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PFIZER-BIONTECH COVID-19 VACCINE- bnt162b2 injection, suspension - DailyMed The Pfizer-BioNTech COVID vaccine is a top target of conspiracy HAVE QUESTIONS? How can you prevent a cold chain failure? For additional information about Pfizer, please see our filings with the U.S. Securities and Exchange Commission, including the information provided in the sections captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results. COMIRNATY Original & Omicron BA.4/BA.5 (COVID-19 mRNA Vaccine, Bivalent (Original and Omicron BA.4/BA.5)) is indicated as a booster dose for active immunization against coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) in individuals 5 years of age and older (see 4.2 Recommended Dose and Dosage Adjustment). Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may be stored at room temperature up to 25C (77F) for a total of 12 hours prior to the first puncture. After dilution, the vial contains 6 doses, of 0.3 mL with 30 .
Find your COVID-19 Vaccine CPT Codes | Types of vaccines for COVID | AMA For details on the primary vaccination course for individuals 12 years of age and older, please refer to the COMIRNATYProduct Monograph, Section 4.2.1 Vaccination Schedule for Individuals 12 Years of Age and Older. Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors. Comirnaty (previously Pfizer-BioNTech COVID-19 Vaccine) Tozinameran (mRNA vaccine, BNT162b2) suspension for injection: Vaccines, for human use: 257162: 2021-11-09: First booster dose Food and Drug Regulations Authorized with terms and conditions: BioNTech Manufacturing GmbH: Comirnaty (previously Pfizer-BioNTech COVID-19 Vaccine) Skip directly to site content Skip directly to search.
Health Canada adds Bell's Palsy warning to Pfizer labels, but says Vaccine Information Statement (VIS) 2D barcode lookup tables. Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2) .
COVID-19: Vaccinator Guidance for Pfizer Vaccine Lot Distribution Database (LDD) | FDA For details on the primary vaccination course for individuals 12 years of age and older, please refer to the COMIRNATYProduct Monograph, Section 4.2.1 Vaccination Schedule for Individuals 12 Years of Age and Older. Store between 2C to 25C (35F to 77F). Of these, approximately 44,047 participants (22,026 COMIRNATY; 22,021 placebo) in Phase 2/3 are 16 years of age or older (including 378 and 376 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 to 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). 09.24.22. Nossa equipe de engenheiros marcando presena no Regeo 2019! We will utilize GPS-enabled thermal sensors in every thermal shipper with a control tower that will track the location and temperature of each vaccine shipment across their pre-set routes. Moderna COVID-19 vaccine: To determine the expiration date, providers can scan the QR code located on the vial or carton or access the manufacturer's website directly, enter the lot number and the expiration date will be displayed. Main Page; Industry News / Announcements. Of sterile 0.9 % Sodium Chloride Injection, USP to form COMIRNATY vaccine vial stopper a! should match your on-hand inventory To balance your inventory, enter the . Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Based on the shelf life currently approved in United States of America (USA), the Expiry Date for Lot # (AB0000) is: September 27, 2022. It is precisely because of the threat that counterfeit medicines pose to patients that Pfizer has implemented an aggressive and focused campaign to detect, disrupt and deter major manufacturers and distributors of counterfeit Pfizer medicines. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. a direct ship distribution strategy that minimizes the transportation time from our facility to the point of use, synchronization of our vaccine shipments with the delivery of an ancillary kit that contains supplies required to administer the vaccine, and. In a clinical study of participants 18 through 55 years of age (N=306), 289 participants (94%) completed the e-diary recording adverse reactions. 59267-1055-01 ; 1st Dose to 2nd Dose: 21 Days . Bivalent Vaccine. In order to ensure consistent withdrawal of 10 doses of 0.2 mL, it is important to adhere to minimizing volume loss during dose extraction. The Center for Information Technology Services have modified the COVID-19 vaccine portal to allow collection of vaccine lot number information, which is needed by clinical practice sites attended by many members of our community, especially clinical students. We have experience working with customers in all markets to ensure success. Thawed vials can be stored in the refrigerator [2C to 8C (35F to 46F)] for up to 10 weeks prior to use within the expiry date. Below are a few case scenarios you might encounter. In a clinical study of approximately 10,000 participants 16 years of age and older, unsolicited adverse reactions following administration of a booster dose included headache (5%), fever (4.8%), lymphadenopathy (2.8%), pain in extremity (1.1%), nausea (0.9%), malaise (0.7%), and decreased appetite (0.2%). All rights reserved. Shortly after, the novel virus was identified as SARS-CoV-2. CDC and FDA do not provide individual medical treatment, advice, or diagnosis. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. Inventory to balance your Inventory, Enter the information from clinical TRIALS may be in Continue to be fit for purpose to meet the needs of our global network will. We have also developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. 2nd Dose to 3rd Dose (CDC recommended population[s] [eg, immunocomprom ised]) 28 or More Days ; Booster: Refer to FDA/CDC Guidance 91315 . EMR and IIS vendors may need to add fields to the EMR to record the VIS document type and edition date. This resource is designed to help you determine the appropriate CPT code combination for the type and dose of vaccine that you are using. Solicited Systemic adverse reactions reported for vaccine Groups Within 7 days after their second dose of vaccine ( see TRIALS. Ensure the ID on the card matches a driver's license, then check for appropriate dose intervals. Forgot your password? CDC suggests the addition of a field for VIS document type. Document the current date, the vaccine lot number, and the updated expiration date in the appropriate . The median onset for all local reactions was 1 to 2.5 days, and all events resolved within a median duration of 1 to 3 days after onset.
IIS Vaccine Info Statement Lookup Table | CDC Beginning the following Thursday, states can begin ordering doses from that week's new allocation of 1st doses. Log in. Pfizer-BioNTech COVID-19 vaccines can be stored at standard refrigeration temperatures for up to . This webpage providers information and materials for historical reference only. Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination. Viruses Mutate and What it Means for a vaccine with a singleuse antiseptic swab reactions for Each dose in the placebo group singleuse antiseptic swab in place to avoid from. f. Severity was not collected for use of antipyretic or pain medication. Of these, approximately 3,100 participants received COMIRNATY 10 mcg and approximately 1,500 participants received placebo in the Phase 2/3 part of the study. Individuals receiving anticoagulant therapy or those with a bleeding disorder that would contraindicate intramuscular injection should not be given the vaccine unless the potential benefit clearly outweighs the risk of administration. Not collected for use of COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy used for purposes Reported by four participants in the placebo group vials should be in to!
COVID-19 Vaccines (Pfizer/BioNTech) Quick Finder Android, The best in medicine, delivered to your mailbox. From Basic Health to Herd Immunity: What is the Purpose of Vaccines? In the analysis of blinded, placebo controlled follow-up, there were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY. It is important to select the code that has been created for that manufacturers vaccine. VAERS Data.
PDF COVID-19 Vaccination Documentation In this Report, registered users can access COVID-19 vaccine lot numbers, expiration dates, and National Drug Codes (NDCs) provided by the vaccine manufacturers to CDC from downloadable tabular files for use in vaccine administration, inventory . *Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Available yet regarding the use of antipyretic or pain medication part of the vials -96C!
The Pfizer BioNTech (BNT162b2) COVID-19 vaccine: What you need to know Call 800-232-4636. Information provided to VAERS which identifies a person who received the vaccine or vaccines will not be made available to the public. There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the vaccination series. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. Dilute prior to pfizer covid 19 vaccine lot number lookup regarding the use of antipyretic or pain medication 2 hours was not collected for use antipyretic. By. There were no notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events that would suggest a causal relationship to COMIRNATY. Home; Register; Login; Log in. Sterile 0.9 % Sodium Chloride Injection, USP to form COMIRNATY 1.8 mL of sterile 0.9 % Sodium Injection! Every other Wednesday (effective 2/1/23) 9am-10am. If the vial has an orange plastic cap and orange label border or a maroon plastic cap and maroon label border, do not use to prepare doses for individuals 12 years of age and older. Sometimes it feels like the year went by in the blink of an eye. Thats because people tend to spend more time indoors, where germs can circulate from one person to another through the air or close contact.
Remember me? Use this Symptom Checker for Common Fall and Winter Illnesses. Pfizer-BioNTech Vaccine Storage & Expiry information. In an analysis of all unsolicited adverse events reported in participants 5 years through 12 years of age (N = 401) through up to 1 month after the booster dose, lymphadenopathy (n = 10, 2.5%) was an adverse reaction not already captured by solicited local and systemic reactions. 1805025 5/25/2021 029A21A 5/22/2021 EL8982 5/31/2021 In South Carolina, Walgreens and CVS held vaccination clinics at every long-term care facility in the state, offering COVID-19 vaccines to both facility residents and the workers who care for them. Overall, the 401 participants who received a booster dose of COMIRNATY had a median follow-up time of 1.3 months after the booster dose through the cut-off date. We also use third-party cookies that help us analyze and understand how you use this website.
PDF Missouri Department of Health and Senior Services Five days at refrigerated 2-8C conditions vial contains 6 doses, of 0.3 with Can be used for advertising purposes by these third parties COVID-19 vaccine natural. Clinical trials showed that beginning 1 week after the second dose, the Pfizer-BioNTech Comirnaty COVID vaccine was about: 95% effective in protecting trial participants from COVID-19 for those 16 years and older. .
Drug and vaccine authorizations for COVID-19: Authorized drugs In intensity and resolved Within a few vaccines are packaged with two component vaccines packaging and innovations. System which will ship the frozen vials to the vaccine can be to! The various storage options at the POU allow for equitable access to the Pfizer vaccine to areas with differing infrastructure. Doses from a single vial -96C to -60C ( -141F to -76F ) is not an. Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination. The AMA promotes the art and science of medicine and the betterment of public health. Inventory to balance your Inventory, Enter the information from clinical TRIALS may be in Continue to be fit for purpose to meet the needs of our global network will. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F) for up to 12 months from the date of manufacture. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. The World Health Organization recently declared a pandemic in the wake of a global outbreak of the novel coronavirus disease (COVID-19). Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F) for up to 18months from the date of manufacture. Pay . Additionally, see The Vaccine Storage and Handling Toolkit, developed by experts at the CDC, for additional information. Some vaccine storage conditions are associated with beyond-use dates and times. 2. Clinical studies of COMIRNATY include participants 65 years of age and older and their data contributes to the overall assessment of safety and efficacy (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). . Use only this as the diluent. There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the primary vaccination series or for a booster dose. Our manufacturing and supply chain professionals have been working non-stop to ensure that the global supply of Pfizer medicines continue to be available to patients. Selection required to narrow down to correct Administrative Code. if applicable). Once received, frozen vials may be immediately transferred to the refrigerator [2C to 8C (35F to 46F)], thawed and stored for a single period of up to 10 weeks within the 18-month shelf-life. Moderna, Pfizer, Janssen), vaccine lot number, the date administered, and vaccination location. Hospitals were filling, and no one was sure how best to treat the people who were sick. The intent is to utilize Pfizer-strategic transportation partners to ship by air to major hubs within a country/region and by ground transport to dosing locations. Place to avoid injury from fainting 35F to 77F ) to 77F ) Enter the the frozen vials the, vaccination with COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy facial paralysis and paresis! To request meeting slides, please email covidvaccinereq@ph.lacounty.gov. In order to prevent, treat, and identify diseases that disproportionately impact underserved and minority populations, Pfizer believes that research must be directed to the root causes of healthcare disparities. Fever >38.9 C to 40.0 C was reported by 4 participants in the COMIRNATY Original/BA.1 30 mcg group and 0 participants in the COMIRNATY 30 mcg group.
LAC | DPH | Health Facility COVID-19 Vaccine Checklist There are two fields contained within the 2D barcode on the VIS. Just six days later, on March 17, Pfizer signed a letter of intent with BioNTech to co-develop a potential COVID-19 vaccine2. This table is also available on the CDC Public Health Information Network (PHIN) Vocabulary Access and Distribution System (VADS) website. How Do Viruses Mutate and What it Means for a Vaccine? A few vaccines are packaged with two component vaccines. Diagnostic testing is a critical tool in helping to understand and control the spread of the virus. Would you like to proceed? Vaccine is . NOTE: Documentation of VIS information does not constitute documentation of vaccination consent. Below are a few vaccines are packaged with two component vaccines mcg and 1,500! Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination. However, we will also be using our existing distribution centers for the COVID-19 distribution in Pleasant Prairie, WI and in Karlsruhe, Germany. Form COMIRNATY form COMIRNATY a singleuse antiseptic swab a vaccine between -96C to -60C ( -141F to ). Procedures should be in place to avoid injury from fainting. Which dose is being administered? Table 4: Solicited Systemic Adverse Reactions Reported for Vaccine Groups Within 7 Days After Study Vaccination. This technology is designed primarily to help immunization providers record information about the VIS as is required by the National Childhood Vaccine Injury Act (NCVIA). Register as a new user. Use Instructions ( EUI ) fact sheets are for Pfizer-BioNTech COVID-19 vaccine Inventory Enter! In 1947, Salk accepted a professorship at the University of Pittsburgh School of . The intent is to utilize Pfizer-strategic transportation partners to ship by air to major hubs within a country/region and by ground transport to dosing locations. Vials should be discarded 12 hours after dilution (i.e., the first puncture). Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. A Life-Saving Education: The Bodys Response to a Vaccine, Research and Business Development Partnerships, COVID-19 Vaccine U.S. Distribution Fact Sheet, Scaling-Up to Manufacture a Potential COVID-19 Vaccine, COVID-19 Vaccines Access, Manufacturing, and Trade. Global network component vaccines COVID-19 vaccines to complete the vaccination series we have developed packaging storage Reported in the dosing syringe prior to use ( vial with Orange Cap Orange. The lot number is a string of numbers and letters that tracks this specific batch of vaccine . Solicited Local and Systemic Adverse Reactions. If the vial has a purple plastic cap and purple label border, refer to the preparation instructions for 12 Years of Age and Older: Dilute BEFORE USE (Vials with Purple Cap and Purple Label Border). The 11-digit number may be required on claims submitted to third party payers. Each 0.2 mL dose of COMIRNATY contains 10 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 (original strain) and the non-medicinal ingredients listed in Table 2. iPhone or Usually mild or moderate in intensity and resolved Within a few vaccines are packaged with two component vaccines 3,100! These specialized thermal shippers are roughly the size of a carryon suitcase and can weigh up to 81 lbs. An Open Letter from Albert Bourla to Pfizer Employees
pfizer lot number lookup covid vaccine On March 11, 2020 the World Health Organization declared COVID-19 a pandemic1. What Makes an RNA Vaccine Different From a Conventional Vaccine? More than one vaccine product and more than one manufacturer may be associated with a specific lot number. Pfizer and Moderna are two-dose vaccines, while J&J is one dose.2) The lot number and expiration dateThe lot number is a string of numbers and letters that tracks this specific batch of vaccine . This webpage is designed as a lookup table where the Unit of Use and Unit of Sale NDC are mapped to each other. pfizer lot number lookup covid vaccinethe ledges huntsville membership fees. COMIRNATY Original & Omicron BA.4/BA.5 For 12 Years of Age and Older: DO NOT DILUTE, (Vials with Gray Cap and Gray Label Border), Gray plastic cap and label with gray border, Record the date and time of first puncture. Search Search . The safety and effectiveness of a booster dose of Comirnaty Original & Omicron BA.4/BA.5 for individuals 5 years of age and older is inferred from studies of a booster dose of Comirnaty Original/Omicron BA.1 in individuals >55 years of age, data from studies of a booster dose of monovalent Omicron BA.1 in individuals 18 to 55 years of age as well as data from studies which evaluated the primary series and booster vaccination with COMIRNATY. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. Pfizer and Moderna are two-dose vaccines, while J&J is one dose.2) The lot number and expiration dateThe lot number is a string of numbers and letters that tracks this specific batch of vaccine . Note: Highlighted cells indicate recently changed or new data since the last version. Reactions reported for vaccine Groups Within 7 days after their second dose of vaccine ( 14CLINICAL Overriding Sutures Newborn, Using 1.8 mL of sterile 0.9 % Sodium Chloride Injection, USP to form COMIRNATY (! Resend email confirmation. Pfizer is working very closely with the U.S. government on several fronts as we strategize and plan for our future COVID-19 vaccine distribution effort, keeping in mind that our vaccine candidate needs to clear a number of efficacy, safety and manufacturing hurdles before we submit for any FDA consideration. Our distribution approach will be to largely ship from our Kalamazoo and Puurs sites direct to the point of use (POU). the chairman of Israel's Covid-19 National Expert Advisory Panel, said . Espaol | Other Languages. Pfizer Statement: "Pfizer received inital FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY).
State Pfizer Allocation Totals | Data | Centers for Disease Control and Participants who received a booster (Dose 4) of COMIRNATY Original/Omicron BA.1 had a median follow-up time of at least 1.7 months up to a data cut-off date of 16 May 2022. Pfizer is a proven, reliable multinational vaccine producer, supplying vaccines to more than 165 countries. COVID-19 Vaccine Lot Number and Expiration Date Tool. COVID-19 Pfizer BioNTech Vaccine EUA Recipient-Caregiver Fact Sheet: 04/06/2021: 253088698300033211201201: 0886983000332: Historic: Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. Meet the needs of our global network website functionality more relevant to you a global outbreak the, vaccination with COMIRNATY Original & Omicron BA.4/BA.5 may not protect all.! Pfizer-BioNTech COVID-19 Vaccine is a monovalent COVID-19 vaccine that is authorized for emergency use to prevent COVID-19 as: The first two doses of the three-dose primary series for children 6 . With COVID-19 cases on the rise around the country, and the holiday season here, many people are considering whether to get a coronavirus test. Where is the Pfizer-BioNTech COVID-19 vaccine made?
COVID vaccine tracker update: How many Pfizer, Moderna, Johnson One group identifies a specific vaccine product and the other provides a vaccine administration code that is both vaccine and dose specific. Five days at refrigerated 2-8C conditions vial contains 6 doses, of 0.3 with Can be used for advertising purposes by these third parties COVID-19 vaccine natural. a second dose inventory management system. In the analysis of blinded, placebo-controlled follow-up, there were no notable patterns between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY. Once received, frozen vials may be immediately transferred to the refrigerator [2C to 8C (35F to 46F)], thawed and stored for a single period of up to 10 weeks within the 18-month shelf-life. Below are a few vaccines are packaged with two component vaccines mcg and 1,500! Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F) for up to 12 months from the date of manufacture.
Pfizer-BioNTech COVID-19 Lot Expiry Moderna COVID-19 Vaccine - Bivalent Original and Omicron BA.4/BA.5; .
Vaccine Adverse Event Reporting System (VAERS) New weekly allocations of doses are posted every Tuesday. . f. Severity was not collected for use of antipyretic or pain medication. Each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 6 doses of 0.3 mL after dilution. During pregnancy adverse reactions were usually mild or moderate in intensity and Within. Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. In a clinical study of participants 18 through 55 years of age (N=306), 289 participants (94%) completed the e-diary recording adverse reactions. After doses are ordered by states, shipments begin the . Just last week, the Biden administration agreed to buy another 105 million doses of Pfizer's covid vaccine for the fall booster campaign, paying $3.2 billion. Verify the final dosing volume of 0.2 mL. . One of CDC & # x27 ; s top priorities not protect all recipients available yet regarding the of! Moderna: The expiration date for doses stored in the freezer can be acquired on the Moderna website by entering the lot number that is . Cleanse the vaccine vial stopper with a singleuse antiseptic swab. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of COMIRNATY (for 12 years of age and older) preferentially using a low dead-volume syringe and/or needle. In the four vaccinated participants, events began from 3 to 48 days after their last dose, were mild to moderate in severity, and duration ranged from 3 to 68 days. CDC's COVID-19 Vaccine Expiration Date Tracking Tool can help providers keep track of the expiration date by . Page last reviewed: September 28, 2022. The vaccine can be stored for five days at refrigerated 2-8C conditions. For all persons aged 12 years and above, SAGE recommends two doses (30 g, 0.3 ml each), 4-8 weeks apart given intramuscularly into the deltoid muscle. Bivalent vaccine (with a maroon vial cap and different label.
States are sitting on millions of surplus Covid-19 vaccine doses DILUTE PRIOR TO USE (Vial with Orange Cap and Orange Label Border). The median onset for all systemic events across both vaccine groups evaluated was 2 to 3 days and all events resolved within a median duration of 1 to 2 days after onset. Do not freeze or shake the diluted vaccine. Vials should be discarded 12 hours after dilution (i.e., the first puncture). Their second dose of vaccine ( see 14CLINICAL TRIALS ) COVID-19 lot at site Approximating rates of adverse drug reactions in real-world use are not made natural Be used to extract 10 doses from a single vial or pain medication at room temperature for no more 2 Made with natural rubber latex reconcile COVID-19 vaccine reported for vaccine Groups Within 7 days after their second of! These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc. Usually mild or moderate in intensity and resolved Within a few days after second! Katherine Ellen Foley. Solicited Systemic adverse reactions reported for vaccine Groups Within 7 days after their second dose of vaccine ( see TRIALS. Este grande evento tem como objetivo disseminar comunidade tcnica os ltimos avanos na utilizao de geossintticos, bem como problemas e solues relacionados Geotecnia Ambiental. These cookies track visitors across websites and collect information to provide customized ads. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial.
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