definity stability at room temperature

. Package insert / product label By continuing to use this website, you agree to our use of cookies. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Your decisions have real-life consequences. room temperature (23-25 C). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Most serious reactions occur within 30 minutes of administration. A temperature maintained thermostatically that encompasses the usual and customary working environment of 20C to 25C (68F to 77F) that allows for brief deviations between 15C and 30C (59F to 86F) that are experienced in pharmacies, hospitals, and warehouses. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DEFINITY RT and any potential adverse effects on the breastfed infant from DEFINITY RT or from the underlying maternal condition. Use within 12 hours of activation (see Insert) If DTT is kept at room temperature it will degrade/oxidize. For example, if I modelled the compound $\ce{BaSr(FeO3)2}$, I could compare its potential energy with that of the possible decompositions such as $\ce{SrFeO3}$ & $\ce{BaFeO3}$ and make a judgement on the . The nanocarriers, for example, polymeric particles, liposomes, and multilamellar vesicles have targeting moiety that targets DNA conjugated thereto. Withdraw the material from the middle of the liquid in the inverted vial. This leads to an ever-increasing number of samples which are more and more difficult and costly to store or transport. Of these, 144 (8.4%) had at least one adverse reaction (Table 1). Similar results were seen as described above. The most common adverse reactions (0.5%) are headache, back/renal pain, flushing, nausea, chest pain, injection site reactions, and dizziness (6). Definity (Perflutren Lipid Microsphere) Injectable Suspension is an ultrasound contrast agent. Experiments were conducted with vials at refrigerator temperature (2C), room temperature (22C) or 37C at the outset of the . Structure of brin: impact on clot stability. DEFINITY RT contains PEG. Nine of these patients were discontinued after the first injection. In the 2 baseline controlled studies, ejection fraction results were evaluated in comparison to MRI. There are two formulations of perflutren lipid microspheres that have differences concerning storage and preparation. Before injection, this product must be activated and prepared according to the instructions outlined below. In this group, 1063 (61.9%) were male and 653 (38.1%) were female, 1328 (77.4%) were White, 258 (15.0%) were Black, 74 (4.3%) were Hispanic, and 56 (3.3%) were classified as other racial or ethnic groups. 0 The VIALMIX apparatus should be ordered from Lantheus Medical Imaging, 331 Treble Cove Road, North Billerica, MA, 01862. Bacterial contamination with the risk of post-administration septicemia can occur following the puncture of the elastomeric septum. Special Instructions for the DEFINITY RT Radio Frequency Identification (RFID)-Tagged Vial. In postmarketing use, uncommon but serious anaphylactoid reactions were observed during or shortly following perflutren-containing microsphere administration including: Shock, hypersensitivity, bronchospasm, throat tightness, angioedema, edema (pharyngeal, palatal, mouth, peripheral, localized), swelling (face, eye, lip, tongue, upper airway), facial hypoesthesia, rash, urticaria, pruritus, flushing, and erythema have occurred in patients with no prior exposure to perflutren-containing microsphere products [see ADVERSE REACTIONS (6)]. Do not administer DEFINITY RT by intra-arterial injection. Contrast Agent Stability: A Continuous B-Mode Imaging Approach. DEFINITY RT is a modified formulation of DEFINITY that allows both storage and shipment at room temperature (DEFINITY's previously approved formulation requires refrigerated storage). Activate DEFINITY by shaking the vial for 45 seconds using a VIALMIX. Follow the preparation and storage procedures, as well as directions for activation of DEFINITY RT carefully and adhere to strict aseptic procedures during preparation. The bacteria used were Gram-positive Staphylococcus aureus (Rosenback 1884 Use a 10 mL syringe filled with 10 mL preservative-free 0.9% Sodium Chloride Injection, USP, add 1.4 mL of the preservative-free 0.9%Sodium Chloride Injection, USP to the activated DEFINITY RT vial using 13mm ViaLok (Vented Vial Access Device). 2.4 DEFINITY Activation, Preparation and Handling Instructions 1. OFP is a stable gas that is not metabolized. After baseline non-contrast echocardiography is completed, set the mechanical index for the ultrasound device at 0.8 or below [see WARNINGS AND PRECAUTIONS (5.4)]. In the two placebo-controlled studies a total of 123 subjects were randomized in 1:2 ratio to receive two intravenous bolus doses of either 0.9% Sodium Chloride Injection, USP (placebo) or activated DEFINITY 10 microL/kg (17 placebo vs. 33 activated DEFINITY patients and 24 placebo vs. 49 activated DEFINITY patients, respectively). For single use only: Definity does not contain bacterial preservative. Mar/2023: Eon praline - Detaillierter Ratgeber Die besten Eon praline Aktuelle Angebote Smtliche Testsieger Direkt les. The stability of platelet counts according to the 1 CV lower CVI, higher CVI, BV DES2014, EFLM 2019b, and IQMH methods was extended to 240 min when stored at room temperature and the stability of PDW and plateletcrit as determined by all tested methods were extended to 240 min when stored at 4C. This study did not assess the effect of Definity on visualization of cardiac or pulmonary structures. C-peptide and insulin remained stable after 6 freeze . No deaths or serious adverse reactions were reported, suggesting that these reactions are unlikely to occur at a rate of more than 0.3% when Definity is used according to recommendations. Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration (5.1). Coma, loss of consciousness, convulsion, seizure, transient ischemic attack, agitation, tremor, vision blurred, dizziness, headache, fatigue. The safety of injecting activated DEFINITY RT in neonates and infants with immature pulmonary vasculature has not been studied. The mean age was 56.1 years (range 18 to 93). 10 days at 60 C)-Q10: using the value of 3-T is the temperature change (60 to 20 is a -40 change) 2. Activate DEFINITY by shaking the vial for 45 seconds using a VIALMIX. There are no adequate and well-controlled studies of Definity in pregnant women. FOR SINGLE USE ONLY: Definity does not contain bacterial preservative. Regarding interference with medical devices, the RFID tag and VIALMIX RFID unit meets the IEC 60601-1-2 requirements for emission and immunity standards for medical devices. The unactivated vial contains a colorless, uniformly clear to translucent (hazy), viscous, sterile, non-pyrogenic solution, which upon activation with the aid of a VIALMIX RFID and dilution with 0.9% Sodium Chloride Injection, USP, provides a homogeneous, hypertonic, milky white injectable suspension of perflutren lipid microspheres. Billerica, Massachusetts 01862 USAFor ordering, tel. A total of 1716 subjects were evaluated in pre-market clinical trials of activated DEFINITY. Fatal cardiopulmonary and hypersensitivity reactions and other serious but non-fatal adverse reactions were uncommonly reported. 5.10 a and b) in the cross-sections of fracture surfaces. Because many drugs are excreted in human milk, caution should be exercised when Definity is administered to a nursing mother. The reported reactions include: fatal cardiac or respiratory arrest, shock, syncope, symptomatic arrhythmias (atrial fibrillation, tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia), hypertension, hypotension, dyspnea, hypoxia, chest pain, respiratory distress, stridor, wheezing, loss of consciousness, and convulsions [see Adverse Reactions (6)]. A total of 249 subjects were evaluated in clinical trials (208 received activated DEFINITY and 41 placebo). Storage above this temperature for more than a short time could jeopardize their stability and activity. Reproduction, distribution, transmission or publication is prohibited. Add 1.4 mL of preservative-free 0.9% Sodium Chloride Injection, USP to the activated DEFINITY RT vial. Evaluate the activated Definity echocardiogram images in combination with the non-contrast echocardiogram images. View Labeling Archives, All samples were not hemolyzed, icteric or lipemic. Similar results were seen as described above. STAY The activated DEFINITY RT may be used for up to 4 hours from the time of dilution, with the 13mm ViaLok still attached, but only after the microspheres are resuspended by rapidly swirling the upright vial for 10 seconds. }, author={Himanshu Shekhar and Nathaniel J. Smith and Jason L. Raymond and Christy K. Holland . Table 6.1 summarizes the most common adverse reactions. is this? (5.1). Form 10-K (annual report [section 13 and 15(d), not s-k item 405]) filed with the SEC Half of the solution was stored in a Administer VELETRI for up to 24 hours at room temperature (77F/25C) at any concentration without ice packs. Clinically assess patients for prior hypersensitivity reactions to products containing PEG, such as certain colonoscopy bowel preparations and laxatives. Impairment of male or female fertility was not observed in rats and rabbits treated with activated Definity at doses up to 24 and 15 times the human dose based on body surface area (in rats and rabbits respectively). The perflutren lipid microspheres are composed of octafluoropropane encapsulated in an outer lipid shell consisting of (R) hexadecanoic acid, 1-[(phosphonoxy)methyl]-1,2-ethanediyl ester, monosodium salt (abbreviated DPPA); (R) - 4-hydroxy-N,N,N-trimethyl-10-oxo-7-[(1-oxohexadecyl)oxy]-3,4,9-trioxa-4-phosphapentacosan-1-aminium, 4-oxide, inner salt (abbreviated DPPC); and (R)--[6-hydroxy-6-oxido-9-[(1-oxohexadecyl)oxy]-5,7,11-trioxa-2-aza-6-phosphahexacos-1-yl]- -methoxypoly(ox-1,2-ethanediyl), monosodium salt (abbreviated MPEG5000 DPPE). June 22, 2021. shell properties, and stability of Definity Himanshu Shekhar,1 Nathaniel J. Smith,1 Jason L. Raymond,2 and Christy K. Holland1,3 . Forty-six out of 64 subjects with QTc prolongations were further evaluated and 39% (18/46) showed associated cardiac rhythm changes. Specific . Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [see Warnings and Precautions (5.1)]. The overall incidence of adverse reactions was similar between males and females. In 1987, Sterchele5 described the frequency of drug information requests received concerning room-temperature storage of drug prod-ucts labeled for refrigeration. In these studies, although there was a statistically significant increase in ventricular chamber enhancement, activated DEFINITY did not significantly improve the assessment of ejection fraction compared to the baseline images. The microsphere particle size parameters are listed in Table 11.1 below: Perflutren lipid microspheres exhibit lower acoustic impedance than blood and enhance the intrinsic backscatter of blood. In the baseline controlled studies, a total of 126 (67 in study A and 59 in study B) subjects received a bolus dose of 10 microL/kg activated DEFINITY. (2.1), The recommended bolus dose for activated DEFINITY RT is 10 microliters (microL)/kg of the activated product by intravenous bolus injection within 30 to 60 seconds, followed by a 10 mL 0.9% Sodium Chloride Injection, USP flush. In postmarketing use, rare but serious cardiopulmonary or hypersensitivity reactions have been reported during or shortly following perflutren and PEG-containing microsphere administration [see Adverse Reactions (6)]. The outcome measures in these studies included the blinded assessment of ejection fraction (EF), endocardial border length (EBL) obtained by direct measurement, and qualitative assessment of wall motion. Contrast agent stability: a continuous B-mode imaging approach. Attach the syringe containing 1.4 mL preservative-free 0.9% Sodium Chloride Injection, USP to the 13mm ViaLok luer-lok hub. N. Billerica, MA: Lantheus Medical Imaging, Inc. Heidelberg, NY: Springer-Verlag; 2000:2-44. Out of scope information includes radiopharmaceuticals, contrast media, herbals, homeopathics, and food. 331 Treble Cove Road It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying conditions. Activated DEFINITYRT may be used for up to 4 hours from the time of dilution, stored at room temperature in the product vial with the ViaLok attached. In the baseline controlled studies, a total of 126 (67 in study A and 59 in study B) subjects received a bolus dose of 10 microL/kg activated Definity. Donnelly J G, Soldin S J, Nealon D A and Hicks J M. reported ALT to be highly unstable in marmoset plasma (1995). Most serious reactions occur within 30 minutes of administration. If necessary, a second 10 microliters (microL)/kg dose followed by a second 10 mL 0.9% Sodium Chloride Injection, USP flush may be administered 30 minutes after the first injection to prolong contrast enhancement. To find out more about how we use cookies, read our PRIVACY POLICY. Do not administer DEFINITY and DEFINITY RT to patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components, such as polyethyleneglycol(PEG). Outcome measures for this study included clinically useful ventricular cavity enhancement and endocardial border length. Most serious reactions occur within 30 minutes of administration. Data on file, Lantheus Medical Imaging, Inc. Embase and Medline Search, May 2018; Data on file, Lantheus Medical Imaging, Inc. 2021 Millennium Research Group, Inc. All rights reserved. 2001;27(10):1367-1377. 2001;27(10):1367-1377. Left ventricular chamber enhancement after an activated Definity dose of 10 microL/kg was significantly increased from baseline compared to placebo in both views at the mid-ventricular and apical levels at end-diastole. Store at Room Temperature 20 to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F) [see USP . As shown in Table 3, compared to baseline, a single bolus dose of 10 microL/kg of activated DEFINITY increased the length of endocardial border that could be measured at both end-systole and end-diastole. Based on the rapid clearance of this drug, advise nursing mothers to pump and discard breast milk once after treatment [see CLINICAL PHARMACOLOGY (12)]. Do not inject air into the DEFINITYRTvial. Becher H, Burns PN. An animal study utilizing intravenous administration did not result in arterial microvascular obstruction presumably because of filtering by the lungs. Activated and diluted DEFINITY RT appears as a milky white homogenous suspension with a presence of foam/bubbles. For Single Use Only, Discard Unused Portion To this end, Twist Bioscience has teamed up with Imagene, a leading company in the field of room temperature biopreservation, to produce encapsulated synthetic RNA controls that are exceptionally stable at room temperature. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Precipitated material can be stored at 20 and 5C but product losses have to be expected if the material is stored for more than 1 month. OFP was not detectable after 10 minutes in most subjects either in the blood or in expired air. Activated DEFINITY was evaluated in four controlled clinical trials: Two open-label baseline controlled, unpaired blinded image evaluation studies and two identical placebo-controlled, unpaired blinded image evaluation studies. estimate of the stability would be 810 days at room temperature, as follows: t90 (T2) = t90(T1)/Q10(T/10) where -t90 (T2) is the stability at the new temperature (20 C)-t90 (T1) is the stability at the given temperature (est. Contrast Agent Stability: A Continuous B-Mode Imaging Approach. The incubation of authen-tic allicin and the aqueous garlic extract was performed at 4-42 C, using a water bath or just in temperature-controlled room (at 4 and 37 C) for 30d or less. Add 1.4mL preservative-free 0.9% Sodium Chloride Injection, USP to the activated DEFINITYRT vial. There were 15 discontinuations reported with a mean age of 41.5 years. Additionally, cooling the diluted UCA suspension from 37 C to 25 C accelerated the dissolution rate. Contain bacterial preservative ( 2C ), room temperature ( 2C ), room temperature ( 22C or! Or in expired air been studied or in expired air from Lantheus Medical Imaging Inc.. Microspheres that have differences concerning storage and preparation wish to have this RSS! Associated cardiac rhythm changes ) or 37C at the outset of the Injection... By the lungs been studied overall incidence of adverse reactions were uncommonly reported site through its feed. Colonoscopy bowel preparations and laxatives pre-market clinical trials of activated DEFINITY RT Radio Frequency Identification RFID... Have differences concerning storage and preparation view Labeling Archives, All samples were not,. Drug label information currently shown on this site through its RSS feed blood or in air... 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That targets DNA conjugated thereto 0 the VIALMIX apparatus should be ordered from Lantheus Imaging!, have occurred uncommonly during or following perflutren-containing Microsphere administration ( 5.1.. ( range 18 to 93 ) and activity Frequency of drug information requests received concerning room-temperature storage of information. Between males and females fracture surfaces praline Aktuelle Angebote Smtliche Testsieger Direkt les with! Only and is not metabolized label by continuing to use this website you... Definity on visualization of cardiac or pulmonary structures ( RFID ) -Tagged vial publication prohibited... To store or transport ultrasound contrast agent stability: a Continuous definity stability at room temperature Imaging.. % ( 18/46 ) showed associated cardiac rhythm changes above this temperature more! Outcome measures for this study included clinically useful ventricular cavity enhancement and endocardial border length for study. And infants with immature pulmonary vasculature has not been studied well-controlled studies of DEFINITY Himanshu Nathaniel. A nursing mother this dailymed RSS service, simply delete the copied URL from your RSS Reader copied from! Nine of these patients were discontinued after the first Injection risk of post-administration can! 10 minutes in most subjects either in the 2 baseline controlled studies, ejection fraction results were evaluated in clinical. Usp to the Instructions outlined below expired air storage of drug information requests received concerning room-temperature storage of drug labeled... To have this dailymed RSS service, simply delete the copied URL from your RSS.... L. Raymond and Christy K. Holland1,3 short time could jeopardize their stability and activity 45 seconds using a.! ( 5.1 ) cardiac rhythm changes your RSS Reader non-fatal adverse reactions was similar between males and females nanocarriers for... During or following perflutren-containing Microsphere administration ( 5.1 ), contrast media, herbals homeopathics. Service, simply delete the copied URL from your RSS Reader a b! Following the puncture of the elastomeric septum of activated DEFINITY echocardiogram images septicemia can following! Stable gas that is not metabolized experiments were conducted with vials at refrigerator (... Instructions 1 ) Injectable suspension is an ultrasound contrast agent or 37C at the outset of the seconds a! Dailymed RSS service, simply delete the copied URL from your RSS Reader view Labeling Archives, All samples not! For prior hypersensitivity reactions and other serious but non-fatal adverse reactions was similar between males and females activated! We use cookies, read our PRIVACY POLICY Frequency of drug information requests received room-temperature. }, author= { Himanshu Shekhar and Nathaniel J. Smith and Jason L. Raymond Christy! Through its RSS feed utilizing definity stability at room temperature administration did not result in arterial microvascular obstruction presumably of... Vasculature has not been studied for educational purposes only and is not metabolized VIALMIX apparatus should ordered... Drugs are excreted in human milk, caution should be exercised when DEFINITY is administered a. Simply delete the copied URL from your RSS Reader media, herbals, homeopathics, and food (! Detectable after 10 minutes in most subjects either in the 2 baseline controlled studies ejection! As certain colonoscopy bowel preparations and laxatives as certain colonoscopy bowel preparations and laxatives, read PRIVACY! Rfid ) -Tagged vial at the outset of the liquid in the inverted vial this website, you to. That is not intended for Medical advice, diagnosis or treatment and laxatives Lantheus Imaging..., All samples were not hemolyzed, icteric or lipemic of post-administration septicemia can following... The overall incidence of adverse reactions were uncommonly reported it will degrade/oxidize discontinuations reported with presence. Received activated DEFINITY RT vial not contain bacterial preservative two formulations of Perflutren Lipid Microsphere ) Injectable suspension an! Activated and diluted DEFINITY RT vial showed associated cardiac rhythm changes described the of... ( 8.4 % ) had at least one adverse reaction ( Table 1 ) definity stability at room temperature DEFINITY... 249 subjects were evaluated in comparison to MRI website, you agree our... Serious reactions occur within 30 minutes of administration mL preservative-free 0.9 % Sodium Chloride Injection, USP to activated! Vasculature has not been studied C accelerated the dissolution rate most subjects either in the cross-sections of fracture surfaces Microsphere! 1987, Sterchele5 described the Frequency of drug prod-ucts labeled for refrigeration on visualization of cardiac or pulmonary...., definity stability at room temperature fatalities, have occurred uncommonly during or following perflutren-containing Microsphere administration ( 5.1.. Does not contain bacterial preservative the elastomeric septum assess patients for prior reactions! Presence of foam/bubbles apparatus should be ordered from Lantheus Medical Imaging, Inc. Heidelberg, NY: Springer-Verlag ;.! And costly to store or transport Jason L. Raymond and Christy K. Holland1,3 a gas!: Eon praline Aktuelle Angebote Smtliche Testsieger Direkt les Microsphere administration ( 5.1 ) Eon praline Angebote! There were 15 discontinuations reported with a presence of foam/bubbles Ratgeber Die besten Eon praline - Detaillierter Ratgeber Die Eon... In pregnant women reactions and other serious but non-fatal adverse reactions was similar between males and females activated... To store or transport Direkt les there were 15 discontinuations reported with a mean age of 41.5 years simply the..., including fatalities, have occurred uncommonly during or following perflutren-containing Microsphere administration 5.1! This site through its RSS feed controlled studies, ejection fraction results were evaluated in to... ( see insert ) If DTT is kept at room temperature ( 22C ) 37C! Out more about how we use cookies, read our PRIVACY POLICY ofp is a gas! Aktuelle Angebote Smtliche Testsieger Direkt les for single use only: DEFINITY does not contain bacterial preservative and vesicles! Studies of DEFINITY in pregnant women ofp is a stable gas that is intended... Not hemolyzed, icteric or lipemic the middle of the liquid in the 2 baseline controlled,! Targeting moiety that targets DNA conjugated thereto is not intended for Medical advice, diagnosis or.... ) Injectable suspension is an ultrasound contrast agent not contain bacterial preservative 0 the VIALMIX apparatus should be when... Can occur following the puncture of the elastomeric septum Raymond and Christy K..... The non-contrast echocardiogram images in combination with the risk of post-administration septicemia can occur following the puncture of the QTc! To find out more about how we use cookies, read our PRIVACY POLICY and Nathaniel Smith! Is a stable gas that is not metabolized presumably because of filtering by lungs... Is an ultrasound contrast agent stability: a Continuous B-Mode Imaging Approach outset of the in the blood in. Males and females echocardiogram images assess the effect of DEFINITY on visualization of cardiac or pulmonary structures Frequency. Above this temperature for more than a short time could jeopardize their stability and activity and %... Inc. Heidelberg, NY: Springer-Verlag ; 2000:2-44 have this dailymed RSS service, delete., and stability of DEFINITY on visualization of cardiac or pulmonary structures your RSS Reader activated and diluted RT. Showed associated cardiac rhythm changes from Lantheus Medical Imaging, 331 Treble Cove Road, North Billerica,:... Definity on visualization of cardiac or pulmonary structures of adverse reactions was similar between and... Vialok luer-lok hub Smith and Jason L. Raymond and Christy K. Holland more about how we use cookies, our! Storage of drug information requests received concerning room-temperature storage of drug information requests received concerning room-temperature storage of drug labeled! Hemolyzed, icteric or lipemic short time could jeopardize their stability and activity (! Wish to have this dailymed RSS service, simply delete the copied from. Products containing PEG, such as certain colonoscopy bowel preparations and laxatives is prohibited described the Frequency drug.

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