Sci-B-Vac

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Sci-B-Vac uses


1 INDICATIONS AND USAGE

Sci-B-Vac® [Hepatitis B Vaccine, Recombinant] is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. Sci-B-Vac is approved for use in individuals of all ages. Sci-B-Vac Dialysis Formulation is approved for use in adult predialysis and dialysis patients 18 years of age and older.

Sci-B-Vac is a vaccine indicated for prevention of infection caused by all known subtypes of hepatitis B virus. Sci-B-Vac is approved for use in individuals of all ages. Sci-B-Vac Dialysis Formulation is approved for use in predialysis and dialysis patients 18 years of age and older. (1)

2 DOSAGE AND ADMINISTRATION

For intramuscular administration. See Section 2.2 for subcutaneous administration in persons with hemophilia.

Sci-B-Vac


Sci-B-Vac Dialysis Formulation

2.1 Dosage and Schedule

Sci-B-Vac:

Persons from birth through 19 years of age: A series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6-month schedule.

Adolescents 11 through 15 years of age: A series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6-month schedule or a series of 2 doses (1.0 mL each) on a 0- and 4- to 6-month schedule.

Persons 20 years of age and older: A series of 3 doses (1.0 mL each) given on a 0-, 1-, and 6-month schedule.

Sci-B-Vac Dialysis Formulation:

Adults on predialysis and dialysis: A series of 3 doses (1.0 mL each) given on a 0-, 1-, and 6-month schedule.

Table 1 summarizes the dose and formulation of Sci-B-Vac for specific populations, regardless of the risk of infection with hepatitis B virus.

Group Dose/Regimen
InfantsFor specific recommendations for infants see ACIP recommendations.{1} , Children and Adolescents

0-19 years of age

(Pediatric/Adolescent Formulation)

5 mcg (0.5 mL)

3 doses at 0, 1, and 6 months

AdolescentsAdolescents (11 through 15 years of age) may receive either regimen: 3 × 5 mcg (Pediatric Formulation) or 2 × 10 mcg (Adult Formulation).

11 through 15 years of age

(Adult formulation)

10 mcgIf the suggested dose (10 mcg) is not available, the appropriate dosage can be achieved with two 5 mcg doses. However, the Dialysis Formulation may be used only for adult predialysis/dialysis patients. (1.0 mL)

2 doses at 0 and 4-6 months

Adults

≥20 years of age

(Adult formulation)

10 mcg (1.0 mL)

3 doses at 0, 1, and 6 months

Predialysis and Dialysis PatientsSee also recommendations for revaccination of predialysis and dialysis patients in [Dosage and Administration (2.4)].

(Dialysis formulation)

40 mcg (1.0 mL)

3 doses at 0, 1, and 6 months

2.2 Preparation and Administration

Shake the single-dose vial or single-dose prefilled syringe well to obtain a slightly opaque, white suspension before withdrawal and use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if the suspension does not appear homogeneous or if extraneous particulate matter remains or if discoloration is observed.

For single-dose vials, withdraw and administer entire dose of Sci-B-Vac intramuscularly using a sterile needle and syringe.

For single-dose prefilled syringes, securely attach a needle by twisting in a clockwise direction and administer dose of Sci-B-Vac intramuscularly.

The deltoid muscle is the preferred site for intramuscular injection for adults, adolescents and children 1 year of age and older whose deltoid is large enough for intramuscular injection. The anterolateral aspect of the thigh is the preferred site for intramuscular injection for infants younger than 1 year of age. Sci-B-Vac should not be administered in the gluteal region, as injections given in the buttocks have resulted in lower seroconversion rates than expected.{2}

Sci-B-Vac may be administered subcutaneously to persons at risk for hemorrhage following intramuscular injections. However, hepatitis B vaccines are known to result in lower antibody response when administered subcutaneously.{3} Additionally, when other aluminum-adsorbed vaccines have been administered subcutaneously, an increased incidence of local reactions including subcutaneous nodules has been observed. Therefore, consider subcutaneous administration only in persons who are at risk of hemorrhage following intramuscular injections.

Do not administer intravenously or intradermally

2.3 Known or Presumed Exposure to Hepatitis B Virus

Known or Presumed Exposure to HBsAg

Refer to recommendations of the Advisory Committee on Immunization Practices (ACIP) and to the package insert for hepatitis B immune globulin (HBIG) for management of persons with known or presumed exposure to the hepatitis B virus (e.g., neonates born of infected mothers or persons who experienced percutaneous or permucosal exposure to the virus). When recommended, administer Sci-B-Vac and HBIG intramuscularly at separate sites (e.g., opposite anterolateral thighs for exposed neonates) as soon as possible after exposure. Administer additional doses of Sci-B-Vac (to complete a vaccination series) in accordance with ACIP recommendations.

2.4 Booster Vaccinations

The duration of the protective effect of Sci-B-Vac in healthy vaccinees is unknown at present and the need for booster doses is not yet defined. The ACIP provides recommendations for use of a booster dose or revaccination series in previously vaccinated individuals with known or presumed exposure to Hepatitis B Virus.

Consider a booster dose or revaccination with Sci-B-Vac Dialysis Formulation (blue color code) in predialysis/dialysis patients if the anti-HBs level is less than 10 mIU/mL at 1 to 2 months after the third dose. Assess the need for a booster dose annually by antibody testing, and give a booster dose when the anti-HBs level declines to less than 10 mIU/mL.{3}

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3 DOSAGE FORMS AND STRENGTHS

Sci-B-Vac is a sterile suspension available in the following presentations:


Sci-B-Vac DIALYSIS FORMULATION is a sterile suspension available in the following presentation:


Sci-B-Vac is a sterile suspension available in the following presentations:


Sci-B-Vac Dialysis Formulation is a sterile suspension available in the following presentation:

4 CONTRAINDICATIONS

Do not administer Sci-B-Vac to individuals with a history of severe allergic or hypersensitivity reactions (e.g., anaphylaxis) after a previous dose of any hepatitis B-containing vaccine or to any component of Sci-B-Vac, including yeast .

Severe allergic or hypersensitivity reactions (e.g., anaphylaxis) after a previous dose of any hepatitis B-containing vaccine, or to any component of Sci-B-Vac, including yeast. (4, 11)

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5 WARNINGS AND PRECAUTIONS

The vial stopper, the syringe plunger stopper, and tip cap contain dry natural latex rubber which may cause allergic reactions in latex-sensitive individuals.

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including Sci-B-Vac, to infants born prematurely should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination. (5.2)

5.1 Hypersensitivity to Latex

The vial stopper and the syringe plunger stopper and tip cap contain dry natural latex rubber, which may cause allergic reactions in latex-sensitive individuals.

5.2 Apnea in Premature Infants

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including Sci-B-Vac, to infants born prematurely should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination. For Sci-B-Vac, this assessment should include consideration of the mother's hepatitis B antigen status and the high probability of maternal transmission of hepatitis B virus to infants born to mothers who are HBsAg positive if vaccination is delayed.

5.3 Infants Weighing Less Than 2000 g

Hepatitis B vaccination should be delayed until 1 month of age or hospital discharge in infants weighing <2000 g if the mother is documented to be HBsAg negative at the time of the infant's birth. Infants weighing <2000 g born to HBsAg positive or HBsAg unknown mothers should receive vaccine and hepatitis B immune globulin in accordance with ACIP recommendations if HBsAg status cannot be determined{3} .

5.4 Prevention and Management of Allergic Vaccine Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration .

5.5 Limitations of Vaccine Effectiveness

Hepatitis B virus has a long incubation period. Sci-B-Vac may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccination. Additionally, vaccination with Sci-B-Vac may not protect all individuals.

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6 ADVERSE REACTIONS

In healthy infants and children, the most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. In healthy adults, injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively.

In healthy infants and children (up to 10 years of age), the most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. (6.1)

In healthy adults, injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

In three clinical studies, 434 doses of Sci-B-Vac, 5 mcg, were administered to 147 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose. Injection site reactions and systemic adverse reactions were reported following 0.2% and 10.4% of the injections, respectively. The most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency, were irritability, fever (≥101°F oral equivalent), diarrhea, fatigue/weakness, diminished appetite, and rhinitis.

In a study that compared the three-dose regimen (5 mcg) with the two-dose regimen (10 mcg) of Sci-B-Vac in adolescents, the overall frequency of adverse reactions was generally similar.

In a group of studies, 3258 doses of Sci-B-Vac, 10 mcg, were administered to 1252 healthy adults who were monitored for 5 days after each dose. Injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively. The following adverse reactions were reported:

Incidence Equal To or Greater Than 1% of Injections

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

Injection site reactions consisting principally of soreness, and including pain, tenderness, pruritus, erythema, ecchymosis, swelling, warmth, nodule formation.

The most frequent systemic complaints include fatigue/weakness; headache; fever (≥100°F); malaise.

GASTROINTESTINAL DISORDERS

Nausea; diarrhea

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

Pharyngitis; upper respiratory infection

Incidence Less Than 1% of Injections

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

Sweating; achiness; sensation of warmth; lightheadedness; chills; flushing

GASTROINTESTINAL DISORDERS

Vomiting; abdominal pains/cramps; dyspepsia; diminished appetite

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

Rhinitis; influenza; cough

NERVOUS SYSTEM DISORDERS

Vertigo/dizziness; paresthesia

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

Pruritus; rash (non-specified); angioedema; urticaria

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

Arthralgia including monoarticular; myalgia; back pain; neck pain; shoulder pain; neck stiffness

BLOOD AND LYMPHATIC DISORDERS

Lymphadenopathy

PSYCHIATRIC DISORDERS

Insomnia/disturbed sleep

EAR AND LABYRINTH DISORDERS

Earache

RENAL AND URINARY DISORDERS

Dysuria

CARDIAC DISORDERS

Hypotension

6.2 Post-Marketing Experience

The following additional adverse reactions have been reported with use of the marketed vaccine. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to a vaccine exposure.

Immune System Disorders

Hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria have been reported within the first few hours after vaccination. An apparent hypersensitivity syndrome (serum-sickness-like) of delayed onset has been reported days to weeks after vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymoses and erythema nodosum . Autoimmune diseases including systemic lupus erythematosus (SLE), lupus-like syndrome, vasculitis, and polyarteritis nodosa have also been reported.

Gastrointestinal Disorders

Elevation of liver enzymes; constipation

Nervous System Disorders

Guillain-Barré syndrome; multiple sclerosis; exacerbation of multiple sclerosis; myelitis including transverse myelitis; seizure; febrile seizure; peripheral neuropathy including Bell's Palsy; radiculopathy; herpes zoster; migraine; muscle weakness; hypesthesia; encephalitis

Skin and Subcutaneous Disorders

Stevens-Johnson syndrome; alopecia; petechiae; eczema

Musculoskeletal and Connective Tissue Disorders

Arthritis

Pain in extremity

Blood and Lymphatic System Disorders

Increased erythrocyte sedimentation rate; thrombocytopenia

Psychiatric Disorders

Irritability; agitation; somnolence

Eye Disorders

Optic neuritis; tinnitus; conjunctivitis; visual disturbances; uveitis

Cardiac Disorders

Syncope; tachycardia

The following adverse reaction has been reported with another Sci-B-Vac (Recombinant) but not with Sci-B-Vac: keratitis.

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7 DRUG INTERACTIONS

Do not mix Sci-B-Vac with any other vaccine in the same syringe or vial.

7.1 Concomitant Administration With Other Vaccines

Do not mix Sci-B-Vac with any other vaccine in the same syringe or vial. Use separate injection sites and syringes for each vaccine.

In clinical trials in children, Sci-B-Vac was concomitantly administered with one or more of the following US licensed vaccines: Diphtheria, Tetanus and whole cell Pertussis; oral Poliomyelitis vaccine; Measles, Mumps, and Rubella Virus Vaccine, Live; Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] or a booster dose of Diphtheria, Tetanus, acellular Pertussis. Safety and immunogenicity were similar for concomitantly administered vaccines compared to separately administered vaccines.

In another clinical trial, a related HBsAg-containing product, COMVAX® [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine], was given concomitantly with eIPV (enhanced inactivated Poliovirus vaccine) or VARIVAX® [Varicella Virus Vaccine Live (Oka/Merck)], using separate sites and syringes for injectable vaccines. No serious vaccine-related adverse events were reported, and no impairment of immune response to these individually tested vaccine antigens was demonstrated.

COMVAX has also been administered concomitantly with the primary series of DTaP to a limited number of infants. No serious vaccine-related adverse events were reported.

7.2 Concomitant Administration with Immune Globulin

Sci-B-Vac may be administered concomitantly with HBIG. The first dose of Sci-B-Vac may be given at the same time as HBIG, but the injections should be administered at different sites.

8 USE IN SPECIFIC POPULATIONS

Safety and effectiveness of Sci-B-Vac have not been established in pregnant women and nursing mothers. Sci-B-Vac should only be given to a pregnant woman if clearly needed.

8.1 Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with the vaccine. It is also not known whether the vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The vaccine should be given to a pregnant woman only if clearly needed.

8.3 Nursing Mothers

It is not known whether the vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when the vaccine is administered to a nursing woman.

8.4 Pediatric Use

Safety and effectiveness of Sci-B-Vac have been established in all pediatric age groups. Maternally transferred antibodies do not interfere with the active immune response to the vaccine. The safety and effectiveness of Sci-B-Vac Dialysis Formulation in children have not been established.

8.5 Geriatric Use

Clinical studies of Sci-B-Vac used for licensure did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects. However, in later studies it has been shown that a diminished antibody response can be expected in persons older than 60 years of age.

11 DESCRIPTION

Sci-B-Vac Sci-B-Vac (Recombinant) is a sterile suspension of non-infectious subunit viral vaccine derived from HBsAg produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Merck Research Laboratories.

The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The fermentation process involves growth of Saccharomyces cerevisiae on a complex fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids and mineral salts. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods. The purified protein is treated in phosphate buffer with formaldehyde and then coprecipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate. Each dose contains less than 1% yeast protein. The vaccine produced by the Merck method has been shown to be comparable to the plasma-derived vaccine in terms of animal potency (mouse, monkey, and chimpanzee) and protective efficacy (chimpanzee and human).

The vaccine against hepatitis B, prepared from recombinant yeast cultures, is free of association with human blood or blood products.

Sci-B-Vac Sci-B-Vac (Recombinant) is supplied in three formulations.

Pediatric/Adolescent Formulation (Without Preservative), 10 mcg/mL: each 0.5 mL dose contains 5 mcg of hepatitis B surface antigen.

Adult Formulation (Without Preservative), 10 mcg/mL: each 1 mL dose contains 10 mcg of hepatitis B surface antigen.

Dialysis Formulation (Without Preservative), 40 mcg/mL: each 1 mL dose contains 40 mcg of hepatitis B surface antigen.

All formulations contain approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate, previously referred to as aluminum hydroxide) per mL of vaccine. In each formulation, hepatitis B surface antigen is adsorbed onto approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate) per mL of vaccine. The vaccine contains <15 mcg/mL residual formaldehyde. The vaccine is of the adw subtype.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Sci-B-Vac has been shown to elicit antibodies to hepatitis B virus as measured by ELISA.

Antibody concentrations ≥10mIU/mL against HBsAg are recognized as conferring protection against hepatitis B infection.{2}

Infection with hepatitis B virus can have serious consequences including acute massive hepatic necrosis and chronic active hepatitis. Chronically infected persons are at increased risk for cirrhosis and hepatocellular carcinoma.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Sci-B-Vac has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.

14 CLINICAL STUDIES

14.1 Efficacy in Neonates with Peripartum Exposure to Hepatitis B

The protective efficacy of three 5 mcg doses of Sci-B-Vac has been demonstrated in neonates born of mothers positive for both HBsAg and HBeAg. In a clinical study of infants who received one dose of HBIG at birth followed by the recommended three-dose regimen of Sci-B-Vac, chronic infection had not occurred in 96% of 130 infants after nine months of follow-up.{4} The estimated efficacy in prevention of chronic hepatitis B infection was 95% as compared to the infection rate in untreated historical controls.{5} Significantly fewer neonates became chronically infected when given one dose of HBIG at birth followed by the recommended three-dose regimen of Sci-B-Vac when compared to historical controls who received only a single dose of HBIG.{6} As demonstrated in the above study, HBIG, when administered simultaneously with Sci-B-Vac at separate body sites, did not interfere with the induction of protective antibodies against hepatitis B virus elicited by the vaccine.{6}

14.2 Immunogenicity of a Three-Dose Regimen in Healthy Infants, Children, and Adolescents

Three 5 mcg doses of Sci-B-Vac induced a protective level of antibody in 100% of 92 infants, 99% of 129 children, and in 99% of 112 adolescents .

14.3 Immunogenicity of a Two-Dose Regimen in Healthy Adolescents 11 through 15 Years of Age

For adolescents, the immunogenicity of a two-dose regimen (10 mcg at 0 and 4-6 months) was compared with that of the standard three-dose regimen (5 mcg at 0, 1, and 6 months) in an open, randomized, multicenter study. The proportion of adolescents receiving the two-dose regimen who developed a protective level of antibody one month after the last dose (99% of 255 subjects) appears similar to that among adolescents who received the three-dose regimen (98% of 121 subjects). After adolescents (11 through 15 years of age) received the first 10-mcg dose of the two-dose regimen, the proportion who developed a protective level of antibody was approximately 72%.

14.4 Immunogenicity in Healthy Adults

Clinical studies have shown that Sci-B-Vac when injected into the deltoid muscle induced protective levels of antibody in 96% of 1213 healthy adults who received the recommended three-dose regimen. Antibody responses varied with age; a protective level of antibody was induced in 98% of 787 young adults 20-29 years of age, 94% of 249 adults 30-39 years of age and in 89% of 177 adults ≥40 years of age.

14.5 Efficacy and Immunogenicity in Specific Populations

Chronic Hepatitis C Infection

In one published study, the seroprotection rates in individuals with chronic hepatitis C virus (HCV) infection given the standard regimen of Sci-B-Vac was approximately 70%.{7} In a second published study of intravenous drug users given an accelerated schedule of Sci-B-Vac, infection with HCV did not affect the response to Sci-B-Vac.{8}

Predialysis and Dialysis Adult Patients

Predialysis and dialysis adult patients respond less well to hepatitis B vaccines than do healthy individuals; however, vaccination of adult patients early in the course of their renal disease produces higher seroconversion rates than vaccination after dialysis has been initiated.{9} In addition, the responses to these vaccines may be lower if the vaccine is administered as a buttock injection. When 40 mcg of Sci-B-Vac (Recombinant), was administered in the deltoid muscle, 89% of 28 participants developed anti-HBs with 86% achieving levels ≥10 mIU/mL. However, when the same dosage of this vaccine was administered inappropriately either in the buttock or a combination of buttock and deltoid, 62% of 47 participants developed anti-HBs with 55% achieving levels of ≥10 mIU/mL.

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

Sci-B-Vac and Sci-B-Vac DIALYSIS FORMULATION are available in single-dose vials and prefilled Luer-Lok® syringes.

Pediatric/Adolescent Formulation (PRESERVATIVE FREE)

0.5 mL (5 mcg) in single-dose vials and prefilled Luer-Lok® syringes

NDC 0006-4981-00 – box of ten 0.5-mL single-dose vials

Color coded with a yellow cap and stripe on the vial labels and cartons and an orange banner on the vial labels and cartons

NDC 0006-4093-02 – carton of 10 prefilled single-dose Luer-Lok® syringes with tip caps

Color coded with a yellow plunger rod

NDC 0006-4093-09 – carton of six 0.5-mL prefilled single-dose Luer-Lok® syringes with tip caps

Color coded with a yellow plunger rod and stripe

Adult Formulation (PRESERVATIVE FREE)

1 mL (10mcg) in single-dose vials and prefilled Luer-Lok® syringes

NDC 0006-4995-00 – 1-mL single dose vial

Color coded with a green cap and stripe

NDC 0006-4995-41 – box of ten 1-mL single-dose vials

Color coded with a green cap and stripe

NDC 0006-4094-02 – carton of 10 pre-filled single-dose syringes with tip caps

Color coded with a green plunger rod

NDC 0006-4094-09 – carton of six 1-mL prefilled single-dose Luer-Lok® syringes with tip caps

Color coded with a green plunger rod and stripe

Sci-B-Vac DIALYSIS FORMULATION

1 mL (40mcg) in single-dose vials

NDC 0006-4992-00 – 1-mL single-dose vial

Color coded with a blue cap and stripe

Store vials and syringes at 2-8°C (36-46°F). Storage above or below the recommended temperature may reduce potency.

Do not freeze since freezing destroys potency.

17 PATIENT COUNSELING INFORMATION

Information for Vaccine Recipients and Parents/Guardians


Manuf. and Dist. by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

The trademarks depicted herein are owned by their respective companies.

Copyright © 2014 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

All rights reserved.

uspi-v232-i-1411r439

Sci-B-Vac pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Sci-B-Vac available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Sci-B-Vac destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Sci-B-Vac Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Sci-B-Vac pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."RECOMBIVAX HB (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [MERCK SHARP & DOHME CORP.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Sci-B-Vac?

Depending on the reaction of the Sci-B-Vac after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Sci-B-Vac not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Sci-B-Vac addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Sci-B-Vac, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Sci-B-Vac consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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