Human Products – Bio-Med

29 Apr

Isopropyl Rubbing Alcohol I.P.

Isopropyl Rubbing Alcohol I.P.(skin disinfectant)

Instantly Kills – 99.9% Virus & Bacteria (without water)

Assured Protection

Skin Disinfectant

70% Isopropyl Alcohol I.P.

Isopropyl Rubbing Alcohol I.P.

Ingredients:

Isopropyl Alcohol I.P. 70% V/V

Purified water Q.S.

Indications: Sanitization & Cleansing of hands, Surfaces, Pre injection site, surgical items.

Caution: Keep away from fire or flame and children. In case of contact with eyes, rinse thoroughly with water. In case of irritation discontinue use. Consult a doctor if irritation persists or product is swallowed.

Storage conditions:

Store in a cool, dry place.

In: Human Products

29 Apr

Ethyl Alcohol Based Hand Sanitizer

Instantly Kills-99.9% Virus & Bacteria (without water)

WHO Recommended Hand Rub Formulation

80% Ethyl alcohol with Free O₂ Radicals & Glycerol

INSTANT HAND SANITIZER

Ingredients:

Ethyl Alcohol I.P. 80% V/V

Glycerol I.P. 1.45% V/V

Hydrogen Peroxide I.P. 0.125% V/V

Purified water q.s.

Indications: Use it as often as required throughout the day, particularly before eating, after using public transport, after a visit to hospitals, touching as an unwell person, after touching a door handle or lift switch, after playing with pets.

How to use: Take a coin-sized drop on your palm and rub your hands briskly until dry.

Caution: Keep away from fire or flame and children. In case of contact with eyes, rinse thoroughly with eyes, rinse thoroughly with water. In case of irritation discontinue use. Consult a doctor if irritation persists or product is swallowed.

Storage Conditions:

Store in a cool, dry place.

Warning: For external use only

In: Human Products

18 Apr

Bio-Med™ Virus Transport Medium (BM-VTM™) Kit for collection & transport of clinical specimens containing viruses

With 3 mL Viral Transport Medium in a 15 mL conical tube and sterile flocked swab(s) with molded break point handle, nylon microfiber suitable for virus sampling, medical grade, individually packed

Introduction:

Bio Med’s disposable Virus Sample Collection and Transport Kit is a specially designed transport system to collect samples from throat or nasal secretions and transport viruses in an active form to the laboratory for isolation/identification. It is designed to maintain the viability and the virulence of the viral sample.

MEDIA COMPONENTS

AMINO ACIDS
L-Alanine, L-Arginine HCl, L-Asparagine H2O, L-Aspartic Acid, L-Cysteine HCL.H2O, L-Cystine 2HCL, L-Glutamic Acid, L-Glutamine, Glycine, L-Histidine HCl.H2O, L-Isoleucine, L-Leucine, L-Lysine HCL, L-Methionine, L-Phenylalanine, L-Proline, L-Serine, L-Threonine, L-Tryptophan, L-Tyrosine 2Na.2H2O, L-Valine

INORGANIC SALTS
CaCl2 (Anhydrous), KCl, MgSO4 (Anhydrous), NaCl, NaH2PO4. H2O, NaHCO3

VITAMINS
L-Ascorbic Acid, D-Biotin, D-Ca Pantothenate, Choline Chloride, Folic Acid, Myo-Inositol, Niacinamide, Pyridoxal HCl, Riboflavin, Thiamine HCl, Vitamin B12

OTHER COMPONENTS
Adenosine, Cytidine, D-Glucose, Guanosine, Lipoic Acid, Phenol Red (Sodium), Sodium Pyruvate, Thymidine, 2’Deoxyadenosine H2O, D’-Deoxycytidine HCl, 2’Deoxyguanosine, Uridine

It is supplemented with cryoprotectant protein for maintaining virus viability even in frozen state for prolonged storage. It has antimicrobial agents incorporated to minimize commensal bacterial and fungal contamination. The medium is isotonic and non-toxic to host cells. It has buffers to control the pH. Phenol red is used as a pH indicator.

SAMPLING SWAB:

Swab(s) are sterile flocked swab with molded break point handle, with nylon microfiber which are non inhibitory to viruses and help release of viruses into the medium easily. They are Medical grade, individually packed. It yields significantly more sample which helps in maximizing the sensitivity of serological and molecular detection assays.

KIT CONTENTS

Kit Code	Description	Quantity
BM VTK	VTM Media – 15 ml Polypropylene clear conical tube with HDPE cap, containing 3 ml sterile virus transport medium.Tube is not deformed after autoclaving . Taper bottom design makes it bear centrifugation	45
BM VTK	Oro-pharyngeal Swab- sterile flocked swab with molded break point handle, with nylon microfiber suitable for virus sampling. Medical grade, individually packed. ( Naso-Pharyngeal swab can also be supplied as per customer requirement)	45

PROCEDURE

A. Collection of Samples
For a complete diagnostic analysis of viral diseases, it is important that the infectivity of the viruses is preserved after sample collection. The infectivity of viruses decreases over time and the decay rate is generally a function of temperature. Stability of samples is enhanced by cooling therefore samples should be kept at 2-8°C. The probability of a successful isolation is more if the samples are processed immediately after collection and the viral load in the sample is more. Viral load is maximum if the samples are collected immediately after the onset of clinical symptoms and before the administration of antiviral medications.

B. Directions for use:

Mark the tube with the relevant information ( name of the patient, date of collection , Patient ID or any other information required by testing laboratory) on the label or attach the bar coded label.
Peel open the pouch to remove the swab.
Ask patient to open his/her mouth. Swab the back of the throat using oro-pharyngeal swab near the tonsils thoroughly. Sample can also be taken using naso-pharyngeal swab from nasopharynx.
Place the swab(s) into the storage tube after sampling , break off / cut the swab (s), dip the head of the swab(s) in the transport medium, discard the swab(s) sample handle and close the cap tightly.

C. Transportation of the Samples:
Samples should be transported to the laboratory as soon as possible. Samples can be refrigerated at 2-8⁰C after collection or can be transported at 2-8⁰C on wet ice / frozen ice gel packs within 48 hours.

If a long delay is expected in transit and processing, samples should be transported on dry ice and should be frozen at or below -70⁰C.

QUALITY CONTROL:

Appearance

Orange to Red colored clear solution

pH at 25°C

7.3 ± 0.3

Osmolality in mOsm/Kg H2O
500.00 – 600.00

Sterility
No bacterial or fungal growth is observed

PRECAUTIONS

Wear clean PPE suit with protective gloves/ mask and goggles during operation.
Isolation of viruses will largely depend on proper specimen collection, timing of sample collection and processing of samples.
Specimen collection should be done in the acute phase of illness.
Do not use the product if (1) there is change in the color of the medium, (2) there is evidence of leakage, (3) there are other signs of deterioration or turbidity.
To maintain infectivity of viruses , it is important that temperature be properly maintained for sample collection to processing.
Avoid repeated freeze-thaw of collected samples.
It is recommended to refer to standard procedures and published protocols for sample collection and processing.
When the sampling material are discarded , the relevant requirement of medical bio-hazard waste management shall be followed.

STORAGE AND SHELF LIFE

Store at 2 to 30°C. (Do Not Freeze or Incubate, Keep the reagent away from direct sunlight) .

Use before expiry date given on the product label.

References

Color Atlas and Textbook of Diagnostic Microbiology. 7th ed. 2016, J.B. Lippincott Co. Philadelphia, PA.
Manual of Clinical Microbiology. 12th ed. 2019, ASM, Washington, D.C.
Clinical Microbiology Procedures Handbook, 3rd Edition. 2010. ASM Press, Washington DC, Section 10-Laboratory Diagnosis of Viral Infections
Bailey and Scott Diagnostic Microbiology. 14th ed. 2018.
National Committee for Clinical Laboratory Standards (NCCLS). 2006. Viral Culture. Proposed Standard M41A.

In: Human Products

30 Dec

BIO POX™

VARICELLA VACCINE, LIVE I.P.BIO POX™

DESCRIPTION :

Bio Pox™ is indicated for active immunization against Varicella virus (Chicken Pox) of healthy subjects with no history of Varicella infection and susceptible healthy close contacts. Bio Pox™ meets the specifications of Indian Pharmacopoeia.

COMPOSITION

Each single dose (0.5 ml) of reconstituted Bio Pox™ vaccine contains:

≥2000 plaque forming units (PFU) of live attenuated Varicella virus (OKA strain) propagated in MRC-5 human diploid cell culture.

DOSAGE AND ADMINISTRATION

Reconstitute Bio Pox™ with the entire content of the vaccine diluent (sterile water for injection I.P.) provided with the vaccine. Shake gently for full reconstitution. Each dose (0.5ml) shall be injected immediately after reconstitution by subcutaneous route. Alcohol or other disinfecting agent must be allowed to evaporate from the site of injection before immunization as they may inactivate the vaccine.
Bio Pox™ is recommended for active immunization of healthy subjects of 1 to 12 years of age.
IAP (Indian Academy of Pediatrics), recommends 1st dose at 15 months or older, 2nd dose at 4-6 years (can be given 3 months after 1st dose). Catch-up vaccination in children, below 13 years – 2 doses 3 months apart, 13 years or more – 2 doses at 4-8 weeks apart.
As per WHO position paper on varicella vaccine, two doses induce higher effectiveness and should therefore be recommended in countries where the programmatic goal is, in addition to decreasing mortality and severe morbidity, to further reduce the number of cases and outbreaks.

CONTRA-INDICATIONS

Vaccination is contra-indicated during pregnancy and pregnancy should be delayed for 4 weeks after vaccination. Termination of pregnancy is not indicated if vaccination was carried out inadvertently during pregnancy.

Ongoing acute or chronic illness like fever, severe infection, persistent diarrhoea, vomiting e.t.c.
Immuno deficient status/immuno suppressive therapy.
There is no data regarding use in nursing women.
Hypersensitivity to any component of the vaccine.

POSSIBLE SIDE EFFECTS

Reaction to vaccination generally consists of localized injection site reaction (pain, swelling, redness) and systemic reaction (fever, skin rash, headache, fatigue, vomiting, cough) which are generally relieved spontaneously after one or two days.
Interspersed rash or blebs may appear to few recipients probably within two weeks after vaccination. No special treatment is necessary. Symptomatic treatment may be helpful in case of need.
As with any vaccine, there is a possibility that large scale use of the vaccine could reveal adverse reactions not observed in clinical trial.

STORAGE AND SHELF LIFE

Store between +2° to +8°C and protect from light. The shelf life of the vaccine is 2 years, if stored at recommended storage conditions. The lyophilized vaccine is not affected by freezing, stability is even better at lower temperatures.

PRESENTATION

Single dose freeze dried vaccine, vaccine diluent (sterile water for injection I.P.) and disposable syringe as combipack.

CLINICAL TRIALS

Bio Pox™ was found to be safe and immunogenic in children against VZV infection.

REFERENCES

Indian Academy of Pediatrics (IAP) Recommended Immunization Schedule for Children Aged 0 through 18 years – India, 2016 and updates on Immunization.
Varicella and herpes zoster vaccines : WHO position paper weekly epidemiological record, No. 25, 2014, 89, 265-288.
Phase-I, open, unicentric clinical trial for evaluation of safety of varicella vaccine, Live (I.P.) – Sharma et. al. (2014) Biotechnology International 7 (1) : 26-34.
Safety and immunogenicity of Bio-Pox™, a live varicella vaccine (OKA Strain) in Indian Children: A comparative multicentric, randomized phase II/III clinical trial – Dubey et. al. Human vaccines & Immuno therapeutics 2017, Vol 13, No. 9, 2032-2037.

In: Human Products

6 Dec

Peda Typh™

Typhoid Vi Conjugate Vaccine

Typhoid in infants often remain unrecognized due to atypical clinical picture.

The infants are more susceptible to typhoid as has been revealed by various studies. The Typhoid Vi Conjugate vaccine have been demonstrated to include ‘T’ Cell dependent response with much higher antibody. The conjugate Vi antigen vaccine also elicits booster response as is common to all conjugated vaccines.

A clear to slightly turbid solution containing purified Vi capsular polysaccharide of Salmonella typhi (Strain Ty2) conjugated with Tetanus toxoid protein for prevention of typhoid fever.

COMPOSITION :

One dose (0.5 ml) contains: 5 µg of Vi polysaccharide of Salmonella typhi (Strain Ty2) conjugated to 5 µg Tetanus toxoid protein in isotonic saline 0.5 ml.

INDICATIONS :

Peda Typh™ is indicated for active immunization against Salmonella typhi in infants of age ? 3 months, children and adults.

CONTRA – INDICATIONS:

Hypersensitivity to any constituent of the vaccine.
Pregnant & lactating women.
In the event of fever or severe infection, persistent diarrhoea and vomiting.

ADMINISTRATION :

Inject 0.5ml intramuscularly. Do not inject intravenously or intradermally. Prevention becomes effective 4 weeks after immunization.

DOSAGE :

One dose followed by booster after 2½-3 years of primary vaccination. Vaccination can be done from 3 months age onwards .

POSSIBLE SIDE EFFECTS :

As for any product, there may be more or less moderate and temporary side effects like: – Pain, induration, erythema, purities at the injection site. – Rare, transient febrile reactions. – Paracetamol or Ibuprofen cover for 36 hours after vaccination shall decrease the intensity of side effects.

STORAGE :

Store between +2° to +8°C in the refrigerator. Do not freeze.

PACK SIZE :

One dose in glass vial with disposable syringe
One dose in prefilled syringe.

SHELF LIFE :

The shelf life of the product is 36 months from the date of manufacture if stored at recommended storage conditions.

CLINICAL TRIAL OF TYPHOID Vi CONJUGATE VACCINE (PEDA TYPH™)

Introduction
The studies were undertaken to assess the immunogenicity and safety in infants and older children of a new vaccine-Vi polysaccharide conjugated with Tetanus toxoid protein. This new technology has avoided the use of recombinant proteins for conjugation. The vaccine has passed the required safety & immunological parameters in animals. The permission to conduct clinical trial Phase III in human was cleared by the Drugs Controller General (India) after necessary evaluation.

Open , multicentric, controlled & comparative study was undertaken. The three consecutive batches of Vi conjugate typhoid vaccine (Peda TyphTM), used for conducting the clinical trial, were found to be of standard quality by Central Drugs Laboratory, Central Research Institute, Kasauli, H.P. of Government of India. The Vi polysaccharide typhoid vaccine manufactured by BIO-MED (P) LTD., was also tested for comparative assessment studies. The study protocols were approved by the ethics committee of eminent medical colleges located in three widely separated zones of India.

Based on the above data, the principle investigators concluded that Peda Typh™ (Vi Conjugated Typhoid vaccine) was safe & well tolerated in all age groups including infants.

Immunological Response
Evaluation of Immunogenicity :
Blood samples(1-2ml) were collected by venipuncture before vaccination on day 0(pre-immune) and 4 weeks after vaccination (post immune). lgG anti Vi antibodies were detemined by ELISA.

ELISA test : (Assay for assessment of immune response in paired serum samples) ELISA test kit was validated and calibrated as per the guidelines of good laboratory practice.

Serum lgG Vi antibodies were assayed by ELISA and expressed in ELISA units relative to a standard reference. The unitage of the standard reference was assigned by NICHD, NIH, USA.

Preparation of standard reference curve and calculation of lgG antibodies was done by program of ELISA version 2.0, Centers for Disease control , Atlanta(USA).

Biostatistical Analysis : Biostatistical analysis of the clinical trial of Peda Typh™ was done by Dr.R.M. Pandey Ph.D.,FRSS(U.K.),Professor and Head, Department of Bio-Statistics, All India Institute of Medical Sciences ,N.Delhi. Biostatistical analysis proved that Peda Typh™ vaccine is safe and immunogenic. The antibody titers of the sera from 100% of the subjects (from all three centers) showed a four fold or greater rise in antibody titer of each group after immunization .No statistically significant differences were found in male and female children.

Results are graphically presented in figure 2. The lgG anti-Vi antibodies of Peda Typh^TM were 97.425 ELISA units in infants and children 3 months to 24 months of age. The geometric mean (95% confidence interval) of all volunteers was 70.32(62.86-78.66).

The Vi conjugate typhoid vaccine (Peda Typh™) under clinical trial have been found to be highly immunogenic in infants and children less than 2 years of age in which unconjugated Vi polysaccharide typhoid vaccine is known to induce very low or nil immunogenic response.

The efficacy of Vi conjugate typhoid vaccine in clinical trials conducted in Vietnam have been found to be 89% over the 46 months period.

On comparing the data of clinical trial of Vi conjugate typhoid vaccine developed by N.I.H (Published in The New England Journal vol.344 no. 17, 2001 pg.No.1263-1269) with Peda Typh™ , it was found that the geometric mean post immune lgG(25-75 percentile) are statistically equivalent.

Immunizations not only prevent mortality and morbidity. They also reduce the expenditure of public and private resources. The latest generation Vi conjugate typhoid vaccine is an effective tool to control the emerging pattern of typhoid fever in children and infants <2 years of age.

The above study has been published in :
Garg P., Garg S., Sharma M.K (2014), Clinical trial of Tetanus Toxoid Conjugated Vi Polysaccharide Typhoid Vaccine in infants and young children, Sharma et al (2014) Biotechnology International 7(4) : 90-100.

Further post licensure studies on Peda Typh™ has been done in SRM Medical college Chennai by Dr. Balaji Chinnasami et al.

Dr. Monjori Mitra et.al conducted a large scale Safety Immunogenicity & Efficacy study in Municipal school children in Kolkata (highly endemic area).

The studies have been published in :

Chinnasami B., Mangayarkarasi V., Prema A., Sadasivam K. & Davis M.J. (2013). Safety and immunogenicity of Salmonella typhi Vi conjugate vaccine (Peda Typh™) is children upto five years. International Journal of Scientific and Research Publication, Volume 3, issue 2, February 2013.
Chinnasami B., Sadasivam K., Vivekanandhan A., Arunachalam P. & Pasupathy S. (2015). A study on Longevity of Immune Response after vaccination with Salmonella typhi Vi Conjugate Vaccine (Peda Typh™) in children. Journal of Clinical & Diagnostic Research. 2015 May, Vol-9(5).
Mitra M., Shah N., Ghosh A., et al (2015). Efficacy and Safety of Vi-Tetanus Toxoid Conjugated Typhoid Vaccine (Peda Typh™) in Indian Children: School Based Cluster Randomized study. Human Vaccine & immunotherapeutics 2016, VoI. 0,No. 0, 1-7

The highlights of the result of the studies are as under :

Efficacy of Peda Typh has been found to be 100% versus 33 cases of typhoid in control group over a follow up period of 1 year.
One dose of the vaccine was found to give protective immunity in infants & children . No significant advantage of two doses regimen over one dose was found.”as per Dr. Chinnasami in his study “ A study on Longevity of Immune Response after vaccination with Salmonella typhi Vi Conjugate Vaccine (Peda Typh™) in children.
Serum analysis of post licensure follow up study at SRM Medical College using Peda Typh™ showed adequate immune response 30 months post vaccination with Single dose – 14 (4.8 – 29.8) µg/ml (which is much greater than earlier seroprotective level 3.52 Elisa unit equivalent to 4.36mcg/ml or current seroprotective level 1.4 µg/ml-2µg/ml).

In: Human Products

5 Dec

POLIOMYELITIS VACCINE, LIVE (ORAL) I.P. (DI-VALENT)

POLIOMYELITIS VACCINE, LIVE (ORAL) I.P. (DI-VALENT)
(Bivalent/b-OPV) Type 1 & Type 3

Oral Polio is a serious but preventable disease. In India, hundreds and thousands of infants and children used to get infected with polio virus and suffer from its serious consequences mainly paralysis.

DESCRIPTION :

Bio-Med’s Oral Polio Vaccine is prepared using attenuated Sabin Strain Polio viruses. The vaccine is clear light pink in liquid form and light pale yellow in frozen form. Bio-Med’s Oral Polio Vaccine conforms to Indian Pharmacopoeia.

COMPOSITION :

Each dose of vaccine contains :

Particulars	Quantity
Attenuated Sabin strain virus Type 1	10⁶ CCID₅₀
Attenuated Sabin strain virus Type 3	10^5.8 CCID₅₀
MgCl₂(Stabilizer)	1M
Kanamycin Sulphate (Preservative)	20mcg per dose

IMMUNIZATION SCHEME :

Poliomyelitis vaccine is indicated for prevention of Poliomyeltis against Type 1 & 3 polio Viruses, pulse polio program and in supplementary immunization activities(SIA’s) in children from 0-5 years of age. The doses and interval of Poliomyelitis vaccination should be according to National Policy.

PRESENTATION :

Squeezable Plastic tube with VVM Label (20 dose). This is latest generation packing is superior in handling quality, leak proof and nozzle designed to deliver exact drops of vaccine.
In glass vial with VVM Label (20 dose) and sterile plastic dropper.

VVM ( Vaccine Vial Monitor) Label :

Bio-Med in an effort to improve product quality came up with the state of the art labeling of Oral Polio Vaccine with imported VACCINE VIAL TIME TEMPERATURE SENSITIVE INDICATOR for the first time in India.

BENEFITS OF USING VVM (Vaccine Vial Monitor) :

Ensures efficacy with round the clock surveillance from the manufacturer to final user.
Improved confidence in the quality and reliability of the product.
Demonstrates compliance with handling rules / regulations.

CONTRA- INDICATION :

Immunodeficiency- Individuals infected with human immunodeficiency virus (HIV) both asymptomatic and symptomatic should be immunized with the vaccine according to standard schedule. However the vaccine is contraindicated for those with primary immuno deficiency disease or suppressed immune response from medication such as leukemia, lymphoma or generalised malignancy.

DOSAGE AND ADMINISTRATION :

2 drops (0.1 ml) of the vaccine is administered orally.

STORAGE :

Vaccine is potent if stored at or below -20ºC until the expiry date indicated on the label.

In: Human Products

5 Dec

Rabies Vaccine, Human I.P. Sure Rab™

DESCRIPTION :

It is an inactivated, purified and lyophilized preparation of Pitman Moore strain of rabies virus. The virus is produced on VERO cell culture and inactivated by ß-propiolactone. Sure Rab™ is manufactured as per Indian Pharmacopoeia. The manufacturing facilities meets the requirement as per cGMP guidelines of revised schedule ‘M’ of the Drugs & Cosmetics Act, Government of India.

COMPOSITION :

Each single dose lyophilized vaccine contains : Inactivated, Rabies virus………………………≥2.5IU
Stabilizer: Polygeline, Sucrose, Salts

CONTRAINDICATIONS :

- Post-exposure immunization – Given the fatal outcome of the declared rabies infection, there are no contraindication to post exposure vaccination.
- Pre-exposure – Allergic (Hyper sensitive) to any of the vaccine component, in case of disease or febrile illness it is preferable to postpone vaccination.

PREGNANCY AND BREAST FEEDING :

No case of harm attributable to use of Rabies Vaccine during pregnancy have been observed to-date in mothers or children.
It is not known whether Rabies Vaccine passes into breast milk. No risk to the breast- feeding infant has been described to-date. It is advisable to carefully weigh expected benefits against potential risks prior to pre- exposure immunization during pregnancy and breast-feeding.

PRECAUTIONS :

The vaccine should be shaken gently and visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either of the above being observed, discard the vaccine. As with other vaccines, in rare cases anaphylactic shock may occur in susceptible individual. The mainstay in the treatment of severe anaphylaxis is the prompt use of adrenaline, which can be life saving. It should be used at the first suspicion of anaphylaxis. The vaccines should remain under observation for not less than 30 minutes for possibility of occurrence of rapid allergic reactions. Hydrocortisone & antihistamines should also be available in addition to supportive measures such as oxygen inhalation.

Storage :

Store between 2^oC to 8^oC (in the refrigerator). The shelf life of Product is 36 months from the date of manufacture if stored at recommended storage conditions.

DRUG INTERACTIONS :

The corticosteroids and immunosuppressive treatment may lead to vaccination failure.

PRESENTATION

Single dose vial with appropriate diluent ,disposable syringe and needle.

DOSAGE AND ADMINISTRATION

Reconstitute the lyophilised vaccine, immediately prior to use with entire content of the vaccine diluent provided with the vaccine, gently agitate until lyophilisate is dissolved completely. Use aseptic technique to with draw the dose. In case of unforeseen delay, keep reconstituted Vaccine at 2º to 8ºC. Reconstituted vaccine shall not be used after 6-8 hours of reconstitution. Dose for adult and infant/child is same. Current W.H.O. guidelines may be consulted for Rabies Vaccination/immunization.

VACCINATION GUIDELINES

Day 0 indicates date of first injection.

Pre-exposure immunization

The vaccine is recommended for high risk professionals e.g. hunters, veterinarians, animal keeper/handler, butcher, rabies laboratory personnel, army professional, postmen, municipal workers, forest workers, subjects staying or visiting in rabies endemic areas or at a continuous risk of exposure. A serological test is recommended (every 6 months) in subjects at risk of continuous exposure. For subject at frequent risk WHO recommends antibody titer estimation annually. If titers are below protective threshold of 0.5 IU/ml, one booster dose should be administered.

A booster injection should be administered after one year of first primary Pre-exposure immunization and subsequent booster every five years.

A.1 Administration by intramuscular route

Pre-exposure immunization consists of a series of three intramuscular injections of 1 ml each (in deltoid muscle or in the anterolateral region of the thigh in small children) on day 0, 7, 21 or 28. A few days variation is not important. It should not be given by intragluteal injection.

A.2 Administration by intradermal route

Pre-exposure immunization consists of a series of three intradermal injections of 0.1 ml each (side of the deltoid) on day 0, 7, 21 or 28. A few days variation is not important. Vaccine when given intradermally should raise a visible and palpable bleb in the skin and shall only be done where trained personnel is available e.g. hospitals / Rabies vaccination clinics. In the event that the dose is inadvertently given subcutaneously or intra-muscularly or in the event of spillage, a new dose should be given intradermally in nearby site.

Post-exposure immunization in unimmunized or incompletely immunized subjects

As with all vaccines, SURE RAB^TM may not protect 100% of people vaccinated.

B.1 Administration by intramuscular route

Post-exposure immunization consists of intramuscular injections of 1 ml each (in deltoid muscle or in the anterolateral region of the thigh in small children) on day 0, 3, 7, 14, 28 & 90 (optional). It should not be given by intragluteal injection.

B.2 Administration by intradermal route

Post -exposure immunization consists of intradermal injections of 0.1 ml each at two locations (one in each upper deltoid region, left & right) on day 0, 3, 7 & 28 (Updated Thai Red Cross Schedule 2-2-2-0-2). Vaccine when given intradermally should raise a visible and palpable bleb in the skin and shall only be done where trained personnel is available e.g. hospitals / Rabies vaccination clinics.

Post-exposure immunization for previously vaccinated subjects

Re-exposure following post-exposure treatment or if pre-exposure vaccination was performed (primary vaccination or booster within 5 years previously) administer two booster doses intramuscularly (1ml)/intradermally (0.1 ml at 1 site) on day 0 and day 3. Treatment with rabies immunoglobulin is not necessary. This does not apply to immunodeficient subjects.

If pre or post exposure vaccination was performed more than 5 years before, if it is incomplete, in case of doubt, or in case of neural tissue vaccine used the subjects vaccination status is not considered as complete and a full post exposure treatment should be started.

SIDE EFFECT :

Ask for any active product, there may be more or less moderate and temporary side effects like :

Pain, induration, erythema, pruritis at the injection site.
Rare, transient, febrile reactions.
Rarely anaphylactic reactions, urticaria, rash may be encountered.

Pharmacovigiliance Programme of India (PvPI) has concluded relationship between anti-rabies vaccine and Erythema Multiforme.

In: Human Products

5 Dec

Peda Hib™

(Haemophilus type b conjugate vaccine)

Peda Hib™ is a highly purified vaccine prepared from capsular polysaccharide (polyribitol phosphate) short named PRP, covalently bonded to tetanus toxoid protein. Addition of lactose and freeze-drying has resulted in a highly stable vaccine.
This vaccine induces ‘T’- cell dependent immune response in infants that is essential for appropriate initial humoral antibody response and priming for booster effects (anamnestic response) of subsequent vaccinations. Such immune response is lacking in vaccines prepared from unconjugated PRP. Peda Hib™ has been manufactured using the latest technology to remove contaminants eg. L.P.S. pyrogens to make it the least reactogenic but highly immunogenic vaccine. Thus Peda Hib™ is the latest generation vaccine of the best quality in its class.
Peda Hib™ conforms to I.P.

COMPOSITION :

Each Single dose of lyophilisate contains :

Particulars	Quantity
Purified Polysaccharide of Haemophilus influenzae type b (PRP)	10 mcg
Tetanus Toxoid protein	20 mcg
Lactose (I.P.) (Stabilizer)	2 mg
Sucrose (I.P.) (Stabilizer)	42.5 mg
Thimerosal (I.P.) ( Preservative)	0.05 mg

INDICATIONS :

Peda Hib™ is indicated for the prevention in children from 6 weeks to 5 years age, of invasive diseases caused by Haemophilus influenzae type b e.g. Meningitis, cellulitis, epiglottitis. In no case can the tetanus protein contained in Peda Hib™ replace the routine tetanus vaccination.

PRESENTATION :

One dose in glass vial with appropriate diluent.

DOSAGE AND ADMINISTRATION :

Reconstitute the lyophilisate with the entire content of the diluent provided. Shake gently for full reconstitution. Administer 0.5 ml by intramuscular injection.

(A) Before 6 moths : Peda Hib™ can be administered to infants from the age 1.5 month with three injection of one dose(0.5ml) at intervals of one or two months followed by a booster (4th injection) at 15-18 months.

(B) Between 6 to 12 Months : Two injections at interval of one or two months followed by a booster (3rd injection) at 15-18 month

(C) Between 1 to 5 years : One single injection

CONTRA- INDICATION :

Hypersensitivity to any of the component of the vaccine.
Acute infection or febrile illness.

POSSIBLE SIDE EFFECT :

As in the case of any active product, there may be more or less moderate and temporary side effects. Mild local pain, redness, induration or fever may occur during the 48 hrs following injection.
D.P.T. vaccine causes more or less moderate temporary side effects, similar side effects may be observed when Peda Hib™ is administered after reconstituting with D.P.T. vaccine.

STORAGE :

The vaccine must be stored at 2° C -8°C . Shelf life of Peda Hib™ is 3 years from the date of manufacture.

In: Human Products

5 Dec

Quadri Meningo™

(Meningococcal Polysaccharide Vaccine)
(Group A, C, Y & W135)

Meningitis or Meningococcemia is caused by Neisseria meningitidis (Groups A, C, Y, W135) bacteria. It may be severe and life threatening. A variety of neurological and immunological complications are generally associated with the primary disease.

DESCRIPTION :

QUADRI MENINGO™ is to be used to protect against cerebrospinal meningitis caused by Neisseria meningitidis (Group A, C, Y & W 135). Quadri Meningo™ conforms to the I.P.

COMPOSITION :

Each dose (0.5 ml) of vaccine contains :

Particulars	Quantity
Purified Polysaccharide of Neisseria meningitidis Group A	50 mcg
Purified Polysaccharide of Neisseria meningitidis Group C	50 mcg
Purified Polysaccharide of Neisseria meningitidis Group Y	50 mcg
Purified Polysaccharide of Neisseria meningitidis Group W 135	50 mcg
Lactose I.P. (Stabilizer)	5 mg
Thimerosal I.P. (Preservative)	0.05 mg

INDICATIONS :

Hajj and Umrah pilgrims heading to Mecca, Saudi Arabia.
Children and adults exposed to infected patients.
Recommended for children above 18 months of age as routine immunization in endemic areas.
Travellers heading to disease prone areas should be vaccinated at least 15 days in advance.
Military recruits.
During epidemic, children between 3-18 months need to be vaccinated 3 months apart. Revaccination is recommended in children at high risk areas who were vaccinated below 4 years of age.

PRESENTATION :

QUADRI MENINGO™ is available in single dose vial with syringe and 10 dose vial packing along with appropriate diluent.

DOSAGE AND ADMINISTRATION :

Reconstitute the lyophilisate with the entire content of the diluent provided with vaccine vaccine. Inject 0.5 ml as S/C or I/M injection.

CONTRA- INDICATION :

Hypersensitivity to any of the vaccine component.
Ongoing acute or chronic illness like fever, severe infection, persistent diarrhoea, vomiting.

SIDE EFFECTS :

Reaction to vaccination generally consists of localized injection site reaction ( Pain , redness) , transient hyperthermia , headache,vomiting in children etc.

STORAGE :

Store at 2° C to 8° C in refrigerator. Product is good to use for 24 months from the date of manufacture.

OTHER INFORMATION :

W.H.O has recommended use of Quadrivalent Vaccine (containing A, C, Y & W 135) in place of bivalent vaccine (containing only A, C ) specially in areas like India where group specific meningococci – causing the disease have not been identified.

In: Human Products

5 Dec

Bio Typh™

Typhoid Polysaccharide Vaccine

Typhoid fever is a contagious and severe disease due to a bacterium called Salmonella typhi. It mostly affects school-age children. Typhoid fever is a widespread disease that is easily transmitted.
It is present in all tropical regions, including our country where it affects most of the population. Each year, over 33 million people worldwide catch Typhoid fever and about 200,000 die.
Bio-Med successfully developed typhoid polysaccharide vaccine and launched it in November 1998. This is the first indigenously manufactured Vi antigen typhoid vaccine and is manufactured as per Indian Pharmacopoeia.

DESCRIPTION :

Bio Typh™ is a clear solution containing purified Vi capsular polysaccharide of Salmonella typhi for prevention of typhoid fever. It contains 25 mcg of Vi antigen per dose and is in liquid form.

COMPOSITION :

Each dose (0.5 ml) of vaccine contains :

Particulars	Quantity
Vi polysaccharide of Salmonella typhi	25 mcg
Phenol I.P. (Preservative)	max. 0.25%
Isotonic saline q.s.	0.5 ml

INDICATION :

Children aged 2 years or more and adults.
Travellers proceeding to endemic areas.
Mela / fair visitors.
Vendors of unprotected food.
Settlers in poor hygienic areas.

PRESENTATION :

Single dose vial (0.5ml)
Prefilled syringe (0.5ml)
5 dose vial
10 dose vial

DOSAGE AND ADMINISTRATION :

Inject 0.5 ml in adults and children over 2 years of age by intramuscular or subcutaneous route.
Vaccine provides protection for a period of three years.
Reimmunization every three years under conditions of repeated or continued exposure is recommended.
Prevention becomes effective 2-3 weeks after immunization.

CONTRA- INDICATION :

Hypersensitivity to any constituent of the vaccine.
Pregnant and lactating women.
In the event of fever or severe infection,diarrhoea, dysentery,debilitating ailment,abdominal pain etc

SIDE EFFECTS :

Mild local pain, redness, induration and mild fever may occur during the 48 hours following injection in few cases.

STORAGE :

Store between 2⁰C – 8⁰C. Do not freeze. Product is good for use within 30 months from the date of manufacture.

In: Human Products

Isopropyl Rubbing Alcohol I.P.

Typhoid Vi Conjugate Vaccine

CLINICAL TRIAL OF TYPHOID Vi CONJUGATE VACCINE (PEDA TYPH™)

POLIOMYELITIS VACCINE, LIVE (ORAL) I.P. (DI-VALENT) (Bivalent/b-OPV) Type 1 & Type 3

Company information

POLIOMYELITIS VACCINE, LIVE (ORAL) I.P. (DI-VALENT)
(Bivalent/b-OPV) Type 1 & Type 3