BCG Vaccine

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BCG Vaccine uses


WARNING

TICE® BCG contains live, attenuated mycobacteria. Because of the potential risk for transmission, it should be prepared, handled, and disposed of as a biohazard material.

BCG infections have been reported in health care workers, primarily from exposures resulting from accidental needle sticks or skin lacerations during the preparation of BCG for administration. Nosocomial infections have been reported in patients receiving parenteral drugs that were prepared in areas in which BCG was reconstituted. BCG is capable of dissemination when administered by the intravesical route, and serious infections, including fatal infections, have been reported in patients receiving intravesical BCG.

DESCRIPTION

TICE® BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis. 1 The TICE strain was developed at the University of Illinois from a strain originated at the Pasteur Institute.

The medium in which the BCG organism is grown for preparation of the freeze-dried cake is composed of the following ingredients: glycerin, asparagine, citric acid, potassium phosphate, magnesium sulfate, and iron ammonium citrate. The final preparation prior to freeze drying also contains lactose. The freeze-dried BCG preparation is delivered in glass vials, each containing 1 to 8 × 108 colony forming units (CFU) of BCG Vaccine which is equivalent to approximately 50 mg wet weight. Determination of in vitro potency is achieved through colony counts derived from a serial dilution assay. A single dose consists of 1 reconstituted vial (see DOSAGE AND ADMINISTRATION ).

For intravesical use the entire vial is reconstituted with sterile saline. BCG Vaccine is viable upon reconstitution.

No preservatives have been added.

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CLINICAL PHARMACOLOGY

TICE® BCG induces a granulomatous reaction at the local site of administration. Intravesical BCG Vaccine has been used as a therapy for, and prophylaxis against, recurrent tumors in patients with carcinoma in situ (CIS) of the urinary bladder, and to prevent recurrence of Stage TaT1 papillary tumors of the bladder at high risk of recurrence. The precise mechanism of action is unknown.

CLINICAL STUDIES

To evaluate the efficacy of intravesical administration of TICE® BCG in the treatment of carcinoma in situ, patients were identified who had been treated with BCG Vaccine under 6 different Investigational New Drug (IND) applications in which the most important shared aspect was the use of an induction plus maintenance schedule. Patients received BCG Vaccine (50 mg; 1 to 8 x 108 CFU) intravesically, once weekly for at least 6 weeks and once monthly thereafter for up to 12 months. A longer maintenance was given in some cases. The study population consisted of 153 patients, 132 males, 19 females, and 2 unidentified as to gender. Thirty patients lacking baseline documentation of CIS and 4 patients lost to follow-up were not evaluable for treatment response. Therefore, 119 patients were available for efficacy evaluation. The mean age was 69 years (range: 38–97 years). There were 2 categories of clinical response: (1) Complete Histological Response (CR), defined as complete resolution of carcinoma in situ documented by cystoscopy and cytology, with or without biopsy; and (2) Complete Clinical Response Without Cytology (CRNC), defined as an apparent complete disappearance of tumor upon cystoscopy. The results of a 1987 analysis of the evaluable patients are shown in Table 1.

Entered Evaluable CR CRNC Overall response
No. (%) of patients 153 119 (78%) 54 (46%) 36 (30%) 90 (76%)

A 1989 update of these data is presented in Table 2. The median duration of follow-up was 47 months.

1989 Status of 90 Responders (CR or CRNC)
Response 1987/CR

n=54

1987/CRNC

n=36

1987 Response

n=90

Percent
CR 30 15 45 50
CRNC 0 0 0 0
Unrelated deaths 6 6 12 13
Failure 18 15 33 37

There was no significant difference in response rates between patients with or without prior intravesical chemotherapy. The median duration of response, calculated from the Kaplan-Meier curve as median time to recurrence, is estimated at 4 years or greater. The incidence of cystectomy for 90 patients who achieved a complete response (CR or CRNC) was 11%. The median time to cystectomy in patients who achieved a complete response (CR or CRNC) exceeded 74 months.

The efficacy of intravesical BCG Vaccine in preventing the recurrence of a TaT1 bladder cancer after complete transurethral resection of all papillary tumors was evaluated in 2 open-label, randomized phase III clinical trials. Initial diagnosis of patients included in the studies was determined by cystoscopic biopsies. One was conducted by the Southwestern Oncology Group (SWOG) in patients at high risk of recurrence. High risk was defined as 2 occurrences of tumor within 56 weeks, any stage T1 tumor, or 3 or more tumors presenting simultaneously. The second study was conducted at the Nijmegen University Hospital; Nijmegen, The Netherlands. In this study patients were not selected for high risk of recurrence. In both studies treatment was initiated between 1 and 2 weeks after transurethral resection (TUR).

In the SWOG trial (study 8795) patients were randomized to BCG Vaccine or mitomycin C (MMC). Both drugs were given intravesically weekly for 6 weeks, at 8 and 12 weeks, and then monthly for a total treatment duration of 1 year. Cystoscopy and urinary cytology were performed every 3 months for 2 years. Patients with progressive disease or residual or recurrent disease at or after the 6 month follow-up were removed from the study and were classified as treatment failures.

A total of 469 patients was entered into the study: 237 to the BCG Vaccine arm and 232 to the MMC arm. Twenty-two patients were subsequently found to be ineligible, and 66 patients had concurrent CIS, and were analyzed separately. Four patients were lost to follow-up, leaving 191 evaluable patients in the BCG Vaccine arm and 186 in the MMC arm. Of the patients, 84% were male and 16% were female. The average age of these patients was 65 years old.

The Kaplan-Meier estimates of 2-year disease-free survival are shown in Table 3. The difference in disease-free survival time between the 2 groups was statistically significant by the log rank test (P=0.03). The 95% confidence interval of the difference in 2-year disease-free survival was 12% ± 10%. No statistically significant differences between the groups were noted in time to tumor progression, tumor invasion, or overall survival.

BCG Vaccine Arm

N=191

MMC Arm

N=186

Estimated disease-free survival at 2 years 57% 45%
95% Confidence Interval (CI) (50%, 65%) (38%, 53%)

In the Nijmegen study, the efficacy of 3 treatments was compared: TICE substrain BCG, Rijksinstituut voor Volksgezondheid en Milieuhygiene substrain BCG (BCG-RIVM), and MMC.

BCG Vaccine and BCG-RIVM were given intravesically weekly for 6 weeks. In contrast to the SWOG study, maintenance BCG was not given. Mitomycin C was given intravesically weekly for 4 weeks and then monthly for a total duration of treatment of 6 months. Cystoscopy and urinary cytology were performed every 3 months until recurrence.

A total of 469 patients was enrolled and randomized. Thirty-two patients were not evaluable, 17 were ineligible, 15 were withdrawn before treatment, and 50 had concurrent CIS and were analyzed separately, leaving 387 evaluable patients: 117 in the BCG Vaccine arm, 134 in the BCG-RIVM arm, and 136 in the MMC arm. Twenty-eight patients (24%) in the BCG Vaccine arm, 32 patients (24%) in the BCG-RIVM arm, and 24 patients (18%) in the MMC arm had TaG1 tumors. The median duration of follow-up was 22 months (range: 3–54 months).

The Kaplan-Meier estimates of 2-year disease-free survival are shown in Table 4. The differences in disease-free survival among the 3 arms were not statistically significant by the log-rank test (P=0.08).

BCG Vaccine Arm

N=117

BCG-RIVM Arm

N=134

MMC Arm

N=136

Estimated disease-free survival at 2 years 53% 62% 64%
95% Confidence Interval (CI) (44%, 64%) (53%, 72%) (55%, 74%)

In both the SWOG 8795 study and the Nijmegen study, acute toxicity was more common, and usually more severe, with BCG Vaccine than with MMC (see ADVERSE REACTIONS ).

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INDICATIONS AND USAGE

TICE® BCG is indicated for the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder, and for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR). BCG Vaccine is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence.

BCG Vaccine is not indicated for papillary tumors of stages higher than T1.

CONTRAINDICATIONS

TICE® BCG should not be used in immunosuppressed patients or persons with congenital or acquired immune deficiencies, whether due to concurrent disease (e.g., AIDS, leukemia, lymphoma) cancer therapy (e.g., cytotoxic drugs, radiation), or immunosuppressive therapy (e.g., corticosteroids).

Treatment should be postponed until resolution of a concurrent febrile illness, urinary tract infection, or gross hematuria. Seven to 14 days should elapse before BCG is administered following biopsy, TUR, or traumatic catheterization.

BCG Vaccine should not be administered to persons with active tuberculosis. Active tuberculosis should be ruled out in individuals who are PPD positive before starting treatment with BCG Vaccine.

WARNINGS

BCG LIVE is not a vaccine for the prevention of cancer. BCG Vaccine USP, not BCG LIVE (TICE BCG), should be used for the prevention of tuberculosis. For vaccination use, refer to BCG Vaccine USP prescribing information.

BCG Vaccine is an infectious agent. Physicians using this product should be familiar with the literature on the prevention and treatment of BCG-related complications, and should be prepared in such emergencies to contact an infectious disease specialist with experience in treating the infectious complications of intravesical BCG. The treatment of the infectious complications of BCG requires long-term, multiple-drug antibiotic therapy. Special culture media are required for mycobacteria, and physicians administering intravesical BCG or those caring for these patients should have these media readily available.

Instillation of BCG Vaccine with an actively bleeding mucosa may promote systemic BCG infection. Treatment should be postponed for at least 1 week following transurethral resection, biopsy, traumatic catheterization, or gross hematuria.

Deaths have been reported as a result of systemic BCG infection and sepsis.2,3 Patients should be monitored for the presence of symptoms and signs of toxicity after each intravesical treatment. Febrile episodes with flu-like symptoms lasting more than 72 hours, fever ≥103°F, systemic manifestations increasing in intensity with repeated instillations, or persistent abnormalities of liver function tests suggest systemic BCG infection and may require antituberculous therapy. Local symptoms (prostatitis, epididymitis, orchitis) lasting more than 2 to 3 days may also suggest active infection (see WARNINGS, Management of Serious BCG Complications section).

The use of BCG Vaccine may cause tuberculin sensitivity. Since this is a valuable aid in the diagnosis of tuberculosis, it is advisable to determine the tuberculin reactivity by PPD skin testing before treatment.

Intravesical instillations of BCG should be postponed during treatment with antibiotics, since antimicrobial therapy may interfere with the effectiveness of BCG Vaccine (see PRECAUTIONS ). BCG Vaccine should not be used in individuals with concurrent infections.

Small bladder capacity has been associated with increased risk of severe local reactions and should be considered in deciding to use BCG Vaccine therapy.

Management of Serious BCG Complications

Acute, localized irritative toxicities of BCG Vaccine may be accompanied by systemic manifestations, consistent with a "flu-like" syndrome. Systemic adverse effects of 1 to 2 days' duration such as malaise, fever, and chills often reflect hypersensitivity reactions. However, symptoms such as fever of 38.5°C (101.3°F), or acute localized inflammation such as epididymitis, prostatitis, or orchitis persisting longer than 2 to 3 days suggest active infection, and evaluation for serious infectious complication should be considered.

In patients who develop persistent fever or experience an acute febrile illness consistent with BCG infection, 2 or more antimycobacterial agents should be administered while diagnostic evaluation, including cultures, is conducted. BCG treatment should be discontinued. Negative cultures do not necessarily rule out infection. Physicians using this product should be familiar with the literature on prevention, diagnosis, and treatment of BCG-related complications and, when appropriate, should consult an infectious disease specialist or other physician with experience in the diagnosis and treatment of mycobacterial infections.

BCG Vaccine is sensitive to the most commonly used antituberculous agents (isoniazid, rifampin, and ethambutol). BCG Vaccine is not sensitive to pyrazinamide.

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PRECAUTIONS

General

TICE® BCG contains live mycobacteria and should be prepared and handled using aseptic technique. BCG infections have been reported in health care workers preparing BCG for administration. Needle stick injuries should be avoided during the handling and mixing of BCG Vaccine. Nosocomial infections have been reported in patients receiving parenteral drugs which were prepared in areas in which BCG was prepared.4

BCG is capable of dissemination when administered by intravesical route, and serious reactions, including fatal infections, have been reported in patients receiving intravesical BCG.3 Care should be taken not to traumatize the urinary tract or to introduce contaminants into the urinary system. Seven to 14 days should elapse before BCG Vaccine is administered following TUR, biopsy, or traumatic catheterization.

BCG Vaccine should be administered with caution to persons in groups at high risk for HIV infection.

Laboratory Tests

The use of BCG Vaccine may cause tuberculin sensitivity. It is advisable to determine the tuberculin reactivity of patients receiving BCG Vaccine by PPD skin testing before treatment is initiated.

Information for Patients

BCG Vaccine is retained in the bladder for 2 hours and then voided. Patients should void while seated in order to avoid splashing of urine. For the 6 hours after treatment, urine voided should be disinfected for 15 minutes with an equal volume of household bleach before flushing. Patients should be instructed to increase fluid intake in order to "flush" the bladder in the hours following BCG treatment. Patients may experience burning with the first void after treatment.

Patients should be attentive to side effects, such as fever, chills, malaise, flu-like symptoms, or increased fatigue. If the patient experiences severe urinary side effects, such as burning or pain on urination, urgency, frequency of urination, blood in urine, or other symptoms such as joint pain, cough, or skin rash, the physician should be notified.

Drug Interaction

Drug combinations containing immunosuppressants and/or bone marrow depressants and/or radiation interfere with the development of the immune response and should not be used in combination with BCG Vaccine. Antimicrobial therapy for other infections may interfere with the effectiveness of BCG Vaccine. There are no data to suggest that the acute, local urinary tract toxicity common with BCG is due to mycobacterial infection, and antituberculosis drugs should not be used to prevent or treat the local, irritative toxicities of BCG Vaccine.

Carcinogenesis, Mutagenesis, Impairment of Fertility

BCG Vaccine has not been evaluated for its carcinogenic, mutagenic potentials, or impairment of fertility.

Pregnancy

Animal reproduction studies have not been conducted with BCG Vaccine. It is also not known whether BCG Vaccine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. BCG Vaccine should not be given to a pregnant woman except when clearly needed. Women should be advised not to become pregnant while on therapy.

Nursing Mothers

It is not known whether BCG Vaccine is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from BCG Vaccine in nursing infants, it is advisable to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of BCG Vaccine for the treatment of superficial bladder cancer in pediatric patients have not been established.

Geriatric Use

Of the total number of subjects in clinical studies of BCG Vaccine, the average age was 66 years old. No overall difference in safety or effectiveness was observed between older and younger subjects. Other reported clinical experience has not identified differences in response between elderly and younger patients, but greater sensitivity of some older individuals to BCG cannot be ruled out.

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ADVERSE REACTIONS

Symptoms of bladder irritability, related to the inflammatory response induced, are reported in approximately 60% of patients receiving TICE® BCG. The symptoms typically begin 4 to 6 hours after instillation and last 24 to 72 hours. The irritative side effects are usually seen following the third instillation, and tend to increase in severity after each administration.

The irritative bladder adverse effects can usually be managed symptomatically with products such as pyridium, propantheline bromide, oxybutynin chloride, and acetaminophen. The mechanism of action of the irritative side effects has not been firmly established, but is most consistent with an immunological mechanism.3 There is no evidence that dose reduction or antituberculous drug therapy can prevent or lessen the irritative toxicity of BCG Vaccine.

"Flu-like" symptoms (malaise, fever, and chills) which may accompany the localized, irritative toxicities often reflect hypersensitivity reactions which can be treated symptomatically. Antihistamines have also been used.5

Adverse reactions to BCG Vaccine tend to be progressive in frequency and severity with subsequent instillation. Delay or postponement of subsequent treatment may or may not reduce the severity of a reaction during subsequent instillation.

Although uncommon, serious infectious complications of intravesical BCG have been reported.2,3,6 The most serious infectious complication of BCG is disseminated sepsis with associated mortality. In addition, M. bovis infections have been reported in lung, liver, bone, bone marrow, kidney, regional lymph nodes, and prostate in patients who have received intravesical BCG. Systemic infections may be manifested by pneumonitis, hepatitis, cytopenia, infective aneurysm and/or sepsis after a period of fever and malaise during which symptoms progressively increase. Some male genitourinary tract infections (orchitis/epididymitis) have been resistant to multiple-drug antituberculous therapy and required orchiectomy.

If a patient develops persistent fever or experiences an acute febrile illness consistent with BCG infection, BCG treatment should be discontinued and the patient immediately evaluated and treated for systemic infection.

The local and systemic adverse reactions reported in a review of 674 patients with superficial bladder cancer, including 153 patients with carcinoma in situ, are summarized in Table 5.

Percent of patients Percent of patients
Adverse event N Overall

(Grade ≥3)

Adverse event N Overall

(Grade ≥3)

Dysuria 401 60% (11%) Arthritis/myalgia 18 3% (<1%)
Urinary frequency 272 40% (7%) Headache/dizziness 16 2%(0)
Flu-like syndrome 224 33% (9%) Urinary incontinence 16 2% (0)
Hematuria 175 26% (7%) Anorexia/weight loss 15 2% (<1%)
Fever 134 20% (8%) Urinary debris 15 2% (<1%)
Malaise/fatigue 50 7% (0) Allergy 14 2% (<1%)
Cystitis 40 6% (2%) Cardiac (unclassified) 13 2% (1%)
Urgency 39 6% (1%) Genital inflammation/
Nocturia 30 5% (1%) abscess 12 2% (<1%)
Cramps/pain 27 4% (1%) Respiratory (unclassified) 11 2% (<1%)
Rigors 22 3% (1%) Urinary tract infection 10 2% (1%)
Nausea/vomiting 20 3% (<1%) Abdominal pain 10 2% (1%)

The following adverse events were reported in ≤1% of patients: anemia, BCG sepsis, coagulopathy, contracted bladder, diarrhea, epididymitis/prostatitis, hepatic granuloma, hepatitis, leukopenia, neurologic (unclassified), orchitis, pneumonitis, pyuria, rash, thrombocytopenia, urethritis, and urinary obstruction.

In SWOG study 8795, toxicity evaluations were available on a total of 222 TICE BCG-treated patients and 220 MMC-treated patients. Direct bladder toxicity (cramps, dysuria, frequency, urgency, hematuria, hemorrhagic cystitis, or incontinence) was seen more often with BCG Vaccine with 356 events, compared to 234 events for MMC. Grade ≤2 toxicity was seen significantly more frequently following BCG Vaccine treatment (P=0.003). No life-threatening toxicity was seen in either arm. Systemic toxicity with BCG Vaccine was markedly increased compared to that of MMC, with 181 events for BCG Vaccine compared to 80 for MMC. The frequency of toxicity was increased in all grades, particularly for grades 2 and 3. The most common complaints were malaise, fatigue and lethargy, fever, and abdominal pain. Thirty-two BCG Vaccine patients were reported to have been treated with isoniazid. Five BCG Vaccine patients had liver enzyme elevation, including 2 with grade 3 elevations. Eighteen of the 222 (8.1%) BCG Vaccine patients failed to complete the prescribed protocol compared to 6.2% in the MMC group. Table 6 summarizes the most common adverse reactions reported in this trial.7

Study arm
BCG Vaccine (N=222) MMC (N=220)
Adverse event All Grades Grade ≥3 All Grades Grade ≥3
Dysuria 115 (52%) 6 (3%) 77 (35%) 5 (2%)
Urgency/frequency 112 (50%) 5 (2%) 63 (29%) 7 (3%)
Hematuria 85 (38%) 6 (3%) 56 (25%) 5 (2%)
Flu-like symptoms 54 (24%) 1 (<1%) 29 (13%) 0
Fever 37 (17%) 1 (<1%) 7 (3%) 0
Pain (not specified) 37 (17%) 4 (2%) 22 (10%) 1 (<1%)
Hemorrhagic cystitis 19 (9%) 3 (1%) 10 (5%) 0
Chills 19 (9%) 0 2 (1%) 0
Bladder cramps 18 (8%) 0 9 (4%) 0
Nausea 16 (7%) 0 12 (5%) 0
Incontinence 8 (4%) 0 3 (1%) 0
Myalgia/arthralgia 7 (3%) 0 0 0
Diaphoresis 7 (3%) 0 1 (<1%) 0
Rash 6 (3%) 1 (<1%) 16 (7%) 2 (1%)

OVERDOSAGE

Overdosage occurs if more than 1 vial of TICE® BCG is administered per instillation. If overdosage occurs, the patient should be closely monitored for signs of active local or systemic BCG infection. For acute local or systemic reactions suggesting active infection, an infectious disease specialist experienced in BCG complications should be consulted.

DOSAGE AND ADMINISTRATION

The dose for the intravesical treatment of carcinoma in situ and for the prophylaxis of recurrent papillary tumors consists of 1 vial of TICE® BCG suspended in 50 mL preservative-free saline.

Do not inject subcutaneously or intravenously.

Preparation of Agent

The preparation of the BCG Vaccine suspension should be done using aseptic technique. To avoid cross-contamination, parenteral drugs should not be prepared in areas where BCG has been prepared. A separate area for the preparation of the BCG Vaccine suspension is recommended. All equipment, supplies, and receptacles in contact with BCG Vaccine should be handled and disposed of as biohazardous. The pharmacist or individual responsible for mixing the agent should wear gloves and take precautions to avoid contact of BCG with broken skin. If preparation cannot be performed in a biocontainment hood, then a mask and gown should be worn to avoid inhalation of BCG organisms and inadvertent exposure to broken skin.

Draw 1 mL of sterile, preservative-free saline at 4–25°C into a small syringe (e.g., 3 mL) and add to 1 vial of BCG Vaccine to resuspend. Gently swirl the vial until a homogenous suspension is obtained. Avoid forceful agitation which may cause clumping of the mycobacteria. Dispense the cloudy BCG Vaccine suspension into the top end of a catheter-tip syringe which contains 49 mL of saline diluent, bringing the total volume to 50 mL. To mix, gently rotate the syringe.

The reconstituted BCG Vaccine should be kept refrigerated (2–8°C), protected from exposure to direct sunlight, and used within 2 hours. Unused solution should be discarded after 2 hours.

Note: DO NOT filter the contents of the BCG Vaccine vial. Precautions should be taken to avoid exposing the BCG Vaccine to direct sunlight. Bacteriostatic solutions must be avoided. In addition, use only sterile, preservative-free saline, 0.9% Sodium Chloride Injection USP as diluent.

Treatment and Schedule

Allow 7 to 14 days to elapse after bladder biopsy before BCG Vaccine is administered. Patients should not drink fluids for 4 hours before treatment and should empty their bladder prior to BCG Vaccine administration. The reconstituted BCG Vaccine is instilled into the bladder by gravity flow via the catheter. DO NOT depress plunger and force the flow of the BCG Vaccine. The BCG Vaccine is retained in the bladder 2 hours and then voided. Patients unable to retain the suspension for 2 hours should be allowed to void sooner, if necessary.

While the BCG is retained in the bladder, the patient ideally should be repositioned from left side to right side and also should lie upon the back and the abdomen, changing these positions every 15 minutes to maximize bladder surface exposure to the agent.

A standard treatment schedule consists of 1 intravesical instillation per week for 6 weeks. This schedule may be repeated once if tumor remission has not been achieved and if the clinical circumstances warrant. Thereafter, intravesical BCG Vaccine administration should continue at approximately monthly intervals for at least 6 to 12 months. There are no data to support the interchangeability of BCG LIVE products.

HOW SUPPLIED

TICE® BCG is supplied in a box of 1 vial of BCG Vaccine. Each vial contains 1 to 8 × 108 CFU, which is equivalent to approximately 50 mg, as lyophilized (freeze-dried) powder, NDC 0052-0602-02.

STORAGE

The intact vials of TICE® BCG should be stored refrigerated, at 2–8°C (36–46°F).

This agent contains live bacteria and should be protected from direct sunlight. The product should not be used after the expiration date printed on the label.

REFERENCES


Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of

MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Manufactured by: Organon Teknika Corporation LLC, Durham, NC 27712, USA, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA

U.S. License No. 1747

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

TICE is a registered trademark of The Board of Trustees of the University of Illinois, used under the license of Organon Teknika Corporation.

Copyright © 1990-2016 Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc.

All rights reserved.

Revised: 09/2016

uspi-v914-pwi-1609r006

BCG Vaccine 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.


BCG Vaccine 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.


BCG Vaccine 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.


BCG Vaccine 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.


BCG Vaccine 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. "BCG vaccine". https://pubchem.ncbi.nlm.nih.gov/su... (accessed August 28, 2018).
  2. "BCG vaccine - DrugBank". http://www.drugbank.ca/drugs/DB1276... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming BCG Vaccine?

Depending on the reaction of the BCG Vaccine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider BCG Vaccine 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 BCG Vaccine 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 BCG Vaccine, 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 BCG Vaccine 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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