FDA label d07bb89b-1d6e-43a0-839d-d85a8f0619c5

WARNINGS: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL RESPIRATORY DEPRESSION Fatal respiratory depression has occurred in patients treated with immediate-release transmucosal fentanyl, including following use in opioid non-tolerant patients and improper dosing. The substitution of ABSTRAL for any other fentanyl product may result in fatal overdose. Due to the risk of respiratory depression, ABSTRAL is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients. [see Contraindications ( 4 )] ABSTRAL must be kept out of reach of children. [see Patient Counseling Information ( 17.1 ) and How Supplied/Storage and Handling ( 16.1 )] The concomitant use of ABSTRAL with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression. [see Drug Interactions ( 7 )] MEDICATION ERRORS Substantial differences exist in the pharmacokinetic profile of ABSTRAL compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl that could result in fatal overdose. - When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products to ABSTRAL. ( 2.1 ) - When dispensing, do not substitute an ABSTRAL prescription for other fentanyl products. ABUSE POTENTIAL ABSTRAL contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. ABSTRAL can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing ABSTRAL in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Because of the risk for misuse, abuse, addiction, and overdose, ABSTRAL is available only through a restricted program, required by the Food and Drug Administration, called a R isk E valuation and M itigation S trategy (REMS). Under the TIRF ( T ransmucosal I mmediate R elease F entanyl) REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program [see Warnings and Precautions ( 5.10 )]. Further information is available at www.TIRFREMSAccess.com or by calling1-866-822-1483. WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL See full prescribing information for complete boxed warning. Due to the risk of fatal respiratory depression, ABSTRAL is contraindicated in opioid non-tolerant patients ( 1 ) and in management of acute or postoperative pain, including headache/migraines. ( 4 ) Keep out of reach of children. ( 5.3 ) Use with CYP3A4 inhibitors may cause fatal respiratory depression. ( 7 ) When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to ABSTRAL. ( 2.1 , 5.2 ) When dispensing, do not substitute with any other fentanyl products. ( 5.2 ) Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics. ( 9.1 ) ABSTRAL is available only through a restricted program called the TIRF REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program. ( 5.10 )

5 WARNINGS AND PRECAUTIONS See Boxed Warning - WARNINGS: IMPORTANCE OF PROPER PATIENT SELECTION and POTENTIAL FOR ABUSE Clinically significant respiratory and CNS depression can occur. Monitor patients accordingly. ( 5.1 , 5.4 ) Do not convert patients on a mcg per mcg basis from another fentanyl product to ABSTRAL. ( 5.2 ) ABSTRAL contains fentanyl in a dose that can be fatal to a child. Ensure proper storage and disposal. ( 5.3 , 16.3 ) Use with other CNS depressants and potent cytochrome P450 3A4 inhibitors may increase depressant effects including hypoventilation, hypotension, and profound sedation. Consider dosage adjustments if warranted. ( 5.4 , 7 ) Titrate ABSTRAL cautiously in patients with chronic obstructive pulmonary disease or pre-existing medical conditions predisposing them to hypoventilation, and in patients susceptible to intracranial effects of CO 2 retention. ( 5.6 , 5.7 ) 5.1 Hypoventilation (Respiratory Depression) Serious or fatal respiratory depression can occur even at recommended doses in patients using ABSTRAL. Respiratory depression is more likely to occur in patients with underlying respiratory disorders and elderly or debilitated patients, usually following large initial doses, including ABSTRAL, in opioid non-tolerant patients, or when opioids are given in conjunction with other drugs that depress respiration. Respiratory depression from opioids is manifested by a reduced urge to breathe and a decreased rate of respiration, often associated with the "sighing" pattern of breathing (deep breaths separated by abnormally long pauses). Carbon dioxide retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. This makes overdoses involving drugs with sedative properties and opioids especially dangerous. 5.2 ABSTRAL and Other Fentanyl Products) ABSTRAL is NOT equivalent to all other fentanyl products used to treat breakthrough pain on a mcg per mcg basis. There are differences in the pharmacokinetics of ABSTRAL relative to other fentanyl products which could potentially result in clinically important differences in the amount of fentanyl absorbed and could result in a fatal overdose. When prescribing ABSTRAL to a patient, DO NOT convert from other fentanyl products. Directions for safely converting patients to ABSTRAL from other fentanyl products are not currently available. (Note: This includes oral, transdermal, or parenteral formulations of fentanyl). Therefore, for opioid-tolerant patients starting treatment for breakthrough pain, the initial dose of ABSTRAL is 100 mcg. Individually titrate each patient's dose to provide adequate analgesia while minimizing side effects. [See Dosage and Administration ( 2.1 )] When dispensing ABSTRAL to a patient, DO NOT substitute it for any other fentanyl product prescription. 5.3 Patient/Caregiver Instructions Patients and their caregivers must be instructed that ABSTRAL contains a medicine in an amount which can be fatal to a child. Even though ABSTRAL is provided in child-resistant packaging, patients and their caregivers must be instructed to keep tablets out of the reach of children. [see How Supplied/Storage and Handling ( 16.1 , 16.2 ), and Patient Counseling Information ( 17.1 , 17.2 )]. Taking ABSTRAL could be fatal in individuals for whom it is not prescribed and for those who are not opioid-tolerant. Physicians and dispensing pharmacists must specifically question patients or caregivers about the presence of children in the home (on a full time or visiting basis) and counsel them regarding the dangers to children from inadvertent exposure. 5.4 Additive CNS Depressant Effects The concomitant use of ABSTRAL with other CNS depressants, including other opioids, sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines, and alcoholic beverages may produce increased depressant effects (e.g., hypoventilation, hypotension, and profound sedation). Concomitant use with potent inhibitors of cytochrome P450 3A4 isoform (e.g., erythromycin, ketoconazole, and certain protease inhibitors) may increase fentanyl levels, resulting in increased depressant effects [see Drug Interactions ( 7 )]. Patients on concomitant CNS depressants must be monitored for a change in opioid effects and the dose of ABSTRAL adjusted, if warranted. 5.5 Effects on Ability to Drive and Use Machines Opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery). Warn patients taking ABSTRAL of these dangers and counsel them accordingly. 5.6 Chronic Pulmonary Disease Because potent opioids can cause hypoventilation, titrate ABSTRAL with caution in patients with chronic obstructive pulmonary disease or pre-existing medical conditions predisposing them to hypoventilation. In such patients, even normal therapeutic doses of ABSTRAL may further decrease respiratory drive to the point of respiratory failure. 5.7 Head Injuries and Increased Intracranial Pressure Administer ABSTRAL with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO 2 retention such as those with evidence of increased intracranial pressure or impaired consciousness. Opioids may obscure the clinical course of a patient with a head injury; use only if clinically warranted. 5.8 Cardiac Disease Intravenous administration of fentanyl may produce bradycardia. Therefore, use ABSTRAL with caution in patients with bradyarrhythmias. 5.9 MAO Inhibitors ABSTRAL is not recommended for use in patients who have received MAO inhibitors within the past 14 days. Severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics. 5.10 Transmucosal immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access Program Because of the risk for misuse, abuse, addiction, and overdose [see Drug Abuse and Dependence ( 9 )], ABSTRAL is available only through a restricted program called the TIRF REMS Access program. Under the TIRF REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program. For inpatient administration (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use) of ABSTRAL, patient and prescriber enrollment is not required. Required components of the TIRF REMS Access program are: Healthcare professionals who prescribe ABSTRAL must review the prescriber educational materials for the TIRF REMS Access program, enroll in the program, and comply with the REMS requirements. To receive ABSTRAL, outpatients must understand the risks and benefits and sign a Patient-Prescriber Agreement. Pharmacies that dispense ABSTRAL must enroll in the program and agree to comply with the REMS requirements. Wholesalers and distributors that distribute ABSTRAL must enroll in the program and distribute only to authorized pharmacies. Further information, including a list of qualified pharmacies/distributors, is available at www.TIRFREMSAccess.com or by calling 1-866-822-1483.

6 ADVERSE REACTIONS Most common (total frequency ≥ 3%): nausea, somnolence, headache, and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ProStrakan, Inc. at 1-888-227-8725 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ABSTRAL has been evaluated in 311 opioid-tolerant cancer patients with breakthrough pain. Two hundred and seventy (270) of these patients were treated in multiple-dose studies. The duration of therapy for patients in multiple-dose studies ranged from 1-405 days with an average duration of 131 days and with 44 patients treated for at least 12 months. The most commonly observed adverse reactions with ABSTRAL include typical opioid adverse reactions, such as nausea, constipation, somnolence and headache. Expect opioid side effects and manage them accordingly. The clinical trials of ABSTRAL were designed to evaluate safety and efficacy in treating patients with cancer and breakthrough pain; all patients were taking concomitant opioids, such as sustained-release morphine, sustained-release oxycodone or transdermal fentanyl, for their persistent pain. The adverse reaction data presented in Table 1 reflect the actual percentage of patients experiencing reactions among patients who received ABSTRAL for breakthrough pain along with concomitant opioid use for persistent pain. There has been no attempt to correct for concomitant use of other opioids, duration of ABSTRAL therapy or cancer-related symptoms. Table 1 lists adverse reactions with an overall frequency of 5% or greater within the total population that occurred during titration by maximum dose received. The ability to assign ABSTRAL a dose-response relationship to these adverse reactions is limited by the titration schemes used in these studies. Table 1: Adverse Reactions Which Occurred During Titration at a Frequency of ≥ 5% System Organ Class Preferred term N (%) 100 mcg (n=22) 200 mcg (n=23) 300 mcg (n=55) 400 mcg (n=38) 600 mcg (n=52) 800 mcg (n=80) Total (n=270) Gastrointestinal disorders Nausea 1 (4.5) 4 (17.4) 5 (9.1) 1 (2.6) 2 (3.8) 2 (2.5) 15 (5.6) Nervous system disorders Somnolence 0 2 (8.7) 4 (7.3) 2 (5.3) 2 (3.8) 2 (2.5) 12 (4.4) Dizziness 0 0 3 (5.5) 2 (5.3) 0 1 (1.3) 6 (2.2) Headache 0 0 0 1 (2.6) 3 (5.8) 1 (1.3) 5 (1.9) Table 2 lists, by successful dose, adverse reactions with an overall frequency of ≥ 5% within the total population that occurred after a successful dose had been determined. Table 2: Adverse Reactions Which Occurred During Maintenance Therapy at a Frequency of ≥ 5% System Organ Class Preferred term N (%) 100 mcg (n=7) 200 mcg (n=12) 300 mcg (n=22) 400 mcg (n=20) 600 mcg (n=35) 800 mcg (n=72) Total (n=168) Gastrointestinal disorders Nausea 1 (14.3) 0 2 (9.1) 0 1 (2.9) 6 (8.3) 10 (6.0) Stomatitis 0 1 (8.3) 1 (4.5) 0 0 1 (1.4) 3 (1.8) Constipation 0 0 1 (4.5) 2 (10.0) 1 (2.9) 4 (5.6) 8 (4.8) Dry mouth 0 0 0 1 (5.0) 2 (5.7) 0 3 (1.8) Nervous system disorders Headache 0 0 0 2 (10.0) 1 (2.9) 2 (2.8) 5 (3.0) Dysgeusia 1 (14.3) 0 0 0 0 1 (1.4) 2 (1.2) General disorders and administration site conditions Fatigue 0 0 0 1 (5.0) 2 (5.7) 0 3 (1.8) Injury, poisoning and procedural complications Accidental overdose 1 (14.3) 0 0 0 0 0 1 (0.6) Respiratory, thoracic and mediastinal disorders Dyspnoea 0 1 (8.3) 0 0 0 0 1 (0.6) Skin and subcutaneous disorders Hyperhidrosis 1 (14.3) 0 0 0 0 1 (1.4) 2 (1.2) The frequencies listed below represent adverse reactions that occurred in ≥ 1% of patients from two clinical trials who experienced that reaction while receiving ABSTRAL. Reactions are classified by system organ class. Adverse Reactions (≥ 1%) Cardiac disorders: bradycardia, tachycardia. Eye disorders: vision blurred. Gastrointestinal disorders: abdominal pain, abdominal pain upper, aphthous stomatitis, constipation, dry mouth, dyspepsia, gingival ulceration, impaired gastric emptying, lip ulceration, mouth ulceration, nausea, stomach discomfort, stomatitis, tongue disorder, vomiting. General disorders and administration site conditions: asthenia, drug withdrawal syndrome, fatigue, malaise. Immune system disorders: drug hypersensitivity. Injury, poisoning and procedural complications: accidental overdose. Metabolism and nutrition disorders: anorexia, decreased appetite. Nervous system disorders: amnesia, disturbance in attention, dizziness, dysgeusia, headache, hypoesthesia, lethargy, parosmia, somnolence, tremor. Psychiatric disorders: affect lability, anxiety, confusional state, depression, disorientation, dysphoria, euphoric mood, insomnia, mental status changes, paranoia, sleep disorder. Reproductive system and breast disorders: erectile dysfunction. Respiratory, thoracic and mediastinal disorder: dyspnea, oropharyngeal pain, throat tightness. Skin and subcutaneous disorders: hyperhidrosis, night sweats, pruritus, rash, skin lesion. Vascular disorders: hypotension.

<table width="100%"> <caption> Table 1: Adverse Reactions Which Occurred During Titration at a Frequency of &#x2265; 5% </caption> <col width="23%" align="left"/> <col width="11%" align="left"/> <col width="11%" align="left"/> <col width="11%" align="left"/> <col width="11%" align="left"/> <col width="11%" align="left"/> <col width="11%" align="left"/> <col width="11%" align="left"/> <tbody> <tr valign="top"> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">System Organ Class</content> <content styleCode="bold"> Preferred term</content> <content styleCode="bold">N (%)</content> </td> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">100 mcg</content> <content styleCode="bold">(n=22)</content> </td> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">200 mcg</content> <content styleCode="bold">(n=23)</content> </td> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">300 mcg</content> <content styleCode="bold">(n=55)</content> </td> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">400 mcg</content> <content styleCode="bold">(n=38)</content> </td> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">600 mcg</content> <content styleCode="bold">(n=52)</content> </td> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">800 mcg</content> <content styleCode="bold">(n=80)</content> </td> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Total</content> <content styleCode="bold">(n=270)</content> </td> </tr> <tr> <td colspan="8" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Gastrointestinal disorders</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Nausea </td> <td styleCode="Botrule Lrule Rrule"> 1 (4.5) </td> <td styleCode="Botrule Lrule Rrule"> 4 (17.4) </td> <td styleCode="Botrule Lrule Rrule"> 5 (9.1) </td> <td styleCode="Botrule Lrule Rrule"> 1 (2.6) </td> <td styleCode="Botrule Lrule Rrule"> 2 (3.8) </td> <td styleCode="Botrule Lrule Rrule"> 2 (2.5) </td> <td styleCode="Botrule Lrule Rrule"> 15 (5.6) </td> </tr> <tr> <td colspan="8" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Nervous system disorders</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Somnolence </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 2 (8.7) </td> <td styleCode="Botrule Lrule Rrule"> 4 (7.3) </td> <td styleCode="Botrule Lrule Rrule"> 2 (5.3) </td> <td styleCode="Botrule Lrule Rrule"> 2 (3.8) </td> <td styleCode="Botrule Lrule Rrule"> 2 (2.5) </td> <td styleCode="Botrule Lrule Rrule"> 12 (4.4) </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Dizziness </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 3 (5.5) </td> <td styleCode="Botrule Lrule Rrule"> 2 (5.3) </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 1 (1.3) </td> <td styleCode="Botrule Lrule Rrule"> 6 (2.2) </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Headache </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 1 (2.6) </td> <td styleCode="Botrule Lrule Rrule"> 3 (5.8) </td> <td styleCode="Botrule Lrule Rrule"> 1 (1.3) </td> <td styleCode="Botrule Lrule Rrule"> 5 (1.9) </td> </tr> </tbody> </table>

<table width="100%"> <caption> Table 2: Adverse Reactions Which Occurred During Maintenance Therapy at a Frequency of &#x2265; 5% </caption> <col width="23%" align="left"/> <col width="11%" align="left"/> <col width="11%" align="left"/> <col width="11%" align="left"/> <col width="11%" align="left"/> <col width="11%" align="left"/> <col width="11%" align="left"/> <col width="11%" align="left"/> <tbody> <tr valign="top"> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">System Organ Class</content> <content styleCode="bold"> Preferred term</content> <content styleCode="bold">N (%)</content> </td> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">100 mcg</content> <content styleCode="bold">(n=7)</content> </td> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">200 mcg</content> <content styleCode="bold">(n=12)</content> </td> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">300 mcg</content> <content styleCode="bold">(n=22)</content> </td> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">400 mcg</content> <content styleCode="bold">(n=20)</content> </td> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">600 mcg</content> <content styleCode="bold">(n=35)</content> </td> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">800 mcg</content> <content styleCode="bold">(n=72)</content> </td> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Total</content> <content styleCode="bold">(n=168)</content> </td> </tr> <tr> <td colspan="8" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Gastrointestinal disorders</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Nausea </td> <td styleCode="Botrule Lrule Rrule"> 1 (14.3) </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 2 (9.1) </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 1 (2.9) </td> <td styleCode="Botrule Lrule Rrule"> 6 (8.3) </td> <td styleCode="Botrule Lrule Rrule"> 10 (6.0) </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Stomatitis </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 1 (8.3) </td> <td styleCode="Botrule Lrule Rrule"> 1 (4.5) </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 1 (1.4) </td> <td styleCode="Botrule Lrule Rrule"> 3 (1.8) </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Constipation </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 1 (4.5) </td> <td styleCode="Botrule Lrule Rrule"> 2 (10.0) </td> <td styleCode="Botrule Lrule Rrule"> 1 (2.9) </td> <td styleCode="Botrule Lrule Rrule"> 4 (5.6) </td> <td styleCode="Botrule Lrule Rrule"> 8 (4.8) </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Dry mouth </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 1 (5.0) </td> <td styleCode="Botrule Lrule Rrule"> 2 (5.7) </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 3 (1.8) </td> </tr> <tr> <td colspan="8" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Nervous system disorders</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Headache </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 2 (10.0) </td> <td styleCode="Botrule Lrule Rrule"> 1 (2.9) </td> <td styleCode="Botrule Lrule Rrule"> 2 (2.8) </td> <td styleCode="Botrule Lrule Rrule"> 5 (3.0) </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Dysgeusia </td> <td styleCode="Botrule Lrule Rrule"> 1 (14.3) </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 1 (1.4) </td> <td styleCode="Botrule Lrule Rrule"> 2 (1.2) </td> </tr> <tr> <td colspan="8" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">General disorders and administration site conditions</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Fatigue </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 1 (5.0) </td> <td styleCode="Botrule Lrule Rrule"> 2 (5.7) </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 3 (1.8) </td> </tr> <tr> <td colspan="8" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Injury, poisoning and procedural complications</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Accidental overdose </td> <td styleCode="Botrule Lrule Rrule"> 1 (14.3) </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 1 (0.6) </td> </tr> <tr> <td colspan="8" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Respiratory, thoracic and mediastinal disorders</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Dyspnoea </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 1 (8.3) </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 1 (0.6) </td> </tr> <tr> <td colspan="8" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Skin and subcutaneous disorders</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Hyperhidrosis </td> <td styleCode="Botrule Lrule Rrule"> 1 (14.3) </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> <td styleCode="Botrule Lrule Rrule"> 1 (1.4) </td> <td styleCode="Botrule Lrule Rrule"> 2 (1.2) </td> </tr> </tbody> </table>