Pediatric Annals

PRODUCT REPORT

Abstract

Polyfin™ IV Tubing

MiniMed, the leader in MINiaturized and Innovative MEDication delivery technologies, introduces a breakthrough in drug delivery tubing - the new Polyfin™ IV extension set.

Most IV tubing is made from polyvinyl chloride (PVC) plastic. PVC has certain drawbacks when placed directly in contact with IV fluids. These include plasticizer contamination and drug loss through absorption. Polyfin™ tubing addresses such problems by bonding an internal layer of polyolefin, a material that is more inert than PVC, to the external PVC layer.

As the least restrictive treatment method available at this time, Bebax is much easier for the practitioner to handle than thermoforming products, plaster casts, and splints. Its predetermined size makes it an ideal replacement for several successive plaster casts.

The Bebax orthosis is available in six sizes to assure effective treatment of the child from birth to 9 months. As a comfortable and removable bootee, Bebax does not cause trophic disorders and is easily tolerated by a newborn child. Bebax provides effective treatment for such structural congenital foot deformities as metatarsus varus, pes talus, talus valgus, pes varus, pes valgus, etc.

Camp International, Inc., Jackson, Ml. Telephone: (800) 492-1088.

Pediapred

Pediapred™ fprednisolone sodium phosphate, USP), the first good tasting liquid corticosteroid free from alcohol, sugar, and dye, has received marketing approval. The raspberry-flavored formulation will be marketed by Fisons Corporation of Bedford, Massachusetts and is available nationally in a 4-oz bottle as of September 15, 1986.

"The absence of alcohol in Pediapred is a significant advantage, especially for patients who need large doses on a long-term basis," according to Kenneth J. Gorelick, MD, Associate Medical Director of Fisons. "We believe the good taste will enhance compliance and prove useful in patients unable to swallow tablets," he noted.

Pediapred, which will be promoted primarily to pediatricians, is seen as a useful addition to the line of anti-asthma and anti-allergy cromolyn sodium products marketed by Fisons. They include lntal, Nasalcrom and Opticrom.

Fisons Corporation, Two Preston Court, Bedford, MA 01730. Telephone: (617) 2751000.

HB has been shown to induce protective levels of antibodies against hepatitis B virus infection in more than 90% of healthy individuals who received the required threedose regimen. Response to the vaccine was dependent on the age of vaccinées; 100% of 73 children I to IO years of age developed antibodies while seroconversion (antibody production) rates ranged from 95% to 99% for 453 adults between the ages of 20 and 39, and 91% for 56 vaccinées 40 years of age and older.

The protective efficacy of the vaccine has been demonstrated in newborn children of mothers who are chronically infected with the hepatitis B virus. The infants received a single dose of hepatitis B immune globulin at birth, followed by the recommended three doses of the new vaccine. Efficacy in preventing chronic hepatitis B infection was 94% among 93 infants studied at 6 months and 93% among 57 infants studied for 9 months.

Among 1,252 healthy adults, who were administered the new vaccine and then monitored for five days after each dose, the most frequent complaints were local reactions at the injection site, including soreness, itching, and swelling. Other reactions with an incidence equal to or greater than 1% included fatigue, headache, fever, malaise, nausea, diarrhea, pharyngitis, and upper respiratory infection.

Recombivax HB is expected to be made generally available in January by Merck Sharp & Dohme, the US pharmaceutical manufacturing and marketing division of Merck & Co., Inc. Detailed prescribing Information, normally enclosed with press material from MSD, Is not currently available, ft will be available soon, upon request, and will be distributed when Recombivax…

Polyfin™ IV Tubing

MiniMed, the leader in MINiaturized and Innovative MEDication delivery technologies, introduces a breakthrough in drug delivery tubing - the new Polyfin™ IV extension set.

Most IV tubing is made from polyvinyl chloride (PVC) plastic. PVC has certain drawbacks when placed directly in contact with IV fluids. These include plasticizer contamination and drug loss through absorption. Polyfin™ tubing addresses such problems by bonding an internal layer of polyolefin, a material that is more inert than PVC, to the external PVC layer.

The polyolefin interior increases drug compatibility by reducing the incidence of leachable contaminants into the IV solution. Polyolefin decreases drug loss by absorption and is less expandable than PVC, which results in greater occlusion alarm sensitivity for syringe pumps. Polyolefin is also less permeable to gases, such as CO2, that can alter solution pH. it does not contain diethylhexylphthalate (DEHP/, a known carcinogen.

The flexible PVC exterior makes Polyfin™ resistant to kinks and tangles. The Polyfin™ extension set, with Iuer lock connectors, fits all standard syringe pumps and IV lines.

MiniMed Technologies, 12744 San Fernando Road, SyImar, CA 91342. Telephone: (818) 362-6822, ask for "MlnlMed Customer Service."

Direct Mononucleosls Antibody Test

Mono-Test® rapid one-step hemagglutination slide test is for the qualitative detection and quantitative determination of infectious mononucleosis heterophile antibodies in serum or plasma. Results are obtained in just 2 minutes with this easy-to-perform single-reagent procedure. The Mono-Tesi Reagent is specially formulated to eliminate the need for differential absorption of serum. The standardized, treated horse erythrocytes react specifically with infectious mononucfeosis antibody thereby avoiding the necessity for differential absorption. The reagent has been shown not to react with Forssman antibodies and, at levels usually found in people in the United States, has been shown not to react with antibodies associated with serum sickness. Mono-Test is highly accurate, with 99% correlation to the Davidsohn differential test.

No special training is required to perform the assay. Each kit includes a Mono-Test Reagent and positive and negative control sera, in addition to a glass slide, disposable card slide, and calibrated capillary tubes and bulbs. Mono-Test is available from Wampole Laboratories in kits of 40 tests (#25D4| and 100 tests (#25D6). The kit is stable for 13 months when stored at room temperature or refrigerated.

Wampole Laboratories, A Division of Carter-Wallace, Inc., Cranbury, NJ 08512. Telephone: (609) 655-6000 or (800) 257-9525.

Merck's Recomblvax HB®

Last July, Recombivax HB® became the first vaccine developed from genetic engineering technology to be licensed for human use by the United States Fooc/ and Drug Administration, according to the Merck Sharp & Dohme Research Laboratories [MSDRL), the vaccines developer.

The new vaccine is for the prevention of hepatitis B, a serious viral infection of the liver that has caused nearly one million cases of chronic liver disease in the U.S. and approximately 200 million cases worldwide.

Recombivax HB is made by recombinant DNA technology with the vaccine antigen produced by a genetically-engineered form of bakers yeast. Aseparate Merck vaccine, Heptavax B®, derived from antigen extracted from human blood plasma, has been in wide use in the United States and many other countries since 1982.

According to Robert Gerety, MD, director of Virus and Cell Biology for MSDRL: "Development of this recombinant human vaccine is a tribute to the scientific foresight of my predecessors in the Merck laboratories who set out some 8 years ago to circumvent dependence on human plasma, a potentially limited raw material, as a source of the hepatitis B vaccine antigen.

"In addition, this achievement is an outstanding example of the benefits that can flow from collaborative efforts between industrial and academic scientists," he added. "Development of baker's yeast as an alternate source of the vaccine antigen began with a research agreement between Merck and university-based investigators in the area of recombinant technology. " Scientists associated with the Chiron Corporation developed, under a contract from Merck, the antigen source material Merck used in its 8-year program to develop the vaccine.

In clinical studies, Recombivax Camp Introduces Orthopedic Bootee

Bebax®, a new product distributed exclusively by Camp International, Inc., of Jackson, Michigan, a leading manufacturer of orthotic and prosthetic products, represents a major advance in the treatment of congenital forefoot deformities in infants.

Described as an orthopedic bootee, Bebax provides structural separation of the fore and rear of the foot through a multidirectional hinge located under the bootee. This patented hinge utilizes two swivel joints to enable the front of the foot to be adjusted on all three planes: vertical, horizontal, and oblique.

As the least restrictive treatment method available at this time, Bebax is much easier for the practitioner to handle than thermoforming products, plaster casts, and splints. Its predetermined size makes it an ideal replacement for several successive plaster casts.

The Bebax orthosis is available in six sizes to assure effective treatment of the child from birth to 9 months. As a comfortable and removable bootee, Bebax does not cause trophic disorders and is easily tolerated by a newborn child. Bebax provides effective treatment for such structural congenital foot deformities as metatarsus varus, pes talus, talus valgus, pes varus, pes valgus, etc.

Camp International, Inc., Jackson, Ml. Telephone: (800) 492-1088.

Pediapred

Pediapred™ fprednisolone sodium phosphate, USP), the first good tasting liquid corticosteroid free from alcohol, sugar, and dye, has received marketing approval. The raspberry-flavored formulation will be marketed by Fisons Corporation of Bedford, Massachusetts and is available nationally in a 4-oz bottle as of September 15, 1986.

"The absence of alcohol in Pediapred is a significant advantage, especially for patients who need large doses on a long-term basis," according to Kenneth J. Gorelick, MD, Associate Medical Director of Fisons. "We believe the good taste will enhance compliance and prove useful in patients unable to swallow tablets," he noted.

Pediapred, which will be promoted primarily to pediatricians, is seen as a useful addition to the line of anti-asthma and anti-allergy cromolyn sodium products marketed by Fisons. They include lntal, Nasalcrom and Opticrom.

Fisons Corporation, Two Preston Court, Bedford, MA 01730. Telephone: (617) 2751000.

HB has been shown to induce protective levels of antibodies against hepatitis B virus infection in more than 90% of healthy individuals who received the required threedose regimen. Response to the vaccine was dependent on the age of vaccinées; 100% of 73 children I to IO years of age developed antibodies while seroconversion (antibody production) rates ranged from 95% to 99% for 453 adults between the ages of 20 and 39, and 91% for 56 vaccinées 40 years of age and older.

The protective efficacy of the vaccine has been demonstrated in newborn children of mothers who are chronically infected with the hepatitis B virus. The infants received a single dose of hepatitis B immune globulin at birth, followed by the recommended three doses of the new vaccine. Efficacy in preventing chronic hepatitis B infection was 94% among 93 infants studied at 6 months and 93% among 57 infants studied for 9 months.

Among 1,252 healthy adults, who were administered the new vaccine and then monitored for five days after each dose, the most frequent complaints were local reactions at the injection site, including soreness, itching, and swelling. Other reactions with an incidence equal to or greater than 1% included fatigue, headache, fever, malaise, nausea, diarrhea, pharyngitis, and upper respiratory infection.

Recombivax HB is expected to be made generally available in January by Merck Sharp & Dohme, the US pharmaceutical manufacturing and marketing division of Merck & Co., Inc. Detailed prescribing Information, normally enclosed with press material from MSD, Is not currently available, ft will be available soon, upon request, and will be distributed when Recombivax HB Is Introduced In the US.

10.3928/0090-4481-19861001-12

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