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A Guide to UnderstandingYour Child’s Food Allergies

Parent Guide

NEOCATE PARENT GUIDE A Guide to Understanding Your Child’s Food AllergiesNEOCATE PARENT GUIDENEOCATE PARENT GUIDE A Guide to Understanding Your Child’s Food AllergiesNEOCATE PARENT GUIDE

Table of Contents

General Information on Food Allergy - page 2

AcknowledgementNutricia North America would like to thank Diana Buckley-Uhrich, RN, MS, CPNP with the Division

of Pediatric Gastroenterology and Nutrition at Massachusetts General Hospital for her help and advice in the preparation of this resource guide.

Note This book has been prepared as a resource guide for parents whose child has been recommended to

use Neocate.

The management of food allergy and intolerance can differ between individuals. As such, it is strongly recommended that this guide be used in consultation with a healthcare professional.

All information provided in this guide is reflective of the most current and relevant recommendations regarding the management of food allergies with Neocate Infant formula.

What is Neocate? - page 4

Neocate Infant DHA and ARA - page 8

Frequently Asked Questions - page 10

Neocate Preparation and Nutrient Profile - page 14

Nutricia Family of Products - page 20

Parent Guide

A Guide to Understanding Your Child’s Food AllergiesNEOCATE PARENT GUIDE2 A Guide to Understanding Your Child’s Food AllergiesNEOCATE PARENT GUIDE 3

What is the difference between food intolerance and food allergy?

Food intolerance is a general term used when a person has a bad reaction to a food or food additive. Often times, food intolerance occurs even when the affected person cannot identify the type of food eaten.

A food allergy always involves an abnormal reaction of the immune system to the food protein. Food intolerance, however, does not provoke an immune response, but rather an abnormal physiological response, such as abdominal pain and cramping or bloating and diarrhea. Some children with severe allergies may experience both types of reactions.

How common are food allergies?

It is estimated that 6 to 8 out of every 100 infants, and up to 3 out of 100 older children are allergic to one or more foods. The 8 most common food allergens are the proteins found in milk, eggs, fish, shellfish, tree nuts (e.g. almonds, walnuts), peanuts, wheat and soy. However, a child can be allergic to almost any food protein. Most children outgrow food allergies by the age of three (although an allergy to fish and peanuts may last a lifetime).

Why does a child become allergic to a food?

It is not clearly understood why some children develop an immune response to one or more food proteins. A child is more likely to have food allergies when other family members have a food allergy or when there is a family history of asthma, hives, hay fever, or eczema.

General Information on Food Allergy

What is a food allergy?

We all have an immune system to protect us from infections. Our immune system attacks the viruses and bacteria that can make us sick. With a food allergy, the body’s immune system mistakenly reacts in a similar way to certain food proteins, which are called allergens. The immune response to the food protein and the symptoms that come from that reaction is called an allergic reaction.

The immune response of food allergy may occur within minutes after a child eats or drinks, or may take several hours or days to develop. Non-life threatening symptoms may include hives, diarrhea, bloody stools, vomiting, poor feeding, eczema, or poor growth. These types of reactions may take longer to develop. Over time, this type of immune response to food may cause inflammation of the esophagus, stomach, small intestine or large intestine. Life threatening symptoms can include swelling of the mouth or throat, difficulty breathing, wheezing, anaphylaxis or shock. Such reactions usually occur within a few hours of ingesting the food containing the allergen.


HypoallergenicThe formula is less likely to cause an allergic response.

Nutritionally CompleteAll of the essential nutrients needed to groware supplied by the formula when consumed

in adequate amounts.

ElementalIngredients are broken down to their simplest and

purest form so they are easier for the bodyto process and digest.

Amino Acid-BasedAmino acids are the non-allergenic building blocks

for all protein.

Dairy-Free ManufacturingNeocate is manufactured in a dairy-free environment providing a safe and effective formula for individuals

with dairy allergies.

What is Neocate?Neocate is a special formula designed for infants and young children with milk protein allergy or multiple food protein intolerance (e.g. allergies to soy protein, hydrolyzed protein in other infant formulas, fish, eggs and nuts). Neocate provides the necessary nutrients required for an infant’s growth and development. Neocate has been recommended by your doctor or dietitian because your baby has difficulty in tolerating or digesting other infant formulas.

Neocate is described on the label as:

NEOCATE PARENT GUIDE A Guide to Understanding Your Child’s Food AllergiesNEOCATE PARENT GUIDE6 NEOCATE PARENT GUIDE A Guide to Understanding Your Child’s Food AllergiesNEOCATE PARENT GUIDE 7

REGULAR FORMULA WITHWHOLE PROTEIN

HYDROLYZED FORMULA

NEOCATEAMINO ACID-BASED FORMULA

Cow/soy milk protein Majority derived from cow milk protein

100% non-allergenic free amino acid-based

What makes Neocate different from other formulas?

The type of protein used in Neocate makes it different from other infant formulas. Neocate is an amino acid-based formula in which the proteins are broken down to their simplest and purest form, making it easier for the body to process and digest. Additionally, because Neocate is hypoallergenic, it is less likely to cause an allergic response than other infant formulas consisting of more intact proteins.

The following table compares some of the different infant formulas and identifies the protein source.

Why is the protein source so important?

Allergic reactions to food are mainly caused by the body’s reaction to the protein present in the food we eat (e.g. milk, soy, eggs, wheat, fish and nuts). Infants and young children are much more sensitive to these proteins as their immune systems are still quite immature. Some infants and young children may be allergic to several food proteins, including cow and soy milk proteins. They can also be allergic to the small protein fragments contained in hydrolyzed infant formulas.

Infants and children require a certain daily amount of protein to help support normal growth and development. For children with protein allergies, it can be difficult for them to meet these needs as they must avoid various types of nutritious foods that could potentially initiate an allergic response. However, a nutritionally complete, amino acid-based formula such as Neocate can provide the child with the required daily nutrition.

MOSTALLERGENIC

LEASTALLERGENIC

Protein Source Protein Type Allergic Reaction

Cow Milk Protein Whole proteinGoat Milk Protein > Casein > Whey

Soy Milk Whole soy protein & soy isolate

Extensively Hydrolyzed Fragments of cow milk protein > Casein hydrolysates > Whey hydrolysates

Neocate Infant Amino acids > Protein in its simplest form


Neocate Infant DHA and ARAThe first amino acid-based formula

to have DHA and ARA to help your infant develop.

DHA and ARA are two important nutrients naturally found in breast milk. They are important for healthy infant growth and development. Studies have shown a direct consumption of these key ingredients will promote your baby’s:

• Visual development• Brain development

Like all Neocate products, Neocate Infant DHA and ARA is:

• Hypoallergenic • 100% non-allergenic free amino acids• Nutritionally complete• Manufactured in a milk protein-free environment

DHA and ARA levels of Neocate are in line with the recommendations of Koletzko et al. (2001),* Child Health Foundation, ensuring beneficial amounts of DHA and ARA for your baby.

Child Health Foundation (Koletzko, et al.)

Neocate Infant DHA and ARA

0.40

0.30

0.20

0.10

0.00 DHA ARA

Gra

ms

per

100

g of

Fat

ty A

cids

* B Koletzko, et al. Long chain polyunsaturated fatty acids (LC-PUFA) and perinatal development. Acta Paediatr. 2001; 90:460-464.


Frequently Asked Questions

When will I see an improvement after starting Neocate?

If your child has been experiencing negative symptoms for some time, his or her condition may take time to improve. Severe allergies can cause inflammation and irritation to the affected areas. This, like a cut or burn, will take time to heal. It is important during this time to keep your child exclusively on Neocate and not give any other formula or foods unless otherwise directed by the doctor or dietitian. If your child has been on solids, it is important to make sure that those foods suspected of causing a problem are completely eliminated from the diet. Use only those foods recommended by your child’s doctor or dietitian.

In clinical studies an elimination diet using Neocate has been shown to improve gastrointestinal symptoms of cow milk allergy such as diarrhea, blood in the stools and vomiting associated with milk protein allergies in just 3-days and improving gastroesophageal reflux and skin irritations, such as eczema and atopic dermatitis in just 14-days.

How long will my child need Neocate?

Many, but not all children, outgrow their food allergies. This will vary for different foods and depends on the child. Your child’s doctor will determine how long your child may need Neocate.

Will Neocate Infant formula meet all of my child’s nutritional needs?

Neocate Infant is formulated to meet the daily nutritional requirements of an infant. If you are concerned that your child is not gaining weight or growing adequately consult your doctor and/or dietitian. They will be able to assess if nutritional needs are being met and if dietary adjustments are necessary.


Neocate tastes and appears different than other infant formulas. Is this normal?

Yes, this is quite normal. The protein source in Neocate is different than milk-based or hydrolyzed formulas. The free amino acids give the formula its characteristic taste, smell and an appearance similar to breast milk. However, our exclusive formulation gives it superior taste, smell and texture.

My baby’s appetite has increased since starting Neocate. Is this normal?

Your appetite can be impaired when you are generally not feeling well and/or have gut inflammation. It may be that Neocate is the first formula your child has taken which does not cause discomfort and distress. As an elimination diet using Neocate improves gut discomfort and distress, a child’s mood and health should improve, which may help to improve appetite. Neocate has also been shown to promote catch-up growth in children with food allergies. As children grow, energy demands increase, as well as their need for formula intake.

My baby has had a change in stools since starting on Neocate. Is this normal?

Yes, this is perfectly normal! Stools can change in consistency and color when a child is introduced to an elemental formula such as Neocate. This is because Neocate is a low residue formula. Low residue formulas lower the number of bacteria in the gut leading to reduced breakdown of bile. More bile is present in the stool making it darker in color.

Will my insurance company cover the cost of Neocate?

Insurance coverage will depend on your plan, as well as the state in which you reside. There are several states that mandate Neocate coverage, for an up-to-date listing of these states visit www.Neocate.com. Hints and tips for successful reimbursement are also available online. Consult with your doctor and/or

insurance company to assist you with any specific questions you may have. For additional suggestions and helpful documents that may assist in obtaining coverage, please contact our Nutrition Department at 1-800-NEOCATE.

Where can I purchase Neocate?

You can order Neocate directly from Nutricia North America at www.Neocate.com or by calling 1-800-NEOCATE. Neocate is also available to order through your local pharmacy.

Why is Neocate only available through the pharmacy and not on my grocery store shelf?

Neocate falls under an exempt infant formula classification. Such formulas typically are prescribed by a physician and must be requested from a pharmacist. Exempt infant formulas are generally represented and labeled solely to provide dietary management for specific diseases or conditions that must be used under medical supervision.

Always consult your doctor or dietitian if you have

questions or concerns regarding your child’s health.


Neocate Preparation and Nutrient Profile

How do I prepare Neocate?

Neocate Infant may be mixed with warm or cool sterile water*. Do not boil formula or use a microwave to prepare or warm formula. For standard dilution, use enclosed scoop (4.75 g) to mix one level scoop per fluid ounce of prepared formula.

How to make a 5 fluid ounce bottle:

1. Add 5 scoops of Neocate Infant to a clean, sterile container.2. Fill up to the 5 fluid ounce line with warm or cool sterile water.3. Shake for 15-20 seconds or until the powder dissolves. Check

the volume. Add additional water if necessary to fill to the 5 fl oz level and shake again.

Freshly mixed formula is best. Refrigerate pre-mixed formula immediately and use within 24 hours of mixing. Shake immediately before use. Throw away formula left in the bottle one hour after feeding. Tube feeding hang time should not exceed 4 hours.

* Boiling is the preferred method for sterilizing water, bottles, nipples, and mixing utensils.

11

22

33


How can Neocate be stored?

• Prepared formula can be stored in a refrigerator for up to 24 hours

• Once a bottle is introduced to your infant’s mouth, all formula remaining in the bottle should be discarded after one hour

• Opened cans of Neocate with plastic lid securely fastened should be stored in a cool, dry place and used within one month

• Sealed cans of Neocate should be stored in a cool, dry place and used by the expiration date, which is located on the bottom of each can

What is the best way for me to warm the Neocate once it has been prepared?

As with any other infant formula, a microwave oven should not be used to reheat Neocate, as this can lead to “hot spots” in the formula. It is recommended to place the prepared bottle either under warm, running water, or in a container filled with warm water.

How do I make different volumes?

Desired Volume Amount of Neocate Powder Water to Add

8 fl oz 8 scoops or 38 g 7 fl oz

12 fl oz 12 scoops or ½ cup or 57 g 11 fl oz

24 fl oz 24 scoops or 1 cup or 114 g 21 fl oz

48 fl oz 48 scoops or 2 cups or 228 g 42 fl oz

Use a gram scale for the most accurate results.

Household measurements

1 cup ½ cup ⅓ cup ¼ cup 1 Tbsp 1 tsp ½ tsp

114 g 57 g 35 g 30 g 7 g 2 g 1 g

Household measurements are approximations only. For accuracy use a gram scale.


Ingredients: Corn Syrup Solids (57%), Refined Vegetable Oil (Medium Chain Triglycerides (Palm Kernel and/or Coconut oil) (7%), High Oleic Sunflower (7%), Soy (6%)), Calcium Phosphate Dibasic (2.5%), and less than 2% of each of the following: L-Arginine L-Aspartate, Tripotassium Citrate, L-Leucine, L-Lysine Acetate, L-Glutamine, L-Proline, L-Valine, Glycine, L-Isoleucine, CAEM (an emulsifier), L-Threonine, L-Phenylalanine, L-Tyrosine, L-Serine, L-Histidine, L-Alanine, Sodium Chloride, L-Cystine, L-Tryptophan, L-Methionine, Magnesium Acetate, Magnesium L-Aspartate, Potassium Chloride, M. Alpina Oil*, Choline Bitartrate, M-Inositol, C. Cohnii Oil**, L-Ascorbic Acid, Ferrous Sulfate, Zinc Sulfate, Taurine, L-Carnitine, Sunflower Oil, Niacinamide, DL-alpha Tocopheryl Acetate, Calcium D-Pantothenate, Cupric Sulfate, Manganese Sulfate, Pyridoxine Hydrochloride, Riboflavin, Vitamin A Acetate, Thiamine Chloride Hydrochloride, Ascorbyl Palmitate, Potassium Iodide, Chromium Sulfate, Mixed Tocopherols, DL-alpha Tocopherol, Phylloquinone, Sodium Molybdate, Folic Acid, Sodium Hydrogen Selenite, D-Biotin, Vitamin D3, Cyanocobalamin

* A source of Arachidonic Acid (ARA)** A source of Docosahexaenoic Acid (DHA)

Nutrient Profile Nutrients Per 100 g Per 100 kcalCalories 421 100

Protein Equivalent, g 13 3.1

Fat, g 19.1 4.5

Carbohydrate, g 49.3 11.7

Linoleic Acid, mg 2850 677

Vitamins

Vitamin A, IU (mcg RE) 1648 (495) 391 (118)

Vitamin D3, IU (mcg) 252 (6.3) 59.9 (1.5)

Vitamin E, IU (mg a T.E.) 4.8 (3.2) 1.14 (0.76)

Vitamin K, mcg 37 8.79

Thiamine, mcg 390 92.6

Riboflavin, mcg 580 137.8

Vitamin B6, mcg 520 123.5

Vitamin B12

, mcg 1.1 0.26

Niacin, mcg 6500 1544

Folic Acid, mcg 43 10.2

Pantothenic Acid, mcg 2610 620

Biotin, mcg 13 3.1

Vitamin C, mg 39 9.26

Choline, mg 55 13.1

Inositol, mg 98 23.3

Minerals

Calcium, mg 522 124

Phosphorus, mg 392 93.1

Magnesium, mg 52 12.4

Iron, mg 7.8 1.85

Zinc, mg 7 1.66

Manganese, mcg 380 90

Copper, mcg 520 124

Iodine, mcg 65 15.4

Molybdenum, mcg 20 4.75

Chromium, mcg 15 3.56

Selenium, mcg 15.7 3.73

Sodium, mg 157 37.3

Potassium, mg 653 155.1

Chloride, mg 325 77.2

Energy Distribution

Protein 12%

Carbohydrate 47%

Fat (MCT 33% / LCT 67%) 41%

Osmolality @ 20 kcal/oz 375 mOsm/kg


Nutricia Family of Products for Infants

and Children

Infant - 10 Years of Age

A family of nutritionally complete elemental formulas and

medical foods for indications which can include:

• multiple food protein intolerance • cow and soy milk allergy • gastrointestinal tract impairment • eosinophilic esophagitis • gastroesophageal reflux • malabsorption

For product information or to place an order call 1-800-NEOCATE or visit our website

www.Neocate.com

Notes

Order direct and SAVE!

For lowest prices, free shipping and product specials, order Neocate Infant DHA and ARA at

www.OrderNeocate.com or call 1-800-Neocate.

Free of dairy, full of nutrition

s,

Nutricia North America • Rockville, MD 20850Tel: (800) 365-7354 • Fax: (301) 795-2302

www.Neocate.com

ZNPG 09/09

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