Enivac HB Safsy Injection: Hepatitis B Vaccine Information
Clinical Reference Standards: CDSCO (Central Drugs Standard Control Organisation), Indian Pharmacopoeia (IP) & WHO | Last Updated: September 2026
When to Call Your Doctor IMMEDIATELY
- Difficulty breathing or wheezing after vaccination
- Swelling of the face, lips, tongue, or throat
- Rapid heartbeat or palpitations
- Severe dizziness or fainting
- High fever with convulsions
- Extensive rash or hives
- Severe pain or swelling at the injection site that worsens
If experiencing severe symptoms, call emergency services immediately.
What is shanvac-b paediatric 10mcg injection used for?
This medicine is a vaccine that protects against hepatitis B infection. It is given as an injection, usually in a series of three doses, to help the body build immunity against the hepatitis B virus.
- Generic Name: Hepatitis B Vaccine (rDNA) (10mcg)
- Manufacturer: Sanofi India Ltd
- Form: Allopathy
- Pregnancy Category: Consult doctor
- Prescription Required: Yes
🇮🇳 shanvac-b paediatric 10mcg injection के बारे में (Hindi Summary)
उपयोग: यह दवा हेपेटाइटिस बी वायरस से होने वाले संक्रमण को रोकने के लिए दी जाती है। यह एक टीका है जो शरीर की प्रतिरक्षा प्रणाली को हेपेटाइटिस बी वायरस के खिलाफ एंटीबॉडी बनाने के लिए उत्तेजित करता है। यह नवजात शिशुओं, बच्चों, किशोरों और वयस्कों के लिए सुरक्षित और प्रभावी है। यह टीका आमतौर पर तीन खुराकों में दिया जाता है - पहली खुराक दिन 0 पर, दूसरी 1 महीने बाद, और तीसरी 6 महीने बाद। यह टीका लीवर कैंसर और सिरोसिस जैसी गंभीर बीमारियों से भी बचाता है।
साइड इफेक्ट्स: इस टीके के सामान्य दुष्प्रभावों में इंजेक्शन वाली जगह पर दर्द, लालिमा या सूजन शामिल है। कुछ लोगों को थकान, हल्का बुखार या सिरदर्द हो सकता है। ये लक्षण आमतौर पर कुछ दिनों में अपने आप ठीक हो जाते हैं। गंभीर दुष्प्रभाव बहुत दुर्लभ हैं, लेकिन अगर सांस लेने में कठिनाई, चेहरे या गले में सूजन, या तेज धड़कन हो, तो तुरंत डॉक्टर से संपर्क करें।
सुरक्षा सलाह: यह टीका केवल प्रशिक्षित स्वास्थ्य कर्मचारी द्वारा ही लगाया जाना चाहिए। टीका लगवाने से पहले अपने डॉक्टर को अपनी सभी एलर्जी, बीमारियों और दवाओं के बारे में बताएं। यदि आप गर्भवती हैं या स्तनपान करा रही हैं, तो डॉक्टर से सलाह लें। टीकाकरण के बाद 15 मिनट तक क्लिनिक में रुकें। पूरी खुराक लेना न भूलें, क्योंकि इससे ही पूरी सुरक्षा मिलती है।
💊 shanvac-b paediatric 10mcg injection Uses & Benefits
- [{"condition":"Prevention of Hepatitis B Infection","description":"This medicine is used to prevent infection caused by the hepatitis B virus in people of all ages, including newborns, children, and adults.","evidence":"Well-established"},{"condition":"Prevention of Hepatitis D Infection","description":"Because hepatitis D virus can only infect people who already have hepatitis B, vaccination against hepatitis B also prevents hepatitis D.","evidence":"Well-established"},{"condition":"Prevention of Hepatocellular Carcinoma","description":"Chronic hepatitis B infection is a major cause of liver cancer.
- Vaccination reduces the risk of developing liver cancer later in life.","evidence":"Well-established"},{"condition":"Prevention of Cirrhosis","description":"By preventing chronic hepatitis B infection, this vaccine lowers the risk of developing cirrhosis and end-stage liver disease.","evidence":"Well-established"}]
Off-label uses: []
Primary treatment for: Hepatitis B infection
Also treats: Hepatitis D infection, Hepatocellular carcinoma, Cirrhosis
📋 Drug Information
| Generic Name(s) | Hepatitis B Vaccine (rDNA) (10mcg) |
| Brand Name | shanvac-b paediatric 10mcg injection |
| Manufacturer | Sanofi India Ltd |
| Packaging / Form | Varies by brand (Allopathy) |
| Therapeutic Class | VACCINES |
| Action Class | Subunit (Purified antigen) |
| Route of Administration | Parenteral (intramuscular injection) |
| Storage | Store this vaccine in a refrigerator at 2°C to 8°C. Do not freeze. Keep it in the original packaging to protect from light. Do not use if the vaccine has been frozen. |
| Shelf Life | The shelf life is typically 24 to 36 months from the date of manufacture when stored properly. Check the expiry date on the label before use. |
| WHO Guideline | The World Health Organization recommends that all infants receive the hepatitis B vaccine as soon as possible after birth, preferably within 24 hours. The WHO also recommends vaccination for high-risk groups, including healthcare workers, people with multiple sexual partners, and people who inject drugs. |
| ICMR Guideline | The Indian Council of Medical Research recommends hepatitis B vaccination for all infants as part of the Universal Immunization Programme, with the first dose at birth. It also recommends vaccination for high-risk adults. |
👨⚕️ Doctor's Practical Tips
Evidence-based practical advice from experienced clinicians
🔍 Is This Medicine Right for Your Symptom?
Educational reference. Always consult a doctor for diagnosis.
🔬 How This Medicine Works (Pharmacology)
Pharmacokinetics
How It Works
This medicine contains hepatitis B surface antigen (HBsAg) produced by recombinant DNA technology. When injected, the immune system recognizes this antigen as foreign and mounts a specific immune response. Specialized immune cells called antigen-presenting cells process the antigen and present it to helper T cells. These T cells then activate B cells to produce antibodies that specifically bind to the hepatitis B surface antigen. The vaccine also stimulates the production of memory B and T cells, which provide long-term immunity. If the person is later exposed to the real hepatitis B virus, these memory cells rapidly produce high levels of protective antibodies that neutralize the virus before it can infect liver cells. The vaccine does not contain live virus, so it cannot cause hepatitis B infection.
Mechanism Steps
💡 How to Take shanvac-b paediatric 10mcg injection
Strength: Injection: 10 micrograms of Hepatitis B Vaccine (rDNA) per 0.5 mL or 1 mL dose, depending on the product presentation.
Dosage Information
| Adult Dosage | For adults, this vaccine is usually given as a series of three intramuscular injections. The standard schedule is 0, 1, and 6 months, meaning the first dose is given on day 0, the second dose one month later, and the third dose six months after the first. An accelerated schedule may be used in certain situations, such as for travelers or healthcare workers, with doses at 0, 1, and 2 months followed by a booster at 12 months. The dose is 10 micrograms of hepatitis B surface antigen per injection. Dose must be individualized by a qualified clinician based on indication, age, weight, renal and hepatic function, and immune status. |
| Pediatric Dosage | For newborns and children, the dosing schedule may vary. Typically, the first dose is given at birth, followed by doses at 1-2 months and 6-18 months of age. The dose may be 5 micrograms or 10 micrograms depending on the product and national immunization schedule. Pediatric dosing is not established from available information for all age groups. Consult a pediatrician for precise dosing. |
| Elderly Dosage | The dosage for elderly patients is the same as for adults. However, the immune response may be lower in older adults, and antibody levels should be checked to confirm protection. No dose adjustment is required based on age alone. |
| Renal Impairment | No dose adjustment is required for patients with renal impairment. However, patients on dialysis may have a reduced immune response and may need additional doses or a higher dose. Consult a nephrologist for individualized recommendations. |
| Hepatic Impairment | No dose adjustment is required for patients with hepatic impairment. The vaccine is safe in people with liver disease. |
| Maximum Daily Dose | Not applicable. This vaccine is given as a single dose per scheduled visit, not daily. |
Dosage Timeline
⏰ What to Do If You Miss a Dose
⚠️ Side Effects of shanvac-b paediatric 10mcg injection
✅ Common Side Effects
🚨 Serious Side Effects
⚠️ Rare Side Effects
Consult your doctor if you experience any unusual symptoms.
🔬 Drug Interactions
| Drug | Severity | Effect |
|---|---|---|
| Immunosuppressants | Moderate |
⚡ Moderate Interactions
- Immunosuppressive therapy (e.g., high-dose corticosteroids, chemotherapy, tacrolimus)
🍷 Alcohol Interaction
Alcohol consumption does not directly interact with this vaccine. However, chronic heavy alcohol use can weaken the immune system and may reduce the vaccine's effectiveness. It is advisable to avoid excessive alcohol intake around the time of vaccination.
🔎 Check Your Other Medicines
Educational tool. Always confirm with your doctor or pharmacist.
🛡️ Safety & Warnings
🚫 Contraindications
["Severe allergic reaction to a previous dose of hepatitis B vaccine or to any component of the vaccine, including yeast.","Known hypersensitivity to the active ingredient or any excipient.","Acute severe febrile illness (vaccination should be postponed until recovery)."]
⚠️ Warnings & Precautions
["This vaccine should be given by a healthcare professional only.","Epinephrine should be readily available to manage any anaphylactic reaction.","People with a history of allergy to yeast should not receive this vaccine.","The vaccine may not provide protection in all individuals; some may not develop adequate antibody levels.","Immunocompromised individuals may have a reduced response to the vaccine.","This vaccine does not protect against hepatitis A, C, or E viruses.","Vaccination should be postponed during acute severe illness.","The vaccine should not be given intravenously or intradermally; it is for intramuscular use only."]
🤱 Lactation Safety
This vaccine is considered safe during breastfeeding. It does not pass into breast milk in a way that would harm the infant. Breastfeeding women can receive this vaccine.
💊 Overdose Management
Overdose with this vaccine is extremely unlikely because it is administered by a healthcare professional in a controlled dose. If a larger dose than recommended is given accidentally, monitor the patient for any adverse reactions and provide supportive care. There is no specific antidote.
⏰ Missed Dose
If you miss a scheduled dose of this vaccine, contact your doctor as soon as possible to reschedule. The vaccination series does not need to be restarted if a dose is delayed; simply continue with the next dose in the schedule. Do not skip doses, as completing the full series is important for long-lasting protection.
Additional Safety Advice
This medicine must be administered by a trained healthcare professional in a clinical setting where emergency equipment is available. Before receiving this vaccine, inform your doctor about any allergies, especially to yeast or previous vaccines, and about any current illness or fever. If you are pregnant or planning to become pregnant, discuss the benefits and risks with your doctor. This vaccine is generally considered safe during pregnancy when the risk of hepatitis B infection is high. If you are breastfeeding, it is safe to receive this vaccine. People with a weakened immune system, such as those on chemotherapy or with HIV, may have a reduced response to the vaccine and may need additional doses or monitoring. This vaccine does not protect against other types of hepatitis, such as hepatitis A or C. Continue to practice safe health behaviors, including using condoms and not sharing needles, even after vaccination. Keep a record of your vaccination dates and bring it to all medical appointments. Do not skip follow-up doses, as the full series is needed for optimal protection.
👴 Special Considerations for Elderly
💡 For Patients Above 65
Older adults may have a weaker immune response to the vaccine. It is safe, but antibody levels may need to be checked to ensure protection. No dose adjustment is required.
🤰 Pregnancy Planning (TTC)
If you are planning to become pregnant, you can receive this vaccine. It is safe during pregnancy and protects both you and your baby from hepatitis B.
🏥 Post-Surgery Considerations
There are no specific restrictions after surgery. You can receive the vaccine when you are medically stable. Inform your surgeon and anesthesiologist about your vaccination status.
🦷 Dental Procedures
There are no special considerations for dental procedures. Inform your dentist about your vaccination status as part of your medical history.
💚 Lifestyle Tips for Better Results
🏋️ Exercise Considerations
There are no specific exercise restrictions after receiving this vaccine. You can resume normal activities immediately, but if you feel tired or have a mild fever, take it easy for a day.
🥗 Diet Recommendations
💼 Impact on Daily Work & Life
This vaccine has no impact on your ability to work or drive. You can return to your normal activities immediately after the injection. Some people may feel mild fatigue, but this usually does not interfere with daily tasks.
🛑 When to Stop This Medicine
You should complete the full vaccination series as recommended. There is no reason to stop unless you experience a severe allergic reaction. If you have concerns, consult your doctor before discontinuing.
📅 Long-Term Use Effects
Long-term protection from this vaccine is excellent. Studies show that immunity persists for at least 20 years and often for life. There are no known long-term adverse effects from the vaccine. Booster doses are not routinely recommended for healthy individuals but may be considered for those with weakened immune systems or high-risk occupations.
🌿 Non-Medicine Approaches
These can complement medicine but do not replace prescribed treatment.
Provides immediate passive immunity after exposure to hepatitis B virus. It is used in combination with the vaccine for post-exposure prophylaxis.
Evidence: Well-established💉 Vaccination Considerations
💉 If You're Getting Vaccinated
This vaccine can be given at the same time as other vaccines, but at different injection sites. It does not interfere with the immune response to other vaccines. Live vaccines should be given at least 4 weeks apart if not administered on the same day.
📦 Storage Guide
✅ DO
Store in a refrigerator at 2°C to 8°C
❌ DON'T
Do not freeze the vaccine
✅ DO
Keep in the original packaging to protect from light
❌ DON'T
Do not expose to direct sunlight
✅ DO
Check the expiry date before use
❌ DON'T
Do not use if the vaccine has been frozen or is expired
✈️ Traveling with This Medicine
When traveling, carry this vaccine in its original packaging with a prescription copy if you need to receive a dose abroad. The vaccine must be stored in a refrigerator at 2°C to 8°C; use a cool bag with ice packs during travel. Plan your vaccination schedule around your trip, as the series requires multiple doses over several months. Check with your destination's health authorities for any entry requirements related to hepatitis B vaccination.
💰 Cost Analysis & Savings
👥 Real Patient Stories
Educational, anonymized scenarios. Individual results may vary.
💬 Questions Patients Often Ask
A: The vaccine starts stimulating your immune system within days, but optimal protection usually develops about 4 to 8 weeks after the complete series.
A: No, the vaccine contains no live virus, so it cannot cause hepatitis B infection.
A: Typically, three doses are needed: at 0, 1, and 6 months. Some schedules may vary.
A: Yes, the vaccine is generally considered safe during pregnancy when there is a risk of hepatitis B infection.
A: Common side effects include soreness at the injection site, mild fever, and fatigue. These usually resolve quickly.
🤔 Common Patient Concerns
🔄 Substitutes for shanvac-b paediatric 10mcg injection
View AllAlternative brands with exact same active ingredient:
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hepatitis b vaccine pediatricSerum Institute Of India Ltd ₹36.97 38.4% CHEAPER
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genevac-b paediatric injectionSerum Institute Of India Ltd ₹40.97 31.7% CHEAPER
-
revac-b plus pediatric vaccineBharat Biotech ₹41.38 31% CHEAPER
-
elovac-b 10mcg injectionIndian Immunologicals Ltd ₹51.56 14.1% CHEAPER
-
hb vac 10mcg injectionZydus Cadila ₹110.00 83.3% COSTLIER
Medical Note: Always consult your doctor before switching medications.
🛑 Myths vs. Facts
- Myth: The hepatitis B vaccine can cause hepatitis B.
Fact: The vaccine contains no live virus, so it cannot cause hepatitis B infection. - Myth: The vaccine is only for children.
Fact: The vaccine is recommended for people of all ages who are at risk of hepatitis B infection. - Myth: Once vaccinated, you don't need to worry about liver health.
Fact: The vaccine only protects against hepatitis B. You should still avoid other liver risks, such as excessive alcohol and other hepatitis viruses.