البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
COMFREY (SYMPHYTUM) CONCENTRATE
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD
M02AX
CREAM
COMFREY (SYMPHYTUM) CONCENTRATE 10 G / 100 G
TOPICAL
Not required
GEHRLICHER PHARMAZEUTISCHE EXTRAKTE GMBH, GERMANY
OTHER TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Traumaplant is a phytodrug (extract of plants) for external treatment of ankle sprains and muscle pains (in case of sports and accidental injuries).
2014-03-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed without a doctor’s prescription TRAUMAPLANT CREAM ACTIVE INGREDIENT: Each 100 gram contains: Comfrey )Symphytum) concentrate 10 g )ex. Herba Symphyti recente 25 g). Inactive ingredients and allergens in the preparation – see section 6 “Further Information.” READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. The medicine is not intended for children and infants under 4 years of age. Use in the correct manner. Consult the pharmacist if you need further information. Consult the doctor if symptoms worsen or if they do not improve after 3-4 days. Traumaplant cream contains an extract of the Comfrey plant. This plant is one of the prominent plants in natural medicine. The plant is characterized by its constricting )reduces swelling) and anti-inflammatory activity. The Comfrey plant also has components that aid in accelerating wound healing. Traumaplant cream is absorbed and does not leave an oily residue on the skin. 1. WHAT IS THIS MEDICINE INTENDED FOR? - For the treatment of ankle sprains due to sports or accidental injuries. - For the treatment of muscle pain. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • you are pregnant or breastfeeding. • you are sensitive )allergic) to the active ingredient or to any of the additional ingredients which the medicine contains. • the medicine is not intended for children and infants under 4 years of age. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE • If you are sensitive to any type of food or medicine, inform the doctor before commencing treatment with the medicine. • If there is no improvement in your condition within 3-4 days, refer to the doctor. • If you feel that the effect of the medicine is too strong or too weak, refer to the doctor. IF YOU ARE TAKING, OR HAVE RECENTLY TA اقرأ الوثيقة كاملة
PRESCRIBING INFORMATION TRAUMAplant ® 1. NAME OF THE MEDICINAL PRODUCT TRAUMAplant ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 100 g of cream contains 10 g Comfrey (Symphytum) concentrate For the complete list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TRAUMAplant ® is a phytodrug (extract of plants) for external treatment of muscle pains (in case of sports and accidental injuries) and ankle sprains. 4.2 POSOLOGY, METHOD AND DURATION OF ADMINISTRATION TRAUMAplant ® is intended for the use of adults, adolescents and children above 4 years old. TRAUMAplant ® can be applied several times a day on the affected tissue of the skin. The patient should spread the cream generously over the entire affected area, than rub it gently and allow it to be thoroughly absorbed. This preparation is especially suitable for occlusive dressings – should be applied on the skin and then covered with a dressing for several hours. The patient is instructed to consult a doctor if improvement does not occur after 3-4 days. Treatment duration should not be more than 3 weeks and it is dependent on the pattern of symptoms. 4.3 CONTRAINDICATIONS TRAUMAplant ® must not be used if there is any hypersensitivity to comfrey or to other ingredients of this medicine. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE General instructions: Contact with the eyes and mucosa should be avoided. 4.5 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION When used as directed, interactions with other medicines are unknown to date. 4.6 PREGNANCY AND LACTATION No adequate data are available concerning use of TRAUMAplant ® during pregnancy and lactation. TRAUMAplant ® should not be given to a pregnant or breastfeeding woman. 4.7 EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES No special precautions are required. 4.8 UNDESIRABLE EFFECTS The following categories are taken as the basis for assessment of side effects: Very common ( ≥ 1/10) Common ( ≥ 1/100 an اقرأ الوثيقة كاملة