The UK/EU does not recognise that any health claims can be made for any "probiotics", which is how Labinic Drops are classed by the Medicines and Healthcare Products Regulatory Agency (MHRA-UK). Labinic is thus a non-medicinal product, and we make no claims that it can treat or prevent disease, nor claim that it "can restore, correct or modify physiological functions by exerting any pharmacological, immunological or metabolic action". Descriptions such as "pro-active" or "natural-support" bacteria are often used.
Therefore the only claim that we can make for Labinic Drops is that it supports the intestinal microbiota of babies and infants. We are not allowed, in the UK/EU, to comment on, or direct anyone to, any research or evidence that might cause it to be viewed as a medicinal product.
We are thus not permitted to supply guidelines for using Labinic correctly, nor information for parents or healthcare professionals on this UK/EU webpage.
Our analysis shows that, if every premature baby born 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 over £20 million every year, as a result of the natural support provided to the intestinal microbiota of babies. The annual saving calculation includes the cost of the Labinic Drops. This does not imply a health claim (see above).
Labinic drops can be stored at room temperature, provided this does not exceed 25 degrees C for prolonged periods (a few hours at 30 degrees C causes no degradation). Do not store below 4 degrees C. Labinic has a long shelf life (2 years) and the active bacterial counts are stable and well maintained throughout this period.
Due to EU and other country rules, we are not permitted to provide you with information to support the clinical use of Labinic Drops. We are allowed to provide the following information which may be useful for further research and evalulation in the interests of patient safety.
What strains are present in Labinic Drops?
There are 3 strains present in equal quantities in Labinic Drops
Precautions for the use of Labinic Drops in Healthcare Settings
Live bacterial preparations such as Labinic Drops should be handled and used with caution and care. Contamination of surfaces and cross-contamination of patients have been reported in clinical studies (e.g. Costello K; PiPS Study; United Kingdom). Whilst they are generally recognised as safe, there are reported cases of sepsis arising from their use 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. In any patient who becomes unwell who is receiving Labinic Drops, the administration should be ceased immediately and appropriate investigations and treatment commenced. Labinic bacteriae 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.
Should I give Labinic if a baby is not receiving milk?
ANSWER: No, we do not recommend this. We recommend that the baby, regardless of age and size, is receiving and tolerating 0.5-1.0ml milk before Labinic is added.
What is the red or white plastic band on the bottle neck?
ANSWER: This is an anti-tamper marker that is placed during bottling. It is not a seal. It does not matter if it is split for example.
Sometimes there is a brown deposit in the dropper or the lid?
ANSWER: This is normal and is harmless. It can simply be wiped away with a sterile gauze.
The printed expiry date / batch number on the bottle is faded by spillage of the oily product?
ANSWER: It is important to store Labinic upright, and after swirling it to mix, please wait a minute for the contents to settle. Any oil on the bottle neck or lid should be wiped by a sterile gauze to reduce mess and spillage. We can always confirm the batch number/expiry date of Labinic supplied.
If you wish to report an SI or AE involving Labinic Drops, then please email anonymised clinical details, along with your name and organisation to Report. Depending on the case we undertake to share written anonymised reports with our customers to promote safety and learning and to update our website with useful links.
Distribution of Labinic Drops in the UK is currently directly managed by Biofloratech Ltd
Labinic Drops are available from our distribution partner Medsurge in Australia and New Zealand.
Labinic Drops are available from our distribution partner Safeline in Southern Africa.
Labinic Drops are available from our distribution partner Miller and Miller.
Labinic drops can be ordered directly from Biofloratech. We welcome enquiries from distributors looking to fulfil orders or develop new marketplaces.
Different brands can be very different. Bacteria may be in liquid or powder form, and can contain different types of bacteria, as well as different amounts. Labinic is designed for babies, who normally have Bifidobacteria as the main bacteria in the healthy gut, along with Lactobacillus. The amount of bacteria given daily is also important, as a couple of billion of natural bacteria are needed to be able to compete with other, potentially harmful bacteria (like E. Coli which causes food poisoning), or fungi (like Candida which causes thrush). It is also important to be reassured that you are not giving your child other substances, such as animal products, sweeteners, preservatives etc
Firstly, whilst "probiotics" is a popular term, it is not one allowed by the European Commission, so we can't call Labinic a "probiotic" in the EU. It is however believed by many health professionals and non-professionals alike that giving ‘healthy’ live bacteria helps to support the normal gut function in babies, children and adults, which is why Labinic is sometimes used in hospitals. These ‘healthy’ live bacteria are called "probiotics" (see above for terminology). In the stool of a healthy newborn infant, we would normally find high levels of these types of bacteria. Giving a preparation of healthy bacteria could be a natural way to maintain and support the existing healthy gut bacteria and promoting a normal digestive tract.
Labinic Drops are therefore used to maintain normal digestive health, rather than to "treat" illnesses. As they are not a treatment, they are not classed as a drug or pharmaceutical
The preparation Labinic Drops has been specially designed for babies and children. Using all the latest evidence, and working with paediatricians, neonatologists and PhD scientists, we have blended 3 important bacteria, in a ratio where the bifidobacteria are in higher numbers just like in the healthy human infant gut.
Not yet, but you can order Labinic Drops directly from us
This is perfectly normal, and usually means that the Labinic needs to be mixed a bit more thoroughly. The deposits are entirely harmless. After more mixing, if the deposit is still present, simply wipe it away with a sterile gauze. The performance of the Labinic will not be affected.
This is NOT the seal - it is an anti-tamper marker and it does not matter if it is twisted or split - it is placed automatically during manufacturing but it is not a seal. The seal for the bottle is embedded inside the lid, so the Labinic can be used normally without any concerns.
We will normally respond to your email within 1-2 working days
Our office is open:
09:30 to 16:30, Monday to Thursday
09:30 to 15:00, Friday
Closed weekends and Public Holidays
Phone (within UK) 01932 506 181
Phone (overseas) +44 1932 506 181
We don't collect any data about you unless you email or phone us your details to make an enquiry or place an order. We don't record your phone calls and we don't collect identifiable data about you when you visit this website
We don't have "mailing lists" or anything that we send out for marketing purposes
If you order Labinic from us, we keep your contact details securely held so that we can supply you with Labinic Drops and provide you with sufficient information to be fully informed about the product to ensure safe and effective use.
We don't share your data / details with any other organisations.
We may contact you, if needed, about issues where there is a legitimate interest for you to be informed, such as changes in how Labinic should be used.
If you have previously purchased Labinic for personal or family use, we will keep your email order details securely, so that if you have any questions or concerns we are able to identify the batch you were supplied with. If you want to purchase more, we can check we have the correct details for you too.
NHS and Private Sector Pharmacies and Hospitals are routinely supplied with batch data by us, and we do not receive any data on patients who have been given Labinic.