INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ANA-GUARD

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ANA-GUARD

Sterile solution for subcutaneous or intramuscular injection, in a ready-to-use syringe.

COMPOSITION:
Epinephrine hydrochloride 1 mg/mL (1 in 1000)
Sodium bisulphite 0,15% m/m
Chlorobutanol 0,5% m/m
as preservatives

PHARMACOLOGICAL CLASSIFICATION:
A 5.1 Adrenomimetics (sympathomimetics)

PHARMACOLOGICAL ACTION:
Epinephrine is a sympathomimetic agent.

INDICATIONS:
Epinephrine is used as an adjunct in the treatment of severe anaphylactic or anaphylactoid (life-threatening) reactions.

Ana-Guard is to be used only when prescribed by a doctor for patients who are highly allergic and in danger of developing a life-threatening reaction.

CONTRA-INDICATIONS:
Hyperthyroidism, ischaemic heart disease, arrhythmias, tachycardia, arteriosclerosis, hypertension, aneurysms, angina pectoris, diabetes mellitus, closed-angle glaucoma. Avoid use with anaesthetics such as cyclopropane, halothane, or other halogenated anaesthetics. NOT INTENDED FOR INTRAVENOUS USE.

Interactions:
Cardiac glycosides, quinidine, tricyclic anti-depressants, MAOI's during treatment and for 14 days after, alpha- and beta-blocking drugs, anti-hypertensives.

WARNING:
Contains sodium bisulphite. Patients with suspected sensitivity to sulphites should consult their doctor well in advance of the need for treatment.

DOSAGE AND DIRECTIONS FOR USE:
The sterile 1 mL syringe contains Epinephrine Injection (1 in 1000) and is designed to deliver two doses of 0,3 mL each.

The solution is for SUBCUTANEOUS or INTRAMUSCULAR injection and is NOT INTENDED FOR INTRAVENOUS USE.
The solution must not be used after the expiry date printed on the syringe, nor if it is discoloured or shows the presence of a precipitate. To avoid contamination the syringe should not be tampered with prior to the need to administer the dose.

IN THE EVENT OF A LIFE-THREATENING SITUATION, FOLLOW THESE STEPS IMMEDIATELY TO ADMINISTER THE EPINEPHRINE
1. Remove (pull off) blue plastic needle cover. Hold syringe UPRIGHT and PUSH plunger to expel air and excess epinephrine (plunger WILL STOP). {illustrated}
2. ROTATE rectangular plunger ¼ turn to the right. Plunger WILL ALIGN WITH SLOT in barrel of syringe. Wipe injection site with alcohol swab, if available.
3. INSERT NEEDLE straight into arm or thigh as illustrated.
4. PUSH plunger until IT STOPS. Syringe will inject a 0.3 mL dose suitable for adults and children over 12 years.
Syringe barrel has 0.1 mL graduations so that smaller doses can be measured.

ONCE THE INITIAL EPINEPHRINE INJECTION HAS BEEN ADMINISTERED, FOLLOW THESE ADDITIONAL STEPS.
1. CONTACT DOCTOR.
2. REMOVE STINGER if stung by insect. (Use fingernails to scrape the skin, DO NOT push, pinch or squeeze, or further imbed the stinger into the skin as this may cause further venom to be injected.) {illustrated}
3. PREPARE SYRINGE FOR A POSSIBLE SECOND INJECTION. Turn the rectangular plunger ¼ turn to the right to line up with rectangular slot in the syringe. (A slight wiggling may aid the turning and alignment of the plunger.)
4. THE SECOND INJECTION. If after 10 minutes from the first injection symptoms are not noticeably improved, a second injection is required. Cleanse skin area with alcohol swab, if available, and make second injection as in STEPS 3 and 4 for the first epinephrine injection. (A small amount of epinephrine will remain in syringe after the second dose and cannot be expelled.) Note: Dispose of syringe and remaining contents if second injection is not required
5. APPLY ICE PACKS IF AVAILABLE, AT THE SITE OF THE STING.
6. KEEP PATIENT WARM AND AVOID EXERTION.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness, psychotic states, reduced appetite, nausea and vomiting. Gangrene, cerebral haemorrhage, pulmonary oedema, reflex bradycardia, tachycardia, cardiac arrhythmias, anginal pain, palpitations, cardiac arrest. Hypotension with dizziness, fainting, flushing, difficulty in micturition, urinary retention, dyspnoea.
Disturbances of glucose metabolism, sweating, hyper-salivation, headache. Tissue necrosis and sloughing.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear colourless solution.

PRESENTATION:
Ready-to-use syringe containing 1 mL Epinephrine Injection 1:1000 U S P, designed to deliver two doses of 0,3 mL each.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light. Keep out of reach of children.

REGISTRATION NUMBER:
Y/5.1/30

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Bayer (Pty) Ltd
Reg. No. 68/11192/07
27 Wrench Road Isando 1600

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1992
        C9348-1295
Davbar Dbn.

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