Before use, a protective liner covering the adhesive layer is removed and discarded. Fentanyl is an opioid agonist. Fentanyl interacts predominately with the opioid mu-receptor. These mu-binding sites are distributed in the human brain, spinal cord, and other tissues. Effects on the Central Nervous System Fentanyl produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation.
Fentanyl causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic e. Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations. In clinical trials of non-opioid tolerant subjects treated with fentanyl transdermal system, 13 subjects experienced hypoventilation. In these studies, the incidence of hypoventilation was higher in nontolerant women 10 than in men 3 and in subjects weighing less than 63 kg 9 of Although subjects with prior impaired respiration were not common in the trials, they had higher rates of hypoventilation.
In addition, postmarketing reports have been received that describe opioid-naive post-operative patients who have experienced clinically significant hypoventilation and death with fentanyl transdermal system. Hypoventilation can occur throughout the therapeutic range of fentanyl serum concentrations, especially for patients who have an underlying pulmonary condition or who receive concomitant opioids or other CNS drugs associated with hypoventilation.
The use of fentanyl transdermal system is contraindicated in patients who are not tolerant to opioid therapy. Effects on the Gastrointestinal Tract and Other Smooth Muscle Fentanyl causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.
Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone is increased to the point of spasm, resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.
Effects on the Cardiovascular System Fentanyl produces peripheral vasodilation, which may result in orthostatic hypotension or syncope. Histamine assays and skin wheal testing in clinical studies indicate that clinically significant histamine release rarely occurs with fentanyl administration. They also stimulate prolactin, growth hormone GH secretion, and pancreatic secretion of insulin and glucagon. Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.
The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see Adverse Reactions 6. Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models. The clinical significance of these findings is unknown.
Overall, the effects of opioids appear to be modestly immunosuppressive. Concentration-Efficacy Relationships The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids. Concentration-Adverse Reaction Relationships There is a relationship between increasing fentanyl plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression.
In opioid-tolerant patients, the situation may be altered by the development of tolerance to opioid-related adverse reactions [see Dosage and Administration 2. Absorption Fentanyl transdermal system is a drug-in-adhesive matrix designed formulation. Fentanyl is released from the matrix at a nearly constant amount per unit time. The concentration gradient existing between the matrix and the lower concentration in the skin drives drug release.
Fentanyl moves in the direction of the lower concentration at a rate determined by the matrix and the diffusion of fentanyl through the skin layers. While the actual rate of fentanyl delivery to the skin varies over the hour application period, each system is labeled with a nominal flux which represents the average amount of drug delivered to the systemic circulation per hour across average skin.
While there is variation in dose delivered among patients, the nominal flux of the systems Following fentanyl transdermal system application, the skin under the system absorbs fentanyl, and a depot of fentanyl concentrates in the upper skin layers. Fentanyl then becomes available to the systemic circulation. Serum fentanyl concentrations increase gradually following initial fentanyl transdermal system application, generally leveling off between 12 and 24 hours and remaining relatively constant, with some fluctuation, for the remainder of the hour application period.
Peak serum concentrations of fentanyl generally occurred between 20 and 72 hours after initial application see Table 7. Serum fentanyl concentrations achieved are proportional to the fentanyl transdermal system delivery rate. With continuous use, serum fentanyl concentrations continue to rise for the first two system applications. By the end of the second hour application, a steady-state serum concentration is reached and is maintained during subsequent applications of a patch of the same size see Figure 1.
Patients reach and maintain a steady-state serum concentration that is determined by individual variation in skin permeability and body clearance of fentanyl. Continued absorption of fentanyl from the skin accounts for a slower disappearance of the drug from the serum than is seen after an IV infusion, where the apparent half-life is approximately 7 range 3 to 12 hours.
NOTE: Information on volume of distribution and half-life not available for renally impaired patients. Distribution Fentanyl plasma protein binding capacity decreases with increasing ionization of the drug. Alterations in pH may affect its distribution between plasma and the central nervous system.
Fentanyl accumulates in the skeletal muscle and fat and is released slowly into the blood. Elimination Metabolism Fentanyl is metabolized primarily via human cytochrome P 3A4 isoenzyme system. In humans, the drug appears to be metabolized primarily by oxidative N-dealkylation to norfentanyl and other inactive metabolites that do not contribute materially to the observed activity of the drug. Skin does not appear to metabolize fentanyl delivered transdermally.
Specific Populations Age: Geriatric Population Data from intravenous studies with fentanyl suggest that the elderly patients may have reduced clearance and a prolonged half-life.
Moreover elderly patients may be more sensitive to the active substance than younger patients. A study conducted with the fentanyl transdermal system in elderly patients demonstrated that fentanyl pharmacokinetics did not differ significantly from young adult subjects, although peak serum concentrations tended to be lower and mean half-life values were prolonged to approximately 34 hours.
Age: Pediatric Population In 1. In older pediatric patients, the pharmacokinetic parameters were similar to that of adults. However, these findings have been taken into consideration in determining the dosing recommendations for opioid-tolerant pediatric patients 2 years of age and older.
For pediatric dosing information, refer to [see Dosage and Administration 2. Hepatic Impairment Information on the effect of hepatic impairment on the pharmacokinetics of fentanyl transdermal system is limited. Renal Impairment Information on the effect of renal impairment on the pharmacokinetics of fentanyl transdermal system is limited.
An inverse relationship between blood urea nitrogen level and fentanyl clearance was found. The interaction between ritonavir, a CYP3A4 inhibitor, and fentanyl was investigated in eleven healthy volunteers in a randomized crossover study. Subjects received oral ritonavir or placebo for 3 days.
The ritonavir dose was mg three times a day on Day 1 and mg three times a day on Day 2 followed by one morning dose of mg on Day 3. Naloxone was administered to counteract the side effects of fentanyl. The concomitant use of transdermal fentanyl with all CYP3A4 inhibitors such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, or grapefruit juice may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression.
Carefully monitor patients receiving fentanyl transdermal system and any CYP3A4 inhibitor for signs of respiratory depression for an extended period of time and adjust the dosage if warranted [see Boxed Warning and Warnings and Precautions 5. Impairment of Fertility The potential effects of fentanyl on male and female fertility were examined in the rat model via two separate experiments.
In the male fertility study, male rats were treated with fentanyl 0, 0. In the female fertility study, female rats were treated with fentanyl 0, 0. Analysis of fertility parameters in both studies indicated that an intravenous dose of fentanyl up to 0.
In a separate study, a single daily bolus dose of fentanyl was shown to impair fertility in rats when given in intravenous doses of 0. Fentanyl transdermal system as therapy for pain due to cancer has been studied in patients. Individual patients have used fentanyl transdermal system continuously for up to days. At one month after initiation of fentanyl transdermal system therapy, patients generally reported lower pain intensity scores as compared to a pre-study analgesic regimen of oral morphine.
In the pediatric population, the safety of fentanyl transdermal system has been evaluated in patients with chronic pain 2 to 18 years of age. Twenty-five patients were treated with fentanyl transdermal system for at least 4 months and 9 patients for more than 9 months. Fentanyl transdermal system is supplied in cartons containing 5 individual child-resistant packaged systems.
See chart for information regarding individual systems. System Size cm 2. Store in original unopened pouch. Store fentanyl transdermal system securely and dispose of properly [see Patient Counseling Information 17 ]. Storage and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store fentanyl transdermal system, out of sight and reach of children, and in a location not accessible by others, including visitors to the home [see Warnings and Precautions 5.
Inform patients that leaving fentanyl transdermal system unsecured can pose a deadly risk to others in the home. Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused fentanyl transdermal system should be disposed of by folding the patch so that the adhesive side of the patch adheres to itself, and immediately flushing down the toilet if a drug take-back option is not readily available [see Instructions for Use ].
Inform patients that they can visit www. Addiction, Abuse, and Misuse Inform patients that the use of fentanyl transdermal system, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions 5. Instruct patients not to share fentanyl transdermal system with others and to take steps to protect fentanyl transdermal system from theft or misuse.
Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting fentanyl transdermal system or when the dosage is increased, and that it can occur even at recommended dosages.
Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling or getting emergency medical help right away in the event of a known or suspected overdose [see Warnings and Precautions 5. Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with fentanyl transdermal system.
Accidental Exposure Inform patients that accidental exposure, especially in children, may result in respiratory depression or death [see Warnings and Precautions 5. Fentanyl transdermal system can be accidentally transferred to children. Instruct patients to take special precautions to avoid accidental contact when holding or caring for children. Instruct patients that, if the patch dislodges and accidentally sticks to the skin of another person, to immediately take the patch off, wash the exposed area with water and seek medical attention for the accidentally exposed individual as accidental exposure may lead to death or other serious medical problems.
Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if fentanyl transdermal system is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions 5.
Serotonin Syndrome Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms and signs of serotonin syndrome, and to seek medical attention right away if symptoms develop.
Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications [see Warnings and Precautions 5. MAOI Interaction Inform patients to avoid taking fentanyl transdermal system while using any drugs that inhibit monoamine oxidase.
Adrenal Insufficiency Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions 5.
Important Administration Instructions Advise patients never to change the dose of fentanyl transdermal system or the number of patches applied to the skin unless instructed to do so by the prescribing healthcare professional. Important Discontinuation Instructions In order to avoid developing withdrawal symptoms, instruct patients not to discontinue fentanyl transdermal system without first discussing a tapering plan with the prescriber [see Dosage and Administration 2.
Warnings About Heat Warn patients of the potential for temperature-dependent increases in fentanyl release from the patch that could result in an overdose of fentanyl. Instruct patients to contact their healthcare provider if they develop a high fever. Instruct patients to:. Hypotension Inform patients that fentanyl transdermal system may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur e.
Anaphylaxis Inform patients that anaphylaxis, including anaphylactic shock, has been reported with ingredients contained in fentanyl transdermal system. Advise patients how to recognize such a reaction and when to seek medical attention [see Contraindications 4 , Adverse Reactions 6 ].
Pregnancy Neonatal Opioid Withdrawal Syndrome Inform female patients of reproductive potential that prolonged use of fentanyl transdermal system during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see Warnings and Precautions 5. Embryo-Fetal Toxicity Inform female patients of reproductive potential that fentanyl transdermal system can cause fetal harm and to inform their healthcare provider of known or suspected pregnancy [see Use in Specific Populations 8.
Lactation Advise patients that breastfeeding is not recommended during treatment with fentanyl transdermal system [see Use in Specific Populations 8.
Infertility Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible [see Use in Specific Populations 8. Driving or Operating Heavy Machinery Inform patients that fentanyl transdermal system may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery.
Advise patients not to perform such tasks until they know how they will react to the medication [see Warnings and Precautions 5. Constipation Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see Adverse Reactions 6 , Clinical Pharmacology An electronic copy of this medication guide can be obtained from www. Important information about fentanyl transdermal system:. Before applying fentanyl transdermal system, tell your healthcare provider if you have a history of:.
The possible side effects of fentanyl transdermal system are:. These are not all the possible side effects of fentanyl transdermal system. Call your doctor for medical advice about side effects. For more information go to dailymed. This Medication Guide has been approved by the U.
Food and Drug Administration. Be sure that you read, understand, and follow these Instructions for Use before you apply fentanyl transdermal system. Talk to your healthcare provider or pharmacist if you have any questions.
Important information about the fentanyl transdermal system appearance:. Applying a fentanyl transdermal system. Skin areas where the fentanyl transdermal system may be applied:. Open the pouch: Fold and tear at slit, or cut at line taking care not to cut the patch. Remove the fentanyl transdermal system.
Each fentanyl transdermal system is sealed in its own protective pouch. Do not remove the fentanyl transdermal system from the pouch until you are ready to use it see Figure 6. Peel: Peel off both parts of the protective liner from the patch. Each fentanyl transdermal system has a clear plastic backing that can be peeled off in two pieces.
This covers the sticky side of the patch. Carefully peel this backing off. Throw the clear plastic backing away. Touch the sticky side of the fentanyl transdermal system as little as possible see Figure 7. Press: Press the patch onto the chosen skin site with the palm of your hand and hold there for at least 30 seconds see Figure 8. Make sure it sticks well, especially at the edges. Wash your hands when you have finished applying a fentanyl transdermal system.
Remove a fentanyl transdermal system after wearing it for 3 days 72 hours. Dispose of the used patch right away. See the section below "Disposing of a fentanyl transdermal system".
Choose a different skin site to apply a new fentanyl transdermal system. Repeat Steps 2 through 6 above when applying a new fentanyl transdermal system. Caldwell, NJ Each transdermal system contains: 1. Each transdermal system contains: 2.
NDC Five In vivo delivery of Each transdermal system contains: 4. Each transdermal system contains: 6. Each transdermal system contains: 8.
Each transdermal system contains: DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.
DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage , we no longer display the RxImage pill images associated with drug labels. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.
Drug Label Info. NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. Drug Label Information Updated August 10, If you are a consumer or patient please visit this version. Approval: Fentanyl transdermal system exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death.
Monitor closely, especially upon initiation or following a dose increase. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Warn patients to avoid exposing the fentanyl transdermal system application site and surrounding area to direct external heat sources. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.
Warn patients to avoid strenuous exertion that may lead to increased body temperature. Avoid use of fentanyl transdermal system in patients with impaired consciousness or coma. Reserve concomitant prescribing of fentanyl transdermal system and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
Limit treatment to the minimum effective dosages and durations. Follow patients for signs and symptoms of respiratory depression and sedation. Fentanyl transdermal system is not indicated as an as-needed prn analgesic. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions 5 ].
Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with fentanyl transdermal system when serum concentrations from the initial patch will peak [see Warnings and Precautions 5. When converting patients from oral or parenteral opioids to fentanyl transdermal system, use Table 1 alternatively use Table 2 for adult and pediatric patients taking opioids or doses not listed in Table 1 and consider the following: These are not tables of equianalgesic doses.
The conversion doses in these tables are only for the conversion from one of the listed oral or parenteral opioid analgesics to fentanyl transdermal system. The tables cannot be used to convert from fentanyl transdermal system to another opioid because these conversions will result in an overestimation of the dose of the new opioid these conversions are conservative and may result in fatal overdosage. Use of Table 1 for conversion to other analgesic therapies can overestimate the dose of the new agent.
Overdosage of the new analgesic agent is possible [see Dosage and Administration 2. Use of Table 2 for conversion to other analgesic therapies can overestimate the dose of the new agent. Application and Handling Instructions Patients should apply fentanyl transdermal system to intact, non-irritated, and non-irradiated skin on a flat surface such as the chest, back, flank, or upper arm. In young children and persons with cognitive impairment, adhesion should be monitored and the upper back is the preferred location to minimize the potential of inappropriate patch removal.
Hair at the application site may be clipped not shaved prior to system application. If the site of fentanyl transdermal system application must be cleansed prior to application of the patch, do so with clear water.
Do not use soaps, oils, lotions, alcohol, or any other agents that might irritate the skin or alter its characteristics. Allow the skin to dry completely prior to patch application.
Patients should apply fentanyl transdermal system immediately upon removal from the sealed package. The patch must not be altered e. Fentanyl transdermal system should not be used if the pouch seal is broken or if the patch is cut or damaged. The transdermal system is pressed firmly in place with the palm of the hand for 30 seconds, making sure the contact is complete, especially around the edges.
Each fentanyl transdermal system may be worn continuously for 72 hours. The next patch is applied to a different skin site after removal of the previous transdermal system. If problems with adhesion of the fentanyl transdermal system occur, the edges of the patch may be taped with first aid tape. If problems with adhesion persist, the patch may be overlayed with a transparent adhesive film dressing. If the patch falls off before 72 hours, dispose of it by folding in half and flushing down the toilet.
A new patch may be applied to a different skin site. Patients or caregivers who apply fentanyl transdermal system should wash their hands immediately with soap and water after applying fentanyl transdermal system. Contact with unwashed or unclothed application sites can result in secondary exposure to fentanyl transdermal system and should be avoided.
Instruct patients, family members, and caregivers to keep patches in a secure location out of the reach of children and of others for whom fentanyl transdermal system was not prescribed. Avoidance of Heat Instruct patients to avoid exposing the fentanyl transdermal system application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated waterbeds, while wearing the system [see Warnings and Precautions 5.
Fentanyl Transdermal System Fentanyl transdermal system is contraindicated in: patients who are not opioid-tolerant. Healthcare providers are strongly encouraged to do all of the following: Complete a REMS-compliant education program offered by an accredited provider of continuing education CE or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain.
Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them. Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patient-prescriber responsibilities.
The following serious adverse reactions are discussed elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions 5. Cardiac Disorders : tachycardia, bradycardia Eye Disorders : vision blurred Gastrointestinal Disorders : ileus, dyspepsia General Disorders and Administration Site Conditions : pyrexia, application site erosion and application site ulcer Investigations : weight decreased Nervous System Disorders : convulsions including clonic convulsions and grand mal convulsion , amnesia, depressed level of consciousness, loss of consciousness Psychiatric Disorders : agitation Respiratory, Thoracic, and Mediastinal Disorders : respiratory distress, apnea, bradypnea, hypoventilation, dyspnea Vascular Disorders : hypotension, hypertension Serotonin syndrome : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Clinically Significant Drug Interactions with Fentanyl Transdermal System Inhibitors of CYP3A4 Clinical Impact: The concomitant use of fentanyl transdermal system and CYP3A4 inhibitors can increase the plasma concentration of fentanyl, resulting in increased or prolonged opioid effects particularly when an inhibitor is added after a stable dose of fentanyl transdermal system is achieved [see Warnings and Precautions 5. Intervention: If concomitant use is necessary, consider dosage reduction of fentanyl transdermal system until stable drug effects are achieved.
Examples: Macrolide antibiotics e. Intervention: If concomitant use is necessary, consider increasing the fentanyl transdermal system dosage until stable drug effects are achieved. Examples: Rifampin, carbamazepine, phenytoin Benzodiazepines and Other Central Nervous System CNS Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome [see Warnings and Precautions 5.
Intervention: If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Intervention: The use of fentanyl transdermal system is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. Intervention: Avoid concomitant use.
Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Fentanyl transdermal system may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
Diuretics Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Intervention: Monitor patients for signs of urinary retention or reduced gastric motility when fentanyl transdermal system is used concomitantly with anticholinergic drugs. Table 7. Table 8. Educate patients and caregivers on how to recognize the signs and symptoms of an overdose.
If naloxone is prescribed, also advise patients and caregivers: How to treat with naloxone, in the event of an opioid overdose To tell family and friends about their naloxone and to keep it in a place where family and friends can access it in an emergency To read the Patient Information or other educational material that will come with their naloxone. Emphasize the importance of doing this before an opioid emergency happens, so the patient and caregiver will know what to do.
Instruct patients to: avoid strenuous exertion that can increase body temperature while wearing the patch avoid exposing the fentanyl transdermal system application site and surrounding area to direct external heat sources including heating pads, electric blankets, sunbathing, heat or tanning lamps, saunas, hot tubs or hot baths, and heated waterbeds.
Kindeva focuses on complex drug programs, and its current offering spans inhalation drug delivery, transdermal drug delivery, microstructured transdermal systems microneedles , and connected drug delivery.
Kindeva employs approximately 1, people worldwide. For more information, visit www. Such forward-looking statements involve both known and unknown risks and uncertainties. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.
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