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In dieser Rubrik beantworten wir Fragen, die uns zu den SANUM-Arzneimitteln und deren Verordnung gestellt werden.

» Questions concerning products
What is the source of Chrysocor?

Chrysocor is an extract from placenta. The placenta tissue was obtained from healthy women – with their permit - during accouchement in hospital. The extracts then were manufactured by a GMP certified contracted pharmaceutical company. The relevant quality control analyses were performed under control of a physician. The corresponding tests are suitable to detect potential pathogens. Despite any external tests, additional analytical tests are performed in house to guarantee the quality of the product.

Do the droppers used for SANUM preparations contain plastic softeners (Phthalates) or latex?

The blue droppers we use naturally do not consist of plastics supplemented with softeners such as Phthalates and Bisphenol A (BPA), but of a synthetic suitable for use in drugs. Furthermore the following substances can be excluded, which are listed in the “Federal Register / Vol. 73, 200, October 15, 2008, FDA”:

- Polycarbonate
- Polyether sulfone
- Polycarbonate/siloxane co-polymer
- Biostable polyurethanes
- Epoxy resin
- BisphenolA diglycidylethermethacrylate (BIS-GMA)
- Bisphenol A diglycidylether (BADGE)
- Bisphenol A dimethacrylate (BISDMA)
- Ethoxylated bisphenol A diacrylate

As remedy manufacturer, we are not permitted to use any dropper but only material which complies with the chemical requirements in the corresponding monograph 3.2.9 for “rubber closures” Type 1 in the valid version of the European Pharmacopoeia. Furthermore, our droppers comply with the monograph [381] of the current US Pharmacopoeia. Through the registration process of our remedies, the droppers, too, are examined and released by the German Federal Institute for Drugs and Medical Devices (BfArM). The consistent quality of the materials used is secured through the continuous monitoring of our suppliers.

We would like to point out further that our droppers do not contain latex, as they are not manufactured from natural rubber.

Does the product Citrokehl contain natural citric acid?

Citric acid is produced by a submerged fermentation process which employs a strain of the micro-organism Aspergillus niger to convert sugar into citric acid. The substrate (carbohydrates like sugar or glucose syrup and certain inorganic nutrients) is sterilized and inoculated with Aspergillus niger for fermentation. The fungus produces citric acid by metabolization of the substrate in a self contained tank (fermentation). The fungus releases the citric acid into the tank. After the fermentation the biomass and the citric acid are separated. The separation can be effected in two different ways.

Process A) The citric acid is recovered from the remaining broth by an adsorption process. The resulting citric acid solution is purified by ion exchange and carbon treatment. Finally the citric acid solution is evaporated, and citric acid is crystallized, dried, sieved and packaged.

Process B) The dissolved citric acid is separated from residual sugars, proteins and other soluble impurities by addition of lime. The resulting calcium citrate precipitate is separated and washed free of soluble impurities. The calcium citrate then is acidified with sulphuric acid resulting in citric acid solution and calcium sulphate (gypsum). After the separation of gypsum the citric acid solution is purified by ion exchange and carbon treatment. Finally the citric acid solution is evaporated, and citric acid is crystallized, dried, sieved and packaged.

The borderline from natural source to synthetic is fluid. However, based on the above stated manufacturing process, it can be stated that the citric acid used for Citrokehl originates from natural sources.

What are the capsule shells of the SANUM products made of?
With the exception of the preparation Lipiscor, the capsule shells of our products are exclusively made of hypromellose (HPMC).

What are the inactive ingredients contained in the SANUM suppositories?
The inactive ingredients of our suppositories are lactose monohydrate and hard fat.

Are there any substances or traces of soy(lecithin) in SANUM suppositories? What kind of fat exactly is the hard fat indicated in “other constituents”?
The suppository base is manufactured by esterification of herbal glycerine (derived from coconut oil respectively palm kernel oil) and herbal fatty acids having chain lengths of C12 to C18 (also from coconut oil respectively palm kernel oil). This suppository base is a 100 % ester from above raw materials. It does not contain any traces of soy.

Can I prescribe NOTAKEHL to patients allergic to penicillin?
Yes, with the following remark: Penicillin is a secondary metabolic product of Penicillium chrysogenum (notatum), discovered by A. Flemming. NOTAKEHL, by contrast, contains apathogenic forms of Penicillium chrysogenum as an active ingredient, and not the metabolic product penicillin. Therefore, an allergic reaction is not to be expected. In order to eliminate the patients’ fears and, at the same time, to avoid excretion reactions due to overdosage, we recommend to prescribe one drop per embrocation into the cubital fossa initially. During the subsequent course of treatment, the drop count is slowly increased.

How long can drops be kept for after opening?

The stability of the preparations after opening depends on the kind of solvent used, e.g. alcohol or purified water.

Isopathics such as FORTAKEHL, NOTAKEHL, etc. are manufactured on an aqueous basis and can be used for 8 weeks at most after opening, if properly handled. Preparations manufactured with alcohol can be used until the last day of the expiry date imprinted on the package.

The package leaflet of the preparation in question contains information on this matter in the sections warnings as well as notes and data on the stability of the medicine.

Mucokehl, Nigersan and Notakehl injections are available in the potencies of 5X, 6X, and 7X. What do you recommend regarding their application?
First of all, the active substance is the same in the different potencies of each preparation.

In homeopathy, the first step is always choosing the correct preparation for a patient. As a golden rule one might say that the potencies of 5X and 6X are used the most often. 7X would be recommended for very sensitive patients. Some practitioners start with a 7X and then slowly increase to 6X and finally, 5X. In this case, the difference between die provided potencies is not very significant.

Of course, one might also determine the best potency for a patient by testing.

Are the SANUM preparations gluten-free?
Yes, they are.

What do the shells of LIPISCOR capsules consist of?
LIPISCOR capsules have a gelatin shell. The actual gelatin originates derives from cattle and complies with the European Directives on the absence of BSE.

Do the preparations contain lactose (fructose)?
Only the application forms of tablets, capsules, and suppositories contain lactose. The preparations are manufactured without fructose and according to the regulations of the German Homeopathic Pharmacopoeia. Prescribing suppositories in cases of lactose intolerance is harmless, since absorption happens via the mucous membrane of the rectum.

What are the sources of the alcohol used in your products?

The alcohol used in several SANUM products is gained from the following raw materials:

- Rye
- Wheat
- Oat
- Corn
- Potatoes
- Fruits

Due to the distillation process, the alcohol is gluten free and thus suitable for patients with a gluten allergy.

Can you freeze SANUM products?

The active ingredients are not harmed if they are frozen. Since the substances are protein structures, the frozen condition even preserves them. Nevertheless, capsules and tablets should not be frozen, as with every thawing process water from the surrounding air moisture condensates around the product or, in the case of capsules, even inside of the capsule shell. This increases the risk of a microbiological contamination.
In the case of drops and ampoules there is more of a risk of glass breakage. The containers have not been developed for freezing. Therefore freezing may cause tensions in the glass, which could even burst the container.
Ointment tubes are also not suitable for freezing.

Conclusion: One-time freezing surely does not pose a problem. In the case of repeated freezing and thawing however, we cannot guarantee the quality of the products, especially that of tablets and capsules.

Are the components of your liquid dilutions rubbed in lactose prior to potentization or is manufacturing done entirely without lactose?
The dilution of drops is done exclusively with purified water. The homeopathic base substance is extracted from the biomass of the respective microorganism. After purification and processing we obtain a powder, which in the case of drops, is diluted directly with purified water in the first potency. Further potentization is done with purified water up to the final dilution. All productions steps are conducted in accordance with the regulations of the German Homeopathic Pharmacopoeia.

I have opened a bottle of Sanuvis about 6 months ago and did not refrigerate it. Can I still use the product?
The taking of Sanuvis from a bottle which has been opened for 6 months does not pose any problem, since a microbial contamination can be virtually ruled out, due to the relatively high content of alcohol.

Is the product ALKALA N powder also suitable for vegans?
ALKALA N is a powder, which consists of sodium bicarbonate, sodium citrate and potassium bicarbonate. It does not contain any excipients or other additives. Since it is a pure salt mixture, it is also suitable for consumption by vegans.

Is there a risk of contracting BSE with the intake of Thymokehl (not registered in Germany)?
The raw materials used for Thymokehl are derived from animal products that are in accordance with the provisions and requirements for animal health, which have been mutually approved pursuant to the resolution 97/132/EG of the board and the provisions of the European Union, and particularly with the law concerning animal products (Animal Product Act) of 1999.

Exclusively materials that originate from animals which were born, continuously reared and slaughtered in a country that is classified as a country with a negligible BSE risk by a ruling pursuant to article 5(2) are used.

Are the SANUM ointments vegan?
The ointment base is wool wax (Adeps lanae) which is obtained from sheep’s wool. For this the raw wool is washed with an alkaline solution and subsequently the obtained wax is separated. This constitutes the base for our ointments which are manufactured and controlled strictly in accordance with homeopathic processes.

Are the Sanum products GMO-free?
We confirm that our products are not derived from genetically modified organisms nor do they contain any genetically modified ingredients.

Can a patient who is lactose intolerant take capsules and tablets containing lactose?
Our capsules and tablets which contain lactose may be taken by patients with a known intolerance to certain sugars after consulting their doctor.

Some of our products carry the information that the intake of tablets and capsules is not suitable for patients who are galactose intolerant, have a genetic lactase deficiency or a glucose-galactose malabsorption.
This information is based on older BfArM (Federal Institute for Drugs and Medical Devices) requirements.

The current information for our capsules and tablets which contain lactose is: “This product contains lactose. Therefore, only take \product name\ after consulting with your doctor, if you have a known intolerance to certain sugars.”

Our product information is being adjusted successively so that unfortunately not all products carry the current information yet.

Is Vitamin B12 SANUM suitable for vegans and vegetarians?
Materials used in the manufacturing process of Vitamin B12 SANUM are not of animal origin and therefore suitable for vegan and vegetarian diet.

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