SMA^® ALTHÉRA^®

INGREDIENTS

Lactose , maltodextrin, vegetable oils (sunflower, rapeseed, coconut), hydrolysed whey protein (milk), minerals (calcium glycerophosphate, potassium phosphate, magnesium chloride, calcium chloride, sodium chloride, potassium chloride, ferrous sulphate, sodium phosphate, zinc sulphate, potassium citrate, copper sulphate, manganese sulphate, potassium iodide, sodium selenate), emulsifier (E472c), Crypthecodinium Cohii oil (DHA), Mortierella Alpina oil (ARA), choline bitartrate, acidity regulator (E330), vitamins (C, E, niacin, pantothenic acid, riboflavin, A, thiamin, B6, folic acid, K, D, biotin, B12), L-Arginine, L-Histidine, taurine, inositol, L-Carnitine.

Packed under a protective atmosphere.

PRESENTATION

400g tin (with a 4.4g scoop).​

Precautions​

• Use under strict medical supervision after full considerations of all the feeding options available, including breastfeeding.
• For oral or enteral use only.​
• Not suitable for galactosemia, glucose-galactose malabsorption, lactose intolerance​
• Althéra^® is not recommended where only an amino acid formula is indicated.​

ALLERGIES​

Contains Milk

IMPORTANT FEEDING INFORMATION​

Do not add any extra powder or water to make feeds stronger or weaker. Using too much or too little powder can make a baby ill. We recommend preparing each feed in individual bottles when required, feed immediately. If there is any unfinished infant milk left after feeding, throw it away. Always hold the baby while feeding. Never leave the baby alone during feeding as there is a risk they might choke.

SHELF LIFE AND STORAGE 

Shelf life of 24 months from date of manufacture when stored at room temperature. ​
Once opened, reseal & store in a cool dry place and use within 3 weeks.​

Important Notice​
A food for special medical purposes. Mothers should be encouraged to continue breastfeeding even when their infants have cow's milk protein allergy. This usually requires qualified dietary counseling to completely exclude all sources of cow's milk protein from the mothers’ diet. If a decision to use a special formula intended for infants is taken, it is important to give instructions on correct preparation methods, emphasising that unboiled water, unsterilised bottles or incorrect dilution can all lead to illness. Formula for special medical purposes intended for infants must be used under medical supervision. For healthcare professionals only.

Preparing Althéra^® is very similar to how you prepare standard infant formula. The standard dilution of 13.2% is made by adding 1 level scoop of Althéra^® (approx 4.4g) to 30ml of water (approx 1 fluid oz). The step by step instructions on how to prepare Althéra^® are:

STEP 1

Wash hands well.

STEP 2

Wash bottle, teat and cap.

STEP 3

Sterilise equipment (by boiling for 5 minutes or with a cold water sterilising solution).

STEP 4

Boil drinking (tap) water. Allow to cool for no more than 30 minutes.

STEP 5

Pour exact amount of water (see feeding table), into the sterilised bottle, carefully to avoid scalds, the water is hot.

STEP 6

Add exact number of level scoops for age of baby.

STEP 7

Place the sterilised teat and cap on the bottle and shake well until powder is fully dissolved. Cool bottle under cold running water until lukewarm. Test the temperature by shaking a few drops onto the inside of your wrist.

STEP 8

Close tin tightly after each use and store in a cool dry place.

“Unboiled water, unsterilsed bottles or incorrect dilution can make your baby ill. Incorrect storage, handling, preparation and feeding can also lead to adverse effects. Follow instructions carefully.”

Directions for use:

• Only prepare one bottle at a time.
• Clean the area where you are going to prepare the bottle.
• Feed immediately and follow the instructions exactly.
• Do not keep unfinished bottle, discard unused portion.
• Always hold baby while feeding.
• Leaving baby unattended may cause choking.

FEEDING TABLE:

* Note: Use only the enclosed scoop (4.4g).​
** A healthcare professional should be consulted before introducing other food to a baby’s diet.

Local guidelines^9,10 describe an ideal prescribing ratio of 90% extensively hydrolysed formula ​and only 10% amino acid formula reserved for special cases.

ALTHÉRA^® is the only eHF with the evidence¹ and formulation⁵ to help you address your AAF​ prescribing imbalance.^1,5,11,12

Getting you closer to an ideal ratio of 90% eHF: 10% AAF.^10,13

Are you spending too much on cows’ milk allergy?​

ALTHÉRA^® IS THE ONLY EXTENSIVELY HYDROLYSED FORMULA TO SHOW SIMILAR EFFICACY^† TO AN AMINO ACID FORMULA (AAF)* IN AN RCT WITH MILD-SEVERE CMA.¹​​

^† In a randomized control trial​
*SMA^® Althéra^® is not recommended where only an amino acid formula is indicated

ALTHÉRA^® is currently the only extensively hydrolysed formula (eHF) to utilise a plant and microbial derived enzyme blend as part of its hydrolysis process⁵. All other eHFs in the UK utilise a porcine (pig) enzyme in the manufacturing process. ​
The ALTHÉRA^® formulation, made with the microbial and plant derived enzyme blend has proven effective in two RCT’s and demonstrated no difference in allergenicity vs the previous ALTHÉRA^® formulation which used porcine derived enzymes.^11,15
As a result of this change, ALTHÉRA^® is now the only eHF in the UK suitable for halal diets and is the only Halal certified and vegetarian eHF in the UK.​
Previously if you were unable to consume porcine-based products (either for dietary or religious reasons). you would have been offered an Amino Acid Formula as the only solution to meet your CMA needs.

The degree of hydrolysis and residual allergen content varies considerably between marketed casein- and whey-based eHF.^16,17 These differences in peptide composition and residual allergen content impact on the clinical efficacy and risk of allergic reactions to eHF.¹⁷

Graph adapted from Nutten et al¹⁷
C1 = Nutramigen LGG^® 1, C2 = Nutramigen LGG^® 2, C3 = Similac^®
Alimentum, W2 = Aptamil^™ Pepti 1, W1 = Aptamil^™ Pepti 2

Da = Daltons    MW = Molecular Weight    BLG = Beta-lactoglobulin

The absence of food allergens in the form of intact proteins is a key feature of extensively hydrolysed protein formulas; complex formulas, composed from many different ingredients from biotechnological or agricultural origin, require a total quality management approach or ‘safety by design’ to ensure batch to batch consistency and the safety of the product.​

Althéra’s ingredients are selected only if they are safe for use in CMA management. The milk proteins are broken down so that the peptide containing allergens are less likely to cause an allergic reaction. To ensure that no larger protein fragments capable to cause an allergic reaction to remain in the finished product, the hydrolysate is filtrated through several types of membranes including ultrafiltration with a specific molecular weight cut off. The production process applied to Althéra is to maximise safety and avoid any cross contamination with strict analytical controls in place in order to guarantee the absence of intact proteins in the finished product.

SMA^® ALTHÉRA^®: CONTAINS LACTOSE BECAUSE IT IS THE PRIMARY CARBOHYDRATE IN BREAST MILK​¹⁹

A 2012 STUDY SHOWED LACTOSE IN SMA^® ALTHÉRA^® POSITIVELY MODULATES THE GUT MICROBIOTA​^18-20

LACTOSE IN SMA^® ALTHÉRA^® CONTRIBUTES TO ITS BETTER TASTE​

Lactose is a sugar and its “presence has been shown to make these naturally strong, bitter tasting extensively hydrolysed infant formulas better tasting”²⁰​
This may help feeding acceptance and health economic savings^2,8,21-22 ​

LACTOSE IN SMA^® ALTHÉRA^® MAY HELP TO INCREASE MINERAL ABSORPTION^8,9

EHFs CONTAINING LACTOSE ARE RECOMMENDED BY
GUIDELINES AND SUPPORTED BY EXPERT OPINION

Nestle Health Science - Cows’ Milk allergy​
      • Nestle Health Science - What is Cows' Milk Allergy​

NICE Clinical Knowledge Summary ​
      • Cow's milk allergy in children | Health topics A to Z | CKS | NICE​
​
NICE Clinical Guidelines Food Allergy in Children and Young People​
      • Overview | Food allergy in under 19s: assessment and diagnosis | Guidance | NICE​
​
Allergy UK​
      • Allergy Symptoms and Conditions | Allergy UK

British Society of Allergy and Clinical Immunology​
      • Cow's Milk Allergy – BSACI​
​
Anaphylaxis Campaign​
      • https://www.anaphylaxis.org.uk/information-training/facts-and-figures/​

Weaning Guide

The SMA^® Althera^® and SMA^® Alfamino^® weaning guide can be downloaded here.

Comiss^TM

The CoMiSS^TM awareness tool can be used by healthcare professionals to quantify CMA symptoms. Learn more here.