05/09/2016 11:20 - VISTAlink folder 2383682 - Page 1/2

S1

SUMMARY OF PRODUCT CHARACTERISTICS

1. PRODUCT NAMEMaxilase 200 U.CEIP / ml Syrup

2. QUALITATIVE AND QUANTITATIVE COMPOSITIONEach milliliter of syrup contains 200 U.CEIP alpha-amylase.It contains excipients:Sucrose: 640 mg / mlFor Methyl-hydroxybenzoate sodium: 0.094 mg / mlFor propyl-hydroxybenzoate sodium: 0.3 mg / mlGlycerol 9 mg / mlSunset yellow (E110): 0.015 mg / mlSodium 0.047 mg / ml (as sodium methyl parahydroxybenzoate andSodium propyl parahydroxybenzoate)Full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORMSyrup.

4. CLINICAL4.1 Therapeutic IndicationsTherapy and prophylaxis of edema in various situations. An adjunct to antibiotic therapy, in the following indications: - Otorhinolaryngology- Rhinoplasty, tonsillectomy;- Various Interventions (sinusitis, laryngectomy, nasal polipectomia, nasal septum resection)- Tonsillitis pharyngitis, sinusitis, laryngitis, Rhino trachea bronchitis - Pneumology- Bronchitis, acute and chronic lung disease;- Respiratory complications of infectious diseases, etc. Stomatology- Maxillo-facial surgery- Extractions of impacted teeth;- Multiple or simple extractions;- Various interventions; apical resection, bone grafts, excision of the submaxil-lary glandsPeriodontitis (complementary treatment).Orthopedics and traumatology- Edema post - traumatic and post-surgical;- Simple Injuries (face ,..);- Sprains;- Dislocations;- Reduced fractures or orthopedic surgery;- Intra-articular interventions (Meniscectomy, foreign bodies);- Reconstructive surgery (tendons);- Plastic surgery; skin grafts, rhinoplasty; - Facial trauma; wounds of the face with or without fractures;- Interventions in soft tissues.4.2 Dosage and method of administrationMethod of administration: Oral.Dosage:The power of enzyme alpha-amylase is expressed in U. IEPC. (Enzyme weight hydrolyses 1 mg of soluble starch in 10 seconds at 37ºC).Infants and children up to 3 years of age (15 kg): 1 teaspoon (5 ml) 3 times a day (5 ml of syrup contain U. IEPC 1000)Children over 3 years of age (> 15 kg): 1 tablespoon (10 ml) 3 times per day (10 ml syrup contain U.CEIP 2000)Adults: 1 tablespoon (15 ml) 3 times a day. (15 ml syrup contain 3.000 U.CEIP).4.3 Contra - indicationsHypersensitivity to alpha-amylase or any of the excipients.4.4 Special warnings and precautions for useWarnings:Due to the presence of sucrose, patients with rare hereditary problems of intolerance the fructose, glucose-galactose malabsorption or sucrase-isomaltase insu�ciency, should not take this medicine.Diabetics should take into account that a teaspoon (5 ml) contains 3.2 g of sucrose and a tablespoon (15 ml) contains 9.6 g sucrose.Maxilase syrup contains sunset yellow (E110) which may cause allergic reactions.Maxilase syrup contains sodium parahydroxybenzoate and methyl parahydroxy-benzoate sodium propyl which may cause allergic reactions (possibly delayed).Special precautions for use:In the case of persistence or appearance of new symptoms (severe sore throat,headaches, nausea, vomiting) or in case of associated fever, must be reevaluated to therapeutic strategy.This medicine should not be used for long periods of time without the physician advice 4.5 Drug interactions and other forms of interactionThere are no known interactions of accounts between alpha amylase and other medicines.4.6 Pregnancy and lactationAs regards alpha-amylase , no clinical data is available on the pregnancyAnimal studies revealed no harmful e�ects direct or indirect on pregnancy,

Brand name: Maxilase syrupArtwork type: Lea�etVersion number (Revision): S1 Bar code: 705 SAP identi�cation no.: E043273 Country: EgyptDate: 08.2016Designer: S.BebawyDimensions: 300 x 200 mmLogo version: A1Minimum point size of text: 9 Pt.Colors:Panton Re�ex blue

embryo-fetal development and delivery. This medecine should only be prescribed to pregnant women with extreme cautionLactation It is not known if the alpha amylase passes into human breast milk. This medicine should be avoided the for use during breastfeeding.4.7 E�ects on ability to drive and use machinesNot relevant 4.8 Undesirable e�ectsAdverse reactions were positioned according to the organ system classi�cation- Class and frequency using the following convention: very common (≥ 1/10);Common (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10000 <1/1000); very rare (<1/10000).Skin and subcutaneous tissue disorders:- Very rare: urticaria type of eruptions.4.9 OverdoseNo case of overdose of this medicine.In case of accidental ingestion, should start appropriate treatment.

5. Pharmacological Properties5.1 Pharmacodynamic properties:pharmacotherapeutic group: 9.5 locomotor apparatus. anti-in�ammatory enzymes.ATC code MO9ABEnzymatic Preparation of anti-edematous and anti-in�ammatory activity.The mode of action of alpha-amylase in in�ammatory edema is characterized by:- Hydrolysis with polysaccharides in�ammatory exudate, making it more �uid - Inhibition of abnormal capillary permeability (which is increased during the �rst stage of in�ammation) by decreasing the output of liquids from vessels allowing easier edema resorption.5.2 Pharmacokinetic propertiesAlpha-amylase is an endoamylase that catalyzes the starch molecules on the links of glucosides so there are no pharmacokinetic data.5.3 Preclinical safety dataNon-clinical data reveal no special hazard for humans based on conventional studies for safety , pharmacology, repeated dose , toxicity; genetic or, reproductive , potential carcinogenicity and..6. PHARMACEUTICAL6.1 List of excipientssucrose;Para-hydroxybenzoate sodium methyl;Para-hydroxybenzoate sodium propyl;glycerol;soluble tangerine essence (S 164);Sunset Yellow (E110);Citric acid monohydrate (q.s. pH 6.5-7.0);Puri�ed water.6.2 IncompatibilitiesNot applicable.6.3 Shelf life18 month 6.4 Special precautions for storageDo not store above 25 ° C.6.5 Nature and contents of containeramber glass bottle with tamper evident seal Type III in white opaque polyethyleneaverage density and capacity of 100 ml.Pack of 1 bottle with 100 ml of syrup.6.6 Special precautions for disposalNo special requirements.

7. MARKETING AUTHORIZATION HOLDER MARKETINGSANOFI-AVENTIS - Pharmaceuticals, S.A.Manufactured by Sano�-EgyptDate of authorization of the review on the market: August 17, 2007

200U.CEIP / ml Syrup

E

<

≤ > ≤ ≤ > > ≤ >

“EXP”

S

E043273 - Pamphlet Maxilase syrup S@n In House

This document has been digitally signed by the following people within the VISTAlink system,

following the sanofi-aventis group guidelines.

Plant: CAIRO- EGYPT

Packaging material code: E043273

Packaging material name: Pamphlet Maxilase syrup S@n InHouse

Second packaging material code:

VISTAlink folder number: 2383682

VISTAlink PDF version: 1

Reason Signed by Date

Market regulatory validation Eman Wahdan (Egypt regulatoryaffairs team) 01/09/2016 12:04:58

Plant quality validation Randa Aref (Cairo qualityassurance team) 01/09/2016 12:45:21

Plant final technical validation Sara Bebawy (Cairo packagingteam) 01/09/2016 12:46:59

Market medical affairs validation Michel Magdy (Egypt medicalaffairs team) 05/09/2016 11:12:43

Market marketing validation Omar Rashad (Egypt marketingdepartment team) 05/09/2016 11:15:55

Plant ready to print Sara Bebawy (Cairo packagingteam) 05/09/2016 11:20:02

05/09/2016 11:20 - VISTAlink folder 2383682 - Page 2/2