ZinCfant®
Zinc tablets for the treatment of acute diarrhoea
Dosage and
Recommendations for use
- For young children aged between 6 months and 5 years : one tablet once per day for 19 to 14 days consecutively.
NB: for infants between 2 and 6 month old, ½ a tablet per day
- ZinCfant® must continue to be given throughout the recommended treatment period, even if the diarrhoea episode is over before this time.
- Strict observance of the treatment period is essential as it enables the child's body to reconstitute its reserves of zinc and thereby will reduce the risk of new diarrhoea episodes for a period of two to three months.
- Directions for use :
- Place the tablet in a small spoon
- Add a little water or breast milk
- Leave the tablet to dissolve (around 45 seconds)
- Give the entire contents of the spoon to the child
NB : If the child should vomit in the 30 minutes following the treatment, give another tablet (or half a tablet for the infants between 2 and 6 months old)
- Contraindications :
- Do not use ZinCfant® if there is an allergy (hypersensitivity) to one of the components in the product, especially the zinc.
- Do not use ZinCfant® in cases of phenylketonuria (hereditary metabolic disorder identified at birth), because of the presence of aspartame.
- If the child is being given iron in the same period, it is recommended that a four-hour gap be left between the two treatments, to ensure that the organism gets the full benefit of both products.
Packaging and conservation
- Primary packaging : ZinCfant® comes in a packet containing 10 blister packs, each with 10 tablets. One blister pack is enough for the treatment of one child.
NB : ZinCfant® packets do not include the oral rehydration salts which must be used in association with the tablets.
- Secondary packaging :cartons of 72 packets (net weight : 4.0 kg ; gross weight : 6.2 kg)
- Palletisation :
- Where possible, to be stored in a dry, cool area, at a temperature of less than 30°C.
Zincfant® 20 mg, is a dispersible tablet containing zinc sulphate for the treatment of acute diarrhoea, used in association with oral rehydration salts (ORS). ZinCfant® is rapidly dispersible in water or breast milk, which effectively masks the taste of the zinc. It is particularly adapted for use with children 2 months old or more. It corresponds to the common recommendations drawn up by the WHO and UNICEF for the treatment of diarrhoea.
Main characteristics, target population and benefits obtained
ZinCfant® 20 mg is a dispersible, scored, zinc sulphate tablet. ZinCfant® is recommended in cases of acute diarrhoea in young children, and is used in association with oral rehydration salts (ORS).
ZinCfant® reduces the severity and duration of episodes of diarrhoea, regenerates the body's reserves of zinc and has a preventive effect up to three months after the end of the treatment.
The development of these tablets began in 2000, in response to a request from the World Health Organisation. Nutriset associated itself with Laboratoire Pharmaceutique Rodael to develop a high quality product conforming to the specifications drawn up by the WHO aimed at facilitating the treatments acceptance by young children.
Among the required characteristics was that the tablets had to mask the taste of zinc, which was used as an emetic up to the start of the 20th century. They also had to be rapidly dispersible, so they could be diluted in a few drops of water or breast milk and given orally, even to the youngest children.
Thanks to the manufacturing process jointly developed by Nutriset and L.P. Rodael, ZinCfant® tablets are the only ones to mask the taste of zinc so successfully.
In 2004, after a large-scale clinical study had shown the effectiveness of zinc sulphate in tablet form, the WHO and UNICEF jointly published a recommendation for the use of zinc combined with ORS in the treatment of acute diarrhoea, and the tablets were included in the WHO Model List of Essential Medicines in 2005.
Since its commercial launch in November 2005, ZinCfant® has been sent to more than 40 countries and Nutriset is referenced by UNICEF as one of the three preferred suppliers in the world. Although it is mainly distributed through humanitarian programmes and national health ministries, ZinCfant® is nevertheless under-used. To improve its availability and accessibility, in 2010 Nutriset set up the ZincField network of local producers, and is working on the introduction of ZinCfant® into the private market sector.
In addition, Nutriset and its pharmaceutical partner L.P. Rodael have initiated a pre-qualification process with the WHO, which would lead to ZinCfant® production being certified as 'Good Manufacturing Practice' (GMP), and should facilitate exportation of the product.
References
- Systematic reviews of zinc intervention strategies, Food and Nutrition Bulletin, volume 30, Number 1, March 2009 (Kenneth H. Brown and Sonja Y. Hess, guest editors)
- WHO-UNiCeF joint statement for the clinical management of acute diarrhoea / Déclaration commune OMS-UNiCeF sur la prise en charge clinique de la diarrhée aiguë, 2004
- Paediatric Zinc as Treatment of Diarrhoea, POUZN (USAiD), and Qualitative Research for a Zinc Treatment Program in Nepal: Finding & Recommendations, POUZN (USAiD), Oct. 2006
- Cochrane review: Oral zinc for treating diarrhoea in children,
Marzia Lazzerini, Luca Ronfani
Evidence-Based Child Health: A Cochrane Review Journal
Volume 4, Issue 4, Pages1351 - 1417
Copyright © 2009 John Wiley & Sons, Ltd.
http://www3.interscience.wiley.com/journal/123214583/abstract - Journal of Pediatric Gastroenterology and Nutrition, March 2006 - Volume 42 - Issue 3 - pp 300-305
doi: 10.1097/01.mpg.0000189340.00516.30
Original Articles: Hepatology & Nutrition
Zinc Supplementation in Acute Diarrhea is Acceptable, Does Not Interfere with Oral Rehydration, and Reduces the Use of Other Medications: A Randomized Trial in Five Countries
INCLEN Childnet Zinc Effectiveness for Diarrhea (IC-ZED) Group
http://journals.lww.com/jpgn/Fulltext/2006/03000/Zinc_Supplementation_in_Acute_Diarrhea_is.10.aspx
