Why is that this medication prescribed?
Remdesivir injection is manufactured and supplied by Taj Pharmaceuticals; Remdesivir injection is used to treat coronavirus malady 2019 (COVID-19 infection) caused by the SARS-CoV-2 virus in hospitalized adults and kids twenty eight days elderly and older United Nations agency weigh a minimum of half-dozen.6 pounds (3 kg). Remdesivir injection is additionally accustomed treat coronavirus malady 2019 (COVID-19 infection) caused by the SARS-CoV-2 virus in non-hospitalized adults and kids twenty eight days elderly and older United Nations agency weigh a minimum of half-dozen.6 pounds (3 kg) United Nations agency area unit at high risk of progression to severe COVID-19, as well as hospitalization and death. Remdesivir is during a category of medicines referred to as antivirals. It works by stopping the virus from spreading within the body.
How ought to this drugs be used?
Remdesivir comes as an answer (liquid) and as a powder to be mixed with liquid and infused (injected slowly) into a vein over thirty to a hundred and twenty minutes by a doctor or nurse during a hospital. For hospitalized patients with severe COVID-19, it’s sometimes given once daily for five to ten days. The length of your treatment depends on however well your body responds to the medication. For non-hospitalized gentle to moderate COVID-19, it’s started inside seven days of 1st symptoms and given once daily for three days. Remdesivir injection could cause serious reactions throughout and when the infusion of the medication. A doctor or nurse can monitor you fastidiously whereas you’re receiving the medication. Tell your doctor or nurse forthwith if you expertise any of the subsequent symptoms throughout or when the infusion: chills or shivering; nausea; vomiting; sweating; giddiness upon standing up; rash; unhealthy or shortness of breath; abnormally quick or slow heartbeat; or swelling of the face, throat, tongue, lips, or eyes. Your doctor may have to impede your infusion or stop your treatment if you expertise these facet effects. Ask your pill pusher or doctor for a duplicate of the manufacturer’s info for the patient. Other uses for this drugs This medication is also prescribed for different uses; raise your doctor or pill pusher for additional info.
What special precautions ought to I follow?
Before receiving remdesivir, tell your doctor and pill pusher if you’re allergic to remdesivir, the other medications, or any of the ingredients in remdesivir injection. raise your pill pusher for an inventory of the ingredients. tell your doctor and pill pusher what different prescription and nonprescription medications, vitamins, organic process supplements, and flavoring product you’re taking or commit to take. make certain to say any of the following: antimalarial or anti-inflammatory (Plaquenil). Your doctor may have to alter the doses of your medications or monitor you fastidiously for facet effects. tell your doctor if you have got or have ever had liver or uropathy.
Remdesivir for Injection 100mg/vial Technical Specification:
| Product Name: | Remdesivir For Injection |
| Brand Name: | Remdetaj |
| Strength: | 100mg/vial |
| Dosage Form: | Lyophilized Powder for Injection (Sterile) |
| Packing: | 1 Single Dose Vial + WFI Tray |
| Route of Administration: | For I.V. use only |
| Pack Insert/Leaflet: | Covid Use Leaflet, PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antiviral & used to treat coronavirus (COVID-19) |
| Indication: | Remdesivir for Injection (Remdetaj) is an antiviral medicine used for treating COVID-19. COVID-19 is caused by a virus called a coronavirus. Remdesivir Injection stops the virus multiplying in cells and this stops the virus multiplying in the body. This can help your body to overcome the virus infection, and may help you get better faster. |
| Storage: | Store below 30°C (86°F). After reconstituted vial can be stored up to 4 hours at room temperature (20°C to 25°C [68°F to 77°F]). Store diluted remdesivir solution for infusion up to 24 hours at below 25°C or 48 hours in a refrigerator (2°C – 8°C). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Remdesivir For Injection 100mg/vial (Remdetaj)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Remdesivir For Injection 100mg/vial
Composition:Each Lyophilized Vial Contains:
Remdesivir ………………………….100mg
Excipients …………………………. q.s
THERAPEUTIC INDICATIONS:
Remdesivir for Injection (Remdetaj) is an antiviral medicine used for treating COVID-19. COVID-19 is caused by a virus called a coronavirus. Remdesivir Injection stops the virus multiplying in cells and this stops the virus multiplying in the body. This can help your body to overcome the virus infection, and may help you get better faster.
DIRECTION OF USE:
Remdesivir must be reconstituted with 19 mL sterile water for injection IP to get 5mg/ml of remdesivir solution. The reconstituted solution should be further diluted in sodium chloride 9 mg/mL (0.9%) saline solution for injection preferred total volume 100ml before being administered via intravenous infusion over 30 to 120 minutes.
After reconstitution, vials can be stored up to 4 hours at room temperature prior to administration or 24 hours at refrigerated temperature.
Dilute within same day as administration or Use immediately after dissolving the contents.
REFER ACCOMPANYING PACKAGE INSERT FOR DETAILED DOSAGE, DIRECTIONS FOR USE AND PRECAUTIONS.
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
Keep out of reach and sight of children.
Do not reuse or save unused Remdesivir lyophilized powder or diluted solution for infusion for future use.
If any foreign particle is visible after dissolving the contents, Please do not use the solution.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store below 30°C (86°F). After reconstituted vial can be stored up to 4 hours at room temperature (20°C to 25°C [68°F to 77°F]).
Store diluted remdesivir solution for infusion up to 24 hours at below 25°C or 48 hours in a refrigerator (2°C – 8°C).
REFER ACCOMPANYING PACKAGE INSERT FOR DETAIL STORAGE CONDITION.
Dosage: As directed by the Physician.
NOTE:
- Before administration of the injection to the patient, it is the responsibility of the treating physician/ institution to administer informed consent form (ICF) as prescribed, CDSCO approved format included inside the carton.
- POM Schedule 2 PP
