Powder and solvent for solution for injection 250 IU
(White or yellowish powder or brittle mass and clear, colorless liquid)<\/p>\n\n\n\n
AFSTYLA is a human coagulation factor (clotting factor) VIII product produced by recombinant DNA technology. The active substance in AFSTYLA is lonoktokog alfa.<\/p>\n\n\n\n
AFSTYLA is used to treat and prevent bleeding in patients with hemophilia A (congenital factor VIII deficiency). Factor VIII is needed for blood clotting. Lack of this factor means that blood cannot clot as quickly as it should and therefore there is an increased tendency to bleed. AFSTYLA works by replacing the missing factor VIII in patients with hemophilia A so that their blood can clot normally.<\/p>\n\n\n\n
AFSTYLA is suitable for use in all age groups.<\/p>\n\n\n\n
Traceability<\/strong><\/p>\n\n\n\n It is strongly recommended that you record the date of administration, the batch number, and the injected volume in a treatment diary each time AFSTYLA is given.<\/p>\n\n\n\n Talk to a doctor, pharmacist, or nurse before using AFSTYLA.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n AFSTYLA does not affect the ability to drive or use machines.<\/p>\n\n\n\n AFSTYLA contains up to 7 mg (0.3 mmol) sodium per ml after reconstitution.<\/p>\n\n\n\n However, depending on your body weight and your dose of AFSTYLA, you may receive more than one vial. This should be considered if you have been prescribed a low-salt diet.<\/p>\n\n\n\n Your treatment should be done under the supervision of a doctor who has experience in the treatment of bleeding disorders.<\/p>\n\n\n\n Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor.<\/p>\n\n\n\n The amount of AFSTYLA you need and the treatment time depend on:<\/p>\n\n\n\n Follow your doctor’s instructions. General instructions<\/em><\/p>\n\n\n\n Before opening the vials, WARRANT powder and liquid to room temperature or body temperature. This can be done either by allowing the bottles to stand at room temperature for about an hour or by holding them in your hands for a few minutes.<\/p>\n\n\n\n Do not expose the vials to direct heat. The vials must not be heated above body temperature (37 \u00baC).<\/p>\n\n\n\n Carefully remove the plastic lids from the bottles and clean the surfaces of the rubber stoppers with an alcohol wipe. Allow the vials to dry before opening the Mix2Vial package (which contains the transfer kit with filter). Then follow the instructions below.<\/p>\n\n\n\n Commissioning and administration<\/strong><\/p>\n\n\n\n Use the supplied venipuncture set and insert the needle into a vein. Let the blood flow back to the end of the tube. Attach the syringe to the threaded locking device at the end of the venipuncture set. Slowly inject the reconstituted solution into the vein (as convenient for you, up to a maximum of 10 ml\/min)<\/strong> according to the instructions given to you by your doctor. Be careful not to get any blood into the syringe with a reconstituted solution.<\/p>\n\n\n\n Find out if you get any immediate side effects. If you experience any side effects that may be due to the administration of AFSTYLA, the injection should be discontinued (see also section 2).<\/p>\n\n\n\n AFSTYLA can be used for children and young people of all ages. In children (under 12 years of age), higher doses or more frequent injections may be needed. Children over 12 years of age can use the same dose as adults.<\/p>\n\n\n\n If you have injected more AFSTYLA than you should tell your doctor.<\/p>\n\n\n\n Do not take a double dose to make up for a forgotten dose. Take the next dose immediately and continue according to your doctor’s prescription.<\/p>\n\n\n\n If you stop using AFSTYLA, you may no longer be protected from bleeding or ongoing bleeding may not stop. Do not stop using AFSTYLA without consulting a doctor or pharmacist.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n Like all medicines, AFSTYLA can cause side effects, although not everybody gets them.<\/p>\n\n\n\n Stop taking the AFSTYLA<\/strong> medicine immediately and contact your doctor immediately if:<\/strong><\/p>\n\n\n\n No age-specific differences in adverse reactions were observed between children, adolescents, and adult patients.<\/p>\n\n\n\n The active substance is:<\/strong><\/p>\n\n\n\n 250 IU per vial; after reconstitution with 2.5 ml of water for injections, the solution contains 100 IU \/ ml of lonoktokog alfa.<\/p>\n\n\n\n 500 IU per vial; after reconstitution with 2.5 ml of water for injections, the solution contains 200 IU \/ ml of lonoktokog alfa.<\/p>\n\n\n\n 1000 IU per vial; after reconstitution with 2.5 ml of water for injections, the solution contains 400 IU \/ ml of lonoktokog alfa.<\/p>\n\n\n\n 1500 IU per vial; after reconstitution with 5 ml of water for injections, the solution contains 300 IU \/ ml of lonoktokog alfa.<\/p>\n\n\n\n 2000 IU per vial; after reconstitution with 5 ml of water for injections, the solution contains 400 IU \/ ml of lonoktokog alfa.<\/p>\n\n\n\n 2500 IU per vial; after reconstitution with 5 ml of water for injections, the solution contains 500 IU \/ ml of lonoktokog alfa.<\/p>\n\n\n\n 3000 IU per vial; after reconstitution with 5 ml of water for injections, the solution contains 600 IU \/ ml of lonoktokog alfa. Other ingredients are:<\/strong><\/p>\n\n\n\n L-histidine, polysorbate 80, calcium chloride dihydrate, sodium chloride (see the last paragraph of section 2), sucrose.<\/p>\n\n\n\n Diluent: Water for injections.<\/p>\n\n\n\n AFSTYLA is a white or yellowish powder or brittle mass and clear, colorless solution for injection.<\/p>\n\n\n\n The reconstituted solution should be clear or slightly opalescent, yellow to colorless, ie it may glisten if held against the light, but it must not contain any visible particles.<\/p>\n\n\n\n Packaging designs<\/strong><\/p>\n\n\n\n A pack of 250, 500, or 1000 IU contains:<\/p>\n\n\n\n 1 vial of powder<\/p>\n\n\n\n 1 vial with 2.5 ml of water for injections<\/p>\n\n\n\n 1 transfer set with filter 20\/20<\/p>\n\n\n\n The inner carton contains:<\/p>\n\n\n\n 1 disposable syringe 5 ml<\/p>\n\n\n\n 1 venipuncture set<\/p>\n\n\n\n 2 alcohol dryers<\/p>\n\n\n\n 1 non-sterile patch A pack of 1500, 2000, 2500, or 3000 IU contains:<\/p>\n\n\n\n 1 vial of powder<\/p>\n\n\n\n 1 vial with 5 ml water for injections<\/p>\n\n\n\n 1 transfer set with filter 20\/20<\/p>\n\n\n\n The inner carton contains:<\/p>\n\n\n\n 1 disposable syringe 10 ml<\/p>\n\n\n\n 1 venipuncture set<\/p>\n\n\n\n 2 alcohol dryers<\/p>\n\n\n\n 1 non-sterile patch Inner packaging<\/strong><\/p>\n\n\n\n CSL Behring GmbH<\/p>\n\n\n\n Emil-von-Behring- Stra\u00dfe 76<\/p>\n\n\n\n 35041 Marburg<\/p>\n\n\n\n Germany This leaflet was last amended on 10\/2019.<\/p>\n\n\n\n Further information on this medicine is available on the European Medicines Agency<\/p>\n\n\n\n Treatment monitoring<\/strong><\/p>\n\n\n\n During treatment, determination of factor VIII levels is recommended as a guide for adjusting the dose and dosing intervals for repeated infusions. Individual patients’ responses to factor VIII can vary, showing different half-lives and different levels of the so-called recovery. Dose based on body weight may need to be adjusted in underweight or obese patients. Particularly in the case of major surgical procedures, close monitoring of substitution treatment by coagulation assay ( factor VIII activity in plasma ) is essential.<\/p>\n\n\n\n Using an in vitro thromboplastin time (aPTT) -based one-step coagulation test to determine the factor VIII activity in the patient’s blood sample, the factor VIII activity in plasma can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay. According to Ph. Eur, there may also be significant discrepancies between the assay results obtained from an aPTT-based one-step coagulation assay and chromogenic assay. This is especially important when changing the laboratory and\/or reagents used in the assay.<\/p>\n\n\n\n The plasma factor VIII activity in patients receiving AFSTYLA should be monitored using either a chromogenic assay or a one-step coagulation test to obtain guidance on the dose to be administered and the intervals for repeated injections. Results from chromogenic analysis reflect the clinical hemostatic potential of AFSTYLA most accurately and are preferred. Results from one-step coagulation tests underestimate the factor VIII activity level compared to results from the chromogenic analysis by about 45%. If a one-step coagulation test is used, multiply the result by the conversion factor 2 to determine the patient’s factor VIII activity level.<\/p>\n\n\n\n Dosage<\/strong><\/p>\n\n\n\n The dose and duration of substitution treatment depend on the severity of the factor VIII deficiency, the location and extent of the bleeding, and the patient’s clinical condition.<\/p>\n\n\n\n The number of factor VIII units administered is specified in International Units (IU), which is related to the current WHO concentrate standard for factor VIII products. The factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma ) or preferably in International Units (relative to an international standard for factor VIII in plasma ).<\/p>\n\n\n\n An International Unit (IU) factor VIII activity is equivalent to the amount of factor VIII present in one ml of normal human plasma.<\/p>\n\n\n\n Allocation of strength is determined using chromogenic substrate analysis.<\/p>\n\n\n\n Factor VIII levels in plasma can be monitored using either chromogenic substrate assay or one-stage clotting assay.<\/p>\n\n\n\n Treatment if necessary<\/em><\/p>\n\n\n\n The calculation of the appropriate dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight increases the factor VIII activity in plasma by 2 IU \/ dl.<\/p>\n\n\n\n The following formula can be used to calculate the appropriate dose:<\/p>\n\n\n\n Dose (IU) = body weight (kg) x desired increase of factor VIII (IU \/ dl or% of normal value) x 0.5 (IU \/ kg per IU \/ dl)<\/p>\n\n\n\n The dose administered and the dosing interval should always be adapted to the clinical effect in each individual case.<\/p>\n\n\n\n Prophylaxis<\/em><\/p>\n\n\n\n The recommended starting dose of AFSTYLA is 20 to 50 IU \/ kg administered 2 to 3 times a week. The treatment regimen can be adjusted based on the patient’s response. Pediatric population<\/em><\/p>\n\n\n\n The recommended starting dose of AFSTYLA in children (0 to <12 years) is 30 to 50 IU per kg administered 2 to 3 times a week. For children under 12 years of age, shorter dosing intervals or higher doses may be necessary to compensate for higher clearance in this age group.<\/p>\n\n\n\n For adolescents from 12 years of age, dosing recommendations are the same as for adults.<\/p>\n\n\n\n Older<\/em><\/p>\n\n\n\n Clinical trials of AFSTYLA did not include people over 65 years of age.<\/p>\n","protected":false},"excerpt":{"rendered":" Powder and solvent for solution for injection 250 IU (White or yellowish powder or brittle mass and clear, colorless liquid) What AFSTYLA is and what it is used for AFSTYLA is a human coagulation factor (clotting factor) VIII product produced by recombinant DNA technology. The active substance in AFSTYLA is lonoktokog alfa. Benefits of AFSTYLA AFSTYLA is used to treat and prevent […]<\/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],"tags":[11416,11419,11425,11420,11422,11421,11426,11417,11423,11424,11418],"class_list":["post-4966","post","type-post","status-publish","format-standard","hentry","category-medicines","tag-afstyla","tag-afstyla-powder","tag-benefits-of-lonoktokog-alfa","tag-bwnefits-of-afstyla","tag-lonoktokog-alfa","tag-side-effects-of-afstyla","tag-side-effects-of-lonoktokog-alfa","tag-what-is-afstyla","tag-what-is-lonoktokog-alfa","tag-what-lonoktokog-alfa-is-used-for","tag-wht-afstylais-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/4966","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=4966"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/4966\/revisions"}],"predecessor-version":[{"id":13023,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/4966\/revisions\/13023"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=4966"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=4966"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=4966"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Other drugs and AFSTYLA<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
AFSTYLA contains sodium<\/h2>\n\n\n\n
How to use AFSTYLA<\/h2>\n\n\n\n
Dosage of AFSTYLA<\/h2>\n\n\n\n
<\/p>\n\n\n\nPreparation and administration of AFSTYLA<\/h2>\n\n\n\n
Preparation and administration<\/em> of AFSTYLA<\/h2>\n\n\n\n
<\/a>1
<\/td>1. Open the Mix2Vial by pulling off the cover. Do not<\/strong>remove Mix2Vial from the blister pack!<\/td><\/tr> <\/a>2<\/td> 2. Place the vial of solvent<\/strong> on a flat, clean surface and hold the bottle firmly. Take Mix2Vial with the blister pack and push the tip of the blue<\/strong> adapter part straight down th<\/strong>rough the vial stopper.<\/td><\/tr> <\/a>3<\/td> Carefully remove the blister pack from the Mix2Vial set by grasping the edge and pulling straight<\/strong> up. Make sure that only the blister pack is removed, not the Mix2Vial set.<\/td><\/tr> <\/a>4<\/td> 4. Place the vial of powder<\/strong> on a flat, firm surface. Invert the liquid bottle with the attached Mix2Vial set and push the tip of the transparent<\/strong> adapter part straight down <\/strong>through the stopper of the powder bottle. The liquid will automatically flow over to the powder bottle.<\/td><\/tr> <\/a> 5<\/td> 5. Grasp the part of the Mix2Vial set where the powder bottle is located with one hand and grasp the part where the liquid bottle is with the other hand and carefully unscrew the set counterclockwise into 2 parts.Dispose of the liquid bottle with the blue Mix2Vial part attached.<\/td><\/tr> <\/a> 6<\/td> Carefully rotate the vial of the product with the attached transparent adapter until the powder is completely dissolved. Do not shake the bottle.<\/td><\/tr>
<\/a> 7<\/td>7. Inhale air into an empty, sterile syringe . While the product vial is upright, the syringe is connected to the Luer lid fitting on the Mix2Vial part by turning clockwise. Inject air into the bottle.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n <\/a> 8<\/td> 8. While holding down the syringe plunger, turn the bottle upside down along with the set and syringe . Pull the solution into the syringe by slowly returning the plunger.<\/td><\/tr> <\/a> 9<\/td> 9. Once all the solution has been transferred to the syringe, grasp the syringe firmly (hold the syringe with the plunger down) and disconnect the transparent Mix2Vial adapter from the syringe by unscrewing it counterclockwise.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n Use in children and adolescents<\/h2>\n\n\n\n
If you use too much OFF <\/h2>\n\n\n\n
If you have forgotten to use AFSTYLA<\/h2>\n\n\n\n
If you stop using AFSTYLA<\/h2>\n\n\n\n
Side effects of AFSTYLA<\/h2>\n\n\n\n
For children who have not been treated with factor VIII before, inhibitory antibodies may be formed (see section 2). This complication is classified as very common (affects more than 1 user in 10). However, the risk is classified as uncommon (occurs in less than 1 in 100 users) in patients who have previously been treated with factor VIII (treatment more than 150 days). If this happens, your or your child’s medication may stop working properly and you or your child may experience persistent bleeding. Contact a doctor immediately if this happens.<\/li><\/ul>\n\n\n\nCommon side effects of AFSTYLA (may affect up to 1 in 10 people)<\/h3>\n\n\n\n
Uncommon side effects of AFSTYLA (may affect up to 1 in 100 people)<\/h3>\n\n\n\n
Side effects of AFSTYLA in children and adolescents<\/strong><\/h3>\n\n\n\n
How to STORE AFSTYLA<\/h2>\n\n\n\n
Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
<\/p>\n\n\n\nWhat the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n250 IU<\/td> Vial made of glass with a rubber stopper, an orange cap and a green striped aluminum seal<\/td><\/tr> 500 IU<\/td> Vial made of glass with a rubber stopper, a blue cap and a green striped aluminum seal<\/td><\/tr> 1000 IU<\/td> Vial made of glass with a rubber stopper, a green cap and a green striped aluminum seal<\/td><\/tr> 1500 IU<\/td> Vial made of glass with a rubber stopper, a turquoise cap and a green striped aluminum seal<\/td><\/tr> 2000 IU<\/td> Vial made of glass with a rubber stopper, a purple cap and a green striped aluminum seal<\/td><\/tr> 2500 IU<\/td> Vial made of glass with a rubber stopper, a light gray cap and a green striped aluminum seal<\/td><\/tr> 3000 IU<\/td> Vial made of glass with a rubber stopper, a yellow cap and a green striped aluminum seal<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
<\/p>\n\n\n\nBelgium \/ Belgique \/ Belgien<\/strong>CSL Behring NVTel: +32 15 28 89 20<\/td> Lithuania<\/strong>CSL Behring GmbHTel: +49 69 30584437<\/td><\/tr> Bulgaria<\/strong>They end up in the Republic of BulgariaTel: +359 2 810 3949<\/td> Luxembourg \/ Luxemburg<\/strong>CSL Behring NVTel: +32 15 28 89 20<\/td><\/tr> Czech Republic<\/strong>CSL Behring sroTel: + 420 702 137 233<\/td> Hungary<\/strong>CSL Behring Kft.Tel .: +36 1 213 4290<\/td><\/tr> Denmark<\/strong>CSL Behring ABTel: +46 8 544 966 70<\/td> Malta<\/strong>AM Mangion Ltd.Tel: +356 2397 6333<\/td><\/tr> Germany<\/strong>CSL Behring GmbHTel: +49 69 30584437<\/td> The Netherlands<\/strong>CSL Behring BVTel: + 31 85 111 96 00<\/td><\/tr> Eesti<\/strong>CSL Behring GmbHTel: +49 69 30584437<\/td> Norway<\/strong>CSL Behring ABTel: +46 8 544 966 70<\/td><\/tr> Greece<\/strong>CSL Behring \u0395\u03a0\u0395:\u0397\u03bb: +30 210 7255 660<\/td> Austria<\/strong>CSL Behring GmbHTel: +43 1 80101 2463<\/td><\/tr> Spain<\/strong>CSL Behring SATel: +34 933 67 1870<\/td> Poland<\/strong>CSL Behring Sp.z ooTel: +48 22 213 22 65<\/td><\/tr> France<\/strong>CSL Behring SATel: + 33 – (0) -1 53 58 54 00<\/td> Portugal<\/strong>CSL Behring LdaTel: +351 21 782 62 30<\/td><\/tr> Croatia<\/strong>Marti Farm dooTel: +385 1 5588297<\/td> Romania<\/strong>Prisum International Trading srlTel: +40 21 322 0171<\/td><\/tr> Ireland<\/strong>CSL Behring GmbHTel: +49 69 30517254<\/td> Slovenia<\/strong>MediSanus dooTel: +386 1 25 71 496<\/td><\/tr> Iceland<\/strong>CSL Behring ABPhone: +46 8 544 966 70<\/td> Slovak Republic<\/strong>CSL Behring sroTel: +421 911 653 862<\/td><\/tr> Italy<\/strong>CSL Behring SpATel: +39 02 34964 200<\/td> Finland \/ Finland<\/strong>CSL Behring ABPuh \/ Tel: +46 8 544 966 70<\/td><\/tr> \u039a\u03cd\u03c0\u03c1\u03bf\u03c2<\/strong>CSL Behring \u0395\u03a0\u0395:\u0397\u03bb: +30 210 7255 660<\/td> <\/td><\/tr> Latvia<\/strong>CSL Behring GmbHTel: +49 69 30584437<\/td> United Kingdom<\/strong>CSL Behring UK Ltd.Tel: +44 1444 447405<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n The following information is intended for healthcare professionals only:<\/h2>\n\n\n\n
Bleeding rate \/ Type of surgery<\/strong><\/td> Appropriate factor VIIIlevel<\/strong>(% or IU \/ dl)<\/strong><\/td> Dosage interval (hours) \/<\/strong>Treatment period (days)<\/strong><\/td><\/tr> Bleeding<\/em><\/td>
<\/td>
<\/td><\/tr>Early osteoarthritis, muscle bleeding or oralbleeding<\/td> 20 – 40<\/td> Repeat injection every 12 to 24 hours. At least one day, until the bleeding episode, detected by pain) ceased or healing was achieved.<\/td><\/tr> More extensive osteoarthritis, muscle bleeding, or hematoma<\/td> 30 – 60<\/td> Repeat injection every 12 to 24 hours for 3-4 days or longer, until pain and acute movement restriction have been lifted.<\/td><\/tr> Life-threatening bleeding<\/td> 60 – 100<\/td> Repeat injection every 8 to 24 hours until the critical condition is lifted.<\/td><\/tr> Surgery<\/em><\/td>
<\/td>
<\/td><\/tr>Minor surgeries including tooth extraction<\/td> 30 – 60<\/td> Inject every 24 hours for at least 1 day, until healing is achieved.<\/td><\/tr> Major surgeries<\/em><\/td> 80 – 100(pre- and postoperatively)<\/td> Repeat the injection every 8 to 24 hours until adequate wound healing is achieved, then continue treatment for at least another 7 days to maintain factor VIIIactivity between 30% and 60% (IU \/ dl).<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
<\/p>\n\n\n\n