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SCIENCE INSPIRED BY NATURE

SMA® Gold Prem H Drops

Food for Special Medical Purposes

SMA Gold Prem® H-Drops is a nutritionally incomplete (liquid) product for premature, low birthweight infants. It is suitable from birth until hospital discharge and contains Human Milk Oligosaccharides (HMOs*) 2'FL and LNnT (10:1) in a ratio that is inspired by preterm breastmilk.

For hospital use only

For Enteral use only

Product description


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Silver molecules

Improve feeding tolerance

Shortening time to reach full enteral feeding by 2 days compared to placebo1

Silver molecules

Support age-appropriate growth

Associated with greater length and significantly greater head circumference growth rates than placebo1

Silver molecules

Safe and well-tolerated1

The first 1,000 days of a baby’s life have a life-long impact on many aspects of future health.

Feeding intolerance in preterm infants is a major concern in neonatal care2 and is associated with the immaturity of the gut and immune functions as well as disturbed gut microbiota3. Up to 50% of all preterm infants suffer from delayed achievement of full enteral feeds4. Achieving timely enteral feeding is critical to support growth and development2,3.

Evidence showed that using SMA Gold Prem® H-Drops reduced time to reach full enteral feeding. Average time to reach full enteral feeding was 2 days faster1 compared to the placebo.

HMOs are unique to breast milk and research suggests that they provide immune support to developing infants5-8. HMOs* may be particularly beneficial for immune health of preterm infants. For more information on HMOs in breast milk click here

SMA Gold Prem® H-Drops is the first and only HMO* product clinically proven to support preterm, low birth weight infants from the very start1 and contains the most abundant HMOs* (2’FL and LNnT) at a ratio inspired by preterm breastmilk9-10.

SMA Gold Prem® H-Drops can be administered alongside parenteral nutrition, mother’s own milk, donor milk and preterm formula.

Suitable for Vegetarian and Halal diets

Data card


Formats


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1 case contains 3 boxes

(1 box contains 90 ampoules)
(1 ampoule is 1.9mls)

SMA Gold Prem H-Drops ampule

Preparation


Feed preparation

WARNING: Always wash hands and sterilize feeding devices before preparing baby’s feed. Feed immediately and follow instructions exactly.

  1. Each feeding device (syringe or ampoule) must be prepared individually just before feeding:

    1. Carefully tear the blister and take one ampoule. Twist and pull cap to open the ampoule.

    2. Using a syringe, measure the required quantity of SMA Gold Prem® H-Drops

  2. Feed immediately either directly into the mouth or through enteral Feeding tube.
    Not to be given with feed and/or medications.

  3. Discard all unfinished quantities of SMA Gold Prem® H-Drops and/or syringe after each use/feed.

  4. Opened ampoule should be used immediately or discarded.

Feeding guide


Feeding guide

Approx. Weight of Baby* 2'FL, LNnT per day SMA Gold Prem® 2'FL, LNnT per day
(kg) (g) (ml)
0.5-1 0.19 1.9 (=0.63 ml x 3 per day)
1-1.5 0.38 3.8 (=1.27 ml x 3 per day)
1.5-2 0.57 5.7 (=1.9 ml 3 per day)
2-2.5 0.76 7.6 (=2.5 ml 3 per day)
2.5-3 0.95 9.5 (= 3.2 ml 3 per day)

* If baby falls on the upper limit of their weight category then administer the dose for the next weight category, e.g. if baby is 1kg, then administer the dose for the 1-1.5kg weight category

Important feeding information


 

This product is not a breast milk substitute and not suitable as the sole source of nutrition.

 

This product can be used for preterm infants who are breastfed or formula-fed.

 

Do not exceed the recommended daily dose.

 

For enteral use only

 

SMA Gold Prem® H-DROPS should be given separately and not mixed with feed and/or medications.

 

The daily dose has to be given as a minimum of 3 equal feedings per day (i.e. every 8 hours).

 

For hospital use only, under medical supervision. Remove cap of ampoule and keep cap away from infants

 

It is recommended that the product be started as soon as 24 hours of trophic feeding has been established.

 

Administer directly into enteral feeding tube or mouth

 

Can be administered alongside parenteral nutrition, mother’s own milk, donor milk and preterm formula

References
  1. Hascoët, JM et al., Abstract presented at WCPGHAN 2021.

  2. Senterre, T. (2014). Practice of enteral nutrition in very low birth weight and extremely low birth weight infants. World Rev Nutr Diet, 110, 201-214. https://doi.org/10.1159/000358468

  3. Fanaro, S. (2013, Oct). Feeding intolerance in the preterm infant. Early Hum Dev, 89 Suppl 2, S13-20. https://doi.org/10.1016/j.earlhumdev.2013.07.013

  4. Indrio, F., Riezzo, G., Cavallo, L., Di Mauro, A., & Francavilla, R. (2011, Oct). Physiological basis of food intolerance in VLBW. J Matern Fetal Neonatal Med, 24 Suppl 1, 64-66. https://doi.org/10.3109/14767058.2011.607583

  5. Zivkovic AM et al., Proc Natl Acad Sci. 2011;108(Suppl)1:4653-8.

  6. Zivkovic AM et al., Funct Food Rev. 2013;5(1):3-12.

  7. Bode L. Early Hum Dev. 2015;91(11):619-22.

  8. Donovan SM et al., Ann Nutr Metab. 2016;69(Suppl 2):42-51.

  9. Newburg, DS., et al. (2004). Innate protection conferred by fucosylated oligosaccaharides of human milk against diarrhea in breastfed infants. Glycobiology, Mar;14(3):253-63.doi: 10.1093/glycob/cwh020.

  10. Austin, S., De Castro, C. A., Sprenger, N., Binia, A., Affolter, M., Garcia-Rodenas, C. L., Beauport, L., Tolsa, J. F., & Fischer Fumeaux, C. J. (2019, Jun 5). Human Milk Oligosaccharides in the Milk of Mothers Delivering Term versus Preterm Infants. Nutrients, 11(6). https://doi.org/10.3390/nu11061282

*HMO: structurally identical human milk oligosaccharides, not sourced from breast milk
Correct as of June 2021)

IMPORTANT NOTICE: 

The World Health Organisation (WHO) has recommended that pregnant women and new mothers be informed on the benefits and superiority of breastfeeding – in particular the fact that it provides the best nutrition and protection from illness for babies. Mothers should be given guidance on the preparation for, and maintenance of, lactation, with special emphasis on the importance of a well-balanced diet both during pregnancy and after delivery. Unnecessary introduction of partial bottle-feeding or other foods and drinks should be discouraged since it will have a negative effect on breastfeeding. Similarly, mothers should be warned of the difficulty of reversing a decision not to breastfeed. Before advising a mother to use an infant formula, she should be advised of the social and financial implications of her decision: for example, if a baby is exclusively bottle-fed, more than one can (400 g) per week will be needed, so the family circumstances and costs should be kept in mind. Mothers should be reminded that breast milk is not only the best, but also the most economical food for babies. If a decision to use a formula 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. This product must be used under medical supervision. SMA Gold Prem® H-Drops is an incomplete food for special medical purposes especially designed for the dietary management of preterm low birthweight infants. It is not a breast milk substitute.