Excipients: water d / and. 1 ml ampoule (5) packings Valium planimetric (1) packs cardboard.

Similar documents
NEW ZEALAND DATA SHEET

NEW ZEALAND DATA SHEET ACUPAN TM. 3. PHARMACEUTICAL FORM White, round, biconvex, film-coated tablets (7 mm diameter) engraved APN on one face.

PRODUCT INFORMATION. SUDAFED Sinus 12 Hour Relief Tablets

SANDOMIGRAN (pizotifen malate)

LEAFLET: INFORMATION FOR THE USER. Freshalgin 500th mg tablets Metamizole sodium (M etamizol sodium)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

AVIOMARIN 50 mg tablets

SUMMARY OF PRODUCT CHARACTERISTICS

3 PHARMACEUTICAL FORM Coated tablet Round, white to off-white, sugar coated tablets, plain on both sides.

PARACOD Tablets (Paracetamol + Codeine phosphate)

PRODUCT INFORMATION. (RS)-N,N-Dimethyl-2-[(2-methylphenyl)phenylmethoxy]ethanamine dihydrogen 2-hydroxypropane-1,2,3-tricarboxylate

PRODUCT INFORMATION. Sudafed* Sinus + Anti-inflammatory Pain Relief Caplets

Migraleve, Migraleve Pink and Migraleve Yellow Product Information

Body weight more than 30kg : 10ml (10mg) of the syrup once daily.

LACIPIL QUALITATIVE AND QUANTITATIVE COMPOSITION

PRODUCT INFORMATION CODAPANE XTRA Paracetamol 500 mg and Codeine Phosphate 15 mg Tablets

SUMMARY OF PRODUCT CHARACTERISTICS

Nausicalm solution for injection is a clear colourless solution, presented in 1 ml ampoules.

PRODUCT INFORMATION. AKINETON (biperiden hydrochloride 2 mg tablets)

M0BCore Safety Profile. Active substance: Bromazepam Pharmaceutical form(s)/strength: Tablets 6 mg FR/H/PSUR/0066/001 Date of FAR:

Cetirizine Proposed Core Safety Profile

PRODUCT INFORMATION. Ammonium chloride is an expectorant that has an irritant effect on mucous membranes.

SPASMEX FORTE 5mg tablets

Physiotens 0.2 mg Abbott

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Translated from Latvian Approved by SAM on

Dexchlorpheniramine maleate (CAS no ) is described chemically as (+)-2-[pchloro-α-[2-(dimethylamino)ethyl]benzyl]pyridine

SUMMARY OF PRODUCT CHARACTERISTICS

Metoclopramide hydrochloride mg (Quantity corresponding to anhydrous metoclopramide hydrochloride) mg

Package leaflet: Information for the user. Cetiristad 10 mg film-coated tablets Cetirizine dihydrochloride

SUMMARY OF PRODUCT CHARACTERISTICS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

New Zealand Data Sheet

SANDOMIGRAN. 0.5mg tablet Pizotifen malate

European PSUR Work Sharing Project CORE SAFETY PROFILE. Lendormin, 0.25mg, tablets Brotizolam

PRODUCT INFORMATION LEAFLET

PATIENT INFORMATION LEAFLET FOR TEXA 10 mg TABLETS AND TEXA SYRUP PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:

PATIENT INFORMATION LEAFLET

PRESCRIBING INFORMATION WITH CONSUMER INFORMATION MYDRIACYL. tropicamide ophthalmic solution, USP. 0.5% and 1% w/v.

SUMMARY OF PRODUCT CHARACTERISTICS

PRODUCT INFORMATION Panadeine EXTRA

Panadeine Tablet, Caplets and Rapid Soluble tablets PRODUCT INFORMATION

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT. Dibondrin - Ampoules. Active substance: diphenhydramine hydrochloride

XYZAL 5 MG FILM-COATED TABLET

TEMGESIC Injection Buprenorphine (as hydrochloride)

PANADOL COLD & FLU RELIEF ORIGINAL FORMULA is a white, capsule-shaped tablet with flat edges, one face marked with C&F, PANADOL on the other.

SUMMARY OF PRODUCT CHARACTERISTICS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

PRODUCT INFORMATION. Bis[(1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl (2RS)-3- hydroxy-2-phenylpropanoate] sulfate monohydrate

Core Safety Profile. Pharmaceutical form(s)/strength: Tablets 5 mg and 10 mg BE/H/PSUR/0002/002 Date of FAR:

AUSTRALIAN PRODUCT INFORMATION APO-MEBEVERINE. Mebeverine hydrochloride

Levocetirizine dihydrochloride

Package leaflet: Information for the patient. Cetirizin Sandoz 10 mg film-coated tablets. cetirizine dihydrochloride

Package leaflet: Information for the patient. [To be completed nationally] 10 mg film-coated tablets Ebastine

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PART III: PATIENT MEDICATION INFORMATION

SUMMARY OF PRODUCT CHARACTERISTICS FOR BENZODIAZEPINES AS ANXIOLYTICS OR HYPNOTICS

PATIENT INFORMATION LEAFLET POLLENTYME S AND TABS

Package leaflet: Information for the user. Ebateva 20 mg Orodispersible Tablets. Ebastine

Core Safety Profile. Pharmaceutical form(s)/strength: Capsules, Tablets / 5 mg, 10 mg ES/H/PSUR/0013/001 Date of FAR:

POLLENTYME S and Tabs Pharma Dynamics (Pty) Ltd Version: July 2017 (G1639) Word copy of G1639 PATIENT INFORMATION LEAFLET FOR POLLENTYME S AND TABS

PACKAGE LEAFLET: INFORMATION FOR THE USER ZIRPINE 10mg TABLETS Cetirizine dihydrochloride

BIKARFEN 50 mg tablets

Composition: Each tablet contain. Levocetirizine. Each 5ml contains. Montelukast. Pharmacokinetic properties:

TOULARYNX DEXTROMETHORPHAN FORTE 3 mg/ml, syrup Dextromethorphan HBr monohydrate

Package Information Leaflet: Information for the user. Calmaben Coated Tablets

M0BCore Safety Profile

PACKAGE LEAFLET: Information for the patient

NEW ZEALAND DATA SHEET

ART 50 Capsules. Symptomatic treatment of functional symptoms and signs of osteoarthritis.

NAME OF THE MEDICINAL PRODUCT IMODIUM CAPS. QUALITATIVE AND QUANTITATIVE COMPOSITION 2 mg loperamide hydrochloride (HCl) per capsule.

MEDICATION GUIDE Oxycodone Hydrochloride (ox-ee-co-dohn) (CII) Oral Solution, USP

Consumer Medicine Information

PANADOL SINUS DAY & NIGHT TABLETS PRODUCT INFORMATION

PACKAGE LEAFLET: INFORMATION FOR THE USER. MEPHENON 10mg/1ml, solution for injection MEPHENON 5mg, tablets. Methadone hydrochloride

SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Package leaflet: Information for the user Zirtek Allergy Relief 10 mg film-coated tablets Cetirizine dihydrochloride

DATA SHEET. PANADOL Mini Caps Capsule shaped tablet with a gelatin coating which is one half green and the other half white.

Antiallergics and drugs used in anaphylaxis

Share the important information in this Medication Guide with members of your household.

Package Leaflet: Information for the User

CYPRODIN. Composition Cyprodin Syrup Each 5 ml contains Cyproheptadine HCl (as anhydrous) 2 mg.

Package Insert. Stugil D

DATA SHEET. Paracetamol (BP) 500 mg and Phenylephrine Hydrochloride (BP) 5 mg

PRODUCT INFORMATION. Sudafed* Sinus Day + Night Relief Tablets

Active ingredients: Metoclopramide Hydrochloride mg Equivalent to metoclopramide hydrochloride anhydrous mg

PRODUCT MONOGRAPH ZONALON CREAM 5% GENERIC NAME DOXEPIN HYDROCHLORIDE CREAM 5% THERAPEUTIC CLASSIFICATION TOPICAL ANTIPRURITIC

AUSTRALIAN PRODUCT INFORMATION APO-BETAHISTINE (BETAHISTINE DIHYDROCHLORIDE) 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM

DESCRIPTION: Each tablet for oral administration contains:

Package leaflet: Information for the user. Cyclizine Lactate 50 mg/ml Injection

SUMMARY OF PRODUCT CHARACTERISTICS. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.

Each 5ml of Sinarest LP New Syrup contains: Phenylephrine

IMODIUM. Janssen Pharma

P-RMS: FR/H/PSUR/0036/001

PACKAGE INSERT TEMPLATE FOR SALBUTAMOL TABLET & SALBUTAMOL SYRUP

Dilaudid, a narcotic analgesic, is prescribed for the relief of moderate to severe pain such as that due to:

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Emergency contraception is an occasional method. It should in no instance replace a regular contraceptive method.

PACKAGE LEAFLET: INFORMATION FOR THE USER. Meptid 100 mg/ml Solution for Injection. Meptazinol Hydrochloride

Transcription:

SUPRASTIN Active material: Xloropiramin When ATH: R06AC03 CCF: Gistaminovыh blocker H 1 -receptors. Allergy medication ICD-10 codes (testimony): H10.1, J06.9, J30.1, J30.3, L20.8, L23, L24, L29, L30.0, L50, T14.0, T78.3, T80.6, T88.7 When CSF: 13.01.01.01 Manufacturer: EGIS PHARMACEUTICALS Plc (Hungary) DOSAGE FORM, COMPOSITION AND PACKAGING Pills white or grayish white color, in the form of a disk with a chamfer, Engraved Understand on one side, with little or no odor. 1 tab. Chloropyramine hydrochloride 25 mg Excipients: stearic acid, gelatin, sodium carboxymethyl (Type A), talc, potato starch, lactose monohydrate (116 mg). 10 PC. blisters (2) packs cardboard. 20 PC. vials of dark glass (1) packs cardboard. Solution for in / and the / m clear, colorless, with a faint characteristic odor. 1 amp. Chloropyramine hydrochloride 20 mg Excipients: water d / and. 1 ml ampoule (5) packings Valium planimetric (1) packs cardboard. Pharmacological action Gistaminovыh blocker H 1 -receptors, ethylenediamine derivative. It prevents the development and facilitates the allergic reactions. It has a mild sedative and antipruritic effect pronounced. It has antiemetic effect, peripheral anticholinergic activity, moderate inflammatory properties. The therapeutic effect develops within 15-30 minutes after ingestion, It reaches a maximum during the first hour after administration and lasts for at least 3-6 no. Pharmacokinetics Absorption Once inside Chloropyramine hydrochloride is rapidly and completely absorbed from the gastrointestinal tract. C max plasma levels achieved during the first 1-2 no, therapeutic level of concentration is maintained for a 3-6 no. Distribution Regardless of the route of administration are well distributed in the body, including CNS. Binding Chloropyramine plasma protein is 7.9%. Metabolism

It is extensively metabolized in the liver. Deduction Introduced primarily in the urine as metabolites. Pharmacokinetics in special clinical situations In children, excretion of the drug faster, than in adults. INDICATIONS - Urticaria; - Angioedema (angioedema); - Serum sickness; - Seasonal and perennial allergic rhinitis; - Conjunctivitis; - Contact dermatitis; - Itching; - Acute and chronic eczema; - Atopic dermatitis; - Food and drug allergy; - An allergic reaction to insect bites. DOSAGE Assign inside, / m and / in. Inside adult appoint 25 mg (1 tab.) 3-4 times / day (75-100 mg / day). Babies the drug is prescribed in the following doses: Age Single dose Reception frequency from 1 to 12 months 1/4 tab. (6.25 mg) 2-3 times / day (Pounded into a powder to form along with baby food) 1/4 tab. from 1 Year (6.25 mg) 3 times / day to 6 years 1/2 tab. (12.5 mg) 2 times / day from 6 to 14 1/2 tab. years (12.5 mg) 2-3 times / day The dose can be gradually increased in the absence of side effects in patients, but the maximum dose should not exceed 2 mg / kg body weight. The tablets should be taken orally with meals, not chewing and drinking plenty of water. Parenteral drug products should be entered in the / m. In / in the introduction is used only in severe cases of acute under medical supervision. Adults the drug is introduced into / m 20-40 mg (1-2 amp.)/d. Babies / m of drug administered in the following doses: Age Dose from 1 to 12 months 1/4 amp. (5 mg)

from 1 Year to 6 years 1/2 amp. (10 mg) from 6 to 14 years 1/2-1 amp. (10-20 mg) The dose can be gradually increased in the absence of side effects in patients, but the maximum dose should not exceed 2 mg / kg body weight. IN severe and acute cases of allergic and anaphylactic reactions treatment can begin with a slow I / injection, then continue to the / m introduction of the drug, then go to the reception of the drug inside. At abnormal liver function It may require dose reduction due to reduction of metabolism of the active ingredient. At impaired renal function also may require a reduction in dose. SIDE EFFECT CNS: drowsiness, fatiguability, dizziness, jitters, tremor, headache, euphoria. From the digestive system: abdominal discomfort, dry mouth, nausea, vomiting, diarrhea, constipation, loss or increase in appetite, epigastric pain. Cardio-vascular system: decrease in blood pressure, tachycardia, arrhythmia (It was not always a direct relationship between these side effects to the drug intake). From the hematopoietic system: rarely leukopenia, agranulocytosis. Other: strangury, muscular weakness, increased intraocular pressure, photosensitivity. Side effects occur, usually, rarely, are temporary and disappear after drug withdrawal. CONTRAINDICATIONS - An acute attack of asthma; - Pregnancy; - Lactation (breast-feeding); - Infants (incl. Premature); - Hypersensitivity to the drug or other derivatives of ethylene diamine. FROM caution use in patients with angle-closure glaucoma, in patients with urinary retention and hypertrophy of the prostate, for violations of the liver and / or kidney, cardiovascular diseases, in elderly patients. Pregnancy and lactation There have been no adequate and well-controlled studies of the use of antihistamines in pregnancy. Therefore, use of the drug in pregnant women (especially in the I trimester and last month of pregnancy) possibly only, if the potential benefit to the mother outweighs the potential risk to the fetus. If necessary, use during lactation should stop breastfeeding.

Cautions With extreme caution should be used drug in the elderly, malnourished patients, tk. such patients often experience side effects (dizziness, drowsiness). Precautions should be prescribed Suprastin simultaneously with sedatives, trankvilizatorami, analgesics, MAO inhibitors, tricyclic antidepressants, atropine and / or sympatholytic. During treatment should eliminate the use of alcohol. Each tablet contains 116 mg lactose monohydrate. This amount can cause unwanted reactions in patients with lactase deficiency or rare metabolic disorders galactosemia and malabsorption syndrome glucose / galactose. Effects on ability to drive vehicles and management mechanisms In the initial, individually defined period of application suprastin not permitted driving vehicles and other classes of potentially hazardous activities, requiring quickness of psychomotor reactions. In the course of further treatment degree of limitation is determined depending on the individual tolerability. OVERDOSE Symptoms: hallucinations, anxiety, ataxia, dystaxia, athetosis, convulsions, midriaz; in infants excitation, anxiety, dry mouth, fixed dilated pupils, facial flushing, sinus tachycardia, urinary retention, fever, coma; adult fever and flushing of the skin faces seen impermanent, after a period of excitement followed by depression, convulsions and poslesudorozhnaya, coma. Treatment: prior to 12 h after dosing gastric lavage (should be considered, that the emptying of the stomach prevents the anticholinergic effect of the drug), appointment of activated carbon, parameter control of blood pressure and respiration, symptomatic therapy, if necessary resuscitation. Spetsificheskiy no known antidote. Drug Interactions In an application Suprastin enhances the effects of sedatives, trankvilizatorov, analgesics, MAO inhibitors, tricyclic antidepressants, atropyna, simpatolitikov and ethanol. While the use of ototoxic drugs Suprastin may mask the early signs of ototoxicity. Conditions of supply of pharmacies A preparation in the form of solution for injection by prescription. The drug is in the form of tablets is approved for use as a means of nonprescription.

TERMS AND CONDITIONS OF STORAGE The drug should be stored out of reach of children at temperature from 15 to 25 C. Shelf life 5 years. This entry was posted on Sunday, October 24th, 2010 in 19:56 and is filed under Instructions for use, Description medicines. FROM. You can follow any responses to this entry through the RSS 2.0 tape. You can leave a comment, or trackback from your site. Online Medicina: http://omedicine.info/es/suprastin.html