Biofloratech Ltd

Labinic is the most frequently used probiotic in neonatal care in the UK. We supply Labinic to over 90 NHS hospitals, including many tertiary neonatal centres. Labinic is the only neonatal Probiotic offered on the NHS Supply Chain

Labinic is also used worldwide, available through our distribution partners

There are 3 strains of probiotics present in equal quantities in Labinic Drops. 0.2ml provides 2 billion probiotic bacteria of:

Please see "Technical Evidence" for research evidence

We can support your implementation of Labinic with:

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To report a clinical concern, please email us

Probiotics: Recent evidence

October 2023: A Network Meta-Analysis of 106 trials was published, involving nearly 26,000 babies, showed that multi-strain probiotics containing B. infantis are more effective. Compared to placebo, they have an RR for all-cause mortality of 0.69 (0.56-0.86). In addition, multi-strain probiotics had an RR of 0.38 (0.30 to 0.50) to prevent NEC.

Labinic: Recent evidence

Labinic leads to reduction of Necrotising Enterocolitis & Mortality (LINK)

Labinic significantly improves gut microbiome diversity in Babies (LINK)

Labinic significantly reduces antibiotic resistant carriage (LINK)

Labinic significantly improves tolerance of feeds in babies (LINK)

These twice yearly newsletters contain reviews of selected probiotic-related publications which health professionals may find useful for their clinical practice and continuous professional education.

July 2024 Click here

January 2024 Click here

July 2023 Click here

January 2023 Click here

August 2022 Click here

January 2022 Click here

May 2021 Click here

January 2021 Click here

August 2020 Click here

April 2020 Click here

Labinic Drops are not classified as medicines in the UK/EU and in some other jurisdictions. In others they have an intermediate classification. Labinic Drops are classified as food supplements with no health claims permitted.

Labinic Drops are manufactured to pharmaceutical standards in specialised registered pharmacy probiotic-only facilities. This is far more stringent than normal dietary supplement manufacturing. This graphic shows the processes.

Facilities: Our new production facilities meet the international standards of Good Manufacturing Practice (GMP) and Good Pharmacy Practice (GPP) and are rated A-grade as a manufacturing pharmacy.

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.

Cost comparison - Labinic

Labinic is considerably less expensive than some other probiotics, which can cost over 7 times more per patient per day. Labinic is extensively quality checked and produced in a certified manufacturing pharmacy. Labinic has also been evaluated in clinical studies (see above). However we do not attend expensive conferences nor do we have a sales team, enabling us to keep the cost of Labinic considerably lower than, for example, Infloran®* or Pro-Prems®*, whilst ensuring comparable quality.

Health Service Economies

The costs of NEC are substantial worldwide (figures adjusted for inflation). In the USA, the (additional) cost of NEC per patient is approximately $23-30,000 for medical and surgical NEC respectively (Johnson ).

In the UK, the annual cost of treatment for NEC to the NHS is approximately £22m (Pokhrel). Surgical NEC is more costly (£27,000 per patient) compared to medical NEC (£2,500) (Renfrew). The costs of sepsis are higher, approx £58m annually (Mahon). It is also possible to assign costs of mortality and disability based on lost QALYs.

Based on the meta-analysis reductions in NEC, mortality and sepsis, we estimate that if every premature baby born in the NHS (UK) at less than 34 weeks was given Labinic Drops once they had started milk feeds, and that Labinic was continued until 37 weeks corrected gestation, then the NHS could save up to £20 million every year (including the cost of the Labinic Drops), based on a conservative reduction by 30% of these morbidities. If only NEC is considered, a saving of up to £11m annually is estimated based on a 50% reduction.

None of this includes the suffering and distress caused by these potentially modifiable conditions, nor any disease modification to a less severe pathophysiology.

* **Pricing checked 08/2023: E&OA

Lactic Acid: L. acidophilus NCFM is predominantly a producer of L-lactate. Please see our Technical Bulletin here (opens in new window) for further details.

Antibiotic Resistance: There are no concerns for transferable antibiotic resistance genes in the probiotic species contained in Labinic Drops. In addition, the use of Labinic has been shown to reduce, by up to 93%, late-onset colonisation with antibiotic-resistant Gram negative bacteria in the neonatal gut. Please see our Technical Bulletin here (opens in new window) for further details.

Nutritional content: Labinic Drops contain no sodium. We have prepared a nutritional information factsheet which also confirms that Labinic contains no preservatives, sweeteners, gluten, dairy, lactose, soya or animal products and is suitable for vegans.

Feed osmolality is important in premature babies - hyperosmolar feeds have been associated with NEC. If powdered probiotics (or other hyperosmolar medicines like sodium acid phosphate) are added to small quantities of milk, the osmolality can be in excess of 700 mOsm/Kg.H2O (which is very high). Labinic does not increase feed osmolality.

NHS Supply Chain: Labinic is the only probiotic approved for inclusion on the NHS Supply Chain. If you have any trouble ordering Labinic on the NHS Supply Chain, you can always order directly from us. We have lots of experience dealing with the Supply Chain if you require help.

Distributors:

United Kingdom NHS and private distribution of Labinic Drops in the UK is managed by Biofloratech Ltd.

Ireland Labinic Drops are available from our distribution partner MedFind Solutions.

European Union Labinic Drops are available from our distribution partners Miller and Miller and DrugsRus Ltd.

Australia and New Zealand Labinic Drops are available from our distribution partner Medsurge in Australia and New Zealand.

Southern Africa Labinic Drops are available from our distribution partner Safeline in Southern Africa.

Middle East and Hong Kong Labinic Drops are available from our distribution partner Miller and Miller.

FDA: In September 2023 the FDA issued a note concerning a death in a premature baby under 1000g associated with the use of a single strain probiotic (Evivo™). Whilst the full report is awaited, the note does not consider any of the positive published literature regarding the use of probiotics in premature neonates. We can reassure our customers that millions of doses of Labinic Drops have been safely administered. Independent safety analyses have been reported during clinical trials of Labinic. Please see our Commentary here (opens in new window) for further details.

Firstly, whilst "probiotic" is a popular and generally well understood term used by the general public and health professionals, it is not permitted for use by the UK/EU. This is because Labinic, as a probiotic, is classed as a food. Health claims for food, regardless of any evidence, are not allowed. Therefore we can't call Labinic a "probiotic" in the UK/ EU. We use the term "Bio-Flora" instead.

It is however believed by many health professionals and non-professionals alike that giving naturally occurring live bacteria helps to supplement the normal intestinal function in babies, children and adults.

Labinic is used for babies in many NHS Neonatal Units and is frequently recommended by Consultant Paediatricians. Giving a preparation of naturally occurring bacteria is a way to supplement the digestive tract and promote good gut health and function.

There are 3 strains of probiotics present in equal quantities in Labinic Drops.

Lactobacillus Acidophilus NCFM Can help with the digestion of lactose which is present in breastmilk and most formula milks, as well as cheese and other dairy products. It also produces anti-infective molecules.

Bifidobacterium bifidum Bb-06 Can help with improving digestion of nutrients and help to "fight off" potentially harmful bacteria. It also may help to reduce allergies and viral infections.

Bifidobacterium infantis Bi-26 Can reduce inflammation in the gut. It offers support with maintaining normal digestive functions, reducing "dysbiosis" which can include pain, wind, abnormal stools and reflux.

All 3 probiotics work together to colonise the small and large bowel, to produce molecules that support the immune system and promote a healthy gut. The bifidobacteria are in a greater proportion in total, just like in the gut. These strains are effective in all age groups, not just babies.

Labinic is available to purchase directly without prescription on Amazon.

This is the same high quality, pharmacist-approved, concentrated preparation that is used in NHS and hospital care, giving 2 billion probiotics per daily dose.

The recommended dose is 5 drops, once per day, with milk or food. This provides 2 billion probiotics a day.

Labinic comes as 5ml of pharmaceutical grade MCT oil-based liquid in a 10ml bottle to enable mixing. It has a neutral taste.

Shake the bottle well before each use and allow 30 seconds before opening. If there are any brownish deposits in the lid or on the dropper, these are completely harmless and can be wiped away.

Tip the bottle and slowly a drop will form in the inbuilt dropper.

Give the 5 drops on a spoon or finger, or add to milk or food. We recommend wiping the lid and bottle neck with a clean gauze/tissue after each use.

After opening, a bottle of Labinic should be discarded after 30 days

Every bottle of Labinic Drops contains a package-insert leaflet with more detailed information for users. Please read it before first use. Keep Labinic out of the reach and sight of children.

There are some important differences which differentiate Labinic from other probiotics:

• A concentrated probiotic mixture giving 2 billion (2 x 109) live probiotics each day


• Labinic Drops are widely used in NHS Neonatal Units and often recommended by Paediatricians for use mainly in babies and infants


• Frequently recommended by Paediatricians for dysbiosis (disturbance of the normal gut bacterial balance)


• Pharmaceutical Quality production with guarantee of live bacterial counts to end of shelf life


• Absolutely no allergens (dairy, egg, gluten etc), no preservatives, no sweeteners or colourants


• Suitable for Vegans


• Highly studied multistrain bacteria, safe and effective, at the right dose