SUMMARY OF PRODUCT CHARACTERISTICS NAME OF THE MEDICINAL PRODUCT
ELEVIT PRONATAL Film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Vitamin A (Retinol) in form of Vitamin A concentrate (powder form), synthetic: Dry Vitamin A palmitate 250 CWS Vitamin B1 (Thiamine nitrate) corresponding to 1.6 mg Thiamine hydrochloride Vitamin B2 (Riboflavine)
Vitamin B6 (Pyridoxine hydrochloride) in form of Rocoat pyridoxine hydrochloride 33 1/3% Vitamin B12 (Cyanocobalamin) in form of powder 0.1% water-soluble : Vitamin B12 0.1% WS Vitamin C (Ascorbic acid) in form of Calcium ascorbate dihydrate Vitamin D3 (Cholecalciferol) in form of Cholecalciferol concentrate (water-dispersible powder form) Dry Vitamin D3 type 100 CWS Vitamin E (DL-α-Tocopherol acetate) in form of DL-α-Tocopherol acetate concentrate (powder form): Calcium pantothenate
Nicotinamide
Folic acid in form of 133.10 mg calcium ascorbate dihydrate in form of 10.50 mg calcium pantothenate in form of 378.89 mg calcium hydrogen phosphate (anhydrous) in form of 183.00 mg ferrous fumarate
Magnesium in form of 114.42 mg light magnesium oxide in form of 217.95 mg magnesium hydrogen phosphate trihydrate in form of 15.00 mg magnesium stearate Manganese in form of 2.52 mg manganese sulfate (monohydrate) brought by 183.00 mg ferrous fumarate in form of 2.51 mg copper sulfate (anhydrous) Phosphorus in form of 378.89 mg calcium hydrogen phosphate (anhydrous) in form of 217.95 mg magnesium hydrogen phosphate trihydrate in form of 20.60 mg zinc sulfate (monohydrate) 1) corresponding to 1080.0 µg of retinol 2) corresponding to 12.5 µg of cholecalciferol 3) corresponding to 15.0 mg of DL-α-tocopherol acetate
Excipient(s): One ELEVIT PRONATAL tablet contains lactose (45,78mg) and mannitol (58.90mg), see section 4.4. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM
Film coated tablets Yellow, biconvex, oblong film coated tablets, with a score line. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal dose. 4. CLINICAL PARTICULARS Therapeutic indications
Prevention or correction of disorders due to a vitamin or mineral imbalance or deficiency diet in preparation for pregnancy and during pregnancy and lactation. 4.2 Posology and method of administration
One tablet daily to be taken as a whole with a glass of water (0.25l) preferably with a meal. In case of morning sickness, it is recommended that the tablet is taken at noon or in the evening The recommended period of administration is one month before conception (or when planning a pregnancy), throughout pregnancy and lactation. 4.3 Contraindications
Hypersensitivity to any of the ingredients Existing hypervitaminosis A and/or D
Contraindication if patient is undergoing treatment with vitamin A or treatment with the synthetic isomers isotretinoin and etretinate. Beta-carotene is considered as a source of vitamin A supplementation Severe impaired renal function Iron accumulation Hypercalcemia Severe hypercalciuria Iron and/or copper metabolism disorders 4.4 Special warnings and precautions for use
The recommended dosage should not be exceeded. Very high doses of some ingredients, in particular Vitamin A, Vitamin D, iron and copper, can be harmful to health Patients receiving other single vitamins or multivitamin preparations, any other medication or those under medical care should consult a health care professional before taking this product This preparation must be taken with particular caution together with any other products, including supplements and/or fortified foods/drinks containing Vitamin A, the synthetic isomers isotretinoin and etretinate, or beta-carotene, since large doses of the latter mentioned compounds are considered harmful to the foetus and may cause hypervitaminosis A. This preparation must be taken with particular caution together with other products, including supplements and/or fortified foods/drinks containing Vitamin D, since large daily doses may cause hypervitaminosis D High doses of iron may be noxious. Folic acid, Vitamin B12 and iron may mask certain forms of anemia. This preparation does not contain iodine. Adequate iodine supplementation should be provided. This medicinal product contains lactose (45,78mg/tablet) and mannitol (58.90mg/tablet) as excipients. Patients with rare heredity problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine. Mannitol may have a mild laxative effect. 4.5 Interaction with other medicinal products and other forms of interaction
Concurrent administration of antacids with oral iron preparations may decrease iron absorption. An interval of three hours should be allowed between the administration of antacids and oral iron preparations. Oral administration of iron preparations inhibits absorption of tetracyclines from the gastrointestinal tract and vice versa, leading to decreased serum concentrations of both the antibiotic and iron. If simultaneous administration of the drugs is necessary, patients should receive the tetracycline 2 hours after or 2 hours before oral iron administration.
Interactions with the following other medicinal products were observed: Levodopa, bisphosphonates, fluoroquinolones, penicillamine, thyroxine, digitalis and thiazide diuretics. 4.6 Pregnancy and lactation
Elevit Pronatal is indicated during pregnancy and lactation, however the recommended dosage should not be exceeded (see section 4.4.). As for every medicinal product, please consult your doctor.
Vitamin A doses of more than 10 000 IU per day have been found to be teratogenic if administered during the first trimester of pregnancy. Thus, this preparation must be taken with particular caution together with other drugs containing vitamin A, the synthetic isomers isotretinoin and etretinate, or beta-carotene, since large doses of the latter mentioned compounds are considered harmful to the
fetus. Chronic overdose of vitamin D might be harmful to the fetus. For pregnant women, the Institute of Medicine (USA) has set the Tolerable Upper Intake Levels (UL) of vitamin D of 50 µg (2000IU) per day, which is considered as safe. Elevit Pronatal contains 500IU/tablet (12.5 µg/tablet). Lactation
Permanent overdose of vitamin D might be harmful to the neonate. Vitamin D and calcium are excreted into breast milk. This must be taken into consideration if the infant is receiving any respective supplements. For lactating women the Institute of Medicine (USA) has set the Tolerable Upper Intake Levels (UL) of vitamin D of 50 µg (2000IU) per day, which is considered as safe. Elevit Pronatal contains 500IU/tablet (12.5 µg/tablet). 4.7 Effects on ability to drive and use machines
Elevit Pronatal has no influence on the ability to drive and use machines. 4.8 Undesirable effects In general, this product is well-tolerated. However, in common cases gastrointestinal symptoms (e.g. constipation, diarrhoea and nausea) may occur, but these generally do not necessitate withdrawal of therapy. In very rare cases (<1/10,000) hypersensitivity reactions including exanthema, asthma, angioderma and urticaria have been reported. A slight yellow discoloration of urine may be noticed. This effect is harmless and is due to the Vitamin B2 contained in the preparation Elevit Pronatal contains iron, which may lead to a black colouring of the stool. This does not have any clinical relevance. 4.9 Overdose There is no evidence that this product can lead to an overdose when used as recommended (see also 4.4). Most, if not all reports concerning overdoses are associated with concomitant intake of high dosed single and/or multivitamin preparations. Acute or long-term overdose can cause hypervitaminosis A and D and hypercalcaemia as well as iron and copper toxicity. Uncharacteristic initial symptoms, such as abrupt onset of headache, confusion, and gastrointestinal disturbances such as constipation, diarrhoea, nausea, and vomiting might be indicative for an acute overdose. If such symptoms occur, treatment must be stopped and a health care professional consulted.
Excessive intake of Vitamin A causes fatigue, irritability, anorexia, gastrointestinal disturbances, skin and hair changes (e.g. erythema and pruritus).
Overdose of Vitamin D leads to hypercalcemia, which shows the following symptoms: Nausea, vomiting, thirst, polydipsia, polyuria and constipation.
High doses of iron cause gastrointestinal irritation and abdominal pain with nausea and vomiting. Other gastrointestinal effects may include constipation and diarrhea.
If symptoms of overdose occur the use of the product must be stopped.
PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Multivitamins and minerals / trace elements, ATC code: A 11A A03
Elevit Pronatal is a multivitamin/multimineral preparation containing 12 vitamins in combination with 3 minerals and 4 trace elements especially designed to ensure an adequate micronutrient supply for both the unborn child and the mother-to-be.
Vitamins are essential nutrients. They are indispensable for the normal development and growth of the foetus and the infant, for the metabolism and formation of carbohydrates, energy, lipids, nucleic acids and proteins, as well as for the synthesis of amino acids, collagen and neurotransmitters.
Multivitamins/multimineral preparations are indicated to prevent and correct nutritional micronutrient deficiencies. Pregnancy and lactation represent periods with increased micronutrient requirements and, as a consequence, increased risks of micronutrient deficiencies for both the mother and the child. Especially during pregnancy, micronutrient deficiencies exhibit a more serious health risk, as they may also impair the normal development of the unborn child. Supplementation with folic acid or folic acid containing multivitamins is recommended to prevent congenital malformations including neural tube defects. Neural tube defects develop in the first weeks after conception, a period during which pregnancy may not have been diagnosed yet, thus supplementation with folic acid is essential at the stage when pregnancy is being planned. 5.2 Pharmacokinetic properties
Human health and well-being is naturally dependent on the continuous uptake and management of vitamins and minerals and their absorption, distribution, metabolism and elimination are maintained by specific physiological mechanisms. The active ingredients of Elevit Pronatal, vitamins, minerals, and trace elements, are essential micronutrients, which are widely distributed in the human body. The discrimination between the physiological nutrient concentration in the plasma and its changes after additional intake of corresponding pharmaceutical preparations is, on the one hand, difficult to assess and conveys, on the other hand, little or no information on the biological activity of the individual nutrient in the target tissue. The plasma and tissue levels of micronutrients are homeostatically regulated and affected by various factors such as diurnal fluctuations, nutritional status, growth, and pregnancy and lactation. No pharmacokinetic data are available on the active ingredients of Elevit Pronatal, but the pharmacokinetic properties of the individual components have been extensively documented. 5.3 Preclinical safety data
The active ingredients of Elevit Pronatal, vitamins, minerals, and trace elements, are essential nutrients, which are considered as safe when given at the recommended doses. No teratogenesis studies have been conducted with Elevit Pronatal in animals. 6. PHARMACEUTICAL PARTICULARS List of excipients
Do not store above 25°C. Store in the original package. 6.5 Nature and contents of container
PVC/PE/PVDC Alu blisters, with 30 and 100 tablets Not all pack sizes may be marketed. 6.6 Special precautions for disposal and other handling MARKETING AUTHORISATION HOLDER
To be completed nationally Name and address tel fax e-mail 8. MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION To be completed nationally 10. DATE OF REVISION OF THE TEXT
PRE-OPERATIVE INSTRUCTIONS FOR IMPLANT, SINUS AUGMENTATION AND EXTRACTION SURGERY • Please plan ahead: make sure you have all the prescription medications that you will need before and after the surgery. Make ice packs, prepare soft foods, and wear comfortable • Please do not take any aspirin, vitamin E or Ginkgo Biloba 7-10 days prior to surgery. If you need a pain medication, use
04_article Stoffels 18.10.2004 8:58 Page 515 IRRC September 2004 Legal regulation of humanitarian assistance inContradictory images of humanitarian assistance in armed conflictpaint a confusing picture. There are now a great many public and privatehumanitarian organizations operating all over the world. The work that theydo is seen to help save lives and alleviate the suffering of those not