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产品名称:纽康特®氨基酸婴儿配方粉

通用名称:氨基酸婴儿配方粉

产品特性:

1. 100%游离氨基酸,真正无过敏原性

2. 不含牛奶蛋白,完全在无牛奶蛋白的环境中生产
3. 高品质DHA/ARA,有助于婴儿大脑及视力的发育

4. 谷氨酰胺(1.22g/100g),有助于修复肠道功能

5. 不含乳糖

 临床证明:
1. 纽康特® 迅速缓解症状
  3天快速缓解胃肠道症状
  14天缓解所有牛奶过敏症状,包括皮肤症状
2. 纽康特®支持牛奶过敏婴儿生长发育

适用于:
1. 牛奶过敏/多种食物过敏的婴儿饮食治疗首选
2. 婴儿牛奶过敏快速有效的辅助诊断工具
3. 其他需要要素膳饮食的住院婴儿,如胃肠手术前后的营养支持

热线电话: 400-820-2101
官方微博: 纽康特-NUTRICIA
官方网站: www.neocate.com.cn


  • 处方资料摘要
  • 产品文献
  • FAQ
  • 科室应用
建议食用的浓度为13.8%(重量/体积,13.8克本品加水稀释至100毫升),在此浓度下的渗透压为340mOsm/kg水。
【重要提示】
- 请在医师/营养师的指导下食用 - 可用作单一的营养来源
- 不可经静脉使用 - 请使用清洁的用具配置以防蛋白质的污染

Allergy to extensively hydrolyzed cow milk proteins in infants: Identification and treatment with an amino acid-based formula

De Boissieu D, et al.

The Journal of pediatrics. 1997;131:744-747

Efficacy and safety of hydrolyzed cow milk and amino acid-derived formulas in infants with cow milk allergy

Isolauri E, et al.

The Journal of pediatrics. 1995;127:550-557

谷氨酰胺在肠道的代谢及其对肠粘膜的保护作用

戴定威

国外医学:临床生物化学与检验学分册. 1995. 16(6): 253-256

Prospective, controlled, multi-center study on the effect of an amino-acid-based formula in infants with cow's milk allergy/intolerance and atopic dermatitis

Niggemann B, et al.

official publication of the European Society of Pediatric Allergy and Immunology. 2001;12:78-82

Intolerance to protein hydrolysate infant formulas: An underrecognized cause of gastrointestinal symptoms in infants

Vanderhoof JA, et al.

The Journal of pediatrics. 1997;131:741-744

Guidelines for the diagnosis and management of cow's milk protein allergy in infants

Vandenplas Y, et al.

Archives of disease in childhood. 2007;92:902-908

Nutritional and other postoperative management of neonates with short bowel syndrome correlates with clinical outcomes

Andorsky DJ, et al.

The Journal of pediatrics. 2001;139:27-33

Eosinophilic esophagitis: A 10-year experience in 381 children. Clinical gastroenterology and hepatology

Liacouras CA, et al.

the official clinical practice journal of the American Gastroenterological Association. 2005;3:1198-1206

Q:Why was Neocate LCP upgraded?
A:The objective of the Neocate (LCP) upgrade was to maintain our position as best in class AAF for the dietary management of CMA/MFPI as well as to differentiate Neocate LCP from the competition.
Q:Which macronutrient levels were amended and how?
A:

To be more in line with breast milk the fat level (en %) of Neocate (LCP) upgrade has been increased, and carbohydrates (en%) have been lowered as breast milk comprises of approximately: 7.5% energy from protein, 53.5% energy from fat and 39% energy from carbohydrate ¨C McCance and Widdowson's 2010

To accomplish this, the energy content needed to be slightly increased, resulting in the advantage of getting more kcal out of a can. Closing the gap with Nutramigen AA creating a competitive edge vs. Elecare.

In addition, the reduced carbohydrate level (less powder in solution) resulted in a lower osmolality in the Neocate LCP upgrade. The osmolality of Neocate LCP upgrade is now in line with ESPGHAN recommendations.

 

Q:Which micronutrient levels were amended and how?
A:

The micronutrients of Neocate LCP infant have been reviewed in line with current global nutritional guidelines and regulations. In addition changes have been made in line with more recent dietary recommendations.


Neocate LCP upgrade is compliant with:


- Commission Directive 1999/21/EC(FSMP) and Commission Directive 2006/141/EC(as laid down in the infant formulae and follow-on formula guidelines)
- CODEX STAN 72-1981(Revision 2007)
- US,Canadian(LSRO US guidelines[1998]),Australian,UK and German infant formula regulations(UK RNI RDA Germany,Austria,Switzerland [2000])ESPGHAN guidelines (Koletzko B et al. Global standard for the composition of infant formula: recommendations of an ESPGHAN coordinated international expert group.J Pediatr Gastroenterol Nutr 2005;41:584-99)


To comply with all these regulations, micronutrients are either slightly lower or higher compared to the former Neocate LCP formulation; however, this won't have any implications on the acceptability of Neocate. Some micronutrients which are worth specifically mentioning are sodium as well as manganese, as these levels needed a significant change, due to various reasons.


Sodium
The sodium content of the former Neocate LCP formulation was relatively low for infants with GI Allergy and chronic diarrhoea (low against UK DRV's). The level in Neocate LCP upgrade was revised to 39 mg/100 kcal (from 25 mg/kcal) which is complying with dietary recommendations as well as the within guidance of the Commission Directive 1999/21/EC (FSMP), CODEX STAN 72-1981 (Revision 2007) (20-60 mg/100kcal)


Manganese
A recent report has highlighted concerns of manganese in infant formula. Hypoallergenic formula analysed had a higher concentration of manganese than the standard infant formulae. Evidence of toxicity is growing-Hardy 2009, Fihilo & Menezes 2009. The level in Neocate LCP upgrade was revised to 0.04mg/100 kcal (from 0.08 mg/kcal) which is more comparable to the level found in term infant formulae as well as more central within guidance of the Commission Directive 1999/21/EC (FSMP), CODEX STAN 72-1981 (Revision 2007) (0.001-0.1mg/100kcal)

Q:What is the rationale behind the addition of nucleotides and the level chosen?
A:

Nucleotides are ubiquitous, low-molecular-weight compounds present in biological tissues and fluids as free monomeric nucleotides and nucleosides, polymeric nucleotides (DNA and RNA), and conjugated to other biologically relevant moieties.

Nucleotides in all their various forms play key roles in energy metabolism, genetic transmission, and signal transduction-Yu, 2002; Aggett et al, 2003. There is sufficient evidence to support the addition of nucleotides to infant formulae based on health benefit related findings (growth/ immune system), independently of the compositional evidence of
their presence in human milk.

 
Based on the scientific literature and the safety recommendations, the upgraded Neocate LCP formulation contains a mixture of five (free) nucleotides at a total concentration of 4.9 mg/100kcals (CMP 1.6; UMP 1.2; AMP 1.0; GMP 0.35; IMP 0.68). This (free) nucleotide
profile of the Neocate upgrade formulation fully complies with the compositional criteria laid down in the Commission Directive on infant formulae and follow-on formulae Commission Directive 2006/141/EC.


Furthermore is this level of nucleotides comparable to that of mature human milk-Leach et al, 1995; Thorell et al, 1996 and other infant formulae such as Nutrilon pepti/ Pepticate.

Q:Which source is used for the nucleotides?
A:

Nucleotides are derived from yeast RNA

- 5'-CMP and 5'-AMP are added as free nucleic acids
- 5'-IMP, 5'-GMP and 5'-UMP are added as disodium salts

Q:How is the hypoallergenicity of Neocate ensured with the addition of nucleotides?
A:When selecting new raw materials for inclusion in our Neocate range of products a strict procedure is followed and raw materials are assessed to ensure that the proven hypoallergenicity of the formula is not compromised. Raw materials are assessed to ensure that they are free from sources of allergenic protein, free from milk protein and that our suppliers have validated quality systems preventing cross contamination. Each batch of commercial product is immunologically tested using validated methods for milk protein detection, thus ensuring a high quality product. The nucleotides selected for the Neocate LCP upgrade passed all the strict requirements laid out above and we therefore concluded the nucleotides to be hypoallergenic.
Q:What is the rationale behind the LCP levels chosen?
A:

Leading experts and new guidance has been published proposing higher levels of LC-PUFA in infant formulae (Koletzko et al. 2008) with recommendations to include a level of at least 0.3% DHA (of total fatty acids) and a level of ARA equal to, or greater than the DHA level. Due to the mechanistic functions of DHA, and because the functional benefits of DHA in growth and maturation of numerous organ systems, most importantly the brain and eye development, the level of DHA for Neocate LCP has been increased to 0.35% of total fatty acids at a level equal to that of ARA in the formulation.
The European Food Safety Authority (EFSA) published their opinions regarding the scientific evidence in the area of LCP's. Based on the presented data they concluded that "a cause and effect relationship has been established between the intake of infant and follow-on formula supplemented with DHA at levels around 0.3% of total fatty acids and visual function at 12 months in formula-fed infants born at term from birth up to 12 months and in breastfed infants after weaning up to 12 months". However, "the Panel considers that a role of ARA on visual development of term infants cannot be established on the basis of the data presented".EFSA stated that the following wording reflects the scientific evidence:"DHA contributes to the visual development of infants"-EFSA 2009. It was further specified that, in order to bear this claim, an infant formula should contain at least 0.3% fatty acids from DHA.


Neocate LCP upgrade contains 0.35% DHA of total fatty acids.


This level will allow Neocate LCP Upgrade to bear the following EFSA claim  'DHA contributes to the visual development of infants'.

Q:What is the rationale behind the 1 to 1 LCP ratio?
A:LCP's also play a role in inflammation and allergy. Increased ARA in diets for allergic infants may potentiate the underlying inflammation via production of pro-inflammatory mediators. Therefore could a 1:1 ratio be advantageous for infants with allergies/ pro-inflammatory responses, resulting in an improved fatty acid profile-Calder, 2003, Koletzko et al 2008.
Q:What are the LCP levels and ratio's used in other formulae?
A:Neocate LCP upgrade contains DHA and ARA both at 0.35% of total fatty acids (1:1 ratio).
Q:Which source is used for the LCP's?
A:Neocate LCP upgrade contains synthetically derived raw material sources of LCP,ARASCO and DHASCO single cell oils (Martek Biosciences Corporation). These oils have been selected as suitable sources of ARA and DHA for Neocate LCP.
Q:Is there any data that supports the hypoallergenicity of LCP’s?
A:Nutricia reviewed the production, processing methods and scientific literature associated with these oil sources (DHASCO and ARASCO) and concluded that there is no allergenic risk posed by the inclusion of these oils in Neocate LCP upgrade. This report was also reviewed by an Independent Expert Panel including Clinical Allergy and Immunology expertise in February 2006. These experts stated that the oil blend used in Neocate LCP upgrade does not compromise the proven hypoallergenicity of Neocate LCP upgrade.
Q:Do all previous study results still apply, in other words may I still expect the same outcomes?
A:Yes, all key benefits of Neocate are still relevant
- Hypoallergenic (Sampson et al 1992)
- Fast and effective relief of symptoms (de Boussieu et al 1997, Vanderhoof et al 1997)
- Promotes growth (Isolauri et al 1995, Niggeman et al 2001)
- Evidence in multiple conditions and multiple age groups (Neocate manuscript 2010)
Q:Are there any differences noted in the acceptability of the compared to the previous Neocate LCP?
A:An internal Consumer Panels (ICP) with parents were conducted to assess the acceptability of the new formula compared to old Neocate LCP.The study showed that there were no significant differences in the overall liking of the new formula compared to old Neocate LCP.
Q:Are there any differences noted in the acceptability of the formula
compared to the old Neocate Infant without LCP's?
A:The sensory profile of the new formula compared to Neocate Infant without LCP's is different due to the presence of LCP's in the form of algae oil. Internal Consumer Panels (ICP) with parents were conducted to assess the acceptability of the new formula compared to old Neocate Infant without LCP's. The study showed that there were no significant differences in the overall liking of the new formula compared to old Neocate Infant without LCP's.
Q:Can I easily switch infants from the current Neocate Infant formula to the
new Neocate LCP formula?
A:The sensory profile of the new formula compared to Neocate Infant without LCP's is slightly different due to the presence of LCP's in the form of algae oil. However there was still no significant difference in acceptability reported. Thus, it will be the decision of the managing health care professional dependant on individual circumstances an infant may be more likely to accept the new formula if transitioned more slowly over 3-4 days.
Q:Can I easily switch infants from their current Neocate LCP formula to the
new Neocate LCP formula?
A:Dependant of the individual infant, health care professionals may choose to transition them to the new Neocate LCP either by a straight switch (100% Neocate LCP (PDS 2675) replaced the next day with 100% upgraded Neocate LCP (PDS 4017)) or at their discretion it can be titrated more slowly over the course of 1-2 days. See below for an example;
Day 1   Half of feeds-75% Neocate LCP: 25% upgraded Neocate LCP
           Half of feeds-50% Neocate LCP: 50% upgraded Neocate LCP
Day 2   Half of feeds-25% Neocate LCP: 75% upgraded Neocate LCP
           Half of feeds-0% Neocate LCP: 100% upgraded Neocate LCP
  • 小儿消化科

    3天快速缓解腹泻、便秘、呕吐等胃肠道症状;腹泻、IBD、SBS等疾病的营养支持

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  • 小儿皮肤科

    14天缓解所有牛奶过敏症状,包括湿疹、风疹、红疹等皮肤症状

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