Peg-3350 And Electrolytes (Colyte)

Trade Name : COLYTE

Meda Pharmaceuticals

POWDER, FOR SOLUTION

Strength 2405.842.986.7222.72 g/4Lg/4Lg/4Lg/4Lg/4L

POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM SULFATE Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Peg-3350 And Electrolytes (Colyte) which is also known as COLYTE and Manufactured by Meda Pharmaceuticals. It is available in strength of 240; 5.84; 2.98; 6.72; 22.72 g/4L; g/4L; g/4L; g/4L; g/4L per ml. Read more

Peg-3350 And Electrolytes (Colyte) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

4 Liters
For Gastrointestinal Lavage

Colyte with flavor packs is a colon lavage preparation provided as water-soluble components for solution. In solution this preparation with one flavor pack added delivers the following, in grams per liter.
Polyethylene glycol 3350u00a0u00a0u00a0u00a0u00a060.00Sodium chlorideu00a0u00a0u00a0u00a0u00a01.46Potassium chlorideu00a0u00a0u00a0u00a0u00a00.745Sodium bicarbonateu00a0u00a0u00a0u00a0u00a01.68Sodium sulfateu00a0u00a0u00a0u00a0u00a05.68Flavor ingredientsu00a0u00a0u00a0u00a0u00a00.805
When dissolved in sufficient water to make 4 liters, the final solution contains 125 mEq/L sodium, 10 mEq/L potassium, 20 mEq/L bicarbonate, 80 mEq/L sulfate, 35 mEq/L chloride and 18 mEq/L polyethylene glycol 3350. The reconstituted solution is isosmotic and has a mildly salty taste. This preparation can be used without the flavor packs and is administered orally or via nasogastric tube.
Each lemon lime flavor pack (3.22 g) contains, hypromellose, natural and artificial lemon lime powder, Prosweet Powder Natural, saccharin sodium, colloidal silicon dioxide. Each cherry flavor pack (3.22 g) contains hypromellose, artificial cherry powder, saccharin sodium, colloidal silicon dioxide.

Colyte with flavor packs cleanses the bowel by induction of diarrhea. The osmotic activity of polyethylene glycol 3350, in combination with the electrolyte concentration, results in virtually no net absorption or excretion of ions or water.

Colyte with flavor packs is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.

Colyte is contraindicated in the following conditions:

Flavor packs are for use only in combination with the contents of the accompanying 4 liter container. No other additional ingredients (e.g., flavorings) should be added to the solution. Colyte with flavor packs should be used with caution in patients with severe ulcerative colitis.

No data

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice.
Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of Colyte. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and usually subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis, and rarely anaphylaxis, angioedema, tongue edema, and face edema have been reported which may represent allergic reactions.
To report suspected adverse events contact Meda Pharmaceuticals Inc. at toll free 1-866-210-5953 or FDA at 1-800-FDA-1088 or .

Colyte with flavor packs can be administered orally or by nasogastric tube. Patients should fast at least 3 hours prior to administration. A one hour waiting period after the appearance of clear liquid stool should be allowed prior to examination to complete bowel evacuation. No foods except clear liquids should be permitted prior to examination after Colyte with flavor packs administration.

Colyte with flavor packs is supplied in 4 liter bottles with an attached package containing flavor packs. Each 4 liter bottle contains polyethylene glycol 3350 240 g, sodium chloride 5.84 g, potassium chloride 2.98 g, sodium bicarbonate 6.72 g, sodium sulfate (anhydrous) 22.72 g. This preparation is supplied in powdered form, for oral administration as a solution.
Colyte with flavor packsu00a0u00a0u00a0u00a0u00a04 literu00a0u00a0u00a0u00a0u00a0NDC 0037-6820-04
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F).
KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS.
DISCARD UNUSED PORTION.
Rx Only
CL-682004-03u00a0u00a0u00a0u00a0u00a0Rev. 4/2018
Manufactured for:MEDASomerset, New Jersey 08873-4120
u00a9 2018 Mylan Specialty L.P.

Colyte (co-light) with Flavor Packs(peg-3350 & electrolytes for oral solution)
Read this Medication Guide before you start taking Colyte. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about Colyte?
Colyte can cause serious side effects, including:
Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause:
Your risk of having fluid loss and changes in body salts with Colyte is higher if you:
Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking Colyte:
See u201cWhat are the possible side effects of Colyte?u201d for more information about side effects.
What is Colyte?
Colyte is a prescription medicine used to clean the colon before a colonoscopy or barium enema X-ray examination. Colyte cleans your colon by causing you to have diarrhea. Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy or barium enema X-ray examination.
It is not known if Colyte is safe and effective in children.
Who should not take Colyte?
Do not take Colyte if your healthcare provider has told you that you have:
What should I tell my healthcare provider before taking Colyte?
Before you take Colyte, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take
Colyte may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of Colyte.
Especially tell you healthcare provider if you take:
Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take Colyte?
See the Instructions for Use at the end of this Medication Guide for dosing instructions. You must read, understand, and follow these instructions to take Colyte the right way.
What are the possible side effects of Colyte?
Colyte can cause serious side effects, including:
The most common side effects of Colyte include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Colyte. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Colyte?
Keep Colyte and all medicines out of the reach of children.
General information about the safe and effective use of Colyte.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Colyte for a condition for which it was not prescribed. Do not give Colyte to other people, even if they are going to have the same procedure you are. It may harm them.
This Medication Guide summarizes the most important information about Colyte. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Colyte that is written for health professionals.
For more information about Colyte, call 1-866-210-5953.
What are the ingredients in Colyte?
Active ingredients:
Inactive ingredients: Flavor packs ingredients:
Lemon lime flavor pack: hypromellose, natural and artificial lemon lime powder, Prosweet Powder Natural, saccharin sodium, colloidal silicon dioxide
Cherry flavor pack: hypromellose, artificial cherry powder, saccharin sodium, colloidal silicon dioxide

Colyte (co-light) with Flavor Packs(peg-3350 & electrolytes for oral solution)
Read this Instructions for Use before you start taking Colyte. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
How should I take Colyte?
Colyte can be taken with or without a flavor pack. If you use a flavor pack, complete Steps 1 through 8. If you do not use a flavor pack, throw away the flavor packs and complete Steps 4 through 8.
Step 1:u00a0
Step 2:u00a0
Step 3:u00a0
Step 4:u00a0
Step 5:u00a0n- No other ingredients should be added to the Colyte bottle.
Step 6:u00a0
Step 7:u00a0
Step 8:u00a0
This Medication Guide and Instructions for Use have been approved by the U.S. Food and Drug Administration.
Distributed by: MEDASomerset, New Jersey 08873-4120
u00a9 2018 Mylan Specialty L.P.
MEDA PHARMACEUTICALS and the MEDA PHARMACEUTICALS logo are trademarks and COLYTE is a registered trademark of Meda AB or a related entity.
CIA79029Cu00a0u00a0u00a0u00a0u00a0CL-682004-03u00a0u00a0u00a0u00a0u00a0Rev. 4/2018

NDC
colyte with flavor packs(peg-3350 & electrolytes for oral solution)
Rx Onlyu00a0u00a0u00a0u00a0u00a0CIA71674Du00a0u00a0u00a0CL-682004-03u00a0u00a0u00a0u00a0u00a0Rev. 4/2018
Note to Pharmacist:u00a0DISPENSE ENCLOSED MEDICATION GUIDE.
Dispense bottle and all attached flavor packs to patient.
Colyte can be taken with or without a flavor pack. If you use a flavor pack, complete Steps 1 through 8. If you do not use a flavor pack, throw away the flavor packs and complete Steps 4 through 8.
Step 1:u00a0
Step 2:u00a0
Step 3:u00a0
Step 4:u00a0
Step 5:u00a0
Step 6:u00a0
Step 7:u00a0
Step 8:u00a0
MEDASomerset, New Jersey 08873-4120
u00a9 2018 Mylan Specialty L.P.
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-866-210-5953 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
COLYTE is a registered trademark of Alaven Pharmaceutical LLC, a Mylan Company.

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Peg-3350 And Electrolytes (Colyte)

Trade Name : COLYTE

POWDER, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Peg-3350 And Electrolytes (Colyte)

Trade Name : COLYTE

POWDER, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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CONTACT US

Can’t find what
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