This product is not to be refrigerated keep at room temperature. There should not be any problems if they are frozen either.
Please direct any questions about the product and its manufacturing process directly to (800-231-5777): http://www.bioticsresearch.com/index.php.
This is a new article and it is excellent-https://evidencebasedbirth.com/evidence-for-the-vitamin-k-shot-in-newborns/
More InformationFour drops provides 2 mg of vitamin K-1 activity. This info is from Biotics. .
Bio-K-Mulsion® supplies vitamin K1 (500 mcg per drop) in an emulsified liquid form to aid in the uptake and utilization of this important vitamin. Vitamin K status is important in bone health, and recent research has linked it to cardiovascular health as well. Bio-K-Mulsion® is an oil-in-water emulsion. Vitamin K oil has been dispersed into microscopic particles to aid with absorption and assimilation. .
Bio-K-Mulsion® is an oil-in-water emulsion. Vitamin K oil has been dispersed into microscopic particles to aid with absorption and assimilation.
Vitamin K (as K1-phytonadione)
This is a manufactured form of vit k1, as the real form is unstable and is too strong. This form is made out of natural things (bacteria)to achieve the a stable and useful form. Other Ingredients:
Water, gum arabic and sesame seed oil.
Because of this dating, returns will not be accepted on this product.
Dosage on this should be given to you by your caregiver, don't call me for that information.
Use this protocol ONLY, no need to call, just do it. Vitamin K Protocols
This is what most CNMs use
4 drops on first day and 1 week later
Then at one month
I offer vitamin oral K as an alternative to the injection. I do this because of a study I read that shows the efficacy matches that of the injectable, as long as you follow the proper protocol. Here's the abstract of the study:
OR just do one drop everyday til all gone
Neonatal vitamin K prophylaxis in Denmark: three years' experience with oral administration during the first three months of life compared with one oral administration at birth.
Hansen KN, Ebbesen F.
Department of Neonatology, County Hospital of Aalborg, Denmark.
A Danish surveillance group established after the introduction of oral vitamin K prophylaxis monitored Danish cases with late onset vitamin K deficiency bleeding by regular questionnaires to all paediatric departments. Six cases were reported, one of whom died and three are severely handicapped. All cases occurred among an estimated 134,500 infants given a single oral 1 mg vitamin K dose at birth. No cases have been reported so far during the existent regimen: 2 mg at birth and 1 mg weekly orally administered vitamin K during the first 3 months of life, given to at least 163,000 infants. The present study is concordant with the only other study on weekly peroral prophylaxis published. We consider the mentioned weekly regimen safe and appropriate.
PMID: 8922069 [PubMed - indexed for MEDLINE]
The one downside is that the version of vitamin K they give is not exactly what is available in the US. I use either Scientifics Botanicals or Biotics brand. Dosing is 2 mg at birth and 1 mg weekly (like the article).
Weekly oral vitamin K prophylaxis in Denmark.
To evaluate oral vitamin K prophylaxis at birth by giving 2 mg phytomenadione, followed by weekly oral vitamin K prophylaxis; 1 mg was administered by the parents until 3 mo of age.
A total of 507850 live babies were born in Denmark during the study period, November 1992 to June 2000. Of these infants, 78% and 22% received oral and intra-muscular prophylaxis, respectively; i.e. about 396000 neonates received oral prophylaxis at birth. Weekly oral prophylaxis was recommended for all infants as long as they were mainly breastfed. A survey of possible cases of vitamin K deficiency bleeding (VKDB) was carried out by repeated questionnaires to all Danish paediatric departments and by checking the National Patient Register.
No cases of VKDB were revealed, i.e. the incidence was 0-0.9:100000 (95% CI). The questionnaires were used to evaluate compliance with the regimen. Parents of 274 infants participated. A dose of vitamin K was regarded as having been given if the infant received a drop of vitamin K or was mostly formula-fed that week, and the prophylaxis was regarded as completed if the infant had received at least 9 doses. Compliance was good, with 94% of the infants completing the course of prophylaxis.
Weekly oral vitamin K supplementation during the first 3 mo of life was an efficient prophylaxis against VKBD. Parental compliance with the regimen was good.
PMID: 12892158 [PubMed - indexed for MEDLINE]
AND, one last one for good measure...
Vitamin K, an update for the paediatrician.
Van Winckel M, De Bruyne R, Van De Velde S, Van Biervliet S.
Department of Paediatrics, UZ Gent, De Pintelaan 185, 9000 Ghent, Belgium. email@example.com
This review summarizes current knowledge on vitamin K for the paediatrician. Vitamin K is a fat-soluble vitamin, present in plants as phylloquinone and produced by bacteria as menaquinone. It is acting as a co-factor for gamma-glutamyl carboxylase. This enzyme is responsible for post-translational modification of some glutamate side chains to gamma-carboxyglutamate. The majority of gamma-carboxylated proteins function in blood coagulation; others play a role in calcium homeostasis.
Newborn babies are at particular risk of vitamin K deficiency, as placental transfer is limited and human milk is a poor source. Vitamin K prophylaxis at birth effectively prevents vitamin K deficiency bleeding (VKDB), formerly known as "haemorrhagic disease of the newborn". Recent epidemiological studies provide data on the effectiveness of different administration routes and dosing schemes. Infants of mothers taking drugs that inhibit vitamin K are at risk of early VKDB and should receive 1 mg intramuscular (i.m.) as soon as possible after birth. Classic VKDB is prevented by intramuscular as well as by oral administration of 1 mg vitamin K. In exclusively breast-fed infants, single i.m. administration at birth is also effectively preventing (rare) late VKDB but single oral administration is not. If given orally, prophylaxis should be continued by either weekly administration of 1 mg till 12 weeks or repeating 2 mg at weeks 1 and 4. Daily administration of 25 microg offers insufficient protection. The only infants not fully protected in this way are those with yet unrecognised liver disease.
Further work is needed before firm recommendations can be made regarding dose in preterm infants and in patients with fat malabsorption/cholestasis or regarding the role of vitamin K in the prevention of osteoporosis.
PMID: 18982351 [PubMed - indexed for MEDLINE]
New Info: Mercola -
By Dr. Mercola
It has been standard practice in the U.S., and most western countries, since 1944 to welcome babies into the world by subjecting them to a variety of medical interventions, one of which is a painful jab with a syringe full of vitamin K.
This injection is routinely done to almost all newborns, unless you, as a parent, refuse to consent.
Birth is an overwhelming sensory experience for your baby. He has never before experienced cold or hunger, been blinded by artificial lights, or felt the touch of hands or metal instruments, paper or cloth. Even gravity is a foreign sensation.
A needle stick is a terrible assault to their suddenly overloaded sensory system, which is trying to adjust to the outside world.
Is this injection really in your baby’s best interest? Is vitamin K really necessary immediately after birth? Or is there a more compassionate alternative?
Vitamin K Shots are Completely Unnecessary for Your Newborn!
I recently had the pleasure of interviewing the foremost expert in the world on vitamin K, Dr. Cees Vermeer, PhD, Associate Professor of Biochemistry at the University of Maastricht (in The Netherlands), I am thrilled to be able to share with you some of the latest information about vitamin K that he shared with me.
The rest of the interview is scheduled to run later this year but this information was so vital and of public health priority that I had to share it with you now.
The great news: Vitamin K shots are completely unnecessary for your newborn.
While this painful injection is inappropriate for reasons I will cover in detail, vitamin K is necessary. But there are other safer and non invasive ways to normalize your baby’s vitamin K levels that don’t have such damaging effects.
Why is this Shot Given in the First Place?
Vitamin K is necessary for normal blood clotting in adults and children. Some babies (in fact, most of them) are born with insufficient vitamin K levels.
In some newborns, this deficiency can lead to a serious bleeding disorder, typically in the first week of life, called Hemorrhagic Disease of the Newborn (HDN). Internal bleeding occurs in the brain and other organs, leading to serious injury or even death.
While this disease is rare (incidence of 0.25 percent to 1.7 percent[i] ),it is has been standard practice to give injections of vitamin K as a preventative measure, whether or not risk factors are present.
Your newborn can be at increased risk for Hemorrhagic Disease of the Newborn if he or she has any of the following:
•Low birth weight
•A forceps or vacuum extraction delivery
•Mother’s use of antibiotics, anticoagulants, anticonvulsants, and some other medications during pregnancy
•Undetected liver disease
•Extremely fast, or extremely prolonged labor, particularly during the pushing phase
•Delivery by C-section
Unfortunately, the current standard of care regarding Hemorrhagic Disease of the Newborn and vitamin K was put into practice without adequate research to determine what was best for the newborns. These shotgun approaches were certainly convenient for the physicians but lacked any sort of consideration of side effects for the baby.
Increased rates of circumcision immediately after birth, before infants can develop their vitamin K levels naturally, has undoubtedly contributed to making vitamin K injections routine, to lower the risk for increased bleeding from these early circumcisions.
As pointed out by one Mercola reader, it is interesting to note that a newborn’s natural prothrombin levels reach normal levels between days 5 and 7, peaking around the eighth day of life, related to the buildup of bacteria in the baby’s digestive tract to produce the vitamin K that is necessary to form this clotting factor. Day 8 is said to be the only time in a baby’s life when his prothrombin level will naturally exceed 100 percent of normal.
As it turns out, Genesis 17:12 of the Bible mandates the circumcision of infant boys on the eighth day after birth—a recommendation pronounced long before we had the science to back it up.
I will leave any conclusions to you about the significance of this anecdote, but it is nevertheless interesting.
As far as I know, only one state has a law mandating vitamin K injections—New York State, which is notorious for restricting and preventing exemptions to vaccinations and other mandated medical treatments for children.
However, you can find specific instructions about how to get around this, for New Yorkers and residents of other states, at Vaccine Liberation Organization, which has a page specific to New Yorkers who wish to avoid the Hepatitis B shot, vitamin K injections, or the application of silver nitrate into your newborn’s eyes.
The organization urges you to consider the option of hiring legal counsel to assist you in exerting your rights as a parent, due to how challenging it is to get an exemption in New York State.
Fortunately, subsequent research has revealed that there are safer, better practices that will protect your child from Hemorrhagic Disease of the Newborn just as well.
The Dangers of the Shot They Don’t Warn You About
There are three primary areas of risk associated with these injections: 1.Probably the most significant is Inflicting pain immediately after birth likely causing psycho-emotional damage and trauma to a newborn, which is totally inappropriate, and unnecessary. It just creates another emotional wound that the helpless and innocent baby needs to overcome to achieve health and wellness.
It is bad enough they will have to overcome unintentional traumas along the way but to mandate this practice is the 21st century is simply unconscionable.
2.The amount of vitamin K injected into newborns is 20,000 times the needed dose[ii] . Additionally, the injection may also contain preservatives that can be toxic for your baby’s delicate, young immune system.
3.An injection creates an additional opportunity for infection in an environment that contains some of the most dangerous germs, at a time when your baby’s immune system is still immature.
It is, however, also important to correct the record about one myth that has been propagated for years about the dangers of vitamin K injections in newborns.
It was suggested some years ago that vitamin K injections were associated with cancer and leukemia. However, that conclusion was in error. There is NO known association between the two.
As mentioned above, these injections are absolutely inappropriate for your baby -- but the increased risk for cancer is not a legitimate concern.
Although premature clamping of the umbilical should be avoided as it can result in brain damage, there is insufficient evidence to say that this can lead to lower vitamin K levels in newborns, although you will occasionally see this claim made.
Inflicting Pain Just After Birth Has Long-Term Effects on Your Newborn
For more than a century, many physicians have maintained a denial of infant pain, based on ancient prejudices and "scientific evidence" that was long ago disproven. Many have made claims that newborns don’t feel pain, or remember it, the way adults do.
In fact, not only do infants feel pain, but the earlier they experience it, the more damaging and longer lasting are the psychological effects.
Dr. David B. Chamberlain, psychologist and co-founder of the Association of Pre-and Perinatal Psychology and Health, wrote in his article “Babies Don’t Feel Pain: A Century of Denial in Medicine[iii] ”:
"The earlier an infant is subjected to pain, the greater the potential for harm.
Early pains include being born prematurely into a man-made "womb," being born full-term in a man-made delivery room, being subject to any surgery (major or minor), and being circumcised.
We must alert the medical community to the psychological hazards of early pain and call for the removal of all man-made pain surrounding birth.”
Back in 1999, Science Daily published an article[iv] about the findings of a research team at the Washington School of Medicine that newborns who are exposed to a series of painful treatments display a variety of long-term effects as older children, including an altered response to pain and an exaggerated stress response.
A 2004 study[v] found that very early pain or stress experiences have long-lasting adverse consequences for newborns, including changes in the central nervous system and changes in responsiveness of the neuroendocrine and immune systems at maturity.
Similarly, a 2008 study of analgesia in newborns and children[vi] concluded:
“Healthy newborns routinely experience acute pain during blood sampling for metabolic screening, injection of vitamin K or hepatitis vaccine, or circumcision.
Acute pain caused by skin-breaking procedures can lead to physiologic instability and behavioral distress, and it has downstream effects on subsequent pain processing, development and stress responsivity.
Because of these detrimental effects, reduction and prevention of pain are worthy clinical goals that are also expected by most parents.”
In addition to the above, the possible trauma from the injection can also jeopardize the establishment of breastfeeding, which is detrimental to both mother and baby.
ORAL Vitamin K is a Safe, Effective Alternative
Fortunately, the alternative to these outrageously unnecessary newborn injections is amazingly simple: give the vitamin ORALLY. It is safe and equally effective, and devoid of any of the previously mentioned troubling side effects.
Oral vitamin K is absorbed less efficiently than vitamin K that is injected. However, this can easily be compensated for by adjusting the dose. And since vitamin K is nontoxic, there is no danger of overdosing or a bad reaction.
If you are breastfeeding, which I hope you are, your baby can be given several low oral doses of liquid vitamin K1 and receive the same protection from Hemorrhagic Disease of the Newborn as he would receive from an injection.
Ultimately, you should consult your pediatrician about the dose that is appropriate for your baby.
However, midwife Ronnie Falcao uses the guidelines formulated by an international committee of physicians called the Cochrane Collaboration. They have determined the following dosing schedule, which results in very similar rates of protection from HDN[vii] :
•1 milligram liquid vitamin K weekly, OR
•0.25 milligram liquid vitamin K daily
In the future, research is needed to better pinpoint guidelines about the oral vitamin K dosing for newborns. However, remember that there have been no adverse effects observed in adults or babies who receive vitamin K doses much higher than what is actually required. And the dose given orally will be far less than the megadose given by injection!
So for now, there is no danger in overshooting the mark somewhat to make sure your baby is adequately protected until precise dosing guidelines are made available by science.
You can also increase your infant’s vitamin K levels naturally if you are breastfeeding by increasing your own vitamin K levels.
The milk of lactating women has been tested, and most milk is low in vitamin K because the women themselves are vitamin K deficient. If women take vitamin K supplements, then their milk becomes much richer in vitamin K, as you would expect.
According to Dr. Vermeer, mothers who are adequately supplementing themselves with vitamin K and are breastfeeding should NOT need to give their infants additional K supplements.
But you must be cautious here that your vitamin K levels are optimal, and for most women, the vitamin K absorbed from foods is typically insufficient, so a supplement might be needed.
What You Need to do BEFORE Your Baby is Born
Ultimately, the choice about whether or not to consent for your baby to be given a vitamin K shot is yours. At least now you have the information with which you can make an informed decision.
How do you want your baby’s first few moments of life to be?
There are plenty of unavoidable pains that you can’t prevent, no matter how much you might want to shield your child from all pain and suffering. Why not eliminate one source of pain that is absolutely unnecessary and under your control?
If you choose to not expose your child to vitamin K1 as a shot and would prefer to have it given orally, you will have to make it VERY clear to not only your OB physician but also ALL the nursing staff, as they would be the ones that actually administer the shot.
During the excitement of the delivery it will be very difficult to remember that your baby was not supposed to have the shot. So it would also be helpful to have someone like your spouse at the delivery reminding them that your child should NOT get the shot.
Please note, that is the same strategy I would suggest using if you reach the same conclusion I did about hepatitis B vaccines given to newborns. I believe this is clearly the most unnecessary and inappropriate of ALL vaccines and should be avoided like the plague.
But remember you HAVE to be proactive. Typically the nursing staff will NEVER ask for your permission to give this vaccine or vitamin K shot as it is STANDARD practice so they don’t need your permission. So you have to be VERY diligent in your request.
I know because this happened to my nephew, (my sister’s son) and that was the ONLY vaccine either of her children ever received. I am very close to my sister as she started my medical practice with me in 1985 and ran the office for many years. Now she is an editor for this newsletter, and on the executive team for our business.
I never had any children of my own and her kids are very dear to me so it pains me to not have been more diligent in preventing this shot. We are both convinced the vaccine caused some side effects to this day, more than 12 years later.
Please remember, YOU will have to exercise extreme diligence in making your wishes known. The system will fight you tooth and nail as they sincerely believe they know better than you.
It is so worth it though to take the extra steps to protect your newborn. I would strongly encourage you to make the additional effort.
•[i] American Academy of Pediatrics Vitamin K Ad Hoc Task Force, “Controversies concerning vitamin K and the newborn,” Pediatrics. 1993 May;91(5):1001-3
•[ii] “Newborn vitamin K injections,” Giving Birth Naturally •[iii] Chamberlain D. “Babies don’t feel pain: A century of denial in medicine"
•[iv] Science Daily, “Infant pain may have long-term effects,” August 16, 1999
•[v] Giboney Page G. “Are there long-term consequences of pain in newborn or very young infants?” J Perinat Educ. 2004 Summer; 13(3): 10-17
•[vi] Anand KJS. “Analgesia for skin-breaking procedures in newborns and children: What works best?” CMAJ. 2008 July 1;179(1):11-12 •[vii] Falcao R. “Vitamin K injection or oral administration”
What about it getting hot?
I contacted corporate on your behalf to get an answer to your question regarding the vitamin k. The answer I received in so few words is that vitamin k is extremely stable and thus you should not worry about heat degradation. In some rare cases the emulsion can break down, however this is accomplished with temperatures far higher than what we have been experiencing. If the emulsion has broken down you will experience a water like discharge when you try to pour out the contents of the bottle. If you are wondering what this looks like image you are pouring out a bottle of ketchup, the water that comes out before the rest of the sauce catches up is what the bio-k- mulsion will look like when the emulsion has broken down. If your bottle isn’t pouring out that watery discharge your good to go!