Helixor M solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

extract of apple tree mistletoe

Available from:

Helixor Heilmittel GmbH Fischermuehle 2

ATC code:

առկա չէ (L01C)

INN (International Name):

extract of apple tree mistletoe

Dosage:

5mg/ml

Pharmaceutical form:

solution for injection

Units in package:

(6) ampoules 1ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-09-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NAME OF THE MEDICINAL PRODUCT
Helixor
®
A
1 mg
Helixor
®
M
1 mg
Helixor
®
A
5 mg
Helixor
®
M
5 mg
Helixor
®
A
20 mg
Helixor
®
M
20 mg
Helixor
®
A
50 mg
Helixor
®
M
50 mg
Helixor
®
A
100 mg
Helixor
®
M
100 mg
Active substance:
Extract of fir mistletoe
Active substance:
Extract of apple tree mistletoe
Solution for injection
Dear Patient,
PLEASE READ THE ENTIRE INFORMATION LEAFLET CAREFULLY. IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
THIS PATIENT INFORMATION LEAFLET COVERS THE FOLLOWING TOPICS:
1.
What is Helixor
®
and what is it used for?
2.
Before you use Helixor
®
3.
How to use Helixor
®
4.
Possible side effects
5.
How to store Helixor
®
6.
Contents of the package and other information
1.
WHAT IS HELIXOR
® AND WHAT IS IT USED FOR?
1.1 Helixor
®
is a herbal medicine used in the complementary treatment of cancer.
1.2 The therapeutic indications include the following. In adults:
stimulating the formative and integrative
forces that dissolve and reintegrate autonomous growth processes. This
includes conditions such as
malignant tumors (as well as
concomitant disorders of the hematopoietic system), benign tumors,
defined precancerous conditions and
for prophylaxis of recurrence after tumor surgery.
2.
BEFORE YOU USE HELIXOR
®
2.1
HELIXOR
® MAY NOT BE USED

if you are under the age of 18 years

during pregnancy or lactation

if you are allergic to mistletoe drugs

if you currently have an acute infectious or febrile disease

if you have an autoimmune disease which is in an acute phase or being
treated with
immunosuppressan

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
1. NAME OF THE MEDICINAL PRODUCT
Helixor A
1 mg
Helixor M
1 mg
Helixor A
5 mg
Helixor M
5 mg
Helixor A
20 mg
Helixor M
20 mg
Helixor A
50 mg
Helixor M
50 mg
Helixor A
100 mg
Helixor M
100 mg
Active substance:
Active substance:
Extract of fir mistletoe
Extract of apple tree mistletoe
_(Viscum album ssp. abietis) _
_(Viscum album ssp. album) _
Solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION BY ACTIVE SUBSTANCES
1 ampoule of 1 ml contains:
Active substance: Extract of fresh fir mistletoe / apple tree
mistletoe
(DER = 1 :20) x mg*
Extraction agent: water for injection, sodium chloride (99.91 : 0.09)
NAME OF THE PRODUCT AND STRENGTH
*X MG QUANTITY OF EXTRACT
Helixor A/M 1 mg
20 mg
Helixor A/M 5 mg
101 mg
Helixor A/M 20 mg
402 mg
Helixor A/M 50 mg
1006 mg
1 ampoule Helixor A/M 100 mg of 2 ml contains:
Active substance: Extract of fresh fir mistletoe / apple tree
mistletoe
(ratio of plant to extract = 1 :20) 2,012 mg
Extraction agent: water for injection, sodium chloride (99.91 : 0.09)
The dosage strength stated in mg indicates the amount of fresh plant
material, which was used to
manufacture 1 ampoule of Helixor. For example: One ampoule “Helixor
A/M 1 mg” contains the
extract of one mg of fresh mistletoe.
The complete list of excipients is listed under Section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adults: stimulating the formative and integrative forces that
dissolve and reintegrate autonomous
growth processes,
_e.g._
-
malignant tumors (as well as concomitant disorders of the
hematopoietic system)
-
benign tumors
-
defined precancerous conditions
-
for prophylaxis of recurrence after tumor surgery
SUMMARY OF PRODUCT CHARACTERISTICS
2
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
INDUCTION THERAPY
Unless otherwise directed, treatment begins with one ampoule of 1 mg
Helixor A, M or P.
_If _
_tolerability is good, the dosage is gradually increased by means of
the different strengths: 1, 5, 20, 50 _