FloraNorm Saccharomyces Boulardii Sachet

FloraNorm

Saccharomyces boulardii

For The Use of Registered Medical Practitioner or Hospitals

 

Composition

Each Sachet contains:

Saccharomyces boulardii 250.0 mg (5 billion live yeast cells)

 

Description

Saccharomyces boulardii is a live, non-pathogenic yeast recommended as a probiotic and as a biotherapeutic in the treatment of diarrhoea of various etiology.

Saccharomyces boulardii is manufactured by a highly controlled process. For better viability and increased shell-life the yeast cells are granulised and formulated under strict GMP conditions. FloraNorm is a creamy white powder with brown coloured granules.

 

Mechanism of Action

Saccharomyces boulardii favourably alters the composition of the gut flora and inhibits the action of pathogenic microorganisms. It maintains a healthy balance of intestinal flora by producing organic compound-such as lactic acid, hydrogen peroxide and acetic acid-that increase the acidity of the intestine and inhibit the reproduction of many harmful bacteria. Studies have revealed that it also produces substances called bacteriocins, which act as natural antibiotics to kill undesirable microorganisms.

It synthesizes vitamin B1, vitamin B2, vitamin B6, pantothenic acid and nicotinic acid. These vitamins are utilized for the nutritional requirements of the body.

 

Indications

• Treatment of diarrhoea – Traveller’s diarrhoea, viral diarrhoea in children and antibiotic associated diarrhoea.

• Treatment of irritable bowel syndrome.

• Treatment and prevention of digestive complications following antibiotic therapy: diarrhoea, colitis, candidiasis.

• Prevention of diarrhoea during continuous enteral feeding in adults.

 

Dosage

Adults & Children: 1 to 2 sachet twice daily or as directed by the physician.

 

Directions for Use

FloraNorm should be taken orally, directly or mixed with water or beverage. It should not be mixed in hot liquids or liquids which contain alcohol. FloraNorm can before or after food. For continuous enteral feeding, the drug may be added to the nutrient solution at the time of preparation.

 

Contraindications

Saccharomyces boulardii is sensitive to antifungal agents.

 

Side Effects

Various clinical trials with Saccharomyces boulardii and post marketing surveillance studies have not shown any significant side-effects. Occasionally, a temporary increase in digestive gas is known to occur.

 

Storage

Store in a Cool, Dry Place. Keep out of reach of children.

 

Presentation

Carton of 10 sachets

 

Marketed by

PRISMA PHARMACEUTICALS LIMITED

Jubilee House, Merrion Avenue, Stanmore,

Middlesex, HA7 4RY United Kingdom

 

Manufactured by

Bharat Biotech International Ltd.

Genome Valley, Shameerpet, Hyderabad – 500 078. India.

Lokmal QS Combi Artemether Lumefantrine Paracetamol Caplets and Tablets

LOKMAL® QS-COMBI

(Artemether 80mg/Lumefantrine 480mg+Paracetamol 500mg)

 

COMPOSITION

Each Satchet of Lokmal QS contains

Artemther 80mg

Lumefantrine 480mg

Each Tablet of Emzor Paracetamol contains

Pracetamol 500mg

 

PHARMACOLOGICAL ACTION

Artemether is a semisythentic chiral acetal derivative of artemisinin. It interferes with parasite transport prateins, produces disruption of mitochondrial function, inhibits angiogenesis, and modulates host immune function. Artemether and its active metabolite have been estimated to reduce parasite biomass by approximately 10,000-fold per reproductive cycle (every 2 days). Lumefantrine is a racemic mixture of a synthetic fluorine derivative and is structurally related to quinine, mefloquine, and halofantrine. It interferes with the conversion of heme, the toxic intermediate step produced during hemoglobin break-down, to non-toxic hemozoin. Accumulation of heme and free radicals results in parasite death.

Artemether, like other artemisinin-derived compounds, acts quickly to rapidly reduce the parasite burden, while lumefantrine serves as a longer-acting agent to eliminate remaining parasites. The combination is effective in strains known to be resistant to traditional antimalarials such as chloroquine, and can be used for infections acquired in areas known to have parasites that are multidrug-resistant.

The mechanism of action of paracetamol is believed to be inhibition of cyclooxygenase (COX), with a predominant effect on COX-2. Inhibition of COX enzymes prevents the metabolism of arachidonic acid to prostaglandin H2 an unstable intermediate byproduct which is converted to pro-inflammatory compounds. In the central nervous system, inhibition of COX enzymes reduces concentrations of prostaglandin E2, which lowers the hypothalamic set-point to reduce fever, and activation of descending inhibitory serotonergic pathways to produce analgesia.

 

INDICATIONS

• Lokmal QS is indicated for the treatment of malaria in children and adults caused by all forms of plasmodium including severe malaria caused by multiple drug resistant strains of P.falciparum.

• Paracetamol is indicated for the relief of pain, headache and feverish conditions.

 

PHARMACEUTICAL PRECAUTIONS AND CONTRAINDICATIONS

LOKMAL QS is contraindicated in individuals who are hypersensitive to artemether and lumenfatrine and in the first trimester of pregnancy, except otherwise prescribed by a physician.

Due to long elimination half life of lumefantrine it is recommended that breastfeeding should not start until at least one week after stopping artemether /lumefantrine combination treatment.

 

DRUG INTERACTIONS

Specific negative drug-drug interaction was not seen. Artemether potentiates the antimalarial activity of other antimalarials. Grapefruit is known to reduce the absorption and metabolism of Artemether / Lumefantrine.

 

DOSAGE AND ADMINISTRATION

BODY WEIGHT (AGE) LOKMAL QS CAPLETS
Adult and Children  35 kg 14 Years and above) DAY 1 DAY 2 DAY 3
0 Hr 8Hrs Morning Night Morning Night
1 Caplet 1 Caplet 1 Caplet 1 Caplet 1 Caplet 1 Caplet
BODY WEIGHT (AGE) EMZOR PARACETAMOL TABLETS
Adult and Children  35 kg 14 Years and above) DAY 1 DAY 2 DAY 3
0 Hr 8Hrs Morning Night Morning Night
2 Tablets 2 Tablets 2 Tablets 2 Tablets 2 Tablets 2 Tablets

 

STORAGE CONDITION

LOKMAL QS Combi should be stored below 30°C.

 

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN

 

PRESENTATION

LOKMAL QS CAPLETS: Blister Satchet of Six Caplets.

EMZOR PARACETAMOL TABLET: Blister Satchet of 12 Tablets.

 

Manufactured by

EMZOR PHARMACEUTICAL INDUSTRIES LIMITED

Plot 3C, BLOCK A Aswani Market Road, Isolo-Lagos Nigeria.

Chi Oral Rehydration Salts BP

ORAL REHYDRATION SALTS®

Oral Rehydration Salts BP 20.5 g

 

DESCRIPTION

Oral Rehydration Salts contains Sodium Chloride, Potassium Chloride, Sodium Citrate, Anhydrous glucose in flavoured mixture with added colour to give a low osmolarity solution when mixed. This carefully prepared mixture when dissolved in prescribed quantity of water is used to replace vital electrolytes lost during episodes of diarrhea and related ailments.

 

COMPOSITION

Each pack of Oral Rehydration Salts contains Sodium Chloride BP 2.6g; Potassium Chloride BP 1.5g; Sodium Citrate BP 2.9g; Anhydrous Glucose BP 13.5g; Colour and Flavour It contains Aspartame.

 

INDICATION

Oral Rehydration Salts® (ORS) is indicated for the treatment of diarrhea in children between 6 months and 5 years of age.

 

DOSAGE AND ADMINISTRATION

Oral Rehydration Salts BP® when dissolved in prescribed quantity of water is used for ORT which is effective in treating fluid loss after acute diarrhea due to various causes, such as dysentery and gastroenteritis, including that brought on by cholera or rotavirus.

Many studies, including those conducted by the World Health Organization, have shown that ORT dramatically reduces the number of deaths experienced during and after epidemics of cholera. ORT is considered to be one of the most relevant public health advances of the 20th century.

 

DIRECTION OF USE

How to make oral rehydration solution (ORS)

Wash your hands with soap and treated water.

Wash container and stirring utensil with soap and treated water.

Put 1 litre of treated water in the clean container. Put ORS powder in the water. Stir the solution with the clean utensil.

2 Sachets of ORS to 1 Litre Treated Water

Under 1 Year

Give the child 100 ml using measuring cup, give every time after diarrhoea.

More than 1 Year

Give the child 200 ml using measuring cup, give every time after diarrhoea.

 

PRECAUTIONS

Water must be boiled and cooled before use. Sugar or sugar-containing liquids cannot be added to the solution. O.R.S has to be taken in the dissolved form. Diabetics should take into account each satchet contains 13.5 grams of glucose. Hypertensive patients should take into account that each sachet contains sodium.

Do not use if you have intestinal obstruction or problems with your liver or kidney function.

 

SIDE-EFFECTS

Oral Dehydration Salts is generally well tolerated.

 

STORAGE INSTRUCTION

Store in a cool and dry place.

Protect from light and humidity.

Keep medicine out of reach of children.

 

NATURE AND CONTENTS OF CONTAINER

Oral Rehydration Salts®is supplied in 2 sachets co-packed with 1 blister strip of Paediatric Zinc Sulfate Dispersible Tablet.

 

NAFDAC Reg. No. 84-0592

 

Manufactured By

Chi Pharmaceuticals Ltd.

14, Chivita Avenue,

Ajao Estate, Isolo,

Lagos, Nigeria.