Product Description

Pharmasin Granules is indicated for the treatment and metaphylaxis of specific bacterial infections across four target species. The disease must be established in the herd or flock before the product is used. Due to likely variability in susceptibility of bacteria to tylosin over time and by geography, bacteriological sampling and susceptibility testing are recommended wherever possible. Under-dosing and/or treating for an insufficient length of time promote the development of resistance and must be avoided.

For Calves:

Treatment and metaphylaxis of pneumonia caused by Mycoplasma spp., when the disease has been established in the herd

For Pigs:

Treatment and metaphylaxis of enzootic pneumonia caused by Mycoplasma hyopneumoniae and Mycoplasma hyorhinis, when the disease has been established in the herd

Treatment and metaphylaxis of Porcine Intestinal Adenomatosis (Ileitis) associated with Lawsonia intracellularis, when the disease has been established in the herd

For Chickens:

Treatment and metaphylaxis of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum and Mycoplasma synoviae, when the disease has been established in the flock

Treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens, when the disease has been established in the flock

For Turkeys:

Treatment and metaphylaxis of infectious sinusitis caused by Mycoplasma gallisepticum, when the disease has been established in the flock

Which Animals Can Use Pharmasin Granules?

Pharmasin Granules is licensed for use in calves, pigs, chickens, and turkeys only. It must not be used in animals with known hypersensitivity to tylosin or other macrolides, in cases of known resistance to tylosin or cross-resistance to other macrolides (MLS-resistance), in animals with hepatic disorders, or in animals vaccinated with tylosin-sensitive vaccines either at the same time as or within 1 week prior to treatment. Critically, this product must never be used in horses — administration to horses carries a danger of inflammation of the caecum. Ensure that treated water is not accessible to horses, other untreated animals, or wildlife. Always use only under the direction of your vet.

Available Strengths & Sizes

Not all pack sizes may be marketed. Shelf life after first opening the immediate packaging: 3 months — reseal the container tightly after each use. Shelf life after dilution in medicated water, milk, or milk replacer: 24 hours — replace medicated preparations every 24 hours and discard any unused medicated solution.

Directions for Use

Pharmasin Granules is a prescription medication and must be used exactly as directed by your veterinary surgeon. The granules are administered orally via the drinking water for all species. For calves only, the product may additionally be administered via milk or milk replacer. No other source of drinking water should be available during the medication period. The body weight of the animals to be treated and their actual daily water, milk, or milk replacer consumption must be taken into account when calculating the correct dose. Consumption may vary depending on age, health status, breed, and husbandry system. Medicated water, milk, or milk replacer must be replaced every 24 hours. If there is no clear clinical response to treatment within 3 days, the treatment approach should be reconsidered. After the end of the medication period, the water supply system must be cleaned appropriately to avoid sub-therapeutic intake of the active substance. If individual animals show signs of a serious infection — such as significantly reduced water or feed intake — they should be treated individually by injection. Do not mix with any other veterinary medicinal product. Refer to the dispensing label and product datasheet for full dosing calculations.

1.1 g of the veterinary medicinal product corresponds to 1 g of tylosin.

Treatment durations and doses by species and indication:

Contraindications

Source: SPC Section 4.3

Do not use in animals with known hypersensitivity to tylosin or other macrolides

Do not use in cases of known resistance to tylosin or cross-resistance to other macrolides (MLS-resistance)

Do not use in animals vaccinated with tylosin-sensitive vaccines, either at the same time as, or within 1 week prior to, treatment with this product

Do not use in animals with hepatic disorders

Do not use in horses — there is a danger of inflammation of the caecum

Storage & Handling

Store in the original container to protect from light. Store below 30°C. Keep the container tightly closed. Shelf life after first opening: 3 months. Shelf life of medicated water, milk, or milk replacer: 24 hours — replace every 24 hours and discard any unconsumed preparation. Do not mix with any other veterinary medicinal product. Do not dispose of medicated water where it may be accessible to untreated animals or wildlife. Do not dispose of via wastewater; dispose of unused product in accordance with local requirements. Keep out of the sight and reach of children.

Withdrawal periods:

Important Warnings

Source: SPC Sections 4.4, 4.5, 4.7 & 4.8

Disease must be confirmed before use: The disease must be established in the herd or flock before the product is used; it must not be used in the absence of confirmed disease

Antimicrobial stewardship: Bacteriological sampling and susceptibility testing are recommended due to likely variability in tylosin susceptibility over time and by geography; under-dosing and treating for insufficient duration promote resistance and must be avoided; after treatment, the water supply system must be cleaned to prevent sub-therapeutic residue intake; official, national and regional antimicrobial policies should be observed

Acute infections: Animals with acute infections may have reduced water and feed consumption and should be treated first with a suitable injectable veterinary medicinal product; individual animals showing signs of serious infection (reduced water/feed intake) should be treated individually by injection

Medicated water access control: Do not leave or dispose of medicated water where it may be accessible to untreated animals or wildlife; ensure horses in particular cannot access any medicated water or feed

Vaccines: Do not use in animals vaccinated with tylosin-sensitive vaccines at the same time as or within 1 week of vaccination — product efficacy of the vaccine may be compromised

Drug interactions — antagonism: Lincosamides and aminoglycoside antibiotics antagonise the activity of tylosin; concurrent use should be avoided

Pregnancy, lactation and lay: Laboratory studies in mice and rats have not produced evidence of teratogenic, foetotoxic, or maternotoxic effects; however, no studies have been conducted in the target species; use only according to the benefit-risk assessment by the responsible veterinarian

Adverse reactions — pigs: Diarrhoea, pruritus, reddening of the skin, swollen vulva, rectal oedema, and rectal prolapse have been reported; all are transient and typically appear 48–72 hours after the start of treatment; no specific treatment is required but the veterinary surgeon should be informed if reactions are severe

Adverse reactions — other species: No adverse reactions established in calves, chickens, or turkeys

Human safety — Macrolide hypersensitivity: Tylosin may induce irritation; macrolides including tylosin may cause hypersensitivity (allergy) following injection, inhalation, ingestion, or contact with skin or eyes; hypersensitivity to tylosin may lead to cross-reactions to other macrolides and vice versa; allergic reactions may occasionally be serious and therefore direct contact must be avoided; do not handle this product if you are allergic to any ingredient

Human safety — Serious allergic reactions: Symptoms such as swelling of the face, lips, or eyes, or difficulty in breathing are serious and require urgent medical attention; if skin rash or other symptoms develop following exposure, seek medical advice and show the physician the warning on the packaging

Human safety — PPE required: To avoid exposure during preparation of the medicated drinking water, wear overalls, safety glasses, impervious gloves, and either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator conforming to EN140 with a filter conforming to EN143

Human safety — Skin and eye contact: In the event of accidental skin contact, wash thoroughly with soap and water; in case of accidental eye contact, flush the eyes with plenty of clean running water

Wash hands after use

Disposal: Do not dispose of via wastewater; do not leave medicated water accessible to untreated animals or wildlife; dispose of unused product in accordance with local requirements

POM-V Prescription Notice

This product is a Prescription Only Medicine — Veterinary (POM-V). It may only be supplied by a veterinary surgeon or, when prescribed by a veterinary surgeon, by a pharmacist or SQP. A valid veterinary prescription is required before this product can be dispensed.

MA Number: Vm 30282/5006