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Synagis 50mg Injection
Prescription Required
Salt Composition : Palivizumab
Manufacturer : ASTRAZENECA PHARMA INDIA LTD
Origin of Medicine : United Kingdom
1 Vial(s)
Introduction to Synagis 50mg Injection
Synagis 50mg Injection contains the active substance Palivizumab, a monoclonal antibody used primarily to prevent severe respiratory syncytial virus (RSV)-related lower respiratory tract infections in high-risk children.
Synagis 50mg Injection is prescribed to infants and young children at high risk for severe RSV infection, including those born prematurely (≤35 weeks gestational age), those with bronchopulmonary dysplasia (BPD), and children with hemodynamically significant congenital heart disease (CHD). It works by inhibiting the RSV F protein, preventing the virus from entering and infecting healthy cells.
Before starting treatment with Synagis 50mg Injection, inform your doctor if your child has any history of allergies or bleeding disorders, as well as any other medications they are currently taking. While Synagis 50mg Injection is generally well-tolerated, regular monitoring is recommended, particularly for any signs of hypersensitivity reactions or coagulation disorders.
Uses of Synagis 50mg Injection
Synagis 50mg Injection is a monoclonal antibody developed to prevent severe RSV-related lower respiratory tract disease in high-risk children. It works by inhibiting the RSV F protein, blocking the virus from entering cells, and has proven to be safe and effective in specific high-risk patient populations.
Synagis 50mg Injection is used to prevent RSV infection in children at high risk, including:
- Children with bronchopulmonary dysplasia (BPD)
- Infants born prematurely (≤35 weeks gestational age)
- Children with hemodynamically significant congenital heart disease (CHD)
Therapeutic Effects of Synagis 50mg Injection
Synagis 50mg Injection is a recombinant humanised monoclonal antibody that provides passive immunity against RSV by binding to the RSV F protein on the virus surface. This action blocks a critical step in the fusion process and prevents RSV-infected cells from fusing with neighbouring cells, thus inhibiting the spread of the virus.
Interaction of Synagis 50mg Injection with other drugs
Synagis 50mg Injection is generally safe when used as directed. However, inform your healthcare provider about any other medications or supplements your child is taking, as some may interact with Synagis 50mg Injection. Always follow your doctor’s instructions and seek advice before starting or stopping any other treatments.
More Information about Synagis 50mg Injection
- Store between 2°C and 8°C (36°F and 46°F) in its original container. Do not freeze. Use before expiration.
- Administer by healthcare professionals as an intramuscular injection. Use with caution in children with thrombocytopenia or coagulation disorders.
- Discontinue immediately if anaphylaxis or severe allergic reactions occur. Provide appropriate emergency treatment.
- It may interfere with certain RSV diagnostic tests (e.g., antigen detection-based assays). RT-PCR is preferred for confirmation.
How to consume Synagis 50mg Injection
Synagis 50mg Injection should be administered intramuscularly at a dose of 15 mg per kg, preferably in the anterolateral thigh. Inspect the vial for any particulate matter or discolouration before use and discard if found. Withdraw the dose using a sterile technique and administer it immediately. For doses over 1 mL, divide the dose. Do not re-enter the vial or reuse syringes and needles. Ensure a healthcare professional administers the drug for proper technique and safety.
Safety Advices for Synagis 50mg Injection
Pregnancy
Synagis 50mg Injection is not safe for use during pregnancy as it may cause fetal harm or could affect reproductive capacity when administered to a pregnant woman.
Breast Feeding
Synagis 50mg Injection is not indicated for use in adults. Consult your healthcare provider before use if you are breastfeeding, as it’s important to weigh the potential risks and benefits.
Lungs
Before starting treatment with Synagis 50mg Injection, talk to your doctor if you have any lung conditions.
Liver
You need to inform your doctor if you have any liver disorders before starting Synagis 50mg Injection.
Alcohol
It is unknown whether it is safe to use Synagis 50mg Injection while consuming alcohol. Consult your doctor before taking this medication.
Driving
Synagis 50mg Injection is not indicated for use in adults. Please consult your healthcare provider for advice before engaging in activities such as driving.
Side Effects of Synagis 50mg Injection
Side effects are unwanted symptoms caused by medicines. Even though all medicines cause side effects, not everyone gets them.
Common side effects of Synagis 50mg Injection:
- Fever
- Rash
- Injection site reactions (e.g., pain, swelling)
- Mild hypersensitivity reactions (e.g., urticaria, pruritus)
Rare or severe side effects of Synagis 50mg Injection:
- Anaphylaxis (severe allergic reactions, including shock)
- Respiratory issues (e.g., dyspnea, respiratory failure, cyanosis)
- Hypotension (low blood pressure)
- Severe thrombocytopenia (low platelet count)
- Coagulation disorders (increased bleeding risk)
- Severe hypersensitivity reactions (e.g., angioedema, unresponsiveness)
Word of Advice
When using Synagis 50mg Injection, monitor for hypersensitivity reactions, including anaphylaxis, and be prepared to administer epinephrine if necessary. Use with caution in patients with coagulation disorders due to the intramuscular administration. Synagis 50mg Injection may interfere with certain RSV diagnostic tests, potentially causing false negatives; RT-PCR is recommended for confirmation.
Administer Synagis 50mg Injection immediately after withdrawing from the vial and discard any unused portion. Keep in mind that Synagis 50mg Injection is intended for the prevention of RSV, not for the treatment of active infections.
FAQs
Q 1. Who is given Synagis 50mg Injection?
Synagis 50mg Injection is given to high-risk infants and young children, including those with bronchopulmonary dysplasia (BPD), premature birth (≤35 weeks gestation), or significant congenital heart disease (CHD), to prevent severe respiratory syncytial virus (RSV) infections.
Q 2. How often is Synagis 50mg Injection given?
Synagis 50mg Injection is given as a monthly injection during the RSV season, typically starting in the autumn and continuing through the winter months. The usual duration of treatment is five doses, depending on the length of the RSV season and the child’s risk factors.
Q 3. What is the route of Synagis 50mg Injection?
Synagis 50mg Injection is administered via intramuscular injection. It is given into the muscle, typically in the thigh or buttock. The injection is usually performed by a healthcare professional.
Q 4. Is Synagis 50mg Injection a live vaccine?
No, Synagis 50mg Injection is not a live vaccine. It is a monoclonal antibody that provides passive immunity against RSV.
Q 5. What is the mechanism of Synagis 50mg Injection?
Synagis 50mg Injection works by binding to the RSV F protein on the surface of the virus. This prevents the virus from entering and infecting healthy cells. It also stops RSV-infected cells from fusing with nearby cells, helping to reduce the spread of the infection.
Fact Box of Synagis 50mg Injection
Molecule Name: Palivizumab
| Therapeutic class: Monoclonal Antibody |
Pharmacological class: Immunoglobulin | Indications: 1. Prevention of RSV infection in high-risk children 2. Children with bronchopulmonary dysplasia (BPD) 3. Infants born prematurely (≤35 weeks gestational age) 4. Children with hemodynamically significant congenital heart disease (CHD) |
References
1. Palivizumab, a humanised respiratory syncytial virus monoclonal antibody, reduces hospitalisation from respiratory syncytial virus infection in high-risk infants. https://pubmed.ncbi.nlm.nih.gov/9738173/
2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103770s5185lbl.pdf
3. https://www.ema.europa.eu/en/medicines/human/EPAR/synagis
4. Rogovik AL, Carleton B, Solimano A, Goldman RD. Palivizumab for the prevention of respiratory syncytial virus infection. https://pmc.ncbi.nlm.nih.gov/articles/PMC2920777/
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