Humate p package insert pdf

In clinical studies, adverse reactions included tingling in. Remove p lastic cap from the other end of the doubleended transfer needle now seated in the stopper of the diluent vial. Insert the syringe needle containing the diluent into the novoseven rt vial through the center of the rubber stopper, aiming the needle against the side so that the stream of liquid. Highlights of prescribing information these highlights do not. If you do not have adobe reader, download it from the adobe web site. Uconn health department of pharmacy procoagulant factor agent 1to maintain vwf. All 5 recombinate dosage strengths are packaged with the same lowvolume 5 ml sterile water for. Factor viiivon willebrand alphanate, humatep, wilate. Antihemophilic factorvon willebrand factor complex human. In order to view pdf documents, you must have adobe reader software installed on your computer. The accumulation of 14 alphamethyl sterols correlates with the subsequent loss of ergosterol in the fungal cell wall and may be responsible for the antifungal. Dosing your life is bigger than hemophilia a, and your factor viii helps keep it that way. Pa 1646 amp humatrope food and drug administration.

Hymovis is a sterile, nonpyrogenic, viscoelastic hydrogel contained in a singleuse syringe. Lift the package away from the adapter and discard the package. Federal law restricts this device to sale by or on the order of a physician. If member meets all the requirements listed above, the medication will be approved for 6 months. Treatment and prevention of bleeding in adults with hemophilia a. While the humate p vial is upright, screw the syringe to the mix2vial transfer set. You are encouraged to report negative side effects of prescription. Kcentra, prothrombin complex concentrate human, is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin k antagonist vkaeg, warfarin therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. Pdf efficacy and safety of the factor viiivon willebrand factor. It is not known whether humate p can cause harm to the mother or the fetus when administered during labor and delivery. Pharmacy medical policy human antihemophilic factor.

Instructions for use 1 information for prescribers hymovis high molecular weight viscoelastic hyaluronan caution. With one hand grasp the humate p side of the mix2vial transfer set and with the other hand grasp the blue diluentside of the mix2vial transfer set, and unscrew the set into two pieces fig. Koatedvi is indicated for the treatment of classical hemophilia hemophilia a in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor viii. Humatep fda prescribing information, side effects and uses. Pharmaceutical compounding sterile preparations, it is important to note that while fda states that compounding does not include products prepared according to package labeling, fdaapproved labeling i. Humate p, koate, kogenate fs, kovaltry, monoclate p, novoeight, nuwiq, recombinate or xyntha may be granted for treatment of hemophilia a when either of the following criteria is met. To reduce any foaming, invert the vial of diluent and insert the exposed end of the needle. Humate p is made from human blood and could contain infectious agents. P l a s m a m c o n c e n t r a t i o n n g m l 0 6 12 18 time hours 0.

Available in 5 dosage strengths, ranging from 250 iu to 2000 iu, recombinate offers 5 options that come with singlevial dosing. Humatep antihemophilic factorvon willebrand factor complex human lyophilized powder for reconstitution for intravenous use only. The aqueous solution is sterile and 24 nonpyrogenic. Alphanate is designed to meet the needs of a variety of patients. Dailymed humatep antihemophilic factorvon willebrand. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020, wolters kluwer updated. If any component of the package is opened or damaged, do not use this component. Highlights of prescribing information antiplatelet. Please see full prescribing information for humatep, including patient product information. Fdaapproved unapproved type of bleed dose interval duration goal factor concentration benefix factor ix recombinant 2000 iu vials. Used regularly prophylaxis, afstyla can reduce the number of bleeding episodes and the risk of joint damage due to bleeding. The risk that these agents may transmit disease cannot be completely eliminated, but has been reduced by screening plasma donors and testing donated plasma for certain viruses, and by inactivating andor removing viruses during manufacturing. Prescribing information kogenate fs, antihemophilic factor.

Rco was not declared on the haemate p package insert, and the iu standards for vwf. Antihemophilic factorvon willebrand factor complex human, humatep is approved to treat and prevent bleeding in adult patients with hemophilia a. Highlights of prescribing information these highlights do not include all the information needed to use humatep safely and effectively. Antihemophilic factorvon willebrand factor complex. Kogenate fs antihemophilic factor recombinant is a medicine used to replace clotting factor factor viii or antihemophilic factor that is missing in people with hemophilia a. Recombinate is a prescription medicine used to replace clotting factor factor viii or antihemophilic factor that is missing in people with hemophilia a also called classic hemophilia. Your healthcare provider hcp may give you advate when you have. Allergictype reactions may result from the administration of antihemophilic factor human preparations. Inject air into the vial and withdraw the quantity required for reconstitution. Xyntha is an injectable medicine administered by intravenous iv infusion. Aug 01, 2018 humate p should be given to a pregnant woman only if clearly needed. More detailed information is available in the product package insert. Humate p should be given during labor and delivery only if clearly needed. Factor viiivon willebrand factor complex human alphanate, humatep, wilate reference number.

Prescribing information afstyla antihemophilic factor. Product information humate p alberta health services. Recombinate antihemophilic factor recombinant official site. Supporting documents older than three years humate p.

Aug 01, 2018 with one hand grasp the humate p side of the mix2vial transfer set and with the other hand grasp the blue diluentside of the mix2vial transfer set, and unscrew the set into two pieces fig. Dosing was based on the german package insert, which lists only factor. Your doctor might also give you afstyla before surgical procedures. Reconstitute and administer kovaltry with the components provided with each package. Rco were not used this was also the case in most hospital laboratories around the world at the time. Jan 20, 2020 retrovir zidovudine capsules, oral solution, and injection have been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced hiv1 disease see warnings and precautions. Benefix humate p given over 320 min max 4mlmin max rate of 2 unitskgmin. Your healthcare provider may give you kogenate fs when you have surgery. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The primary mode of action of voriconazole is the inhibition of fungal cytochrome p 450mediated 14 alphalanosterol demethylation, an essential step in fungal ergosterol biosynthesis.

Presentation carton ndc number component 20 ml 0053768001 one vial containing 5 grams of albumin ndc 0053768090 50 ml 0053768032 one vial containing 12. Highlights of prescribing information these highlights do not include all the information needed to use humate p safely and effectively. Retrovir zidovudine capsules, oral solution, and injection have been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced hiv1 disease see warnings and precautions. Advate is used to prevent and control bleeding in adults and children 016 years with hemophilia a. Csl behring contraindications albumin human usp, 25%. This document is provided in portable document format pdf. For any questions about the handling, reconstitution and administration of kovaltry, contact bayer medical communications at 188884bayer 18888422937. Results suggested an underestimation of the actual dose of vwf. Antihemophilic factorvon willebrand factor complex fda. Afstyla, antihemophilic factor recombinant, single chain, is used to treat and control bleeding episodes in people with hemophilia a. Insert the needle of the syringe into the histidine diluent vial. Insert the exposed end of the needle through the center of the stopper in the diluent vial. Recombinate is used to prevent and control bleeding in people with hemophilia a.

Humate p is not known to prevent spontaneous bleeding episodes. Dailymed retrovir zidovudine capsule retrovir zidovudine. Advate is a medicine used to replace clotting factor factor viii or antihemophilic factor that is missing in people with hemophilia a also called classic hemophilia. Humatep antihemophilic factorvon willebrand factor. While holding onto the diluent vial, carefully remove the outer package from the mix2vial, being careful to leave the mix2vial attached firmly to the diluent vial fig. Indications and usage panhematin is a hemin for injection indicated for the amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women, after initial carbohydrate therapy is known or suspected to be inadequate. Connect the diluent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while firmly pushing and turning the syringe clockwise until the connection is secured. Prescribing information kcentra prothrombin complex. Riastap, fibrinogen concentrate human, is indicated for the. Supporting documents older than three years humatep. Uconn health department of pharmacy procoagulant factor. The aqueous solubility is 34 1,000 mgml in distilled water. In addition, no adverse health effects are anticipated as a result of incidental contact or exposure to this product by those handling it or administering it in a therapeutic setting.