TRAUMAPLANT

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

COMFREY (SYMPHYTUM) CONCENTRATE

Διαθέσιμο από:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD

Φαρμακολογική κατηγορία (ATC):

M02AX

Φαρμακοτεχνική μορφή:

CREAM

Σύνθεση:

COMFREY (SYMPHYTUM) CONCENTRATE 10 G / 100 G

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

Not required

Κατασκευάζεται από:

GEHRLICHER PHARMAZEUTISCHE EXTRAKTE GMBH, GERMANY

Θεραπευτική ομάδα:

OTHER TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

Θεραπευτικές ενδείξεις:

Traumaplant is a phytodrug (extract of plants) for external treatment of ankle sprains and muscle pains (in case of sports and accidental injuries).

Ημερομηνία της άδειας:

2014-03-31

Φύλλο οδηγιών χρήσης

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

Αρχείο Π.Χ.Π.

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