{"id":5958,"date":"2020-12-29T15:08:20","date_gmt":"2020-12-29T15:08:20","guid":{"rendered":"https:\/\/zeepedia.com\/?p=5958"},"modified":"2021-07-05T07:57:18","modified_gmt":"2021-07-05T07:57:18","slug":"benefix","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/benefix\/","title":{"rendered":"BeneFix &#8211; Nonacog alpha uses, dose and side effects"},"content":{"rendered":"\n<p>\n\n250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU&nbsp;powder and solvent for&nbsp;injection&nbsp;, solution&nbsp;<br>nonacog alpha (&nbsp;recombinant&nbsp;coagulation factor&nbsp;IX)<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What BeneFIX is and what it is used for<\/h2>\n\n\n\n<p>BeneFIX is an&nbsp;injectable&nbsp;product containing&nbsp;coagulation factor&nbsp;IX produced by&nbsp;recombinant DNA&nbsp;technology.&nbsp;The active substance in BeneFIX is nonacog alfa.&nbsp;People born with&nbsp;haemophilia&nbsp;B (Christmas disease) do not have enough&nbsp;coagulation factor&nbsp;IX to control bleeding.&nbsp;BeneFIX works by replacing factor IX in&nbsp;hemophilia&nbsp;B patients to allow their blood to coagulate.<br><\/p>\n\n\n\n<p>BeneFIX is used for treating and preventing bleeding in patients with&nbsp;haemophilia&nbsp;B (&nbsp;congenital&nbsp;haemorrhagic disease&nbsp;I&nbsp;coagulation factor&nbsp;IX) in all age groups.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before using BeneFIX<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use BeneFIX<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to nonacog alfa or any of the other ingredients of this medicine (listed in section 6).<\/li><li>if you are allergic to hamster protein.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>Talk to your doctor or pharmacist before using BeneFIX.<\/li><li>Contact your doctor immediately if the bleeding does not stop as expected.<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li>Allergic reactions are possible.&nbsp;The product may contain traces of hamster proteins (see &#8220;Do not use BeneFIX&#8221;).&nbsp;Potentially life-threatening anaphylactic reactions (severe&nbsp;allergic reaction&nbsp;) have occurred with factor IX products, including BeneFIX.&nbsp;Early signs of allergic reactions include difficulty breathing, shortness of breath, swelling,&nbsp;hives&nbsp;that may be widespread throughout the body,&nbsp;itching&nbsp;, chest tightness, wheezing, low&nbsp;blood pressure&nbsp;, blurred vision and&nbsp;anaphylaxis&nbsp;(severe&nbsp;allergic reaction&nbsp;that may cause difficulty swallowing and \/ or or breathing,&nbsp;redness&nbsp;or swelling of the face and \/ or hands).<\/li><li>If allergic or anaphylactic reactions occur,&nbsp;<strong>discontinue&nbsp;injection&nbsp;of BeneFIX immediately and consult a physician<\/strong>&nbsp;, or seek&nbsp;emergency&nbsp;medical attention&nbsp;immediately&nbsp;.&nbsp;If severe allergic reactions occur, alternative&nbsp;therapy&nbsp;should be considered.<\/li><li>It is less common for previously treated patients receiving factor IX products to develop neutralizing&nbsp;antibodies&nbsp;(inhibitors).&nbsp;However, during treatment with BeneFIX, you should be closely monitored to check if factor IX inhibitors have been developed.&nbsp;The same applies to treatment with all products containing factor IX.<\/li><li>In the literature, it has been reported that there is an association between the presence of factor IX inhibitors and allergic reactions.&nbsp;Therefore, if you get allergic reactions such as those described above, you should be investigated for the presence of inhibitors.&nbsp;It should be noted that patients taking factor IX inhibitors may be at higher risk of&nbsp;anaphylaxis&nbsp;during additional BeneFIX treatment sessions.<\/li><li>The body&#8217;s production of factor IX is regulated by the factor IX gene.&nbsp;Patients who have specific&nbsp;mutations&nbsp;on the factor IX gene, such as larger deletion mutations, may be more likely to develop factor IX inhibitors and \/ or have allergic reactions.&nbsp;If you are known to have such a&nbsp;mutation, your doctor may monitor you extra closely for signs of an&nbsp;allergic reaction, especially when you start treatment with BeneFIX for the first time.<\/li><li>Due to the risk of allergic reactions to factor IX, your first&nbsp;injections&nbsp;of BeneFIX should be given under medical supervision so that appropriate medical treatment for allergic reactions is available.<\/li><li>Even in the absence of inhibitors, a higher&nbsp;dose&nbsp;of BeneFIX may be needed compared to other plasma IX products that you may have taken before.&nbsp;Careful monitoring of factor IX plasma activity (which measures your blood&#8217;s ability to coagulate) must therefore be performed to adjust&nbsp;dose&nbsp;one.&nbsp;If the bleeding is not under control after the recommended&nbsp;dose&nbsp;, consult your doctor.<\/li><li>If you have liver or heart disease or if you have recently undergone surgical treatment, there is an increased risk of clot formation (coagulation complications).<\/li><li>Renal impairment (&nbsp;nephrotic syndrome&nbsp;) has been reported at high&nbsp;doses&nbsp;of factor IX produced by blood plasma in&nbsp;haemophilia&nbsp;B patients with factor IX inhibitors who have previously experienced allergic reactions.<\/li><li>Sufficient data have not been obtained from&nbsp;clinical trials&nbsp;regarding BeneFIX treatment in patients who have not previously received any treatment (patients who have never received a&nbsp;factor IX&nbsp;infusion&nbsp;before&nbsp;).<\/li><li>It is recommended that you note the name and batch number of the product each time you use BeneFIX.&nbsp;You can use one of the removable labels on the bottle to document the batch number in your diary or to report&nbsp;side effects&nbsp;.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and BeneFIX<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n<p>If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, you should only take BeneFIX as&nbsp;prescribed&nbsp;by your doctor.&nbsp;It is not known whether BeneFIX can cause harm to an unborn baby when taken by pregnant women.&nbsp;Your doctor may advise you to stop taking BeneFIX if you are breast-feeding or pregnant.<br><\/p>\n\n\n\n<p>Ask your doctor or pharmacist for advice before taking this medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>BeneFIX has no effect on the ability to drive or use machines.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">BeneFIX contains sodium<\/h2>\n\n\n\n<p>After&nbsp;preparation&nbsp;BeneFIX contains 0.2 mmol (4.6 mg)&nbsp;of sodium&nbsp;per&nbsp;vial&nbsp;, ie essentially &#8220;sodium-free&#8221;.&nbsp;However, depending on your body weight and your&nbsp;dose ofBeneFIX, you may receive several vials.&nbsp;This should be considered if you have been prescribed a low-salt diet.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use BeneFIX<\/h2>\n\n\n\n<p>Always use this medicine exactly as your doctor or pharmacist has told you.&nbsp;Ask your doctor or pharmacist if you are unsure.<br><\/p>\n\n\n\n<p>Your doctor will decide on the&nbsp;dose of&nbsp;one of BeneFIX that you should take.&nbsp;The doseand duration of treatment depends on your individual need for factor IX replacement therapy and how quickly your body uses up factor IX, which will be checked regularly.&nbsp;You may notice a difference in the&nbsp;dose&nbsp;you receive if you switch from a plasma factor IX product to BeneFIX.<br><\/p>\n\n\n\n<p>Your doctor may change the&nbsp;dose&nbsp;of BeneFIX you receive during treatment.<br><\/p>\n\n\n\n<p><strong>Preparation&nbsp;and&nbsp;administration<\/strong><\/p>\n\n\n\n<p>The instructions below are advice for the&nbsp;preparation&nbsp;and&nbsp;administration&nbsp;of BeneFIX.&nbsp;Follow your doctor&#8217;s instructions for venipuncture.<br><\/p>\n\n\n\n<p>BeneFIX is given by&nbsp;intravenous&nbsp;(IV)&nbsp;infusion&nbsp;after&nbsp;reconstitution&nbsp;of the powder for&nbsp;solution&nbsp;for&nbsp;injection&nbsp;with the supplied&nbsp;diluent&nbsp;(sodium chloride (saline) solution) in the pre-filled syringe.<br><\/p>\n\n\n\n<p>Always wash your hands before doing the following.&nbsp;Aseptic technique (meaning clean and germ-free) should be used during&nbsp;reconstitution&nbsp;.<br><\/p>\n\n\n\n<p><strong>Preparation<\/strong>&nbsp;:<\/p>\n\n\n\n<p>BeneFIX is given by&nbsp;intravenous&nbsp;(IV)&nbsp;infusion&nbsp;after&nbsp;reconstitution&nbsp;with&nbsp;sterile&nbsp;diluent&nbsp;.<br><\/p>\n\n\n\n<p>1. Allow the bottle of freeze-dried BeneFIX and the pre-filled syringe to reach room temperature.<br><\/p>\n\n\n\n<p>2. Remove the plastic cap from the BeneFIX bottle so that the middle part of the rubber stopper is visible.<br><\/p>\n\n\n\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.fass.se\/LIF\/product?userType=2&amp;nplId=20070824000023#\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/www.fass.se\/res\/RootMedia\/Wyeth\/Media\/BeneFIX\/Bild1.jpg\" alt=\"The picture describes how the plastic cap is removed\"\/><\/a><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<p>3. Clean the stopper with the supplied&nbsp;compress&nbsp;one with alcohol or use another&nbsp;antiseptic&nbsp;solution and let it dry.&nbsp;Do not touch the rubber stopper with your hand after cleaning and do not allow the stopper to come into contact with any surface.<br><\/p>\n\n\n\n<p>4. Remove the cap from the bottle adapter&#8217;s clear plastic package.&nbsp;Do not remove the adapter from the package.<br><\/p>\n\n\n\n<p>5. Place the bottle on a flat surface.&nbsp;While holding the adapter package, place the adapter over the bottle.&nbsp;Press firmly down on the package until the adapter clicks into place at the top of the bottle and the adapter needle passes through the rubber stopper of the bottle.<br><\/p>\n\n\n\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.fass.se\/LIF\/product?userType=2&amp;nplId=20070824000023#\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/www.fass.se\/res\/RootMedia\/Wyeth\/Media\/BeneFIX\/Bild2.jpg\" alt=\"The picture describes how the adapter is put on the bottle\"\/><\/a><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<p>6. Lift the package off the adapter and discard the package.<br><\/p>\n\n\n\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.fass.se\/LIF\/product?userType=2&amp;nplId=20070824000023#\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/www.fass.se\/res\/RootMedia\/Wyeth\/Media\/BeneFIX\/Bild3.jpg\" alt=\"The picture describes how to remove the packaging from the adapter\"\/><\/a><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<p>7. Attach the piston rod to the syringe with&nbsp;diluent&nbsp;by pressing and screwing firmly.<br><\/p>\n\n\n\n<p>8. Break the plastic cap from the syringe with&nbsp;diluent&nbsp;by breaking the perforation on the cap.&nbsp;This is done by bending up and down until the perforation is broken.&nbsp;Do not touch the inside of the cap or the top of the syringe.&nbsp;The lid may need to be used again (unless the reconstituted BeneFIX is administered immediately), so set it aside by placing it on top.<br><\/p>\n\n\n\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.fass.se\/LIF\/product?userType=2&amp;nplId=20070824000023#\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/www.fass.se\/res\/RootMedia\/Wyeth\/Media\/BeneFIX\/Bild4.jpg\" alt=\"The picture describes how the plastic lid is broken from the syringe\"\/><\/a><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<p>9. Place the bottle on a flat surface.&nbsp;Attach the&nbsp;diluent&nbsp;with the&nbsp;diluent&nbsp;to the bottle adapter by placing the top of the syringe in the adapter opening while pressing firmly and screwing the syringe clockwise until it has stabilized in place.<br><\/p>\n\n\n\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.fass.se\/LIF\/product?userType=2&amp;nplId=20070824000023#\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/www.fass.se\/res\/RootMedia\/Wyeth\/Media\/BeneFIX\/Bild5.jpg\" alt=\"The picture describes how the syringe is attached to the bottle\"\/><\/a><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<p>10. Slowly push in the plunger to transfer all the liquid to the bottle of BeneFIX.<br><\/p>\n\n\n\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.fass.se\/LIF\/product?userType=2&amp;nplId=20070824000023#\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/www.fass.se\/res\/RootMedia\/Wyeth\/Media\/BeneFIX\/Bild6.jpg\" alt=\"The picture describes how the plunger is pushed into the syringe\"\/><\/a><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<p>11. Without removing the syringe from the adapter, gently rotate the bottle until the powder has dissolved.<br><\/p>\n\n\n\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.fass.se\/LIF\/product?userType=2&amp;nplId=20070824000023#\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/www.fass.se\/res\/RootMedia\/Wyeth\/Media\/BeneFIX\/Bild7.jpg\" alt=\"The picture describes how the bottle is rotated\"\/><\/a><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<p>12. The finished solution should be inspected visually for particulate matter prior to&nbsp;administration&nbsp;.&nbsp;The solution should be clear and colorless.<br><\/p>\n\n\n\n<p>Note: If you use more than one bottle of BeneFIX per&nbsp;injection&nbsp;, each bottle should be reconstituted according to the previous instructions.&nbsp;The&nbsp;diluent&nbsp;syringe&nbsp;should be removed, the bottle adapter left in place, and a separate large luer syringe (a device that connects the syringe to the bottle) can be used to draw the reconstituted contents from each bottle.<br><\/p>\n\n\n\n<p>13. Make sure the syringe plunger is still fully depressed, and then turn the bottle upside down.&nbsp;Slowly withdraw all solution to the syringe.<br><\/p>\n\n\n\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.fass.se\/LIF\/product?userType=2&amp;nplId=20070824000023#\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/www.fass.se\/res\/RootMedia\/Wyeth\/Media\/BeneFIX\/Bild8.jpg\" alt=\"The picture describes how all the solution is withdrawn to the syringe\"\/><\/a><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<p>14. Remove the syringe from the bottle adapter by gently pulling and screwing the syringe counterclockwise.&nbsp;Discard the bottle with its fitted adapter.<br><\/p>\n\n\n\n<p>Note: If the solution is not to be used immediately, carefully place the spray cap back in place.&nbsp;Do not touch the top of the syringe or the inside of the cap.<br><\/p>\n\n\n\n<p>BeneFIX should be administered immediately or within 3 hours after&nbsp;reconstitution&nbsp;.&nbsp;The reconstituted solution should be stored at room temperature before&nbsp;administration&nbsp;.<br><\/p>\n\n\n\n<p><strong>Administration&nbsp;(&nbsp;intravenous&nbsp;injection&nbsp;)<\/strong><\/p>\n\n\n\n<p>BeneFIX should be administered using the supplied pre-filled syringe or&nbsp;steriledisposable plastic lure syringe.&nbsp;In addition, the solution should be withdrawn from the vial using the vial adapter<br><\/p>\n\n\n\n<p>BeneFIX should be injected&nbsp;intravenously&nbsp;over several minutes.&nbsp;Your doctor may change your recommended injection rate to make&nbsp;the injection&nbsp;more comfortable for you.<br><\/p>\n\n\n\n<p>There have been reports of agglutination of&nbsp;red blood cells&nbsp;in the tubing \/ syringe during&nbsp;administration&nbsp;of BeneFIX.&nbsp;No&nbsp;side effects&nbsp;have been reported as a result of this observation.&nbsp;To reduce the risk of sticking, it is important to limit the amount of blood that enters the tube.&nbsp;Blood should not enter the syringe.&nbsp;If&nbsp;red blood cellsticking&nbsp;in the tubing \/ syringe is observed, discard all affected material (tubing,&nbsp;syringe&nbsp;and BeneFIX solution) and continue&nbsp;administration&nbsp;with a new pack.<br><\/p>\n\n\n\n<p>As&nbsp;continuous&nbsp;infusion&nbsp;(drip) of BeneFIX has not been evaluated, BeneFIX must not be mixed with infusion solutions or given as a drip.<br><\/p>\n\n\n\n<p>Any unused solution, empty vials, used needles and syringes should be disposed of in an appropriate manner to avoid injury to others.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you use more BeneFIX than you should<\/h2>\n\n\n\n<p>Contact your doctor immediately if you have injected more BeneFIX than your doctor recommended.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop using BeneFIX<\/h2>\n\n\n\n<p>Do not stop using BeneFIX without consulting a doctor.<br><\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">4. Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause&nbsp;side effects, although not everybody gets them.<br><\/p>\n\n\n\n<p><strong>Hypersensitivity reactions \/ allergic reactions<\/strong><\/p>\n\n\n\n<p>Allergic reactions such as&nbsp;hypersensitivity reactions&nbsp;are possible with BeneFIX.&nbsp;Such reactions may include swelling of the face or throat, burning and stinging sensation at the infusion site, chills, hot flashes,&nbsp;itching&nbsp;, headache,&nbsp;hives&nbsp;, low&nbsp;blood pressure&nbsp;,&nbsp;lethargy&nbsp;, nausea, restlessness, rapid heart rate, chest tightness, tingling, vomiting, wheezing.&nbsp;In some cases, these reactions have developed into severe&nbsp;anaphylaxis&nbsp;.&nbsp;Allergic reactions have occurred over time close to the development of factor IX inhibitors (see also \u201cWarnings and Precautions\u201d).<br><\/p>\n\n\n\n<p>These reactions can be life-threatening.&nbsp;If allergic \/ anaphylactic reactions occur,&nbsp;<strong>discontinue&nbsp;infusion&nbsp;of BeneFIX immediately and contact your doctor<\/strong>&nbsp;or seek immediate&nbsp;emergency&nbsp;care.&nbsp;The treatment to be used depends on the nature and severity of the&nbsp;side effects&nbsp;(see also \u201cWarnings and Precautions\u201d).<br><\/p>\n\n\n\n<p><strong>Inhibitor development<\/strong><\/p>\n\n\n\n<p>Patients with&nbsp;haemophilia&nbsp;B may develop neutralizing&nbsp;antibodies&nbsp;(inhibitors) to factor IX.&nbsp;An indication that such inhibitors have been developed may be that an increase in the amount of BeneFIX normally required to treat a haemorrhage or continued haemorrhage after treatment is required.&nbsp;In such cases, it is recommended that a specialized haemophilia center be contacted.&nbsp;Your doctor may want to monitor you to see if any inhibitors develop (see &#8220;Warnings and Precautions&#8221;).<br><\/p>\n\n\n\n<p>Renal impairment has been reported following high&nbsp;doses&nbsp;of plasma-derived factor IX products to induce immune tolerance in patients with&nbsp;haemophilia&nbsp;B and factor IX inhibitors and who have previously had allergic reactions (see also \u201cWarnings and precautions\u201d).<br><\/p>\n\n\n\n<p><strong>Blood clots<\/strong><\/p>\n\n\n\n<p>BeneFIX may increase the risk of&nbsp;thrombosis&nbsp;(formation of blood clots) in your body if you have risk factors for the formation of blood clots.&nbsp;A residual venous catheter can also be a risk factor for blood clots.&nbsp;There have been reports of severe thrombotic events, including life-threatening blood clots in severely ill newborns receiving BeneFIX by drip into a central venous catheter.&nbsp;Cases of&nbsp;peripheralthrombophlebitis&nbsp;(pain and&nbsp;redness&nbsp;of veins) and deep&nbsp;vein thrombosis&nbsp;(blood clots in the arms and legs) have also been reported.&nbsp;In most cases, BeneFIX had been administered by drip, which is not an approved method of administration.<br><\/p>\n\n\n\n<p><strong>Very common&nbsp;side effect&nbsp;are<\/strong>&nbsp;(can occur in more than 1 in 10)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Headache<\/li><li>Cough<\/li><li>Fever<\/li><\/ul>\n\n\n\n<p><strong>Common&nbsp;side effects&nbsp;are<\/strong>&nbsp;(may affect up to 1 in 10 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Hypersensitivity reactions \/ allergic reactions<\/li><li>Dizziness, altered taste<\/li><li>Phlebitis&nbsp;(pain and&nbsp;redness&nbsp;of veins), hot flashes<\/li><li>Vomiting, nausea<\/li><li>Skin rash,&nbsp;hives<\/li><li>Chest discomfort (including chest pain)<\/li><li>Infusion site reactions (including&nbsp;itching&nbsp;and&nbsp;redness&nbsp;at the infusion site), pain and discomfort at the infusion site<\/li><\/ul>\n\n\n\n<p><strong>Less common&nbsp;side effects&nbsp;are<\/strong>&nbsp;(may affect more than 1 in 100 people)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Development of neutralizing&nbsp;antibodies&nbsp;(inhibitors)<\/li><li>Cellulite&nbsp;at the infusion site (pain and&nbsp;redness&nbsp;of the skin)<\/li><li>Fatigue, tremors<\/li><li>Visual impairment (including blurred vision, blemishes and streaks of light in front of the eyes)<\/li><li>Fast heart rate, low&nbsp;blood pressure<\/li><li>Renal infarction (stop blood flow to the kidney)<\/li><\/ul>\n\n\n\n<p><strong>Adverse reactions&nbsp;with no known frequency<\/strong>&nbsp;(frequency can not be calculated from the available data)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Anaphylactic reaction<\/li><li>Thrombotic events (abnormal blood clots)<\/li><li>Lack of response to treatment (failure to stop or prevent bleeding episodes)<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store BeneFIX<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<br><\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the carton and bottle label.&nbsp;The expiration date is the last day of the specified month.<br><\/p>\n\n\n\n<p>BeneFIX must be stored at a maximum of 30 \u00b0 C and used before the expiry date which is stated on the label.<br><\/p>\n\n\n\n<p>Do not freeze to avoid damaging the pre-filled syringe.<br><\/p>\n\n\n\n<p>Use the reconstituted solution immediately, but not later than 3 hours after&nbsp;reconstitution&nbsp;.<br><\/p>\n\n\n\n<p>Do not use BeneFIX if the solution is not clear and colorless.<br><\/p>\n\n\n\n<p>Use only the pre-filled syringe that is included in the package for&nbsp;reconstitution&nbsp;.&nbsp;Other sterile disposable syringes may be used for&nbsp;administration&nbsp;.<br><\/p>\n\n\n\n<p>Medicines should not be disposed of via wastewater or household waste.&nbsp;Ask your pharmacist how to dispose of medicines no longer required.&nbsp;These measures will help to protect the environment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">6. Contents of the packaging and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content declaration<\/h2>\n\n\n\n<p>&#8211; The active substance is nonacog alfa (&nbsp;recombinant&nbsp;coagulation factor&nbsp;IX).&nbsp;Each&nbsp;vial of&nbsp;BeneFIX nominally contains 250, 500, 1000, 1500, 2000 or 3000 IU nonacog alfa.<\/p>\n\n\n\n<p>The other ingredients are sucrose,&nbsp;glycine&nbsp;, L-histidine, polysorbate 80. A&nbsp;diluent(0.234% sodium chloride solution) is also included in the&nbsp;preparation&nbsp;.<\/p>\n\n\n\n<p>&#8211; After&nbsp;reconstitution&nbsp;with the supplied&nbsp;diluent&nbsp;(0.234% sodium chloride solution), each&nbsp;vial&nbsp;contains&nbsp;50, 100, 200, 300, 400 or 600 IU \/ ml (see Table 1).<br><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><thead><tr><th scope=\"col\"><strong>Amount of BeneFIX per bottle<\/strong><\/th><th scope=\"col\"><strong>Amount of BeneFIX per 1 ml of reconstituted&nbsp;solution for injection<\/strong><\/th><\/tr><\/thead><tbody><tr><td>250 IU<\/td><td>50 IU<\/td><\/tr><tr><td>500 IU<\/td><td>100 IU<\/td><\/tr><tr><td>1000 IU<\/td><td>200 IU<\/td><\/tr><tr><td>1500 IU<\/td><td>300 IU<\/td><\/tr><tr><td>2000 IU<\/td><td>400 IU<\/td><\/tr><tr><td>3000 IU<\/td><td>600 IU<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and contents of the pack<\/h2>\n\n\n\n<p>BeneFIX is supplied as a powder for&nbsp;solution&nbsp;for&nbsp;injection&nbsp;in a&nbsp;glass&nbsp;vial&nbsp;and a&nbsp;diluent in a pre-filled&nbsp;syringe&nbsp;.<br><\/p>\n\n\n\n<p><strong>Package contents:<\/strong><\/p>\n\n\n\n<p>\u00b7 A&nbsp;vial&nbsp;BeneFIX 250, 500, 1000, 1500, 2000 or 3000 IU powder<\/p>\n\n\n\n<p>\u00b7 A pre-filled&nbsp;syringe&nbsp;with&nbsp;diluent&nbsp;, 5 ml&nbsp;sterile&nbsp;0.234% sodium chloride solution for&nbsp;injection&nbsp;for&nbsp;reconstitution&nbsp;, with flask<\/p>\n\n\n\n<p>\u00b7 A&nbsp;sterile&nbsp;bottle&nbsp;preparation&nbsp;adapter<\/p>\n\n\n\n<p>\u00b7 A sterile injection set<\/p>\n\n\n\n<p>\u00b7 Two&nbsp;compresses&nbsp;are with alcohol<\/p>\n\n\n\n<p>\u00b7 A&nbsp;patch<\/p>\n\n\n\n<p>\u00b7 A&nbsp;compress<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorisation Holder<\/h2>\n\n\n\n<p>Pfizer Europe MA EEIG<\/p>\n\n\n\n<p>Boulevard de la Plaine 17<\/p>\n\n\n\n<p>1050 Brussels<\/p>\n\n\n\n<p>Belgium<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Wyeth Farma SA<\/p>\n\n\n\n<p>Autovia del Norte.A-1, Km.&nbsp;23. Desvio Algete, Km.&nbsp;1, 28700 San Sebastian de los Reyes, Madrid<\/p>\n\n\n\n<p>Spain<br><\/p>\n\n\n\n<p>Contact the representative of the marketing authorization holder to find out more about this medicine:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><thead><tr><td><strong>Belgium \/ Belgique \/ Belgien<\/strong>Pfizer SA \/ NVTel: +32 (0) 2 554 62 11<\/td><td><strong>Lithuania<\/strong>Pfizer Luxembourg SARL branches in LithuaniaTel.&nbsp;+3705 2514000<\/td><\/tr><\/thead><tbody><tr><td><strong>Bulgaria<\/strong>Pfizer Luxembourg SAAR\u041b, Clone of BulgariaTel: +359 2 970 4333<\/td><td><strong>Luxembourg \/ Luxemburg<\/strong>Pfizer SATel: +32 (0) 2 554 62 11<\/td><\/tr><tr><td><strong>Czech Republic<\/strong>Pfizer, spol.&nbsp;s roTel: +420 283 004 111<\/td><td><strong>Hungary<\/strong>Pfizer Kft.Tel .: + 36 1 488 37 00<\/td><\/tr><tr><td><strong>Denmark<\/strong>Pfizer ApSTel: +45 44 20 11 00<\/td><td><strong>Malta<\/strong>Vivian Corporation Ltd.Tel: + 356 21 344610<\/td><\/tr><tr><td><strong>Germany<\/strong>Pfizer Pharma GmbHTel: +49 (0) 30 550055 51000<\/td><td><strong>The Netherlands<\/strong>Pfizer bvTel: +31 (0) 10 406 43 01<\/td><\/tr><tr><td><strong>Eesti<\/strong>Pfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500<\/td><td><strong>Norway<\/strong>Pfizer ASTel: +47 67 52 61 00<\/td><\/tr><tr><td><strong>Greece<\/strong>PFIZER \u0395\u039b\u039b\u0391\u03a3 \u0391.\u0395.:\u0397\u03bb: +30 210 67 85 800<\/td><td><strong>Austria<\/strong>Pfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0<\/td><\/tr><tr><td><strong>Spain<\/strong>Pfizer SLTel: +34 91 490 99 00<\/td><td><strong>Poland<\/strong>Pfizer Polska Sp.&nbsp;z oo,Tel .: +48 22 335 61 00<\/td><\/tr><tr><td><strong>France<\/strong>PfizerTel: +33 (0) 1 58 07 34 40<\/td><td><strong>Portugal<\/strong>Pfizer Laboratories, Lda.Tel: +351 21 423 5500<\/td><\/tr><tr><td><strong>Croatia<\/strong>Pfizer Croatia dooTel: + 385 1 3908 777<\/td><td><strong>Romania<\/strong>Pfizer Rom\u00e2nia SRLTel: +40 21 207 28 00<\/td><\/tr><tr><td><strong>Ireland<\/strong>Pfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161<\/td><td><strong>Slovenia<\/strong>Pfizer Luxembourg SARLPfizer, a company in the field of pharmaceuticals, LjubljanaTel: + 386 (0) 1 52 11 400<\/td><\/tr><tr><td><strong>Iceland<\/strong>Icepharma hf.Phone: + 354 540 8000<\/td><td><strong>Slovak Republic<\/strong>Pfizer Luxembourg SARL, organizerTel: + 421-2-3355 5500<\/td><\/tr><tr><td><strong>Italy<\/strong>Pfizer SrlTel: +39 06 33 18 21<\/td><td><strong>Finland \/ Finland<\/strong>Pfizer OyPuh \/ Tel: +358 (0) 9 43 00 40<\/td><\/tr><tr><td><strong>\u039a\u03cd\u03c0\u03c1\u03bf\u03c2<\/strong>PFIZER \u0395\u039b\u039b\u0391\u03a3 \u0391.\u0395.&nbsp;(CYPRUS BRANCH):\u0397\u03bb: +357 22 817690<\/td><td><\/td><\/tr><tr><td><strong>Latvia<\/strong>Pfizer Luxembourg SARL subsidiary Latvij\u0101Tel: +371 670 35 775<\/td><td><strong>United Kingdom<\/strong>Pfizer LimitedTel: +44 (0) 1304 616161<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>BeneFIX is an injectable product containing coagulation factor IX produced by recombinant DNA technology. The active substance in BeneFIX is nonacog alfa. People born with haemophilia B (Christmas disease) do not have enough coagulation factor IX to control bleeding. BeneFIX works by replacing factor IX in hemophilia B patients to allow their blood to coagulate.<\/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":[2202,2200],"tags":[9138,9141,9140,9133,9136,9135,9142,9134,9137,9139],"class_list":["post-5958","post","type-post","status-publish","format-standard","hentry","category-b","category-medicines","tag-benefix","tag-benefix-injection","tag-benefix-side-effects","tag-nonacog-alpha","tag-nonacog-alpha-injection","tag-nonacog-alpha-side-effects","tag-what-benefix-is-used-for","tag-what-is-nonacog-alpha","tag-what-nonacog-alpha-is-used-for","tag-wht-is-benefix"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5958","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=5958"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5958\/revisions"}],"predecessor-version":[{"id":12105,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5958\/revisions\/12105"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=5958"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=5958"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=5958"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}