PregOmega Plus References and Regulatory

From Downloadable Resource: Growing your baby

  1. Role of micronutrients in the periconceptional period, Human Reproductive Update, 2010, 16(1);80-95, http://humupd.oxfordjournals.org/content/16/1/80.short.
  2. American Pregnancy Association (APA). Preconception Nutrition. [Internet] 19 Nov 2015. Available from: http://americanpregnancy.org/getting-pregnant/preconception-nutrition/.
  3. WHO Guideline: Daily iron and folic acid supplementation in pregnant women, Geneva: World Health Organization, 2012.
  4. Bhutta ZA and Hasan B. Periconception supplementation with folate and/or multivitamins for preventing neural tube defects: RHL commentary [last revised: 7 January 2002]. The WHO Reproductive Health Library; Geneva: World Health Organization.
  5. Merck Manual Professional Version. Spina Bifida; 2015 [updated 2014 Dec]. Available from: http://www.merckmanuals.com/professional/pediatrics/congenital-neurologic-anomalies/spina-bifida.
  6. Janakiraman, V. et al, Calcium supplements and bone resorption in pregnancy: a randomized crossover trial, Am J Prev Med., 2003, 24(3): 260.
  7. Thomas, M. et al, Calcium supplementation during pregnancy and lactation: effects on the mother and the fetus, Am J Obstet Gynecol., 2006, 194(4): 937-45.
  8. Ladipo, O. A., Nutrition in pregnancy: mineral and vitamin supplements, Am J Clin Nutr., 2000, 72(1): 280S-290S.
  9. Opperman, M., What health professionals should know about omega-3 fatty acid supplements, S Afr J Clin Nutr., 2013, 26(2):56-61.
  10. Hadders-Algra, M., Prenatal and early postnatal supplementation with long-chain polyunsaturated fatty acids: neurodevelopmental considerations, Am J Clin. Nutr., 2011, 94(6): 1874S-1879S.
  11. Duley, L. Pre-eclampsia and the hypertensive disorders of pregnancy, British Medical Bulletin. 2003; 67(1).
  12. Dahle, L. et al, The effect of oral magnesium substitution on pregnancy-induced leg cramps, American Journal of Obstetrics and Gynaecology 1995.
  13. Natural Medicines Comprehensive Database. Vitamin B6 [Internet]. USA: Therapeutic Research Faculty; 2015 [updated 2015 05 Feb]. Available from: http://naturaldatabase.therapeuticresearch.com/nd/Search.aspx?rn=1&cs=&s=ND&pt=100&id=934&ds=&name=Vitamin+B6+(PYRIDOXINE+(VITAMIN+B6))&searchid=50240297.
  14. Natural Medicines Comprehensive Database. Iron [Internet]. USA: Therapeutic Research Faculty; 2015 [updated 2015 05 Feb]. Available from: http://naturaldatabase.therapeuticresearch.com/nd/Search.aspx?m=18cs=&s=ND&pt=100&id=912&ds=&name=IRON&searchid=50240297.
  15. Natural Medicines Comprehensive Database. Calcium [Internet]. USA: Therapeutic Research Faculty; 2015 [updated 2015 05 Feb]. Available from: http://naturaldatabase.therapeuticresearch.com/nd/Search.aspx?m=18cs=&s=ND&pt=100&id=781&ds=&name=CALCIUM&searchid=50240297.
  16. Greenburg, J.A. et al., Omega-3 Fatty Acid Supplementation During Pregnancy. Rev Obstat Gynecol. 2008 Fall; 1(4): 162-169.
  17. Saldeen, P. et al., Women and Omega-3 Fatty acids. Obstetrical & Gynecological survey. OvidSP. October 2014; 50(10): 722-730.
  18. Mason P. Dietary Supplements 4th ed fish oils. London: The Pharmaceutical Press; 2012.
  19. American Pregnancy Association (APA). Nutrients & Vitamins For Pregnancy. Available from: http://americanpregnancy.org/pregnancy-health/nutrients-vitamins-pregnancy.

Proprietary name (and dosage form): PregOmega® Plus Tablets and Soft Gel Capsules. Composition: Each fish oil soft gel capsule contains: 822 mg Pharmaceutical Grade Fish Oil (derived from tuna and deep marine fish oil) providing: 260 mg DHA, 91 mg EPA. Each calcium tablet contains: 500 mg calcium, 400 IU vitamin D3 and 125 mg magnesium. Each vitamin & mineral tablet contains: 2 666 IU Vitamin A, 3 mg Vitamin B1, 2 mg Vitamin B2, 10 mg Vitamin B3, 1 mg Vitamin B6, 2 µg Vitamin B12, 50 mg Vitamin C, 100 IU Vitamin D3, 230 mg Calcium, 0,15 mg Copper (AAC), 500 µg Folic Acid, 15 mg Iron (AAC), 0,5 mg Magnesium, 0,05 mg Manganese (AAC), 0,025 mg Molybdenum (AAC), 0,84 mg Potassium, 0,085 mg Zinc. Name and business address: iNova Pharmaceuticals (Pty) Ltd Co. Reg. No. 1952/001640/07, 15E Riley Road, Bedfordview. Tel. No. 011 087 0000. www.inovapharma.co.za. Further information is available on request from iNova Pharmaceuticals. IN202/17