Havrix Vaccine Dosage,Interactions, Side effects

Havrix Vaccine

Havrix Vaccine is given to protect against Hepatitis A. Hepatitis A is a serious disease which is caused by the Virus. This disease can cause Cirrhosis and liver cancer.

Hepatitis A has spread the contact with the stool of a person infected with the hepatitis A virus. If you are eating food or drinking water by the infected person, there is a chance you also infected by Hepatitis A.

So this vaccine is given to the 12 months old children or more than that.

After the vaccine, it releases small amounts of viruses and making the body more resistant to the disease.

Like any other vaccines, this vaccine also not provide protection to everybody.

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Havrix Vaccine Dosage

Havrix Vaccine

Like other vaccines shake well before use it. This Vaccine is a turbid, Homogenous and white suspension.

This vaccine must be given intramuscularly. Use separate sterilization needles and syringes for each person.

Do not give this vaccine subcutaneously, Intradermatly or Intravenously.

Those people age is between 12 months to 18 years old. A 0.5 ml single dose is given to them. 0.5 ml booster dose administered anytime after 6 to 12 months.

Those people age is more than 19 (adults) 1ml dose given to them. 1 ml booster dose administered anytime (6-12 months) after the first dose.

ReadRotateq Vaccine 

Presentation of the Vaccine

0.5 ml single-dose vials and prefilled Tip-lok syringes.

1 ml single-dose vials and prefilled Tip-lok syringes.

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Follow The Guideline before taking the vaccine

If anyone already affects by the virus then this vaccine does not work at all.

If you have any allergic reaction then you should not receive this vaccine.

Call your healthcare provider if you have

1〉 Allergic reactions to natural rubber latex.

2〉 Weak immune system by any medicine.

If you have a minor cold you still receive this vaccine. In case you have a serious kind of fever or any type of serious infection just wait until you are well.

The vaccine is not good for unborn children or pregnant women. Not vaccinating to the mother could be more harmful for the baby. So you can consult with your doctor if you are infected by Hepatitis. Follow the doctor’s instructions.

FDA does not approve the Havrix vaccine to use younger than 12 months old children.

ReadVaccine Definition

Havrix Vaccine given process

This vaccine is given as an injection intramuscularly. You must receive this injection in the Hospital or Doctor Clinic.

Depending on your situation to the risk you will receive 2 separate injections of Havrix over a period of 6 to 12 months.

You must take the Havrix vaccine at least 2 weeks before your trip to prevent Hepatitis while traveling.

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Havrix Interactions

Before receiving the Havrix Vaccine tell your doctor if you receive any drug that weakens your immune system.

Medicine that helps to prevent organ transplant rejection.

Injectable steroid medicine.

Any kind of medication to treat Rheumatoid arthritis, psoriasis, Cancer.

Azithromycin.

Aspirin.

Boostrix.

Famotidine

Typhim

Metoprolol

Naprosyn

Toradol

Tramadol

Twinrix(Hepatitis A and B adult vaccine).

Vaqta (Hepatitis A adult Vaccine).

Metronidazole.

Metoclopramide.

If you receive any of these medicines you can not take the Havrix vaccine until the previous treatment is finished.

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Side Effects Of Havrix Vaccine

Havrix Vaccine

After receiving Havrix you should track you or your child. After receiving the first dose if you notice any allergic reaction. You should not receive the Booster dose of Havrix.

You must consult with your doctor if you have

High Fever

Extreme Drowsiness

Headache

Swelling, Warmth, Tenderness

Loss of Appetite

Nausea

Weakness or tiredness

Cough

Chills

Body Pain

Ear Congestion

Breathing Difficulty.

Voice Loss

Hoarseness

Runny Nose

Nasal Congestion

Sore Throat

Sneezing

Wheezing.

Voice change

Swollen glands in the neck

Swelling inside the nose

Itching

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Some very rare side effects

Muscle pain or Joint pain.

Joints inflammation.

Agitation

Back pain

Stomach pain or abdominal pain.

Bleeding Gums.

Confusions.

Coma.

Diarrhea.

Dark color urine

Dizziness

Increase Sweating

Difficulty in moves legs and arm

Hallucinations

Symptoms like Flu

Depression

Faster Heart Beat.

Swollen Lymph Glands

Vomiting of Blood

Yellow color skin or eye.

Stabbing Pain.

Seizures.

Slurred Speech.

Stiff Neck.

Havrix adult vaccines can cause some side effects that usually do not require any medical care.

Weight Loss.

Swelling, Redness, Pain

Warmth at the injection area.

Bleeding amount changes during periods.

Monthly Period pattern changes.

Arm pain.

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Rare Side Effects are

Difficulty in Sleeping.

Welts.

Muscle Tightness or Tension.

Taste Loss.

Spinning Sensation.

Excessive Muscle tone.

Moving Difficulty

Vision problem.

Taste Changes.

Changes in color Vision.

Collection of Blood under the Skin.

Importance of Havrix Vaccine

Remember this you should not receive Havrix Vaccine. If you have life-threating allergies to the neomycin.

Havrix is always recommended to the adults if you are traveling around the world where Hepatitis A is a common disease.

Some other risk factors include Hepatitis are, chronic liver disease, use an intravenous drug. If you are receiving treatment for any bleeding disorders. If you are always around animals especially monkey then there is a chance to infect by Hepatitis A.

Havrix Vaccine Clinical trial experience

The vaccine safety evaluates by the 64 clinical trials. It involves approximately 37,000 individuals receiving a dose of 360 EL.U (n=21, 928 in 3 or 4 dose schedule),720 EL. u (n=12,274 in 2 or 3 dose schedule) or 1440 EL.U (n=2,782 in 2 or 3 dose schedule).

After the clinical trials most frequent reports are Injection site soreness(  according to 56% adults and 21%).

14% of adults report a headache and only 9% of children report a headache.

During the clinical trials, some other solicited and unsolicited reactions are

Psychiatric Disorders– Insomnia

Nervous system Disorders– Hypertonia, Dysgeusia.

Gastrointestinal Disorders -Vomiting, Abdominal pain, Diarrhea, Nausea.

Blood & Lymphatic system Disorder– Lymphadenopathy

General Disorder– Swelling of the injection site, Fatigue, Fever, Malaise

Metabolism Disorder– Anorexia.

Eye disorder-Photophobia

Skin and Subcutaneous Tissue Disorders– Rash, Urticaria, Pruritus.

Musculoskeletal and Connective Tissue disorder– Myalgia, Arthralgia.

Co-administration study of Havrix Vaccine Between 11 to 25 months old Children

For this study, almost 3,152 children (age between 11 to 25) receive a one dose of Havrix Vaccine.

In the studies, Hav 23 conducted in the U.S in 1,241 children age between 15 months were randomized to receive group 1 Havrix alone Group 2. Havrix concomitantly with mumps, measles, and rubella vaccine and Varicella vaccine. Group 3 who receive MMR and Varicella vaccines receive the first dose of Havrix 42 days later. A second dose of Havrix administrates 6 to 9 months after the first dose of Havrix vaccine.

Record The adverse Reactions after the Vaccinations

After vaccination Solicited adverse reaction recorded by the parents/Guardians on Dairy cards for 4 days. Unsolicited adverse events record the next 31 days on a dairy card after vaccination. Telephone follow-up also conducted the next 6 months after the last vaccination. 6 months followup done on a total of 1,035 children. It contains 53% are male, 69% subject is white, 16% are Hispanic. 9% were black and 6% are racial or Ethnic groups.

Solicited Local adverse reaction and General Adverse reaction 4 days of Vaccination

Group 1(Havrix) Dose 1 Group 2

Havrix MMR TV Dose 1%

Group 1 Havrix Dose 2% Group 2 Havrix Dose 2 %
Local Injection site 298 411 272 373
Pain 24 24 24 30
Redness 20 20 23 24
Swelling 9 10 10 10
General 300 417 271 375
Irritability 33 44 31 27
Irritability Grade 3 0 2 2 0
Drowsiness 22 35 21 21
Drowsiness Grade 3 1 2 1 0
Loss of Appetite 18 26 20 21
Loss of Appetite grades 1 1 0 0
Fever>100 degrees 6 degree F 3 5 3 3
Fever>101.5 Degree F 2 3 2 2
Fever> 102.4 Degree F 1 1 0 1

Serious adverse events reported in children between 11 to 25 months of age. According to the 4 studies, only 0.9% of the subject report serious adverse events 31 days period Following vaccination of Havrix. Those are receiving Havrix concomitantly with other childhood vaccines. 0.9%  reported serious adverse events.

Experience of Post Marketing

Havrix Vaccine

According to the clinical trials report. The global entry of this vaccine as a global voluntary report for Havrix has been listed below.

Hepatobiliary Disorders– Jaundice and Hepatitis.

Vascular Disorders– Vasculitis

Congenital, Familial and connective tissue disorder– Musculo Skeletal Stiffness.

General Disorders and administration site condition– Chills, Influenza-like symptoms, Local swelling, Injection site reaction.

Infections and infestations– Rhinitis

Immune system Disorder– Serum Sickness, Anaphylactic reaction, and Anaphylactoid reaction.

Blood and Lymphatic system disorder– Thrombocytopenia.

Nervous System Disorder– Neuropathy, Syncope, Convulsion, Dizziness, Encephalopathy, Hypoesthesia.

Vaccine use in Specific Population

This is for pregnancy-c category

Actually it is also not clear whether Havrix can cause fetal damage or affect fertility if administered to a pregnant woman. Given this vaccine, if pregnant women really need this.

Pediatric use

Havrix Vaccine efficacy and evaluated in 20,869 subjects, age between 1 year to 18 years.

This vaccine is not less than 12 months of age.

Hepatic Impairment

Chronic liver disease subjects had a lower antibody response to Havrix than healthy subjects.

Geriatric use

Havrix efficacy and safety to the 65 years of age or older is not clear. The clinical experience did not identify a difference in overall between these subject and Young adults subjects

Clinical Pharmacology of Havrix Vaccine

Normally Hepatitis A virus belongs to the picornavirus family. It is one of the several Hepatitis viruses that can cause systemic disease through the liver.

Hepatitis A incubation period is 28 days. The course of infection in Hepatitis A is highly variable ranging from Asymptomatic infection to icteric hepatitis and death.

The presence of antibodies in HAV protects against Hepatitis A infection. However, the minimum number of Titer has not been determined to provide protection.

Nonclinical Toxicology

Mutagenesis, impairment of fertility and Carcinogenesis.

This vaccine is not evaluated for mutagenic potential, Carcinogenic potential, and Potential for impairment of Fertility.

ReadBoostrix Vaccine 

Havrix Handling, Storage and Supplied

This vaccine is available in a single-dose vial and prefilled Tip-lok syringes. It contains latex and Preservative free formulation.

720 EL.U/0.5 ml

NDC 58160-825-41 syringe tip cap and plunger contain latex in a package of 5:NDC 58160-825-46.

NDC 58160-825-41 syringe tip cap and plunger contain latex in a package of 10:NDC 58160-825-51

NDC 58160-825-01 Vial contains no latex in a package of 10:NDC 58160-825-11.

NDC 58160-825-43 syringe tip cap may contain latex in a package of 10:Ndc 58160-825-52.

1440 EL.U/Ml

NDC 58160-826-43 Syringe tip cap may contain latex in a package of 10:NDC 58160-826-52.

NDC 58160-826-43 syringe tip cap contain latex in a package of 5: NDC 58160-826-48.

NDC 58160-826-41 syringe tip cap and plunger contain latex in a package of 5:NDC 58160-826-46.

NDC 58160-826-31 syringe tip cap and plunger contain latex in a package of 1:NDC 58160-826-32.

NDC 58160-826-01 vial contains no latex in a package of 10:NDC 58160-826-11.

You should store this vaccine between 2 to 8-degree c. Do not store this vaccine in the freezer section.

ReadNewborn Vaccines

Counseling information on Patient

Notify Havrix vaccine recipients and parents or Guardians of Potential Benefits and risks of vaccination with Havrix.

Always educating vaccine recipients and parents or guardians about possible side effects. Tell that Havrix has a non-infectious Killed virus and can not transmit Hepatitis A.

Always instruct vaccine receptors or parents or Guardians. If they notice any kind of adverse event, they must consult with their healthcare provider.

Give vaccine information statements to the parents or Guardians or vaccine recipients. Because it required by the national childhood vaccine injury act of 1986.

 

Read AFM Vaccine

ReadPPSV23 Vaccine

 

Referrals Gsksource.com

FDA.GovDrugs.com

 

Havrix Vaccine Dosage,Interactions, Side effects
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