Sars-Cov-2 (Covid-19) vaccine, Mrna-LNP, spike protein (Moderna) (intramuscular)

Sars-Cov-2 (Covid-19) vaccine, Mrna-LNP, spike protein (Moderna) (intramuscular)

Sars-Cov-2 (Covid-19) vaccine, Mrna-LNP, spike protein (Moderna) (intramuscular)

Possible uses for Sars-Cov-2 (Covid-19) vaccine, MRNA-LNP, spike protein (Moderna)

This vaccine should only be given by or under your doctor's direct supervision.

The monovalent Moderna COVID-19 vaccine is no longer approved for use in the United States.

Before using the SARS-Cov-2 (Covid-19) vaccine, MRNA-LNP, spike protein (Moderna)

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

Relevant studies conducted to date have not shown any pediatric-specific problems that would limit the benefit of the SARS-CoV-2 (COVID-19) vaccine, supplied in a vial with a red cap and a label with a light blue border, in children 12 years of age and older: Vial with a dark blue cap and a label with a purple or light blue border in children aged 6 to 11 years and a vial with a dark blue cap and a label with magenta border for children aged 6 months to 5 years of age. Safety and effectiveness have been proven.

geriatrics

Related studies conducted to date have not shown any geriatric-specific issues that would limit the benefit of the SARS-CoV-2 (COVID-19) vaccine in the elderly. However, older patients are at higher risk of age-related liver, kidney, or heart problems, so caution may be warranted in patients receiving this vaccine.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are receiving this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

Using this medicine with any of the following medicines is not usually recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Elivaldogene Autotemcel
• Rituximab
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. Discuss using your medicine with food, alcohol or tobacco with your doctor.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Herzerkrankungen (z. B. Myokarditis, Perikarditis), Vorgeschichte von – Mit Vorsicht anwenden. Kann diese Bedingungen verschlimmern.

• Probleme mit dem Immunsystem (z. B. Patienten, die eine Organtransplantation erhalten haben) – Dieser Zustand kann die nützliche Wirkung des Impfstoffs verringern.

Proper Use of Sars-Cov-2 (Covid-19) Vaccine, MRNA-LNP, Spike Protein (Moderna)

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as an injection into one of your muscles.

Spikevax COVID-19 Vaccine: This vaccine is given in 2 doses at least 1 month apart. If you have received one dose of the Spikevax COVID-19 vaccine, you should receive a second dose of this vaccine to complete your vaccination series.

Primary series of Moderna COVID-19 vaccine (supplied in a vial with a dark blue cap and magenta border label): This vaccine is administered to children 6 months to 5 years of age in 2 doses at least 1 month apart. Patients with weak immune systems can receive a third dose at least a month after the first two doses.

Primary series of Moderna COVID-19 vaccine (supplied in a vial with a dark blue cap and a label with a purple or light blue border): This vaccine is administered to children 6 to 11 years of age in 2 doses at least 1 month apart. Patients with weak immune systems can receive a third dose at least a month after the first two doses.

Primary series of Moderna COVID-19 vaccine (supplied in a vial with a red cap and a light blue border label): This vaccine is administered in 2 doses at least 1 month apart to adults and children 12 years of age and older. Patients with weak immune systems can receive a third dose at least a month after the first two doses.

First booster dose of Moderna COVID-19 Vaccine (supplied in a vial with a red cap and label with a light blue border): You may receive a first booster dose of Moderna COVID-19 Vaccine at least 5 months after your primary dose of this vaccine. It is usually given to patients aged 18 and over. You may also receive a first booster dose of this vaccine after your primary vaccination course with another approved or authorized COVID-19 vaccine (e.g. Janssen COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine).

Second booster dose of Moderna COVID-19 Vaccine (supplied in a vial with a red cap and light blue border label): You may receive a second booster dose of Moderna COVID-19 Vaccine with an approved or approved COVID-19 vaccine at least 4 months after your first booster dose. It is usually given to patients aged 18 and over with a weak immune system and patients aged 50 and over.

This vaccine comes with an information sheet for recipients and caregivers. Read and follow the information in the leaflet carefully. Ask your doctor if you have any questions.

Precautions when using Sars-Cov-2 (Covid-19) Vaccine, MRNA-LNP, Spike Protein (Moderna)

Be sure to tell your doctor about any side effects that occur after vaccination.

This vaccine can cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor immediately if you experience rash, itching, rapid heartbeat, difficulty breathing, difficulty swallowing, or swelling of your hands, face, or mouth after vaccination.

This vaccine may increase your risk of serious heart problems (e.g., myocarditis, pericarditis), especially after receiving the second dose. Contact your doctor immediately if you have anxiety, blue or pale skin, chest pain, possible movement in your left arm, neck, or shoulder, fever, chills, fast heartbeat, trouble breathing, or unusual tiredness or weakness.

Fainting may occur after vaccination. You may also experience blurred vision, numbness or tingling in the arms, hands, or feet, or jerky movements of the arms and legs. Your doctor may want you to be observed after the injection to prevent and treat fainting spells.

This vaccine may not protect everyone who receives it. This vaccine does not treat the symptoms of COVID-19 infection if you already have the disease. It is very important that you take precautions to reduce the risk of contracting COVID-19.

Do not take any other medicines unless you have discussed this with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medications and herbal or vitamin supplements.

Side effects of SARS-Cov-2 (Covid-19) vaccine, MRNA-LNP, spike protein (Moderna)

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Contact your doctor or nurse immediately if any of the following side effects occur:

More common

• Schüttelfrost
• Schwierigkeiten beim Bewegen
• Fieber
• Kopfschmerzen
• Gelenkschmerzen
• Muskelschmerzen, Krämpfe, Schmerzen oder Steifheit
• Brechreiz
• geschwollene Gelenke
• ungewöhnliche Müdigkeit oder Schwäche
• Erbrechen

Incident not known

• Angst
• blaue oder blasse Haut
• Beschwerden oder Engegefühl in der Brust
• Brustschmerzen, möglicherweise Bewegung in den linken Arm, Nacken oder die Schulter
• Husten
• Schluckbeschwerden
• Schwindel
• schneller Herzschlag
• Ohnmacht
• Schwellungen oder Schwellungen der Augenlider oder um die Augen, das Gesicht, die Lippen oder die Zunge
• Atembeschwerden

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

Incident not known

• Blutungen, Blasenbildung, Brennen, Kälte, Verfärbung der Haut, Druckgefühl, Nesselsucht, Infektion, Entzündung, Juckreiz, Knoten, Taubheitsgefühl, Schmerzen, Hautausschlag, Rötung, Narbenbildung, Schmerzen, Stechen, Schwellung, Druckempfindlichkeit, Kribbeln, Geschwürbildung usw Wärme an der Injektionsstelle

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand names

In the USA

• Spikevax

Available dosage forms:

• Suspension

Therapeutic class: COVID-19 vaccine

More information