soluvit Uses, Dosage, Side Effects, Precautions & Warnings
SOLUVIT, lyophilisate for parenteral use, box of 10 vials (glass) of 1 >>> Generic Medication Therapeutic Class: Anesthesia, resuscitation, analgesic
active ingredients: Thiamine , Riboflavin (E101) , nicotinamide , pyridoxine , sodium pantothenate , sodium ascorbate (E301) , Biotin , Folic Acid , Cyanocobalamin
Table of Contents
what is soluvit ?
It is a water-soluble vitamin supplementation
what is soluvit medication used for and indication?
Supplementation with water-soluble vitamins to cover the daily needs of adults and children in parenteral nutrition.
PRESENTATION (S) AVAILABLE FOR SOLUVIT
2 presentations are available for this medication:
- 1 glass bottle (s)
- 10 glass bottle (s)
FEATURE | DESCRIPTION |
Pharmaceutical class | blood derivatives and various infusions |
Active substance (s) | for a lyophilisate: biotin (0.060 mg), riboflavin (sodium phosphate) dihydrate (4.9 mg), folic (acid) (0.4 mg), sodium (ascorbate) (113 mg), cyanocobalamin (0.005 mg) , nicotinamide (40 mg), pyridoxine (hydrochloride) (4.9 mg), thiamine mononitrate (3.1 mg), pantothenate-sodium (16.5 mg) |
General medicine | no |
Pharmaceutical form | lyophilisate for parenteral use |
Route (s) of administration | intravenous |
Social security reimbursement rate | 65% |
Laboratory (s) | FRESENIUS KABI FRANCE |
Conditions of issue | restricted prescription drug |
soluvit Dosage
- In adults and children weighing 10 kg and over, the recommended dosage corresponds to the vitamin intake from one reconstituted vial per 24 hours.
- In children weighing less than 10 kg, the recommended dosage corresponds to the vitamin intake of one milliliter from a reconstituted vial per kilogram of weight and per 24 hours.
COMPLY WITH THE MEDICAL ADVICE
soluvit Contraindications
Never use SOLUVIT, lyophilisate for parenteral use in the following situations:
- in the event of known hypersensitivity to any of the components, in particular do not inject into subjects who have shown signs of intolerance to thiamine (vitamin B1) and to methyl parahydroxybenzoate;
- in combination with drugs based on levodopa.
How To Take soluvit ?
Method and route of administration
- Strict intravenous use.
- SOLUVIT, lyophilisate for parenteral use must be reconstituted before use.
- Reconstitution is accomplished by the addition, under aseptic conditions, of an injectable lipid solution or emulsion for intravenous infusion.
- The reconstituted lyophilisate should never be injected directly into the vein, but should always be added to a solution or an emulsion for intravenous infusion, the compatibility of which with the reconstituted lyophilisate SOLUVIT has been determined beforehand.
COMPLY WITH THE MEDICAL ADVICE
Frequency of administration
COMPLY WITH THE MEDICAL ADVICE
Duration of the treatment
COMPLY WITH THE MEDICAL ADVICE
how does soluvit work?
Pharmacotherapeutic group: ADDITIVES FOR INTRAVENOUS SOLUTIONS / VITAMINS, ATC code: B05XC
(B: Blood and hematopoietic organs)
SOLUVIT is a balanced combination of water-soluble vitamins covering the daily needs during parenteral nutrition. SOLUVIT does not contain fat-soluble vitamins, which are nevertheless essential in the case of exclusive parenteral nutrition.
The pharmacodynamic properties of SOLUVIT are those of each of the 9 water-soluble vitamins included in its composition. The main properties are as follows:
- Vitamin B1 (thiamine): in association with ATP, formation of a coenzyme involved in the metabolism of carbohydrates.
- Vitamin B2 (riboflavin): coenzyme action in cellular energy metabolism, tissue respiration systems and macro-nutrient metabolism.
- Vitamin B3 (PP): component of NAD and NADP coenzymes involved in oxidation-reduction reactions essential for the metabolism of macro-nutrients and tissue respiration.
- Vitamin B5 (pantothenic acid): precursor of coenzyme A involved in the oxidative metabolism of carbohydrates, gluconeogenesis and synthesis of fatty acids, sterols, steroid hormones and porphyrins.
- Vitamin B6 (pyridoxine): coenzyme in the metabolism of proteins, carbohydrates and fats.
- Vitamin B12: exogenous source necessary for the synthesis of nucleoproteins and myelin, cell reproduction, growth and maintenance of normal erythropoiesis.
- Vitamin C: antioxidant properties, essential for the formation and maintenance of intercellular substance and collagen biosynthesis of catecholamines, the synthesis of carnitine and steroids, metabolism of folic acid and tyrosine.
- Folic acid: exogenous source necessary for the synthesis of nucleoproteins and the maintenance of normal erythropoiesis.
- Biotin: linked to at least four enzymes, is involved in energy metabolism including gluconeogenesis.
How To Store soluvit ?
- Keep this medication out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the vial after EXP. The expiration date refers to the last day of that month.
- Store at a temperature not exceeding + 25 ° C and store the vial in the outer carton, in order to protect from light.
- Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.
soluvit Side Effects
Like all medicines, SOLUVIT, lyophilisate for parenteral use can cause side effects, although not everybody gets them.
- Taking into account the presence of vitamin B1 (thiamine), it is possible to observe anaphylactic reactions in subjects presenting an allergic ground.
- If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.
- Keep out of the reach and sight of children.
soluvit Interactions
Combinations subject to precautions for use
(Related to the presence of sodium ascorbate)
DEFEROXAMINE
- Increased risk of iron-induced heart failure due to increased iron mobilization by supraphysiological vitamin C supplementation.
- In case of hemochromatosis, give vitamin C only after starting treatment with deferoxamine. Monitor cardiac function in combination. For specific precautions, refer to the Summary of Product Characteristics for deferoxamine.
(Related to the presence of folic acid)
PHENOBARBITAL, PHENYTOIN, PRIMIDONE, FOSPHENYTOIN
- Decrease in plasma concentrations of enzyme-inducing anticonvulsants by increasing their hepatic metabolism, folate of which is one of the cofactors in the enzymatic reactions concerned, which increases the risk of convulsions.
- Clinical monitoring, monitoring of plasma levels of phenobarbital, phenytoin, primidone or fosphenytoin. Adjustment, if necessary, of the antiepileptic dosage during folic supplementation and after its discontinuation.
Associations to take into account
(Related to the presence of pyridoxine)
ETHIONAMIDE
PYRIDOXINE ANTAGONISTS (including cycloserine, hydralazine, isoniazid, penicillamine, phenelzine)
- May cause pyridoxine deficiency.
(Related to the presence of folic acid)
FLUOROPYRIMIDINES (5-fluorouracil, capecitabine, tegafur)
- Increased cytotoxicity of fluoropyrimidines when combined with folic acid.
FOLATE ANTAGONISTS (e.g., methotrexate, sulfasalazine, pyrimethamine, triamterene, trimethoprim) AND HIGH DOSES OF TEA CATECHINS:
- Blocking the conversion of folate to their active metabolites and reducing the effectiveness of supplementation.
Interactions with other vitamin and / or mineral supplements
- Some drugs can interact with certain vitamins and / or minerals at doses significantly higher than those provided by SOLUVIT, lyophilisate for parenteral use. This should be taken into account in patients receiving vitamins and / or minerals from more than one source; where appropriate, patients should be monitored for these interactions and managed appropriately.
Other forms of interactions
- Depending on the reagents used, the presence of ascorbic acid in blood and urine may interfere with the results of some blood and urine glucose monitoring systems, including test strips and portable glucose monitors . precautions for use).
- This medicinal product must not be mixed with other medicinal products except those mentioned in the section Posology and method of administration.
Effects on ability to Drive and use machines
- Not applicable.
- Not applicable.
- Not applicable.
- Not applicable.
Warnings and Precautions
- SOLUVIT, lyophilisate for parenteral use, does not contain any fat-soluble vitamin which is nevertheless essential in the event of exclusive parenteral nutrition.
- SOLUVIT, containing folic acid, may delay the diagnosis of Biermer’s anemia.
- SOLUVIT, lyophilisate for parenteral use must be reconstituted before use.
- The reconstituted product must not be injected directly into the vein but always added to a solution or an emulsion for infusion compatible with SOLUVIT: see.
- Check before use that the bottle is free from cracks or splinters.
- Do not keep a partially used vial.
PREGNANCY & BREAST-FEEDING & FERTILITY
Pregnancy
- Studies in animals have not shown any teratogenic effect of the vitamins that make up SOLUVIT. In the absence of a teratogenic effect in animals, a malformative effect in humans is not expected. Indeed, to date, the substances responsible for malformations in the human species have been shown to be teratogenic in animals during well-conducted studies on two species.
- In humans, there are no relevant clinical data from the use of SOLUVIT during pregnancy.
- Therefore, SOLUVIT should only be administered to pregnant women if clearly needed.
Feeding with milk
- The administration of SOLUVIT is not recommended in case of breast-feeding because of a risk of vitamin overdose in the newborn.
What happens if I overdose from soluvit ?
An overdose of water-soluble vitamins for parenteral use is not expected. No adverse effects related to overdose have been reported to date.
What should I do if I miss a dose?
COMPLY WITH LAVIS MEDICAL
What happens if you stop taking soluvit ?
- Not applicable.
- Not applicable.
- Not applicable.
- Not applicable.
- Not applicable.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse for more information.
What is Forms and Composition ?
SHAPES and PRESENTATIONS
- Lyophilisate for parenteral use: Bottles, box of 10.
COMPOSITION
p bottle | |
Thiamine (vitamin B1) | 2.5 mg |
(as mononitrate: 3.1 mg / vial) | |
Riboflavin (vitamin B2) | 3.6 mg |
(as sodium phosphate: 4.9 mg / vial) | |
Nicotinamide (vitamin PP or B3) | 40 mg |
Pyridoxine (vitamin B6) | 4 mg |
(as hydrochloride: 4.9 mg / vial) | |
Sodium pantothenate (vitamin B5) | 16.5 mg |
(as pantothenic acid: 15 mg / vial) | |
Ascorbic acid | 100 mg |
(as sodium ascorbate: 113 mg / vial) | |
Biotin | 0.06 mg |
Folic acid (vitamin B9) | 0.4 mg |
Cyanocobalamin (vitamin B12) | 0.005 mg |
- Excipients: glycocoll, sodium edetate. Preservative: methyl parahydroxybenzoate (E218).
- Excipient with known effect: methyl parahydroxybenzoate (E218).
NOT’s
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general information:
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Additional information:
- General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
Special warnings:
- For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
Side effects:
- It treats possible side effects and drug interactions that require attention and its effect on continuous use.
- The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.