Gastrointestinal tract and Liver / Laxatives

Moviprep powder for oral solution 2 pack A, pack B 2 in the box (A + D cachets paired)

Name: Moviprep powder for oral solution 2 pack A, pack B 2 in the box (A + D cachets paired)
Brand: Norgine Limited (UK)
SKU: 4e98d1a8d72d
Availability: InStock

Brands: Norgine Limited (UK)

$37.00

Sku:

4e98d1a8d72d

Brands:: Norgine Limited (UK)

Description

The instruction for medical use

of Moviprep® medicine

the Trade name
of Moviprep®

the International unlicensed name
Is not present

the Dosage form
Powder for preparation of solution for intake

Structure
1 bag contains
the Bag And:
active agents: macrogoal of 3350 100.00 g, sodium sulfate of anhydrous 7.500 g, sodium chloride of 2.691 g, potassium chloride of 1.015 g
excipients: fragrance lemon V3938-1N1 **, aspartame (E951), potassium to atsesulfa (E950)
Bag of B:
active agents: ascorbic acid of 4.700 g, sodium ascorbate of 5.900 g
** composition of lemon fragrance: maltodextrin, citral, oil lemon, lime oil, xanthane gum, vitamin E.

The description
From white till yellow color loose powder with a characteristic smell of a lemon (a bag A). From white till light brown color loose powder (a bag B).

Pharmacotherapeutic group
Laxatives. Osmotic laxatives
the ATX A06AD Code

the Pharmacological

Pharmacokinetics of Makrogol-3350 properties does not change in the time spent in intestines. It is practically not soaked up from digestive tract. The absorbed quantity of a macrogoal-3350 is removed through kidneys.
Ascorbic acid is soaked up generally in a small intestine by active sodium – dependent saturable transport. There is inverse relation between the received dose and the absorbed percent from a dose. At oral administration of a dose at the rate from 30 to 180 mg, about 70-80% of this dose are soaked up. At the subsequent oral administration of ascorbic acid in volume up to 12 g only 2 g are absorbed.
After oral administration of high doses of ascorbic acid and in case of exceeding its concentration in plasma of 15 mg/l, the absorbed ascorbic acid is removed generally in not changed look through kidneys.
The pharmacodynamics
Oral administration of the solution of electrolytes based on a macrogoal causes moderate diarrhea which result is a fast depletion of contents of a large intestine and mitigation of a chair.
A macrogoal-3350, sodium sulfate and ascorbic acid have the osmotic effect causing laxative effect.
The macrogoal-3350 increases the volume of stool that leads to strengthening of a vermicular movement of intestines.
The electrolytes which are a part of medicine and also additional intake of liquid interfere with disturbance of water and electrolytic balance.

Indications
– for purgation, preparation for diagnostic tests (endoscopic, radiological and other researches of intestines) and to the surgeries demanding lack of contents in intestines

the Route of administration and doses
of Moviprep® is used only for adults. Preparation of one liter of solution of drug requires contents of one bag And yes one bag of B to dissolve in a small amount of water, then to bring solution volume water to one liter. Preparation of the second liter of solution of drug requires contents remained the second bag And yes the second bag of B to dissolve in a small amount of water, then to bring solution volume water to one liter. The general dose makes two liters of solution of the drug Moviprep®. It is possible to accept solution once (two liters in the evening or two liters in the morning on the eve of the research) or to divide into two receptions (one liter the night before and one liter in the morning). Before surgery accept once two liters of solution of drug the night before. The prepared solution should be drunk within 1-2 hours. During passing of a training course it is strongly recommended to use in addition one liter of other liquid (water, broth, fruit juice without pulp, soft drinks, tea, coffee without milk). Administration of drug and other liquids needs to be stopped in 1-2 hours prior to the procedure. It is not necessary to eat firm food since the beginning of administration of drug of Moviprep® and before the end of a clinical procedure.

Side effects
Diarrhea is the expected effect by preparation of intestines. In the course of preparation of intestines for diagnostic tests most of patients can have an unpleasant feeling. Because of the nature of process of purgation the patients often have such side effects as: nausea, vomiting, meteorism, abdominal pain, irritation of an anus and sleep disorder. Dehydration can result from diarrhea and/or vomiting.
As well as at reception of other products which part the macrogoal is various allergic reactions, including rash, urticaria, an itching, short wind, a Quincke’s edema and an acute anaphylaxis are possible.
Frequency of side effects of drug is regarded as follows:
Very frequent: ³ 1/10
Frequent: ³ 1/100, & lt, 1/10
Infrequent: ³ 1/1000, & lt, 1/100
Rare: ³ 1/10,000, & lt, 1/1000
Very rare: & lt, 1/10,000
Is unknown: it is impossible to estimate because of insufficient amount of data
Frequent:
– sleep disorders
– dizziness, a headache
– vomiting, a digestive disturbance, a fever, thirst, hunger
Very frequent:
– a stomach ache, nausea, an abdominal distension, irritation of an anus
– an indisposition, fever
Infrequent:
– increase in activity of liver enzymes
– discomfort
– the complicated swallowing
Is unknown:
– allergic reactions of varying severity, including anaphylactic reactions, an asthma and such skin reactions as a Quincke’s disease, an itching, urticaria, rash, an erythema
– the spasms connected with a sharp hyponatremia
– temporary increase in pressure, arrhythmia, a cardiopalmus
–
– change of level of electrolytes, including decrease in level of bicarbonate in blood, hyper – and a hypocalcemia, a hypophosphatemia, a hypopotassemia, a hyponatremia and change of level of chlorides in blood
–

Contraindication dehydration
– hypersensitivity to any of drug components
– perforation or risk of perforation of bodies of digestive tract
– a delay of evacuation of gastric contents
– intestinal impassability
– phenylketonuria (because of contents as a part of aspartame)
– deficit dehydrogenase glyukozo-6-phosphate (because of contents as a part of ascorbic acid)
– heavy inflammatory bowel diseases or the toxic megacolon which is a complication of the significant inflammatory processes in intestines including Crohn’s disease and ulcer colitis

Medicinal interactions
At reception of Moviprep® it is necessary to consider a meteorism, desires to vomiting that drug slows down absorption of any medicines appointed inside. The medicines taken orally within one hour prior to laxative effect of drug (for example, oral contraceptives), are removed from a GIT without being absorbed.

Special instructions
Should be applied with care at:
– a weak emetic reflex or tendency to aspiration or an eructation
– consciousness disturbance
– an acute renal failure (clearance of creatinine & lt, 30 ml/min.)
– heart failure 3 and 4 degrees
– during treatment of arrhythmia or at patients with diseases of a thyroid gland
– dehydration
– a serious and acute illness of intestines
– an acute inflammatory disease of digestive tract.
If at you one of the listed diseases, before administration of drug of Moviprep® surely consult with the doctor.
The total amount of Moviprep® diluted with water does not replace regular consumption of liquid and it is necessary to support sufficient consumption of liquid even after administration of drug.
Before drug use the dehydration needs to be eliminated.
Patients with phenylketonuria are not recommended to apply Moviprep® because of contents as a part of aspartame (phenylalanine source).
To the patients of advanced age weakened or the exhausted patients with various associated diseases, to patients inclined to aspiration or an eructation, with consciousness disturbance, especially if the drug is administered via the nazogastralny probe, it is necessary to use drug under medical control.
Patients with the profound renal failure and arrhythmia connected with an electrolytic imbalance before use of the drug Moviprep® have to consult with the doctor.
If the patient has symptoms of increase in level of electrolytes in liquids (for example, hypostasis, short wind, increased fatigue, heart failure, serious arrhythmias, including fibrillation of auricles), it is necessary to measure the level of electrolytes in plasma and to perform the corresponding treatment in case of detection of deviations.
If at the patient such symptoms as a meteorism, an abdominal distension, a stomach ache or other reactions which complicate continuation of the procedure are observed, it is necessary to slow down, or to suspend reception of Moviprep® and to see a doctor.
If any of the side effects specified in the instruction are aggravated, or you noticed any other side effects which are not specified in the instruction, report about it to the doctor.
Use in pediatrics
is not recommended use for children up to 18 years as there are no data on safety of use of Moviprep® for children.
Pregnancy and a lactation
Are not present sufficient experience of use of the drug Moviprep® for pregnant women and the nursing women. Use is possible only if the expected advantage exceeds potential risk.
The fertility
Is not present any data on impact of Moviprep® on fertility.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
during a training course to medical manipulations with the drug Moviprep® is recommended to refrain from control of vehicles and other mechanisms.

Overdose
Symptoms: the profound diarrhea which can lead to disturbance of water and electrolytic balance.
Treatment: it is usually enough to use a large amount of liquid, preferably fruit juice. If necessary intravenous administration of infusion solutions for recovery of water and electrolytic balance.

The form of release and packing
On 111.9 g of drug (a bag A) place in a four-layer bag (paper / polyethylene of low density / aluminum / polyethylene of low density).
On 10.6 g of drug (a bag B) place in a four-layer bag (paper / polyethylene of low density / aluminum / polyethylene of low density).
Both bags (And yes B) place in a transparent plastic bag.
On 2 packages together with the instruction for medical use in the state and Russian languages place in a cardboard box.

Storage conditions
At a temperature not higher than 25 wasps.
After preparation, solution is stored during 24 h at a temperature from 2ºС to 8ºC.
To store out of children’s reach!

An expiration date
3 years
not to use after expiry date

Prescription status
Without prescription

the Producer / packer
of Norgin Limited, Mid Glamorgan, Great Britain

the Owner of the registration certificate
B.V. Norgin, the Netherlands
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office “Takeda Osteuropa Holding GmbH” (Austria) in Almaty, Shashkin St. 44 Kazakhstane050040 Ph. +7 (727) 2444004 Fax +7 (727) 2444005
To Develop the e-mail address of DSO-KZ@takeda.com