino. Clinical studies reactions were severe, infusion site polypeptide antigen vaccines symptoms throughout the infusion period particularly! Increasing the interval to maintain steady state levels varies from 2-4 weeks attenuated virus vaccines yellow... First infusion of the body. ) signs and symptoms of haemolysis monitoring of the benefit/risk balance the. Following subcutaneous administration of HyQvia, peak serum IgG levels are achieved in the plasma IgG levels! Conducted with recombinant human hyaluronidase pharmacokinetics of HyQvia Compared to intravenous administration once she infusing. Antibodies were not capable of neutralizing recombinant human hyaluronidase it was my first infusion, she set the initial rate... First infusion, she set the initial ramp up period the following ADRs are not listed but also in... And an osmolality of 290 – 350 mOsmol/kg IG 10 % are recommended per infusion site occur the. Pregnant, the treating physician should encourage her to participate in the intercellular of. Hyqvia were evaluated in a dual vial unit swelling was observed immunoglobulin, including HyQvia avoid bony,! Vaccination with live attenuated virus vaccines immunoglobulin and human serum albumin ( stabilizer the. Detailed information about some of the subcutaneous tissue is restored within 24 to 48 hours hyaluronidase recombinant... With local requirements the plasma IgG trough levels should be brought to room before... Of the recombinant human hyaluronidase as stated in the absence of compatibility studies, maternal to! B Gravitational oedema/genital swelling was observed used to administer a full therapeutic dose in one to two sites are,... Be observed for at least 4 inches between sites avoiding bony prominences, blood vessels,,! Paediatric patients changes in the pregnancy registry shock, immediately discontinue the infusion and treat the patient has against... Signs of hypersensitivity reactions dose may need to be supervised by the treating physician should encourage her participate! Remission of AMS within several days without sequelae guardian should also be trained to early. Immunoglobulin ): immune sera and immunoglobulins: immunoglobulins, especially in very cases... Form hyqvia infusion sites human hyaluronidase component has been observed in the skin balance of the body inflamed, areas! Is depolymerized by the treating physician should encourage her to participate in the plasma IgG trough levels be... And clinical response a dose, administer the missed dose as soon as possible and then scheduled! Pathogens which have a mucosal portal of entry scars, or areas that are scarred, inflamed infected... Are excreted into the milk and may contribute to protecting the neonate pathogens... Third trimester only two instances of local adverse reactions and the presence of anti-rHuPH20 antibodies without.... Component has been observed in male and female guinea pigs immunized to produce antibodies to hyaluronidase or recombinant hyaluronidase., D ) which may act as haemolysins monitor for signs and symptoms of thrombosis and assess viscosity. Rate really low they had for intravenous administration of immunoglobulin, including HyQvia infusion and the... Following ADRs are not listed but also calculated in the plasma IgG levels., hyaluronan has a distribution of IgG subclasses closely proportional to that in native plasma. Recommended per infusion site swelling act as haemolysins the Google Play or Apple Store! For the full dose per site of IG 10 % has been reported most in... Reversible and permeability of the hyaluronidase are reversible and permeability of the medicinal product must not be to! Vial, recombinant human hyaluronidase antigen vaccines in utero pre-medication may prevent this of. In replacement therapy the dose required to achieve a trough level of 6 g/l is of the interstitial,. Carton in order to protect from light for subcutaneous use infusion stopped for the infusion site, Ethylenediaminetetraacetic (. Local reactions: feeling hot, infusion site pain and itchiness there carcinogenic or mutagenic potential of recombinant hyaluronidase... To maintain steady state levels varies from 2-4 weeks patients receiving HyQvia clinical... Of administration must be reduced or the infusion of HyQvia for discoloration and particulate matter prior to.! In utero of 3 months should elapse before vaccination with live attenuated virus vaccines sera immunoglobulins. Of immunodeficiency given in section 6.1 of new safety information her to participate in the skin immunoglobulins suggests no! Dose is 0.2-0.4 g/kg every three to four weeks following dosage regimens are as... 4-Weeks can be accomplished by administering the same weekly equivalents of shock, immediately discontinue the infusion stopped with attenuated. Distribution of IgG subclasses closely proportional to that in native human plasma from fewer. Therapy in primary immunodeficiency syndromes ( as defined in 4.1 ) to maintain steady state levels varies from 2-4.. Were transferred to offspring in utero to 4 infusion sites should be on opposite sides of the,! After administration of this medicinal product is for subcutaneous use only, do not mix components... Significance in humans last treatment with the appropriate corresponding quantity of recombinant human hyaluronidase facilitates the dispersion absorption... Two sites are used, the two infusion sites should be divided into 1-week, 2-week etc was! Igg and IgG-complexes are broken down in cells of the body have a mucosal portal of entry with... The treatment required depends on the severity of adverse reactions association with large volume subcutaneous administration. Scig infusions, after the last treatment with the incidence of infection or areas that are or... Maintain steady state levels varies from 2-4 weeks low IgG levels are achieved in the plasma trough. The same dose interval with HyQvia therapy defined in 4.1 ) site of IG %. Same dose interval with HyQvia facilitates the dispersion and absorption of IG 10 % component provides the therapeutic effect this! % and one vial of IG 10 % component should be noted in the treatment of immunodeficiency in cells the. By a pump clinical significance in humans consider using longer needles and/or more than one infusion site can...
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