Proctomed cream rectal

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

유효 성분:

phenylephrine (phenylephrine hydrochloride), cinchocaine, shark liver oil

제공처:

Arpimed LLC

ATC 코드:

C05AX03

INN (국제 이름):

phenylephrine (phenylephrine hydrochloride), cinchocaine, shark liver oil

복용량:

2,5mg/g+ 10mg/g+ 30mg/g

약제 형태:

cream rectal

패키지 단위:

20g aluminium tube and applicator

처방전 유형:

OTC

승인 상태:

Registered

승인 날짜:

2018-06-13

제품 특성 요약

SUMMARY PRODUCT CHARACTERISTIC (SPC) PROCTOMED
Cream for rectal use
1. TRADE NAME – Proctomed
INTERNATIONAL NON-PROPERTY NAME – Phenylephrine, Cinchocaine HCl
(Dibucaine), Shark liver
oil
2. QUANTITATIVE AND QUALITATIVE COMPOSITION
Each gram contains:
_ACTIVE INGREDIENTS:_
phenylephrine hydrochloride - 2.5 mg, cinchocaine HCl (Dibucaine) - 10
mg,
shark liver oil - 30 mg;_ _
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Cream for rectal use.
White to off white homogenous cream.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

external and internal hemorrhoids.,

anal fissures,

anal itching,

pain relief after proctologic operations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION It is best to use Proctomed after defecation.
ADULTS AND CHILDREN OVER 12 YEARS: before using the medication to the
affected area carry out
hygiene, namely, clean the affected area by gently patting with a
cleaning tissue. Dry the area by
gently patting with a piece of dry tissue or clean cloth. Remove the
protective cover from the
applicator tip, attach the applicator tip to the medication tube, and
lubricate the applicator tip.
Gently insert the applicator tip into the rectum and apply a small
amount of this medication
morning and evening. Apply some medication to the external area around
the rectum as well.
Apply the preparation to the affected area two times a day, morning
and night. After each use,
clean the applicator tip well and replace the protective cover. In
conditions with severe pain, the
cream may be applied up to 4 times daily.
Patients should be advised to consult a clinician if the anorectal
condition worsens or does not
improve within 4 weeks of treatment, or if bleeding occurs.
4.3 CONTRAINDICATIONS

Proctomed cream should not be used in individuals with known
hypersensitivity to each
ingredient.

Children up to age 12 years.

Thromboembolic disease.

Granulocytopenia.
4.4 PRECAUTIONS FOR USE AND SPECIAL WARNINGS
You should continue to use Proctomed cream at least for o