LABINIC DROPS IN NEONATAL CARE

Meta-analysis of studies of over 19,000 babies have consistently shown a substantial reduction in necrotising enterocolitis, mortality and Late onset sepsis in premature babies receiving multi-strain probiotics.

A recent review showed a significant reduction in NEC and mortality in a UK NICU using Labinic Drops.

Labinic has been used even in the most premature babies (22 weeks onwards) due to its excellent safety profile.

A dose of Labinic of 0.2ml provides 2 billion probiotics which is the dose previously recommended by Deshpande et al.

REGULATORY

Labinic Drops are manufactured to pharmaceutical standards in specialised facilities. This is far more stringent than normal dietary supplement manufacturing.

Facilities: The new, probiotic-only production facilities meet the international standards of Good Manufacturing Practice (GMP) and Good Pharmacy Practice (GPP) and are rated A-grade.

Quality Control: Every batch undergoes pre- and post-production quality checks, to verify that they meet strict quality and safety standards. This is supervised by a Pharmacist and a Microbiologist.

Contaminant checks: Labinic is manufactured in positive-pressure clean-room conditions. Full bacterial and fungal contaminant monitoring is carried out and available for every batch.

Live strain viability counts: Certificates of Compliance and Certificates of Analysis are produced for every batch. This includes live counts at time of manufacture. In addition, we have conducted 2 year stability testing, at different environmental temperatures. The live CFU count at the end of shelf-life meets the Conformance Standards.

INTESTINAL DYSBIOSIS

Exposure to antibiotics (either at Caesarean Section, through breast milk or from courses of antibiotics) can cause intestinal dysbiosis. In addition, antacids (e.g., omeprazole, lanzoprazole) can also cause dysbiosis. This may present with abdominal pain, excessive/painful wind, diarrhoea and/or mucousy stools.

Labinic Drops can help to correct a dysbiosis and assist in the restoration of a more normal microbiome, with subsequent resolution of symptoms.

WHICH BACTERIAL SPECIES ARE IN LABINIC DROPS ?

There are 3 strains of Bio-Flora (probiotics) present in equal quantities in Labinic Drops:

  • Danisco Howaru Dophilus – Lactobacillus Acidophilus NCFM
  • Danisco Florafit Bifidobacterium bifidum Bb-06
  • Danisco Florafit Bifidobacterium infantis Bi-26

PRECAUTIONS

Live bacterial preparations such as Labinic Drops should be handled and used with sensible precautions and care. Whilst they are generally recognised as safe, there are rare reported cases of infections arising from use of probiotics particularly in immunocompromised individuals, such as extremely preterm babies and patients receiving immune suppressants, patients with damaged intestinal tract (e.g. intestinal perforations and necrotising enterocolitis) where the live bacteria can enter the blood stream.

No reports of infections have been reported from the use of Labinic Drops, and over 1.5 million doses have to date (2020) been given.

In any patient who becomes unwell who is receiving Labinic Drops, the administration should be ceased immediately and appropriate investigations and treatment commenced. Labinic bacteria would normally be sensitive to combinations of Penicillin/Gentamicin, Ampicillin/Gentamicin, Meropenem/Vancomycin, Piptazobactam/Vancomycin, Cefotaxime/Vancomycin although the advice of a Pharmacist and Microbiologist should always be sought.