{"id":6290,"date":"2021-01-04T15:17:08","date_gmt":"2021-01-04T15:17:08","guid":{"rendered":"https:\/\/zeepedia.com\/?p=6290"},"modified":"2021-06-24T18:06:46","modified_gmt":"2021-06-24T18:06:46","slug":"bupivacaine-accord","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/bupivacaine-accord\/","title":{"rendered":"Bupivacaine Accord &#8211; Bupivacaine hydrochloride uses, dose and side effects"},"content":{"rendered":"\n<p>\n\n2.5 mg \/ ml, 5 mg \/ ml&nbsp;injection&nbsp;solution&nbsp;<br>bupivacaine hydrochloride<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Bupivacaine Accord is and what it is used for<\/h2>\n\n\n\n<p>Bupivacaine Accord contains the active substance bupivacaine hydrochloride.&nbsp;It belongs to a group of medicines called&nbsp;amide-type&nbsp;local anesthetics.<\/p>\n\n\n\n<p>Bupivacaine Accord is used to numb parts of the body.&nbsp;It is used to prevent pain or to provide pain relief.&nbsp;It can be used to:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>numb parts of the body during surgery in adults and children from 12 years of age<\/li><li>relieve pain during childbirth<\/li><li>relieve pain in adults, infants, and children from 1 year of age.<\/li><\/ul>\n\n\n\n<p>Bupivacaine hydrochloride contained in Bupivacaine Accord may also be approved for the treatment of other conditions not mentioned in this product information.&nbsp;Ask your doctor, pharmacist, or another healthcare professional if you have any further questions and always follow their instructions<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before taking Bupivacaine Accord<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Bupivacaine Accord:<\/h2>\n\n\n\n<p><strong>Bupivacaine Accord should not be given:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to bupivacaine hydrochloride or any of the other ingredients of this medicine (listed in section 6)<\/li><li>if you are allergic to any other local anesthetic in the same class (eg&nbsp;lidocaine&nbsp;or ropivacaine)<\/li><li>if you have a skin infection near the place where you should get the&nbsp;injection&nbsp;one<\/li><li>if you have something called a&nbsp;cardiogenic&nbsp;shock&nbsp;(a condition that means that the heart cannot transport enough blood to the body)<\/li><li>if you have something called hypovolemic&nbsp;shock&nbsp;(very low&nbsp;blood pressure&nbsp;leading to collapse)<\/li><li>if you have problems with blood clotting (coagulation disorder) or ongoing treatment with blood thinners<\/li><li>if you have diseases of the brain or spine&nbsp;meningitis&nbsp;(&nbsp;meningitis&nbsp;), polio, or ryggkotsinflammation (spondylitis)<\/li><li>if you have a severe headache due to bleeding in the brain (&nbsp;intracranial hemorrhage)<\/li><li>if you have spinal cord problems due to&nbsp;anemia&nbsp;(&nbsp;anemia&nbsp;)<\/li><li>if you have sepsis (&nbsp;septicemia&nbsp;)<\/li><li>if you have recently suffered an injury, tuberculosis, or&nbsp;tumor in&nbsp;your spine<\/li><li>if you get&nbsp;obstetric&nbsp;paracervical blockage (a type of anesthesia during childbirth)<\/li><\/ul>\n\n\n\n<p>You should not receive a Bupivacaine Accord if any of the above apply to you.&nbsp;If you are not sure, talk to your doctor or nurse before getting Bupivacaine Accord.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and Precautions<\/h2>\n\n\n\n<p>Tell your doctor or nurse before you are given Bupivacaine Accord:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you have heart, kidney, or liver problems.&nbsp;This is because your doctor may need to adjust the&nbsp;dose of&nbsp;a Bupivacaine Accord<\/li><li>if you have a swollen stomach due to more fluid than normal<\/li><li>if you have a&nbsp;tumor&nbsp;in your stomach<\/li><li>if you have been told that you have reduced blood volume in your body (&nbsp;hypovolemia&nbsp;)<\/li><li>if you have fluid in your lungs<\/li><li>if you have&nbsp;epilepsy<\/li><li>if you are to receive adrenaline-containing bupivacaine for special techniques (eg, penis-blocked, colon-blocked) to numb parts of the body where areas of the arteries are affected.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Children<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>For children under 12 years of age: Some&nbsp;injections&nbsp;of Bupivacaine Accord used to numb parts of the body during surgery have not been established in younger children.&nbsp;The use of Bupivacaine Accord has not been established in children under 1 year of age.<\/li><\/ul>\n\n\n\n<p>If you are not sure if any of the above applies to you, talk to your doctor or nurse before taking Bupivacaine Accord.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Bupivacaine Accord<\/h2>\n\n\n\n<p>Tell your doctor if you are taking, have recently taken, or might take any other medicines.&nbsp;This also applies to over-the-counter ones and herbal medicines.&nbsp;This is because Bupivacaine Accord may affect the way some medicines work and some medicines may affect the way Bupivacaine Accord works.<\/p>\n\n\n\n<p>This is especially true if you are taking any of the following medicines:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Drugs used to treat irregular heartbeats (&nbsp;arrhythmia&nbsp;) such as&nbsp;lidocaine, mexiletine, or&nbsp;amiodarone.<\/li><li>Drugs used to prevent blood clotting (&nbsp;anticoagulants&nbsp;).<\/li><\/ul>\n\n\n\n<p>Your doctor needs to know that you are taking these medicines in order to calculate the correct&nbsp;dose of&nbsp;Bupivacaine Accord for you.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n<p><em>Pregnancy<\/em><\/p>\n\n\n\n<p>There are no or limited amount of data from the use of Bupivacaine Accord in pregnant women.&nbsp;If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.<br><\/p>\n\n\n\n<p><em>Breast-feeding<\/em><\/p>\n\n\n\n<p>Bupivacaine Accord passes into breast milk.&nbsp;Discuss options with your doctor if you are breast-feeding.<br><\/p>\n\n\n\n<p><em>Fertility<\/em><\/p>\n\n\n\n<p>There are no data on the effect of bupivacaine hydrochloride on&nbsp;human&nbsp;fertility.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Bupivacaine Accord may make you feel tired and affect your ability to react.&nbsp;Once you have received the Bupivacaine Accord, do not drive or use any tools or machines until the following day.<br><\/p>\n\n\n\n<p>You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.&nbsp;One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or&nbsp;side effects.&nbsp;Descriptions of these effects and&nbsp;side effects&nbsp;can be found in other sections.&nbsp;Read all the information in this leaflet for guidance.&nbsp;If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Bupivacaine Accord contains sodium<\/h2>\n\n\n\n<p>1 ml Bupivacaine Accord 0.25% w \/ v&nbsp;solution for injection&nbsp;contains 0.15 mmol (3.4 mg)&nbsp;sodium&nbsp;.&nbsp;1 ml Bupivacaine Accord 0.5% w \/ v&nbsp;solution for injection&nbsp;contains 0.14 mmol (3.2 mg)&nbsp;sodium&nbsp;.&nbsp;This should be considered in patients prescribed a low-salt diet.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use Bupivacaine Accord<\/h2>\n\n\n\n<p>You get Bupivacaine Accord from a doctor.&nbsp;Your doctor has knowledge of the correct&nbsp;administration&nbsp;of this medicine.<br><\/p>\n\n\n\n<p>The&nbsp;dose&nbsp;that your doctor gives you depends on the type of pain relief you need and in which part of your body the medicine is to be administered.&nbsp;It also depends on your body size, age, and physical condition.&nbsp;Usually, one&nbsp;dose&nbsp;is enough, but several&nbsp;doses&nbsp;can be administered if the operation takes a long time.<br><\/p>\n\n\n\n<p>You will receive the Bupivacaine Accord as an&nbsp;injection&nbsp;or&nbsp;infusion&nbsp;.&nbsp;In which part of the body you get the&nbsp;injection&nbsp;one depends on why you are getting Bupivacaine Accord.&nbsp;Your doctor may give you Bupivacaine Accord in the following places:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Close to the part of the body to be anesthetized.<\/li><li>In an area that is not close to the part of the body that is to be anesthetized.&nbsp;This is the case when you get an&nbsp;epidural injection&nbsp;(an&nbsp;injection&nbsp;around the spinal cord).<\/li><\/ul>\n\n\n\n<p>When Bupivacaine Accord is injected into the body in one of these ways, it leads to the nerves not being able to send pain messages to the brain.&nbsp;The effect slowly disappears when the procedure is completed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you take more Bupivacaine Accord than you should<\/h2>\n\n\n\n<p>It is unlikely that you will get serious&nbsp;side effects&nbsp;if you get too much Bupivacaine Accord.&nbsp;They require special treatment and the doctor treating you is trained to deal with these situations.&nbsp;The first signs that you have received too much Bupivacaine Accord are usually the following:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>You feel dizzy or unsteady<\/li><li>Numbness in the lips and around the mouth<\/li><li>Numbness in the tongue<\/li><li>Hearing problems<\/li><li>Vision problems<\/li><\/ul>\n\n\n\n<p>To reduce the risk of serious&nbsp;side effects, your doctor should stop giving you Bupivacaine Accord as soon as these signs occur.&nbsp;This means that if any of these affect you, or if you think you have been given too much Bupivacaine Accord, tell your doctor straight away.<br><\/p>\n\n\n\n<p>More serious&nbsp;side effects&nbsp;that can occur if you have received too much Bupivacaine Accord are muscle twitching, seizures, and unconsciousness.<\/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>Severe allergic reactions (rare, may affect up to 1 in 1,000 people)<\/strong><\/p>\n\n\n\n<p>In case of signs of a severe&nbsp;allergic reaction, contact a doctor immediately.&nbsp;These signs may include sudden onset of:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Swelling of face, lips, tongue, and throat.&nbsp;This can make it difficult to swallow<\/li><li>Severe or sudden swelling of the hands, feet, and ankles<\/li><li>Breathing difficulties<\/li><li>Severe&nbsp;itching&nbsp;of the skin (with raised lumps)<\/li><\/ul>\n\n\n\n<p><strong>Other possible side effects:<\/strong><\/p>\n\n\n\n<p><strong>Very common: may affect more than 1 user in 10<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Low&nbsp;blood pressure.&nbsp;This can make you feel dizzy or unsteady<\/li><li>Nausea<\/li><\/ul>\n\n\n\n<p><strong>Common: may affect up to 1 in 10 users<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Nausea (vomiting)<\/li><li>Dizziness<\/li><li>Tingling and numbness<\/li><li>High&nbsp;blood pressure&nbsp;(&nbsp;hypertension&nbsp;)<\/li><li>Slow heartbeat<\/li><li>Difficulty urinating<\/li><\/ul>\n\n\n\n<p><strong>Less common;&nbsp;may affect up to 1 in 100 users<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Feeling unsteady<\/li><li>Seizures<\/li><li>Numbness in the tongue or around the mouth<\/li><li>Earrings or sound sensitivity<\/li><li>Speech difficulties<\/li><li>Dimsyn<\/li><li>Unconsciousness<\/li><li>Tremors (&nbsp;tremor&nbsp;)<\/li><li>Muscle twitches<\/li><\/ul>\n\n\n\n<p><strong>Rare may affect up to 1 in 1,000 people<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Double vision<\/li><li>Nerve damage can lead to sensory changes or muscle weakness (&nbsp;neuropathy).&nbsp;This may include&nbsp;peripheral&nbsp;nerve damage (mainly in the arms and\/or legs)<\/li><li>A condition called arachnoiditis (&nbsp;inflammation&nbsp;of the membrane surrounding the spinal cord).&nbsp;Signs include stabbing or burning pain in the lower back or legs, and tingling, numbness, or weakness in the legs<\/li><li>Weak or paralyzed legs<\/li><li>Uneven heartbeat (&nbsp;arrhythmia&nbsp;).&nbsp;This can be life-threatening<\/li><li>Slow breathing or respiratory arrest or cardiac arrest.&nbsp;This can be life-threatening<\/li><\/ul>\n\n\n\n<p><strong>Any&nbsp;side effects&nbsp;seen with other&nbsp;local anesthetics&nbsp;that may also be caused by the Bupivacaine Accord include:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Problem with liver enzymes.&nbsp;This may occur with long-term treatment with this medicine<\/li><li>Nerve damage.&nbsp;This can in rare cases become permanent<\/li><li>Non-permanent blindness or problems with the muscles of the eyes that are long-lasting.&nbsp;This can happen with certain&nbsp;injections&nbsp;given around the eyes<\/li><\/ul>\n\n\n\n<p>Do not worry about this list of possible&nbsp;side effects.&nbsp;You may not get any of them.<br><\/p>\n\n\n\n<p><em>Reporting of side effects<\/em><\/p>\n\n\n\n<p>If you get any side effects, talk to your doctor, pharmacist, or nurse.&nbsp;This includes any possible side effects not listed in this leaflet.&nbsp;You can also report side effects directly to the Medical Products Agency,&nbsp;www.lakemedelsverket.se.&nbsp;By reporting side effects, you can help increase drug safety information.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Bupivacaine Accord<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<br><\/p>\n\n\n\n<p>Use before the expiry date which is stated on the&nbsp;ampoule, vial, and carton.&nbsp;The expiration date is the last day of the specified month.<br><\/p>\n\n\n\n<p>Do not use this medicine if you notice that the contents are discolored in any way or if there are particles.<br><\/p>\n\n\n\n<p>Store in a cold place.&nbsp;Do not freeze.<br><\/p>\n\n\n\n<p>Bupivacaine Accord is usually stored by a doctor or hospital and they are responsible for the quality of the medicine once it has been opened unless used immediately.&nbsp;They are also responsible for not disposing of unused Bupivacaine Accord properly.<\/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>The active substance is bupivacaine hydrochloride.<\/p>\n\n\n\n<p>Bupivacaine Accord 2.5 mg\/ml&nbsp;solution for injection&nbsp;:<\/p>\n\n\n\n<p>1 ml contains 2.5 mg bupivacaine hydrochloride (as monohydrate)<\/p>\n\n\n\n<p>5 ml contains 12.5 mg bupivacaine hydrochloride (as monohydrate)<\/p>\n\n\n\n<p>10 ml contains 25 mg bupivacaine hydrochloride (as monohydrate)<\/p>\n\n\n\n<p>20 ml contains 50 mg bupivacaine hydrochloride (as monohydrate)<br><\/p>\n\n\n\n<p>Bupivacaine Accord 5 mg\/ml&nbsp;solution for injection&nbsp;:<\/p>\n\n\n\n<p>1 ml contains 5 mg bupivacaine hydrochloride (as monohydrate)<\/p>\n\n\n\n<p>2 ml contains 10 mg bupivacaine hydrochloride (as monohydrate)<\/p>\n\n\n\n<p>4 ml contains 20 mg bupivacaine hydrochloride (as monohydrate)<\/p>\n\n\n\n<p>5 ml contains 25 mg bupivacaine hydrochloride (as monohydrate)<\/p>\n\n\n\n<p>10 ml contains 50 mg bupivacaine hydrochloride (as monohydrate)<\/p>\n\n\n\n<p>20 ml contains 100 mg bupivacaine hydrochloride (as monohydrate)<br><\/p>\n\n\n\n<p>The other ingredients are water for injections, sodium chloride, and sodium hydroxide (E524) (for&nbsp;pH&nbsp;adjustment).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n<p>Bupivacaine Accord&nbsp;solution for injection&nbsp;is a clear, colorless,&nbsp;sterile&nbsp;solution for injection.&nbsp;It is available as a&nbsp;type I clear glass&nbsp;ampoule&nbsp;and type I clear glass vials with a rubber stopper and flip-off seal.<br><\/p>\n\n\n\n<p>Bupivacaine Accord 2.5 mg\/ml&nbsp;solution for injection&nbsp;:<\/p>\n\n\n\n<p>5 ml&nbsp;vial&nbsp;s with a white band in packs of 5 and 10&nbsp;ampoule&nbsp;s<\/p>\n\n\n\n<p>10 ml&nbsp;vial&nbsp;s with green bands in packs of 5, 10, 15, and 20&nbsp;ampoule&nbsp;s<\/p>\n\n\n\n<p>20 ml vials with chlorobutyl rubber stopper and an orange flip-off seal are supplied in packs of 1&nbsp;vial<br><\/p>\n\n\n\n<p>Bupivacaine Accord 5 mg\/ml&nbsp;solution for injection&nbsp;:<\/p>\n\n\n\n<p>2 ml&nbsp;vial&nbsp;s with two orange rings in packs of 5 and 10&nbsp;ampoule&nbsp;s<\/p>\n\n\n\n<p>4 mL&nbsp;vial&nbsp;s with red tape in packs of 5 and 10&nbsp;ampoule&nbsp;s<\/p>\n\n\n\n<p>5 ml&nbsp;vial&nbsp;s with the blue band in packs of 5 and 10&nbsp;ampoule&nbsp;s<\/p>\n\n\n\n<p>10 ml&nbsp;vial&nbsp;s with yellow bands in packs of 5, 10, 15, and 20&nbsp;ampoule&nbsp;s<\/p>\n\n\n\n<p>20 ml vials with chlorobutyl rubber stopper and a red flip-off seal are supplied in packs of 1&nbsp;vial<br><\/p>\n\n\n\n<p>Not all pack sizes may be marketed<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p><strong>Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n<p>Accord Healthcare BV<\/p>\n\n\n\n<p>Winthontlaan 200<\/p>\n\n\n\n<p>3526 kV Utrecht<\/p>\n\n\n\n<p>Netherlands<br><\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Accord Healthcare Limited<\/p>\n\n\n\n<p>Sage House<\/p>\n\n\n\n<p>319, Pinner Road<\/p>\n\n\n\n<p>North Harrow<\/p>\n\n\n\n<p>Middlesex HA1 4 HF<\/p>\n\n\n\n<p>UK<br><\/p>\n\n\n\n<p>Accord Healthcare BV,<\/p>\n\n\n\n<p>Winthontlaan 200,<\/p>\n\n\n\n<p>3526 KV Utrecht,<\/p>\n\n\n\n<p>Netherlands<br><\/p>\n\n\n\n<p>Accord Healthcare Polska Sp.z oo,<\/p>\n\n\n\n<p>ul.&nbsp;Lutomierska 50,95-200 Pabianice, Poland<br><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Bupivacaine Accord contains the active substance bupivacaine hydrochloride. It belongs to a group of medicines called amide-type local anesthetics.<\/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":[8259,8261,8254,8258,8263,8256,8262,8257,8260,8255],"class_list":["post-6290","post","type-post","status-publish","format-standard","hentry","category-b","category-medicines","tag-bupivacaine-accord","tag-bupivacaine-accord-side-effects","tag-bupivacaine-hydrochloride","tag-bupivacaine-hydrochloride-side-effects","tag-side-effects-of-bupivacaine-accord","tag-side-effects-of-bupivacaine-hydrochloride","tag-what-bupivacaine-accord-is-used-for","tag-what-bupivacaine-hydrochloride-is-used-for","tag-what-is-bupivacaine-accord","tag-what-is-bupivacaine-hydrochloride"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6290","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=6290"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6290\/revisions"}],"predecessor-version":[{"id":11760,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/6290\/revisions\/11760"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=6290"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=6290"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=6290"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}