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READY – TO – USE

LAXATIVE SALINE ENEMA

 

Sodium phosphates solution

 

For Kids Between 2 – 11 Years

 

Information for the user

Active ingredients

Name

Strength (in each 67.5 ml delivered dose)

Purpose

Monobasic sodium phosphate

9.5 g

Saline laxative & bowel cleanser

Dibasic sodium phosphate

3.5 g

Saline laxative & bowel cleanser

Inactive ingredients:

Benzalkonium chloride, disodium EDTA, Purified water

What is ENEMA ROY?

It is a laxative saline enema containing phosphate and sodium diphosphate, which works by drawing water from the body into the intestines, which helps to soften stool and increase bowel movement, thus stimulating and facilitating the process of stool removal from the intestines.

It is used for relief of occasional constipation or bowel cleansing before rectal examination

Warnings

For rectal use only

Dosage warning:

Using more than one enema in 24 hours can be harmful.

Do not use without asking a doctor:

  • If your child has a kidney disease.
  • If your child has a heart problem.
  • If your child is dehydrated.
  • For more than 3 days.
  • Do not use more than directed. Serious side effects may occur from excess dosage.

Ask a doctor before using this product if the child is:

  • Is on sodium-restricted diet
  • Has a kidney disease.
  • taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Ask a doctor before using this product if the child has:

  • abdominal pain, nausea or vomiting
  • already used a laxative for more than 1 week.
  • noticed a sudden change in bowel habits that lasts over 2 weeks

stop using this product and consult a doctor if the child has:

  • rectal bleeding
  • no bowel movement or o liquid comes out of the child’s rectum after 30 minutes of use of the enema.
  • Symptoms of dehydration (feeling thirsty, dizziness, vomiting less than normal).

These symptoms may indicate a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions of use

Do not use more unless directed by a doctor. See Warnings. Do not use of your child is taking another sodium phosphates product.

Age

Dose per day

Children 5 to 11 years

one bottle per day or as directed by doctor

Children 2 to under 5 years

1/2 bottle per day

Ask your doctor

Children under 2 years

DO NOT USE

Caution:

REMOVE THE PROTECTIVE SHIELD BEFORE INSERTING; HOLD BOTTLE UPRIGHT,

GRASPING BOTTLE CAP WITH FINGERS. GRASP PROTECTIVE SHIELD WITH OTHER

HAND AND PULL GENTLY TO REMOVE. PROTECTIVE SHIELD PREVENTS CONTAMINATION.

ENEMA - ROY is Latex Free.  Allergic reactions to materials containing Latex is a growing and serious medical problem.

Positions for using this enema:

Left-side position: Place child on left side with knees bent, and arms resting comfortably.

Knee-chest position: Have child kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded comfortably.

Administering enema:

  • Remove the protective shield from enema comfort tip before inserting.
  • With steady pressure, gently insert enema tip into rectum with a slight side-to-side movement, with tip pointing toward navel.
  • Insertion may be easier if child receiving enema bears down, as if having a bowel movement. This helps relax the muscles around the anus.
  • Squeeze bottle until recommended dose is expelled (it is not necessary to empty until completely).

Bottle contains more liquid than needed for effective use. A small amount of liquid will remain in

bottle after squeezing).

  • Remove tip from rectum and keep child in position until urge to evacuate is strong (usually 1 to 5 minutes).
  • If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.
  • Do not force the enema tip into rectum as this can cause injury.
  • stop using if tip is hard to insert. A small amount of lubricant such as Vaseline can be used to facilitate the insertion process. Forcing the tip into rectum can cause injury. If enema tip causes rectal bleeding or pain, get immediate medical care.

Other information

  • each 67.5 mL contains: sodium 2.2 g
  • additional liquids by mouth are recommended while taking this product.
  • store at room temperature 20º-25ºC
  • this product generally produces bowel movement in 1 to 5 minutes
  • bottle sealed for safety. If bottle wrapper with Enema – Roy emblem is torn, damaged or missing, do no use.

Professional Use Warnings:

Do not use in patients with congestive heart failure, clinically significant impairment of renal function, ascities, known or suspected gastrointestinal obstruction, megacolon (congenital or acquired) or imperforate anus.  Use with caution in patients with impaired renal function, pre-existing electrolyte disturbances or in patients on diuretics or other medications which may affect electrolyte levels or where colostomy exists.   Since ENEMA - ROY contains sodium phosphates, there is a risk of elevated serum levels of sodium and phosphate and decreased levels of calcium and potassium, and consequently hypocalcaemia, hyperphosphatemia, hypernatremia, hypokalemia and acidosis may occur. This is of particular concern in children with megacolon or any other condition where there is retention of enema solution. Additional liquids by mouth are recommended.

ENEMA - ROY 67.5 ml

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